2016
“We can no longer avoid the issue of preventive medicine. This is not trivial� Mikel Arriola, Director General of the Mexican Social Security Institute (IMSS)
The year 2016 has been one of change in the Mexican public health sector, highlighted by new leadership and new policies promoting cost-effectiveness and efficiency. Mexico has continued to attract an increasing number of clinical trials and new companies, bringing fresh ideas and scientific innovation. An oncoming wave of patent expirations has further prompted medicinal innovation, with Big Pharma companies racing to discover the next big treatment while others prepare to release life-saving generics and biosimilars. But the country’s most common problems remain: obesity, diabetes and cancer are the top concerns for healthcare providers and the biggest sappers of healthcare budgets, with the public and private sectors increasingly emphasizing the importance of prevention.
The health industry transforms and advances at breakneck speed. Mexico Health Review 2016 offers important insight into the changes to the public system that have occurred over the year, the mind-blowing innovations under development and the growth opportunities the industry presents. Mexico Health Review 2016 is an essential read, packed with interviews with the most relevant industry leaders and analyses of the state of the health sector in Mexico.
ALL RIGHTS RESERVED Š Toguna, S. de R.L. de C.V., 2016. This annual publication contains material protected under International, United States and Mexican Laws and international Treaties. Any unauthorized reprint or use of this material is prohibited. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system without express written permission from Toguna S.A. de C.V. Mexico Health Review is a registered trademark. The publisher has made all reasonable efforts to provide accurate information, and the information contained in this publication is derived from sources believed to be true and accurate. However, the information in this publication should not be considered to be complete or definitive, and may contain inaccuracies or typographical errors. The publisher accepts no responsibility regarding the accuracy of information and use of such information is at your own risk. The publisher will not be liable to any party for any direct, indirect, special or other consequential damages arising out of any use of information in this publication. The publisher provides no representations or warranties, express or implied, including any implied warranties of fitness for a particular purpose, merchantability or otherwise in relation to any information provided by the publisher in this publication.
ISBN: 978-0-9968026-3-5
TABLE OF CONTENTS
1
YEAR IN REVIEW
8
CLINICAL RESEARCH
2
HEALTHCARE SYSTEM
9
INNOVATION & BIOTECH
3
BIG PHARMA
4
BRANDED GENERICS & OTC
5
MEDICAL DEVICES
12
LOGISTICS & SUPPLY CHAIN
6
DIAGNOSTICS & PREVENTION
13
MEDICAL TOURISM
7
DIGITAL HEALTH
14
DOING BUSINESS IN MEXICO & INSURANCE
10 11
AESTHETIC MEDICINE & SKINCARE
NUTRITION & WELLNESS
YEAR IN REVIEW
1
New regulations. New authorities. New opportunities. 2016 has been a year of change and advancement for Mexico’s health industry as public and private healthcare providers look for more efficiency and better processes, pharma companies look to improve and tailor their offerings, with an eye on export possibilities and fastpaced developments in areas like biotechnology, stem-cell research and minimally invasive surgery, while service providers face fresh challenges as government institutions ask for simpler solutions to increasingly difficult issues. Sector players are springing into action over Mexico’s growing obesity and diabetes epidemic, hunting for preventive strategies but also better, less costly treatment options.
State institutions, privately run foundations, regulators, NGOs, researchers, logistics companies and many others are all adding their particular expertise to improve Mexico’s health and take advantage of its welcoming business environment and new regulatory framework, as well as growing tendencies like medical tourism and digital health systems, while waiting for longer-term initiatives like the government’s Private-Public Associations (PPA) that could open new investment opportunities.
5
| CHAPTER 1: YEAR IN REVIEW 8
ANALYSIS: A Year of Deep Changes and Opportunities
10
VIEW FROM THE TOP: Julio Sánchez, COFEPRIS
12
VIEW FROM THE TOP: Armando Ahued, Minister of Health of Mexico City
14
VIEW FROM THE TOP: Gerry Eijkemans, PAHO & WHO
16
INSIGHT: Isabel Crowley, UNICEF
18
VIEW FROM THE TOP: Miguel Lombera, SMSP
19
VIEW FROM THE TOP: Marlene Llópiz, AMEIFAC
20
VIEW FROM THE TOP: Cristóbal Thompson, AMIIF
22
VIEW FROM THE TOP: José Campillo, FUNSALUD
24
VIEW FROM THE TOP: Roberto Tapia, Fundación Carlos Slim
26
INSIGHT: Laura Magaña, INSP
27
EXPERT OPINION: María Bonilla, World Bank
28
INSIGHT: Marlene Llópiz, AMEIFAC
30
EXPERT OPINION: Julia López, FENIN
31
INNOVATION SPOTLIGHT: B. Braun Aesculap’s EinsteinVision 2.0
32
EXPERT INSIGHT: José Lixa, Parque TecniA Universidad Anáhuac
32
VIEW FROM THE TOP: Saúl Ancona, SEFOTUR
7
| ANALYSIS
A YEAR OF DEEP CHANGES AND OPPORTUNITIES Mexico’s health sector is evolving into a hub of
efforts to improve third-party review processes and
innovation and quality, driven by a cost-conscious
reduce registration times this year.
private and public sector demanding better and more 8
efficient services and the determination of the country’s
Össur, a medical devices firm headquartered in Iceland,
regulatory agencies to change laws and guidelines.
is one of those betting on Mexico’s technological savvy
Standardized - and easier - compliance requirements
and closeness to large export markets. In an interview
have opened the door to controlling skyrocketing
with Mexico Health Review, Össur’s Site Director Eduardo
costs and reducing medical backlogs, a win-win for the
Salcedo says that aside from Mexican workers’ expertise,
country’s population.
labor competitiveness against manufacturers in Europe and the US are a significant factor helping to keep product
Geographical advantages have also come into play,
prices down.
especially for medical services entrepreneurs, as the country’s proximity to the US and Canada has turned
A LARGE AND DEMANDING POPULATION
medical tourism into a booming business. In the north,
Mexico’s approximately 128 million inhabitants pose a
Monterrey and Tijuana have solidified their position as
business challenge and an opportunity at the same time.
nearby destinations for travelers in need of complex
The vast country presents a complex proposition for
medical procedures at a lower price than at home but with
logistics companies to come up with new ideas to transport
the same quality, while the southern paradises of Cancun
medicines and supplies at low costs and on time, while a
and Merida on the fabled Riviera Maya are attracting
growing middle class is increasing demand for medical
more and more foreign patients with the promise of
treatments as rates of chronic conditions such as diabetes
convalescence by a Caribbean beach.
and hypertension climb. The desire for better health has also led to a rise in demand for access to facilities for
PRESENT AND FUTURE BUSINESS APPEAL
physical exercise, such as health clubs, and a strong focus
But as the number of companies on the outside looking in
on prevention by both the public and private sectors.
increases, so do the ranks of those already in the country setting up shop with an eye to turning Mexico into a base
Around 70 million Mexicans are under the care of the
of operations for endeavors such as clinical research
massive Mexican Social Security Institute (IMSS), a
facilities producing tomorrow’s treatments, large-scale
behemoth operating over 6,000 medical facilities and also
manufacturing both of patented and generic medication
responsible for the livelihood of millions of pensioners.
and cutting-edge manufacturing facilities for prostheses
Mikel Arriola, who for last year’s edition of this book was
that will help people around the world stay active to a
interviewed as the head of COFEPRIS, has taken the
more advanced age.
helm at IMSS with a firm focus on reducing costs. An overweight population of close to 70 percent of adults has
BMI Research, part of the Fitch Group, says in a report on
prompted a culture shift at IMSS to emphasize prevention,
Mexico’s health industry that the Latin American nation
with campaigns targeting changes in eating habits and
is the sixth most attractive pharmaceutical market in
promoting more active lifestyles. “We can no longer spend
the Americas, with projected medication sales of over
80 percent of our budget on 20 percent of the population
US$10 billion in 2016 and US$11.2 billion for next year,
that failed to prevent their health conditions,” Arriola says.
hovering around 0.9 percent of GDP. Mexico’s investment
“If we do nothing, by 2050 we will go from spending MX$80
promotion agency, ProMéxico, forecasts the production of
billion (US$4.2 billion) treating chronic disease to spending
medicines in the country will grow 5.2 percent between
MX$350 billion (US$18.5 billion), which is unsustainable.”
2015 and 2020. The medical devices industry shows even better potential. BMI Research sees a 2014 to 2019
Global organizations such as UNICEF have taken an active
compound annual growth rate (CAGR) of 6.3 percent for
role in helping Mexico deal with nutritional habits and also
the sector. Sales could amount to US$4.3 billion in 2016.
to address the need to help the most vulnerable sectors of
“Market competition will drive prices down and increase
society integrate and develop according to their potential,
access to the latest medical devices,” the firm says. The
looking after children and mothers and working together
Federal Commission for the Prevention of Sanitary Risks
with the authorities to accomplish internationally agreed
(COFEPRIS), it added, will help the industry through
objectives.
And while private hospitals take a large chunk of Mexico’s
and are ready for aesthetic surgery,” says Fernando
out-of-pocket medical expenditures, which represent around
García, Director General of Tijuana Bariatrics, referring
44 percent of the country’s total health expenses, they are
to patients at his specialty clinic just south of the border
also working hard to increase their service offerings in the
across from San Diego, California. The beauty market has
face of better-informed and more demanding patients who
also bloomed. According to the umbrella organization for
are taking full advantage of the Internet information age.
the cosmetic industry CANIPEC, the country has attracted over US$300 million in foreign direct investment annually
PREVENTION ON SIGHT
during the last decade.
The growing population coupled with the increase of chronic diseases has also made Mexican institutions focus
SERVICES AT THE READY
on preventive strategies to stop the spread of maladies
In a fast-moving environment, doctors and hospitals
in their tracks. Institutions like the National Institute of
cannot hope to handle things alone. After the regulatory
Cancerology (INCan) and the National Institute for Public
changes that created more pathways for development of
Health (INSP) are taking a hard look at cancer, the third
medical advances, consultants, law firms and certification
cause of death in the country, with policies like the creation
specialists have taken the lead to guide scientists, medical
of the National Tumor Bank to provide more research
practitioners and entrepreneurs through the legal system
tools for doctors, while companies are looking into more
and toward a faster deployment of modern treatments.
9
effective testing methods. One of the oldest methods of prevention, vaccination, is successfully implemented in
Medical and technology clusters are increasingly becoming
Mexico as some child vaccination rates rank above those
the vehicle of choice for hospitals, manufacturers and
of developed countries like France, with around 98 percent
others to organize and promote regional specialties
of children inoculated against measles.
and helping to come up with unified processes and accreditations that ease concerns for both patients and
AESTHETICS AND BARIATRICS BOOM
industry newcomers. State governments are seizing the
Mexico is the 10th most populous country in the world
opportunity to bring jobs and income to Mexico’s regions
but it is the third most important center for aesthetic
by actively promoting the formation of these aggregates
surgery, trailing only the US and Brazil, according to
of knowledge and innovation.
the International Society of Aesthetic Plastic Surgery (ISAPS). Mexican doctors performed over 4.8 percent of
Mexico is not without challenges. Hypertension, cancer
all surgical aesthetical procedures in the world last year.
and underage pregnancies are at high levels despite the
A relevant portion of these come paired with weight-loss
best efforts of many and the push toward a universal
related procedures such as bariatrics surgery, a specialty
healthcare system. But the sector is increasingly turning
in growing demand by medical tourists. “When a patient
into an example of how discipline, collaboration and
turns to plastic surgery it is because they have already
ingenuity can help guide patients, businesspeople and
reached a point where they have lost 30, 40, 100 kilograms
scientists toward more efficient and modern practices.
RATE OF OVERWEIGHT (percentual) OVERWEIGHT AND OBESITY RATES IN SELECTED OECD COUNTRIES (percent) 75 70
past projection
65
new data points
60 55 50 45 40 35 30 25
1972
1976
Mexico Mexico US US
1980
1984 UK
1988
Australia Australia Canada
1992
1996
2000
Canada France Italy Switzerland
2004
2008
France
2012 Korea
Switzerland
Source: OECD estimates based on national health surveys. UK and weight in Australia, Italy Korea Note: Measured height England, Korea, Mexico and USA; self-reported data in other countries.
Source: OECD estimates based on national health surveys. Note: Measured height and weight in Australia, England, Korea, Mexico and USA; self-reported data in other countries.
2016
2020
| VIEW FROM THE TOP
TECHNICAL AUTHORITY BASED ON SCIENTIFIC ANALYSIS JULIO SÁNCHEZ Commissioner of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)
10
Q: How has the current administration contributed
of specialization possible in the Americas. Secondly,
and followed up with existing policies, while creating
COFEPRIS passed the global exam on sanitary evaluation
complementary regulations to increase efficiency?
for vaccine development and manufacturing. By securing
A: Mikel Arriola’s contributions to Mexico’s health policies
these two achievements, COFEPRIS proved that a
have tremendously boosted the industry. When he first
quality management system was put in place, showing
took on the role of Commissioner in 2011, he focused on
an assessment standardization from civil servants in
reducing the registration backlog of the pharmaceutical
Mexico. There should never be different decisions made
industry. Having served as his Chief of Staff, I took on the
on equal applications, which is precisely what our quality
primary duty to improve the efficiency of certification
management systems prevent.
procurement. For example, the pharmaceutical industry accounts
for
4.5
percent
of
Mexico’s
GDP.
Each
Q:
How
will
stringent
regulations
influence
the
pharmaceutical registration for market authorization is
pharmaceutical market and new product development?
worth around MX$1 million (US$53,000). In 2011, we had a
A: The Mexican pharmaceutical industry and COFEPRIS
backlog of close to 30,000 applications.
want to offer the best possible solutions to the population. Our pharmaceutical policy is strengthened
The impact of deficient procedures on the part of the
by our presence as a technical authority whose work
country’s sanitary authority can be enormous on the
is based on scientific analysis. Our professionals have
economy. COFEPRIS’ administrative tasks and legal
science-based backgrounds that allow them to analyze
structure were not properly organized. As such, Arriola
product conditions. We create reliable, rapid, flexible
developed a strategy to minimize certification backlogs
and accessible plans for sanitary authorizations to certify
and modernize the institution’s regulations. We classified
products promptly and create incentives for new product
COFEPRIS’ shortcomings and assigned them to different
developments. COFEPRIS must also remove entry barriers
teams based on their specific nature. Although backlogs
to the Mexican market and we have harmonized our
were a major issue, modernizing our regulations was
protocols to international practices. These points have
equally important. We aimed to align and standardize
established Mexico’s pharmaceutical policies, including
our sanitary practices to those established in first world
the deregulation of certain products.
countries with prominent sanitary authorities. Thereafter, we streamlined our communication with international
There are instances when products were developed by new
organizations,
Health
technologies, giving way to new treatments with a high
Organization (PAHO) and the World Health Organization
technological background. In their natural development
(WHO). We wanted to gather information regarding
process, medical devices are changing and minimizing risk
best international practices, bringing certainty and
levels. Considering the medical device arena is filled with
predictability to our processes, while also establishing
new technologies, COFEPRIS must be aware of their origin
an efficient and rapid authorization protocol. Through
and assess the risk alignment of a specific product.
such
as
the
Pan
American
risk-based analysis, COFEPRIS could ensure quality product releases with ample efficiency, quality and safety
For example in 2012, we found that 1,800 products were no
components.
longer considered medical devices abroad but Mexico still evaluated them as sanitary liabilities. Afterward, we started
COFEPRIS
has
obtained
international
recognition.
deregulating them. The results saw 2,300 deregulated
We have secured the status of National Regulatory
products starting in 2013, reducing COFEPRIS’ regulatory
Authority Regional Reference Level IV through PAHO’s
workload by 16.2 percent. It also freed up over MX$5 billion
drugs and vaccines recognition plan, the maximum level
(US$266 million) in public resources. The most influential
change was incentivizing foreign companies to come to
In terms of medical devices, we imposed sanctions in
Mexico and commercialize their products.
2012, and by 2015, we had eliminated two tons of medical devices that were inappropriate for sale. In 2016, 300
Q: How has COFEPRIS decreased approval times more
million cigarettes and 5 million liters of alcohol were
than Japan, the US and Canada?
removed from sale due to quality issues. COFEPRIS has
A: COFEPRIS’ pharmaceutical policy of broadening
an important economic impact because we regulate
its market access was implemented after in-depth
40 cents out of each peso that is spent on medicines,
planning and strategizing. One of these strategies
beverages, food and cosmetics. If we regulate well, we
recognized previous registrations in foreign sanitary
can generate incentives for the industry to be more
institutions, such as the Food and Drug Administration
efficient and we can create a more competitive market
(FDA), Canada’s Health Products and Food Branch and
with more options.
Japan’s Pharmaceuticals and Medical Devices Evaluation Agency. As a result, COFEPRIS issues the correspondent
The sanitary authorization agencies around the world
registration of medical devices after only 30 working days.
must comply with three important mandates. The first is to
While we are seeing more medical devices in-house, we
provide authorization for products that we review in terms
still monitor them extensively. For instance, in 2015, we
of quality, safety and manufacturing practices and this
disposed of two tons of irregular medical devices that did
is done through market authorization analysis. Secondly,
not follow COFEPRIS’ lines.
we must monitor the quality of the products that are already in the market through market intelligence. Thirdly,
We have created the same equivalence scheme with
we must communicate with the public through sanitary
Europe, Canada, Australia and the US for innovative
promotion. The primary feature in the smooth running of
drugs. New molecule certifications are reduced by 60 to
any sanitary regulation authority is cooperation and we
360 days, improving Mexico’s attractiveness for foreign
want to establish a center of excellence based on the idea
laboratories. In 2011, we developed a plan to analyze all
that technical knowledge is created inside the laboratory.
pharmaceutical patents that were soon to expire and
We want to create a channel wherein all expertise is
those with a bioequivalent application. COFEPRIS aimed
shared. For this reason, COFEPRIS is creating a national
to recognize which similar drugs could be used in Mexico’s
laboratory of sanitary sciences. We will form a number
healthcare system, lowering costs and budget allocation
of strategic alliances, one of which will be with UNAM's
in the public sector. The value penetration of the generic
Faculty of Sciences and the other will be with CONACYT.
market in Mexico shifted consequently, so that in 2011, 52
This will allow us to stay up to date and share information
percent of the market was attributed to generics. In 2016,
with institutions around the world.
that number grew to 82 percent. We have moved from 36 generic substances to 491 options derived from the former. Q: How do you plan to increase restrictions and regulations of miracle products and nutritional supplements? A: We have to maintain the strictest standards in reviewing and analyzing all the products in our market so that we can ensure the patient is given access to quality products. In the last few years, so-called miracle products have caused problems because advertising regulations for these products failed to account for the fact the media was also partly responsible for advertising campaigns. Advertising of all other products was subject to regulation and we had the ability to impose sanctions for non-compliance. Essentially, there was no requirement by miracle product suppliers to demonstrate to the media that the product was legitimate. From 2012 onward, there was a significant change in terms of the way the advertising was regulated. The advertising media is now obliged to seek a permit. We were also able to impose sanctions that were 400 times more powerful than we had before. We then began to see this advertising reduced in the space of six months.
Sanctions eliminated two tons of medical devices
that were inappropriate for sale, 300 million cigarettes, and 5 million liters of alcohol due to quality issues
in 2016
11
| VIEW FROM THE TOP
HOUSE CALLS FOR THE PREGNANT AND SICK ARMANDO AHUED Minister of Health of Mexico City
12
Q: Last year we talked about maternal mortality rates
to the huge impact it is having. This year we have been
and “Médico en tu Casa”. How are things coming along?
buying vehicles and other necessary equipment. The
A: The “Médico en tu Casa” program is almost 2 years
remainder of the money will be used to employ more
old and emerged as a response to maternal and infant
doctors and nurses so we can reach more people. It will
mortality. Many had never received antenatal care. Today,
survive the budget cuts because it is part of the law in
we have more than 8,500 pregnant women who had not
Mexico City, which means it is not subject to the whims of
been to a single session of antenatal care and 40 percent
incoming ministers. It is an obligation of the government
of those had high-risk pregnancies, that is to say their
and the local institutions.
lives were at risk. Most of those were children 11-14 years old. I can now say 93 percent of those women have given
There also are many doctors that work full time in this
birth with no deaths. This is due to us going to their
program, which gives it sustainability. There are 10,000
houses and administering prenatal and antenatal care
medical students participating in the “Médico en tu
and taking them to hospital when needed. If we keep
Casa” program and there are nurses, psychologists,
waiting until emergency obstetric care is needed, many
odontologists and social workers working as trainees and
women will surely continue to die.
practitioners. It is a great force with qualified personnel and is also helping train professionals with a greater
Why do you think many women have never received
sense of solidarity and humanitarian and vocational
antenatal care when the free clinics are open from 8am
understanding. These students come from 17 universities.
to 8pm and hospitals are open 24 hours? The services
Three are public, IPN, UNAM and UAM, and 14 are private,
are free and accessible. It is because there is no health
such as La Salle, Anáhuac, ITESM, the Panamericana,
education and women are not conscious that they have
Westhill and Iberoamericana colleges. These students
to take care of themselves and go to antenatal care.
learn lessons that cannot be taught in the classroom, in
We have not educated and made people responsible
the health center or the hospital. They learn in patients’
for looking after their health and we have not taught
homes, interacting with patients. Seeing how they live
people about sexual and reproductive health. When we
becomes decisive for health. It reminds them that people’s
ask children 11-13 years old in their seventh month of
health and sickness depends on the conditions in which
pregnancy why they did not go to antenatal care, they
they live, whether they have running water, plumbing, a
say it is because they did not think about going.
refrigerator and safe water to drink in their houses.
We need to create this consciousness, avoid child and
Q: What are the main challenges in terms of implementing
teenage pregnancies and work extensively on health and
this in other cities in Mexico or internationally?
sexual health education. Through the “Médico en tu Casa”
A: It is implemented in almost nine states, it has been
program we have visited over 2.5 million homes, we have
signed in eight states: Michoacan, Sinaloa, Chihuahua,
found over 200,000 people in vulnerable conditions,
Durango, Tlaxcala, Tabasco, Chiapas and Nuevo Leon.
almost 175,000 elderly adults who cannot leave their
Jalisco has done something similar. They call it “El
homes and almost 1,900 bedridden people in terrible
Médico en tu Barrio” but it is almost the same model.
conditions.
Internationally, it has been adopted by Kuwait, Dubai and will soon be adopted by Paris, Madrid, Ukraine,
Q: What level of investment is needed for a program
China and Cuba, which already has a similar model but
such as this?
they really liked the work we were doing, Bogota and
A: This year it was priced at MX$170 million (US$9 million),
Medellin, Guatemala, Panama, Buenos Aires, Santiago de
which may seem high but in reality is not when compared
Chile, Peru, Ecuador, Dominican Republic and Costa Rica.
We have agreements in place with five US universities:
métete en cintura” (move and get yourself in shape). We
University of Philadelphia, University of Washington,
are giving zumba and physical activity classes in many
Harvard University, University of San Francisco and soon
places, we implemented squats in the Metro, the Ecobici
the University of Miami.
program, free gyms in public spaces so that people can exercise outside, we are increasing the number of indoor
Q: What has been the key to your success?
gyms, taking salt shakers out of restaurants, we are in the
A: The key has been daring to change the paradigm of
midst of reducing the sugar in sweet bread by 10 percent
medical attention, having gone to knock on doors instead
and the theme of soda in schools is highly debated
of building more hospitals because people were not
but we need parents and grandparents to participate.
reaching those hospitals either due to their condition or
They need to make children do physical activities and
because they did not want to. We dared to instigate this
move. Nowadays they only move two fingers to play
program and give it medical resources.
videogames and they do not play ballgames anymore. The city presents many opportunities, even for those
Many doctors and nurses asked me why we needed to
with less means, but parents need to seek them out and
go looking for patients in their homes. They thought it
encourage children. We are telling people how to eat a
was patronizing but they understood once they went to
balanced diet and why physical activity is important. We
houses and saw patients sprawled on beds 24/7 with no
have brigades for education and medical teaching in over
vehicle, no money to pay for a taxi and no ability to take
90 schools, giving recommendations to parents.
public transport. They saw almost 19,000 people with physical disabilities unable to leave the house. These people live and exist and were not present in the health system. There are diabetics and people with hypertension we are now monitoring. If we had not identified these patients they would have become an extra burden for the health system as they would have arrived at a hospital with a heart attack, a cardiovascular condition, advanced cancer or with diabetes that requires amputation or dialysis, or blind already. Caring for these people in their homes is the most cost-effective solution. We use generic medicine and when the doctors go to houses, they take their medicine bags directly to the patient. Q: How did this program obtain an international reach?
“We have found over 200,000 people in vulnerable conditions, almost 175,000 elderly adults that cannot leave their homes and almost 1,900 bedridden people in terrible conditions” Armando Ahued, Minister of Health of Mexico City
A: Ten doctoral Harvard students came and spent 10 days working here. Seeing our work, they uploaded it to their
I am convinced that there should be an obligatory health
social media saying, ´look at what Mexico City is doing´.
class in schools. It should be the most important subject
We then began to receive calls from health ministries
at school not because I work in health, but because there
from Guatemala, Panama and other countries that were
is nothing more important for a human than knowing how
interested in what we were doing. It is because they
the body works, how to maintain it in a healthy state and
came from such a high level of education that people
what the main risks are for your health. If we do not set
paid attention and asked how we were managing, what
a good example, how do we expect children to take care
strategies we were using to make it work. The Parisian
of themselves?
mayor was saying she wanted to implement the program for refugees, so did Madrid and a province in China for its
Q: What have been the results from the campaigns?
70 million inhabitants. This week I will be welcoming the
A: I think they have made progress, although no policies
Indian and Israeli ambassadors.
yield immediate results. We need to continue our efforts distributing information to the population. We have
Q: How is the situation of chronic degenerative diseases
already taken away salt shakers, made glasses of water
evolving in Mexico?
free and put a tax on soft drinks, which has resulted in
A: We have the most overweight children in the world
a rapid drop in the consumption of soft drinks. But no
and the second most overweight adults. This leads to
single action alone leads to long-lasting results. Many
many problems such as hypertension and diabetes and
policies need to be implemented. The government needs
we need to take action, starting with education. We
to have a wide range of offers but people need to be
have many campaigns in place, for example “muévete y
proactive.
13
| VIEW FROM THE TOP
HEALTHY CHOICES NEED INFORMED COOPERATION GERRY EIJKEMANS Representative of Pan American Health Organization (PAHO) and World Health Organization (WHO) in Mexico
14
Q: What have been the most valuable developments in
prevalence from 2009, which means not enough is being
public policy over the last few years and what remains
done. There is a lot of movement but it is not precise
to be done in the Mexican health system?
enough, not homogenous enough. Definitely, packages
A: Mexico has made significant progress in terms of
and labeling have an impact but packages alone have
health care. The creation of the Seguro Popular has
limited impact. Of course the package that says,
been important in giving access to more people.
“Smoking Kills” or with unattractive pictures can affect
Discussions are ongoing about portability, universality
a smoking decision, particularly among young women
and strengthening a model that is based on primary
about to take up smoking because of the idea of it being
care. If you look at the health situation in Mexico and
attractive or sexy. The neutral package is important but
many other countries, chronic diseases have completely
this strategy must go hand in hand with other elements.
overtaken infectious diseases. Applying tax on sugary drinks is an important step in creating a healthier
When we talk about chronic diseases, it is easy to say
population. Prevention and promotion are essential, as
people must take care of their own health. This is fine and
is the recognition that health is not created in hospitals
well if you have all the information, resources, finances
but rather at home or in the community, where people
or the choice but with those who are in a particularly
live and children go to school. Helping people make
poor situation and have very little money, their decision
healthy choices and making unhealthy products more
is shaped by the choices available. This is why the state
expensive go hand-in-hand with giving access to quality
has a very important role to play in helping people make
health services, with a focus on primary care. These are
the right healthy choice.
the big processes that are starting to have an impact on health. In general, life expectancy has increased, infant
Q: In terms of Mexico’s drive toward a universal health
mortality has decreased significantly and diseases have
system, what practices have you seen in other countries
been eliminated in Mexico. These are huge advances in
that Mexico can adopt?
public health.
A: What Mexico is doing in terms of strengthening the primary care model is very important because that is
Q: The WHO has been pushing through legislation to
where you get more value for your money, many more
neutralize cigarette packets. How do you think this will
people can be reached and you can work on prevention
impact the chronic diseases we see here in Mexico?
and promotion in a more holistic and extensive manner.
A:
several
The discussion on portability is very important as well. If
components. I think the most effective part is taxation.
you have a hospital or clinic of IMSS we should be able
If you make tobacco expensive enough, at some point
to find a mechanism to treat and receive people that do
people will stop smoking. This is a very effective tool
not have the same insurance. This is all very possible but
to create healthier habits. The second big measure
not necessarily easy. If we manage to look at groups of
is banning smoking in public places. Mexico City has
people and their risk profile and work together to treat
been at the forefront of this. There has already been
them, Mexico will be able to move forward. This is what
legislation in place for several years and here we can see
PAHO is supporting. Mexico, like many other countries,
that smoking habits are changing. At the national level, it
has built a hospital-based model that does not put
is still a challenge to get good legislation to ban smoking
enough resources and power at the local primary care
in public places in all the states. On 31 May, 2016, World
level. This model cannot deal effectively with chronic
No Tobacco Day, the National Institute of Public Health
diseases and we are failing when we wait to see the
published a study called the Global Adult Tobacco Survey
patient who comes for an amputation. This is failing the
and we do not see a significant difference in smoking
people, the economy and the health system and in the
The
strategy
on
tobacco
control
has
long run it is unaffordable. This is why the main focus
we are educating in Mexico are also important. We have
should be on primary care.
skilled specialists but too few family doctors. We are in talks with universities to see how we can ensure there
Q: How do you assess the advances in education?
will be the necessary resources to implement the primary
A: Education is definitely essential for shaping and
care strategy. First-line physicians should be equipped
changing
that
to resolve 50 to 80 percent of health issues without
on
having to refer to a hospital. The training of primary
prevention. It is in school where children will learn
care doctors must go hand-in-hand with the training of
healthy habits and hopefully take them back home.
specialists as part of a universal health strategy.
new
educational
generations.
programs
include
It
is
important
health,
focusing
We must work with teachers in schools to give children
15
the information they need. But it goes beyond chronic
Q: What do you think will be the next big development
diseases. There is a problem of teenage pregnancies
in Mexican healthcare?
and sexual education cannot wait for secondary school
A: We still do not spend enough public money on health.
when girls are becoming pregnant before even getting
Mexico spends about 3 percent of GDP on healthcare
there. Most teenagers in Mexico know they have access
and another 3 percent is private spending, mainly out-
to preventative resources but still about 50 percent of
of-pocket expenditure. Unfortunately, there are many
teenagers who are having sex do not use anything to
people who have to pay for services and cannot afford
protect themselves. So there is this big gap between
it. So there needs to be more public money in healthcare.
what they know and what they do and this gap must
Another important point is how we use money. WHO
be analyzed and understood clearly to close it. The
studies show that about 20 to 40 percent of healthcare
issue of empowering girls is also important because we
expenditure is wasted. It is important to not just see how
know they are more likely to get pregnant early if their
much money we put in but how we spend it to make it
mothers had a first child at a young age. Other issues
work effectively.
like alcohol and drug use are also part of the bigger picture of how sex is perceived. These topics need to
Those two things to strengthen the health system,
be included appropriately in the education of our youth.
together with focusing on primary care and promotion and prevention, are going to be making a very big
Q: A big danger in these rural communities is maternal
difference in Mexico. If you look at countries that have
and child health and they don’t necessarily have access
managed to create a healthier population, it is not done
to quality health services, so how does the government
exclusively through providing healthcare services, but
ensure a good quality of life for the baby and mother?
through public policies, addressing social determinants
A: There are strategies in place in Mexico with inter-
such as access to clean water, decent work and income
sectoral approaches to reduce maternal mortality, which
and quality education. These are long-term strategies
has been significantly reduced over the last 20 years
that require a social agreement between government,
but continues to be one of the biggest challenges in
private sector and the community working together
Mexico. We have made progress in expanding coverage
toward common goals.
and access to antenatal and neonatal care but we have increasing problems with the comorbidities. A pregnant woman with diabetes and hypertension has a much riskier pregnancy. We are working with the government to close the gaps beyond providing coverage and access to primary care, but also making sure that the women actually go to antenatal care. Q: One of the innovative strategies that Seguro Popular is implementing is related to E-Health and Digital Health. How do you think this is increasing coverage, especially in these rural areas? A: This is a necessary strategy and giving remote community clinics access to communicate with the rest of the country and with specialists and hospitals really helps. The digital aspect is complementary and good but only works when part of a bigger universal health and primary care strategy. The physicians and health workers
World Health Organization studies show that about 20 to 40 percent of healthcare expenditure is wasted
| INSIGHT
NO CHILD LEFT BEHIND FOR UNICEF At UNICEF we are here to support every child. It does not matter what kind of children or where they are. We focus on the 39 million children in Mexico. Of these, about 54
16
ISABEL CROWLEY
percent, about 21.4 million, are living in poverty and 4.6
UNICEF Representative
million are living in extreme poverty. So this already puts
for Mexico
the dynamic on the health factor because these children are living with less access to their right to health. Also, when you look at all the children, we know that if they are
UNICEF works depending on the capacity of the country
a girl, indigenous or if they live in a rural area, they have the
and what level of involvement the government has. So the
worst indicators in the country. This gives you an indication
type of assistance we give in Africa is not the same as in
of what we need to focus on. We are looking at the totality
Mexico. In Africa we would be implementing programs
of the children and the status we have helps to provide
with and for the government. In Mexico the capacity of
data and analyses with the Mexican government.
the government, both in resources and finances, is high in comparison to other countries although it is not equal in
Every two years since 2010 we launch a study on poverty
all the states. One tool we provide is the Situation Analysis
that highlights what we need to work on and looks at the
of Women and Children (SITAN) that we have been doing
six dimensions of rights, one of which is access to health
in eight of the poorest states for the last 2 1/2 years. There
services. We are looking at this analysis and see there is
are many dynamics that influence what happens in a state
little investment in children 0 to 5 years old, and this is a
depending if it is a rural or urban area. These studies inform
real problem because this is the basis for any future for
the government of the situation of women and children
these children. So if we are not investing in the 0 to 5 year
and the areas of opportunity where we can focus our work.
olds when we know that major brain development takes place from ages 0 to 2, we are not creating the basis or
Sometimes we do not have the resources at UNICEF to do a
environment for the future generation of Mexicans we want
national program, so we demonstrate through a pilot to the
in 15 years. Sometimes some of these things, like obesity,
government what needs to be done and implement it with
are not visible until afterward.
the government. We placed educational inserts in vaccine cards, for example. The idea is that UNICEF does it the first
These are the sort of things we do — we work with the
time and the government takes over afterward. This has
government and we highlight areas of health, education,
been our way to help prevent obesity, early infant death
protection, social security, wherever there are gaps and then
and promote breastfeeding. We believe the upcoming
we work with the government to identify which areas are
results will show positive change. We cannot say it is all
of concern and which areas we need to start working on.
thanks to UNICEF but we have definitely provided support.
For example, an area that has emerged is definitely obesity. Another is childhood pregnancies. We have children from
“If we are not investing in the 0 to 5 year olds when
10-14 years old that are becoming parents, so we are working with the government on that. We provide tools so that we can address these issues. We are also doing a national survey, which is done in over 100 countries, which provides
we know that major brain
many indicators disaggregated by gender and age. We will
development takes place
the areas where we have some gaps in information in terms
from ages 0 to 2, we are not
based on these results which will come out in September.
creating the basis for the future generation of Mexicans
look at the totality of what the survey says all over the world, of Mexico and then we’ll make proposals to the government This is the first time we have done it in Mexico despite doing it for over 20 years around the world. We also work very closely with the government to
we want in 15 years”
complete the general bill on the Rights of Children and
Isabel Crowley, UNICEF Representative for Mexico
This is a recommendation of the committee on the rights
Adolescents, which is something we are very proud of.
17
of the child and also the convention on the rights of the
important issue because it is related to many problems like
child, which Mexico signed 25 years ago. This is important
mental health and addictions.
because not only do we have the right to health very clearly defined in the law, we also helped the government bring
We also need to work hard on preventing adolescent
the law to 32 states and it is now a right in the constitution.
pregnancies, which are numerous in Mexico. These children
Now, it is not just saying the kids in this country have the
are not equipped, physically and psychologically, for having
right to health, we have to work with the government to
babies. First is prevention, then helping the girls that were
make that a reality. It took us a year to get this brought into
not able to avoid it. That means providing education, since
the states, and we have to make sure that it goes to the
they will most likely drop out of school. We try to see our
municipalities, which is where all the kids are.
work as the continuum of care. One is to prevent pregnancy in adolescents. Then we want to improve the care during
We have been working closely with the Integral Protection
pregnancy, birth and after birth because of the short and
System for Children and Adolescents, which has made a
long-term influence it has on children and mothers. We
big difference in Mexico. In the past, all departments were
want to see newborn babies with their rights because even
working in isolation. Each one was doing something for
though we have achieved the millennial development goal
children, but there wasn’t a body that coordinated all these
number 5 for lowering the under 5-years-old mortality rate,
activities and had a national plan. Now, every six months the
we see now that almost 60 percent of children that die
coordinating body sits down with the President, who is the
under 5 years old are dying in the first month of life. That
head of this Sistema, the cabinet and with the governors to
is why we start before the baby is born and then continue
discuss and approve issues that will then be brought to the
for the first five years during early child development.
states. This body really coordinates everybody’s activities
We want to help protect and help develop this kid in all
so they do not waste resources because they were not
stages of life, from the moment he or she is conceived to
talking with each other, and we can also easily identify the
adulthood. If we detect something in that cycle of life that
areas of opportunity where we still need to work. This is
is not working well, we will alert the government. We also
how we have been involved with bringing the Sistema to
find that life skills are important to teach as well. If you
the states. In these six months, we still have three states
are a parent and were not given love and attention, which
missing — Mexico City, which is on the forefront and very
is part of the early childhood development stage, you are
important for the rest of the country, State of Mexico
handicapped in cognitive and emotional ways. Also, they
and Queretaro. All the other states have established their
will not be able to give these things to their children and
coordinating bodies and are beginning to implement all the
the cycle perpetuates. About 90 percent of your brain
regulations necessary to make it a reality.
develops in the first two years of life. You can leave your baby in a corner to sleep or you can really stimulate him or
We are also looking at one area that has not been perceived
her. If you do not develop these connections in the brain in
as a health issue but is: violence. We think violence is an
the first two years, you can never catch up.
| VIEW FROM THE TOP
IMPLEMENTING PROGRAMS TO DECREASE MATERNAL MORTALITY MIGUEL LOMBERA President of the Mexican Society of Public Health (SMSP)
18
Q: What challenges does the country face in terms of
A: Interaction between the public and private sectors is
public health?
paramount. There should not be any political interest when
A: The first issue is the rate of maternal mortality in
developing these studies and public health should be the
childbirth. We need to reduce the risk especially in the
main focus. Associations like the SMSP exist for this reason,
most remote localities where the rate of teen and child
to work as an intermediary and maintain neutrality. Public
pregnancy is significant. Most of these girls, primarily
health’s mission should be to preserve health in society
indigenous, are not receiving the proper medical care or
through prevention, promotion, control, protection and
preventive education to avoid high-risk pregnancies. The
lobbying. In the family planning project, the SMSP took a
second biggest issue is that some women have very little
public sector initiative and found the resources in the private
antenatal care and that can impact the mortality rate for
sector, which is the ideal interaction from all three sides.
mothers and unborn children. A lack of family planning leads to older women entering high-risk pregnancies.
Q: If this project is replicated at a national level, how could the private sector help it come to fruition?
Q: What steps have been taken to investigate and provide
A: We collaborated with the Department of Planning and
solutions to high-risk pregnancies?
Health Development on a program called Fortalecimiento
A: The SMSP has initiated a project concerning maternal
a la Atención Médica, aimed at providing medical attention
mortality. We are focusing our efforts on preventing teen
with independent health mobile units, small vehicles in
pregnancies and helping provide proper antenatal care
which a doctor and a nurse go to remote communities to
for mothers in vulnerable groups. Such a venture requires
help the most vulnerable people. We want to collaborate
resources such as personnel, vehicles and material. We
with the ministry on this project.
carried out a beta test to intervene and educate these groups, so they may start making better decisions while
Q: What other projects relating to public health is the
still respecting their own customs. This initial test was
SMSP working on and how and when will these have an
quite successful, which led to a three-year program in
impact?
a small number of localities where we not only focused
A: We have been working on different projects; some are
on prevention and planning, but also in interacting with
having a very strong impact on our country already such
the people. For two years we have targeted 20 localities
as our vector-borne disease project. This is particularly
that have around 2,000 inhabitants in six states: Chiapas,
relevant in Mexico with diseases such as dengue, zika
Hidalgo, the State of Mexico, Oaxaca, Veracruz and Yucatan.
and chikungunya transmitted by the mosquito Aedes
We concluded that women with high-risk pregnancies
aegypti. A year and a half ago we found if the mosquito
were not experiencing proper antenatal care due to either
did not exist, neither would the illness. Today both zika
cultural issues or misinformation. We undertook a pilot
and chikungunya are public health issues. We offered the
test in Yucatan to ensure people understood the message
Ministry of Health a study to determine if the pesticide
without misconceptions. We researched the effectiveness
used for the campaigns was effective. We captured nearly
of using their local dialect instead of standardized Spanish
150,000 mosquitoes and showered them with pesticide.
and developed comic-book style material to support
After 48 hours, if the mosquito remained stationary it
educational and training efforts. The best promoters for
was most certainly dead but we found that due to the
this type of venture were local health professionals.
mosquito’s resistance to pyretrhoid the pesticide would only immobilize them and after a period of four to five
Q: As these types of efforts and campaigns require funds
hours the insect would recover. Our study proved that
the public sector cannot absorb in its entirety how can
in reality pyrethroid pesticides kill only four out of 10
the private sector help and participate in these projects?
mosquitoes.
| VIEW FROM THE TOP
TAKING MEXICO INTO THE 21ST CENTURY MARLENE LLĂ“PIZ President of the Association of Medical Specialists in the Pharmaceutical Industry (AMEIFAC)
Q: What is the new vision for this association in the 21st
Q: Given the influx of resources into the country, what are
century and what do you want to achieve with it?
the priorities for the association in terms of helping the
A: This is an association that has been around for 50 years
industry grow?
and is considering modifying its name to make it more
A: A priority is to help orient new companies when they
inclusive to other professionals in the pharmaceutical
come into Mexico. We must be sure of what we are
industry. There are not only medical specialists in the
bringing into the country. We are always searching for
pharmaceutical field but chemists, biologists, lawyers,
quality, efficient and safe drugs for our population. We
nutritionists and many others. The second thing I want
also believe in providing a strong platform for continuing
to do is to modernize the statutes, which are somewhat
education in the pharmaceutical sector.
outdated. The association has four commissions with two people in each and it states that they must be physicians. I
Q: Despite regulatory systems becoming friendlier, what
want to open it to three members per commission and have
are the obstacles to improvement?
two of them be non-medical. There is great diversity and
A: One of the main problems is dealing with government
talent in the pharmaceutical field that is not being brought
agencies because of the bureaucratic processes. The
into the association because of these outdated statutes.
simpler the government can make it without compromising restrictions, the easier it would be for our industry to
We also want to expand internationally, especially into
move forward and make drugs available to the population.
Latin America to create collaborative agreements with
COFEPRIS has done an outstanding job in listening to
other associations to share information. We are preparing
the pharmaceutical industry, collaborating closely and
large meetings for Mexico City. The first, in September
providing new platforms for moving drugs to the market
this year, is a national meeting that serves as a platform
in a shorter time span.
for COFEPRIS to discuss diverse hot topics. Next year, we will have an international meeting where we will be
Q: How do the actions of pharmaceutical companies
inviting people from North, Central and South America,
match up with the actual state of public health in Mexico?
as well as Europe and speakers from diverse fields of
A: It matches up entirely because the generic and biotech
pharmaceutical medicine. They will be instrumental
drugs are directed toward the aging and those chronic
in letting us know how their regulations are changing
diseases most prevalent in Mexico, like diabetes. But it
and new aspects on pharmaceutical medicine. The
is important to remember that problems like obesity go
pharmaceutical field has changed drastically over the past
beyond the pharmaceutical and public health reach. They
few years and I foresee that generics, biotechnological
require educational and social change as well.
products, and oncological products will be the most Q: In terms of trends and new drug development, are we
important topics for the near future.
looking more at treatment drugs or drugs that cure the Q: What are the trends in Mexican clinical research?
disease?
A: Mexico is an outstanding place to conduct clinical
A: I think the trend is more toward treating diseases because
trials because there are extremely qualified researchers
there is still a lot to be done to cure the main diseases.
with
state-of-
Science such as genetics behind cancer or vaccinations
the-art infrastructure and facilities. In the past each
against HIV are moving forward, but not as fast as we would
pharmaceutical company conducted their clinical research
like them to. The ideal scenario would be to find a cure but I
in-house whereas now the trend is to outsource this
do not think we are there yet. We are focusing on improving
service. In-house or outsourced, there will be a huge boom
quality of life by treating those that are already ill, aging or
in clinical research here in Mexico.
suffering from chronic degenerative diseases.
specific
know-how,
experience
and
19
| VIEW FROM THE TOP
HEALTHCARE DRIVES PRODUCTIVITY CRISTÓBAL THOMPSON Executive Director of the Mexican Association of the Pharmaceutical Research Industry (AMIIF)
20
Q: In light of industry trends, what has been the main
and healthcare systems in place. We believe that a healthy
focus of AMIIF over the course of the last year?
Mexico is a productive Mexico and this will also have a
A: Our main priority has always been to ensure effective
strong impact on the country’s development abroad. We
access to pharmaceutical innovation and we are doing
are working closely with other associations such as AMID,
this through an extensive approval rate with public
the Health and Wellness Council, ACROM, FUNSALUD
institutions mainly IMSS, ISSSTE and Seguro Popular.
and 25 patient associations. Last year, we established four
Only 10 percent of innovative medicines are approved
possible scenarios for Mexico ranked on attractiveness,
for use in public healthcare institutions and this must
and today the country places in the third segment. The
change, both in terms of the number of approved
optimum scenario includes access to innovation and all
medicines and speed of access. Nowadays, these
activities we are implementing at this point target that
drugs take an average of 4 1/2 years to be introduced
goal.
into public healthcare institutions, affecting patients with non communicable diseases who are unable to
Q: In the face of an ever-changing healthcare system,
receive adequate treatment. Our second priority is to
what are the main challenges you have experienced?
guarantee the highest quality standards, especially for
A: COFEPRIS and the General Health Council (CSG)
biotechnological medicines and biosimilars. We are
have made significant developments in the matter of
pleased that NOM 257 has been enforced but we still
regulations for biotechnological products and the CSG has
have to ensure the requirement standards for biosimilars
approved 65 percent of them. The low healthcare budget
are sufficient to provide patient safety. In addition,
is among the main problems the sector is facing since only
we are focusing on bringing more clinical research to
6.2 percent of the GDP is invested in healthcare in Mexico,
Mexico, for which it is necessary to update all internal
while the OECD average is 8.9 percent. Pedro Aspe, CEO
processes. At AMIIF, we greatly support all regulatory
of Evercore, compiled a comprehensive report of the
modifications COFEPRIS has implemented in recent
healthcare system and discovered that 8.8 percent of the
years but there are still opportunities for improvement
budget was spent on administrative expenses, while the
including the acceleration of clinical studies at IMSS and
OECD average for administrative expenses is 3.4 percent.
the implementation of a clinical research program at
We believe that Mexico can analyze these expenditures
ISSSTE. We are working alongside COFEPRIS to improve
and save expenditures by using that money to invest in
the regulatory environment in the country.
healthcare services directly. Our first recommendation would be for the healthcare system to identify the areas
Q: What other strategic alliances have you developed to
in which it is overspending and redirect this money to
position healthcare as key to improving productivity in
increase efficiency, hence, the healthcare budget should
Mexico?
be increased. The OECD estimates that in the next 30
A: This was among the largest shifts in our strategy.
years, the resource allocation must increase by between
There is a strong link between health and productivity
7-11 percent to satisfy growing demand.
and we are discussing this connection within several associations, including COPARMEX and CONCAMIN. We
Q: To what extent does the healthcare system in Mexico
want healthcare to become a priority for the Mexican
adopt a patient-centered approach and what can be done
government, which will allow the country to improve
to improve this?
patient outcome and fully understand the impact of health
A: The healthcare system as a whole must undergo a
on productivity. Mexico’s working population will increase
reform. There are several discussions regarding the next
in the next 10 years from 70 million to 88 million and our
steps the system must undertake. Recently, Dr. Mercedes
goal is to ensure these individuals have solid education
Juan, the director of the National Council for the Inclusion
and Development of the Disabled (CONADIS) mentioned
Q: Given the volatility of the market in the last year, what
that the government is open to discussing the Health
should we expect from the industry in terms of new
Reform, thus all the actors in the system will have to
products and M&A activities in 2016?
develop a proposal to place the patient at the center of
A: Regarding products, it is clear that innovation is at the
the conversation. This has not been done so far but it is a
forefront of the industry and we will have the opportunity
highly necessary step to improve the system. Among the
to see many new products in Mexico, including one for
problems that damage the efficiency of the healthcare
hepatitis C that can cure approximately 90 percent of
system is its fragmentation, so to increase efficiency it
patients. We also hope to have an approved medicine for
will be necessary to align the entire organization with
dengue that is undergoing registration. Several companies
the regulatory authority. Another topic to discuss is
have a strong pipeline so we will provide a forum for all
portability, which will allow the system to capitalize on its
of them to present their latest developments within our
current infrastructure.
Innovation Week. These pipelines are expected to include many biotechnology products. In terms of M&A, we saw
Q: Are you engaged in conversation with IMSS and
several in the final months of 2015 and we expect this
ISSSTE to reduce the speed with which these institutions
trend to continue throughout 2016. AMIIF’s first priority
incorporate new medicines into their basic formularies?
is to work with major employer associations. The second
A: We have continuous talks with IMSS regarding basic
is to ensure that health becomes a significant priority for
formulary registrations and one of the topics being
the government, which will allow increased efficiency and
reviewed is the implementation of new models to
eventually raise the healthcare budget. We expect that
incorporate innovation, a priority for both the government
this surge will translate into reinvestments in infrastructure
and the industry. These models can be diverse and are
and human resources, including recruiting more nurses
generally implemented after discussions between all
and doctors. Finally, we plan to work on further increasing
interested parties. One successful example is the case of
access to medicines.
Hepatitis B, despite the fact the details of each process are confidential between IMSS and each pharmaceutical company. Distribution models are also evolving mainly for specialty products as companies are identifying new ways to reach their patients more efficiently. Q: Mexico has the potential to triple clinical research investment from US$200 million to US$600 million in five years. What is the best way to achieve this? A: Clinical research funds are assigned to a country based on the needs of the multicenter study and the regulatory authority’s approval speed. COFEPRIS’ approval speed has greatly increased as approval times were reduced by 60-70 percent in the last year. It is necessary to ensure the proper authorization for these studies is received and that researchers are properly compensated. At this point, we are in the process of bringing all stakeholders together. This year, we signed an agreement with the Autonomous University of Nuevo Leon (UANL) because it has a large capacity for clinical trials. Our role in this negotiation was to ensure innovative companies were fully aware of all the services the university has to offer. UANL already has 250 protocols with several innovative companies and in April 2016 will host our Innovation Week where we will gather all service providers for clinical trials in Mexico. This includes hospitals, academia and research centers and all companies that might require these services. One of our goals is to support investment in Mexico and contribute to research in the country, which will eventually lead to its development. To do so, we are collaborating with CONACYT, ProMéxico and several healthcare institutions.
21
| VIEW FROM THE TOP
HARD-HITTING INITIATIVES TO COMBAT PRIORITY MALADIES JOSÉ CAMPILLO 22
Executive President of FUNSALUD
Q: How is FUNSALUD contributing to improve and
acting on our goals for universal healthcare. There is a clear
promote the healthcare system?
commitment to universality, but there is misunderstanding
A: Every year we refine our mission of generating scientific
surrounding what that entails. It means being able to
evidence to support public policies. Simultaneously, we
provide basic services little by little regardless of a patient’s
are an internationally recognized think tank, acting as
employment status. Employed by the private sector or the
a platform to discuss ideas and opinions. We adapt to
public sector, in the armed forces or not, everyone should
problems and opportunities as they present themselves.
be able to access a basic set of health services and have one assigned provider. To achieve this, we must finish the
President Peña Nieto’s administration has prioritized other
implementation of a registry called the Padrón Único de
industries over a profound reform of the healthcare system.
Beneficiarios (PUB). Some citizens are registered with up
A significant Energy Reform and a very complicated
to three different health providers and have private health
educational reform in which political leverage was slowly
insurance. As a result, our calculations of the amount
dwindling, took precedence. We then saw crude oil price
of resources needed are inflated. Institutions reap the
drops, and by the time the planned health reform was
benefits of patients that will never come. Improving this
due, the sociopolitical factors to support it were no longer
issue requires purifying the PUB.
present. Therefore, the Health Plan has been put on hold. We are not yet resigning ourselves to a lame duck administration
Q: How should spending on healthcare be allocated to
as we still have three years in front of us. A new and very
use resources efficiently?
experienced Minister of Health is in office and is also an
A: We are spending more than 6 percent of GDP on
expert in local political mechanisms to take effective action.
health, most of which goes toward the acquisition of
We are replanting our strategy to aid the Ministry of Health
health technology. Despite being a lot of money, it is still
with the most relevant topics in the health sector.
insufficient. We are not sure that purchases match the ideal strategy for the country. We therefore want to conduct
Q: What are the most relevant health issues and in which
studies that can help us define the technology we need.
is FUNSALUD prioritizing its participation?
Incredible technology exists, such as remote attention
A: The concerns seem to be similar to last year although
and diagnosis centers that allow experts concentrated in
we may add one or two new issues. Budgetary needs are
specialized institutions to interpret diagnosis images. We
struggling to solve problems such as chronic diseases.
do not limit the health system to the personnel onsite at
Diabetes, breast cancer, obesity and mental illness are
each hospital or clinic. Having this information available
prevalent. By 2030, a third of productive years and life
would allow every universal case file to be assessed by
expectancy lost will be due to mental illnesses. Funds ought
specialists, improving spending allocations. We need to
to be transferred to chronic degenerative diseases, for
move toward technology that can allow us to provide
which there is an attention deficit of more than 70 percent.
massive medical attention without depersonalizing it.
In addition, Dr. José Narro has identified underage
Q: What other public policy initiatives have you been
pregnancy as a serious problem. An oversight in
encouraging since last year?
campaigning for safe sex and prevention has aggravated
We are very optimistic about the Ministry of Health’s
a multitude of factors affecting our youth, who begin their
support on two initiatives that FUNSALUD proposed. We
active sex life from a very young age.
do not have a national register for cancer or chronic kidney diseases, two conditions that affect Mexicans greatly. The
Primary care is our priority and we want to call on different
lack of these numerical registries means that any strategy
sectors to adopt models of primary care that can start
we propose could be thwarted. Nevertheless, the Ministry
23
of Health has begun preliminary data-gathering and we
The UK is following Mexico’s example of a sugar and fat
should have the first results of these registries during the
tax and is already heading toward a 20 percent tax rate.
course of this year.
To what extent these disincentives can help is not known, but a tax will not be enough in Mexico. We could restrict
FUNSALUD has been carrying out studies on the integrated
expenses on food, education and transport, but sodas
cost of diabetes. We also released a study on doctors’
have become indispensable in our diet. FUNSALUD must
offices that are adjacent to pharmacies, which was highly
be at the center of the nutrition, wellbeing, and metabolic
polemic and interesting. Their increasing presence shows
syndromes discussion to reach a consensus as to how to
a problem in the public sector’s level of attention. Next,
tackle the problem appropriately. The obesity problem is
we want to measure satisfaction and attention received by
multi-factorial and we should re-evaluate our sedentary
patients to understand the trend and decide how to take
lifestyle. All technological advances are designed to avoid
advantage of this newly created infrastructure. We also
non-necessary or unwanted physical activity so we need
need to measure doctors’ ability to identify serious illnesses
to study scenarios focused on inactivity, to confront this
and to direct patients to specialized care. We know that
issue’s effect on our weight.
these offices mostly treat digestive, respiratory and skin problems as small, but necessary fixes, but in more serious
Q: Where do you see your projects in 2016?
cases we do not know if patients are receiving referrals.
A: As a foundation, we must amplify our membership base, and go beyond pharmaceutical companies. We could
We are also working with the Inter-American Development
strengthen the presence of insurance companies and
Bank (IADB) to engage important telephone companies in
hotel chains, due to the growing trend of medical tourism.
raising awareness on health issues. The initiative is called
Mexico has stumbled on a market that creates nearly
M-Salud and uses a bi-directional platform to care for
US$3.5 billion a year in revenues and has the potential to
diabetic patients. The IADB is interested in the Mexican
improve medical practices.
population due to its size, its level of development and the spread of cell phones. Moreover, given our racial and
There are two important legislative initiatives. One is the
genetic similarities, Mexico could be a springboard to the
reform on the Law of Science and Technology together
rest of Latin America.
with the Law of Responsibilities of Public Servants, which will improve the relationship between the public
Q: How did your Niño Sano y Activo program help create
and private sector for scientific research and enable new
a prevention culture around chronic diseases, particularly
support systems to be built for researchers. Scientists
diabetes?
can benefit from this in terms of discoveries, patents
A: The Niño Sano y Activo program concluded with some
and in general, but it has not been given the importance
interesting results. Obesity in children begins at home. We
it deserves. There is also a project to reform the law
have tried to tackle this problem in two distinct manners,
surrounding public health institutes, which has been the
one with the Nestlé Nutrition Foundation (NNF) and
same since 2000. As hospitals and specialized institutions
the other through a new council inside FUNSALUD that
are at the forefront of R&D, reform could have an extremely
promotes nutrition and health.
favorable impact on innovation in Mexico.
| VIEW FROM THE TOP
AWARDING OUTSTANDING CONTRIBUTIONS TO HEALTH ROBERTO TAPIA Director General of Fundación Carlos Slim
24
Q: What are the objectives of the Foundation’s national
free to train their personnel. Lastly, the implementation of
vaccine program?
a modern database will be required.
A: Many years ago our foundation, with the help of experts, evaluated the obstacles vaccine programs face
Paper records need to be substituted for digital databases.
in Latin America. It found the region is a leader when it
Mexico would be the first country in the world to adopt
comes to vaccine policies yet there is plenty of room for
a digital, en-masse system. Technology is a useful tool
improvement. The issues and recommendations became
that needs to be incorporated into health institutions.
part of the Foundation’s vaccine program. We worked hard
Adhesive chips are promoted because they can capture
to create a legal framework to strengthen the program
a child’s immunization records. The chips are connected
with the help of health authorities and the Mexican Society
to a computer or a tablet that give up-to-date information
of Public Health. The proposal has been approved by the
to vaccinators anywhere in the country. Our goal for 2018
Senate and is awaiting a response from Congress.
is to create electronic records for 3 million children. The project is being resourced by the Río Arronte Foundation
Once applied, the law will guarantee funds for vaccine
and ourselves. It is coordinated with the help of the Health
programs. Children, teenagers and adults will all benefit.
Ministry. We are pleased with the fact that it is being
Our passion is rooted in the fact that vaccines are one
implemented in communities that are mostly indigenous
of the best preventive measures that can be offered and
with the IMSS-Prospera Program and in highly populated
cutting public funds for vaccines is counterproductive.
cities. This technology has the advantage of working in
People are more at risk of becoming ill and ultimately
areas that do not have Internet access, and updates
public resources are wasted in curing preventable health
automatically when it is connected to a network.
issues. Q: How would you describe the annual awards ceremony
“The region is a leader when
the Foundation started in 2008? A: This year we had our ninth edition, where we presented
it comes to vaccine policies
our two awards. The first award is recognition of
yet there is plenty of room for
impact on a health-related area, primarily in vulnerable
improvement”
in the long run, as well as a model that can be replicated
Roberto Tapia, Director General of Fundación Carlos Slim
Latin American not-for-profit institutions that have an communities. The jury looks for sustainability and impact elsewhere, with emphasis in our region. Organizations are selected by a panel of independent judges. We received more than 140 proposals from 14 countries in 2016. This year the award was granted to TeenSmart International,
The legal framework consists of three important elements.
based in Costa Rica.
The first bans officials from cutting vaccination funds. Next, it promotes the inclusion of more qualified agents and the
Our second award is reserved for a researcher whose
training required for the latter as the administration is
work has benefited the health of the people living in the
more specialized and cannot be done by volunteers. The
Latin American region. The researcher can reside in a
program will always welcome volunteers when it comes
country outside the region but the work must be geared
to other areas but vaccinations need staff with medical
towards the region. We have had winners who are high-
knowledge. Fundación Carlos Slim also provides online
profile leaders from Europe or the US and who developed
certification courses that medical institutions can use for
strategies to improve nutrition levels.
The award represents one of the most significant amounts available for health in the Latin America region, a US$100,000 prize. Its objective is to provide economic value and enrich the selected projects. Even though the Foundation does not demand a particular use, personal use of the award is actually quite rare. Our panel finds the selection of a winner increasingly difficult each year. Dr. Rafael Lozano, a world class researcher, was awarded the prize this year. 25
Q: Why is Dr. Rafael Lozano’s research so relevant? A: The most important element of Dr. Lozano’s work includes his talent as a global leader and the knowledge he has contributed toward the burden of disease. The latter entails a measurement of how the health of population is affected in comparison to the mortality rate. It is a way to measure the number of years of life lost to preventable conditions. A teenager that passes away in a car accident would have lost 60 years of life. The accumulation of lost
Q: TeenSmart is an institution that is in touch with youth
life years can exhibit the impact of mortality not just as a
and helps them make better decisions. How did this
number but on the overall economic and social spheres of
initiative place them as a candidate for the award?
a country and its sustainability.
A: We are pleased that this year’s judges made the decision to grant this organization an award as youth are a priority
The measurement can be added to other calculations
for us. The age group is essential to the wellbeing of all
to create a clearer picture. It can include data such as
countries as they bear the responsibility as future leaders
the amount of time someone is sick and the amount of
in politics, the economy and social matters. The youth of
healthy years a person has. It can measure how much was
today are a complex result of a health focused period in
lost during a drop in health conditions. The data is meant
history that changed the paradigm of premature mortality
to standardize and describe the effects of an illness in a
of infants. The generation was born with better physical
society. The information is helpful when it comes to injuries.
conditions than previous groups, but the same cannot be
There are also different categories in the system for people
said about their mental health. Stress and a lack of proper
that become disabled in situations like paralysis. The sum
decision-making create obstacles for many youths.
of all of this data becomes the weight of an illness. TeenSmart is an important piece of the puzzle as they Dr. Lozano is one of the most relevant leaders due to
are teaching this generation to manage the pressure
his innovative work in Latin America. Mexico is one of
with values, respect and resilience, combined with
only three countries in the world that has developed
the importance of having a life plan. The organization
the methodology internally in each state; the others are
gives hope to many and guarantees a brighter future.
Great Britain and China. It has placed itself among a quite
It collected enough points to win first place due to its
selective group.
positive intervention amid the rough battles youths face in Latin America. Fundación Carlos Slim has taken this
The purpose is to improve public policy decisions. The
opportunity to link our Clikisalud.net web portal with their
country has 90 percent of its populations on public
platform.
insurance. The services are limited by fiscal resources, taxes and inputs. Consequently, efficient public health
Q: What are the Foundation’s goals for the next year?
policies and accurate information are important. Officials
A: We want to solidify our work and make sure public
can use the data to create better decisions and receive a
policies are directly helping communities. It is all part of
new perspective about the country’s reality.
a national strategy to create deep changes in Mexico. Fundación Carlos Slim is thankful for all the support it
Lozano has worked with many groups in Latin America
receives from institutions and Dr. José Narro, the Health
to expand the collection of this type of information
Minister, and his team. It has become part of the official
throughout the region. Dr. Lozano leads the research team
Mexican strategy. Our mission is to continue to achieve
and his impressive efforts have qualified him to receive the
and implement these methods into institutions and public
Fundación Carlos Slim award.
policies.
| INSIGHT
FROM REVOLUTION TO EVOLUTION: 90 YEARS OF ESPM prevention. From 1945 to 1982, the school faced important challenges resulting from complex international socio-
LAURA MAGAÑA
26
Assistant Director General
political contexts. World War II, the Cold War and different
and Isabel Vieitez, Director
armed and student movements in Latin America caused
at Mexican Institute of Public
the school to respond to foreign interests, mostly from the
Health (INSP)
US, to build a continental shield against the Axis countries (Germany, Italy and Japan) and the Soviet Union. US aid from Health for the Americas provided an opportunity
Springing from the turmoil of revolution, the School of
to enrich public health officers’ academic and scientific
Public Health of Mexico (ESPM) is a pioneering institution
backgrounds in Latin America.
that deals with an array of public health challenges. Starting as a hygiene and sanitation training center, it has
Efforts to cement a scientific foundation into health
evolved into one of the leading academic and research
professionals’ education, as indicated by the Flexner report,
schools of public health in the developing world. Since its
started to flourish with academic programs, partnerships
foundation in 1922, the first of its kind in Latin America and
with the Infectious and Tropical Disease Institute, and student
the second in the Americas, after the School of Hygiene
exchanges with counterparts in the US such as Harvard and
and Public Health at Johns Hopkins University, the ESPM
Johns Hopkins. Financial support from the US Office of the
has undergone several structural changes to respond
Coordinator of Inter-American Affairs helped Latin American
to public health issues, as well as to the national health
students train at ESPM. Mexico, alongside other countries
organizational restructuring and health education reforms.
in the region, founded the Latin-American Association of Schools of Public Health to incorporate a continental scope
The ESPM was established in response to the need for a
for public health practice. This close collaboration, alongside
health and sanitation workforce during the complex health
ideology discussions, provided the vision for modernizing
and social situation faced during the armed movements
public health practice by reaching a balance between
of the Mexican Revolution in 1910. Within the same period,
academic, research and service components.
international health education reforms were triggered by the Flexner and Welch-Rose reports and the philanthropic
During the ‘70s, there was a break in public health’s
participation of the Rockefeller foundation. This entity
modernization process because of outdated academic
established training centers to combat infectious epidemics
programs. This was the result of lost formal links with
and also constituted a key element for ESPM’s foundation.
international research and academic institutions and
In 1943, the school became the Ministry of Health’s welfare-
the reorientation of policy and health infrastructure
training center for medical doctors, nurses and sanitation
development. This trend changed in the '80s through
personnel. During its first two decades of existence,
the vision of highly qualified officials returning from
ESPM adopted a more social perspective, providing
postgraduate studies at renowned international public
technical campaigns teaching skills that promoted disease
health schools, bringing new ideas for modernization.
“The ESPM, now part of the
A major reform occurred with the creation of the National
INSP, has been key to improving
of ESPM, the Center of Public Health Research (CISP) and
Mexico’s public health
reform made INSP legally independent from the Ministry
programs and public policy by
strategically to address emerging public health challenges.
generating scientific evidence
Institute of Public Health (INSP) in 1987, through the fusion the Infectious Disease Research Center (CISEI). Additional of Health, which allowed the institute to plan more Structurally, INSP has embodied different decision-making organisms that allow it to adapt to different needs and
to orient strategic decisions”
challenges and make it accountable for its decisions.
Laura Magaña, Assistant Director General and Isabel
graduate training and continuing education programs were
Vieitez, director at Mexican Institute of Public Health
envisioned. A clear goal was set to transform the newly
(INSP)
formed INSP into a highly academic and scientifically
After the creation of the INSP, research consolidation,
qualified institution. It was intended to address burdens
facing epidemiological emergencies such as influenza in
on the health system and other emerging public health
2009, followed by cholera and zika. More than 250,000
threats following a deep analysis of the academic offering
health workers have been trained in this format. To
to identify its needs and flaws. This process also included
guarantee high academic standards and continuing
changes in the pedagogical model, incorporating the use
improvements, the INSP has been credited by the National
of information technology and communications, and the
Council for Science and Technology in 1994 and by the US
professionalization of teaching.
Council for Education in Public Health in 2006. This makes it the first institution with this accreditation outside the US.
Currently, the INSP offers more than 30 professional and research-focused degree programs. These include an M.Sc.
The ESPM, now part of the INSP, has been key to improving
in Health Systems Quality, a Ph.D. in Public Health, a Ph.D.
Mexico’s public health programs and public policy by
in Public Health Sciences, Nutrition and Environmental
generating scientific evidence to orient strategic decisions.
Health, a residency program in Preventive Medicine, as
As well as developing the workforce’s expertise through
well as certification programs. Their M.Sc. in Public Health
a wide range of degrees and continuing education
covers 10 focus areas, and the M.Sc. of Health Sciences
programs, many of the school’s courses are implemented
straddles eight areas of concentration. The institute offers
in partnership with the Ministry of Health and state-level
diverse educational formats beyond the standard school
health departments. Evidence from national health surveys
timetable and format, such as executive programs on
conducted by the INSP from 1996 to 2012, has provided
weekends and an intensive online program.
insight into different health and development challenges, from
infant
iron-deficiency
and
non
communicable
In the last 10 years, the continuing education program
diseases to the need to promote a health reform initiative
has allowed the Institute to strengthen the public health
to create universal coverage. This evidence, along with
workforce by training over 60,000 professionals. The
program evaluations, has provided essential information
development of MOOCs (Massive Online Open Courses),
for decision making in the implementation of social
has been fundamental to update the in-service workforce
programs in the country.
| EXPERT OPINION
FORTIFYING GLOBAL PRACTICES
The World Bank Group has supported and will continue to support the Mexican health system to ensure better quality and access to health services to all, and particularly to
MARÍA BONILLA
vulnerable population groups. This support is contingent
Senior Economist at
on the government’s requests. It can include not only
the World Bank
financial services but also technical assistance and analytical work, and convening services. Specifically in the health sector, the World Bank Group The health sector cannot improve health outcomes
continues to support and strengthen the monitoring and
alone. Support from sectors such as the environment,
evaluation of the National Strategy for the Prevention and
social protection, transport and education is essential.
Control of Overweight, Obesity and Diabetes. Through
Within the World Bank, the latter support is often
building awareness and through data collection, the entity
provided by other global practices and not necessarily
is providing support to the Ministry of Health’s efforts to
through the Health, Nutrition, and Population Global
fortify primary healthcare services.
Practice. This is exemplified in the World Bank’s Social Protection Global Practice, which supports the Prospera
Contingent on the government’s request, the World Bank
program, while other global practices work on the
would be happy to extend this support to other areas or
environment alongside a Cross Cutting Solution Area.
deepen the already existing support through financial
This department supports climate change issues in
services. This could also include activities that mimic the
client countries.
previous World Bank and Oaxaca partnership.
27
| INSIGHT
GLOBAL REACH EXPOSES ETHICAL ISSUES IN RESEARCH MARLENE LLÓPIZ
28
in the research trials. The potential for such exploitation
President of Mexican
is cause for a concerted effort to ensure that protections
Association of Medical
are in place for all persons who participate in international
Professionals Specialized on
clinical trials. This is heavily enforced by the regulatory
the Pharmaceutical Industry
agencies and ministries of health in all Latin American
(AMEIFAC)
countries. As a first step, in most Latin American countries research
The increasingly global nature of health research, and in
protocols are carefully reviewed by ethics committees that
particular the conduct of clinical trials involving human
may be externally contracted agencies serving as a third
subjects, and dealing with pharmaceutical drugs –
party for approving trials or as part of the hospitals/sites
whether reference drugs, biopharmaceutics, generics, or
where the trials will be conducted.
devices – has highlighted a number of ethical issues. This is especially true in those situations where researchers or
This is often followed by state or national regulatory
research sponsors from one country decide to conduct
agencies dedicated to the detailed review of all trial
research in another, in this case in Latin America. The
documents. In some countries, both state and national
research protocols might simply be one way of helping
agencies are in charge of reviewing all paperwork related
the host country address a public health problem, or they
to a clinical study. After the protocol is reviewed, the most
might reflect a research sponsor´s assessment that the
important document that follows is the informed consent
foreign location is a more convenient, cost-efficient or less
form. This special document is reviewed by several entities
troublesome site for conducting a particular clinical trial.
for the protection of the participants. In countries, such as Mexico, additional paragraphs are added to the informed
Sometimes, the hosting countries serve as sites where the
consent form detailing special law-abiding conditions, as
drugs or devices have not been marketed or the region
well as the need for two witnesses to sign when participants
serves as a zone where trial conduction is less expensive,
agree to partake in a trial. This is in addition to requiring
has a greater number of naïve patients and adequate sites,
insurance for the patients during their participation in a
as well as experienced researchers. It may also be that for
clinical study.
registration purposes in other countries, testing drugs/ devices in different regions helps companies accelerate
Inversely,
scientists
from
developing
countries
are
submissions to regulatory authorities in their home
becoming more involved as collaborators in research,
countries.
as many of their home countries have developed their capacity for technical contributions to research projects
Other studies may serve as a joint effort to address an
and for appropriate ethical review of research protocols.
important health concern faced by both parties, as in
Clear examples are researcher-initiated trials. Although
the development of vaccines due to the outbreak of an
the source of funding for such collaborative research is
epidemic or a public health issue. In these situations,
likely to continue to be the wealthier developed countries,
sponsors and hosting countries rush to solve an emerging
collaborators from developing countries are seeking to
problem that requires an immediate solution. Ethical
take part in the research enterprise. These may be through
issues should not be left aside, no matter the urgency.
international organizations, pharmaceutical sponsors or government agencies. In either direction, ethical issues
Whatever the reason, as the pace and scope of international
have to be carefully reviewed and considered.
collaborative biomedical research have increased during the past decade, long standing questions about the ethics
The current landscape of international research also
of designing, conducting and following up on international
reflects
clinical trials have re-emerged. Some of these issues have
conducted by pharmaceutical, biotechnology and medical
begun to take center stage because of the concern that
device companies. It seems as if market forces have
research conducted by scientists from more prosperous
pressured governmental institutions to become more
countries in poorer nations that are more heavily burdened
efficient in reviewing the types of clinical trials that enter
by disease may be seen as imposing ethically inappropriate
the designated countries in the conduct of research.
burdens on the host country and on those who participate
ministries of health in Latin America have become more
the
growing
importance
of
clinical
trials
29
rigid and careful in analyzing study documents. They are
by whom after their participation in a trial has ended; and
now known for taking their time in reviewing protocols,
what benefits, if any, should be made available to others in
insuring that patients are not disregarded, are carefully
the host community or country. Governments often require
guarded and cared for. Although the extent, relevance and
treatments to be continued and provided free of charge to
force of these pressures are widely debated, it is clear that
participating subjects until the patients succumb or the
such pressures can exist regardless of the funding source.
treatment is available for purchasing on the market.
Complex and important ethical concerns are likely to be
Many issues come into play when dealing with the
more pressing in clinical trials than in many other types
ethical aspects of clinical research whether sponsored
of research investigations. Other major topics addressed
by a pharmaceutical or device company or investigator
when reviewing ethical issues are the choice of research
initiated. Special consideration must be given to trials in
designs, especially in situations where a placebo control
children, in the mentally disabled, in the elderly, in the
is proposed when an established effective treatment is
blind, etc. When deciding on conducting a trial in Latin
known to exist; issues arising in the informed consent
America, careful consideration should be given to the
process in cultures whose norms of behavior differ; what
ethical issues involved in protecting participants. It is no
benefits should be provided to research participants and
different in Latin America, nor should it be.
| EXPERT OPINION
MEXICO CRUCIAL ON GLOBAL MAP OF OPPORTUNITIES companies through the organization of specific forums aiming to bring new technologies to the market. FENIN
JULIA LÓPEZ
30
Technical Consultant for
also collaborates with public R&D centers developing
the Spanish Federation
innovative initiatives in hospitals and other healthcare
of Sanitary Technology
institutions. We are certified as an internationalization
Enterprises (FENIN)
agent, helping companies to expand their business to international markets. To promote internationalization, we attend important exhibitions and congresses about the
Q: What role does the healthcare industry play in Spain
industry, including MEDICA in Düsseldorf, one of the major
and how is FENIN organized to reach the most companies
healthcare summits in the world.
in the sector? A: FENIN represents 80 percent of the total market sales
Q: How will your visit to Mexico help your Spanish
in Spain and 5 percent of the market share in Europe,
members expanding their business to America?
which is in part possible thanks to the 500 members
A: We are on a commercial mission to analyze the market
that belong to FENIN. The market for healthcare
conditions and provide an in-depth perspective to our
technologies in Spain was worth around US$7.75
clients willingness to enter or consolidate their presence in
billion (EUR$7.000 billion) in 2015, US$2.55 billion of
Mexico. So far, our agenda has consisted of visiting Mexican
which corresponded to exporting products. FENIN’s
healthcare institutions, including different hospitals. We
members include multinational companies that have
had, for instance, a meeting with the healthcare division
a strong presence in the market, as well as innovative
of the National Chamber of the Manufacturing Industry
small and medium enterprises (SMEs) manufacturing
(CANACINTRA), the innovation sector, and the Direction
and exporting healthcare products from Spain. At the
of Innovation and Technology of IMSS. We also have held
moment, SMEs represent close to 90 percent of our
meetings with the COFEPRIS, the healthcare division
membership, which is in line with the scale distribution
of PEMEX, as well as different private actors such as
found in the Spanish industrial sector. In the case of
the Hospital Español. The meeting with COFEPRIS was
multinationals, we are working with most of the main
particularly relevant as we might be able to coordinate
multinational companies of this sector, representing
the certifications provided by them with those of Spain
their medical divisions in international markets. We
to help companies entering the two markets. Mexico has
work under a vertical organization based on product
multilateral agreements established with the governments
areas due to the high level of diversification found in the
of Japan, Canada and the US, facilitating the homologation
healthcare market, now having over 500,000 references.
of sanitary certifications among the different territories.
FENIN’s administration is managed by a national board
Regrettably, Spanish companies do not enjoy these
of directors and a regional one for Catalonia, a region
benefits. Additionally, we are in talks with infrastructure
where the healthcare industry is showing buoyant
centers and associations to analyze the potential of
activity.
developing innovative infrastructure projects for the healthcare sector. For instance, we have visited Sacyr
Q: How is FENIN helping its members in Spain to move
and the Mexican Association of Specialized Healthcare
their businesses forward?
Architects (SMAES). In Spain, we are the only association
A: Our goal on an institutional level is to represent and
dealing with the industry of healthcare technologies while
defend the interest of the healthcare sector before
there are several actors working in this area in Mexico, a
national stakeholders. We help our members with legal and
situation that has also enriched our commercial mission.
regulatory aspects of the industry, as well as innovation, internationalization and sustainability issues. For instance,
Q: What crucial discoveries have you made during your
we analyze the potential impact of regulatory changes
commercial mission to Mexico and how will you apply the
in our market. At the moment, we are following the
lessons learned to your work in Spain?
advancements done in the Code of Good Practices, which
A: The similarity of COFEPRIS’s requirements with those
will avoid the direct sponsorship of healthcare professionals
of the FDA was an important aspect arising during this
to congresses, implementing the use of an external entity
mission. We have now identified the need to help our
for this purpose. Regarding innovation, we promote the
members comply with American standards as most of
collaboration
them have no experience exporting products outside
between
entrepreneurs
and
healthcare
Europe, in addition to communicating Mexico’s specific
mapping of the business opportunities around the world,
requirements that our clients need to be aware of. For
where Mexico plays a crucial position.
instance, Mexican regulations require enterprises to have local representation in the country, which must be
Q: What are the advantages that Mexico offers to
considered in the estimated costs of expanding their
international healthcare companies, and what areas
business to Mexico. We have also identified a wide range
should be improved to foster foreign investment?
of opportunities among the healthcare institutions,
A: The market size is definitely one of Mexico’s most
companies and associations that we have visited in
attractive points, for instance, the 60 million people
Mexico, particularly within the public healthcare system.
affiliated with IMSS. We have identified a strong demand
An important fact we discovered in Mexico is the lack
for imported healthcare products, offering a wide range
of local technology manufacturers, which makes it one
of business opportunities to multinational and SME
of the largest importers of these kinds of products. In
companies. Mexico’s geographical position is also highly
particular, we see interesting opportunities for companies
attractive, particularly as it shares borders with the US and
dealing with in-vitro diagnostics, chemical reagents for
has coasts on the Atlantic and Pacific oceans.However,
medical use, sterilization and medical equipment. We
the Mexican market is also fragmented and complex,
also see an important opportunity for software and
which represents important challenges for our members.
apps connected to medical equipment with the purpose
Long and complicated bureaucracy is also a challenge for
to optimize healthcare costs, as well as IT solutions for
European companies, so we see room to improve in this
remote medical consultation. Getting back to Spain, we
area. We are analyzing the best strategies to speed up
are planning to share this information with our members,
this process, which includes using a local distributor or
putting special attention on our SMEs associates. These
establishing a local subsidiary. Companies generally avoid
companies require more training and are in greater need
the use of subsidiaries as it raises costs considerably, but
of the institutional networks we have developed during
in some cases, it just makes economic sense. The public
our commercial mission in Mexico. Our objective is to be
healthcare system in Mexico is so broad that getting a slight
a facilitator agent across different levels of the healthcare
share of it is enough to assure the investment return and
market so we aim to provide our members a general
the company’s position in the market.
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31
| EXPERT INSIGHT
SOUTH A HUB FOR MEDICAL EXPERTISE JOSÉ LIXA
the southeast with amazing results in health, education and
Broker and International
safety. This has turned the city into the favorite destination
Consultant of Parque TecniA Universidad Anáhuac
of southern Mexican inhabitants to enjoy the quality services this destination offers. Every day the clinics and hospitals have inhabitants from Campeche, Quintana Roo, Tabasco,
32
There are several views on medical tourism in Mexico but
Veracruz or Chiapas who specifically come to undergo
it is important to realize that to talk about Mexico is to talk
procedures that can be ambulatory, such as dental health,
about a country with different styles and particularities.
or for more complex treatments, such as for cancer and
There are characteristics that naturally drive states toward
cardiovascular illnesses.
specific activities, be it services or industry development, agricultural activities and in some cases tourism.
Being connected with both the East and West coasts of the US, through Houston and Dallas, the proximity to Belize and
Yucatan is a state that for over a century has had a perhaps
Guatemala and the opening of direct flights from Merida
limited inclination toward industry or big companies but
to Toronto and Havana have strengthened the number
it has some of the most natural attractions in the country,
not only of holidaymakers and business travelers, but also
positioning its tourism offerings above destinations that do
medical tourists. The notable quality and training of over
not have beaches, haciendas, cultural sites or the Mayan
4,500 doctors and the infrastructure of the city has allowed
civilization that calls to foreigners so much.
it to diversify its hospitality offerings from boutique hotels to all business suites.
Unlike other states, Yucatan does not have a natural terrestrial border that would have helped patients, mostly
Before the arrival of tourists from Mexico, the east of the US
from the US, come for medical services. Still, without a doubt
and Canada, the state government launched during this six-
its capital Merida has become the most prosperous city of
year term the platform Yucatan Healthcare that has brought
| VIEW FROM THE TOP
STATE SUPPORT FOR MEDICAL TOURISM SAÚL ANCONA Minister of the Yucatan Ministry for Tourism Promotion (SEFOTUR)
Q: Why is Yucatan a prime medical tourism destination?
Q: What strategies is the state government implementing
A: Medical tourism has been developing in Yucatan for
to promote Yucatan in the US and Canada and what other
many years due to the high quality and globally competitive
markets is it primarily targeting?
hospital infrastructure and the long tradition of training
A: The strategies in place to promote the Yucatan
excellent doctors in local universities. Patients from
healthcare digital platform are reinforced by participation
nearby states such as Campeche, Chiapas, Tabasco and
in international medical tourism exhibitions that occur
Quintana Roo travel year on year to Yucatan for checkups
once a year in Canada and the US. As members of the
and various medical procedures. Yucatan receives year-
Medical Tourism Association (MTA) the platform is
round visits from abroad due to its privileged geography.
promoted in specialized reviews and on the association’s
Particularly from November to April when countries like
website. Nationally our visitors are mostly from the
the US and Canada are in winter, many visitors decide to
southeast. Internationally, they come from Belize, Canada
come to a warmer beach climate and some have medical
and the US. We also give the private hospitals of Yucatan
checkups, attracted by the lower prices and the quality of
training on obtaining the IPSC, given by the Medical
service.
Tourism Association, and the state government gives
Yucatan, its main doctors and private institutions to the
with professionals that can give globalized and personal
attention of important associations and brokers.
care and would help avoid pitfalls, generate real statistics and allow the client to have a smooth process. As a
The warm climate is an advantage to welcome tourists
broker allied with the entire value chain, without thinking
looking to escape cruel winters. Between October and April
of a patient’s limitations, I need to know exactly what his
there are communities full of Canadians in Yucatan, which
or her budget and needs are: the link between patient and
has forced surrounding clinics to improve and has created
doctors, hotel and transport arrangements, airport transfers,
clusters of health due to existing needs.
bilingual translations and 24-hour assistance and special requirements such as wheelchairs.
In 2015 the Anáhuac University Certification in Medical
33
Tourism was launched, targeting doctors, brokers and
With “Tailor-Made Yucatan”, we have succeeded in having
administrative personal in the health sector. Almost MX$10
every provider focus on their specialty and it results in a team
million (US$530,000) has been set aside from the state
of professionals that guide the patient to the best results.
budget for marketing purposes. In terms of certifications, we
Companies like Yucatan Medical Services are fundamental to
are not only counting on the JCI but are giving clinics tools to
the optimal performance of the workforce in the state and
work under Canadian accreditation. This shows the growth
the government and academic alliances have shown our
in demand and in the purchasing power patients possess to
competition that is not state-wide but international that we
migrate to other destinations for care that is available in their
have triumphed, thanks to low costs and fast response times.
cities of origin. The goal for the end of 2016 is to see a larger flow of The figure of the medical broker is paramount. In other
visitors due to the promotion and marketing carried out
industries such as real estate or construction, it is true that
and measure which were the most effective methods.
a house or apartment complex can be sold without help,
2017 should be a year of reaffirming institutions with
but the specialists that have formed around constructors
international certification and 2018 should be the year in
have professionalized the industry with fewer risks
which we see results of adjusted marketing techniques,
to clients. Similarly, the needs of patients going to an
certified care providers and economic benefits of the
unknown destination alone has bestowed the industry
secondary sector we can compare with statistics.
them 70 percent of the total cost to motivate clinics to
the Accreditation Canada International, based on the
obtain certification. Private clinics have also received help
prestigious Canadian healthcare model.
in obtaining an “M” distinction from the Programa de Calidad Moderniza and “H” from the Programa de Manejo
Q: What impact will we see on the country’s foreign
Higiénico de los Alimentos.
investment, capital retention and GDP from medical tourism inflows?
Q: How will medical tourism contribute to a shift in the
A: Medical tourism could have a strong and positive impact
perception of Mexico and what are the main challenges?
on the country. The diversification of products and services
A: According to Patients Beyond Borders, in 2014 Mexico
that a country offers is the key for a strong economy.
was the second country globally for medical tourism. An
Medical tourism has an extensive value chain because the
increasing number of visitors are seeing the country’s
distribution of capital inflows is not concentrated on a
potential as a medical destination as in the last few
small group of actors. The benefits medical tourism brings
years more clusters have been created, generating more
will increase in Yucatan with the arrival of private hospitals
competiveness. Security is a key factor that has positioned
and the implementation of international certification.
us so highly internationally and within the country. Changing the exterior perception of Mexico remains a goal.
Q: What are the state’s plans for 2016? A: In 2016, Yucatan Healthcare will participate in two
Several renowned hospitals have seen the potential of
international exhibitions focused on medical tourism. One
having a presence in Yucatan. The new Faro del Mayab
is “Destination Health” in September in Ottawa. The second
de la Red Médica Sur hospital will have JCI certification,
is in Washington, D.C. also in September and is organized
which will raise the competitiveness of the state and will
by the Medical Tourism Association. In both events we
attract more foreign patients, who have expectations
will meet with companies interested in medical tourism to
of high quality and know the prestige such certification
create agreements of mutual benefit so patients can travel
entails. Some hospitals are also working on obtaining
to Yucatan to undergo medical procedures.
2
HEALTHCARE SYSTEM
With multiple budget cuts to the health sector over the year, the public healthcare system is increasingly working in partnership with private institutions to maintain quality of care. Healthcare expenditure in 2015 fell to 5.9 percent of GDP from a high of 6.2 percent in 2010, according to the OECD. This is one of the lowest rates among OECD countries. There have been shifts during the year. Mikel Arriola moved to IMSS from COFEPRIS, Julio Sánchez took over COFEPRIS and respected academic José Narro became Minister of Health. Public social security institutions made great advances over the past year in decreasing waiting times for patients, reducing the backlog of operations and reducing costs through consolidated purchases. As of this year, they will actively minimize duplication among IMSS, ISSSTE and Seguro Popular. Many also stress the importance of reducing the burden on the secondary and tertiary levels of healthcare through improved prevention and early diagnosis. Public institutions are implementing preventive campaigns such as “Chécate, Mídete, Muévete” to improve public health and curb the epidemic of
chronic diseases like diabetes and hypertension clogging hospitals and clinics. This chapter reviews the public system’s efforts to cover a larger number of people more effectively and the role the private sector plays.
35
37
| CHAPTER 2: HEALTHCARE SYSTEM 38
VIEW FROM THE TOP: Mikel Arriola, IMSS
40
VIEW FROM THE TOP: Gabriel O’Shea, Seguro Popular
42
VIEW FROM THE TOP: Armando Ahued, Minister of Health of Mexico City
44
VIEW FROM THE TOP: Germán Fajardo, UNAM
46
VIEW FROM THE TOP: César Athié, Hospital General de México
48
VIEW FROM THE TOP: Alejandro Alfonso, ABC Hospitals & Association of Private Hospitals
50
MEXICAN HOSPITAL STATISTICS
51
VIEW FROM THE TOP: Javier Aluni, Hospitaria
54
VIEW FROM THE TOP: Francisco Villarreal, Swiss Hospital
55
VIEW FROM THE TOP: Roberto Bonilla, Hospital San Ángel Inn
56
VIEW FROM THE TOP: Arturo Martínez, Hospital Galenia
Olivia Laviada, Hospital Galenia
57
VIEW FROM THE TOP: Luis Navarrete, Clínica de Mérida
58
VIEW FROM THE TOP: Roberto Sosa, CODY
59
VIEW FROM THE TOP: Ricardo Bojalil, ASMED
| VIEW FROM THE TOP
PROMOTING EFFICIENCY THROUGHOUT IMSS MIKEL ARRIOLA Director General of IMSS 38
Q: During your tenure as COFEPRIS Commissioner
such as the Unifila program, now adopted by 46 percent
you drove an agenda of simplification of bureaucratic
of our hospitals, so that people who arrive without an
procedures and digitalization. How do you bring those
appointment don’t have to wait at least a day as before, but
subjects to a much larger institution like IMSS?
can be in front of a healthcare professional in less than an
A: One of the main aims of our strategy at IMSS is deregulation
hour. Another problem was appointments with doctors on
toward increased efficiency, both in medical services and the
the second level of care, which had taken up to four days
economic services related to the pensions system, such as
and now takes half an hour in 60 percent of our hospitals.
retirement and disability. We tend to 70 million people, more than half the country. Regarding deregulation, we provide
We also had a hospitalization bottleneck because it took
medical and social security services to around 1 million
24 hours to ready a bed for a new patient after the last
people daily and back in 2012 all bureaucratic procedures
one left and now it takes only eight, increasing availability.
had to be done in person, at an annual cost of about
We have implemented this new procedure in 46 percent
MX$3.0 billion (US$158.7 million). From 2013 at the behest
of our hospitals. We also had to reduce a backlog of about
of President Enrique Peña Nieto, IMSS started changing to
8,700 surgeries but since mid-April we started using
a digital platform called IMSS Digital and now 72 percent
surgical theaters on weekends, adding around 200 more
of the 25 formal procedures we review are done digitally,
surgical procedures per weekend. We have performed
meaning that in the last three years we have served 80
2,237 programmed surgeries on weekends.
million procedures in a digital manner, saving around MX$2.5 billion (US$132.3 million). We aim to close this administration
Another
in 2018 with 35 million digital procedures a year and nearly
prescription. Whereas before a patient with a chronic
zero done in person. This includes everything from proof-of-
illness had to attend a medical consultation once a month
life certification for pensioners to employee registration and
to fill out his or her prescription, after a medical-risk
from day-care registration for toddlers to maternity leave
evaluation we were able to determine nine treatments
registration for pregnant women.
where we could fill prescriptions quarterly, saving 8 million
subject
we
attacked
was
chronic-patient
consultations a year. Q: In terms of health services, how much has IMSS advanced on easing procedures and digitalization?
We are also trying new protocols in 44 percent of our
A: We operate about 6,000 medical facilities, we are
hospitals for triage in emergency situations to properly
the largest healthcare provider in Latin America with
and efficiently classify patients according to the urgency
a capacity for 500,000 medical consultations, 6,000
level. In 12 facilities for example, we have implemented a
surgical procedures and 1,070 daily births, around 30,000
protocol for heart attack patients, called Código Infarto,
beds, 36 third-level hospitals, including 25 specialty units
that has reduced the treatment time from the first early
and 350 second-level hospitals. We are also dealing with
symptoms to when a stent is put in to half an hour from
an increase in chronic diseases like diabetes, cancer and
three hours. That has cut mortality rates by 60 percent.
hypertension and heart disease. These patients represent 20 percent of our affiliated population but demand 80
Q: According to the OECD, IMSS receives far less financing
percent of our budget for preventable diseases which
from the system’s final users than in other countries in the
were not prevented.
group. How has IMSS learned to work around this deficit? A: The OECD provides data but what needs to be compared
We are looking to modernize bureaucratic procedures. We
is the tax burden in terms of salary for affiliates. After doing
cannot forgo face-to-face consultations but on the primary-
that you can say the current burden is acceptable. If by
care level we have since March put in place new procedures,
increasing the burden we affect the size of the workforce,
39
we would have a serious problem. We need more jobs.
Q: Another important cost-cutting strategy goes through
That is what helps in the end in terms of financial terms
preventive care, as with campaigns like the “Chécate,
for IMSS. The 2.04 million jobs created in the three years
Mídete, Muévete.” But what other efforts are being made
and seven months to July 2016 have helped increase IMSS
to reduce costs tending to illnesses like diabetes?
intake by 26 percent, some MX$50 billion (US$2.6 billion).
A: We can no longer avoid the issue of preventive medicine. This is not trivial. We need to stop the encroachment of
IMSS has two main financial pressures. Firstly, the pensions
chronic diseases. At IMSS we are working on a concrete
from the old retirement system that was modified in
policy to correct two big flaws of our health system,
1997 and are fully funded by the State. That creates a
which are detection and control. We are working on a new
financial burden of MX$2.0 trillion (US$105.8 billion),
model for community family health units with the ability
close to 10 percent of Mexico’s GDP, with 10 percent
to lead youths toward better habits, with metrics we can
annual growth, causing payments of about MX$70 billion
track to detect diabetes and hypertension and also breast
(US$3.7 billion) every year. Secondly, the epidemiological
and prostate cancer, and to treat adults with early stage
and demographic transition the Mexican population is
diabetes and hypertension. This will be our turning point
undergoing creates financial pressures on IMSS to provide
to get from curing a disease to preventing it. We can no
medical services.
longer spend 80 percent of our budget on 20 percent of the population that failed to prevent their health condition.
In the last three years we have reduced the IMSS deficit by
If we do nothing, by 2050 we will go from spending
60 percent and now sport a fiscal surplus, which means we
MX$80 billion (US$4.2 billion) treating chronic disease
have been able to pay for pensions and medical services.
to spending MX$350 billion (US$18.5 billion), which is unsustainable.
Q: Regarding costs, the possibility of having PPPs building hospitals has been increasingly in the spotlight.
Q: What fallout has IMSS had to deal with after this year’s
Is IMSS involved in this at all?
budget cuts?
A: What IMSS has done is to take advantage of this
A: We are an independent government entity with our
new legislation to facilitate the construction of new
own resources coming from taxation and contributions by
infrastructure, clearly without medical care being in the
employers. We are not affected by budget cuts, but that
hands of the private sector at any point. That is a legal
is not an excuse not to be more efficient. This year we
impossibility. We are having facilities built at a faster pace,
are committing to fiscal savings of MX$7.0 billion (US$370
more efficiently and without the hurdles associated with
million). We started to consolidate medical supplies
direct public investment. We have had bidding processes
purchasing, we have also had savings in medical services
for four hospitals. We are looking to be more efficient. We
such as tests and also promoting competition via bidding
want to build more hospitals with less money, we have
processes for procedures like dialysis that has led to
MX$20 billion (US$1.06 billion) to build 12 hospitals and
savings of around MX$7.0 billion (US$370 million) annually
four of those will be through PPPs.
for the last three years, with a similar goal for 2016.
| VIEW FROM THE TOP
PUTTING THE SPOTLIGHT ON PEOPLE NOT PROCESS GABRIEL O’SHEA National Commissioner of Seguro Popular 40
Q: Since the introduction of Seguro Popular, what
Q: How will you balance the budget cut and Seguro
have been the changes you have witnessed in Mexico’s
Popular’s announcement of increased coverage to
healthcare sector?
ensure you still provide quality healthcare to Mexicans?
A: Over the past 14 years we have managed to cut
A: We are constantly working to include more illnesses
out-of-pocket spending by 11 points, down from 55.7
into the Universal Health Services Catalog (CAUSES)
in 2003 to 44.7 in 2013. Although the system is young,
directory, or to increase access to the Catastrophic
this profound effect shows we are certainly on the
Expenses Fund. Ovarian cancer was recently included
right path. We have also witnessed an epidemiological
because
transition. The incidence of infectious and transmittable
interventions, which include the most expensive illnesses,
diseases has been reduced while there is an increased
with MX$12 billion (US$ 600 million) in funding. In the
prevalence of chronic degenerative diseases usually
three years I have been at Seguro Popular I have removed
found in developed countries. Now Mexicans live longer,
cataracts from this Catastrophic Expenses Fund because
they have an average lifespan of 75 years which presents
this does not qualify as a catastrophe, whereas ovarian
greater challenges and costs to the healthcare system,
cancer requires a great deal of money to treat.
the
Catastrophic
Expenses
Fund
has
61
because they can develop conditions such as diabetes mellitus, entailing dialysis, hemodialysis and amputation.
At the moment, we have 82,000 patients with HIV with access to the Catastrophic Expenses Fund in which we
Q: These diseases are largely due to Mexico’s retroactive
invest approximately one quarter of the total budget.
approach to healthcare, so how are you changing the
Each of these patients costs roughly MX$39,500
system to implement a more preventive approach to
(US$2,000 ) per year and these are costs that are
medicine?
catastrophic for patients. The removal of cataracts from
A: Of the 57 million Mexicans affiliated with our system,
CAUSES freed an extra budget of MX$1 billion (US$50
about half are given an initial clinical assessment in which
million), which allowed the addition of ovarian cancer
we examine several factors such as hereditary illnesses
to the register and allows us to treat on average 3,364
and probability of contracting certain conditions. We
patients each year. We do not receive more money to
then implement regular testing to detect any potential
incorporate more treatments into CAUSES, but we are
illnesses if red flags are raised. If a condition cannot be
constantly evaluating the value of those treatments that
prevented as is the case with hereditary diabetes, we
are incorporated. I would like to increase the maximum
use the clinical assessment program as a way to control
age of coverage of acute myocardial infarction from 60
the symptoms. Seguro Popular’s budget for 2016 is a
to 65 years old.
little over MX$77 billion (US$4.1 billion), 20 percent of which is allocated to preventive medicine. This involves
Q:
screening for breast cancer, cervical cancer, and control
impacted budgetary restrictions?
How
have
consolidated
purchasing
strategies
of obesity. If I could, I would dedicate the entire Seguro
A: The system has great merits and has significantly
Popular budget to primary points of care to emphasize
changed the healthcare system. While some states buy
the benefits of preventive medicine. Primary points of
aspirin for MX$5 (US$0.27), others can purchase at MX$1
care deal with 80 percent of the illnesses Mexicans suffer
(US$0.05) or even MX$0.5 (US$0.02). Making a large
from, whereas only 20 percent of the illnesses are seen
consolidated purchase means costs will be reduced. This
at secondary and tertiary points. In the next few years
system works very well. In 2014, we saved MX$3.7 billion
Seguro Popular will focus on the quality of medical care
(US$198 million) in the purchase of medication. In 2015,
at primary points of care. We aim to refurbish 2,500
we saved MX$4.5 billion (US$241 million). These savings
health centers in the next two years.
can now be used in other ways.
Q: How is Seguro Popular helping to change the system
and Sinaloa, and although this is expensive, it is easier
to focus more on people rather than processes?
than relocating medical professionals to remote areas.
A: According to the OECD, Mexico is the country with the most administrative processes for its healthcare system
Q: With IMSS, ISSSTE, and Seguro Popular, there is
in the world. We are paying a great deal of administrators
a great deal of duplicated coverage. How are the
while facing a shortage of doctors and nurses. It is
organizations working to eliminate this?
difficult to change this process and it is happening
A: Of the 57 million Mexicans we cover, 4.7 million currently
because of the ease of administrators recruitment. We
have IMSS coverage too. Both government institutions
are committed to reducing administrative costs and
must pay for treatments, doubling the cost. These 4.7
increasing the number of doctors and nurses employed
million affiliates will be reduced by 1.5 million this year,
by Seguro Popular.
followed by a further 1.5 million the subsequent year. This situation arose because we never had an updated register
It is very clear how Seguro Popular’s budget should
before, but now when affiliates renew their policy after
be distributed, with 40 percent destined for medical
three years, we receive a notification if they are already
personnel, 20 percent for preventive medicine, 30
registered with IMSS or ISSSTE. This will prevent affiliates
percent on medications and 6 percent allocated to the
from renewing their Seguro Popular policies.
offices in each state. But in many states more of the budget is spent on administration and less on medical professionals.
“We do not want to privatize
We are working on this problem and we are in discussions
healthcare in Mexico but make
with each state to convince them to increase the number of medical professionals in their hospitals. We have opened an account at the Ministry of Finance for each state in which we deposit their respective budgets. After making purchases, each state will then approach the Ministry of Finance with their receipts to be reimbursed
it more accessible to more people” Gabriel O’Shea, National Commissioner of Seguro Popular
from their nominated account. This avoids misdirection of funds, and there is much more accountability in terms
Q: What is the future for Mexican healthcare, and what
of payments.
role will Seguro Popular play in a higher quality of life for the population?
Q: With the need to extend coverage to the most remote
A: A few months ago President Peña Nieto spoke of the
and rural areas, how are you incentivizing medical
beginning of a universal healthcare system in Mexico,
professionals to work in isolated regions?
starting with an exchange of services between IMSS,
A: It is difficult to create incentives for doctors who have
ISSSTE, and Seguro Popular. We do not want to privatize
studied for half their lives to work in a rural community
healthcare in Mexico but make it available to more people.
and be paid MX$24,000 (US$1,300) per month. When
The exchange of services will mean that patients will
I discussed the issue with the Ministry of Health, we
not have to be flown to the other side of the country for
arrived at the conclusion that municipal governments
treatment with a certain expensive piece of equipment.
should be obligated to offer these professionals an extra
Rather, each institution will be able to access the technology
MX$5,000 (US$270) per month and they would help the
possessed by the others, cutting costs of treatment and
doctor find a house, for which the community would pay
travel. This raises the question of how this exchange will
half the rent.
be possible since these services are all saturated, but we should really all be thinking about what we can offer. For
Seguro Popular has invested in mobile clinics, in which
example, Seguro Popular could cover cataract removal
doctors rotate, traveling to various rural locations over
for the entire State of Mexico, and IMSS could cover heart
the course of a week to provide treatment. In the State of
surgeries, and each agency would reimburse the other.
Mexico there are certain areas that are difficult to reach, so we bought medical robots equipped with cutting edge
The main problem will be in harmonizing prices as
technology at a cost of MX$20 million (US$1.07 million)
procedures cost a different amount in each agency. This
each. With telemedicine, it only takes one specialist to
is simply the beginning of a universal healthcare system.
consult with patients through the robot’s screen, and
We will reinforce infrastructure at the primary points
this can be done from anywhere in the country. This
of care and focus on providing clinics with the correct
robots are located in various states such as Zacatecas
equipment and staff.
41
| VIEW FROM THE TOP
CARE IN MEXICO’S LARGEST METROPOLIS ARMANDO AHUED Minister of Health of Mexico City 42
Q: What have you seen in terms of private investment in
Q: This year we have seen a new COFEPRIS regulation
the health sector in Mexico City this year?
that incentivizes research and development in Mexico.
A: Very important advances have been made. The
What can the public sector do to attract more investment
Regional General Hospital of Iztapalapa is almost
for Mexican development?
finished. Since 1985 this hospital had been unable
A: In Mexico, we have important institutions such as UNAM
to keep up with the demand in Iztapalapa and its
and the IPN that develop new technologies and medicines
equipment could not be modernized. It was necessary
and that make us attractive for these investments. I think
to throw everything out and start from scratch. The
one of the main development opportunities in Mexico
second HIV/AIDS clinic in Iztapalapa is spectacular. The
City is the study of the impact of pharma economy,
existing clinic in Condesa was overrun by demand so
pharma vigilance, new processes and new technological
a second, ambulatory clinic was urgently needed. It is
therapies. I would say the public sector is carrying out
now in operation and running smoothly and this model
research on the same high level as private institutions.
will be replicated in Latin America. I was invited to a UN
We have people with high capabilities such as engineers,
HIV event in New York, where Mexico City received an
biomedics and medical specialists, we have patients and
award for its work in HIV/AIDS. We also built the first
beds and all the technology necessary to evaluate the
clinic for autism and in a few months we will finish the
results. It becomes very attractive to those who do R&D
first geriatrics clinic, and a second diabetes clinic. The
as there are facilities in place.
first public veterinary hospital in both Mexico and Latin America is remarkable as it safeguards the health of pets
Q: What has the impact of the cooperation between
and also human conditions caused by animals. We are
IMSS and the Ministry of Health been?
also building the hospital that will replace one damaged
A: Mexico City's Ministry of Health has instigated
by an explosion. In total, over a dozen health centers are
cooperation among the states. There are now regional
being renovated or built.
and metropolitan actions for which we are designing coordinated health policies, among the entire public
Q: What is your plan for the coming year?
health sector. We have made great advances on linking
A: We are being conservative as there has been a budget
the public health sector of the country.
cut of 300 million pesos (US$16.3 million) for the city and the Seguro Popular and a further cut of 6.0 billion
Q: We are now seeing a tendency of registering generics.
pesos (US$325 million) to the health sector has just
What benefits will this have?
been announced. Because of this, it will be difficult to
A: Generics are a wonderful means of providing quality
begin new projects. Most probably we will focus on
in medical attention and making it more accessible. We
maintenance, new equipment and continue to give
buy medicine in consolidation with IMSS and we buy
medical attention to those who need it. We will not be
generics. We treat 22 million people and it works very
thinking of growth in our infrastructure but on the quality
well. We are giving high-quality care and I believe this
of patient care. The recruitment of doctors and nurses
is the way to ease the high cost of medicine. Medicine
will also be affected but there will not be any job cuts
is increasingly effective but costly, which renders certain
as we are using fiscal resources from the city to ensure
medicines unaffordable for the public sector as the
no one has to leave. Medicine is an area to which cuts
budget can’t withstand it. Treatment for Hepatitis C can
cannot be applied. In Mexico City there are 135 clinics,
cost up to MX$1 million (US$54,000). The development
32 hospitals and 12 subway clinics. We employ 37,000
of generics is one of the great possibilities of medicine
people and see 22 million patients per year, so not a
reaching the masses, more so in a system where people
single aspirin can be cut.
do not pay out-of-pocket and receive medicine for free.
Q: What is being done about the lack of quality
We are promoting campaigns to prevent water from
treatment received in some doctors’ offices associated
accumulating. Mosquitoes breed in clean water, not
with generics’ pharmacies?
dirty water, so if people have pots and watering cans
A: COFEPRIS and the agencies of patient protection are
in their gardens and water gathers, that is where the
working on this. We are checking that doctors do not
mosquito reproduces. We need people to act and throw
prescribe medicines just for the sake of it, but according
things away. Many actions do not depend solely on the
to ethics. We need to continue to work on this without
government and alone we cannot control everything.
a doubt. Fundamentally, everyone should be seeing to the health and wellbeing of the patient. We can continue
Q: What is the public sector implementing in terms of
to do what we are doing, inspecting, observing the
new technologies that help develop the health sector?
actions of the doctors and making sure that they are not
A: We are advancing. Here in the Ministry of Health
profiting from patients.
we implemented the System for Medical and Hospital Administration and electronic patient records. We
Q: How can the private sector help the public sector?
are already working with video-medicine or video-
What can they bring?
consultations, electrocardiograms and respirometers.
A: We need to continue with the present synergy. There
We have 140 electrocardiographs in the city. An
are companies such as SANOFI that have helped us
electrocardiogram is sent automatically to the National
educate children on eating, diabetes and hypertension.
Institute of Cardiology, then the cardiologist reviews
We have just vaccinated 40,000 children against
it and sends instructions to the doctor in the medical
the human papilloma virus and they are studying the
center. They know what medicine to start with and what
impact of this, they supported us with the costs of the
medicine they need to buy. Heart attacks need to be
vaccination to make it possible. Bayer and many others
treated within the first hour. This gives the patient an 80
have approached us. They are our allies. Working with
percent chance of surviving.
the private sector presents many opportunities to study impacts and implement new strategies.
We have 70 respirometers connected to the National Institute of Respiratory Diseases, and molecular biology
Q: What about seasonal illnesses and viruses like zika
laboratories. We are close to seeing a laboratory for
and chikungunya?
detection of epidemiological diseases. We have MRI
A: We tell people we are in a period of gastroenteritis:
machines,
do not eat in the street, wash your hands, do not self-
equipment. We are implementing technology but we are
medicate. In October, we will start vaccinating against
limited by our resources.
tomography
machines,
and
other
new
influenza. There is a vaccine, it is free and people need to come and get it. We do not have a problem with any of the three mosquito-borne diseases, dengue fever, zika virus and chikungunya in Mexico City, because the aedes aegypti mosquito can only live in altitudes up to 1,700 meters above sea level and Mexico City sits above 2,200 meters. The most common form of dengue is not fatal. It is inconvenient, causes pain and there is no treatment. All that can be done is to protect oneself against mosquitoes. Secondly, chikungunya does not kill. Again, it causes pains but is not lethal. As for zika, eight out of 10 patients do not even present symptoms. It is most dangerous during pregnancies due to microcephaly. Q: What is the Ministry of Health doing to control these epidemics? A: We are doing what we can, but people travel and go to places where the mosquito is present and risk being infected. We are carrying out campaigns to warn people to protect themselves, to watch where children go and to sleep with a mosquito net, but it is not easy.
Mexico City has 135 clinics, 32 hospitals and 12 subway clinics, employing
about 37,000 personnel and caring for 22 million people every year
43
| VIEW FROM THE TOP
INFORMED PEOPLE CAN ACT AS HEALTH BRIGADE GERMÁN FAJARDO Medical Faculty Director of Universidad Nacional Autónoma de México (UNAM) 44
Q: What have been the most important developments the
strengthened by the new minister. Our country needs to
health sector has witnessed in 2016?
go from being a research consumer to a research producer,
A: Probably, the most important development the health
focusing on the needs of the Mexican population. Research
sector witnessed in the last year were the leadership
protocols, patent registration and development of clinical
changes in the three most important health federal
products need to increase. Publication efforts are not
institutions. The Ministry of Health, the IMSS and ISSSTE
enough. They need to be transformed into concrete
renewed their leadership, which suggests interesting
solutions.
changes in the health arena. AMIIF and COFEPRIS have played an important role in the The appointment of Dr. José Narro to the Ministry of
development of research. AMIIF has done a fine job in the
Health is particularly important since he is working to
past years increasing their membership to several new
resume the universal health approach Mexico is supposed
organizations and approaching health institutions for joint
to be looking for, a task that had long been neglected.
efforts, while COFEPRIS has named several universities
Unfortunately, sometimes people cannot be treated in the
and national institutes as third authorized research
nearest hospitals because those are not included in their
parties, which means they do not require the same
health coverage, forcing them to travel long distances to
amount of paperwork other institutions need for research
find a hospital that is included. The proposed changes are
protocols. UNAM’s School of Medicine is also committing
based on the exchange of services, meaning that federal
to expanding medical research by offering two degrees
and local institutions will work together to offer the best
focused on biomedical and clinical research.
possible services to citizens and that patients will be redirected to the clinics that best suit their conditions.
Q: Will the restoration of US-Cuban relations have an
That is our goal, opening the possibility for people to
impact on Mexico’s medical tourism industry?
access any government-funded hospital, regardless of
A: Cuba has high quality public health services and is
their health coverage specifics.
excelling in epidemiology programs and life-expectancy rates. But medical tourists are drawn to a different kind
The IMSS director is also focused on tackling problems
of medical services’ offering, an offering in which Mexico
ignored by his predecessors. For many years, high-school
is highly competitive. But medical tourism is more related
students and higher education students in public schools
to private-sector efforts rather than a government
have had access to IMSS’ services. Even though it is an
objective. Mexican authorities can help medical tourism
official disposition, many students do not possess a social
by guaranteeing the quality of the infrastructure, the
security number that would allow them access to IMSS’
hospitals, specialized clinics and doctors that focus on a
services. The IMSS’ new director is pushing an agenda
specific line of business.
that will allow all public education students to have a social security number. Young people accessing IMSS
Q: How do prevention campaigns contribute to the
services would automatically have access to programs
solution of public health threats?
such as PrevenIMSS or JuvenIMSS, contributing to the
A: One of Mexico’s biggest problems regarding public
consolidation of prevention culture.
health is the lack of prevention. Several conditions Mexicans suffer from can be easily prevented with changes
Q: How has the medical research field evolved in Mexico
in our lifestyle. Therefore our country needs to work on
over the past years?
prevention campaigns and efficient communication plans
A: The medical research field in Mexico has developed
that could help prevent many diseases. A good example
positively over the past few years. However, it needs to be
of this is the “Chécate, Mídete, Muévete” campaign IMSS
has been working on. I do not know if obesity rates have
population rather than waiting for the population to reach
decreased, but I do believe that people are more conscious
for them.
regarding obesity and its risks, especially children. People are becoming more aware of the necessity of
Prevention campaigns also work to stop the spreading
having healthy eating habits as well as the benefits of
of infectious diseases such as dengue fever, zika, and
performing physical activity. I do credit this awareness to
chikungunya. When people are informed they can act as
the campaign.
health brigades, taking the necessary measures to avoid its spread and making sure that their immediate environment
Another public health issue we are concerned with is
has the needed sanitary conditions. That is why it is vital to
the high rate of teenage pregnancy. Every year around
have assertive communication campaigns that encourage
7,000 girls, 14 years old or less, become mothers. This is
a culture of prevention.
an alarming rate. UNAM is working to launch a prevention campaign to decrease this alarming number. There needs
Q: When talking about universal health, how do we make
to be a joint effort with the federal government and the
sure that isolated communities receive adequate medical
Ministry of Health to make sure we are reaching the youth
attention?
in the country and providing them with all the necessary
A: In theory, every Mexican can access health services
information regarding pregnancy. Teenagers need to
through different types of health coverage. Around 70
have access to birth control methods and to realize the
million Mexicans have access to IMSS’ services, some 12
consequences unwanted pregnancies at a young age can
million Mexicans have access to ISSSTE and around 50
bring. If we want this campaign to be effective we need
million people have Seguro Popular. Regarding coverage
to design effective communication techniques to reach
services, we could say that every Mexican can access them.
the entire population. This means providing information
If people do not have any kind of coverage it is because
to every community in the country, urban, rural and
they are unaware of this, which means the government has
indigenous. It is a matter of bringing health services to the
been unable to communicate its message.
45
| VIEW FROM THE TOP
HEALTH EDUCATION FOR DOCTORS AND PATIENTS CÉSAR ATHIÉ Director General of Hospital General de México 46
Q: How is the General Hospital of Mexico managing
we prefer to invest in curative medicine to avoid
challenges from the industry?
expensive complications. Technology is another challenge
A: The hospital is a grand example due to its huge size, 45
as equipment quickly becomes obsolete. We find that
specialties and unique three level division. Primary care
renting equipment makes much more sense than buying
is emphasized on the first floor where general doctors
it. It is a cost-effective method that keeps our devices up
diagnose patients and refer them to the more specialized
to date.
second and third floors or specialty clinics. The second level treats 90 percent of the most frequent pathologies while
Q: How has Hospital General maintained its quality in a
the top floor oversees the remaining 10 percent, reserved for
landscape brimming with budget cuts?
the most complex conditions in need of medical surgeons.
A: Our income comes from the federal budget, Seguro
The hospital has a heavy surgical load and we handle all
Popular and other agencies. We receive an abundance of
types of cases. Disease is managed mostly through medical
support because the hospital manages the biggest chunk
care and complemented by education and research.
of the pathological cookie in Mexico. Some of our cases and convalescence rooms are covered by Seguro Popular. We
We take pride in the quality our hospital offers and work
offer important qualitative and quantitative information as
hard to keep up with medical innovation that can improve
our size and the number of cases we treat give an accurate
our services. The health sector is constantly undergoing
glimpse of what is happening in the country when it comes
changes thanks to the evolution of illnesses and the
to health.
consequent adaptation of treatment. The hospital also receives external support from visionaries Curative
and
preventive
medicine
have
equally
who grant donations on their own or upon request. Some
experienced dramatic shifts, which make the transition
lend a hand by buying or renting our equipment. For
that much more difficult. As our budget is quite limited,
instance, patients that undergo kidney or liver transplants receive support from the Carlos Slim Foundation, which
“Curative and preventive medicine have equally experienced dramatic shifts,
sponsors subsequent costs. Q: Mexico spends 6.2 percent of its GDP on its healthcare system, yet only 8-10 percent is assigned to medicine and administrative expenses carry the biggest weight. What
which make the transition
is being done to prioritize patients over administrative
that much more difficult. As
A: The organizational structure of the hospital is constantly
our budget is quite limited,
important piece of the puzzle that lessens administrative
we prefer to invest in curative
productivity and quality. We are constantly evaluating
medicine to avoid expensive
processes in the HGM? under revision and modernization. New technology is an hassles. The changes in our system reap higher rates of and receiving feedback to assure best practices. Our three levels of care and specialties are molded according
complications”
to the needs of the country and our patients, which are
Cesar Athié, Director General of Hospital
resources priority as it straightens out the dents in medical
General de México
care. Accurate diagnostics and adequate treatment are
constantly changing. Hospital General also gives human
essential to minimizing complications, which can only be
A: The Hospital General de México is 111 years old. The
achieved with a coordinated and prepared staff.
hospital has European origins and when it was created in 1905, the tendency was to develop horizontal clinics. In
We are starting to focus on minimally invasive surgery
this century, horizontal buildings are inefficient and the
as it is the largest type of surgery in the hospital,
hospital is pushing toward verticalization. The first tower
particularly laparoscopic. Our studies found that patients
was for oncology, the second for surgery. We are working
are in need of smaller hospitals. We are finding ways to
on finishing another three by the end of the year. A project
optimize our patients’ stays and save them time. The
is also being developed to sew together the units with their
new buildings and towers are starting to be managed
associated services. We made sure that construction did
as outpatient areas and short-stay areas for minimally
not obstruct the flow of the Hospital by relocating the staff
invasive surgeries.
to other sections to continue operations. The advantage is we have better installations and surgeons.
Q: What strategy does the hospital use to attract the best qualified surgeons, considering the health industry suffers
Q: How would you describe your most outstanding success
from a lack of doctors and nurses?
stories?
A: Hospital General has no issues when it comes to
A: The hospital considers rehabilitation cases to be
specialized doctors, as it handles their training through
some of the most outstanding, especially if the patient is
UNAM, the IPN and other private universities. Depending
young and has a bright future. Complications are always
on the needs of the hospitals, we even send doctors to be
a possibility. The loss of a body part requires transplants,
educated abroad.
an extremely difficult procedure that is now possible thanks to our new equipment. Some patients have critical
The real issue is the availability of specialized nurses, a
pathologies like placenta accreta, a condition where
worldwide conundrum. Our best nurses are prepared
the placenta attaches itself to the uterus. It can cause
inside the hospital at a school we hope to expand. We
uncontrollable bleeding and has a high mortality rate. We
also have general nurses that jump from being trainees to
have learned strategies that minimize risk in these cases.
professionals. Unfortunately, Mexico is experiencing a drain
For instance, a small caesarean incision can take out a
of nurses to Canada.
product that is passed to interventional radiology, while leaving the placenta attached to the uterus. The arteries
Q: How does the Hospital emphasize the importance of
that feed the uterus are then treated to stop the bleeding
general doctors?
and remove the entire uterus without losing more than one
A: Our entire first floor is dedicated to general doctors that
liter of blood, ultimately saving the patient’s life. Pregnancy
form part of our training program. Many do not have enough
complications are a challenge in Mexico as premature
expertise and we help them become family practitioners.
pregnancy is a health epidemic. Our latest case involved a
Afterward, we focus on internists who are doctors with a
nine-year-old girl from the streets.
higher level of preparation. From this group, cardiologists and heart surgeons among others, are trained.
Q: As a main teaching hospital in Mexico, what is the role of education in medicine and how can the public and
The hospital avoids many problems by developing its own
private sectors collaborate to promote more academic
experts through training cycles with the help of its modern
participation?
infrastructure. The relationship has mutual benefits as the
A: The hospital believes that a country cannot grow without
doctors grow professionally and pass on their knowledge
education, particularly rural areas that lack services.
to the hospital’s 782 medical residents.
Paradigms need to be broken to allow comprehensive educational programs. Education can solve many problems
The hospital makes sure to prepare itself by equipping its
within Mexican society such as obesity, hypertension and
general doctors with enough knowledge to serve efficiently
diabetes. The health sector can help by offering tools
on the first floor. We have plenty of specialists and worry
and improving quality of life for the general population.
more about having trained staff in primary care, as incorrect
We receive many patients with advanced cases of breast
evaluations can cause a hurricane of complications, and
cancer that could have been prevented.
costs. Improving the quality of primary care is vital. At HGM we run a patient university, a program inspired Q: Recently, MX$730 million (US$38.8 million) was invested
by places like Barcelona and Stanford where patients are
in a new surgical tower and the development of other new
taught self-care practices for a wide variety of illnesses. We
cardiology and rehabilitation units is being financed. What
place them in classrooms so that they can share information
other expansion plans is the hospital considering?
and experiences in pairs, similar to AA groups.
47
| VIEW FROM THE TOP
ABC HOSPITALS COMMITS TO HEALTHCARE IMPROVEMENT ALEJANDRO ALFONSO CEO of ABC Hospitals and President of the National Association of Private Hospitals 48
Q: As President of the National Association for Private
non-governmental organizations are funded by private
Hospitals, how are you planning to strengthen the sector?
hospitals, insurance companies, the government, and
A: I spend most of my time meeting with local and federal
pharmaceutical corporations, among others.
authorities including the General Health Council (CSG), which is one of the most relevant organizations involved
On the contrary, the CSG is subject to administrative
in the creation of Mexican healthcare policies. We discuss
changes at the end of each term, constantly losing its
issues related to medical tourism, its quality, and areas of
experienced personnel and know-how. We should also
improvement. Attracting patients from abroad is mostly
take into account that CSG audits are free of charge
contingent on the quality of service. Unfortunately,
whereas similar JCI processes cost up to US$200,000. JCI
many non-certified physicians provide unsafe services
is highly experienced in researching and analyzing quality
throughout the country. Therefore, the CSG aims to create
standards, which is a missing practice at CSG. Private
a network of certified specialists, ensuring patient safety
sector investment is crucial in creating a solution as it can
along the care continuum. Due to the lack of standard
bring fundamental benefits to the entire sector. So far,
procedures and proper physicians’ credentials in Mexico
3-4 percent of Mexican private hospitals have received
foreign patients undergoing hip replacement surgeries
certifications, and most of Mexico’s private infrastructure
in Mexico realize that no service provider in their country
works without guaranteeing a quality standard. Medicine
is willing to offer rehabilitation therapy and follow up
has progressed impressively in the past few years, and
examinations. There are private hospitals bordering
today we can identify previously undetectable diseases.
the US that perform surgeries on obese patients, who
In addition, providing treatment to chronic diseases
should otherwise be carefully examined and selected for
patients is secured, ensuring them better quality of life.
bariatric intervention. Only 30 percent of patients filing
Creating a solid medical network with proper processes
applications at our obesity clinic are suitable candidates
and infrastructure is fundamental as a patient’s medical
for surgery, the remaining 70 percent are directed to
care could involve up to five physicians per diagnosis.
exercising, dieting, and enrolling in group therapy. Even if in the short term performing blanket surgeries without
Q: How is the Association addressing the lack of data
factoring individual circumstances may be lucrative, it will
sharing among hospitals on clinical outcomes?
eventually damage Mexico’s image. We must work hard on
A: This is a global trend that is not exclusive to Mexico.
standardizing methods and world-class procedures in the
A few weeks ago, the board of a public hospital held a
care chain. We do not expect much revenue in the short
meeting in which a figure for infection rate was presented
term but we will show the world Mexico’s ability to deliver
but there was no reference or baseline parameter that
high quality services in the long term.
could help interpret it. Failing to acknowledge medical mistakes is one of the industry’s biggest problems
Q: To what extent will the CSG certification help hospitals
involving indicators. By shifting the mentality, directors
improve their standards and image among foreign
could use data as a pathway to continuous improvement.
patients?
Secondly, leaders must inform their staff on how their
A: Although accreditation is a requirement guaranteeing
work affects indicators and realize that accountability and
patient safety the CSG has many auditing requirements
trust are two main issues in Mexico.
stressing the organization. We believe the accreditation process should be reallocated from the CSG to a capable
Q: What can be learned from ABC Hospitals experience in
and highly resourceful third party organization. Mexico
earning the JCI accreditation?
could then replicate models like the Joint Commission
A: We are an accredited JCI hospital but if inspections
International (JCI) and the Canadian Council. These
reveal there have been healthcare oversights we could
lose it. However, organizations do not understand that
life. We also have a Kardias program for congenital heart
accreditation serves as a means to an end, not an end in
diseases through which 100 surgeries were performed
itself. Nine years ago when we first became JCI certified
last year. This is an affiliate of Texas Children’s Hospital in
the process did not end there. The JCI accreditation is a
Houston, and is committed to providing the same quality
tool to improve, which has to be clearly understood by
of service in infant medical care. We have other initiatives
all members in an organization. Our mission is to serve
that address cleft palate, Parkinson’s disease, and
patients and improve their quality of life not retain an
kidney transplant. Last year, 90 kidney transplants were
accreditation.
completed and 30 of them were performed in Mexico’s most vulnerable population. Our initiative for Parkinson’s
Q: How would you justify investment in procurement
disease consists of treating the symptoms by positioning
when there is a growing concern about underutilized
electrodes in the patient’s brain. We have also carried out
beds?
hip replacements and bariatric surgeries for vulnerable
A: Both the public and private sectors struggle with
people. In fact, 7 percent of our revenue is invested in
this problem. Many politicians think that infrastructure
vulnerable groups and education, accounting for MX$350
development resolves many of the healthcare industry’s
million (US$18.8 million) each year.
challenges. But this approach worsens the problem. Scarce resources are used to build new hospitals and acquire
Q: What are your strategic plans for 2016?
equipment but there is still a lack in human talent. When a
A: We are in the process of building a new intensive care
new facility opens and starts operating the directors must
facility at our Observatorio Campus, which will include a
find qualified nurses, physicians and technicians, as well as
larger transplant unit and a palliative care unit. We will
implementing processes, best practices and international
further expand our hospital buildings in Santa Fe, installing
rules. Infrastructure is often used as a way to prove
specific equipment for the Kardias program, as by 2020
growth and investment in the sector but human talent
we expect to perform 400 surgeries for congenital heart
development must significantly advance. The Ministry
disease annually. We have plans to build eight additional
of Health should question whether Mexico has the right
operating rooms in Santa Fe totaling 14. We are projecting
people and processes in place, and whether purchasing
the opening of a third hospital in the northern region of
cutting-edge technology is actually going to solve the
Mexico City. We have two clinics in Mexico City including
current problems in the system. Once the issue is solved
breast imaging centers with laboratory, rehabilitation, and
then infrastructure expansion in healthcare services should
obesity treatment services. In our main building we have
be considered. We need to double the number of nurses
a simulation center that aims to stop the use of animals
over the next 10 years to satisfy the demand for services
for educational purposes turning to robots instead. Finally,
while providing staff with the right training courses and
our residency program for oncology and neurology is
qualifications. Considering medical and science advances,
growing. As of today, we have 180 residents in both
including
facilities, which we expect will increase in the short-term.
the
discovery
and
development
of
new
treatments, staff needs to be trained up to par. Q: To what extent is your teaching program supporting the development of the sector? A: We have a strong residency program as part of our partnership with ITESM’s School of Medicine. We will not see significant change unless we educate the new generation of physicians. We approach them in their late teens, starting their college education. Considering that many courses date back to 1970 we need to change physicians’ mindsets so they are able to face upcoming global and local challenges. Q: What is the scope of your social responsibility programs to improve the health of Mexico’s population? A: We have an extensive outreach program. We are creating a new plan solely focused on children. There is plenty of scientific data showing that the development of children will be negatively affected if they do not receive enough medical attention during the first three years of
We should take into account that CSG audits are free of charge whereas similar JCI
processes cost up to US$200,000
49
| MEXICAN HOSPITAL STATISTICS
hospitals in Mexico, giving it the second most hospitals
medical care for an ailment. Many do not visit primary
in Latin America behind the 6,954 hospitals in Brazil.
points of care at the first sign of illness or practice adequate
Twenty-nine percent of these hospitals perform over 200
prevention, putting a heavy burden on the country’s
procedures per year and on average, 270 procedures are
hospital infrastructure. There are 3,820 public and private
conducted per hospital per year.
On average hospitals
BREAKDOWN OF HOSPITALS BY NUMBER OF BEDS BREAKDOWN OF HOSPITALS BY# OF PROCEDURES
in Mexico
received 2,691 patient visits in 2014; hospitals in Peru received an average of 30,900 patient visits
36% Hospitals with <100 procedures hospital with <200 procedures 35% Hospitals with 100 - 199 procedures
AVERAGE NUMBER OF PROCEDURES PER HOSPITAL
PROCEDURES
120
Source: Global Health Intelligence
On average there are only
100
six computers per hospital in Mexico, compared to 33
80 60 40
computers per hospital in
Neurological
Thoratic
Spinal
Cardiovascular
Urology
Orthopedic
Other
General
20 0
29% Hospitals procedures hospital with with >200 100-199 procedures hospital with <100 procedures
OBGYN
50
Much of Mexico´s population will wait before seeking
Colombia
BREAKDOWN OF HOSPITALS BY NUMBER OF PROCEDURES OF HOSPITALS BREAKDOWN BY # OF BEDS
Source: Global Health Intelligence
81 percent of hospitals in Mexico have birthing rooms but only 70 percent of hospitals have newborn cribs
hospital with >100 beds 14% Hospitals with >100 beds 12% Hospitals withhospital 50 - 90 with beds50 - 90 beds 23% Hospitals with 20 - 49 beds hospital with 20-49 beds 36% Hospitals with < 20 beds Global Health Intelligence 2015 hospital Source: with <20 beds
Source: Global Health Intelligence
| VIEW FROM THE TOP
HOSPITALS JOINING THE MEDICAL TOURISM BOOM JAVIER ALUNI Director General and CEO at Hospitaria 51
Q: What opportunities can the medical tourism industry
tells our patients we are committed to their health and
take advantage of in Mexico?
safety. In nutrition we have the H Distinctive that the
A: Medical tourism receives much interest from the
Ministry of Tourism awards to establishments that comply
government and investment as it thrives in very specific
with the strictest hygiene rules regarding the management
locations. Border cities tend to be very economical. Other
of food. It includes food preparation, storage, and delivery.
important destinations are beach towns, so people can
We also have the Moderniza distinctive that certifies the
come for their medical procedures but also for a vacation.
management of food and beverages in the hospital.
It all depends on your area of influence and the money you can dedicate to medical procedures. Monterrey has
We are now looking to certify our emergency department
influence in the southern part of Texas. Hospitaria is not
by the Joint Commission. The team uses the latest
far from the border which makes us an attractive option
technology and we are looking for third party accreditation.
for people coming by car from the southern part of the US.
In preparation, we are sending groups of doctors and nurses to train in emergency room in Mexico City. Since
Medical procedures can be expensive in the US, so when
we will always have competition, our main strategy is to
people come to Mexico the currency helps make our
focus on three fundamental things: patient satisfaction,
procedures less costly, although this depends on the
fair prices and family satisfaction.
procedure and the specialty that patients require. Some specialties target middle or low income families in the US.
Q: What problems would you say should be Mexico’s
Other procedures such as aesthetic surgery are targeted
priority to overcome?
at middle or high-income families. For instance, a doctor
A: The biggest health issue in Mexico is the lack of
that operates in Houston and in Cancun can offer his or
preventive culture. Unfortunately, people do not go to
her patients aesthetic surgery in Cancun since it is more
the doctor to avoid having health issues, people go to the
affordable. This is not Hospitaria’s case. All our doctors
doctor once they are sick. That is why health campaigns
are Mexican and operate in Mexico. When we have foreign
are so important. We need to make people understand the
patients it is because they have searched specifically for
importance of prevention. We have somewhat succeeded
our doctors to treat them.
in convincing women about the importance of breast examinations, we now have to duplicate these efforts for
It is hard to determine the number of Hospitaria patients
other diseases. Hospitaria is playing its part in trying to
who come to Mexico for the sole purpose of medical
create a preventive culture. There needs to be a shift in the
tourism. Hospitals and medical centers must ask their
way people approach prevention.
patients to indicate their place of origin to measure the number of foreign patients whom we tend to. This allows
We have just opened the first urology clinic in Monterrey to
us to identify more clearly if we have a growing demand
prevent urinary infections. We also support the Women’s
for medical tourism.
Medical Center, focused on women and pregnancy and the Cancer and the Nutrition Center.
Q: What advantages does Hospitaria have over its competitors?
Q: What future projects has Hospitaria planned?
A: Hospitaria was created four years ago. It is an intelligent
A: Hospitaria’s plans include opening new specialties.
hospital, designed to provide comfort to our patients
We want to focus on hemodynamics, heart procedures,
and their families. We have just received the CSG Health
neurosurgery and traumatology. We want to expand
Certification, which is not yet mandatory. We are among
Hospitaria not only in Monterrey but to many different
the first 100 hospitals to obtain this certification, which
cities of the country.
52
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53
| VIEW FROM THE TOP
SPECIALIZED CARE ATTRACTS PATIENTS FROM AFAR FRANCISCO VILLARREAL Medical Director of Swiss Hospital 54
Q: What is the origin of Swiss Hospital?
It has multiple universities with thriving health faculties,
A: The original concept behind Swiss Hospital was to
such as Monterrey’s Technological Institute of Higher
create a specialized environment that focused on specific
Education (ITESM), Monterrey’s University (UDEM), the
services. We first targeted and attracted our clientele
Autonomous University of Nuevo Leon (UANL) and the
based on previous evaluations that helped us foresee
University of Montemorelos. For many years the city has
the ailments in highest demand. It was decided that
developed important medical human capital for the whole
Swiss Hospital would be a small, secondary healthcare
country, but most importantly for Monterrey.
hospital focusing on certain medical surgery specialties. We kept away from tertiary healthcare practices that
Q: Swiss Hospital provides its patients and family
include cardiovascular and oncological surgeries and
members with a warm experience, based on innovation,
neurosurgical care. Swiss Hospital wanted to retain the
safety and excellence. How have you ensured these three
best doctors in the region in well-defined specialty areas
principals?
including orthopedics and traumatology.
A: We are constantly re-evaluating the infrastructure we have and making investments and refurbishments if need
Q: What are the results of Swiss Hospital’s specialist
be. In terms of patient safety, our indicators speak for
approach?
themselves. For example, over the last four months, we
A: By becoming a center of excellence in its fields, both
have seen 0 percent post-operative infection rates. In 2016
the hospital and its physicians could be a reference point
as a whole, we have had 0.6 percent. As such, we have been
in Mexico. From an orthopedic standpoint, Swiss Hospital
entrusted by patients and doctors that our epidemiologic
attracted the best spine, shoulder, knee and hand specialists.
vigilance is of the highest standard. Swiss Hospital has never had a post-operative thromboembolism, and
Given the success of our specialty approach we were
minimal surgical reoperations. On average, the hospital
able to attract other types of surgeons, such as bariatric
sees 160 surgical interventions per month in a total of four
specialists. We added this service to our operations and
operating rooms. Swiss Hospital is equipped with 24 beds
expanded the demographics of our patients, which only
with an occupational average of 70 percent, which is the
boosted our success rate. In fact after only two and a half
industry norm. Most of our services are ambulatory but
years in the market, we broke even and started profiting
hospital stays are on average 2 1/2 days.
from our operations. This is especially remarkable for hospitals, as the initial investment and subsequent
Q: How close is Swiss Hospital to reaching its goal of
financing is extremely high. Months later and after further
being a specialty reference in the region?
evaluations, peripheral and central vascular surgery
A: We are receiving more and more patients from
followed. Finally, we complemented our services with
peripheral states. San Luis Potosi, Tamaulipas, and
urologic and otolaryngology (ENT) surgery. We needed
Zacatecas demand our orthopedic services the most.
the right infrastructure to support our specialty areas,
Our obesity specialists see most of their patients
which led us to heavily invest in our intensive care unit
coming from Monterrey and Texas. Even though there
and other complementary services such as blood banks,
are highly specialized hospitals in the US, we have
laboratories and our imaging department.
detected an important area of opportunity. Take MD Anderson Cancer Center for example, one of the best
Q: How did Swiss Hospital attracts and retains the best
oncology hospitals in the world. They do not refer
specialists in the area?
patients to Swiss Hospital but we have seen Mexicans
A: Monterrey has differentiated itself from other cities
initially seeking treatment at this cancer center to whom
around Mexico, leading to its status as “the city of health.”
we offer follow-up services.
| VIEW FROM THE TOP
A NEED TO IMPROVE INSURANCE LEVELS IN PATIENTS ROBERTO BONILLA General Director of Hospital San Ă ngel Inn 55
Q: What strategy is Hospital San Ă ngel Inn following to
There is no general strategy for controlling obesity in the
consolidate its presence in Mexico City?
country. If the government and private enterprises team
A: The past few years were marked by several hospital
up, perhaps we could come up with a solution that could
acquisitions, mostly big hospital groups acquiring small or
have a bigger impact on the country. The government
medium-size hospitals. Hospital San Ă ngel Inn has been
needs to take advantage of the number of tools that
fortunate enough to maintain its independence. We have
technology provides. Performing free examinations in the
always been part of Grupo Dalinde but we are autonomous
city and in isolated locations is not enough, they need to
in decision making. Our business philosophy has always
conduct follow-ups on the diagnosis. Technology allows us
been to focus on the service we provide to our patients
to perform a more specialized follow-up.
and doctors. We provide quality services to our patients. Our general hospitals can tend to 100 percent of patient
Q: How do epidemiology cases in private hospitals differ
conditions and we are considerably more affordable than
from the ones you see in public hospitals?
other hospitals as our prices are approximately 30 percent
A: The epidemiologic composition in private hospitals is
lower than the most important hospital groups.
very different than the one in public hospitals. In our case, most of our surgical procedures are elective surgery. In
Our advantages make us attractive to corporate clients.
most private hospitals elective surgeries tend to be related
Enterprises sign contracts with us for coverage for their
to general, orthopedic, urologic and plastic surgery.
employees. We are among the top establishments for
Influenza cases are also among the variety we attend too
institutional accounts.
and last year we attended more influenza cases than in 2009. Due to our alliances our patients are diverse and
Q: What joint efforts could private hospitals and the
suffer from many different conditions.
government make to reduce obesity levels? A: Obesity problems have to be treated from a more integral
Q: How can you overcome the challenges private hospitals
perspective favoring preventive schemes rather than just
face?
reactive solutions. Unfortunately hospitals only attend
A: A challenge we usually face is the never ending struggle
the most serious cases in which the patient is suffering
between insurance companies and hospitals. Hospitals
from known complications. The private sector is offering
think insurance companies do not want to pay for their
interesting possibilities for the treatment of patients with
services and insurance companies believe the hospitals
obesity. There are personalized programs that, with the
are charging for unnecessary procedures. We need to
guidance of a health coach, aim to inform and educate
understand that we are reaching the same markets and we
patients on healthy lifestyles and eating habits.
have the same clients. Hospitals and insurance companies need to work on innovative business models to allow us to
Diabetes and obesity are conditions that can be prevented
tend to more patients at a lower cost.
by promoting healthier lifestyles. Hospitals do not play a very important role in terms of promoting those. As a
We need to change the idea that more medical choices
hospital, what we have done is work with our corporate
on insurance coverage equates to better coverage. This is
accounts to create prevention campaigns for their
inefficient for insurance companies since it has become
employees, assigning them health coaches to conduct
extremely expensive to have hundreds of doctors listed as
constant follow-ups of biomarkers. The information is
options. Having fewer options is not appealing to patients but
registered in a database that allows us to monitor our
this traditional model only increases costs for companies and
patients and to distinguish the specific treatments we
for the patient. A change in the way we approach medical
provide that have the bigger impact.
coverage could help us implement more economical services.
| VIEW FROM THE TOP
HEALTHCARE PROVIDER WITH THREE SIMULTANEOUS CERTIFICATIONS 56
Arturo Martínez Medical Director of Hospital Galenia
Olivia Laviada Sales & Medical Tourism Manager of Hospital Galenia
Q: Can you give us a brief history of Hospital Galenia’s
have to remain valid health care providers with the
operations?
CSG certification. Furthermore, if we were to provide
AM: After assessing the local market Dr. Eduardo Loya, the
subrogated services to social security health services'
Director General of Hospital Galenia, realized that Cancun
covered patients (IMSS and ISSSTE), we would have to
needed a high-quality hospital that could cover a growing
keep the certification. Patients are not necessarily aware
health service demand. Although this market generated
of our certifications but they recognize the difference in
higher margins treating foreign patients, Hospital Galenia
patient experience.
targeted the needs of locals. To date, 60 percent of our work is directed at local residents. We are the only
Q: How have Hospital Galenia’s certifications impacted
hospital in the Yucatan peninsula with nuclear medicine
medical tourism?
infrastructure so we also attract patients from neighboring
OL: Hospital Galenia has become Cancun’s reference for
states. Health necessities have shifted over the last years,
healthcare services, leading to an upsurge in medical
and so has Hospital Galenia’s approach. In Mexico, chronic
tourists visiting the city and our facility. Third party
degenerative diseases have become the biggest health
administrators, insurance companies and facilitators,
concern. These include diabetes, hypertension and most
mostly look for certifications, as they ensure patient safety
importantly cancer. As globally infectious diseases are
and treatment outcome. Those paying from their own
no longer the primary cause of death and Cancun is an
pockets are more focused on cost. These two variants are
attractive center for retired professionals over the age of
contingent on the procedure, considering some are not
60, most of our operations treat chronic conditions.
covered by insurers, such as plastic or bariatric surgeries. As a result, part of our job is to make patients understand
Q: How close is Hospital Galenia to fulfilling its goal of
the cost-benefit of Hospital Galenia.
becoming regional leader in quality, security, and service? AM: What Hospital Galenia has done in recent years
Canadian patients that receive free healthcare in their
and the effect it has had on its community are the best
homeland even travel abroad to avoid waiting lists of up
indicators. Firstly, we went from 20 beds to 54 after
to two years. For the most part, medical tourists look for
opening the second wing of the hospital. We have
plastic, orthopedic, general and bariatric surgery, as well
increased operating rooms, coupled with increased luxury
as oncologic and prostate cancer treatments. Stem cell
room availability. Our intensive care unit also underwent an
treatments are not authorized in the US, forcing some US
expansion process. As a hospital that uses opportunities to
citizens to travel to Mexico and obtain the ambulatory
reinvest and shows healthy financial outcomes, while also
procedure. When we first began operations, we developed a
covering the service demand, we must be doing things
prostate cancer program that was in high demand by foreign
right. Hospital Galenia is the only healthcare provider in
patients. Thereafter patient admission volumes grew.
the country with three simultaneous certifications, and an array of yearly re-certifications. Firstly, we hold the
The hospital developed the medical tourism division in
General Health Council (CSG) certification in Mexico,
2013, which forced us to be more organized and trace
followed by the Joint Commission International (JCI)
down protocols. We also created the facilitator figure,
and the diamond certification emitted by Accreditation
a position that helps us link foreign patients and third
Canada International. We not only comply with domestic
party administrators with the hospital. The patient’s
standards but also with international requirements.
only responsibility is filling in the admission form after providing us with a copy of their passport. We coordinate
A significant number of local and foreign patients use
their
pre-operative,
their private insurance in Mexico and as a hospital we
schedule if needed.
operative
and
post-operative
| VIEW FROM THE TOP
FIRST OF ITS KIND LUIS NAVARRETE Director General of Clínica de Mérida 57
Q: What motivated Clínica de Mérida to establish its
Q: What is the main demographic you treat, and how are
practice?
you able to support them economically?
A: In Yucatan, when we started 50 percent of the
A: About 70 percent of our patients come from the
population was not enrolled in IMSS, ISSSTE, or any other
Yucatan peninsula, but we also get business from South
governmental plan. Nevertheless, private healthcare costs
American countries and other states within Mexico.
were prohibitively high, so our clinic was a sound option
Although there are other hospitals in Merida, our size,
for this demographic. The construction of the Clínica de
expertise and mentality make the Clínica de Mérida stand
Mérida hospital began in 1961, and completed in 1964. The
out. Patients come from all over the peninsula, including
project was the vision of a group of doctors led by Arturo
Playa del Carmen Cancun, and even Cozumel, reaching us
Ponce G. Cantón, who raised the funds for the clinic.
by boat. This speaks volumes about our service.
In its 52 years of operations, none of the 200 partners in the
The dominating demographic is the middle to lower end of
clinic have taken dividends, making it a completely non-
the socioeconomic spectrum, but we also cater to higher
profit organization. The clinic was the first of its kind to
income sectors. Patients often seek a second opinion
reinvest profits into operations and technology. Moreover,
from Clínica de Mérida on more complex diseases such
medical professionals were given the opportunity to
as cancer. We help the lower socio-economic classes with
develop their skills and gain experience while offering a
a third-party payment we offer, which reduces the stress
more affordable price for their services. At the time of
related to financing treatment.
construction, no other private institution offered the same specializations for doctors and adhered to world-class
Q: How are you encouraging medical tourism from
standards. Today, we see between 600-700 patients and
countries such as Canada, the US and South America?
carry out around 400 surgeries per month, 50 percent
A: We see few medical tourists from Canada and the US,
being outpatient surgeries. This equates to around 55
although the number of Canadians, some of whom own
occupied beds per day. About 42 percent of our patients
vacation homes in Mexico, has been increasing. Few of
are funded through a third party, including insurance
our patients travel especially for health services but when
companies, bank loans, the Universidad Autónoma de
they visit family or their holiday homes they see local
Yucatán or other institutions that offer healthcare.
services as a reliable option. People also are increasingly coming to the Yucatan peninsula for six months or more,
Q: Aside from price, what attracts patients to Clínica de
so it is only natural that in that time they would require
Mérida instead of its competitors?
healthcare.
A: We have 65 SensAble beds, another 35 standard beds, a staff of 120 doctors, and a great deal of technology such as
Q: How do you plan to develop Clínica de Mérida in the
an ECT machine, hemodynamics systems and tomography
short term?
machines. We can carry out laparoscopy surgery, heart
A: As the city grows, the traffic and transport links become
surgery, transplants, ultrasounds, and invasive radiology,
more complex, complicating travel for some residents to
among other procedures. We also have a top of the line
reach the Clínica de Mérida. We intend to expand to the
laboratory to test all our samples. Doctors have a great
north of the city. There are also plans to establish units
deal of input into our hospital’s management. Instead
outside of the city. A laboratory in Motul is currently being
of competing with surrounding hospitals, we consider
built and also we aim to expand to Valladolid and other
ourselves part of a healthcare network. If a treatment costs
rural towns. Limited logistics options mean that we are
less in another institution, we will provide this information
unlikely to establish more hospitals but rather implement
to the patient.
units to support rural communities.
| VIEW FROM THE TOP
CODY DRILLS INTO DIFFICULT DENTAL CASES ROBERTO SOSA Leading Maxillofacial Surgeon and Founder of Central Odontológica de Yucatán (CODY) 58
Q: What distinguishes CODY from its competitors?
due to incoming foreign patients. We do not raise our
A: CODY employs highly specialized personnel and
prices for patients coming from abroad. Foreign patients
technology, such that the quality of our work is first-rate.
mostly request dental implants to take advantage
In Merida we have become a reference point thanks to our
of our prices and guaranteed quality service. Some
state of the art equipment. When dentists cannot solve a
foreign patients ask for operative dentistry such as
patient’s problems, they refer them to us as we specialize
dental crowns, incrustations, and fillings. For our dental
in difficult cases. Our digital dental lab helps us make our
implants, we use Straumann, which we believe to be the
molds and dental crowns with an accuracy of microns,
best brand of its type. Most of the materials we use are
sometimes employing zirconium. CODY’s two milling
shipped from Europe, especially from Germany, Spain,
machines, maxillofacial scanner, and x-ray device are built
and Lichtenstein.
in Finland. In the case of any electrical failure, our power station immediately supplies the clinic with electricity and
Medical tourism is generating an impressive economic
we do not need to interrupt our services. Moreover, we
spillover so we must push to attract more foreign patients.
offer all our services at market price, which has always
We already have the Yucatan Health accreditation, and are
been CODY’s philosophy.
working with Canada to be certified by their standards as we are try to obtain the ISO certification. In terms of
However, it is very expensive for us to operate and offer
promoting ourselves, in September we will attend the
competitive costs to clients. We employ an extensive
Medical Tourism Trade Show in Canada, so we are preparing
personnel, including a maintenance crew, our specialists,
to tour Ottawa, Toronto and Montreal, visiting retirement
and four engineers so maintenance costs are also high.
centers and travel agencies to promote Yucatan Health,
Including periodic renovations, together these reduce our
and to promote the clinic. Most of our foreign patients
profit margin. Taxes in Yucatan total 2.4 percent of our
hear about us through recommendations. We need to
total invoicing to federal and state taxes. Our total revenue
expand this to appeal online to other potential patients by
corresponds to 10-15 percent of total billing, much of which
offering them service packages including transportation,
is reinvested in renovations to remain competitive. For
accommodation, translation services and of course dental
comparison purposes, in the US an implant crown is usually
services.
sold for US$3,000 and CODY is selling it for US$900. Q: How do you expect CODY to grow? Q: What opportunities in Mexico pushed you to open
A: By 2018, we will be operating a local clinic in the northern
CODY?
part of the city. We would like to open a dental clinic with a
A: CODY started 32 years ago to fulfill a personal dream,
more affordable concept, offering quality services at very
rather than a commercial venture. I wanted to achieve a
low costs. This clinic would focus on preventive odontology
radical change in dentist and patient mentality. In Mexico,
work and restorative works, meaning extractions, callous
a traditional dentist does not cover additional treatment
injuries, dental fillings and acrylic based prostheses.
such as orthodontics or surgery. Our idea was to consolidate all dental services in a single space, ensuring
To fulfill this, we need help from the state Ministry of Health
the quality of every procedure.
to allow students from colleges to work with us during their social service period. In the worst-case scenario, the
Q: To what extent has CODY benefited from increased
investment for this project would come from our pockets
medical tourism in the state of Yucatan?
because we are keen to implement the program. The clinic
A: There has been an increase in regular clients. Numbers
needs only a small profit margin to ensure operation and
have improved but our finances have not increased solely
future growth.
| VIEW FROM THE TOP
AMBULATORY SURGERY AN EASY PILL TO SWALLOW RICARDO BOJALIL CEO of ASMED 59
Q: What needs did ASMED identify in the Mexican market,
are poorly maintained and their medical technology is
leading to its establishment in the country?
irregularly refurbished. Under these circumstances, our
A: The gap between large and small hospitals in Mexico
operations have secured the best of both worlds. ASMED’s
was extensive, so much that we saw a gap in the market for
infrastructure is conveniently equipped and well suited to
a sustainable business model. ASMED differentiated itself
handle ambulatory low-risk procedures, while delivering
from the rest by inquiring about the Ambulatory Surgery
good value for the money.
Center (ASC) industry model. ASC has been implemented around the world but especially in the US. By providing
Q: How do you encourage doctors and hospitals to refer
proper surgical and medical services in a secure and cost
people to ASMED’s outpatient facilities?
effective manner, we have positioned ourselves solidly in
A: ASMED is a facilitator of positive health outcomes,
an extremely competitive field after only four years in the
which is sufficient to secure their attention. We accentuate
market.
our services’ convenience, coupled with high quality and cost effectiveness. We also provide infrastructure and
Even though the ASC model is new in Mexico, there are
secure processes needed to procure the best patient
some operating rooms (ORs) running outside hospitals in
outcomes, which we take a lot of pride in. Consequently,
the country. However, their professionalism is not up to par.
ASMED being the service of choice for both doctors and
Most lack sufficient certifications and stricter policies to
patients is our immediate goal.
secure COFEPRIS’ authorizations. Hospitals have a broad range of services, creating managerial and operational
We complement hospitals’ and other healthcare providers’
challenges. ASMED has established and maintained high
operations. Considering the large amounts of medical
standards due to its specific OR focus.
devices and state-of-the-art infrastructure they are equipped with, servicing ambulatory procedures is too
Q: How has demand for these services increased over the
expensive to be considered effective. Competing against
last four years?
tier 1 hospitals is not our goal. We prefer to work toward
A: We have seen sustained double and triple digit growth
improving patients’ and physicians’ overall approach to
on a yearly basis. New found niches have resulted in this
surgery.
type of market growth. However, we continue to work toward obtaining full consent and support from doctors.
Q: How has the company benefited from being certified
We are popular among insurance companies and major
by the General Health Council?
insured enterprises who purchase these policies. The
A: Being awarded the General Health Council’s certification
newly found interest in the ASC model is contingent on
is not our ultimate goal. We must continue to build on this
our top-notch quality and competitive prices, which we
and maintain what we have achieved in terms of quality,
continue to nourish. For instance, by choosing ASMED’s
safety, and hygiene. These practices range from simple
services, clients can save up to 40 percent on surgical-
sanitary principles to rigorous processes, in compliance
related costs.
with
international
standards.
The
certification
has
enhanced our performance and our internal monitoring, Despite having garnered significant success in the Mexican
consequently improving our standards. The certification
market, paradigm shifts are always a hard pill to swallow.
has helped us achieve our purpose, which is driven by high-
As such, reluctance from key players like doctors is not
quality service offerings and zero medical contingencies.
unexpected. The level of specialization in Mexican private
The enterprise is filing for international accreditation for
hospitals is remarkable, but their services are not accessible
specialized ambulatory surgical care, which no other
to all social strata. On the contrary, some small hospitals
company has been granted in Mexico.
BIG PHARMA
3
The pharmaceutical industry accounts for 4.5 percent of Mexican GDP, according to COFEPRIS. Innovation is an important factor for drug companies as patent expirations approach and companies are investing heavily in R&D in a race to produce the drugs the world and Mexico desperately need to fight chronic and degenerative diseases. Cardiovascular diseases, diabetes and cancer are three of the biggest killers in Mexico. A stable economy and a population of about 128 million with a growing middle class make the country a fertile market for drugs to fight those diseases.
Proximity to the US market and regulatory efforts to homogenize regulations between Mexico, Canada and the US, partners in the NAFTA trade pact, are drawing companies not only to sell but to manufacture products locally. As the second largest pharmaceutical market in Latin America, Mexico is also an important gateway to the Central and South American regions. This chapter will present insight into the big pharmaceutical companies, the innovative drugs they are working on and the regulatory changes they are responding to, as well as the ethical challenges arising from a growing need to research for the next cure.
61
| CHAPTER 3: BIG PHARMA 64
VIEW FROM THE TOP: Rodrigo Puga, Pfizer Mexico
65
VIEW FROM THE TOP: Alexis Serlin, Novartis
66
VIEW FROM THE TOP: Karel Fucikovsky, Pierre Fabre
68
VIEW FROM THE TOP: Miguel Salazar, Boehringer Ingelheim Mexico and Central America
69
VIEW FROM THE TOP: Francisco Kuri , Landsteiner Scientific
70
VIEW FROM THE TOP: Mario Sturion, Janssen Mexico
72
VIEW FROM THE TOP: Morten Vaupel, Novo Nordisk
74
VIEW FROM THE TOP: Elvin Penn, Amgen
76
VIEW FROM THE TOP: José Caamaño, Takeda
77
VIEW FROM THE TOP: Vincenzo D’Elia, Alfa Wassermann Mexico
78
VIEW FROM THE TOP: Francisco Millán, Cetifarma
80
VIEW FROM THE TOP: Enrique Martínez, IIIFAC
José Ferreyra, IIFAC
81
VIEW FROM THE TOP: Alberto Wicker, SignuFarma
82
VIEW FROM THE TOP: Carlos López, Productos Medix
82
VIEW FROM THE TOP: Rebeca Madrid, Medix Pharma
84
VIEW FROM THE TOP: Sandra Sánchez, PROBIOMED
63
| VIEW FROM THE TOP
MEXICAN R&D CONTRIBUTES TO INNOVATIVE DRUGS RODRIGO PUGA CEO of Pfizer Mexico 64
Q: What is the distribution of output from your Toluca
A: Annually, Pfizer invests around 17.8 percent of its
plant in terms of therapeutic areas and is there one
income in research to develop the cure of the future.
particular sector you would like to focus on, such as
In Mexico, US$16 million is invested every year. For
vaccines or infectious diseases?
Pfizer it is important to work for the benefit of patients
A: Overall, 45.5 million units from the plant are destined
and their health to improve their quality of life. With
for the internal market and 16.5 million units are exported.
65 years in Mexico, Pfizer is working to strengthen its
Of that, our pharmaceutical products include oral solids,
portfolio to offer our country an alternative therapy for
liquids, non sterile semisolids, including vitamins, and a
metastatic breast cancer. This has been shown to control
13-valent vaccine. The therapeutic areas we work in are:
the progress of the condition and made therapies less
biosimilars, cardiovascular, immunology, infectious diseases,
invasive, which is reflected in a better quality of life and
inflammation and pain, metabolic diseases, neuroscience,
care for the illness.
oncology, rare diseases, vaccines and internal medicine. Q: Recently Pfizer Mexico published a press release Q: Globally, Pfizer has said it devotes around 18 percent
discussing the large increase of GIST cancer diagnoses
of revenues to R&D. Is that percentage being reproduced
in Mexico. Is the company aiming to dip its feet into
in Mexico, taking advantage of the friendlier regulations
diagnostics
toward clinical trials in the country?
detection of the KIT gene receptor mutation?
A: In Mexico investment in R&D has risen to MX$288 million
A: We are working with civil organizations and we are
(US$15.3 million) in clinical research. To maximize new
interested in all that is related to illness to find better
research opportunities in biopharmaceuticals, Pfizer has
options of treatment through innovation. Due to Pfizerâ&#x20AC;&#x2122;s
two R&D departments: pharmatherapeutics, centered on
research, we have developed a treatment for patients with
the discovery of small molecules and related modalities,
this type of tumor, which brings hope for the fight against
and biotherpauetics, centered on big molecule research,
this illness.
technology,
such
as
helping
with
the
including vaccines. Q: What other areas of the chronic disease spectrum is Responding to global needs, at Pfizer we are working on a
Pfizer looking at from a business perspective?
new model to undertake the clinical research necessary for
A: Pfizer is developing therapies for chronic diseases such
our medicine, which implies collaborating with strategic
as rheumatoid arthritis and other rare diseases, including
partners known as clinical research organizations who are
Gaucher disease, hemophilia and mucopolysccharidosis.
now responsible for the clinical trials we are conducting.
We also work on the most important diseases in the country such as systemic arterial hypertension.
Q: How has this area progressed in the country since the 68 active research protocols you reported in 2013?
Q: Is cardiovascular disease, which is among the two main
A: We have 70 clinical trials underway and 842 randomized
causes of illness in Mexico along with diabetes, a priority
patients in different therapeutic areas such as biosimilars,
for Pfizer?
cardiovascular,
diseases,
A: Cardiovascular diseases can be asymptomatic in
inflammation and pain, metabolic diseases, neuroscience,
immunology,
infectious
initial phases so patients need strategies for early
oncology, rare diseases, vaccines and internal medicine.
detection and handling of risk factors and consequently morbidity and mortality caused by disease. Over the
Q: Are there any new investments planned in the country
past few years, Pfizer has been working on therapies
to increase capacity or to diversify the products offered
that significantly improve the quality of life of patients
by the company?
with cardiovascular conditions.
| VIEW FROM THE TOP
SHARED RISK MODEL LEADS TO INNOVATION ALEXIS SERLIN President and Director General of Novartis 65
Q: What is the strategy behind Novartis' restructuring,
All pharmaceutical products are either small chemical
and what benefits have you already seen?
molecules or biologic components. Novartis is taking
A: Novartis became a patient centric enterprise while also
the lead in innovation by investing in cellular therapy, for
building a new culture largely focused on innovation and
example targeting pediatric refractory leukemia which is
entrepreneurship. Novartis is a large company with a wide
a condition unsolved by science. Novartis extracts cells
portfolio, which called for a business unit partition. This
from a childâ&#x20AC;&#x2122;s body, adapts them to create affinity with the
has helped us increase our focus on sub-market segments,
cancer cells, and reinserts them in the patientâ&#x20AC;&#x2122;s system.
increasing our effectiveness in patient servicing. We
The immunological system recognizes its own cells and
are strong advocates of improving our outcomes and
multiplies them, directly attacking the cancer. Our tests
producing the evidence to back it up. Supplying patients
had an almost 100 percent success rate.
with drugs that are not needed will become an obsolete practice in the industry.
Q: Why is Novartis investing US$50 million in research in Mexico, and what will be the benefits to the company and
Q: What new drugs and products does Novartis have in
the country?
the pipeline and what conditions is it focused on?
A: Our science advancements are usually developed in
A: According to international healthcare analysts, our
key centers around the world. We are trying to expand
pharma division has one of the most robust pipelines in
our R&D footprint in Mexico. Novartis envisions its
the industry. Novartis recently received the largest FDA
Mexican operations partaking in the development of every
breakthrough designations for molecule development,
breakthrough molecule for the company. That is the type
which is the highest rating any molecule can attain. As
of relevance our subsidiary will have worldwide. Coupled
such, a large number of innovative drugs will be released
with our commitment to the country, COFEPRIS incentives
by the company in the near future. Novartis will launch a
made our decision much easier.
heart failure product in 2016. Our drug will reduce mortality by 20 percent, while hospitalization will be reduced by
Q: Novartis is one of the few pharma companies using a
21 percent. Heart conditions are the main cause of work
shared risk business model. What is the reason?
absenteeism as they result in death or serious deterioration
A: This is an integral part of our goal to become health
of the human body. Patients diagnosed with heart failure
partners of choice for key institutions. Novartis wants to
have a life expectancy of five years, which is less than
bring predictability to the resources institutions use. Our
some cancers. Unfortunately, innovation in this field was
drugs are so innovative, costs associated with the disease
absent over the last 10 years until Novartis decided to take
drop. By reducing hospitalization through prevention a
the lead.
large number of institutional resources are spared, largely compensating the medicine cost. The shared risk model
Novartis follows science and we try to be at the top of the
allows us to bring predictability to the next level. When
curve in creation. The mapping of the human genome is a
pharmacoeconomic models show the benefits of adopting
perfect example as it defines the type of molecules that
new technologies.
will be developed. Novartis has recognized the wide array of diseases that the human body can contract but there are
Novartis absorbs the risk. If pre-established outcomes are
only a few hundreds of molecular expansion mechanisms
not achieved we pay the incurred drug costs. If the goal is
that a disease can have. Novartis has identified the
reached, the costs are absorbed by the institution. So far,
pathways in which those diseases can penetrate, further
Novartis has signed over 10 cooperation agreements with
developing molecules that can intercept them, which can
key institutions, making us the fastest growing company in
be later applied to a broad number of conditions.
the segments we apply this methodology.
| VIEW FROM THE TOP
MATURE PRODUCT GROWTH TO GROW THE MARKET KAREL FUCIKOVSKY Director General of Pierre Fabre 66
Q: What have been the results of Pierre Fabre’s R&D
cancer treatments. Pierre Fabre has a strong commitment
investment in the last year in Mexico?
to continue delivering successful and novel therapeutic
A: In past years and most thoroughly following the company’s
alternatives on the field.
Corporate Strategic Plan “Trajectorie” 2018, Pierre Fabre’s Toulouse R&D cluster reshaped its focus on oncology and
Q: With what companies have you partnered up in Mexico
clinical dermatology. This major change has impacted
and which partnerships are you looking for?
our operations by designing a leaner R&D structure,
A: So far we have a three-year partnership with Janssen for
gaining efficiency and a positive turnover of capabilities
a specific pool of their women’s health products, which we
and deliveries. That being said, Mexico and LATAM have
will continue in the future. We are partnering with Ferring
significantly benefitted from novel drug introduction into
Pharmaceuticals, securing the local license for Lysteda® in
the market place, such as JAVLOR® and Hemagiol®, indicated
Mexico, indicated in heavy menstrual conditions. We are
for bladder cancer and hemangioma patients respectively.
also in active negotiations with a robust Swiss company
Hemagiol® is under registration process before regulatory
specializing in the oncology field. One of our company’s
agencies in both Mexico and Brazil.
strategic imperatives relies on the continued search for co-promotion agreements, licenses, distribution channels
Pierre Fabre continues to build strong partnerships in
and collaborations with other international pharmaceutical
the global oncology field due to its R&D and business
entities engaging in the oncology, woman’s health and
development focus. LATAM with Brazil and Mexico
orphan drug fields. Under these circumstances, multiple
in particular is a key region for the group as they will
companies are knocking on our doors and exploring
serve as main pillars for the success of this treatment in
potential partnerships with us.
following years. Q: What can be learned from Pierre Fabre’s different R&D Q: How big is the opportunity in the oncology field in
and business development path?
Mexico and what are the main drivers?
A: Big pharmaceutical companies have bet their future on
A: Chronic diseases will drive the demand and growth of new
biotech and high-end technologies, which we consider a
therapeutic alternatives, including high-specialty products.
strategical mistake. This approach leaves behind mature
As the Mexican population ages healthcare services
products on low investment divestment with carry over
have to adapt and satisfy evolving needs. Considering
capabilities, losing brand equity and critical mass.
private and public healthcare providers are equipped with a broader arsenal of techniques and diagnosis tools,
Companies underestimated the difficulties that LATAM
cancer diagnoses are systemically increasing in number.
emerging countries like Mexico would have in terms of
These tools allow treatments to begin at initial stages
market access, restrictions and regulations. The public
leading to more favorable therapeutic outcomes. There
sector has significantly downsized its budget, swiftly
has been a significant switch in resource allocation from
moving to generic substitution. As such, the environment
acute diseases to chronic and degenerative conditions.
for new molecules is becoming uncertain as both private
For instance, the PrevenIMSS campaign and infrastructure
and public companies are undergoing severe budgetary
development with the PrevenIMSS initiative is the clearest
constraints. Pierre Fabre is going against the current,
example of this.
completely trusting in its mature products. We decided to invest in their development while also securing co-
Mexico’s life expectancy must also be taken into account,
promotion opportunities. This has been a successful
which is 75 years for males and 77 years for females. As
strategy for us, allowing us to have an organic top line
such, this is the right time to develop strong capabilities in
growth of 51 percent over the last four years.
Large pharmaceutical companies are often commanded
web channels and points of sale, such as Farmacias San
and motivated by their global headquarters, which are
Pablo and other department stores. Mexico is Pierre Fabre
not well acquainted with local trends. Although focusing
group’s main affiliate in a vast range of products and
on high-technology products and medical devices is
brands within the segment.
understandable, Mexico’s access barriers are complex. Lacking a local partner to support an access strategy could
Q: What are your expectations for the dermocosmetic
easily result in failure. The pharmaceutical industry and its
market in Mexico?
landscape has significantly changed since 2013, not only
A: Pierre Fabre’s slogan reads “From Health to Beauty”.
from a public perspective but also from a retail standpoint.
Covering both the health and beauty segments is truly a
For example, new players are constantly coming in while
core element to the company’s mission. We are one of the
old ones exit the market. Strategies like the physicians at
few companies that has successfully serviced this broad
the point of sale have established themselves in Mexico,
spectrum.
with close to 25,000 operating in the country. The dermocosmetic market is extremely dynamic and Q: What is Mexico’s relevance for the company’s cosmetic
continues to foster new emerging companies, products
and consumer products?
and strategic alliances. The dermocosmetic market is
A: Growth will be fairly easy considering Pierre Fabre’s
also switching toward an aesthetics approach. As a
vast experience and expertise in the segment. We will do
result, products and their combinations will have better
this not only by re-inventing our brand portfolio and their
therapeutic and cosmetic outcomes such as the combined
components but also by listening and understanding our
use of the botulinum toxin and dermal fillers. This
consumers’ needs. Pierre Fabre has developed a consistent
phenomenon is creating more awareness for end users,
communication strategy to reach consumers through
patients and consumers.
67
| VIEW FROM THE TOP
MEXICAN MINDSET UNDERPINS GROWTH MIGUEL SALAZAR President and Country Managing Director of Boehringer Ingelheim Mexico and Central America 68
Q: What are the highlights of your new plant?
A: Mexico has quality, trustworthiness and reliability of
A: As one of Boehringer Ingelheimâ&#x20AC;&#x2122;s top 10 units,
processes and products. Our corporate authorities think
Boehringer Ingelheim Mexico has influence over decisions,
beyond the quarterly reports of the markets as we are
one of which was to designate Boehringer Ingelheim
privately owned. We are much more prepared for the
Mexico as a strategic global production hub for the world.
long term. We have demonstrated that with sufficient
This is due to the quality of production. We are still the
empowerment, we are able to deliver quality products in
only Mexican pharmaceutical company allowed to export
addition to timely sales.
veterinary, OTC and prescription drugs to the US. We have been approved by the FDA since 1998. We have one of
Q: What were the reasons behind the decision to invest
Boehringer Ingelheimâ&#x20AC;&#x2122;s five strategic plants across the
more in your veterinary division?
world. Ours will be specialized in diabetes and our import-
A: Worldwide, there are two areas of innovation in
export volumes will increase.
Boehringer Ingelheim. One is human pharmaceuticals and the other is veterinary health products. We are
Q: How do you adapt to the changing economic
convinced our animal health business is going to double
landscape?
rapidly in terms of size. We plan to invest and transform
A: A distinctive characteristic of Boehringer Ingelheim is
the products, becoming the number one company in the
the way we plan for the future. We do not plan in terms
Mexican market. Hopefully this will happen by 2017.
of euros, dollars or pesos. We think in terms of how many patients can benefit from our treatments. We are very
Q: What are your new investment plans?
clear. We do not do everything; we concentrate on specific
A: We are going to increase our investment in animal
therapeutic areas in line with the Mexican population
health tremendously and we are looking to almost double
and aging. Diabetes, oncology, respiratory diseases and
our infrastructure. In terms of human pharmaceutical
cardiology are clear areas of focus. Our strategy is not to
products, we will be expanding our diabetes range by
diversify but to concentrate. However, we must overcome
three to five products over the next three years. We are
many hurdles, mostly related to access.
going to be launching CNS products by 2018. We are the highest ranked manufacturer of biosimilars in the world.
The government is proposing budget cuts and we
We will also be delivering a large number of products for
are trying to help them assess those from a different
oncology.
perspective since they could adversely affect patients. The population is getting older. The problem lies within
Q: What challenges have you encountered from the
the costly impact of diseases in the elderly. We must plan
structural change in COFEPRIS and how do you convince
for this as a country. Boehringer Ingelheim is investing
public institutions to opt for your innovative products?
heavily in ethical and compliant ways of providing access
A: The changes in COFEPRIS have been well received.
to patients, independently of whether they are in the
The commissioner and his predecessor share a passion for
government, the private sector, with or without insurance,
simplifying things. That is good news for the country. The
in urban centers or in rural areas. The idea is to allow as
commissioner is open to innovation and other alternatives
many patients as possible to have access to our products
such as biosimilars. We have discussed this topic with him
if those products are suitable for them.
extensively and we think he has the right mindset but he also knows it is not an executive decision he can take. He
Q: What advantages of the Mexican market allowed
must create a multi-disciplinary team with different points
you to become the ninth top subsidiary in Boehringer
of view and perspectives. I think this is the strength of
Ingelheim?
COFEPRIS today.
| VIEW FROM THE TOP
SPECIALTY DRUGS A PRIORITY FOR LOCAL GIANT FRANCISCO KURI Director of New Developments at Landsteiner Scientific 69
Q: What is the strategy behind the double digit growth
A: We were involved in the development of the new
for Landsteiner Scientific?
regulations for these products in Mexico as the government
A: In 2014 we started exporting to some countries in
got fully involved in discussions with academia and the
Central America, such as Guatemala and El Salvador,
industry to develop a world-class normativity. Clear
which are very close to Mexico and eager to have our
regulations and guidelines were essential to ensuring
medications. Before that, Landsteiner was only focused on
quality, safety and efficacy of all biotechnology products,
the local market. COFEPRIS has signed several recognition
whether innovative or biosimilar. This was not properly
agreements in the region, and we are capitalizing on that
established before and regulators argue that patient
to consolidate our export business. We are working with
safety was in jeopardy. The new regulation will therefore
nine countries in Central and South America, as well as the
segregate between large and small companies according
Caribbean. Also, we are finishing a new manufacturing site
to their ability to comply with new requirements,
in Toluca, State of Mexico, where some of our operations
arguably resulting in a decreasing number of companies
started in October 2015, giving us the chance to produce
commercializing biocomparables.
and process many more drugs. We are going to transfer all of our production lines to this new site while our current
Q: How do you foresee the competitive landscape of the
facility will undergo some renovations to exclusively use it
biopharmaceutical business?
to manufacture high-specialty products requiring separate facilities. High-specialty drugs and biotechnology are
A: International players have long been interested in
a priority area for Landsteiner and we want to cover
entering the Mexican market and now that having
ophthalmology, oncology and hormonal products.
a manufacturing plant in the country is no longer a requirement to commercialize pharmaceutical products,
Q: What are your latest developments in areas such as
obtaining product registration in the country is much
genomic medicine and oncology?
more accessible. Nevertheless, public institutions are the
A: We have different projects with a subsidiary of
main buyers of high-specialty drugs and to be allowed to
Landsteiner in Spain that is fully dedicated to genomic
participate in a tender companies have to demonstrate
medicine research. It has three research lines including
that 70 percent of the added value activities of a
obesity, colon cancer and Alzheimerâ&#x20AC;&#x2122;s disease. Colon
product were done in Mexico. Producers not located in
cancer is one of the most common types of cancer in the
Mexico have to find a way to demonstrate this national
US, while in Mexico prostate cancer is highly prevalent
integration through partnerships with local players for
among men. Alzheimerâ&#x20AC;&#x2122;s is still underdiagnosed in Mexico
either manufacturing, clinical development, marketing,
and being highly difficult to treat, our researchers have
distribution or commercialization.
identified candidate molecules for drug development. We expect to have the authorization for preclinical studies
Q: What do you want to achieve in 2016?
of two potential obesity drugs this year. Next year we
A: Landsteiner has had a broad line of products so it can
will conduct clinical studies in Mexico. Spain has good
provide physicians with alternatives for whatever need.
infrastructure and expertise in genomics. There is a huge
This has helped us to get a position within the healthcare
database for the Caucasian population in this Spanish
system but now we want to specialize in certain areas.
center and we want to know if their findings also apply to
We want to organize our pipeline per therapeutic lines
Mexico through our genomics division.
including obesity, cancer, ophthalmology, anemia and so on. We are aiming to grow in biotechnology and in other
Q: How can companies capitalize on the opportunity the
products, such as new combinations and we want to
new regulation for biosimilars is bringing?
strengthen our presence in the private market.
| VIEW FROM THE TOP
PUTTING PATIENT WELFARE FIRST MARIO STURION Director General of Janssen Mexico 70
Q: What goals have you set as Director General of Janssen?
been demonstrated that improvements in healthcare
A: Aligned with our pharma group strategy, we continue to
and expanding access to innovative medicines can
focus on innovation to prolong and improve the lifespan of
improve productivity. We are investing in robust medical
Mexican patients. As the pharma market has evolved over
educational programs as the pace of innovation is very
time, the competitive advantage will come only by bringing
fast. Our commitment is to ensure the correct use of new
true medical innovation that generates an impact on patient
products. They should treat the right patient with the
lives. In Mexico the approach is the same: to introduce and
correct dosage, indication and with the precise method
provide access to innovative therapies. As an industry
of administration.
and country we face several challenges in healthcare. We must attract and retain the best talent as they are the main
Q: What perception shift have you seen in governmental
element to success. We have a set of values we live by.
institutions in putting prevention ahead of cost?
These values indicate that our first responsibility is to the
A: Everyone agrees that investing in prevention is the
patients and consumers of our products, followed by our
better long-term strategy in healthcare but the execution
employees and the communities where we live. By getting
is complex. The earlier you detect and act in healthcare
that right, our shareholders should also receive a fair return.
the better the outcome. Janssen established the Disease
We live by our values and they are taken into account in our
Interception Accelerator in early 2015, an innovative
decision making processes.
platform focused on leading a shift from diagnosis and treatment of disease to one of prediction and pre-emption.
Q: How is it possible to put patients at the center of a
We began in type 1 diabetes and have since initiated
healthcare system and what should big pharmaceutical
additional ventures in presbyopia, perinatal depression
companies do to push for this?
and, most recently, oropharyngeal cancer. The pharma
A: We have been working with Mexican Institutions to help
industry needs to help to provide the right perspective
bring clinical trials to the country. Those trials will also
when evaluating innovation and move from a limited
contribute to develop hospitals and centers of excellence
view of cost to a more broad vision of value for the whole
in Mexico. In this way, the medical community, nurses and
system.
researchers will have the opportunity to work with the best support in their medical field and Mexican patients can be
Q: What can you tell us about the program you have in
included in trials with the newest treatments available. The
place with UNAM in terms of scientific investigation and
pharmaceutical industry must continue to work to show
human capital?
the value of new innovative treatments and how they can
A: In 2014 Janssen Mexico signed a collaboration agreement
transform Mexican patientâ&#x20AC;&#x2122;s lives.
with the UNAM in order to develop scientific research in the country. One of the new strategic elements in our
Q: What are the main obstacles the new drugs you
Global Research and Development group is that we will
launched have faced in in the Mexican market?
augment our internal research with external innovation by
A: As an industry we need to do more to demonstrate
implementing open innovation and building collaborations
the value of our products. Therapies that will extend a
with leading scientists in the world. Universities are great
patientâ&#x20AC;&#x2122;s life reduce the total cost to treat a patient by
sources of talent. This partnership can allow UNAM to
avoiding further hospitalization, surgeries, co-medications
interact with our R&D, medical affairs and clinical operation
and other medical intervention costs. Capturing those
teams.
benefits requires a significant effort in emerging markets due to lack of information, fragmented healthcare
Q: What can you tell us about the social programs you
services and limited electronic patient records. It has
have put in place?
A: In 2016 we received the Socially Responsible Enterprise
Q: What new projects do you have on the way?
(ESR) recognition for the 15th year in a row. It represents
A: We are confident of the impact our new wave of
our commitment to social responsibility. It is part of our
innovative treatments can bring to patients. Janssen is
core values, we are responsible for the communities we
well-positioned to drive continued annual growth until 2019
live and work with. Worldwide, navigating healthcare can
above the industry average. Our plan is to file more than 10
sometimes be difficult and some people need help when
new molecular entities and more than 40 line extensions
they are most vulnerable with a disease. Patient support
by 2019, demonstrating industry-leading R&D productivity.
programs like Enlaces in Mexico help patients under treatment by providing them with services, education
New treatments for diabetes are an unmet medical need
and tools. This is a trend in the industry, especially when
in Mexico. We are going to launch this year a fixed dose
patients with chronic diseases and under treatment
combination of canagliflozin and metformin, a new
with innovative drugs require special care to take the
class of drug that uses the kidneys to release glucose.
treatment such as injections or small procedures. They
We will continue our efforts in the area of oncology and
can get the treatment from well-trained healthcare
hematology to launch two new products in 2016 and more
professionals with the necessary equipment and receive
in 2017-2019. We have just received regulatory approval for
nutritional support.
bendamustine in Mexico for hematologic indications. We have a new immunology product in oncology for multiple
Creative psychological interventions such as art therapy
myeloma. Our commitment to neuroscience is reinforced by
are widely used in combination with drugs to help patients
the upcoming introduction of a long-acting injectable drug
with schizophrenic diseases. Janssen Mexico has developed
to treat schizophrenia, which requires only four injections
and sponsored a painting contest called “Sensibilidad sin
a year. We recently received regulatory approval for a new
Límites”, a long-term commitment to provide an additional
combination of drugs to help patients with HIV.
incentive to patients under art therapy. Our corporate vision: “Caring for the world, one person at a Janssen has developed the short story contest called “¿Te
time inspires and unites the people of Janssen Pharmaceutical
cuento mi cuento?” for children with diagnosed attention
Company of Johnson & Johnson. We embrace research and
deficit disorder with hyperactivity, aimed at recognizing
science bringing innovative ideas, products and services to
creativity and imagination and to reduce disease stigma.
advance the health and well-being of people.”
Innovation. Imagine the possibilities. At Janssen, we have big dreams. We imagine a time when diseases can be treated before people feel sick. When those in need can access life saving medicines, no matter where they are. And when treatment options are so convenient people can spend more time doing what they love. It’s about radically challenging the way diseases are thought of, dealt with, prevented and intercepted. Now, and in the future. By collaborating with the brightest minds in every field, we’re turning big visions into game-changing solutions. Because patients are waiting. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com.mx
Janssen Cilag, S.A. de C.V. © JC, S.A. de C.V 2016 The image depicted contains models and is being used for illustrative purposes only.
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PREVENTION CAN MINIMIZE DIABETES EPIDEMIC MORTEN VAUPEL VP & Director General of Novo Nordisk 72
Q: What impact has Mexico had on the company’s core
prevention would minimize the epidemic. We want to
global business and its plans for the market?
be a responsible partner with the public sector to raise
A: The state of obesity and diabetes in Mexico made it a
awareness and to implement initiatives to support change.
core market for Novo Nordisk. The company has invested
We offer medication and print publications and reports in
heavily in our operations in the last five to six years. This
collaboration with the Federal and Mexico City Ministry
effort has been rewarded. The company has climbed from
of Health. Those publications involve an annual report
eighth or ninth in the private diabetes market to number
and magazines that explain the impact of obesity on a
three. Evidently this also pushed us to strengthen our
person’s health. It is interesting to evaluate the facts of
position in the global diabetes market. In the last four
obesity to understand why it is now considered a chronic
years, we have grown in double digits and we expect
disease instead of a lifestyle issue or simple risk factor. Our
to continue to do so in coming years. To do so we must
investigations even explore the financial impact of obesity
continue to raise our market position. Our clients are
on society, like the implications of Mexican investment in
balanced between the private and public sector but we
obesity complications.
are particularly proud to be the biggest supplier of human Q: What trends do you expect will reign in the next
insulin to the public sector.
decade in obesity and diabetes? Q: On top of the government campaigns to raise
A: Optimistically, we hope the country has reached a peak
awareness, what support does Novo Nordisk offer to
in obesity and diabetes. Mexico has one of the youngest
combat diabetes?
populations in the world and as birth rates have dropped
A: As 70 percent of the population qualifies as overweight
we may see an aging generation and an increase in type
or obese, increasing numbers of diabetes cases are
2 diabetes. Realistically however, if we break the habit
unavoidable.
several
among younger generations we may preempt diabetes
years of untreated overweight or obesity, interlinking
Type
2
diabetes
results
from
resulting from long-term obesity. The government is
the two issues. Therefore, overweight and obesity
dedicating sufficient attention to the issue, following the previous Minister of Health’s diabetes and obesity strategy published three years ago. President Peña Nieto supported this and simply recognizing the disease as a problem for the country has raised awareness. With education, prevention and strong treatment, Novo Nordisk can declare cautious optimism for the obesity issue facing Mexico. Q: What are the advantages that Mexico could present to companies interested in investing in the health industry?
Around 20 percent of patients in Mexico go to the hospital for treatment of chronic diseases such as diabetes
A: Mexico is an excellent location for clinical trials. Novo Nordisk has quintupled its staff working in clinical trials in the last five years and has increased the number of trials and patients enrolled in them. We expect 2016 to close with 10 clinical trials and next year seven more are scheduled. This number will continue to increase, concentrating on private clinics that host our trials. Costs are competitive in the country and our company has invested considerably
in this area in Mexico. The regulatory authorities recognize
increased our prices by that quantity. However, our belief
the benefits of a proportion of the local population
that the Mexican economy is sound has meant that we will
testing a drug, as it helps them feel safer authorizing the
allow fluctuations and trust that the underlying economy
medication.
will cause the peso to recover its value. We will keep our price developments modest as always regardless of
Novo Nordisk has doubled the size of its organization in
inflation. While this will temporarily affect our bottom line,
Mexico in five years, exemplifying the importance of the
it will protect our patients from drastic price increases of
market for our company. Our investment in clinical trials
medication they depend on.
is supported by product launches. Seven products in the pipeline to treat type 1 and 2 diabetes will likely be tested
Every year we launch a new compound. Our existing
in Mexico. Some of these products, such as semaglutide,
insulin has been on the market for 15 years, but we recently
treat both diabetes and obesity. Our trials catering
launched an update called Tresiba速 that works for longer
to obesity and diabetes are largely tested in Mexico,
and has fewer side effects. Ryzodeg速, another release,
though we do not yet have plans to introduce hemophilia
is a fast acting drug with the basal insulin component
treatments to clinical trials in the country. These will play a
that diabetes patients can take when they eat. This year
part in our expansion plans.
Saxenda速 was introduced to the market to target obesity and product launches are planned for items like Xultophy速
Q: How does the company expect to expand in light of
next year and in 2018. This once-a-day injection has
recent global changes to increase market penetration?
passed clinical trials. While we are the third company in
A: The peso has lost approximately 30 percent of its value
the market, in the long term we hope our new products
against the dollar in the last year, so we ought to have
will help Novo Nordisk to lead the market.
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INVESTMENT OPPORTUNITIES IN BIOTECH ELVIN PENN Director General of Amgen 74
Q: Amgen has one of the most remarkable portfolios
Q: What market needs are you aiming to satisfy in the
in the pharmaceutical industry. What new products do
Mexican market with your upcoming products?
you have in the pipeline?
A: We will launch an important cardiovascular disease
A: We have been present in Mexico since 2006 with our
drug – the first biologic to be approved worldwide
R&D operations and we started commercializing our
for the treatment of hypercholesterolemia. This is a
products in 2009. We have launched 10 products to the
monoclonal antibody that aims to cover a significant
market and eight are already included in the National
portion of the Mexican population. As we know, obesity
Basic Formulary. The main focus of our company is
and hypercholesterolemia are prevalent diseases in the
innovation and we keep investing in R&D. Last year
country and this medicine will target LDL cholesterol
we devoted 19 percent of global revenue to this area,
levels in patients who are uncontrolled. We are certain
accounting for US$3.9 billion worldwide, and focusing
that our new medicine will set up a revolutionary trend
mainly on oncology, hematology, bone health and
in the treatment of high cholesterol.
nephrology. At this point we have 20 new molecules in the pipeline, some of which are already in phase III trials.
Q: What barriers do you think your product Evolocumab will have to overcome to gain access to the public
Q: What role are emerging markets such as Mexico
sector?
playing in the company’s growth?
A: Mexico is a very important market but still has much
A: Amgen is present in more than 100 countries and we
room to improve access to innovation in the public sector.
expect Mexico to continue growing as it is the second
Equivalence agreements between COFEPRIS, the FDA
largest market in Latin America after Brazil. We are
and EMA have made drug approvals more expedite. But
focused on innovation and increasing access.
the public sector can further improve patients’ access to high-specialty drugs since a new drug can still take
Q: How much local and multinational competition do
up to four years to be included on institutional basic
you see in the Mexican biopharmaceutical market?
formularies. All players in the healthcare sector have to
A:
Biotechnology
is
continuously
growing
in
the
work in collaboration to improve this situation. We are
pharmaceutical industry at a faster pace than chemical
committed to continue working with local authorities to
entities. Data from FUNSALUD show that the ratio of
improve the timelines for both approval and access to
biotechnology products to chemical entities is 3:1, hence
innovative drugs.
we expect this segment to continue growing. According to COFEPRIS, 35 percent of the drugs that are approved in
Q: To what extent are Mexican product registrations
Mexico are biologics and we assume this to be a sustainable
already recognized in other countries?
trend. Moreover, biologics account for around 30 percent
A: COFEPRIS has signed equivalence agreements not
of the products undergoing clinical development.
only with the FDA and EMA but also with other Latin American countries. This does not mean all products
“Mexico’s potential to grow
registered in Mexico can immediately enter other
in clinical research is very
Regulatory recognition among countries is evolving
promising compared to other countries” Elvin Penn, Director General of Amgen
markets in the region but the process is actually faster. and will certainly play a much more relevant role in upcoming years. Q: What sort of patients should be prescribed with Evolocumab?
A: High cholesterol has been traditionally treated with
we will keep focusing on our R&D operations. Amgen
statins. There is still a need in the market because there
has invested more than MX$300 million and we have
are many high-risk patients with uncontrolled levels of
18 ongoing clinical trials in important centers such as
cholesterol despite being on a statin regime. Genetic
INCMNSZ and La Raza. Our new treatment for high
diseases such as familial hypercholesterolemia are also
cholesterol is also going to be on top of our agenda
a good target for this new treatment, as well as patients
thanks to the opportunity it offers to control cholesterol
with statin intolerance. This medicine represents a unique
levels. Mexicoâ&#x20AC;&#x2122;s potential to grow in clinical research is
opportunity for both patients and healthcare professionals.
very promising compared to other countries. We have to make sure this medicine gets to Mexico and physicians
Q: Innovative biotech drugs are perceived as expensive
use it as soon as possible. Mexico is a very important
treatments in the public sector, which is always pushing
market for the global pharmaceutical industry because of
for lower costs, how are you going to valuate this new
its huge population, and we see a significant opportunity
drug in the market?
to increase our investment in clinical trials. Mexicoâ&#x20AC;&#x2122;s
A:
The
potential to grow in clinical research is very promising
development of a new medicine can take more than 10
Innovation
requires
significant
investment.
compared to other countries. The industry is investing
years of work and between US$1 billion to US$2 billion, so
US$160 million in clinical research in the country today,
these efforts must be compensated to continue existing.
and there is potential to increase that investment up to
Healthcare institutions also have to realize that in most
US$5 billion in 10 years.
cases, innovation represents savings in the long term as new treatments solve medical problems faster and more effectively. Ensuring ROI is crucial in the biotech industry given that patent expirations are likely to be followed by the launch of biosimilars. When this happens, the system can increase savings because costs go down, whereas innovative companies have to ensure a continuous return. Amgen is committed to developing and launching biosimilars since they can cover a wider population, helping the healthcare system. These medicines require a significant effort to be developed because their comparability and effect has to be demonstrated through clinical
studies,
not
only
through
physicochemical
characterization methods. We expect to launch our first biosimilar in a couple of years in Mexico. Q: What are your biggest priorities for 2016? A: We will continue promoting our products and expanding access in the public market in Mexico. Also,
The development of a new medicine can take more than 10 years of work and
between US$1 billion to US$2 billion
75
| VIEW FROM THE TOP
ACCESS TO MARKET VITAL TO SUCCESS JOSÉ CAAMAÑO Director General of Takeda 76
Q: Where does Mexico fit in Takeda’s transformation into
Q: How does the fragmentation of the healthcare system
a global company?
affect your strategy of putting patients at the center?
A: Mexico is among the top 10 countries for Takeda and it
A: We must seek better collaboration considering public
is extremely relevant to the company’s growth and global
institutions cover 90 percent of Mexico’s population. The
strategy. Gastro is Takeda’s most significant product line,
Mexican system consists of many institutions, each with
making it a leader in Mexico. It is also building its oncology
different policies and processes. We are building a solid
portfolio but market access is vital to the company’s
structure to adapt to each institution and to proactively
success. We have recently launched two products in this
accelerate our processes, which results in timely and
area, with two more in development. OTC products are an
efficient product availability for patients. This is a good
important element to our strategy, For diabetes we have
time for the private market, which can be seen by the
a hypertension drug and a DPP-4 inhibitor because one in
number of investors coming to Mexico. According to
two diabetic patients suffer from hypertension. In Mexico,
Business Monitor, Mexico is the third safest country
ferranin is a market leader and accounts for more than 20
to invest in Latin America, behind Chile and Uruguay.
percent of Takeda’s revenue stream.
Although these countries are more stable their market size is smaller. In addition, Mexico’s GDP will continue to
The company’s main social responsibility program focuses
grow by 2-3 percent in following years, making it the best
on anemia, with 54,000 units of ferranin administered to
private market to invest in.
over 40,000 Mexican children. Selling or licensing other specialty portfolios is also part of Takeda’s strategy,
Q: How are you collaborating with public institutions to
which was recently achieved with three main respiratory
improve market access so that more patients can benefit
products awarded to AstraZeneca. Considering vaccines
from your new medicines?
are part of our global core business, we are working with
A: We should not only be a supplier to the government but
Univercells to introduce new vaccines to the Mexican
allies and business partners focusing on the health of patients.
market, such as a new dengue vaccine undergoing clinical
Access to medicines plays a critical role in putting patients
phases II and III. The key stakeholders in the vaccine
at the center of the healthcare system. We are developing
industry are the WHO, PAHO and the government. We
new and unique risk-sharing models. This approach will help
expect to develop our vaccine unit in the mid to long
us collaborate and benefit larger volumes of patients with
term, while focusing on the GOODX strategy in the short
innovative medicines. Considering our products are directed
and midterm.
to niche market segments from catastrophic diseases, we must cover them through any institution, which cannot
Q: How has the culture of Takeda changed as part of the
happen without full alignment with the government.
process to become a company with global operations and standards?
Q: What do you want to achieve in 2016?
A: Transforming a company’s culture and incorporating
A: We are committed to launching six innovative products
new sets of values and beliefs takes between three to
over the next three years, which includes a first class drug
five years. Every decision we make must improve the life
for multiple myeloma, a medicine for hyperuricemia and a
quality of our customers. Putting patients at the center of
complement for our diabetes line. Takeda will be a largely
any pharmaceutical operation is no easy task as physicians
recognized company in Mexico, not only for its sales but
are considered direct clients for pharmaceutical firms but
also for its positive impact on both patients and society. We
physicians now serve as strategic allies. As we cannot
will receive the Great Place to Work certification by 2020,
directly talk to patients our collaboration with physicians
as well as the inclusion in Mexico’s top 100 ranking. We are
is that much more valuable to us.
building a brighter future for our stakeholders and patients.
| VIEW FROM THE TOP
WINNING MEXICO WITH AN EYE ON LATAM VINCENZO D’ELIA Director General of Alfa Wassermann Mexico 77
Q: What were the market opportunities that led
Q: What can you tell us about Alfa Wassermann’s online
Alfa Wassermann to Mexico and what has been the
Campus?
development of this subsidiary?
A: Through our e-learning platform we can train our sales
A: Alfa Wassermann is an Italian company whose initial
force in-house with an internally developed matrix. Alfa
focus was Europe. When the company decided to expand
Wassermann understands the importance of continuous
operations to Latin America, assessing the most viable
training and the Campus program ensures it. We will
entry market for the region was crucial, factoring the
continue to use this means of teaching to evaluate our
country’s economy, availability of capable human labor,
sales force’s performance and knowledge on a regular
political stability, tax law, regulatory issues and extensive
basis but the online Campus will never exclude face to face
distribution channels. Under those circumstances and
training. We have inserted content from clinical studies,
coupled with its growth potential, we realized Mexico was
helping our sales force understand medical conditions
the most attractive market. Domestic medical needs were
at a deeper level. In addition, we can keep track of our
aligned to Alfa Wassermann’s product offerings and so
sales force’s development and performance, helping us
Mexico became our Latin American point of origin.
produce a clear evaluation of each individual. Under these conditions, the impact of the Campus program has been
During the last decade, the pharmaceutical industry has
quite fruitful. Even though this is a Mexico initiative, other
undergone major changes in areas like regulatory practices,
global operations have developed a similar e-learning
market
distribution
platform. We expect to soon integrate them into a single
channels and healthcare providers. This new environment
access,
generic
development,
network and homogenously insert the solution to all
has impacted the industry’s growth, leaving clear winners
operations.
and losers. Alfa Wassermann has been quite successful in understanding this new scenario, implementing strategies
Q: How does the Mexican tendency to focus on generic
that helped it fall on the winning side. For instance, from
drugs affect Alfa Wassermann’s growth strategy and how
2012 to date, the company has had an average market
will the company face this hurdle?
evolution of 125 percent.
A: We do not compete directly with the generic segment because all of our products are still under patent. However,
Q: What are the main therapeutic areas Alfa Wasserman
their growth has undoubtedly impacted our operations,
is targeting?
eating away market share previously attributed to
A: Alfa Wassermann focuses mainly on gastroenterology
branded products. Alfa Wassermann plans years ahead
and peripheral vascular diseases. As of today, our biggest
of the potential arrival of a generic counterpart. As such,
blockbuster is Flonorm© but we plan to broaden our
we coordinate new product innovations and releases with
gastroenterology
patent expirations.
portfolio
with
new
products
and
innovations. The company invests 12 percent of its yearly revenue in R&D operations, keeping true to its DNA as
We also develop programs targeting our patients’ needs,
an innovative enterprise. Gastro will continue to be Alfa
adding benefits to our products before the arrival of a
Wassermann’s main therapeutic segment as becoming
given generic drug. To cover the growing competition,
the world leader in gastroenterology is its biggest goal.
as well as future product launches, the company has
We also can expect a future entry to cardio-metabolic
systemically increased its headcount on a yearly basis. As
and rheumatology-orthopedic segments. Mergers and
a newcomer in the Mexican market, Alfa Wassermann is on
company acquisitions will provide additional access to
the winning side of the industry. Still, we continue to work
new products and therapeutic areas, directly helping us
exhaustively to reach market share critical mass and brand
in this endeavor.
recognition.
| VIEW FROM THE TOP
ETHICAL GUIDELINES SUPPORT INDUSTRY GROWTH FRANCISCO MILLÁN Director General of Cetifarma 78
Q: What is the main purpose of Cetifarma in the Mexican
agreement between the pharmaceutical industry and the
industry?
medical societies of private and public hospitals.
A: Over 10 years, we developed a self-organization plan linked to the compliance of the ethical and deontological
The pharmaceutical industry also needs to establish criteria,
codes. Cetifarma has incorporated as members not only
indicators and standards on what can be considered quality
pharmaceutical companies that produce chemical or
medical training and how to certify our training.
natural medicines but also companies that manufacture medical devices. The decision to include medical devices
There is also a need to increase support for research and
manufacturers is related to non-infectious chronic diseases
clinical trials. The pharmaceutical industry is committed to
that
musculoskeletal
increasing investment in these two fields in our country.
system diseases are usually solved through the use of
affect
Mexicans.
For
example,
Cetifarma needs to make sure that every clinical trial that
prosthesis or special devices. Cardiovascular diseases are
is performed observes the ethical principles and guidelines
also common among Mexicans, including hypertension.
that have been accepted worldwide. Pharmaceutical
For this particular disease several medical devices have
companies that perform human trials need to respect their
been designed, such as cardiac pacemakers and stents.
patients’ autonomy and dignity. They also need to respect
The compliance of all our members with the ethical and
and comply with the decisions that ethics committees
deontological codes helps the industry to have a better
take regarding their procedures or products. Cetifarma
communication process, respecting the patients’ needs.
works closely with the National Commission of Bioethics, the institution that approves the conformation of research
Q: What are the main opportunities Cetifarma has
ethics committees in the private and public sector.
detected in the Mexican Industry? Q: There are several opportunities we have detected that
Another issue requiring our attention is the promotion of
would allow us to strengthen our self-regulation system.
a transparent culture within organizations. It is important
Cetifarma needs to take concrete action to reinforce its
that we make the effort to provide transparency on the
relation with medical societies. We need to work closely
interactions that take place between pharmaceutical
with physicians to make sure they comply with a code
enterprises and health professionals. Our objective is
of ethics so we can ensure the pharmaceutical industry
that by July 2017, individuals will be able to find reports
supports the training of health professionals that act
on the companies’ websites regarding the support and
according to ethical guidelines. There needs to be an
investment they have given to medical societies, to continuous medical training of interactions and to research
“Our objective is that by July
and clinical trials.
2017, individuals will be able to
The strengthening of consensus with stakeholders is
find reports on the companies’
transparency agreement with the General Health Council.
websites regarding the support
provide health services, national medicine academies
and investment they have given to medical societies” Francisco Millán, Director General of Cetifarma
also a point that needs attention. In 2007 we signed a Signatories were the sanitary authorities, institutions that of surgery and pediatrics, UNAM’s and IPN’s medical schools, the National Association of Private Hospitals and the National Medical School. This agreement allows a complementarity between authorities, professional health institutions and the pharmaceutical industry.
Another linking mechanism we are working on is an
world face. Our participation on international forums
agreement on co-regulation between the pharmaceutical
allows us to update constantly our practices and to
industry and the sanitary authorities. This agreement
improve them.
specifies that law abidance is tied to the compliance of ethical principles. The regulator entity must confirm the
Q: What is the ethical discussion that took place in Mexico
law is being followed and Cetifarma has the responsibility
regarding the usage and production of biotechnological
to confirm that ethical codes are being met. This
medicinal products?
agreement considers complementarity and information
A: The ethics discussion was focused on ensuring that
sharing between Cetifarma and the authorities.
the safety, quality and efficiency of biotechnological products are equivalent to those of the innovator. For this
Unfortunately, we have found that not every medical-
to happen, pharmaceutical companies that produce bio-
related entity complies with the necessary guidelines.
similar products must comply with the necessary norms.
When these cases are detected we are forced to apply
Not only the legislative conditions must be met but also
sanctions. In 2007 and 2009 we witnessed an important
the ethical commitment of providing products with the
increase in controversies. The increase arose because
same quality characteristics the sanitary authorities
those were the years that our conduct codes were
demanded from the branded product.
updated to meet international standards. This particular situation led Big Pharma companies to make adjustments
Unlike biochemical products, biotechnological medicines
to comply with international codes. Part of our job is to
involve the usage of biological molecules, which have a
work as a mediator when these situations arise between
less stable behavior than pharma chemicals. Therefore,
pharmaceutical enterprises.
the production process of biotechnological products must be controlled to ensure the quality and efficiency
The most important thing regarding the promotion of
of these products. The patient’s safety must always
an ethics culture is the prevention of practices that do
be the final purpose. It is important to recognize the
not comply with the codes. That is our mission: prevent
efforts made by the pharmaceutical industry, the medics,
through education and monitoring. For the monitoring
the authorities and organizations such as Cetifarma.
task, we have developed alongside the companies’
Medicines in the Mexican market comply with safety and
compliance officers a monitoring focused on probable
efficiency standards.
risks. For the model to work, the firms must identify the areas that are more prone of failing to meet the conduct code. Once they have been identified, the companies can take the necessary actions to prevent inappropriate conduct. Q: What is the extent of Cetifarma’s participation in the international arena? Q: Since 2006, Cetifarma is the only Latin American pharmaceutical association that has a seat at the IFPMA’s Code Compliance Network. On this compliance network are Big Pharma companies and self-regulation organisms, sharing experiences of the progress made in the obedience of conduct codes. Also, we were asked by the Ministry of Economy to participate in the drafting of ethical guidelines known as the Mexico City Principles, for the interaction of bio-pharmaceutical companies of the APEC region. Cetifarma is an active member of the working group of this region. Cetifarma also is a member of a Latin American Compliance Group that allows us to share information between countries
regarding
challenges
the
pharmaceutical
companies face in the region. The technical secretary of the IFPMA also participates in these meetings and shares information of the challenges that other regions in the
Cetifarma publishes ethics and deontology codes for several aspects of the pharmaceutical industry, covering
transparency to good advertising and publicity practices and also serves
as an arbiter in cases of disputes
79
| VIEW FROM THE TOP
INTEGRAL SERVICES LEAD PUBLIC SECTOR PURCHASING
80
Enrique MartĂnez Director General of the Pharmaceutical Innovation and Research Institute (IIIFAC)
JosĂŠ Ferreyra President of IIIFAC
Q: What information can pharmaceutical companies
EM: The concept of market access is also understood
obtain from the audits IIIFAC conducts?
differently by companies. A pharma-economic study is
EM: We conduct audits of the public sector market, the most
just one part of the process in developing a full health
important one being INEFAM-SP, which provides strategic
economics study but regardless of the results obtained we
information on pharmaceutical sales to that segment. This
know the studies will not guarantee access to institutions.
audit stands out for its comprehensive information, covering
An actual access strategy must include communicating
95 percent of market value and representing excellent
scientific knowledge to create understanding and demand.
input for pharmaceutical companiesâ&#x20AC;&#x2122; strategic decisions.
This is why companies have developed models to improve
Looking closely at the public sector is essential, considering
access through specialized human resources who are
that it accounts for more than 50 percent of the overall
knowledgeable of the public market and the differences
pharmaceutical market. On the other hand, our INEFAM-RX
among institutions. Within a company, coordinated efforts
audit generates data on the prescription market.
should be made by leaders opening the market and executives positioning the products. Different strategies
JF: The Mexican public healthcare system consists of
are required depending on the nature of the product
more than 150 public institutions or payers, which provide
such as generics, high specialty or orphan drugs. Other
healthcare services to more than 115 million Mexicans.
important factors are the targeted institutions and price.
These institutions have different purchasing habits, basic formularies and pricing lists, making drug acquisition
Q: What services are public institutions demanding with
highly complex. Basic formularies have different formulary
the rise of consolidated purchasing and subrogation?
codes for each medicine, and our mission is to help clients
JF: The practice of consolidated purchasing is standardizing
understand what products are acquired, at what price,
the sector. Decentralized institutions are acquiring integral
and who is providing them. While there can be a dominant
services for purchasing, storage and distribution of
player taking over IMSS and ISSSTE its presence can be
supplies, as well as the delivery of services directly related
weak in other states or institutions.
to the patient. Integrators also support institutions by managing sophisticated and expensive equipment along
Q: What are the most relevant purchasing behaviors of
with expert personnel. In addition, specialized services
public institutions regarding innovative drugs?
such as hemodialysis are being handled by third-party
EM: Institutions have their own drug review processes,
clinics today. This is changing market dynamics in such a
which duplicate the process executed by the General
way that pharmaceutical providers now have to negotiate
Health Council. They face the problem of allocating
with private companies holding subrogated services. These
resources to a specific medicine while divesting in other
kinds of services are now worth MX$20 billion (US$1.8
areas. Like any other healthcare system in the world, there
billion) and are growing significantly. This is an innovative
is a plethora of needs and scarce resources to satisfy
commercialization model and as declared by the Ministry
them. A study we conducted between 2009 and 2013
of Health the greatest demand for the industry is to stop
found there are medicines incorporated into the National
selling supplies and provide health services instead. The
Formulary that are still not acquired by any institution and
fact the market is demanding integral services and shared
sometimes they only buy 40 or 50 percent. In the case
risk models will make professionals understand how to
of biotech drugs, 111 out of 128 products were acquired
deliver value.
by public healthcare institutions between 2009 and 2014. EM: From 80-90 percent of sales of high specialty Q: Given the lack of resources in public institutions, how
medicines are made to government institutions so
can companies improve market access?
companies will have to face the challenge of adapting.
| VIEW FROM THE TOP
PATIENT COMPLIANCE TO REDUCE PHARMA LOSSES ALBERTO WICKER General Director of SignuFarma 81
Q: Where is the pharma industry heading?
companies. We have developed several tools, like a patient
A: In the pharma industry you cannot only provide
feedback program. We interview patients regarding their
medicine anymore. The industry is heading toward
quality of life improvements with treatment and then we
delivering the product along with support for the patient
deliver evidence-based results to the physician, for him to
to achieve the best outcome possible. In 1997, SignuFarma
see in real time and in the voice of their own patients the
started its integrated doctor-patient system. Many saw
positive outcomes. A common complaint from patients
this as just a temporary program to follow the trends at
is that they have difficulty finding the medication in
the time, but we saw that there wasnâ&#x20AC;&#x2122;t an answer to solve
pharmacies, so we have operated for the past nine years
the big problem, which was the large amount of money
a mail-order pharmacy to distribute medicine nationwide.
lost, around about 40 percent of the business the pharma industry loses because of lack of patient compliance.
Q: How can patients be sure their data is safe with the use
Patients need relevant material to help with their treatment
of these information-sharing apps?
so we have created several solutions. One is to accompany
A: We complete a tech-response paper that tells us the
the patient through their medical journey and treatment
needs of every company we work with. This document
to see what they truly need. They need patient education
says which firewalls and what technological protection
where they can learn what to expect from the treatment.
they will need for us to work with them. As everyone knows, data is never 100 percent protected but we use
Q: What are you doing to accomplish these goals?
cloud-based
A: We are taking advantage of technology such as
strong protection. Also our call centers have special
sophisticated and dynamic CRM programs that deliver
computers that block anyone from removing information
information to our clients in the pharmaceutical industry.
from them. All employees sign a confidentiality contract
We gather the information, put it in our apps and transfer
that bars them from giving any of this information to other
to our platform on a daily basis. We have an app for data
parties. About 95 percent of the patients have given their
managers that interview physicians about patients to
informed consent. And finally, the physicians also sign a
deliver the information to us. Another app is a disease
disclaimer that says the information collected can only be
management program for physicians. We deliver a tablet
used for the stated purposes.
encrypted
technologies
that
guarantee
to them and they add the information to collect in real time. We also have a patient app in development. With
Q: Who do you work with and who are you looking to
this technology, we have reached 95-97 percent patient
work with?
compliance, which means at least 95 percent of patients
A: We were pioneers with Pfizer for more than 10 years,
are compliant within 1-3 years. For the first time we have
BMS, Roche, Janssen, Lundbeck and Amgen, who we
developed an agreement that bases pay on positive
are working with and developing a strategy to deliver
patient outcomes. The average cost of treatment for a
biotech drugs to patients. We have worked with almost
patient is around MX$300,000 (US$16,000).
every international company in Mexico and abroad, and some national companies. Our next step is becoming more
Q: How do you give patients medical education and
technological. We would like to implement cost-effective
information?
ways to monitor the quality of life for patients using
A: Most of this first class medical information is sent by mail,
digital health. There are some new interesting devices
e-mail and sometimes with packages of medicine. There
on the market like a pill bottle that monitors medicine
are also many points to consider with compliance and
intake. We would also like to deploy a big program for the
regulatory laws to observe in COFEPRIS, so SignuFarma
government. To expand the benefits for more people, we
takes care of those things on behalf of pharmaceutical
need to be able to reach them through public institutions.
| VIEW FROM THE TOP
CREATING PERIPHERAL SOLUTIONS TO EXPAND REACH CARLOS LÓPEZ CEO of Productos Medix
82
Q: How has the company evolved in the Mexican market?
known as an integral drug provider, it also wants to service
A: Medix changed its business focus in 2006 concentrating
the industry through differentiated products. As such,
on
a
every new product release must have an added benefit,
pharmaceutical manufacturer and creating peripheral
the
overweight
and
obesity
fields.
We
are
which CIDEFARMA helps us develop. All in all, Medix’s
solutions that could help us expand our reach was part of
biggest differentiator is its integral treatment model,
our model. Our overweight and obesity crusade accounts
which we are constantly improving and polishing through
for 15 percent of our sales. It looks to build link-up programs
data gathering.
between companies and public institutions and to create health initiatives to fight the issue. We also imported a line
Q: What is Medix’s market share and how is brand
of meal replacements from the US called Medifast.
recognition in the Mexican market? A: We are the market leader in obesity and overweight
Q: How has CIDEFARMA helped in terms of creating
pharmaceuticals. We hold 47 percent of Mexico’s market
additional tools in the fight against obesity?
share, in addition to 50 percent Central America. The latter
A: We created the Center for Pharmaceutical Research
does not account for our most recent product releases in
and Development (CIDEFARMA) to help the company
Argentina and Brazil, which will boost brand recognition in
stay ahead of the innovation curve. Even though Medix is
Latin America. We are constantly expanding our product
| VIEW FROM THE TOP
PROMOTING DIAGNOSIS THROUGH FREE TREATMENT REBECA MADRID Corporate Commercial Director of Medix Pharma
Q: How has Medix Pharma’s business model changed with
Q: How have you managed to create a successful product
the surge of different treatment options, such as low-cost
portfolio in relation to your competitors?
pharmacies with free medical consults?
A: We are specialized in overweight and obese conditions.
A: In the past we had a very traditional business model.
We have a very broad portfolio with more than 13
Our sales representatives would go into a doctor’s
alternatives that can be customized and can work together
office and offer our product. But pharmacies with free
to create integral, personalized solutions for our patients.
medical offices generated an interesting change for the
We are expanding our product ranges due to the change in
pharmaceutical industry. This new model was initiated by
patient needs. We are seeing complications from obesity
generic drug pharmacies that notified patients looking for
we did not see in the past, such as venous insufficiency,
treatment.
spine and knee pain. Despite the need to grow our portfolio, we are not introducing OTC medication, we are
We started in public squares offering people the
not overriding doctors.
opportunity to know their weight, their glucose index and the possible risks they could face if they were overweight.
Among all the products we offer, we have two very
The idea was to present the solution to a problem many
successful products. Oblecox® and Redotex® are our best
people did not think they had.
positioned products, especially the latter. The success
and service portfolio, further improving our position as
A: Besides common distribution to pharmacy stores and
differentiated solution providers. Through the International
communication with general doctors, we have opened
Division, Medix is expanding its integral solutions to
other distribution channels. For instance, Medix evaluates
countries in the Latin American region. We have detected
and develops health programs with partnering companies,
a lack of specialized companies with enough history
helping its employees reach their desired weight. Medix
behind them and as a result we will continue to increase
also opened a Consumer Division, focusing on aesthetic
our presence in the region. Dominican Republic, Brazil,
and overweight issues, rather than in obesity. We want to
Paraguay, Argentina and Ecuador are among the markets
tackle the problem before it escalates and our Consumer
where Medix has a strong footprint.
Division offers that opportunity. Ten years ago, Medix was the fifth largest pharmaceutical manufacturer of
Q: Mexico suffers from the highest obesity margins in the
overweight and obesity products. Placing these ailments as
world. How can it improve?
the company’s core business gave way to its current market
A: Both overweight and obese conditions are complex
share, coupled with its integral business model. We have
issues that deeply impact the health of society. They
the largest portfolio of differentiated products for these
require specialized and individualized solutions, contrary
types of ailments, adding effectiveness to our treatments.
to common belief. Even though it may increase the intricacy of our treatments, it also adds effectiveness.
Q: How is Medix helping the industry create a preventive
The biggest misconception surrounding this type of
culture against obesity and overweight?
condition is that through diet and exercise everything can
A: Educating physicians and patients is the first step.
be fixed. Psychological and genetic propensities, labor
Unfortunately, not enough attention is given the preventive
requirements, cultural and family issues should be taken
scope of obesity, as academic institutions are more
into account by our health specialists.
focused on healing and remediation once the disease presents itself. Medix offers training programs through
Q: What are Medix’s distribution channels that are helping
its collaboration with the Latin American Institute against
it achieve 47 percent market share?
obesity and overweight.
of Redotex® can be explained by its efficiency in helping
the costs of obesity treatments for people with economic
people lose weight.
shortcomings.
Q: Why would you say that obesity’s rates have tripled in
If we expect to solve the obesity crisis, we need to increase
the past 10 years, making Mexico the leading country in
awareness and prevention campaigns. The Crusade is a
weight-related problems?
program focused on diagnosing employees from private and
A: The Mexican population’s lifestyle has played an
public enterprises for free. We conduct our diagnosis and
important role in obesity rates. Physical inactivity is more
we present the company with a general panorama of their
common than it used to be. I think that children’s obesity is
employees’ health and a working plan so we can help them to
related to crime problems. If a city has a high crime index
achieve an ideal health goal. We have worked with more than
parents will not allow children to go out and play and they
800 companies. The Crusade helps our obesity research and
will spend more hours sitting in front of a screen. Obesity
we are able to compile data from different people in different
problems are also due to purchasing power. Attending
places to better understand the psychological, metabolic,
a health club is very expensive so physical activity is
genetic and behavioral problems that lead to obesity.
becoming a luxury. It is also important to consider our eating habits. Our high sugar consumption is generating
Q: What joint efforts is Medix Pharma pursuing with the
increases in diabetes rates.
government to work on the obesity crisis? A: Mexico City’s government is our partner but Medix
As a country, we still have a lot to learn in terms of obesity
Pharma is expanding its alliances with several local
and poverty. Twelve percent of the population living below
governments for medical training. We are investing in
the poverty line also suffers from weight-related problems.
equipment donations for obesity-specialized clinics and
Reaching this sector is a problem we have not been able to
prevention campaigns. We promote the benefits of having
solve. An interesting possibility for treatment that needs to
a healthy lifestyle at government operated clinics and when
be explored is to create alliances between pharmaceuticals
there are government-organized sports events we attend
and government, committing both to cover a percentage of
them with our medical units to diagnose people for free.
83
| VIEW FROM THE TOP
BECOMING A GLOBAL MEXICAN COMPANY SANDRA SÁNCHEZ Director General of PROBIOMED 84
Q: How has PROBIOMED evolved with the implementation
no other company has. Having the right partner would
of corporate governance and what has the company
help us accelerate time to market and thereby hold a
achieved in this respect?
stronger position among actual and future incumbents.
A: At this point, we have well-defined processes through
For years we have relied on one team fully dedicated to
which our company objectives are set. We have set
developing new biosimilar products with no real pressure
and implemented the right policies, procedures, levels
on time to market as competition was scarce. This has
of authority, delegation of responsibilities and the
changed significantly, making it difficult to stay on top
organization we need based on our mission, vision and
of the game unless we further invest in R&D and develop
values. This goes hand in hand with balancing the interests
several biosimilars in parallel.
of key stakeholders, such as the shareholders, financers, customers, internal management and the government
Q: Apart from time to market, what other features are
We have put together a holistic approach to achieve solid
essential for a biotech company to remain competitive?
corporate governance. This is a step we needed to take
A: PROBIOMED’s competitive advantage relies on our
before moving forward in our search of a partner, raising
18-year experience in biosimilars. No other company in
capital or even considering a future IPO. Finding a strategic
Mexico has this, and Big Pharma innovative companies
ally rather than just investors is crucial for the future of the
have just recently tapped into this field. The biotechnology
company. Corporate governance strengthens the internal
innovators business model is very different from that
capabilities of PROBIOMED to build partnerships and
of biosimilar manufacturers and this will be a challenge
transforms the organization’s cultural mindset as we must
for them as they will have to adapt to achieve low-cost
ensure all 1,400 employees keep up. We are working toward
biosimilars, which is very different from selling high
obtaining the Great Place to Work (GPW) certification,
cost innovator medicines. Being vertically integrated,
which will only strengthen our market position. We are
controlling costs, ensuring high quality and delivering a
determined to become a global Mexican company and
better value proposition is easier at PROBIOMED. Today, all
we have already opened a few international markets but
biotechnology companies, both national and multinational
continuing with our corporate governance build-up plans,
in Mexico, either import API or finished product, making
complying with the new regulation standards in Mexico
cost control more complex as they are subject to import
and growing our sales base are our three most important
and cost variations from abroad. On the contrary,
priorities today.
PROBIOMED produces biosimilar drugs from gene to final product all in Mexican territory and our value proposition
Q: How will the right partner impact your competitive
will continue to be provisioning high quality at a low cost.
position in today’s biotechnology environment?
All institutions and patients globally are searching for this.
A: We are interested in creating partnerships locally or internationally but attracting capital is not as important
Q: To what extent has biosimilar characterization
as choosing the right partner. This aligns with our vision
progressed
and our goals as well as with the current business
capabilities?
environment. In the past, mainly Chinese and Indian
A: The development of infrastructure for biosimilar
companies participated in the biosimilar market but today
development, including characterization studies, has not
major pharmaceutical firms are entering. PROBIOMED
advanced in Mexico at the same speed as regulation. This is
has a business model whereby it invests 20 percent of its
understandable as the biosimilar market is just starting to
sales in R&D, the same level of investment as Big Pharma
be developed. The new regulation just came into effect in
companies. Our vertical integration in the biotechnology
February 2016. PROBIOMED has developed state-of-the-
arena represents a competitive advantage in Mexico that
art orthogonal analytical techniques given the embryonic
in
Mexico
in
terms
of
infrastructure
infrastructure available in Mexico across the R&D chain of
matures so will the requirements throughout the world
biosimilar development. Most analyses were conducted
to demonstrate the manufactured biosimilar products are
in-house with proprietary methods, which are in line and
high quality, safe and effective, placing more emphasis
are validated to comply with NOM 257 standards and
on the chemical and physical composition of the
requirements. Characterization has been performed in
medicinal product and less on redundant and expensive
collaboration with Mexican universities and academia, as
clinical trials. We will continue prioritizing emerging
well as with world renowned scientists and institutions
markets, which are the most in need as they have the
that are endorsed by COFEPRIS. PROBIOMED has 16
biggest patient populations and the lowest budgets. We
biosimilars that were registered as generics under the
are focusing on serious chronic-degenerative diseases
previous regulation and that are undergoing renovation
that have the highest social and economic impact. We
process, and we have five more products in the pipeline.
are already operational in 14 countries in four continents, albeit with an incomplete product portfolio, but we will
Q: How advanced is PROBIOMED in grasping the
make sure all of our products are launched there as soon
biosimilar opportunity in Mexico and becoming a global
as we renew their marketing approval in Mexico. The
company?
better we comply with the regulation the faster we can
A: Mexico is facing crucial challenges regarding the
enter other markets, Latin America being our natural and
demographic and epidemiological shift as the population
main entry point.
is aging and chronic degenerative diseases are increasing. As the number of patients with comorbidities increase,
Q: How does fragmentation of Mexico’s healthcare system
the number of taxpayers decrease along with public
prevent patients from benefiting from high specialty
budget and cost containment strategies. Therefore,
drugs?
we visualize several opportunities to provide efficient
A: There are no clear or harmonized processes and
solutions including research that can turn into treatments
policies for budget and resource allocation across public
for Mexican patients, biosimilar development to ensure
institutions. For instance, the budget that Seguro Popular
access to added value products at affordable costs and
receives per state depends on the size of the population
savings at healthcare institutions, and becoming an
covered and not on disease incidence, prevalence or
active player shaping the Mexican biopharmaceutical
healthcare needs. Also the budgets allocated to each state
industry. An example of this in Mexico can be attested
are not subject to supervision.
with erythropoietin, a drug for the treatment of anemia in patients undergoing chemotherapy or dialysis. Before
States have the discretionary decision where to invest,
undergoing patent expiration, the innovative drug was
and often funds are devoted to other administrative
only available to treat 3,500 patients given its high cost;
areas or other activities rather than healthcare or
upon expiration in 2001, biosimilars entered the market
medicines. Again, there is no real accountability, tracking
and dropped the price 90 percent making it accessible for
or resource control. The intent today is to centralize the
80,000 patients at a lower cost. Savings add up MX$7.5
resources of Seguro Popular and manage this process
billion (US$400 million) so far, which equates to 10
to guarantee transparency. Mexico should have just one
regional hospitals with 250 beds each, 10,000 ambulances
healthcare system. This proposal has been discussed for
or 122 clinics with 10 consultation offices each. Those
many years with an abundance of political will but no
savings could be invested in infrastructure or in innovative
real progress.
medicines. Q: What impact do you expect the Trans Pacific The biosimilar industry is facing very rapid development,
Partnership to have on Mexico’s biosimilar industry?
maturation and harmonization. As the certainty to enter
A: We are convinced the agreement will provide the
markets evolves with a harmonized regulatory framework
pharmaceutical industry with great impulse, and this will
the
PROBIOMED’s
certainly benefit patients and healthcare institutions in the
products will follow. PROBIOMED is dedicated to the
country. We recognize Commissioner Mikel Arriola’s work in
development and commercialization of biosimilars that
having positioned COFEPRIS as a leader and a benchmark
can offer value through unquestionable quality and
for regulatory agencies from countries participating in the
access to affordable medicines. To accomplish this, we
TPP. As well as their prominent role in the negotiations
have to be extremely responsible in the way we invest and
of this agreement that will, without a doubt, promote
demonstrate the quality of our products. Regulators still
economic growth and pharmaceutical innovation in Mexico.
need to define the depth and breadth of clinical studies
It will also impact positively in terms of the capacity to treat
that are scientifically or regulatory sound for a biosimilar
a larger number of patients in our country and become
that has a very solid characterization. As the industry
crucial for the health sector in the region.
penetration
of
biosimilars
and
85
4
BRANDED GENERICS & OTC
The mistrust Mexican patients once held for generics has disappeared and generics now represent 82 percent of the pharma market, according to COFEPRIS. Many patents are due to expire in the next four years and companies are preparing to fill the void with generics, biosimilars and branded own products. Generics have also become the medicine of choice for public institutions that need reliable products in bulk but are financially restricted by federal budget cuts and the high price of specialized medicines.
OTCs are still a key part of the medicinal market. Some industry insiders believe effective branding is the key to creating and maintaining brand loyalty. Regulations have tightened in recent years and in early 2016 the new NOM-059-SSA1-2015, which sets the standard for medication sold in the country, came into force. This has not slowed down companies that are innovating and looking to improve standards, often by obtaining the Good Manufacturing Practices (GMP) certification from COFEPRIS. This chapter will review the companies producing OTCs and branded generics, the challenges they face, the opportunities they are seizing and the future they expect.
87
89
| CHAPTER 4: BRANDED GENERICS & OTC 90
VIEW FROM THE TOP: Alfredo Rimoch, Liomont
92
VIEW FROM THE TOP: Adrián Ruíz, Hetlabs Mexico
94
VIEW FROM THE TOP: Eugenio García, Glenmark
95
VIEW FROM THE TOP: Américo García, Apotex Latin America
97
VIEW FROM THE TOP: Carlos Abelleyra, Aspen Labs
98
VIEW FROM THE TOP: Efrén Ocampo, Grupo Neolpharma
99
VIEW FROM THE TOP: Luis Zerecero, Laboratorios Keton
100
VIEW FROM THE TOP: Juan Aguirre, Brudifarma
102
VIEW FROM THE TOP: Alejandro Martín, Mayoly Spindler
103
VIEW FROM THE TOP: Iván Wong, Novag
104
VIEW FROM THE TOP: Roberto León, Farmacias GI
105
VIEW FROM THE TOP: Salvador Berríos, Qually
Graciela Aguilar, Qually
| VIEW FROM THE TOP
MEXICO AS A SPRINGBOARD FOR EXPANSION ALFREDO RIMOCH Director General of Liomont
90
Q: What are the main drivers of the double-digit growth
Q: How are you competing against pharmacy chains that
Liomont has been experiencing in recent years?
are growing by pushing their own generic brands?
A: According to IMS Health, the pharmaceutical private
A: Our main strategy to build the brand is to visit physicians.
market has been growing between 6 to 7 percent
Liomontâ&#x20AC;&#x2122;s sales force consists of 1,000 representatives
annually. Liomont has grown 10 percent in this market
distributed throughout the country who visit an average of
and 13.5 percent overall. This is a result of a strong
40,000 physicians. Pharmacy owned brands are our main
marketing strategy based on effective demand creation
competitors today and doctors adjacent to pharmacies
and the development of an effective network of sales
represent a potential conflict of interest when it comes to
representatives
which
substituting prescriptions. Therefore, we have to create
has earned the trust of the whole value chain. We have
more demand of our brands and products to remain
a consistent strategy targeting distribution channels and
competitive and counteract the number of prescriptions
pharmacy chains and we disclose information to them so
being
they are aware of our products. Also, we make sure our
manufacturing agreements with local producers and
products are always available at the sales point and we are
while we are always open to this arrangement, we are not
committed to launching eight to 12 new products a year,
engaged in this kind of negotiations because this is not
which surely puts us at the forefront.
our main focus at the moment.
Q: For what reasons has Liomont decided to focus its
To participate in other activities such as R&D we must
business strategy on the private market despite public
ensure a certain level of profit margin that could be
institutions being the largest buyers of medicines?
reinvested. We are creating alliances with academic
A: Forty percent of the units we manufacture go to the
institutions such as the UNAM Biotechnology Institute,
public market, but that only represents 7 percent of our
CINVESTAV and others to advance R&D. Yet if we were to
sales. This is due to public institutionsâ&#x20AC;&#x2122; limited budget
focus entirely on the generics market our R&D would not
to purchase medicines and the constant search for
be possible.
constantly
visiting
physicians,
substituted.
Pharmacy
chains
have
contract
lower prices. The public healthcare system spends 40 percent on acquiring 2 percent of the products, which
Q: While Liomont is a leader in OTC products and branded
are innovative drugs for highly specialized treatments.
generics, you are strongly focusing on biotechnology.
The rest is used to purchase 98 percent of mostly generic
What do you want to achieve with your biotech portfolio?
products. We are aware of the importance of a Mexican
A: Our main business line is branded generics, which
company creating and improving access to medicines but
create equity for the company and this is where we
with a devaluating peso and the public sector pushing
base our success. OTC products account for 20 percent
for lower prices it is more difficult to participate in that
of our business despite the many complications taking
market. Liomont has traditionally focused on the private
place in recent years. It is true we are focusing on
market and I truly believe this has given us the strength
biotechnology and we are aiming to grow in this area.
we have today. According to the OECD, public institutions
In 2015, we obtained market authorization for the first
should significantly improve their processes as there are
biotechnology-based vaccine for influenza called Flubok,
still several issues, such as the tender system being based
marking an important milestone for Liomont. We also
on an all-win and all-lose model. This creates a situation
have a number of biosimilar products in the pipeline,
in which price is the only factor to be considered in a
some of them in association with a US company called
negotiation. There are some other things that add value to
Oncobiologics. These are also long-term projects as
processes, such as the ability to track products along the
biosimilar development itself takes three to four years and
supply chain and providing integral solutions.
we have to time it with patent expiration. We are aiming
â&#x20AC;&#x153;Other local biotech
Q: What do your expansion plans include?
companies are aiming
international. We are already present in Europe with some
to export biosimilars to
the US and we are in the process of launching generics
international markets, and I
A: We are focused on growing and becoming stronger and generics. Some of our OTC products are also present in into this market. We are consolidating our infrastructure capabilities with our new plant for biotechnology
think it is a very good sign
medicines,
that local players think about
our brand as to be associated with quality, ethics and
going internationalâ&#x20AC;?
partnerships to enter the US genericsâ&#x20AC;&#x2122; market but our
Alfredo Rimoch, CEO of Liomont
vaccines
and
other
highly
specialized
medicines. Also, we are working to create awareness of trust, which are the pillars of the industry. We are creating biggest challenge is to improve perception of Mexican products. We are building a new facility in the State of Mexico that is going to be a highly specialized site for
to be in the market with two biosimilars, one programmed
the production of biotechnology drugs and injectable
for late 2017 and the other in 2018.
products. The first stage of our plant will open in 2017 and is part of a bigger project. We are aiming to produce
We are also developing products in collaboration with
highly specialized treatments for cancer, rheumatoid
UNAM Biotechnology Institute, which is a really good
arthritis and other chronic non-communicable diseases.
initiative and we expect to launch the product in 2017.
In line with this, I think the government should play a
The company wants to become a global player, so we
much more active role in supporting local companies
are creating partnerships with international companies
and Mexico should be independent in terms of providing
to reach international markets. This would only lead us to
healthcare to the population through local manufacturing
meet the highest quality standards and to be authorized
and infrastructure. This is something we have not
in any country of the world. Local markets are sometimes
seen lately but I think there is much more interest and
small and highly dependent on the government. We are
awareness today with key figures realizing the strategic
going to manufacture biosimilars locally and then export
importance of the pharmaceutical industry. Prioritizing
them to Latin America, Europe and probably the US. Other
healthcare as a driver of economic development is also
local biotech companies are aiming to export biosimilars to
one of the main challenges and educational healthcare is
international markets and I think it is a very good sign that
crucial to the system.
local players think about going international. Regarding the flu vaccine, we are already entering Argentina and Chile in the next 12 months. Q: What are the advantages of the biotechnology based influenza vaccine? A: There are several producers of vaccines for influenza. The existing vaccines are based on a 60-year-old technology that mainly uses eggs inoculated by the virus. Producers work with a deactivated virus but it is still a virus. Biotechnology techniques enable us to stop using the virus and work with its DNA instead. This creates an immune response from the organism and the vaccine is a lot cleaner because it does not use either the actual virus, chicken embryos, preservatives or allergens. We expect new strains of influenza virus to appear in the future as viruses constantly mutate. In the case of a pandemic, it would take egg-based vaccines six to eight months to be ready, whereas the recombinant DNA vaccine would be ready in around two months. Every year the WHO identifies the most prevalent strains and identifies three or four of them to produce trivalent or quadrivalent vaccines. Our vaccine is trivalent and next year we will have the quadrivalent.
91
| VIEW FROM THE TOP
INDIAN GIANT BETS ON LOCAL BIOSIMILAR MANUFACTURING ADRIÁN RUÍZ Director General of Hetlabs Mexico
92
Q: What recent commercial achievements would you like
to do so with a good quality of life. Thus, multinational
to share as the most relevant Indian company according
companies are aiding patients with their chronic illnesses.
to IMS Health?
Regulations
A: In 4Q14, we achieved 65 market authorizations on
bioequivalence studies for generics is not enough. Active
finished dosages for several customers. As an active
pharmacovigilance is an essential requirement for generic
pharmaceutical ingredients (API) supplier we interact
producers to demonstrate their product’s safety. Mexico
with our customer’s development departments and now
is starting to reap the benefits of all these efforts and I
have 35 new market authorizations. Hetlabs has 91 market
would say we have more opportunities than challenges.
authorizations for molecules and 81 licenses.
Balancing quality and price is perhaps the most important
have
become
stricter
and
conducting
challenge for companies today. As the most successful We also submitted new fixed combinations to the Mexican
Indian company we are committed to complying with
Institute of Intellectual Property (IMPI) gazette and four of
all regulatory requirements and therefore we will only
our patents for innovative molecules have been published,
compete against those companies with the same level of
so we are submitting two more. We plan to launch these
quality and compliance.
products in 2016 and expect revenues of at least US$10 million per molecule. We have one fixed combination
Q: How have you developed your manufacturing site?
product for erectile dysfunction and expect to position it
A: We acquired one of the best facilities and rebuilt
in the top five. We also want to be ranked in the top five
it to be a high-specialty manufacturing site aimed at
biggest companies for cardiovascular and central nervous
producing biosimilars and cancer drugs. We found
system products in Mexico. In the specialty care business
the right partner in Mexico and we hold 90 percent
segment, we have submitted three more patents for
of the company. We have established communication
antiretroviral (ARV) drugs, where we are the world leaders
with the Subcommittee of Biotechnology Products
with a 30 percent market share. We expect to launch
at COFEPRIS and we presented the layouts for our
related products by 1Q16 in a joint venture with Vanquish
biosimilar manufacturing site. In addition, we had a pre-
Pharmaceuticals. We expect to achieve at least 15 percent
meeting for the authorization of our first biosimilar and
of the ARV market share in the first year and 30 percent
we are working closely with CONACYT and the State of
in the second year.
Mexico’s Council for Science at Technology (COMECYT). We are committed to talent development in this facility.
Q: What are the most relevant trends shaping the generics
At launch we will have Indian people working on the
environment in Mexico?
technology transfer process and Mexican workers will
A: Mexico has become one of the most interesting
join subsequently. Initially, this site will supply biosimilars
markets worldwide. The black market used to represent
to Latin America. Secondly, with the site meeting EMA
30 percent of Mexico’s pharmaceutical market. It had a
requirements, we will export products to the US and
strong presence in remote areas that were not covered by
Europe. As Mexico gains greater recognition among
any formal distributor. But now pharmaceutical companies
those countries exports will be easier from Mexico than
and distributors are reaching those areas and along with
from India. We are conducting preclinical studies in
a stronger COFEPRIS, they have weakened the black
mice and monkeys in the US and clinical trials phase I, II,
market. Moreover, the population is undergoing a cultural
and III for biosimilars in Mexico. The characterization of
transformation in which patients are more informed and
biosimilars includes non-inferiority studies, knowledge
demand better services, while physicians evaluate the
of drug behavior in patients and risk management.
health benefits and risks of medications more carefully.
In the short term we will begin phase I of a product in
People not only want to turn 80 years old but they want
collaboration with UNAM.
Q: Why did you decide to invest in manufacturing in Mexico unlike other multinational companies divesting in this area? A: Hetero Groups is confident that Mexico is a great place to do business and I think multinational companies are making a huge mistake. The country has a high level of technical expertise and educated professionals. Pharmaceutical manufacturing costs are as low as in India
“We are striving to make generics and biosimilars for top specialty care areas our focus” Adrián Ruíz, Director General of Hetlabs Mexico
and Mexican workers are among the best in the world in terms of performance. I have seen top-level manufacturing sites being built in two years in Mexico, which is something
Q: What steps will you take in order to ensure a leadership
that does not occur in the US, Europe or Russia. India can
position in the biopharmaceutical market?
have this kind of development but not at the same level
A: We will start commercializing biosimilars next year and
of technical performance. Economically speaking, Mexico
we will prepare for the next tender. This means we need to
has an inflation rate of 2.8 percent compared to other
obtain market authorizations soon, which is an ambitious
Latin American countries.
but achievable goal. Failure to accomplish this would mean products have to be imported from India. As this
Q: How easy will it be for Hetlabs to tap into the
country does not belong to any relevant trade agreement
biotechnology market in Mexico?
in the region we would be the last option. We will be ready
A: Mexican regulation is at the level of the EMA. However,
for manufacturing in April or May 2016. The first batches
Europe has several years of experience in this area while
will be ready for short and medium term stability tests,
Mexico is just going through the learning curve. There are
which will pave the way for market authorizations. We are
strong committees in the pharmaceutical and regulatory
conducting clinical trials aimed at collecting data over a
chambers pushing biotechnology forward. COFEPRIS wants
six-month period.
more availability of biopharmaceuticals in the market so that more people have access to treatments, but to achieve
The data will allow us to be ready for the market
this all stakeholders need to understand the business and
authorization submission. As the authorities have overseen
regulatory environment of the products. Phase III and
the manufacturing and clinical development processes we
IV clinical trials have been conducted in Mexico for many
expect to be the first to market oncology biosimilar drugs.
years and companies are interested in conducting phases
We are also launching two generic oncologic drugs. We
I and II. Biopharmaceuticals are much more complex than
have a complete portfolio of molecules belonging to the
chemical drugs, not only in terms of manufacturing but also
tyrosine-kinase inhibitors (-tinib) category, such as imatinib
transportation since they need special care to remain stable.
and gefiniti, that are part of the latest generation of drugs.
It takes three months to release the product for quality
As their development and manufacturing is really complex
assurance when it arrives in Mexico. In this case, we are not
there are only two or three producers. Bioequivalence
providing a bioequivalence study but non-inferiority studies,
studies for these products are very complex and
which is the reason why they are called biosimilars because
expensive. The average cost of a bioequivalence study for
they are not identical to the innovator.
the chemotherapy drug capecitabine is US$19,000 while for -tinib molecules it costs US$450,000. We are striving
The first line of products we are introducing to Mexico
to make generics and biosimilars for top specialty care
under this venture are the monoclonal antibodies,
areas our focus.
and we are ensuring compliance with all of COFEPRIS requirements, which is why we have delayed product
Q: In what way is TPP going to transform the biotechnology
launch. The question is whether these products will be
landscape in Mexico?
able to participate in the same tenders as innovators and
A: TPP can bring many opportunities to the industry,
how IMSS and ISSSTE are going to manage them. Now
and the biggest challenge is finding them. Since India
that rules are clear and transparent many companies
is not included in NAFTA, European Trade Agreement,
are competing to be first in the market. Despite the
Latin American Trade Agreement, or TPP it will be
government urgently needing low cost biosimilars it does
challenging for Indian companies to remain competitive
not want to infringe patent issues or affect the revenues of
in terms of costs due to taxation. This supports our
multinational companies that have invested over the years.
strategy of building and opening a manufacturing site in
The market is completely aware of patent protection today
Mexico because having a direct presence in the country
and nobody wants to have a problem with intellectual
makes Hetlabs a Mexican company, and thus TPP will
property in Mexico.
benefit us.
93
| VIEW FROM THE TOP
RETAIL AND PRIVATE GENERICS MARKETS SHOW GROWTH EUGENIO GARCĂ?A Director General of Glenmark
94
Q: What do you think is essential for multinational
that have commercial agreements with Mexico. In the
branded generic companies like Glenmark to grow in the
meantime, authorities may save on consolidated tenders
Mexican market?
if they are open to international competitors. The retail
A: The Mexican pharmaceutical industry has interesting
market presents the most relevant opportunity as it
retail and public growth opportunities. In the retail market
represents 72 percent of the market value and we presume
multinational branded generic companies need to keep
this trend will remain for the next decade.
investing in broader portfolios to satisfy physician and patient needs. There are still limitations to the institutional market
Q: Aside from limitations in the public sector, and in your
such as the national integration requirement to participate
sales volume, what explains your growth in the private
in tenders. Multinational branded generic companies have
sector?
many things to offer to public institutions and if they open
A: There are no limitations in this market and providing a
to international tender, competition would be much fairer
complete portfolio with high-quality products at competitive
and public institutions would save larger amounts. For this
costs is our greatest strength. This is not a matter of price
to happen, Mexico needs to have commercial agreements
but a matter of providing people with affordable products
with more countries such as Brazil, Argentina, India and
so they can buy other medicines as part of their treatments.
China. The Trans Pacific Partnership (TPP) will bring
Our growth is going to be sustainable for a long time in
positive changes, new opportunities for companies, and the
this sector because we are a research-driven global and
possibility to sign further agreements. The governmentâ&#x20AC;&#x2122;s
integrated pharmaceutical company. Glenmark is a leading
commitment to expand its commercial agreements across
player in the discovery of new molecules, both NCEs and
the world will certainly benefit patients and the continuum of
NBEs with seven molecules in various stages of clinical
care in Mexico. I am certain branded generics manufacturers
development and pre-clinical development. The company
will have more opportunities, which is actually driving other
has a significant presence in branded generic markets
companies to enter the generics market.
across emerging economies. Glenmark Pharmaceuticals LTD also markets APIs to regulated and semi-regulated
Q: What is your strategy to meet the national integration
countries. Glenmark has offices in over 20 countries, 16
requirement to participate in public tenders?
manufacturing facilities in five countries and six R&D
A: Meeting the national integration requirement is not
centers dedicated to enriching lives across the globe. This
easy as the law requires companies to undergo significant
enables us to participate in key therapy segments such as
transformation. An alternative to achieving the minimum
dermatology, respiratory, oncology and cardio-metabolics.
65 percent of national integration is through local third party manufactures and sourcing products from countries
The sustained growth in the retail and private markets will continue with consistent innovation, customer need
Generic medication represents over 80 percent
of the market in Mexico. Pharma sales are expected to grow an average of 5.6 percent annually until 2018
satisfaction, field force effectiveness, ensuring effective supply to the point of sale and strong compliance. Q: You mentioned that some of your plans to grow in Mexico might include licensing, what opportunities and partners are you looking for? A: We are looking for opportunities in the therapeutic areas we operate in and in co-promotion, co-marketing and out licensing. We seek products that would complement our existing portfolio.
| VIEW FROM THE TOP
GENERICS GIANT TAPS INTO THE BIOSIMILARS’ MARKET AMÉRICO GARCÍA Director General of Apotex Latin America
Q: How did Apotex increase its presence in Mexico and
local industry. According to IMS Health, the Mexican
Latin America in 2015?
biotechnology market is growing faster than other
A: Apotex went through a renovation period in 2015 during
segments in the pharmaceutical industry and this trend
which we reviewed the company’s main processes from
will continue thanks to 12 biopharmaceutical complex
reducing centralization to promoting a radical change in
molecules losing their patents in the upcoming years.
the human resources area to adapt to new industry trends. We are now reaping the rewards of the transformation,
Biosimilars cannot be treated in the same way as small
including obtaining the Good Manufacturing Practices
chemically synthesized generics since traditional safety
(GMP) certification by COFEPRIS, reversing the downward
standards, efficacy and quality are not suitable for proving
trend in our market share and increasing customer
that a particular biological medicine is a generic version of
satisfaction while achieving stronger brand presence
another. In Mexico the Ministry of Health and COFEPRIS
among our clients. Our progress is partly explained by the
published an amendment to the General Health Law in
double-digit growth exhibited by private label medicines
October 2011, aimed at establishing new provisions for
in pharmacy chains, which are looking for manufacturers
the approval of biopharmaceuticals and biocomparables
with GMP certification.
including approval requirements, prescription rules, the role of COFEPRIS in determining the scope of pre-clinical
Q: Apotex is a company with a strong product portfolio.
tests and trials and labelling requirements, all of which were
What new innovative medicines do you have in your
aligned to European Medicines Agency (EMA) regulations.
pipeline?
We believe there are clear rules and regulations for these
A: We cover solid dosage and injectables to aerosols and
products in Mexico now and we are planning to start the
biopharmaceuticals. Apotex has more than 600 products
application process for biocomparables soon.
under development across all technology platforms. In Mexico, we have a strong pipeline focused on the central
Q: Do you anticipate the Trans Pacific Partnership (TPP)
nervous system, cardiometabolic diseases and specialty
having a discernable impact on the local biosimilar
products. The mission of Apotex in the country is to
industry?
strengthen its growth through the commercialization of
A: A paragraph addressing unreasonable shortenings and
new, world class quality molecules.
delays was incorporated in TPP provisions and although the obligation is in the text, Mexico might not be in the
Q: How will your experience in the US market help you to
position to grant the extension of the patent term. The
tap into Mexico’s biosimilar industry?
country has already granted five years of data protection
A: Apotex is a rising competitor in the global biosimilar
for new chemical entities, including combination products,
market. In February 2015, the FDA approved Apotex’s
and it was possible to exempt Mexico from granting data
Filgrastim. This is the second biologic product Apotex
protection for new uses as it provides data protection
has submitted to the FDA via the abbreviated approval
for combinations. Eight years were granted for products
pathway created by the Biosimilar Price Competition
consisting of or containing proteins obtained through
and Innovation Act (BPCIA). Apotex also has a biosimilar
biotechnology processes, or five years’ data protection for
application for the long-acting pegylated formulation of
biologics with the potential to extend market exclusivity.
filgrastim under FDA review. Filgrastim is used for helping
Ensuring intellectual property protection for medicines has
cancer patients under chemotherapy fight infections and
expanded the population’s access to innovative medicines
fever by boosting white blood cell counts. The fact that
in Mexico, which has resulted in increased life expectancy
biosimilars are set to boom in the US market in the next
and quality, reduced hospitalization and boosted savings
couple of years will help Mexico develop a substantial
for Mexican households.
95
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FIGHTING MEDICAL BIAS WITH EFFECTIVE GENERICS CARLOS ABELLEYRA LATAM Director of Aspen Labs
Q: What are the most relevant market needs in Mexico
first two years it needs a product and when the competitorsâ&#x20AC;&#x2122;
and Latin America that will drive Aspen Labsâ&#x20AC;&#x2122; growth in
volume increases we retire from that segment and try to sell
the region?
another product they are starting to demand. No one can
A: In the past, Big Pharma companies had capacity to
supply the full volume required by consolidated purchases
generate patents that became the blockbusters we all are
leading manufacturers to sell products through distributors
familiar with. The need to explore new markets is changing
at the same price.
industry rules and Mexico is no exception since more than 70 percent of products are generics. Yet the level
Q: How do you manage to position your OTC brands,
of enforcement or use of generics in the private sector is
especially when there are several OTC products that do
not elevated. This is due to the lack of legal enforcement
not necessarily have the therapeutic benefits they claim?
in following prescriptions as pharmacy chains use doctor
A: Branding is fundamental to the success of OTC products.
consultancies to prescribe their own products. Doctors
In the branded generics business we are constantly
at hospitals are losing the power to define the correct
looking to acquire well-known OTC brands. In Mexico
treatment for patients and this has to change. At Aspen Labs
we are developing a product line for gastrointestinal
we are working in specific therapeutic areas and focusing on
diseases, targeting a launch in the second half of 2017. In
products that can be sold without a prescription. Pediatric
other countries we have a stronger position in the OTC
products are a good example of this as mothers prefer to
market but we are developing it here. OTCs have many
have a prescription and not only recommendations from
opportunities especially given the economic situation
clerks. This requires us to create product awareness among
of the country where the cost of a medical consultation
physicians instead of fighting against pharmacy chains,
plus the medicine can be expensive. OTC drugs for acute
and doctors at the sales point. Focusing on these kinds
diseases will become an important part of the equation
of products has turned out to be an effective strategy to
and we see promising growth in this area.
ensure return of investment in promotion. Q: What are the main hurdles of the infant formula Q: Your strategy is pretty much focused on acquiring
industry and how do you deal with its detractors?
existing products from other companies. How do you
A: The industry has to work together not to push for the
manage to change their life cycle and capitalize on the
use of infant formula but to avoid political positions that
opportunity they still have in the market?
are detrimental. Some people believe that women should
A: We tend to believe companies divest product lines
only give babies breast milk. Instead of saying infant
because they are not interested in them anymore. However,
formulas are detrimental they should recognize there are
this has more to do with strategic areas companies are
still many regions where the nutrition level of mothers is
focusing on including research and innovation. Although
so bad they are not able to provide quality milk for their
products are still doing well in the market, sometimes there
babies. Additionally, employed mothers often find it very
is no budget to promote them. Our business is still interested
difficult to breastfeed their children. A huge percentage of
in buying products and companies but we are more focused
babies are delivered by C-section and if the baby does not
on specific areas where prescription is necessary or OTCs
receive breastmilk in the first three days it is more difficult
for therapeutic areas on which few companies are focusing.
for mothers to keep producing milk on a constant basis. In
Last but not least, and this is relatively new for us, is the
Aspen Labs we support breastmilk and we give mothers
hospital business. Cancer and thrombosis are very important
an additional month after they have a baby. However, we
for generics today but they need to be produced by a
are against those who claim breastmilk has to be given by
formal company. Oncology generics are not an easy thing
law when it should only be a health recommendation. We
to handle. We sell generics to the government only for the
are innovating to be as close as we can to breastmilk.
97
| VIEW FROM THE TOP
NEOLPHARMA GROWTH POISED ON CARDIO-METABOLICS EFRÉN OCAMPO Director General of Grupo Neolpharma
98
Q:
How
has
Neolpharma
and
the
companies
it
improving worldwide. The country is now a reference
encompasses grown and expanded in the last year and
point for the Pan-American Health Organization (PAHO).
what are the main strategies and drivers of growth?
Grupo Neolpharma will adapt its medicine manufacturing
A: Grupo Neolpharma’s growth rate slightly surpasses
practices to the new NOM-059-SSA1-2015. In fact, the
the market average. We strategize in a way that our role
company has adapted its operations to the new NOM
in every drug segment is secured especially in regards to
beforehand, gaining ground on its competitors.
prescription drugs. We continue to expand our product lines. Grupo Neolpharma’s newly created cardio-metabolic
Q: With Grupo Neolpharma’s new cluster investment of
health branch will have a great impact on our operations,
MX$750 million (US$19 million), what products are you
which will be released in the following months. After
aiming to manufacture and what type of growth will the
this, we expect double digit growth. Finally, the group
company see?
will continue to industrialize its procedures and internal
A: This investment falls in line with our internationalization
structures.
plans, as it will cover most of our export demand. Neolpharma’s new laboratory is added to four existing
Q: What other new areas of specialization is the company
manufacturing plants in the country increasing the
expanding to?
company’s production capacity by 150 million units per
A: Grupo Neolpharma will release a neuropsychiatric
year. Our business projections for 2020 foresee double
product in 2016. The company is looking into different
the growth of 2015. Grupo Neolpharma will incorporate
alternatives to drop costs in biotechnological product
a broad range of products in a multiplicity of markets. To
releases as clinical trial costs remain one of our biggest
this day, our Central and South American operations have
deterrents. This is a national problem that must be carefully
a total of 16 distribution points further pushing our growth
analyzed if we expect a healthy Mexican biogeneric market
to new grounds. Our new cluster positions us as the largest
segment. Producing this type of drug is not difficult
drug manufacturer in Mexico’s key segments.
but creating molecule bio-comparability is. Investing in characterization studies could reduce the number of
Q: What collaborations have you established?
subjects needed for successful clinical studies as recently
A: We collaborate with multiple universities like UNAM to
promoted by the World Health Organization (WHO).
develop the right talent in areas where it is needed the most.
Q: How much competition do you face against pharmacy
Grupo Neolpharma is working with the Center of
owned branded generics at the point of sale?
Investigation and Advanced Studies (CINVESTAV) in
A: Competition will evolve in the near future and the market
granting awards in the nanotechnology field. This is a
will see premium products. The company’s production
focal point for the group’s future development as it will
plants have been built with state-of-the-art technology.
release a new nanotechnology product line in years
We do not want to engage in competition with pharmacy
to come directly supporting the growth expected by
owned brands as their prices do not reflect their costs.
2020. We are also working with CINVESTAV on new
Survival prices are not uncommon in this market segment,
product developments with neurological and oncological
which does not fit Grupo Neolpharma’s business strategy.
applications.
We are a company with highly competitive product offerings maintaining top quality at all times.
Finally, Grupo Neolpharma commercializes an orphan drug patent with oncological applications in the US market
Due to Mikel Arriola’s newly implemented COFEPRIS,
developed alongside National Instute of Cancerology
the perception of Mexico’s pharmaceutical industry is
(INCan).
| VIEW FROM THE TOP
PARTNERING WITH INTERNATIONAL COMPANIES LUIS ZERECERO Director General of Laboratorios Keton
Q: Can you give our readers a brief history of the
making us partners of choice in the country. For the time
company’s background?
being, we are waiting for COFEPRIS recertification as
A: Laboratorios Keton is a family-owned Mexican
our plant undergoes structural changes. Our equipment
company that recently celebrated its 60th anniversary.
will be refurbished, which will triple our production
We manufacture beta-lactam and oral cephalosporin
capabilities, set at 600,000 tablets per day. In return,
antibiotics for major pharmaceutical companies running
we will provide our clients with better services and
operations in Mexico. We represent foreign companies
response times while also improving the quality of our
from Indian, Austrian, Italian, Colombian and Spanish
products.
origins looking to leave their mark on the country. To date, 80 percent of Laboratorios Keton’s profits derive
Q: What are the biggest business opportunities for
from its subcontracting activities while the remaining
Laboratorios Keton’s manufacturing activities?
20 percent results from representing international
A: We have set the goal of expanding our production
enterprises.
capabilities by 2020 or 2022. After a US$5 million investment we will establish a new pharmaceutical
Q: What does representing foreign companies entail?
manufacturing plant. But COFEPRIS requirements in this
A: Three years ago, a person could not import medicines
regard are extremely strict, which we have to factor in
to the country, forcing them to use the services of
advance.
established pharmaceutical laboratories in Mexico. This is no longer true as companies can import drugs without
Q: How has the pharmaceutical industry evolved
previously registering in the country. This new market
through the years?
opening has resulted in large volumes of foreign medicines
A: I have been part of the Mexican pharmaceutical
coming into the country, but companies continue to
industry for over 56 years and the changes it has
use our services, limiting their involvement in tariff
undergone are dramatic. The evolution has been
and customs operations. Laboratorios Keton registers
systemic always improving protocols and strengthening
products under its brand once internal evaluations and
regulations. But the biggest shift began four years ago as
certifications are held, further referencing them to its
major and significant changes recently came into force.
clients’ Mexican subsidiary for future commercialization
Homogenizing a plant’s capabilities to international
under their independent branding.
standards is one of the biggest problems companies face when applying for COFEPRIS certifications but it
Q: How have Laboratorios Keton sales grown over the
keeps the quality of Mexican products up to par.
past few years and what is the company’s market share? A: In 2015, the company’s sales amounted to US$5
Q: How is the rise in biosimilars and generics affecting
million. This year, our profit base is set at MX$50-60
Laboratorios Keton?
million (US$3.4 million to US$4 million). Laboratorios
A: Even though it is helping our operations generics, will
Keton is substantially smaller than the companies it
occupy 80 percent of the Mexican antibiotics market in
services, which can be seen in its profitability margins.
the near future. As a result, major Big Pharma entities are acquiring generic manufacturing plants in Mexico.
Under these circumstances, covering the costs of setting
Laboratorios Keton has approximately 20 patented
up a manufacturing plant in Mexico is not a constraint but
products, a considerable task in a market where most
receiving authorization from headquarters can take up
molecules
to five years. Keton has a well-established, state-of-the-
registered. This is especially true as we lack innovative
art facility that falls in line with all regulatory practices,
technology that leads to new product types.
and
applications
have
been
previously
99
| VIEW FROM THE TOP
DEMAND SPIKES FOR GENERICS
JUAN AGUIRRE Commercial Manager of Brudifarma
100
Q: What has been the biggest change within the generics
Q: How do you compete against foreign products entering
market in Mexico?
the market?
A: The biggest change has been customersâ&#x20AC;&#x2122; perception. If
A: I have noticed a strange behavior in the market resulting
you go back five years, the Mexican market did not accept
from their entry. What happened to generics 10 years ago is
generic medicines believing they were less effective than
now happening to foreign products. People are comfortable
patented ones. The government has made a huge effort to
with brands or Mexican generics but do not trust foreign
get the public on board by providing them with information
generics be they Canadian or Israeli. Their origin makes no
about the testing generics undergo, and this has helped
difference. Although many companies have come to the
significantly. Nowadays, 90 percent of people trust
market they have not experienced the expected results and
generics and buy them. There is still some suspicion around
have only gained market at a slow rate.
generics for chronic disorders or very specialized ones but cold medicine and anti-inflammatories are widely accepted.
Q: What impact did COFEPRISâ&#x20AC;&#x2122; latest modification have and what repercussions would stricter regulations have
Q: What type of generics is most demanded right now
on the market?
and what trends have you spotted in the Mexican market?
A: The impact on quality has been minimal because companies
A: There has been a shift from penicillin-based antibiotics
had been slowly migrating to the new requirements over
to third generation ones. Trixona is our second top seller,
the past five years, already ensuring top quality. The biggest
which is both good and bad. Common belief is that a
hassle is the requirement to renew registrations every two
good doctor heals as fast as possible but this is not always
years for Good Manufacturing Practices (GMP) and every
the best way to go. One of Mexicoâ&#x20AC;&#x2122;s problems is that
five years for products. Pharmaceutical companies are now
people do not finish their treatments because they start
constantly renewing their registration, leaving little time for
feeling better and these half-complete treatments have
innovation. Although these new requirements have been
been strengthening viruses. Doctors tend to go for the
good for the industry, since more regulations were needed,
strongest antibiotics available, which should only be used
it is slowing the innovation process. At the moment our
in cases of extreme infection, contributing to this decrease
standards and quality are very high. We had the opportunity
in public health. Although this is a profitable approach for
to visit laboratories in Mexico and we know many that are
companies such as Brudifarma and patients feel better
up to international standards but it has now become more
very quickly, it also means stronger viruses. Humanity
cumbersome for them to get new registrations. Due to
would benefit if longer-lasting but more appropriate
this, the market is experiencing an increase in price. Three
antibiotics were prescribed. The shift to cephalosporin-
or four years ago the Mexican market underwent a price
based antibiotics has been the biggest change in the
war as ibuprofen, diclofenac and similar medicines turned
Mexican market.
into commodities. Manufacturers were fighting, and the only weapon they had was price. Unfortunately for the
Q: How is the government contributing to taming the
customer, the consequence is that prices stabilized and
problem?
have even increased. This is because distributors have also
A: The government has been pushing several initiatives. Every
had to adapt to the new situation, increasing our capacity to
single medicine box will say that it requires a prescription
ensure products are in the best condition from the time they
to avoid OTC selling. Pharmacies are required to have an
are made to the time they are in the pharmacy and this has
inventory log of all of their antibiotics, including who they
rendered the entire process much more expensive. On the
were sold to and which doctor prescribed them. There is a
bright side, we can now ensure the product that comes out
lot more control and although we are a long way from where
from our plants is top notch and in the best state possible all
we should be we are moving in the right direction.
the way through their delivery to the pharmacies.
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MAYOLY SPINDLER OUT TO CONQUER GASTROENTEROLOGY ALEJANDRO MARTÍN Director General of Mexico and LATAM DIrector for Mayoly Spindler
102
Q: Can you give us a brief overview of Mayoly Spindler’s
is developed with two of the most thoroughly studied
history in Mexico?
strains Lactobacillus acidophilus and Bifidobacterium
A: The company has been present in the Mexican market
lactis, which recolonize intestinal microbiota. Regular use
for over 10 years, commercializing solutions to frequent
of Progiolog® is beneficial for users.
gastroenterology ailments such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional
Q: What partnerships has the company created to
constipation and diarrhea. Meteospasmyl® is one of the
broaden its market presence?
company’s blockbusters prescribed for IBS treatment.
A: Mayoly Spindler can be found in multiple decentralized
It is a soft gel presentation of alverine and simethicone
public
compounds. Mayoly Spindler’s manufacturing plant is the
Guadalajara’s
best equipped for soft gel creation, further positioning it as
for Social Security and Services for State Workers
segment leader. IPRIKENE®, on the other hand, is a natural
(ISSSTESON). In addition, we partially participate with
clay called diosmectite that is effective as a treatment for
the Ministry of National Defense (SEDENA) and PEMEX.
diarrhea, considering it combats toxins, viruses and bacteria.
We are convinced that our alternative treatments have
organs,
such
Civil
as
Chihuahua’s
Hospitals
and
Civil
Sonora’s
Pensions, Institute
an enormous social impact and will soon grow our Q: Considering diarrheic conditions account for one of
relationships with centralized public organs.
the government’s biggest healthcare expenditures, what measures has the company taken in this regard?
Q: What growth has the company seen over the last
A: Diarrhea is the second cause of infant mortality in
couple of years?
Mexico. Therefore, supplying governmental institutions
A: Mayoly Spindler has seen sustained growth in its 10-
that lack complementary adjuvants for oral rehydration
year presence in Mexico. We even achieved double digit
with our products is of the utmost importance. Mayoly
growth during the tough years of 2014 and 2015. Due to
Spindler’s diosmectite clay is the only antidiarrheal
the extraordinary acceptance our products have had, we
authorized for consumption in 1 month-old infants.
slightly surpassed the 20 percent mark. In 2015 the health industry grew by 6 to 11 percent while Mayoly Spindler
IBS is a hypersensitive chronic condition correlated to
achieved 30 percent growth. On average the company’s
abdominal pain, and distension or inflammation, which
market share is 17.2 percent. We hold the 23rd position
has a direct impact on a patient’s bowel evacuation habits.
in a growing Rx segment that evaluates a total of 156
The most common manifestations of IBS are diarrhea,
laboratories. We expect to improve our position by at least
constipation or a combination of both. Even though the
three slots by the end of 2016.
ailment has no present cure it can be controlled with the right medication. The use of Meteospasmyl®, coupled
Q: What type of product portfolio expansions is the
with probiotics can help minimize symptoms. Probiotics
company foreseeing in the mid-term?
are booming in Mexico. Mayoly Spindler’s Progiolog®
A: We foresee 19 product releases over the next five years averaging three per year. Our goal is to become leaders in
“Our goal is to become leaders in the gastroenterology
the gastroenterology segment and our focus and efforts will remain confined to those markets. Mexico has become a reference for Mayoly Spindler worldwide as operations
segment”
have maintained an optimal performance since their
Alejandro Martín, LATAM Area Director and CEO
oversees all Latin American operations and it saw 40 percent
of Mexico for Mayoly Spindler
establishment. Mayoly Spindler’s Mexican division now growth at the close of 2015, the biggest of the company.
| VIEW FROM THE TOP
PRODUCT DEVELOPMENT LEADS TO SUCCESS IVÁN WONG Business Development Manager of Novag
Q: How much potential does the generic segment have in
as its excess space can easily cover the generic demand
Mexico and what role does Novag play in it?
created by the government.
A: The generic segment has grown on a yearly basis as generic drugs have become vital for Mexican consumers
Q: How does Novag differentiate its generic products
and their wellbeing. Even though Big Pharma has been
from its branded generics?
impacted,
chronic
A: Novag’s strength is in its product expansions resulting
diseases has been greatly improved due to our operations.
society’s
health
in
degenerative
in nine yearly product launches. Therefore, growing and
Evidently, costs and availability play a big role in their
strengthening both portfolios is Novag’s best course of
success, which is unfolding on a global scale.
action. We cover the demand of public institutions and individuals. Novag is one of the largest branded generic
Novag’s background as a Mexican company has strongly
manufacturers, which makes for a large part of its business.
positioned it in the generics market segment. We have
Product development is fundamental for Novag’s success
close to 100 products, most of which are manufactured in
and profitability.
our Tlalpan facility. Novag has consistently reached double digit growth over the past 10 years varying between 56
Q: How have pharmacy-own brands affected Novag’s
and 63 percent. We are 19th on IMS’ latest ranking for the
operations?
ethical market, demonstrating that our work has positively
A: These market trends have been beneficial to our
impacted the segment.
operations. New marketing models have propelled Novag’s growth as its market share participation in the
Q: Novag is planning a MX$100 million (US$6.7 million)
branded generic segment is quite large. We are not
investment for a new manufacturing facility. How is this
selling a brand but rather a molecule. Distributing our
project moving along?
own branded generics has propelled the company’s
A: We acquired a new manufacturing plant in Tizayuca,
growth over the past two years. We are strong suppliers
Hidalgo. We are still in redevelopment stages, refurbishing
to pharmacy stores, supermarkets and a number of
it and acquiring new certifications. But we are yet to
convenience stores amounting to 55 percent of Novag’s
define the products that will be manufactured there.
overall sales. The remaining 45 percent is attributed to
Although there are still loose ends Novag took a big step
the public sector, as we have secured multiple tenders
by investing and acquiring its new facility. Our business
throughout the years.
model is supported by extensive volume production, which will be secured with our Tizayuca plant.
Q: What new projects does Novag have in store for 2016? A: We will finally see the Novag brand reach Central
We are working on expanding our portfolio in areas
America. Last year, the company won three product
that have not yet been covered, such as hormones.
tenders in Honduras and we are registering six products in
Novag recently developed two retroviral drugs for
the Costa Rican market. Regional regulations are no easy
HIV treatment. We are still evaluating the injectable
task, especially in Costa Rica as it follows FDA guidelines.
pharmaceutical formula. The generic HIV segment has
Nonetheless, the company will gain recognition and grow
grown significantly in recent years as patent expiration
exponentially when it prevails. Ecuador and Peru will surely
has further increased their accessibility coupled with the
follow, further expanding our presence in Latin America.
government’s push for their development. We may move
Novag settled on Guatemala, Honduras and Costa Rica,
these developments to our Tizayuca plant. However, our
mainly because they are similar to Mexico’s market. The
next course of action is yet to be defined. Manufacturing
regional market volume these countries jointly make up is
large volumes of drugs in our new facility makes sense
extremely interesting.
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SHOOTING FOR 1,500 SALES POINTS BY 2018 ROBERTO LEÓN Director General of Farmacias GI
104
Q: Farmacias GI’s main vision is to become the largest
A: We evaluate which chronic conditions affect the
pharmaceutical distributor in Mexico. How close is the
Mexican population the most then we look for a range
company to reaching this goal?
of medication that will soothe those ailments and
A: By mid-2016, the transformation of Farmacias GI’s
laboratories. Our partners must comply with all health
corporate image must be complete. Then we will begin
registries established by COFEPRIS, mainly regarding the
our expansion efforts, which are already strategized
NOM-059 that impacts both laboratories and distribution
and analyzed. According to our agenda we will maintain
warehouses. The company will always put quality first.
controlled but significant growth in the coming months and there will be 1,500 selling points within the brand by 2018.
Q: What are the most innovative products that Farmacias
After our new branding is secured all new stores will be
GI sells?
incorporated into our company marketing strategy, which
A: We have many more specialized products than we
mainly focuses on the lower and middle socio-economic
once did. We have not lost track of our original purpose
strata, commonly known as the D and C segments.
of focusing on generic medication. We will continue bulking up on similar volumes. Today eight out of 10 drugs
Q: How will your new image translate to an increased
consumed by patients are generics. We want to encourage
number in sales and market share?
R&D in Mexico and support laboratories that create new
A: Our corporate image restructuring has so far resulted
biotechnological
in a 20-25 percent sales increment as new socioeconomic
drugs and commercialize them. But the Mexican market
spheres are paying attention to Farmacias GI simply because
is moving toward generic drugs and major transnational
of our new image and refurbished distribution points. The
companies are acquiring local generic laboratories to
middle-class market share initially fell as it was believed
cover the growing demand.
molecules,
manufacture
specialized
our products would see a price increase. After realizing our change merely referred to image and quality of service with
Q: Where will we mostly see the Farmacias GI expand?
no impact in our prices we re-stabilized our margins.
A: Our brand has been well received in every market we enter, most of all in Jalisco and Queretaro due to
Q: How does Farmacias GI ensure the right training of its
the number of franchises. Aguascalientes will see more
doctors at the point of sale and how does it attract the
franchises, as our new image has helped establish 18 new
best available talent?
pharmacies. Guanajuato, Colima and Michoacan will see
A: At the end of the day, we must keep in line with
the biggest growth as they are responsible for a significant
COFEPRIS regulations. It states that all physicians must
portion of our business. Farmacias GI will first strengthen
have a valid professional license and an individual service
its position then explore new markets. We will eventually
registry that Farmacias GI takes care of. That is the
have a presence throughout Mexico.
foundation of our operations. We also hold continuous training sessions with our commercial partners mostly led
Q: How has Mexico’s generic market evolved in and where
by laboratories in Mexico. They help us by providing our
is it heading?
physicians with up-to-date information of the products we
A: The taboo surrounding generic products has been
commercialize for them allowing them to better assess our
removed. Through NOM-059 pharmacovigilance generics
clients’ conditions and achieve better patient outcomes.
has strengthened, requiring larger investments and certifications from manufacturers. The market understands
Q:
into
the efficiency of generic products largely as the result of
consideration in their commercial partner selection
What
elements
does
Farmacias
GI
take
the government’s efforts. This information is reaching all
process?
socioeconomic segments.
| VIEW FROM THE TOP
REGULATORY COMPLIANCE IS AN ADVANTAGE
Salvador Berríos Director General of Qually
Graciela Aguilar Technical and Regulatory Director at Qually
Q: Only 1.2 percent of multinational clinical trials are
SB: Maintaining COFEPRIS certification is one of Qually’s
conducted
Qually
main strategic pillars, which calls for ongoing investment
implemented to attract more studies and clients into the
in
Mexico.
What
strategies
has
every two years. Adapting to new norms requires large
country?
expenditure in both financial and human capital. COFEPRIS
GA: Qually signs agreements with third party clinical trial
demands that we adapt to newer and better quality-
institutions, while the company monitors studies and
management systems and although we have complied
analyzes samples. We conduct our analysis through state-
systemically, doing so is quite problematic. Training our
of-the-art analytical instrumentation. After obtaining
workforce is essential as we must show comprehensive
comparative results between generics and referenced
technical competence at all times. Qually is an extension
drugs, Qually conducts statistical analysis based on
to Mexico’s sanitary authority and although its clients
COFEPRIS norms and regulations, later producing a
are extremely important, producing comprehensive and
comprehensive report. The company’s strategy to secure
accurate reports is even more so.
business is directly correlated to its capabilities as an analytical entity. Qually’s certifications and platforms have
Q: How is Qually developing new processes, products and
validated its mechanisms giving us an edge against our
services, seeing as only 0.45 percent of Mexico’s GDP is
competitors. We make our analytic methodology available
allocated to R&D?
to clinical trial sponsors and we get reliable results in a
SB: Rather than innovating our services we are adapting
timely manner.
our laboratories. In return, we will offer a broader line of services. At a policy level, Qually cannot innovate, because
Q: What do you perceive as the biggest challenges the
the company must keep in line with the enforced legal
industry is facing?
framework. By continuously investing in our operations
GA: Even though the Mexican market does not have many
we can better service our clients. Thereafter, internal
third party clinical research entities, competition will
growth will follow by expanding our technical capabilities.
continue as Qually’s biggest challenge. When companies
Instead of developing innovation, Qually uses innovation.
like us initially began the demand for our services was
We must have sufficient purchasing strength to refurbish
booming. Clinical trial studies grew substantially as
our facilities.
compliance with the 2005-2010 regulations overloaded the industry.
GA: Innovations are becoming increasingly stagnant worldwide. Between 2015 and 2018 a large number of
Most analytical methods were provided by Qually sticking
high cost and high specialization patents will expire.
to its trademark responsiveness and timeliness. We are
Qually starts its generic bioequivalence studies two years
usually given four weeks to conduct analytical studies
before patent expirations, licensing them with COFEPRIS
however our excellent equipment takes as little as one week
immediately after. Promptly filing dossiers drops a
to produce reliable reports. As such, we retrained most of
product’s costs by at least 60 percent.
the business servicing a big part of the demand. Not every contract research organization (CRO) is capable of handling
Q: What are Qually’s ambitions and where will we see the
such a workload with high-efficiency levels as sensitive
company in 2016?
equipment and analytical mechanisms like Qually’s require
GA: Qually is looking to expand its operations in Mexico.
large investments. Although competition became fiercer
We will look into different regions as more space is
as the demand grew thinner we have the mechanisms to
needed. We have reached full capacity in our facility
guarantee prompt health-record-approvals. There is little
putting a halt on our goal. So far, we have looked at
room for inaccuracies as the financial stakes are enormous.
Guadalajara and Toluca.
105
MEDICAL DEVICES
5
From the companies that assemble products locally for the export market to those who are developing cutting-edge technologies in the country, Mexico is increasingly becoming a hub for high-tech medical device manufacturing and commercialization. This market segment turns the newest digital and electronic advances into solutions for patients with increasingly demanding lifestyles and who remain active to more advanced ages.
Mexico has become a home to companies pushing the envelope to bring medical care into the 21st century and beyond, with devices ranging from state-of-theart scanners that help doctors take a deeper, more understanding look at their patientsâ&#x20AC;&#x2122; conditions to prostheses that allow their users to hear better, walk longer, breath more deeply and keep potentially debilitating conditions in check. Industry clusters also are increasingly involved in turning places like Tijuana, across the border from San Diego in the US, into vital hubs for innovation and manufacturing to help medical practitioners deal with the challenges of a globally aging population. This chapter showcases some of the key participants in the medical innovation field, as well as the companies that facilitate system integration and certification to get health-improving technology to the market.
107
| CHAPTER 5: MEDICAL DEVICES 110
VIEW FROM THE TOP: Martín Armesto, GE Capital
110
VIEW FROM THE TOP: Mario Amadio, GE Healthcare
112
VIEW FROM THE TOP: Martín Ferrari Del Sel, Dräger Medical Mexico
113
VIEW FROM THE TOP: Francisco Morales, 3M
114
VIEW FROM THE TOP: Alejandro Paolini, Siemens Healthineers
115
VIEW FROM THE TOP: Guillaume Corpart, Global Health Intelligence
116
VIEW FROM THE TOP: Patricia Villar, Canon Mexicana
118
VIEW FROM THE TOP: Carlos Jiménez, B. Braun Aesculap of Mexico
119
VIEW FROM THE TOP: Jorge Hernández, Greatbatch
120
VIEW FROM THE TOP: Fernando Oliveros, Medtronic Mexico
122
VIEW FROM THE TOP: Luis Nieto, ConvaTec
124
VIEW FROM THE TOP: Eduardo Salcedo, Össur
126
VIEW FROM THE TOP: Matt Jordan, Providien
128
VIEW FROM THE TOP: Kota Yamamura, Terumo
129
INSIGHT: Luisa Gutiérrez, Medisi
130
VIEW FROM THE TOP: Cristina Hermosillo, Cluster Tijuana EDC
Ángel de la Campa, Medical Devices Cluster
Miguel Félix, Medical Devices Cluster
131
INSIGHT: Carlos Pérez, NYCE
132
EXPERT INSIGHT: Rubén Gaitán, Alandra Medical
133
VIEW FROM THE TOP: Lourdes Camp, Ventura Medical Technologies
109
| VIEW FROM THE TOP
GE TO FINANCE HEALTHCARE TECHNOLOGY ACQUISITION MARTÍN ARMESTO Regional Manager of GE Capital
110
Q: What is the future of GE Capital Health Financial
way by financing healthcare technology acquisition. GE
Services as GE transforms into a more industrial company?
is the only medical equipment manufacturer with a real
A: We have financed equipment acquisitions in Mexico
bank supporting its capital and financial operations in
for the last 25 years. However, GE Capital is undergoing
Mexico.
a number of structural changes. We will be more focused on helping GE Healthcare with specific products and
Q: What is behind GE Capital's focus on the healthcare
tailor made solutions developing new business models
industry?
similar to the shared risk structure seen in the US. Even
A: There are several opportunities with consumers
though it will take some time for this trend to catch
acquiring new technology, which is especially true with
up in Mexico, we are already doing things differently
doctors and health institutions. Although there are
with our customers. GE Capital will eliminate all pieces
opportunities in the public sector that are worth pursuing
unrelated to its four integral business solutions, which
timely payments are an issue. The industry pushes for
are Healthcare, Energy, Working Capital Solutions and
equipment replacement every five to seven years, but the
Capital Aviation Services (GECAS). The company is
public sector does not have enough resources to fund
paying more attention to its GE Healthcare division,
this. As such, the lifetime of their equipment is extended
which will increase sales in a smart and risk-controlled
by three, four or even five years, quickly becoming
| VIEW FROM THE TOP
LONGER LIVING POPULATIONS DRIVE HEALTHCARE INNOVATION MARIO AMADIO President and Director General of GE Healthcare
Q: What is the history of GE Healthcare in Mexico?
lead company in the digital industry. Bringing this to
A: This year, GE will be celebrating 120 years in Mexico,
our Healthcare division is a real challenge but we also
an important step in both GE’s and Mexico’s history. GE
consider it a responsibility and opportunity.
Healthcare Mexico has always had the best international standards and today we are present across the country
Q: What growth has Mexico experienced in its internal
and in all of the same business lines as GE Global. Looking
consumer market and solution exports over the past years?
to the future, we would like to speak less and less about
A: The healthcare industry developed as a consequence
boxes and products and more about solutions. Mexico
of an aging population. The challenge that healthcare
is extremely important for GE Healthcare Global for
systems across the world are experiencing is that people
various reasons. Because of its geographical closeness
are now living longer than ever before and this trend is only
to the US, Canada, and Latin America, we are allowing to
starting. Not only are these people living longer, but they
create many opportunities. Mexico is also Latin America’s
also demand a better quality of life, which puts even more
second biggest market after Brazil, and its approximately
pressure on healthcare systems, placing this challenge
128 million inhabitants provide a significant internal
as one of the top priorities. I do not predict exponential
consumer market. I also see many opportunities in
growth for the industry but rather a rationalization of
the digital area now that GE has defined itself as the
expenses. Investments in the health industry will go
obsolete in an evolving environment. Large volumes
a market willing to purchase secondhand equipment. This
of used equipment are imported to Mexico from the
will undoubtedly reach Mexico within three years. Another
US, often in poor condition, which is one of the largest
trend will be a plethora of investors and entrepreneurs
sources of competition within the Mexican medical device
in the healthcare industry. Today, there are several
industry. As the US market grows it generates yearly
investment funds seeking opportunities in the industry. In
tons of turnover equipment. But challenges related to
the past, it was mostly physicians who were looking for
investment remain. With the US reimbursement act the
funds to develop a business. With the digital revolution,
MRI studies has dropped significantly. However, annual
healthcare services were lagging behind as all information
per capita expenditure in the US is US$11,000, whereas
was confined and considered strictly confidential. But
in Mexico it is close to US$800. Considering some of
new investors are trying to understand patient needs,
our customers are major hospital chains and clinical
and healthcare is being addressed directly from a supply-
laboratories expanding throughout the country their
demand standpoint.
strong purchasing capabilities must be supported by financial solutions that will help them in this endeavor.
Q: Do you offer financial services to the government,
Key players are expanding and consolidating their
and how are integrators enabling public institutions to
operations, opening up a new realm of opportunities for
acquire technology?
GE Capital.
A: The value proposition of integrators is providing customers with technology, technicians, logistics, IT
Q: Tailored solutions like the shared risk model are
solutions and administrative tools for supplies and
already operational in other countries. When should we
equipment. Formerly, public institutions acquired their
expect their implementation in Mexico?
assets from providers. Nowadays, a large percentage are
A: Shared risk solutions are an essential part of healthcare
managed by integrator companies, which led us to lending
negotiations in the US as they offer financing alongside
them money directly. Although public sector lending is not
actual solutions. There are instances where technology
in our immediate plan this is something we will explore in
renovation can be easily achieved, which shows there is
the near future.
toward better health and better care, and expenses will
say it has had a tremendous impact. Mexico has strongly
be scrupulously analyzed to make sure they contribute to
benefited from our strategy to tackle areas of opportunity
this improvement. GE wants to support and be part of this
and to increase coverage. The latter has allowed us to reach
response. From there, topics such as accessibility, cost and
all areas of the country.
quality come up and these have been the three pillars of our strategy for a few years now. When it comes to growth
Q: What are the biggest advantages of GE’s medical
in the Mexican healthcare industry, this is happening
imaging equipment compared to your competitors?
slowly. I do see a huge opportunity particularly in the
A: Our strength in that area and in the entire company is
digital industry. It is estimated that over the past few years,
innovation. It is part of our three main characteristics along
the most relevant industry has been online consumption,
with service and solutions. Our challenge is to innovate in
expected to duplicate business turnovers.
a wide portfolio and also differentiate ourselves through quality.
Q: Has GE’s “Amplia el Acceso” program been implemented in Mexico and what have been the results if so?
Q: What does your Health Imagination initiative involve?
A: In 2000, 70 percent of GE’s market was the US domestic
A: The three pillars of this initiative that began seven years
market while the rest was the international market. In the
ago are accessibility, cost and quality. GE put this concept
past few years, this figure has changed and the market
forward to be audited by external companies to ensure
outside the US has become a great market with several
that all investment fell under one of these three mentioned
opportunities for growth. Not counting Europe, this
categories. The success of this initiative is linked to a
leaves us with the emerging markets, where we’ve found
redefinition of our market strategy. Our next projects will
considerable opportunities so we have put great effort
be centered around the digital realm, which we believe this
into creating products tailored to that region. We have
to be the next area of opportunity. We have our research
lowered the cost to make them more affordable without
center in Queretaro, which is important for the development
compromising on quality. There is no hard figure as to
of our digital strategy. We focus on offering better products
the impact of our “Amplia el Acceso” program but I can
with better technology, availability and clinical value.
111
| VIEW FROM THE TOP
TECHNOLOGY FOR PUBLIC AND PRIVATE HEALTHCARE MARTÍN FERRARI DEL SEL Director General of Dräger Medical Mexico
112
Q: What opportunities do you see for Dräger in the
capabilities. This helps doctors and personnel understand
country’s plans to construct new hospitals?
how the patient is doing during the anesthesia but also
A: We are working with IMSS on their new projects to
which level of anesthesia is necessary for an optimal
see how our solutions could help reduce costs and make
operation,
investments even more efficient. We also want to help
Of course, these advantages go hand in hand with
make the operating room more efficient and contribute to
cost reductions. We have also launched a new LED-
a transition toward a digital future. More than just thinking
technology lamp called Polaris 600 for the operating
about the equipment bought in terms of boxes, we want
room. It is completely integrated with the rest of the
IMSS and ISSSTE to consider the solution. Dräger has
operating room's control systems. More and more, we
systems that integrate all of the information collected by
are talking about intelligent or hybrid operating rooms,
our equipment, be it on our processes, machinery or on the
where all the pieces of equipment are integrated from
patient. Although digitalization is spreading throughout
the lamps to the chairs. Mexico is still behind in this
the various departments of a hospital, the technology has
respect but we are trying to bring the technology to the
yet to reach some of them.
country.
Q: What does your intensive care package involve and
Q: How do the planning and buying processes of the
how does it benefit hospitals?
private and public sector differ?
A: We have had a regional and national initiative since 2015
A: INCAN has developed a new hospital with the latest
to create a solution using the extent of our international
technology, which required significant investment. For
portfolio. Packages can be created from this wide range
this, they did not just consider the equipment but the
of products that are adapted to local needs. The neonatal
entire clinical process involved. The hospital is equipped
care package for instance is entirely tailored to the
with the latest equipment, machinery and measurements.
Mexican market and we are continuously making it more
Although one might not expect this, we have observed
and more attractive price wise. We have an important
that the public sector is more willing to innovate or acquire
presence throughout the country’s Ministries of Health
innovation than the private one. This is especially the case
and IMSS and ISSSTE clinics. We have also strengthened
in highly specialized areas of the public sector.
depending
on
the
patient’s
physiology.
our presence in SEDENA, particularly in anesthesia and mechanical ventilation.
Q: How do you ensure you maintain a good supply chain and competitive products?
Q: What new technologies are you going to introduce to
A:
the market?
destination than the US, we are neither manufacturing nor
A: In areas such as critical care and intensive therapy, we
assembling here. This is in our short-term plan for certain
are introducing a new line of mechanical ventilators that
products. To date, our manufacturing and assembly has
will be applicable to everyone from newborns to adults.
been carried out in the US or Germany and this is one of
This piece of equipment helps reduce the duration of
our main strengths. We do not want to lose our “made in
stays in intensive care units, reducing all of the associated
Germany” quality trademark. Now that we are present in
costs and the pathologies associated with the treatment.
the Latin American region, we might take advantage of
Although
Mexico
is
a
cheaper
manufacturing
its cost competitiveness. The headquarters for this area When it comes to the operating room, we have launched
are located in Panama and we have seven branches from
new technologies for anesthesia equipment that is
Mexico to Argentina and Chile, as well as Peru, Colombia
completely integrated with our patient monitoring
and Brazil. This is advantageous in terms of the closeness
technology, providing the equipment with predictive
of the service, sales and supply chain.
| VIEW FROM THE TOP
INNOVATING FOR CHRONIC, DENTAL AND FOOD HEALTH FRANCISCO MORALES Healthcare Division Director at 3M
Q: Why did 3M decide to focus on three areas?
experience where the product can be tested. We have a
A: In Mexico, we have the hospital market, which is divided
center of innovation in Santa Fe where we receive many
into infection prevention and critical & chronic care
customers to test the product and learn how to use it in
solutions products. The second market is oral care, which
a risk-free environment.
is divided between dental and orthodontist services. The third area, food safety, is important for Mexico. We based
Q: What strategies are you implementing to grow your
our three areas on customer needs. Looking at the market
market share?
today, each category would occupy 20-30 percent. When
A: We want to grow organically, with more units sold in
the market evolves and practices improve, the market will
the marketplace as that represents sustainable growth
increase. For example, a product is usually used in surgery
for the business. We are focused on gaining a better
once a week. Bio indicators can show if there is any bacteria
understanding of the customers and providing better
present. Should the practice become daily, then the market
solutions. We have switched from providing product-
for bio indicators will be multiplied by seven, and to be sure
based solutions to a care pathway that involves better
hygiene products may be tested more than once.
control during operating procedures, which makes the outcome of operations constant, providing safety and
Q: What barriers have you encountered in convincing
improving processes. The care pathway is implemented
both private and public sectors to switch to an electronic
in all three sectors. We are particularly looking to reduce
system?
infections in hospital operating rooms. As for the food
A: Interfaces have to be user friendly. We have technology
safety department, there are companies that produce
that rapidly detects pathogens in the food industry. The
goods here in Mexico and export them to the US. They
interface is easy to use and customers love it. As soon as
need to comply with high-quality standards and this
users are convinced that a protocol is correct, they will use
is what we assist with. We estimate this area will grow
the product and the barriers fall. In dental for example,
around 7 percent and we have been investing heavily.
we have a digital scanner. When going to the dentist patients undergo an indirect procedure, an impression of
Q: What relationship do you have with academic
the mouth. This requires a 5-to-6 minute wait, the product
institutions and the government to ensure specialization
must then go to the lab and a mold has to be made. Our
of human capital and to make sure they are channeled to
digital scanner has a wand to scan the mouth. It takes
the right careers?
a digital scan that is stored on a computer and can be
A: We have a lot of talent in Mexico. I used to work in
sent to a lab without the need of a physical item. This
the Minnesota headquarters and many Mexicans held
accelerates the work flow.
strategic positions. As for working with universities, we actually held an event to which we invited students from
Q: What added value are you bringing through your
any university in Mexico. They presented their work,
dental and orthodontic training programs?
we provided them with a specific task they must find a
A: The educational side is strategically important for
solution to and thus we capture the talent early on. This is
us because we tend to do the same things every day
a global program called Invent a New Future in which we
and when changing practices we need to learn from
work with many institutions. It starts with a competition
someone else. All our healthcare training comes under
at the national level, then they apply to the international
the umbrella of our healthcare academy. It is a global
level and two students are chosen from each country.
initiative we implement in every sector. In dental,
There are various winners who win a six-month internship
this mostly takes the form of a speaker presenting a
with one of the directors. Of last yearâ&#x20AC;&#x2122;s six winners, one
product and the practice. Then there is a more hands-on
was Mexican.
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| VIEW FROM THE TOP
TECHNOLOGY FACILITATES MINIMALLY INVASIVE SURGERY ALEJANDRO PAOLINI Vice President Mesoamerica of Siemens Healthineers
114
Q: What are the results you have had in 3D image-guided
Q: What separates Siemens Healthineers and its medical
surgery and how do you commercialize this?
imaging devices from those of your competitors?
A: We have six business areas: Diagnostic Imaging,
A: We are the only company that covers 100 percent
Advanced Therapies, Ultrasound, Laboratory Diagnostics,
of the diagnostics field. Probably less than 5 percent of
Point of Care and Services. 3D image-guided surgery is part
diagnostics are based solely on physical examinations.
of Advanced Therapies. Siemens used to be concentrated
One possibility is to base a diagnostic on an image of the
on the diagnostic phase of prevention, diagnostics, therapy
body, while another is to use laboratory tests. Siemens is
and monitoring. We are now expanding our products to
the only company to cover both imaging (in vivo) and lab
the therapy phase. 3D image-guided surgery falls directly
tests (in vitro).
into the third phase. Our solutions facilitate the work of the surgeon as we are guiding the surgery, so the outcome is
As for our medical imaging devices, of course we want
assured. Our therapy phase solutions provide alternatives
to differentiate them from those of our competitors. More
to invasive procedures. This results in important savings
than US$1 billion was invested in R&D in 2015 and we
from both surgery and recovery phases. With minimally
registered around 1,500 new patents. Every innovation has
invasive procedures, the patient can sometimes return to
to go through our internal filters and provide advantages
their normal activities much faster.
in three fields: the clinical field, the operational field and the financial field. An innovation that provides wonderful
Q: What are Siemens Healthineers' innovations in terms
clinical advantages but does not bring financial advantages
of digital health?
may not be feasible.
A: Digitalization is one of the main market trends. It could definitely help with the mismatch between the
Q: What are the main benefits of the Public Private
budgets and costs of health systems. A clear trend is the
Partnership (PPP) approach that you have?
prevalence of mobile applications. We are paying close
A: Managing equipment services (MES) is one of the many
attention to market trends and transformations. This
solutions we offer our clients. It is an alternative to the
is vital for Siemensâ&#x20AC;&#x2122; strategy globally and for Siemens
typical purchase of equipment. In the case of PPPs, we
Healthineers. Just like in our services area, we have a
believe this is a good solution as usually, a PPP is long-
digital services line of business. We are investing greatly
term. Examples from Mexico show PPPs last around 20-
in this area. We have the typical solutions such as picture
25 years. An advantage of MES is that you can reduce
archiving and communication systems (PACS), radiology
the initial capital investment and this capital expenditure
information system (RIS), and laboratory information
is turned into operational expenditure. Our clients have
system (LIS).
a reduced need for initial funds and they can also easily predict operational expenses over the term of the project.
We are also exploring new alternatives because in
This differs from the traditional route of us selling the
emerging countries we are still moving from analog
equipment, then after the expiry of the warranty providing
systems to digital. It is vital to invest in this as we know
maintenance contracts. In this case, we still own the
everything will be 100 percent digital at some point. We
equipment so we are responsible for maintaining it. The
also have a cloud-based platform (TeamPlay) where
client instead is buying a service. We are sharing the risk
clients can share information and results with the rest of
because they are paying based on performance.
our clients at a global level. This allows them to discuss new treatments and different results. There are many
At this moment, we have several projects in the funnel but
solutions we are offering and that we want to offer in the
none is being fully implemented. This model works well in
digital era.
mature markets such as the US and Europe.
| VIEW FROM THE TOP
PRIVATE SECTOR EXPANSION PUSHES DEVICES GROWTH GUILLAUME CORPART Managing Director of Global Health Intelligence
Q: Even though the medical device market has not grown
manufacturers and distributors have had to reduce their
much in value, there has been an increase in volume.
margins. There is limited innovation in the medical device
What is behind this growth?
space in Latin America, with 95 percent of equipment
A: A vast expansion of the private sector across the region,
being imported. In a time of currency devaluation, this
particularly in Mexico, is the main cause coupled with
situation makes it more challenging for hospitals to acquire
the growth of specialty low-cost clinics. Traditionally, the
new equipment. As such, a shift in purchasing trends is
private healthcare market was reserved for the wealthiest
spotted in the types of equipment being imported. The
15 percent of the population while the rest of the population
volume of medical equipment being imported increased
depended on public services. A transition is occurring
15-20 percent from 2014 to 2015, while the value increased
where the private sector is now focusing on expanding its
a mere 2 percent, from US$5.1 billion to US$5.2 billion.
services toward the middle class and working class. Salud
This implies that institutions could be buying less
Digna in the northwest of Mexico is a perfect example. It
expensive equipment, such as refurbished or second
started six years ago as a small clinic in Sonora with the
hand goods, as well as squeezing their suppliersâ&#x20AC;&#x2122; margins.
intention of being an affordable private clinic. Now, it owns
Out of the 25 percent depreciation in Mexico in the past
over 40 clinics throughout Mexico and some in the US,
months, distributors absorbed 10 percent internally, and
covering 15 specialties from eye care to diabetes. People
manufacturers as well, but only passed 5 percent of cost
are willing to pay a little bit of money to have faster and
differences to the payer. On their end, institutions are
better services than what the public health sector offers.
purchasing less expensive equipment and turning to less
The growth potential is tremendous. When it comes to
dollarized economies for imports. In the past year, some
care, a boom is coming that has not yet reached Mexico.
of our clients switched from importing US equipment to
Growth in the home care market is already being seen in
importing from Eastern Europe where there is a smaller
Chile and Brazil. Rather than treating people in the hospital
currency shift. Chinese products are also starting to take
and occupying beds for patient monitoring, people are
a strong position in the market. Mexico is still the biggest
being sent home with portable monitoring devices. A visit
exporter of capital equipment thanks to its maquiladoras.
to the hospital should only occur for patients that need to
Items that are part of the maquiladora category are
see a doctor or nurse. Individuals that only need check-
required to be exported even if some are meant to be
ups should be able to take these devices and do it in the
imported back later. A shift in this particular reality is not
comfort of their home. The equipment will communicate
expected any time soon as the US will continue to be a
with the doctor when a problem occurs. The idea of home
strong market.
care is expected to come to Mexico in the next three to four years.
Q: For the next year, how does Global Health Intelligence hope to position itself?
Q: The specialty medical devices market grew 20 percent
A: In 2016, we are striving to initiate work in Cuba, a
in 2015 in Latin America and even though Mexico is the
truly interesting project as quite little is known about
largest exporter in the region, most of its medical devices
the country from independent sources. We will focus our
are imported. What can we expect in Mexico when it
efforts on medical devices in emerging markets, notably
comes medical device commerce?
Latin America and Asia for both the public and private
A: We saw a 35 percent currency depreciation across
sector. We have the unique advantage of holding a pan-
the region over the past 18 months. Mexico was no
regional database that can help drive policy decisions in
exception, witnessing a 25 percent currency depreciation.
an informed manner. We welcome the idea of collaboration
The devaluation has made equipment more expensive in
with manufacturers, distributors and integrators as well as
local currency. To maintain sales and hold on to clients,
the government and policymakers.
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| VIEW FROM THE TOP
OPTICAL DEVELOPMENTS FOR A HEALTHIER LIFE PATRICIA VILLAR Sales & Marketing Manager Healthcare Division of Canon Mexicana
116
Q: What is the importance of the healthcare solutions
Q: What part of your sales go to the private and to the
division within the Canon global strategy?
public sector and what market needs are you targeting?
A: For Canon, the Healthcare Solutions Division has
A: At this point, the most important buyer of healthcare
become a relevant investment priority for the global
products is the public sector, with 75 percent of our sales
strategy. The company is committed to innovation and
and the rest in the private. In both sectors demand is
health promotion and our research centers in the US and
important, but in the public division the investment will
Europe are focusing on developing the most accurate
start growing. One of the most relevant epidemiological
diagnosis equipment, always considering the least invasive
diseases is diabetes and one of its complications is
methods for the patient. We are developing state-of-the-
retinopathy. In the eye care area we have diagnostic
art medical products using advanced expertise in optics
solutions for these diseases and we see a huge business
and CMOS sensibility technology. Canon’s investment
opportunity there. With the increasing demand for high-
through Canon Life Science and Canon Biomedical, which
quality services in Mexico, there is an increasing need to
was founded a couple of years ago, will result in many
be more efficient and innovative. We are aware of today’s
innovative products that will expand our portfolio in the
economic circumstances affecting the healthcare market
following years. As a group, stakeholders are guiding the
and especially the public sector. Canon is focusing on
global strategy, focusing on diversifying our business
offering innovative technology that provides the highest
opportunities to bear the fluctuating market situation and
resolution images in the market at affordable prices.
global challenges. Q: What kind of innovative technological solutions do you Q: What was the strategy behind establishing Canon’s
provide and how do they stand out in the market?
medical devices and applications in the country in 2012
A: We have cutting-edge retinal cameras and in the short
ahead of other countries in Latin America?
term we will have an optical coherent tomography. We
A: We had a presence for many years in the Mexican market
also have tonometers to measure intraocular pressure
through distributors, who have successfully positioned our
and the high levels in glaucoma as well as auto-refractor
brand. A few hundreds of our digital detectors are already
keratometers that measure the diffraction of the eye. In
installed in the most important healthcare institutions,
radiology, we have digital detectors that deliver very good
thanks to their hard work. Our strategy of having a direct
images and are supported by high-tech software. These
presence in Mexico includes working together with our
technologies already exist in the market but the most
distributors and letting them commercialize our products,
important part of our equipment is their quality, and we
while we take care of regulatory affairs, imports and
have the experience in the camera business and in high-
technical support. We want to build synergies and back our
quality images to back us up. Another differentiator is
distributors in integrating our products into sophisticated
our expertise in the imaging-related technology products,
solutions, creating strong relationships with institutions
applied to medical diagnosis development. For instance,
and medical centers.
we have also successfully developed a CMOS sensor that delivers an image resolution of approximately
Mexico is the second most important market for healthcare
120 megapixels, the world’s highest level of resolution.
products in the Latin American region after Brazil.
By
Canon is broadening its opportunities and increasing its
technologies, we believe Canon’s camera technology has
participation in the healthcare business in the Americas
the power once again to drive the company’s growth. We
in general and specifically in Mexico where the medical
also always try hard to maintain our prices at competitive
devices market is expected to have an annual growth of
levels by preserving our resources, being internally
6 to 7 percent.
efficient and economically strategic.
thoroughly
raising
our
powerful
camera-related
Q: How have you managed to build brand loyalty in the
the diagnostic services and equipment in institutions, they
healthcare market?
would eventually save much more.
A: We provide training to doctors and we also work very closely with them to detect market needs. The company
Q: What products do you have in the pipeline?
does not only provide quality products but strong post-
A: We have the optical coherent tomography and we are
sale services. There are satisfied physicians who own
strongly focusing on our X-ray portfolio this year. Digital
20-year-old Canon products that are fully functional,
radiology is a highly promising market, so we will bring new
creating a tight relationship based on trust. Word-of-
technologies in this area. We are changing our strategy
mouth is the most powerful way of advertising and
throughout the Mexican territory and in our target market.
Canon has really benefited from it. We have seen that our
That is why we will not only focus on big institutions, but
customers usually think of Canon again when they need to
we will work with our distributors to reach remote areas
replace their equipment.
that have unattended needs.
Furthermore, closeness is essential to keep building
Decision makers in healthcare are centralized and the
customer
preference,
market in big cities is saturated now. We want to make
ultimately leading to success. Every accomplishment
our technologies accessible in other parts of the country
requires hard work and effort and our distributors have
to benefit more patients. If we expand our sales force
done an excellent job positioning our brand. We are still
throughout the country we will have more opportunities.
loyalty
and
preserving
their
finding new customers that are surprised when they hear Canon also manufactures healthcare products.
Q: What do you want to achieve going forward and what
Fortunately, they are familiar with the quality image and
makes Canon different from other companies from the
the service associated with our brand, and consequently
business philosophy standpoint?
they feel confident to acquire our diagnostic equipment.
A: We will focus on providing dependable services and increasing customer loyalty by consolidating our brand,
Q: How do you collaborate with the public sector to
helping us to be more profitable and competitive. Canon
develop the best model for institutions to acquire your
is really focusing on diversifying its business and the
equipment?
healthcare market is very promising.
A: We are participating in the public sector through integrators and these players offer shared risk solutions so
We are investing 9 percent of our revenues in R&D, which
that institutions can acquire innovative technologies. We
will keep on making us very competitive. Our corporate
provide the end user with technical support and holistic
philosophy is based on “Kyosei”, which means living and
service plans. The most important advantage of working
working together for the common good. This philosophy
with integrators is their solid experience in implementing
reflects our true commitment to human wellbeing and that
complex and valuable solutions to customers so they
is why the healthcare division suits perfectly well with the
can fulfill market needs in a specific way. Teamwork and
company’s mission, vision and core values.
synergies are always better than working alone. Q: To what extent are regulations for registering new medical devices supporting growth in this industry? A: We sell radiology and ophthalmology products that need sanitary registrations to be imported and commercialized in Mexico. This process can take us from two to six months. We usually undergo fast track procedures in which we use equivalences with the aid of Health Canada documentation. We also receive support from Canon in Tokyo and the US in the case of FDA 510(k) documentation. COFEPRIS recognizes these certifications and it has worked really hard to streamline authorization processes. More efforts are needed for healthcare to become a priority in the government’s agenda. The Ministry of Health
“Canon is broadening its opportunities and increasing its participation in the healthcare business in the Americas in general and specifically in Mexico, where the medical devices market is expected to have an annual growth of 6 to 7 percent”
has to realize that it is better to prevent diseases rather
Patricia Villar, Sales & Marketing Manager Healthcare
than curing them. If the authorities invest in strengthening
Division at Canon Mexicana
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| VIEW FROM THE TOP
HEALTH TRADE GAP HIGHLIGHTS BUSINESS OPPORTUNITY CARLOS JIMÉNEZ Director General of B. Braun Aesculap of Mexico
118
Q: How has the medical device industry contributed to
The new prostheses have benefited 250 people so far, an
the country’s health sector?
impressive statistic for an implant in its first nine months
A: The Ministry of Economy is increasing its involvement
on the market. Our 3D endoscope equipment is another
in this sector, as the country ranked eighth in the world
example of innovative technology. This system allows a
for medical device manufacturing. Mexico is No. 28 in
surgeon to observe depth on a screen while operating,
consumption of said products. While this is excellent for
which makes tying and closing surgery easier and more
our trade balance, the gap indicates too little spending on
accurate. This year we are launching hydrocephalus valve
medicine in the public sector and a lack of integration of
systems, a further example of our pioneering treatments.
innovation. B. Braun specifically exports 4 percent of its
Our business models aim to combine products with
total sales and 6 percent of its manufacturing. Last year
services and offer added value for patients. Our integral
we grew an outstanding 46 percent as a company and to
services are targeted at equipment and sterilization
date we have grown 30 percent. B. Braun hopes to close
central rules and across surgical treatments. The cost of
2016 with 25 percent growth.
our solutions is reasonable, which is vital for long-term treatments. That our prices are in Mexican pesos means
The medical devices that are most popular in Mexico tend
we can offer the same value for clients over 12-month
to be those with very basic applications. The public sector
periods.
represents 70 percent of our business and the majority neglects to employ innovative products. A large part of
Q: What are the greatest challenges you have faced in
the costs of treating a patient is in infrastructure or other
pharmaceutical logistics?
non-medicinal aspects, as the treatment only tends to be
A: We directly manage our own logistics, for which we are
5 percent of the cost. The public sector’s focus on saving
beginning to construct a new 3,000m2 logistics center
money in this small proportion of patient cost simply
with space for 4,000 pallets. This narrow-aisle center
generates a cost-oriented mentality.
will manage heights of up to six pallets, advanced water treatments and sustainable elements including Helios
Q: Which areas of the industry drive growth for B. Braun?
photovoltaic technology. We manage a mixed logistics
A: Hemodialysis is one of the fastest growing areas,
solution, including direct delivery to hospitals or personally
with a 10-15 percent market share. B. Braun’s vanguard
collecting medical equipment that requires maintenance.
technology for hemodialysis helped gain our market
This type of service cannot be matched by other logistics
participation. Glaucoma is another expanding market, as
providers due to technical particularities. Logistics is
chronic renal failure is affecting an increasing number of
becoming more challenging. Federal institutions are
people and B. Braun has solutions for these conditions.
participating in a consolidated purchase system, wherein
Across all business areas, our company is growing by a
they offer one price for about 900 locations and require a
minimum of 18 percent thanks to the high level of service
logistics solution across several states.
that differentiates us. Q: Where is B. Braun focusing the reinvestment of its Our new short-stem hip prosthesis, metaphyseal prosthesis,
profits in Mexico?
is becoming more popular. This minimizes the bone
A: Every year, B. Braun invests MX$20-30 million in
damage on implantation, making future replacement hips
modernization and introducing new technology to its
easier to insert. The previous product offered by B. Braun
manufacturing. We are focusing investments in three key
designed according to the anatomy of Mexican citizens,
areas, the most important of which is our logistics center.
Logical Angioplasty System (SLA), enjoyed 15 years of
The center’s cost will surpass MX$50 million (US$2.7
success in the market for more than 20,000 individuals.
million).
| VIEW FROM THE TOP
SHARING RISK FOR BETTER CARDIOVASCULAR CARE JORGE HERNÁNDEZ Operations Director of Greatbatch
Q: Greatbatch and Lake Region Medical have merged to
catheters and catheter shafts, acetabular reamers used
become Integer. What are the advantages of this merger
for hip implants and batteries for high-end applications
and what value will this bring to your patients?
like external defibrillators and to power external sustaining
A: There are two main advantages with this merger. We
medical devices. Our products are recognized for their
have become one of the largest medical device outsourcers
quality and performance and Integer has the roots set
in the world. This is valuable for our customers because we
down from its experienced legacy companies.
are able to offer a wide range of technical capabilities and business experience. Also, the two companies’ portfolios
Q: What continues to make Mexico attractive for
complement each other instead of competing. With this
manufacturing?
comprehensive portfolio of technologies and services, we
A: In 2005, Greatbatch built their first manufacturing plant
can continue driving innovation for customers.
in Mexico in Tijuana. The second was started in 2014 and we are finishing the transfer for that building to make it
Q: What are the benefits of being an outsourcing
fully operational. There are about 250 employees there.
company?
Mexico and specifically Tijuana, is attractive because
A: For our customers, one benefit of outsourcing is
of our strategic geographic location and our talented
sharing the risks of any enterprise. For example, you don’t
people. At Integer in Mexico, we do more than running
need to invest a lot of capital, rather use others’ capital
the company as a low-cost manufacturing site, adding
to continue the business or accelerate your initiatives
value to the process and therefore creating value for our
by expanding your ability to handle several strategic
customer in this global market where price reductions are
projects. Other resources, like infrastructure, facilities,
a big constraint for all the players. Our customer service
technical capabilities and leadership are all used to
metrics make us one of the best companies around the
support the strategy of any medical device manufacturer.
world, with on-time delivery rates above 98 percent for
Our infrastructure and technical capabilities allow Integer
the past seven years and less than 300 defective parts per
to support our customers needs, from R&D to a finished
million produced.
medical device or system ready for commercialization. This business model allows our clients to support their
Q: Where does Greatbatch export from Tijuana and how
business growth strategy.
much of the products are sold to the Mexican market? A: We ship parts to the US and some countries in Europe,
Q: What are the projects you have here in Mexico?
like Germany, the UK and Italy. Uruguay was first a customer
A: Our main projects for this year are the transfer
in Latin America. In Asia, we export to Korea, Japan and
processes for our vascular products as well as our Power
China. Basically all of our products are meant for export. It
Solutions product line. We are manufacturing power
is difficult to give an exact number of how many finished
solution batteries into our new location and in this building
products end up returning to Mexico because it depends
we are executing our vascular products transfer. For the
on the customer market strategy. Most of our customers
upcoming years, one of the main projects across Integer is
are public medical device manufacturing companies
completing the integration process after the merger.
and are considered the largest of their categories. For example, 95 percent of the pacemakers, defibrillators and
Cardiovascular products were the main products for Lake
neuro stimulators sold around the world had at least one
Region Medical and Greatbatch has a stronger experience
component manufactured here. For vascular products
developing and manufacturing components for the cardio
we have catheters that are used in traditional procedures
rhythm management market, like defibrillators, pacemakers
and steerable catheters that are minimally invasive for
and
faster recovery.
neuro-stimulation.
We
also
produce
steerable
119
| VIEW FROM THE TOP
PAVING THE WAY FOR A BOOMING MEDICAL DEVICES SECTOR FERNANDO OLIVEROS Vice President of Medtronic Mexico
120
Q: What role is Mexico playing today as a worldwide
A: Mexico is spending only 6.2 percent of GDP on
medical device manufacturing hub?
healthcare and half of that is out of pocket. Despite
A: Mexico has not been playing the role it should until
having a long way to go to improve this figure, I think
now. Considering the size of the Mexican population and
current budgets and expenditure can be optimized to
despite the country being a large manufacturer of medical
deliver treatments more efficiently. Companies need
devices the level of penetration on a national level is still
to collaborate with the government in important areas
small. The market for medical devices is becoming more
such as diabetes and cardiovascular care. We need to
important and represents an opportunity for Medtronic
understand that there is no single actor that could come
to close existing gaps in the commercialization and
up with a solution for this problem alone and this is why
manufacturing process. We will be investing significant
the new message we want to get across after our merger
amounts of money in the next couple of years to enhance
with Covidien is â&#x20AC;&#x153;further togetherâ&#x20AC;?. It is also crucial to
the role medical devices play in the continuum of care,
understand the role that innovation plays in streamlining
including education, prevention, diagnosis, treatment and
costs in the medium to long term. We need to change our
post-surgery. To contribute to the growth of this segment,
mindset and become more responsible when it comes
we are not only bringing new medical devices to Mexico
to healthcare investment as a combined challenge to do
but also connecting the dots in the care process. In doing
things better. In this way, the market for medical devices
this, Mexico will hold a more strategic position for us in
could double or triple.
Latin America since our target is to double the size of our revenues within three to five years in the country.
Q: How should models such as shared risk and pay for performance be used to optimize budgets in healthcare
Q: What would you say is the main reason for the low
institutions?
penetration of medical devices in Mexico?
A: These models can be quite effective as long as they
A: The cause of the low-penetration level is multifactorial
are implemented in a collaborative way. In the case of
and Mexico is facing an epidemiological transition. In
diabetes, despite representing a significant investment
a period of four decades acute diseases have been
for the government the percentage of people achieving
overtaken by chronic ones and the system has not been
metabolic control is around 5-15 percent, and more can
able to adapt quickly enough to these changes. More
be achieved with the same amount of money but with
education and professionals are needed in the country.
a different approach. The government could certainly increase access and improve control if budgets were
Despite the effort being made by COFEPRIS to improve
optimized. Implementing shared risk models should not
efficiency to increase Mexicoâ&#x20AC;&#x2122;s competitiveness, greater
be seen as a transaction but the parties involved should
integration of the healthcare system is needed to move
analyze existing problems and find solutions together. We
forward. In an ideal situation, Mexico would have just one
are more than open and willing to work with models based
system instead of a fragmented one. Patient education
on per capita expenditure, risk sharing, or guaranteed
and awareness is also an important factor, which until only
results. Integrated solutions also play an important role in
recently has become relevant. People need to take better
optimizing costs. For instance, we help hospitals reduce
care of their health and be taught more about diseases
60-75 percent of the amount of products they need as
such as diabetes, hypertension and others.
we offer integral solutions instead of having different suppliers for a specific procedure. Medtronic is working
Q: To what extent is healthcare considered a priority for
with integrators, which are relatively unique to Mexico
the government and how do recent budget constraints
and have had a positive impact on the system. These
impact the penetration of medical devices?
integrators have already helped to increase efficiency
in public institutions, and we want to work closely with
while being monitored. It is commonplace that when a
them to move one step forward together. Integrators
person has a heart attack a lot of time can pass from the
have a lot of data and information that can be used to
moment the episode begins to the moment the patient
really improve healthcare outcomes in an institution.
receives medical attention. Technology can help reduce times by enabling physicians to know immediately the
Q: How is the Medtronic–Covidien merger capitalizing
patient has had a heart attack and send an ambulance
on both companies’ capabilities?
while preparing everything inside the hospital to treat
A: We are the only medical device company providing full
the patient upon arrival. Just a 40-minute difference in
solutions for the most concerning ailments today such as
such a scenario can be the difference between life and
diabetes, cardiovascular diseases and obesity. Following
death.
the merger, we are now able to offer a complete portfolio for hospitals and healthcare professionals and ultimately
Q: Where do you see Medtronic Mexico in the near future
for patients. This has resulted from the combination of
and how would you like to see the industry progress in
capabilities of both companies. For instance, Covidien
the short term?
had a strong portfolio for obesity surgery and since
A: We are working toward Mexico playing a leading role
many obese patients also have diabetes, Medtronic’s
in Latin America by expanding growth. To achieve this we
expertise in diabetes helps to create an integral solution.
will launch new products and technologies always keeping
Regarding manufacturing, Medtronic has six plants
in mind their economic value and clinical outcomes. We
located in Baja California, Chihuahua and Sonora and
will increase our capabilities to deliver products and
14,000 employees. Both companies are combining
valuable solutions for the public and private sectors, while
their technical competences to become better. This
we continue to expand our manufacturing capabilities,
has resulted in the development of better products in
creating a hub for medical devices in Mexico. We want the
a more efficient way, making Mexico more attractive
medical devices sector to be as strong as automotive and
for exporting. The products manufactured in our plants
aerospace in the country. The country needs to be able
support sales of US$4-5 billion worldwide and we still
to capitalize on today’s opportunities in the segment and
need to work on how to use these capabilities to further
stakeholders need to collaborate to attract investment
grow in Mexico as a great deal of production goes to
and the necessary resources to grow at an accelerated
other countries. We are discussing with COFEPRIS and
pace. More importantly, healthcare should become a
the Ministry of Economy the value these plants represent
priority for the government and a motor for economic
for the country. Manufacturing in Mexico has lower costs
development, driving productivity and competitiveness
than in other countries but we need to find a way to
in the country. It seems the government is heavily focused
benefit the country with these products.
on the O&G and automotive sectors. Nevertheless, there are companies like Medtronic employing 14,000 people
Q: Can you share with us some of Medtronic’s cutting-
in Mexico and representing strong actors in terms of job
edge devices?
creation and investment. I think that more efforts can be
A: We developed a heart rate monitor that is implanted
made to help the government understand the relevance
in the patient’s chest allowing the physician to receive
of this sector.
remote real-time data of the patient’s cardiac rhythm. In my opinion, innovation is only of true value when it helps make operations more efficient and reduce resource waste. IMSS receives millions of people every day, which is a clear sign that something needs to be done to optimize operations and costs. Many patients who come from other cities have to deal with frequent cancellations of medical appointments and suspension of laboratory services, which increases the amount of money spent on patient transport and accommodation. Sometimes these patients come only to be told they are in good health, so a more efficient approach can be taken. Devices like our monitor have the ability to inform physicians about the health status of patients. They are required to visit the hospital only when a problem is detected or suspected, reducing unnecessary costs and allowing patients to keep their normal activities on track
“We will continue to expand our manufacturing capabilities, creating a hub for medical devices in Mexico. We want the medical devices sector to be as strong as automotive and aerospace in the country” Fernando Oliveros, Vice President of Medtronic Mexico
121
| VIEW FROM THE TOP
HELPING PATIENTS HELP THEMSELVES LUIS NIETO Director General of ConvaTec
122
Q: Have you seen any developments in the acquisition
increasingly managed by what is known as integrators.
of medical devices due to regulatory improvements in
They have gained significant power to control what they
Mexico?
sell and how they sell it or integrate it. It is not clear
A: Healthcare expenditure and access to medicine and
how this has impacted access in a positive way. Mexico’s
medical devices are still relevant challenges for Mexico. 2015
economy is certainly stronger than other countries’ in
was a difficult year for the public sector due to an increase
the region, but this is not reflected in usage, access and
in budget control. The approach many companies are taking
benefits for the patients. We keep seeing diseases such as
is to work together and strengthen the bond with end
hypertension and diabetes rising.
users, physicians and nurses. Companies around the world are demanding an accurate estimate of market potential.
Q: What new business models are being developed in the
Executives are struggling locally to get current market value,
industry to adapt to barriers in the healthcare system?
a step before in the chain. No actual information exists and
A: Administrative processes should be easy for customers
“guesstimates” are no longer acceptable. There are different
to operate. Companies should, and most of them are,
alternatives to market valuation, the most viable being an
heavily investing in new technology, effective tools for
entity coordinating a third party to compile information
approaching potential customers and raising awareness.
from as many companies as possible and presenting it in the
Achieving or at least getting close to standard of care levels
form of intelligence. The association grouping multinational
for the diverse therapies offered by innovative companies
innovative device manufacturers (AMID) might be the best
is now possible as the main barrier has been traditionally
entity to conduct this effort, due to the rising importance it
physician and patient awareness. With the correct
is taking in our day to day activities.
approach and use of the available digital platforms, you can truly impact the right audience and based on quality
The distribution channels are changing with little or
content, including clinical evidence, develop patient flow,
no perceived value. Public sales are commonly and
benefits and growth.
OUT-OF-POCKET HEALTH EXPENDITURE (percent of total expenditure on health) OUT-OF-POCKET HEALTH EXPENDITURE (% OF TOTAL EXPENDITURE ON HEALTH) 70 60 50 40 30 20 10 0
1996
1998
2000
2002
2004
2006
2008
2010
2012
India
Portugal
Australia
United States
Mexico
Switzerland
Turkey
Canada
Chile
Brazil
Norway
France
Source: The World Bank
2014
“The government invests 3.2
insurers and the incredibly high and not necessarily
percent of GDP in health and
sector has a great opportunity to improve with benefits
properly prescribed consumption of medicines. The for patients and economic development for the country
due to poor awareness, late
and the industry.
detection of diseases and a
Q: Services subrogation is an increasing trend in the
questionable exercise of the
public sector. To what extent will this affect the way you
public budget (...) coverage is
A: I do not see a lot of subrogation. At current rates, I
a humongous challenge”
amounts of patients to private hospitals. What I think is a
negotiate with buyers? find it impossible for public institutions to send massive possibility is for private companies to build and run public
Luis Nieto, Director General of ConvaTec
hospitals, which might prove successful if supervision and transparency are ensured. We do business with public
Q: Part of ConvaTec’s value proposition is increasing
institutions, integrators, distributors and retailers, as we
quality of life through innovation. How do you measure
continue to create clinical acceptance of our products
quality of life?
among users.
A: One of the ways in which companies measure success is the extent to which patients are able to take care of
Q: What opportunities do you see in participating in
themselves. About 60 percent of our consumers are either
consolidated purchase tenders?
ostomy patients or wound patients, so ConvaTec provides
A: I do not see any benefits in this initiative if product
training and abundant information for them to control
quality and patient differences are not considered. Rather,
their condition. The idea is to create a new situation
we will continue selling to different institutions. Pricing
where the patient is entirely responsible for his condition
of consolidated purchases is an issue since they ask for
and is able to do something about it. By no means are
extremely low prices, yet companies are not open to
they going to stop needing healthcare professionals, but
offering low prices while they are expected to also invest
if they know more about managing their own health their
in innovation and education. Every state’s healthcare
condition will certainly improve. The government invests
system and institution creates an opportunity to invest in
3.2 percent of GDP in health and due to poor awareness,
awareness and channel development.
late detection of diseases and a questionable exercise of the public budget in terms of efficiency and transparency, coverage is a humongous challenge. Three percent of GDP is invested in health privately, which includes less than 10 percent of the population covered by private
This transcription is a written reproduction of an interview with Luis Nieto in his personal capacity as an executive in the medical device industry. The opinions expressed are the author’s own and do not reflect the view of ConvaTec or any of its subsidiaries. This transcription was not subject to the approval of Convatec or any of its subsidiaries.
HEALTH EXPENDITURE, PUBLIC (percent of total expenditure on health) PUBLIC 80 70 60 50 40 30 0
1996
1998
2000
2002
2004
2006
2008
2010
Norway
Canada
Portugal
Chile
France
Australia
Mexico
Brazil
Turkey
Switzerlan
United States
India
Source: The World Bank
2012
2014
123
| VIEW FROM THE TOP
TIJUANA EQUALS ADAPTABILITY AND SUCCESS IN NORTHERN MEXICO EDUARDO SALCEDO Operations Director at Össur
124
Q: What is the importance the Mexican plant has for
Our Mexican plant only manufactures about 15 percent
Össur globally? What percentage of prosthetics does it
of the prosthetics but strategically this plant is the most
manufacture?
important as it is close to the US market, which is one of
A: Our central offices are located in Iceland but we are
our biggest.
present with corporate offices in the US. The head of the Americas division is located in Foothill Ranch, California.
Q: What makes you different from your competitors?
Tijuana is the only manufacturing plant in Mexico and
A: Our products are custom made, that is the main
it has shown the most growth in the past year because
difference. We are also willing to invest the highest
it continues to evolve both in size and complexity. It
level of technology in local operations. Many people still
was founded in September 2010 and began with small
use Mexico for low-tech operations, but our corporate
operations focused on molding and plastic injection. In
headquarters leverages the Mexican workforce’s abilities
six years it has grown from 40 employees to over 450
for higher technology, products with higher margins. We
employees. The number of diverse technologies we
shifted operations to Tijuana to keep costs down as our
offer has also increased as we now offer radiofrequency,
competitors manufacture mostly in Europe and a little in
ultrasonic welding, solvent bonding, stamping presses,
the US.
pad printing, metal cutting by waterjet and carbon fiber processing. We have one of the broadest ranges of
Q: Do you work with the government and universities to
technological capabilities under one roof in Tijuana. We
ensure you have human talent here in Össur?
specialize in orthopedics and active functional prosthetics
A: We are trying to strengthen our links with local
and we are the only plant that produces these types of
universities. We want to invest in trade schools, putting
components in Baja California. DGS, a high level division
German/Japanese technology and equipment’s into
that shares ownership with Össur, also operates in our
schools and universities in Tijuana to develop our future
plant and in less than a year they have gone from 11
engineers and technicians. We believe deeply in being in
employees to 150. They produce 300 units per day, which
contact with the community as tomorrow we will be hiring
are different types of active hearing aids.
those human resources. This week we will be developing our strategic plan for the coming fiscal year. We hope
Our Mexico operation has teams capable of managing
to work with universities to design curricula with our
cutting edge technology. We are successfully operating
needs in mind. This means a generation of engineers will
in Tijuana with state-of-the-art machinery, processing
graduate with the know-how the local industry needs.
titanium-based components with the most stringent level
This is a win-win for both companies and students.
of tolerances, products and components that at one point would only be manufactured in our home base in Iceland
Q: What do you hope to gain from the acquisition of
but nowadays manufacturing is migrating toward Tijuana.
TouchBionics in terms of technology and market share? A: We recently acquired TouchBionics, a company that
“The fact that we live longer, are
manufactures upper body prosthetics, as we want to
active to a more advanced age
functioning of the human body. Our products are non-
and the rise of extreme sports
advance into this field. What Össur does is replicate the invasive and aim to restore our patients to a normal life, so people can run and climb stairs again. TouchBionics
contribute to a growing market”
developed an interface linking the neural system and
Eduardo Salcedo, Mexico Site Director at Össur
prosthetic will be controlled by the brain like a human
mechanical components of a prosthetic, meaning the
limb. Once the acquisition is complete, we will add their specialties to ours. This acquisition will put our company in its next technological level. The new technology opens more doors for a product already mechanically and functionally good, seamlessly integrating those products on to the human body is the future of the industry and its true contribution to Össur. Q: What other innovative products do you produce? A: We make high-end hearing aids. In a nutshell, the audiologist injects a rubber compound into the ear of a patient, it solidifies, performs a 3D scan, sends the digital file here to us in Tijuana and then 3D printers generate 125
the model in plaster designed precisely for each person’s individual ear. We produce 300 of these biometric hearing aids daily. Each employee here in Tijuana is trained for three to six months to manually piece together the components of this model. Once they can piece it together with a microscope, we initiate functional tests of the apparatus to detect if there is any feedback. If so, we need to adjust the components by micrometers so the patient can hear with no echoes or other noises. We are talking about linking these hearing aids to smartphones via Bluetooth. Our new generation of products will include this feature and will link to any household electronics with
Q: What are your expansion plans in Mexico?
Bluetooth. Typically, a hearing aid user must face their
A: For the moment we plan to stay in Tijuana due to its
interlocutor or the sound they wish to hear. No more.
ideal location. Corporate America for Össur and R&D is an
Our technology will scan the room, identify the walls and
hour away. Being close to our R&D center of excellence is
distances, and the user will be able to hear speakers to the
key for the design engineers to be in contact with those
side and behind them.
that will manufacture their products.
Q: Who are the main consumers of your products?
More broadly, another competitive advantage is that when
A: Diabetes causes 2 million people a year to lose a limb.
comparing labor costs in China and Mexico, all points to
There are of course amputees from the military and
Mexico. It is most interesting when asked: why Tijuana
accidents happen but our main market is diabetes. We
specifically? From a strategic point of view, and from a
also manufacture braces and soft goods to support other
labor force point of view, I can tell you that Guanajuato
joints in the body. Extreme sports impact the human
and Nuevo Leon for instance have experts in textile,
body in stressful ways that were unheard of 20 years ago
Guadalajara and Queretaro have automobile experts but
and we need to manufacture preventive equipment. For
the people of Tijuana are experts in an impressive broad
example, a 70-year-old playing tennis will wear one of our
range of industries, including electronics, aerospace, food
braces to prevent an injury. That we live longer, are active
processing and medical devices.
to a more advanced age and the rise of extreme sports contribute to a growing market.
The Tijuana workforce has been exposed to working in all of these industries. Besides that, the diversity of
Q: Will future growth be organic or inorganic?
international corporate offices in the city is second to
A: It has been both so far and our strategy remains the
none worldwide. The working people in Tijuana have
same. We want to grow organically but we continue to
developed a trait that you cannot buy with money. That
be on the lookout for potential acquisitions related to our
trait is “adaptability”.
products or which could complement them. Inorganic growth such as the acquisition of TouchBionics can be
Our strategy for 2017 revolves around three concepts:
extremely significant in terms of long-term strategy.
innovation, efficiency and growth. Tijuana encompasses
There is also much potential for organic growth in Mexico.
all three because of its demonstrated capabilities.
We are seeing increasing technology levels and volumes
Technological proficiency is no longer a question mark
of production in Mexico.
when it comes to Mexico.
| VIEW FROM THE TOP
ADVANTAGES OF NEARSHORING FOR MEDICAL TECHNOLOGY MATT JORDAN Vice President and General Manager of Providien
126
Q: Why is a presence in Mexico important for you? A:
Providien
provides
contract
engineering
confidentiality
is
paramount.
That
said,
we
have
and
partnerships with leading medical device companies in
manufacturing services to many of the top medical
the world and focus on providing class II & III devices. Our
device companies in the world. A presence in Mexico
product portfolio is diverse, ranging from cardiovascular
is important to us and our customers for a number of
and orthopedics to women’s health.
reasons. First and foremost, because Mexico offers skilled labor at a reduced and competitive rate.
Q: What are the advantages of uniting all Providien
Manufacturing wages in Tijuana are globally competitive
subsidiaries under the Providien banner?
and as a result Tijuana is one of the largest medical
A: Providien has been operating as one organization for
device manufacturing cities in the world. Second, the
several years, so tactically nothing has changed. The
in-country local supply base is more sophisticated
advantage of operating under one unified corporate
than that of other low-cost regions. For example, in
banner is that we can better market our complete value
the Dominican Republic, Asia and other emerging
offering. Providien consists of four primary business units
geographies, manufacturing companies need to import
focused on plastics, metals, thermoforming and device
commodities and other specialized materials, which
assembly, but they all work together to provide solutions
drives up cost. In Mexico, those same commodities may
in the medical device industry. For example, recently
be stationed and warehoused only a few minutes away.
one of our customers developed a strategic objective to
Third, in relation to the US, Mexico is considered “near-
reduce costs by a significant percentage. Providien has
shore”. Providien can build cost competitive products in
subsequently made sizeable capital investments in two
Mexico, and have the goods imported and distributed
different business units and has provided that customer
across the US in a matter of days. If building in Asia, that
with annual cost savings in excess of 1 million dollars per
same lead time extends into weeks and months.
year. We were able to achieve that success by operating as one organization to provide a powerful solution.
“It’s a priority to leverage all of its US supply offerings
Q: To whom do you supply in Mexico and what are the most demanded products? A: In addition to the leading medical devices companies,
and consolidate in Mexico
we also supply to tier two and tier three Original
to deliver an economical
three require a slightly different solution, one that has
solution. Mexico is a favorable
Equipment
Manufacturers
(OEMs).
Tiers
two
and
more of an emphasis on engineering and Design for Manufacturing (DFM). At Providien, we have a team of
geography with regards to an
seasoned engineers who not only help improve complex
organization’s ability to scale”
as the products of high demand, there are generally two
Matt Jordan, Vice President and General
manufacturing processes but also develop them. As far types. High-volume disposables and/or products that require a high degree of manufacturing labor.
Manager of Providien Q: What partnerships and alliances do you have in Q: Who do you provide your products to?
place in Mexico?
A: We are exposed to and work with valuable intellectual
A: We have formed partnerships with many local
property in the medical industry. As a result, customer
suppliers in Mexico. These relationships have extended
into the US and into our California divisions. We also
government and we provide employees with food and
partner with a Mexican logistics company called JD
gift certificates. Providien now offers formal education
Group. They have been fantastic to work with. JD Group
to engineers and sponsors them through technical
is the only logistics company that has both US and
certifications.
Mexican customs brokers, which allows Providien to move product in and out of Mexico very quickly.
Providien has emerged as the preferred outsourcing partner in the medical device manufacturing industry
Q: What are your strategic priorities here in Mexico?
in Mexico. With continued growth forecasted, 2016
A: Expansion. As cost pressures continue to mount, the
and 2017 will be very important years for Providien. In
demand for cost competitive manufacturing increases.
Mexico, our growth is specific to Tijuana.
Strategically for Providien, itâ&#x20AC;&#x2122;s a priority to leverage all of its US supply offerings and consolidate in Mexico to
Moving to another country in Latin America would
deliver an economical solution. Mexico is a favorable
mean forfeiting some of the advantages mentioned
geography with regards to an organizationâ&#x20AC;&#x2122;s ability
earlier. Providien always looks to add new customers but
to scale. The supply and demand ratio for labor is
organic growth with our existing partners is a strategic
such that adding labor can quickly be accomplished.
objective.
Having reduced costs and the ability to quickly ramp up operations this close to the United States makes
Q: How do you maintain your competitive edge in the
expansion in Mexico a strategic priority.
medical device manufacturing market? A: Commercially, we maintain a competitive edge by
Q: What has been the impact of the growth of the
utilizing all of our business units and providing vertically
medical devices market on your operations?
integrated solutions. Internally, we excel operationally
A: The impact has been sizable and our business has
and focus on continuous improvement. We strive for
grown. One of the top priorities has been to give back
continuous improvement not just in manufacturing,
to the labor workforce here in Mexico. Weâ&#x20AC;&#x2122;ve invested
but in all areas of the organization ranging from human
in improving the employee work experience in Tijuana
resources to logistics. We understand that our people
and offer upgraded facilities and an increased number
and our teams make us great. We have an impressive
of local recognition events. We partner with the local
team in Mexico and I am proud of our operation.
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| VIEW FROM THE TOP
MEDICAL TECHNOLOGY COLLABORATION ACROSS THE PACIFIC KOTA YAMAMURA President of Terumo
128
Q: How has the medical devices market evolved since
by our mission, we are not just providing high-quality
Terumo’s foundation in Mexico?
products but we are contributing to society.
A: We have a more than 20-year history in Mexico, since we established a regional office in 1992. Initially we
Q: How do you collaborate with the government to
focused on syringes, needles and disposable products
contribute to the growth of this sector?
but over the last 10 years the axis of the company has
A: As mentioned before, we have training programs,
changed and now we have another pillar, the cardiology
most of them on the cardiology field and supported
field. Our main priority has been to provide a high-quality
by the government. We have sent doctors to receive
portfolio of products so we can improve the patients
specialized cardiovascular training in Japan. In the same
quality of life. At the same time, our products are easy
way, these Mexican doctors share their experiences with
to use by doctors and medical staff, which has influenced
their Japanese colleagues, enriching the experience
both in society and in how medical procedures are carried
for both parties. Sophisticated techniques are covered
out in the country.
during the trainings and a few months later the Japanese doctor that trained them comes to Mexico to evaluate the
Terumo has a presence in more than 160 countries. We
effectiveness of the training and to get to know Mexican
support our customers with global clinical evidence
medical practices. These trainings have been performed
that backs up the quality of our products and their use
for five years and still there is a lot of room for growth, for
in different medical fields to obtain the desired clinical
example with trainings for nurses and engineers.
outcomes. We are also providing international training in different areas that concern the users of our devices.
Q: Some executives in the medical devices industry have
Together, the international experience and our training
expressed that COFEPRIS could further reduce approval
programs provide the doctors and medical staff with the
times. What are your thoughts on this?
strongest support. This is the best way to capitalize on
A: COFEPRIS has improved in recent years. As a member
good practices that Terumo has acquired over the years.
of the Japanese Chamber, I am in charge of supporting Japanese companies in sorting out regulatory issues
Q: What would be the main difficulties faced in terms
with COFEPRIS and I can say the Commission is open to
of Mexico’s medical devices industry and how do you
collaborate and provide positive answers. For example,
overcome these?
in 2012 Japan and Mexico signed a fast track agreement
A: Mexico and Japan have a similar population around
for medical devices, which has allowed acceleration of
125 million people, but the number of medical cases is
the approval of Japanese medical devices, including our
not the same as Japan. It means Mexico has a strong
devices.
potential to increase the access to medical treatments from different specialties. Added to this, the country´s
Q: What are your main objectives for this year?
economic growth will certainly lead to a greater
A: Innovation is not moving at the same pace today as
demand for healthcare services. Thinking on this we
10 years ago, when many new products and technologies
have already performed several trainings for doctors in
were developed. Nowadays we are focusing on developing
the Interventional Cardiology field to offer a different
new easy-to-use and safe products with an added value.
treatment approach that allows reducing the time
Training is also extremely important for us and we see it as
a patient needs to stay in the hospital. By reducing
a contribution to improve the healthcare sector in Mexico.
hospitalization time, expenses are directly reduced
Collaborating more closely with doctors is also at the core
too. Both the Japanese and Mexican governments have
of our strategy, as their opinions are a valuable source of
supported these training programs and as dictated
input for the improvement of our products.
| INSIGHT
PRODUCT REGISTRATION IN MEXICO GETS STREAMLINED When international companies decide to enter the Mexican market, they are extremely enthusiastic to take advantage of the many opportunities it offers. However, they either perceive the regulatory framework as a complicated
LUISA GUTIÉRREZ
barrier or are unaware that they need to plan a strategy
Director General of Medisi
to effectively register their products in Mexico. Despite offering high-quality services, international consulting firms usually lack local knowledge and this is where
backlog on reviewing submissions, which is partly
Medisi becomes relevant since it supports international
because they never deny an authorization without asking
companies
to
for further information first,” Gutiérrez says. She also
regulatory affairs to achieve commercial goals. For
considers that COFEPRIS needs to optimize a regulation
instance, as new product registrations can take up to a
for
year and a half, companies can spend 12 months putting
understand medical devices as it is a universe of diverse
a dossier together. This is not encouraging for medical
products. Wound care materials are completely different
devices companies willing to launch new versions of their
from medical equipment such as a laser treatment for
equipment every year, which is why product registrations
cancer. In my opinion, we are moving toward a more
in Mexico should be planned strategically.
accurate classification for medical devices.”
Companies interested in entering the Mexican market
The classification according to risk has I, Ia, II, and III
should be correctly advised to avoid a path full of
categories requiring different legal documents. Classes I,
obstacles
in
developing
a
strategic
approach
medical
devices.
“COFEPRIS
needs
to
better
are
II and III take between three to seven months to obtain a
usually seen as mere requirements to be met,” says
registration with COFEPRIS plus the time it takes to prepare
Luisa Gutiérrez, Director General of Medisi. “When in
the dossier, while it takes between 2.5 and six months to
reality, regulatory affairs strategies have a tremendous
get a registration through a third party authorized unit.
impact on the commercial success of a product.”
Medisi help its clients get a dossier in four months, so the
Some companies need to register 10 products in a row
whole registration process is completed within a year.
and
disappointment.
“Regulations
while others 35. A common mistake is undergoing an individual submission process for each of the products
For Gutiérrez, the opportunity for medical devices
when they could strategically group them according
companies is huge. Mexico’s total population is about
to their manufacturing and core features. As Gutiérrez
128 million inhabitants. Launching a product targeting 2
says, medical devices companies need to be aware that
million people in Mexico equals covering one-third the
product registrations in Mexico can take from 17 to 25
population of Israel. However, registration processes can
months, and Medisi can do it in 7 1/2-13 1/2 months due
be convoluted for international companies when they
to their efficient submissions and follow-up. “We have a
do not have the knowledge in negotiating the arena.
project management tool that is useful for determining
“They usually believe that contacting a local partner or
milestones, timescales and the workload,” she adds. “If
a distributor will solve all their problems,” Gutiérrez says.
something gets delayed by COFEPRIS, we will notify our
“On the other hand, many other companies have realized
client and develop a plan to decide the most appropriate
that it is worth having their own registrations in Mexico and
way to optimize time to market.”
they are striving to expand their portfolio in the country.”
Regulatory timelines in Mexico have become quite
Medisi employs 25 people including quality assurance,
competitive around the world due to vast improvements
regulatory affairs and business development experts.
made by COFEPRIS in the last three years. Nonetheless,
It is now focusing on providing training to companies
there are still some challenges such as regulatory offices
so they understand Mexico’s regulatory framework and
providing bilingual services to companies outside Mexico.
realize there is always a strategy to easily obtain product
Also, as many distributors and companies ignore the
registrations. “We are also aiming to expand to places
requirements to submit a dossier, regulatory agents
with a similar environment to Mexico. We are interested in
spend more time than they should reviewing incorrect
building strategic alliances in Latin America – a region with
submissions. “Historically, COFEPRIS has had a huge
great potential yet to be unlocked.”
129
| VIEW FROM THE TOP
TIJUANA A GROWING HEALTH TECHNOLOGY HUB
130
Cristina Hermosillo President of Cluster Tijuana EDC
Ă ngel de la Campa President of Cluster Tijuana EDC at Medical Devices Cluster
Miguel FĂŠlix President of Cluster Tijuana EDC at Medical Devices Cluster
Q: What are the tendencies in the medical devices sector
AC: Baja California represents 50 percent of the medical
and what future tendencies will we see?
devices industry in terms of plants and 25 percent in terms
AC: I think we will see a tendency for more personalized
of employees.
devices with a high degree of integration with electronic devices. For example we will see apps that give patients
Q: What are the clusterâ&#x20AC;&#x2122;s strategic priorities?
easier control of devices and will enable monitoring of
MF: We have updated our strategic plan. We used to
the patient and sending out alerts. This is a world trend.
have seven lines, which we have reduced to five: human
We have heart valves that no longer require weeks of
capital development, supplier development, promotion
recovery but only 24 hours. We have catheters that enable
of the sector, government relations, R&D. We have had
the doctor to enter the blocked artery and use digital
successes in all.
technology to check both ends of the artery, find the clot and remove it. We help manufacture the latest products
Q: Why is Tijuana attractive to foreign companies? What
that are being thought up and designed in R&D centers
facilities are there?
and head offices.
AC: We have people with over 25 years of experience that are bilingual, who know the culture of both the US and
CH: Companies are getting bigger and there is world
Mexico. We have access to the international airports of
pressure to lower the cost of commodities. This is usually
Tijuana and San Diego, we have an international port so we
the first outreach we have with companies. They begin
can import and export and Long Beach port is not far either.
by making simple products and move toward more
From a logistics point of view, we have access to all means
complex operations. There are companies like Foxton who
of transport. We have world class facilities and universities
traditionally make electronics and are looking to move into
that can give us calibration systems we need and we have
medical devices, or Thermalfusion, who are moving toward
support from the government. Unlike other industries, we
big data and analytics and medical device software.
are not content with 99 percent quality because in medical terms that means one in every 100 patients dies, which is
MF: We have been in the industry for 30 years. In contrast
not good enough for us. We have been successfully audited
to other industries we do not receive obsolete technology
by the FDA many times.
but the latest and newest advances in the field. We are participating in the design of devices from a manufacturing
Q: To what extent do you believe you will grow?
point of view.
MF: There are many medical devices opportunities in Nordic countries. They are trying to enter the US market and Tijuana
Q: What percentage of the cluster does medical devices
is an ideal place to start. Other countries such as the Czech
represent? How important is it for you?
Republic have companies looking to move here. Mexico has
MF: In Tijuana, there are almost 580 manufacturing
important commercial power in terms of certifications and
companies, 44 of which belong to the medical devices
trade agreements. We also have R&D, which is the message
sector, which is 7.5 percent. In terms of employees, we
we are taking to international embassies.
employ 42,000 of approximately 200,000 people. AC: In the medical sector, Mexico will grow the most, even CH: In 2015, medical devices represented 10 percent of
compared to Italy, Germany, the UK, the US and Japan. We
investment in Baja California and 25 percent for Tijuana.
project to grow between 7 and 10 percent.
| INSIGHT
REGISTRY PLUS CERTIFICATION A WINNING FORMULA Third party authorized centers are invaluable to COFEPRIS when it comes to product evaluation for sanitary registration. With 20 years of experience as a certification and inspection body for electric and electronic devices,
CARLOS PÉREZ
and with official branches in countries such as China
Director General of NYCE
and Colombia, NYCE decided to tap into the Mexican pharmaceutical and medical device sector as soon as the government authorized third parties. NYCE is one of the 19
650 medical devices so far we are the third largest in the
third party centers but the only one offering the possibility
market according to COFEPRIS,” says Pérez. The market is
to obtain product registrations along with certifications
dynamic and based on price so companies should focus on
that comply with international standards. “This has helped
offering a better customer experience. According to Pérez,
us develop both technical and professional capabilities,
a recent market study showed that price is not the only
which are indeed very difficult to replicate,” says Carlos
element defining customer preference. Clients are seeking
Pérez, Director General of NYCE.
high quality-services, active support from their partners and experienced customer service. Equipment certification
Global standards represent a major trend and all industries
should not be viewed as a tool to simply gain access to a
are moving toward homogeneity. Standardization makes
market but to provide customers and end consumers with
it easy for companies to expand. NYCE is a certification
safe and efficient equipment.
and standardization body capable of implementing international canons for electronics, telecommunications,
NYCE will continue expanding its capabilities to several
IT and more recently, healthcare devices. In Mexico, there
areas outside of electronic and medical devices. In the
are 11 standardization entities and NYCE is one of the
next few months it will cover herbal medicines and
larger ones. It also offers validation services in the form
COFEPRIS will release the bid for pesticides, plaguicides
of conformity assessment, as regulatory requirements are
and fertilizers. “We are training our staff in these fields and
not considered standards but specifications to comply.
we will approach chemical companies to offer third party
It decided to establish operations in China because
evaluations for their products,” says Pérez. NYCE wants
65 percent of electronics consumed in the world are
to become accredited in conducting good manufacturing
manufactured there and they need to comply with local
practices audits in pharmaceutical plants since it believes
regulations and official norms to enter the Mexican
that ensuring quality manufacturing will help get products
market. Having a representation of its services near the
registered quicker. At this point, audits in medical devices
manufacturers was a significant move for NYCE and it now
plants are attractive as most of the production is exported
holds a recognition agreement with a Chinese laboratory
and would not impact product registrations in Mexico.
to ensure product compliance according to Mexican
Nevertheless, quality certifications should definitely be
requirements. This helps manufacturers avoid logistics
recognized in destination countries. “As COFEPRIS gains
expenses associated with sending products for evaluation
international recognition we expect Mexican registrations
and makes their entry easier.
and norms to be valid around the world,” says Pérez. “Our activities and efforts will certainly impact more countries in
“Regarding medical devices the largest producers are
the short to medium term.”
European and American companies, therefore we contact them to offer a package including product registration with COFEPRIS and certification for electronic devices,” says Pérez. Most third parties in the healthcare industry do not certify electronics and this is one of NYCE’s main differentiators. Unlike other third party entities, NYCE is directly involved with several industries. NYCE’s multi-
“As COFEPRIS gains international recognition, we expect Mexican registrations
sectorial experience is a great competitive advantage.
and norms to be valid around
“Today we have 8 percent of the healthcare Industry
the world”
third party units’ market share and having evaluated
Carlos Pérez, Director General of NYCE
131
| EXPERT INSIGHT
COMPLIANCE KEY TO ENTER DEVICES MARKET then to the US and to Mexico for the sole reason that the regulatory environment is more predictable.
RUBÉN GAITÁN Design Development Manager
Q: Here in Mexico, to what extent do you gauge market
of Alandra Medical
suitability when deciding whether to commercialize a product? A: In Mexico, our main product is consultancy services for
132
Q: What can you tell us about the company’s history and
other startups. We have also worked with the Mexican army
how it made the decision to come to the Mexican market?
to help them with a medical device they are developing
A: Alandra Medical was created after merging the best
with Monterrey’s ITESM and other entrepreneurs. In Mexico
intellectual property (IP) portfolios from two Mexican
we are not marketing any device because at the end of
medical devices companies, Innovamédica and HOLOS,
the day, Alandra is most interested in taking ideas from
with Gerbera Capital, which is a Mexican venture capital
academia, building up a portfolio and then transferring
firm that was interested in developing medical devices
these ideas to large companies like GE. Of course the
for the healthcare industry. Since six years ago, we have
IP is important but in the industry it is also necessary
undergone a great deal of change. The first step was to try
to demonstrate compliance to industry standards and
to outsource services and devices from US companies like
clinical evidence that the device works and that it is safe.
Medtronic or Boston Scientific. We discovered that Mexico
Many entrepreneurs in Mexico believe that trials can be
manufactures medical devices but there is a long way to go
performed on humans having only received approval
regarding the expertise and regulatory discipline needed
from the institute’s ethical committee, but approval is also
to sell product development services. We have customers
needed from COFEPRIS.
from Johns Hopkins University and from the University of California and it was mostly these types of academic
Q: To what extent do you believe that work is needed in
customers who proved a strong match for Alandra Medical.
establishing a more comprehensive system for regulating medical devices?
Alandra has its own medical technology that it has
A: I would say it depends on the environment. There are
acquired from other companies. We have benefited from
major clusters in Chihuahua, and in the northern area of
several grants from the National Council for Science and
Mexico there are serious companies that build devices
Technology (CONACYT) and the entrepreneurship institute
to standard. I believe there is a lot of work to do in the
INADEM, which helped us develop internal capabilities
entrepreneurial environment. There is an aim within the
and an internal quality control system. The company is
Ministry of Economy to develop the Mexican software
certified to ISO 13485. We spun off another company in
industry to a similar or superior standard to India. We have
California called Critical Perfusion to market and launch our
an advantage in that we are neighbors with the US. There
first medical device, which is a monitor for surveilling the
is support from the Ministry of Economy, we have an ideal
perfusion status of the gastric mucosa. We also contributed
geopolitical relationship with the US and it is something we
to developing a therapy system for diabetic patients who
can leverage through the development of the industry in
have injuries that are very slow to heal. This technology
the coming years.
helps to heal them through the application of certain magnetic fields.
Our main goal is to obtain clearance to market our device in Europe, which will lower the perceived risk of investing
We
other
in our company. Many companies are relatively afraid
entrepreneurs but our system relies on developing products
also
carry
out
outsourcing
projects
for
to develop products and seek startups that struggle to
with regulatory and quality control norms. Of course,
get clearance and only once obtained will they invest.
Alandra makes money from involvement in operations
Regulatory clearance for innovative high-risk devices
but even today we are still dependent on the contribution
created by entrepreneurial developers has declined over
that Gerbera Capital is making. It has taken us six years to
the past few years because of the substantial investment
develop the product to this point, which is relatively quick
that such innovations require and startups face a major
given that similar companies in the US and in Europe take
financial burden. Alandra Medical has identified that we
up to ten years. We are thinking about going to Europe first
need clearance to attract more investment.
| VIEW FROM THE TOP
CATALAN TECHNOLOGY EXPERTISE HELPING MEXICAN PATIENTS LOURDES CAMP General Manager of Ventura Medical Technologies
Q: What are the unique characteristics of the products
A: Registration processes vary widely in length. If there is
Ventura Medical Technologies is bringing to the Mexican
already a similar product in the market registration only
market?
takes seven months. One of a kind, innovative products
A: We are entering the Mexican market with our new
have to undergo clinical trials before approval. We still do
thoracic implant, the Pectus Up Surgery Kit, designed to
not know how many patients will be required for the trials
treat a congenital malformation called pectus excavatum,
and its registration will influence how fast we can perform
and my goal is to register it to begin commercialization. We
them. It would be significantly faster to perform them
have already spoken to thousands of doctors and have good
with two than with 50. Yet, we have enough candidates
expectations from governmental offices, including PEMEX,
both in doctors and hospitals, to perform these trials in
SEDENA, ISSSTE and IMSS. We have great expectations for
one or two months. Taking into account the time cost of
this last institution as its head of innovation used to work for
clinical trials, we expect to have the product approved
Ventura Medical Technologies in Barcelona, Spain. For that
in a year.
reason, we expect to perform some clinical trials both with IMSS and ISSSTE.
Q: What are your expectations for the Mexican market and how do you expect doctors to receive the product?
Q: What led Ventura Medical Technologies into Mexico
A: We have great expectations for this product and I am
and what is the companyâ&#x20AC;&#x2122;s proposition for the Mexican
certain that we will have a significant number of sales
market?
as soon as we acquire the registration. We have many
A: Ventura Medical Technologies is an engineering
potential clients both in the public and the private sector.
company which prides itself on its close relationships with
Most doctors are pleasantly surprised by this product as
doctors and allows them to turn their most innovative ideas
it is minimally invasive in comparison to other techniques,
into products, which are marketed through our global
some of which even cause small mortality rates. As the
distribution network. We are devoting ourselves to health
product is minimally invasive, its indirect costs are greatly
and the development of new medical devices, promoting
reduced which is attractive to public health institutions.
innovation among health professionals and helping them get their products to the market. Normally we offer expert advice and look for synergies between their innovative capabilities and our own expertise. The company is based in Spain but the product is patented in 18 countries, including Mexico. I am developing a commercial strategy for the country using both my experience as a doctor and my large network both with the public and the private healthcare sector. We gained interest in the country from the great enthusiasm I saw from Mexican doctors I met at international healthcare events. I have also had close relationships with many potential clients in the country who seemed greatly interested in the product, so bringing it into Mexico seemed a logical next step. Q: What are the main challenges Ventura Medical Technologies has had to overcome to commercialize its products in Mexico?
Pectus excavatum or funnel chest is a congenital deformity in which several ribs and the sternum grow abnormally, producing a concave appearance in the chest wall
133
6
DIAGNOSTICS & PREVENTION
Under pressure to reduce costs and improve efficiency on a shrinking budget, the push is under way in Mexico to promote a culture of prevention in view of a growing epidemic of obesity and related illnesses like diabetes, hypertension and glaucoma. While the public sector is leading the charge with information campaigns, companies and NGOs are also getting on board with their own projects to improve the countryâ&#x20AC;&#x2122;s health and reduce the debilitating effects of these conditions.
Life-threatening illnesses like cancer are being observed and studied to improve detection and prevention strategies, with a focus on genetic predisposition and long-term strategies such as INCanâ&#x20AC;&#x2122;s Tumor Bank, which keeps tissue samples for later research. Among institutional efforts, companies are also working to create modern tools and develop digital systems to help stop sickness in its tracks. This chapter showcases some of the organizations and firms at the forefront of the prevention and diagnosis battle in Latin Americaâ&#x20AC;&#x2122;s second-largest economy.
135
| CHAPTER 6: DIAGNOSTICS & PREVENTION 138
ANALYSIS: Companies and institutions leading the diagnostics charge
140
VIEW FROM THE TOP: Luz Ruíz, INCan’s Tumor Bank Coordinator
Abelardo Meneses, Instituto Nacional de Cancerología
142
VIEW FROM THE TOP: Erick Alexanderson, Mexican Cardiology Society
143
VIEW FROM THE TOP: Carlos Sánchez, MyHeart
Óscar Sánchez, MyHeart
144
EXPERT INSIGHT: Eduardo Lazcano, National Institute for Public Health
146
VIEW FROM THE TOP: Frank Admant, BioMérieux
148
ANALYSIS: Vaccination Culture Prevalent in Mexico
149
VIEW FROM THE TOP: Juan Tamayo, COMOP
150
VIEW FROM THE TOP: Carlos Hernández, Siemens Healthineers
151
VIEW FROM THE TOP: Jorge Soto, Miroculus
137
| ANALYSIS
COMPANIES AND INSTITUTIONS LEADING THE DIAGNOSTICS CHARGE From outlining long-term plans against life-threatening
including regular medical check-ups will go a long way.
illnesses like cancer to coming up with new and improved
“People should be making lifestyle changes that lead to
technology for early detection and prevention, Mexico is
lower cholesterol levels, reducing tobacco consumption,
increasing its focus on preventive medicine. Organizations
increasing physical activity, achieving a healthy weight … to
like the National Institute of Cancerology (INCan) have
reduce the risk of cardiovascular disease,” he says. Women
created initiatives such as the tumor bank to keep a tissue
are also an underdiagnosed demographic, which is why
registry while the country’s main health provider, the
the SMC partnered with the American Heart Association
Mexican Social Security Institute (IMSS), is looking to shift
(AHA) on preventive campaigns.
attitudes toward a healthier lifestyle in the face of severe 138
overweight and obesity ratings threatening epidemics on
Hard science is also needed to create reliable indicators,
diseases such as diabetes and heart disease.
an area where INCan is working non-stop via collaboration with state health providers like Seguro Popular, but the
The importance of prevention is impossible to overstate,
country is still a few years away from having all the data in
as preventable or treatable diseases such as heart disease,
hand. However, advances such as testing family members
diabetes and cancer account for almost half of Mexico’s
of cancer patients for genetic markers predisposing them
deaths. In 2014 heart conditions including myocardial
to the disease have shown promising results, say doctors
infarction were the main killer in Mexico, with over 19
Abelardo Meneses and Luz Ruíz, from the Institute.
percent of deaths, followed by diabetes with 15 percent and malignant tumors in third place with 12 percent,
Technology firms like Siemens Healthineers are teaming
according to official data.
up with diagnostics laboratories on strategies and digital solutions to reduce diagnostic costs and time, also looking
Against this stark background, Mexican and international
to help in a time of financial pressures brought about by
companies are leading efforts on early detection and
governmental budget cuts. “By detecting predispositions,
prevention
potentially
laboratory diagnostics can improve disease prevention
debilitating conditions such as osteoporosis, setting their
and will become more important, reducing cost of care
sights on a stronger and healthier population.
with higher possibilities of success,” says the company’s
for
those
illnesses
but
also
Hispanic America Regional Director for their Diagnostics For some such as Doctor Erick Alexanderson of the
Division, Carlos Hernández.
Mexican Cardiology Society (SMC), simple measures Financial constraints are on everybody’s mind, as state health providers spend most of their resources treating
MEXICO’S DEADLIEST DISEASES Heart disease
121,427
conditions related to diabetes and obesity, according to the
Diabetes mellitus
94,029
Director General of IMSS, Mikel Arriola. Miroculus is looking
Malignant tumors
77,091
into the growing field of molecular research to offer simple
34,444
to use diagnostics tools for stomach cancer and is aiming to
33,166
start clinical testing in Mexico by the end of the year, while
Liver diseases Cerebro-vascular conditions Influenza & pneumonia Chronic pulmonary diseases
20,550
Osteosol is working to stop osteoporosis from the womb.
19,715
Perinatal conditions
13,089
Vaccinations, one of the main areas of traditional
Kidney failure
12,788
preventive medicine, looks like a bright spot, as the
Congenital malformations and anomalies
9,569
country ranks high in children’s inoculation levels in the
Malnutrition
7,300
OECD, even surpassing first-world nations like France
Chronic bronchitis
5,060
and the US. And Mexico’s National Public Health Institute
4,811
(INSP) is also looking at adults and conducting trials to
Septicemia
3,805
improve vaccination rates against Human Papilloma Virus
Anemia
3,640
(HPV), a leading cause of cervical cancer in the country.
Infectious Instestinal diseases
3,449
HIV-related diseases
Non-categorized causes Total Deaths, 2014 Source: INEGI
10,583
This chapter takes a look at both companies and
633,641
institutions fighting to stop the spread of diseases before they hurt Mexicans.
139
| VIEW FROM THE TOP
A LONG BUT AMBITIOUS ROAD TO PREVENTIVE CULTURE Luz Ruíz INCan’s Tumor Bank Coordinator
140
Abelardo Meneses Director General of Instituto Nacional de Cancerología
Q: One of INCan’s objectives is applied research. Where
Q: With Seguro Popular, 36 percent of the population is
are you investing your efforts in this area?
entitled to medical care, including for cancer. How have
A: INCan performs both basic and clinical research. A few
detection indicators increased and what states are the
years ago, we started the practice of translational research
most afflicted?
to benefit patients. It is designed to go from the lab to the
A: Primary and secondary prevention efforts to reduce
hospital bed and research is applied from the prevention to
exposure to risk factors, such as high-calorie diets,
the palliative care stages. Soon we’ll also apply it to cancer
adopting a healthier lifestyle, stopping smoking and
survivors and our goal on the clinical side will be to obtain
exercise, do not happen overnight. Similarly, increasing
molecular and genetic responses and also best practices,
early detection indexes for malignant tumors susceptible
while also gathering patient success stories related to the
to
different treatment protocols and clinical stages.
commitment. Both primary and secondary prevention
early
diagnosis
takes
considerable
time
and
require at least two decades of constant application to We are focusing prevention research on populations
see results in the population.
suffering from hereditary cancers, such as malignant breast, ovarian, endometrial, colon and prostate tumors.
Catastrophic coverage of neoplastic disease within the
Close to 10 percent of patients suffering from these have
Seguro Popular has been available for about 10 years
genetic mutations that aid tumor development. We have
for breast and cervical cancer and for close to five years
centralized genetic studies of the patients’ families for
for testicular, prostate, colon and ovarian cancer and
early detection and diagnoses of the asymptomatic
non-Hodgkin lymphoma. This is too little time to have
relatives carrying the gene mutation that predisposes
measured relevant results.
them to develop one of these tumors. Close to 90 percent of our patients suffer from breast, ovarian or
Of all deaths in Mexico, about 13.7 percent are due
colon cancer and in each of these patient’s families we
to cancer. Every year 190,000 new cancer cases are
have encountered three or four relatives at high risk of
diagnosed and mortality rates are around 60 percent.
developing malignant tumors, known as asymptomatic
The most frequent malignant tumors are breast, prostate,
carriers. We have started a hereditary and family cancer
cervical, colon, lymphoma and lung related. Malignant
clinic to study people at high risk of carrying a genetic
tumors show regional patterns in Mexico’s 32 states
mutation and their relatives to provide them with
depending on sex, age, socioeconomic status, exposure
genetic advice, follow-up and possibly diagnose them
to risk factors and lifestyles.
at an early stage. Generally speaking, there is a higher number of cases Q: What are the needs of the Mexican population and
in the country’s north, with greater incidence of breast,
how can we reduce mortality?
prostate, colon, lung cancer and lymphoma. In the south,
A: Developed countries have reduced the incidence of
we have breast, cervical, gastric and liver cancer, with a
advanced cancer and of certain types of tumors. This
higher mortality because of the advanced stages they are
is not happening in developing countries where cancer
usually diagnosed at and the lesser access to healthcare.
cases and mortality are on the rise. INCan took the lead in developing the Mexico Cancer Prevention and Control
Q: Which preventive measures can Mexicans implement
Program (PIPCCM), an integral part of which is the creation
in their daily lives to reduce the chance of falling victim
of cancer registries that are based on population and
to cancer?
strategically located. It also promotes lifestyle, education
A: There are several things people can and should do to
and awareness to diminish exposure to risk factors.
reduce their chances of catching a chronic, non contagious
disease such as cardiovascular afflictions, diabetes and
We will generate research from the tumor bank INCan
some types of cancer. It is possible to prevent around 40
has developed over the past few years, which has
to 50 percent of malignant tumors if we adopt healthier
preserved over 6,500 fabric samples of different types
lifestyles and remember to do detection studies. There
of tumors and over 9,000 samples of plasma for the
are risk factors heavily linked to cancer, such as tobacco
purpose of researching biomarkers and to use the fabric
intake, high-calorie diets leading to obesity, heavy intake
in collaborative national or international research projects.
of sugary drinks and alcohol, lack of exercise, exposure to
The main objective of the INCan tumor bank is to create
human papilloma virus (HPV) and Hepatitis B and C, high
a platform for oncological research, preserving tumor
exposure to sunlight and UV rays and carcinogens in the
fabric in an optimal condition and when conditions permit,
environment and workplace.
we conserve the fabric of a recurring tumor. Even so, active participants in malignancy projects such as the
Q: What other programs have been put in place to
breast cancer project are most often young women. The
educate the population?
INCan tumor bank is supporting 10 translational medicine
A:
state
and clinical research projects. It also is participating in
governments and members of the chambers of deputies
Together
with
civil
organizations,
some
international projects such as the Regional Center for
and senators, INCan has adopted specific programs for the
Research of Excellence and Non-Transmissible Diseases.
diffusion of knowledge on breast, colon, stomach and lung cancer, as well as leukemia. Through these activities we
Within senior management’s program and with the
seek to disseminate the concept of high-quality care, early
finality of strengthening the culture of prevention, we will
adequate and effective treatment and the enhancement of
continue to undertake activities such as the Cancerton
palliative and rehabilitative care. INCan also has a permanent
and to implement early diagnosis opportunities for the
information program on tumors called Infocáncer.
main tumor types in various Mexican states.
This program has been much consulted and not only
The road is long and ambitious but we want to change
have patients and their families been able to obtain
from being a reactive country to cancer, to a country with
information but so have those who want to learn more on
a preventive culture.
different malignant tumors, their behavior and treatment options. Q: Having a preventive approach not only improves recovery chances of the patient but also has a lesser impact on public spending. What support has INCan received from the Health Minister to promote a preventive culture? A: Fiscal and physical resources are engaged for the year on operation and investment plans. Nonetheless, through special programs INCan staff is able to manage resources for capacitation, diffusion, rehabilitation and research for the prevention and treatment of malignant tumors, specifically for breast, cervical, ovarian and lung cancer, HIV/AIDS and hereditary cancer. INCan also participates in breast and cervical/uterine cancer prevention programs with the Health Ministry. Q: What are INCan’s future projects? A: The National Institute of Cancer will continue to promote prevention programs that encourage lifestyle changes and the empowerment of cancer survivors to change the perception that cancer equals death and replace it with success stories. We will also promote the “Integral Program to Prevent and Control Cancer in Mexico” and develop three more population-based cancer registries in Guadalajara, Monterrey and Puebla, in addition to the existing one in Merida.
141
| VIEW FROM THE TOP
NETWORKING HELPS TAP INTO CARDIO SOCIETY ERICK ALEXANDERSON President of the Mexican Cardiology Society (SMC)
142
Q: What resulted in the creation of the Mexican
agreements
Cardiology Society and how does it serve its members?
societies such as the American Heart Association (AHA),
A: In 1924, Dr. Ignacio Chávez, an acute clinician and
the Egyptian Cardiology Society and the Argentine
highly regarded professor of the School of Medicine of
Cardiology Federation, among others. These agreements
the National Autonomous University of Mexico (UNAM),
allow the members of our international partners to
was asked to reorganize the department of cardiology
participate in our academic courses and our members
at the General Hospital in Mexico City, the main teaching
in theirs, which opens the door for our membership to
hospital in the country. Dr. Chávez then traveled to Europe
present at international conferences.
with
different
international
cardiology
to continue his specialist training in this field and upon his return convened a group of esteemed cardiologists with
Q: How does SMC grow research in the cardiology field?
strong academic reputations to incorporate innovative
A: This year, SMC will create national registers for the
European technologies. This group of doctors began
collection of epidemiological data regarding the most
holding scientific meetings, with guest speakers, which
frequent cardiovascular diseases in Mexico. We are aware
resulted in the creation of the first formal postgraduate
of the urgent need to obtain our own data to be able to
course in cardiology in 1933, during the tenure of Dr.
make decisions. This great step forward is starting during
Chávez as Dean of UNAM’s Faculty of Medicine. The
this administrative period and marks the beginning of a
strong interest generated by these events resulted in the
long-term data collection strategy. CardioAcademic is a
founding of the Mexican Society of Cardiology (SMC) in
Spanish language website where cardiologists can find
1935, with the objective of promoting research, education
updated information, clinical cases, blogs and useful
and a science-based practice of cardiology.
clinical information for their patients. Internet and social media are without a doubt powerful weapons for medical
SMC supports its partners and members by organizing
information dispersal and have to be used to the maximum.
high-quality academic events, granting scholarships that enable residents to study abroad as well as facilitating the
Q: What are the main challenges that women with
participation of residents and cardiologists in international
cardiology conditions are facing and what are the
conferences such as those organized by the American
objectives of the #GoForRedWomen initiative?
College of Cardiology, the European Society of Cardiology
A: Cardiovascular disease is the main cause of death
and this year’s World Congress of Cardiology. The
and disabilities for women, according to the WHO. In
benefits of SMC membership primarily include partaking
the past, women were often overlooked for treatment of
in academic events, access to SMC’s official publication
cardiovascular diseases since it was believed that these
Revista Archivos de Cardiología de México, receiving
predominantly affected males. As a result, women were
updated information through our social media and
not submitted to routine testing and when they were
website, as well as being part of an important professional
diagnosed, the cardiovascular disease was already too
network.
advanced and with a bad prognosis.
Q: How is SMC linked with its international counterparts
#GoForRedWomen aims to raise awareness among women
and what are the objectives of international cooperation?
about cardiovascular diseases, encouraging them to take
A: SMC is one of the founding members of the
care of their health with simple measures like medical
Interamerican Cardiology Society, it is a member of the
check-ups, exercising and eating healthy. This year, SMC
World Heart Federation (WHF) and is affiliated with the
will sign an agreement with AHA to obtain the license for
European Society of Cardiology and the American College
#GoForRedWomenin Mexico and work to promote and
of Cardiology. This year, SMC established collaboration
prevent female cardiovascular health.
| VIEW FROM THE TOP
REASONABLY PRICED CARDIO MONITORNG ALTERNATIVE Carlos Sánchez R&D Manager at MyHeart
Óscar Sánchez Process Manager at MyHeart
Q: What proportion of the 17.3 million people suffering
to decrease incident numbers. However, equipment costs
from cardiovascular conditions worldwide does Mexico
continue to be the main reason behind the problem.
represent?
Federal budget allocation has been reduced resulting in
CS: Approximately 5 million people have some type
supply scarcity.
of cardiovascular condition in Mexico. Between 20-40 percent of them are aware of their problem with an even
OS: MyHeart’s main goal is to help doctors understand
smaller percentage treating the disease. The remaining
this problem, and adapt to new technologies. Veteran
population is vulnerable to cardiac arrest. In 2015, heart
MDs are reluctant, and even afraid of using newly available
disease came second to diabetes as the most common
technology such as mobile applications that are part
cause of death in Mexico. Although our strategy is focused
of the new digital health era. Our main goal is to create
on patients, MDs also benefit from our products because
accessible devices providing coverage for both private
the incurred investment is far lower than market average.
and public hospitals.
Our devices are US$3,000 to US$6,000 cheaper than our competitors’ products, lowering clients’ expenses.
Q: How does MyHeart ensure the data it gathers is the
The usual checkup price is MX$1,000-3,000 in private
highest quality for the lowest price?
institutions and waiting times in public hospitals are
CS: The components used in our products are medical
excessive. This, coupled with poor-quality and scarce
grade quality. A team of cardiologists and physicians as
infrastructure, reduces the long-term effectiveness of
well as engineers specializing in biomedicine supports our
treatment. This allows public institutions to make large
operations. Finally, we hold on-the-field trials in multiple
purchases
hospitals, and public and private clinics. This helps us
of
MyHeart
electrocardiograms
servicing
patients in public institutions.
gather opinions from many cardiologists and adapt our product to their recommendations. R&D plays an
Q: How do you hope trends will move to reduce chronic
important role in ensuring accessible costs. We only apply
diseases in Mexico?
what the market demands. Moreover, MyHealth has a two-
CS: Lack of information has hindered Mexico’s cultural shift
way encryption mechanism that secures all data gathered
toward prevention. Our products offer almost immediate
in the mobile application. We strive to protect our clients
data to patients regarding their health allowing them to
at all times.
seek treatment quicker. This improves their treatment success rate. Heart attacks happen without warning, and
Q: How has your business model developed?
patients have a 50 percent chance of survival. Even if
OS: We are in the earliest stages of acquiring funds to
they survive the organ suffers irreversible damage that
commercialize our product soon. We plan to launch
will need monitoring. Through prevention campaigns,
our solution in 2016. We foresee MyHeart products
and government subsidies we can put an end to this.
being used in many ambulances, and hospitals further
Fortunately, we are slowly starting to see some changes
along the road. We have previous experience in Class 2
in prevention trends. More people are monitoring their
product releases complying with COFEPRIS’ previous
weight because of health concerns and the number of
regulations. Nowadays, the NOM-240, NOM-241 and
products monitoring physical activity, such as Smartbands,
NOM-137 have undergone changes, and our device has
is on the rise.
adapted accordingly. MyHeart’s is waiting for COFEPRIS’ good practices audit that will result in future certifications.
Q: What role should the government take to ensure
Considering a standardization process between COFEPRIS’
service availability to treat heart problems?
NOM-241 and the FDA is underway we also expect to be
CS: An array of prevention programs must be put in place
granted access to the US market.
143
| EXPERT INSIGHT
THE CANCER BATTLE AND COSTEFFECTIVE INTERVENTIONS EDUARDO LAZCANO
utility of the HPV test in Mexico. These studies included
Director of the Research
over
250,000
Mexican
women
and
demonstrated
Center for Population Health
that clinical and self-sampled HPV tests have greater
at National Institute for Public
sensitivity than cytology. Community-based studies
Health (INSP)
showed that a single yearly HPV test is more sensitive than two Pap tests in a year. A randomized, communitybased trial showed that HPV tests done on vaginal
144
At the end of the 80's, cervical cancer constituted one of
samples that were self-collected at home were four times
the principal public health problems in Mexico. Given this,
more sensitive than cervical cytology as practiced in
during the 1990s a line of research on cervical cancer was
healthcare facilities located in rural areas in Mexico. In
created at the National Institute of Public Health (INSP)
addition, this self-sampled test is low-cost, allows semi-
of Mexico, with three principal areas: as the basis for later
automatized analysis, is easy to implement and has a
operational research, evaluation of processes and quality
lower false negative rate than cytology. Advantages
of care within the national cervical cancer detection
include that it can be done either at home or at a local
program based on cytology (Papanicolaou or Pap smears);
clinic or health center and this, in combination with
development of research using a case-control design, to
the high acceptability of self-sampled tests, allows for
identify associated factors including human papillomavirus
increased coverage.
(HPV) infection as well as epidemiological research on the impact of the cervical cancer early detection program;
Mexico has adopted evidence-based public health policy
and the first population-based studies to characterize HPV
and practice for the prevention and control of cervical
DNA genotypes in healthy women in Mexico.
cancer, including detection of and vaccination against HPV in all regions and socioeconomic groups, albeit
The initial scientific findings demonstrated that Mexicoâ&#x20AC;&#x2122;s
targeting specific age groups. In 2006 the HPV test was
national cervical cancer detection program had fairly
introduced for primary detection in the countryâ&#x20AC;&#x2122;s 150
severe quality issues, including low-quality cytology
most disadvantaged municipalities. Based on scientific
specimen collection, given that close to 60 percent of
evidence produced by the INSP, laboratory infrastructure
a randomly selected sample of cytology (Pap smear)
for HPV DNA analysis has been established throughout
slides lacked endocervical cells, mucus and metaplastic
most of Mexico in recent years for Seguro Popular and
cells, making them of little use for diagnostic purposes.
ISSSTE patients. Over 5 million HPV tests have been
Likewise, research established that there was an extremely
processed, concentrating principally on women above
high rate of false negative results on Pap smears. In spite
35 years of age. Women with positive HPV results are
of these findings, cytology did have a protective effect
referred for cytology. The INSP is carrying out triage
in terms of secondary prevention of cervical cancer in
studies that will provide evidence on what the best
Mexico.
diagnostic referral processes are for these women.
Given this, our research team used qualitative and
Universal vaccination against HPV among girls between
quantitative approaches to identify the principal barriers
10 and 11 years old was introduced in Mexico in 2012
to accessibility in the cervical cancer early detection
with an alternative, extended vaccine schedule. The
program as well as limitations in local program processes.
INSP recommended an HPV vaccination program using
Our research group developed the first population-based
a preliminary extended schedule of 0-6-60 months,
regional studies to characterize the presence of HPV DNA
and later confirmed that the third dose would not be
in different age groups in Mexico. This research established
necessary. As of 2014 the policy proposed by the World
that HPV is endemic in the Mexican population and has a
Health Organization is to provide two doses before
bimodal distribution by age; that is, the highest frequency
the age of 15, which has been implemented in over 80
is reached before age 25 and a second peak in frequency
countries including Mexico thanks to initiatives such as
occurs after age 65.
that recommended by the INSP.
In 2006, the Ministry of Health commissioned the INSP to
A clinical trial implemented by the INSP to evaluate
carry out two large demonstration studies to evaluate the
the immunogenicity and non-inferiority of alternative
HPV
vaccination
schedules
showed
that
vaccine-
induced antibody titers were significantly higher after
for cancer progression such as E6 oncoprotein for HPV 16 and 18 as well as p16INK4a/Ki67 biomarkers.
administration of two doses in girls 9-10 years old than after three doses in women 18-24 years old at 24
A new cervical cancer prevention and control paradigm
months after the last dose. The INSP research group is
will also be researched through a strategy that a group
analyzing the immune response observed at 48, 51 and
of international experts has called the HPV-FASTER
61 months within that clinical trial. In collaboration with
approach. This approach consists of including women
Mexico’s National Center for the Prevention and Control
up to 30 years or older in vaccination programs and
of HIV and AIDS (CENSIDA), the INSP will evaluate
pairing this with at least one HPV screening test in this
pilot programs focusing on introduction of universal
same age group. The previously mentioned INSP-IMSS
HPV vaccination among women and men with HIV.
group will coordinate a study in Tlalpan, in the southern
This research will explore acceptability of the target
part of Mexico City, focusing on producing evidence on
population and among health professionals as well as
potential benefits to adult women of a combination of
accessibility and organizational issues in implementing
HPV vaccination and screening based on testing of high-
vaccines through the national program of Ambulatory
risk HPV DNA. This could have an enormous positive
Centers for Prevention and Care of AIDS and sexually
impact since it allows exploration of the possibility for
transmitted infections (Capasits).
extending screening intervals in cancer prevention and control programs.
Cervical cancer prevention and control programs that are opportunistic, as is the case for Mexico, face a series
Given these initiatives, the INSP group has established
of challenges in terms of efficiency when following-
itself as one of the principal innovators in cervical
up diagnosis and treatment for women with HPV or
cancer prevention and control programs at a global
positive cytology. During the initial phases of HPV test
level. This research group is on the cutting edge of the
implementation, in areas where quality control and
INSP’s mission to increase social equity and protect the
follow-up processes for cervical cytology were especially
population’s health by generating and disseminating
deficient, women with positive HPV test results were
scientific evidence, in that it has proposed organized
sent directly to colposcopy. The result was a system
social responses and achieved their implementation to
overload with higher probabilities of over-diagnosis and
contribute to important reductions in cervical cancer’s
over-treatment.
impact on the community.
The principal problem Mexico’s cervical cancer prevention and control program faces is the high proportion of false negative results for cytology and a loss to follow-up of close to 50 percent after initial testing. Given this, at present women with a positive HPV test are referred for a Pap smear, which requires high-quality cytology and improved colposcopy to reach the necessary levels of diagnostic sensitivity. In Mexico and the Latin American region more research is needed on the best triage strategy for HPV positive women, which should employ biomarkers with a better predictive value for development of disease. Such a study, called FRIDA, is being carried out in Mexico, in a projected universe of 100,000 women. This is the most ambitious initiative of its kind worldwide and is being developed through collaboration between the INSP and the Epidemiologic Research Unit of IMSS of the central Mexican state of Morelos. Infrastructure for this research has been set up within the HPV molecular biology laboratory at the INSP that will allow evaluation of the utility of tests for clinical management as triage strategies, including HPV 16 and 18 typing as well as convention liquid cytology. The research will also explore cellular markers
HPV tests done on vaginal samples that were selfcollected at home were four times more sensitive than cervical cytology as practiced in healthcare facilities located in rural areas in
Mexico
145
| VIEW FROM THE TOP
SIMPLIFYING DIAGNOSTICS TO CREATE MORE SOLUTIONS FRANK ADMANT Country Manager Mexico & LATAM Northern Region of BioMérieux
Q: 146
How
are
economic
fluctuations
affecting
the
realize that incorporating innovations can save money
diagnostics segment?
by reducing the patient hospitalization times. Thus,
A: Mexico’s potential financial growth is surpassed by
hospitals could provide medical services to more patients
possibilities in healthcare. We aim to create win-win
with the same infrastructure. The new director of IMSS,
situations alongside hospitals to expand our business,
Mikel Arriola, recently announced plans to build 40 new
and help them to provide better services. Unfortunately,
clinics but we believe they should focus on improving
the current budget pressure and the weakened peso has
diagnostics
led public institutions to continuously push for lower
percent more in diagnostics could generate significant
costs. Public institutions are constantly pushing for 10
savings in areas such as treatment and hospitalization.
to 30-percent cost cuts, and that is not easy with the
The system needs more people with a holistic view,
current exchange rate.
making decisions to serve the bigger purpose, which is
inside
existing
hospitals.
Investing
30
having a healthy population. Economic turmoil also affects ongoing projects such as the microbial resistance program. This initiative collects
Q: According to clinics operating your equipment, should
data about microbial sensitivity to antibiotics and
the healthcare system prioritize hiring specialized
the doses in which these drugs are effective. There is
technicians or increasing infrastructure?
room to introduce new platforms in public institutions
A: Staff members generally leave within their first six
to support the identification of pathogens quicker.
months significantly increasing job rotation. Considering
This will result in better health outcomes for patients,
technicians’ learning curve of four to five months we have
and represents an important measure in stopping the
to provide training twice a year. Moreover, hospitals and
spread of superbug microbes that are highly resistant
clinics lose their expertise as high-technology diagnostic
to most if not all antibiotics. Budget constraints and
equipment requires fully trained personnel.
high exchange rates are causing ROIs on these kinds of projects to take five years, conflicting with public tenders
We
that last three years. Therefore, we focus on generating
applications that do not require highly specialized
sustainable growth and increasing effectiveness within
operators. We aim to simplify diagnostics to bring
the organization to do more with fewer resources.
more solutions to areas lacking specialized personnel.
have
created
user-friendly
molecular
biology
Molecular biology applications are already employed in Players in the healthcare sector should increase their
private and public markets and shorten diagnostic times
focus on pharmacoeconomics. Public institutions must
while improving pathogen detection accuracy. Many key decision makers in the public sector are interested in
“The system needs more people with a holistic view making decisions to serve the bigger purpose, which is
new technology but struggle against budget constraints, and depend on discounts. Our company wants BioMérieux’s platforms to be included in the basic formulary. However, this is a
sophisticated
process
and
we
are
conducting
pharmacoeconomic studies to collect enough evidence
having a healthy population”
of the impact and value they can generate for institutions.
Frank Admant, Country Manager Mexico & LATAM
cases, or nosocomial diseases is available, and we
Northern Region of BioMérieux
cannot fix a problem that cannot be measured. This is
However, little information on mortality, septicemia
a huge gap in Mexico and we cannot fix a problem that
now available in private hospitals and not in public
is not measured. In Europe and the US all these cases
institutions, yet physicians in public hospitals are aware
are reported and recorded, so there is plenty of data
that this application exists and are interested in acquiring
available for healthcare providers and patients. In the
it. Insurance companies can benefit greatly from this test
US there have been trials that resulted from ineffective
to avoid unnecessary expenses.
detection of septicemia, whereas in Mexico septicemia cases are not properly reported and are excused as
Q: What role should new molecular biology applications
mere complications. The first step to finding a solution
play in improving patientsâ&#x20AC;&#x2122; access to diagnostic tests?
is recognizing the problem.
A: Mexico has many challenges to deliver healthcare services to rural and remote areas. Sometimes patients
Q: What is unique about your molecular biology
have to travel 50 km to visit the nearest clinic, which
platform for pathogen detection?
increases
A: A clinician can identify up to 20 pathogens with
enough to be taken to remote communities, so this
this test. We are commercializing panels for infections
changes the whole paradigm of medical care. Instead of
of the digestive and respiratory tracts, and for sepsis.
expecting patients to travel long distances, we take the
The respiratory panel includes influenza and detection
equipment with us and improve access to cutting-edge
of other viruses, parasites, fungi and bacteria, while the
diagnostic tools. Mexico is not the only country with this
gastrointestinal panel mostly detects parasites.
problem, this happens in all Latin America, including
expenditures.
Our
FilmArray
is
portable
Brazil and Argentina. This panel is helpful to avoid misuse of antibiotics, for instance during viral infections, and detects the drugs
Our platform is the simplest to use with a broad coverage
to which these pathogens are sensitive. It is perfect to
of more than 200 pathogens of infectious diseases that
diagnose infectious diseases and design the best treatment.
have a high impact on public health. These include sepsis, respiratory meningitis and gastrointestinal infections.
When physicians receive cases of acute and severe
Symptoms of all of these pathologies overlap representing
infections, they can use the panel to detect the reason
a diagnostic challenge. Many of these illnesses are time-
behind the symptoms within an hour. This is relevant
sensitive, and FilmArray provides rapid information to
in the detection and treatment of septicemia, which
improve medical decisions and patient recovery. We
becomes more deadly every hour the patient remains
believe that molecular testing will become routine.
without treatment. The mortality rate of septicemia is 98 percent after 36 hours.
This molecular biology platform for pathogen detection is our priority. We are also tapping into implementing
Q: Influenza is considered an important driver in your
process automatization solutions in laboratories. These
annual financial report. What applications do you have
require significant investments and changes to how
for this disease?
processes are managed inside institutions and hospitals.
A: The flu pandemic is certainly driving this business division. Physicians frequently use a low cost, rapid test to detect influenza. But this is a test for an individual virus, so every day they do several tests to identify what virus or pathogens patients have. We have a very affordable solution for that and also a molecular biology platform, which costs 15 times more than the rapid test but itâ&#x20AC;&#x2122;s better to use from the beginning and provides results within an hour. This is a multiplex PCR technology called FilmArray that was commercialized by BioFire, a company acquired by BioMĂŠrieux in 2015. The healthcare system needs people with a wider view, who can push for the implementation of these solutions. The latter are quite important in the treatment of immunosuppressed patients or those with complex diseases such as diabetes and cancer. Our test is
Investing 30 percent more in diagnostics could generate significant savings in treatment and hospitalization
147
| ANALYSIS
VACCINATION CULTURE PREVALENT IN MEXICO Routine vaccines are among the most important yet simple
of children in France and 91 percent of children in the US
preventive practices a country can implement. “Vaccines
receive the same treatment. The percentage of vaccinations
are one of the best preventive measures that can be offered
against diphtheria, tetanus and pertussis, however, is lower.
and cutting public funds for vaccines is counterproductive.
Only 87 percent of children in Mexico are vaccinated within
People are more at risk of becoming ill and ultimately public
the recommended timeframe.
resources are wasted in curing preventable health issues,” Organizations such as UNICEF are taking advantage of
says Roberto Tapia of the Fundación Carlos Slim.
widespread vaccinations to further improve the preventive culture among Mexicans. “We placed educational inserts in
give parents a booklet that contains all information related
vaccine cards, for example. The idea is that UNICEF does
to a person’s health and a strict guide of ages at which
it the first time and the government takes over afterward.
their children should receive a particular vaccine. Schools
This has been our way to help prevent obesity, early infant
across the world bring in nurses to administer vaccines to
death and promote breastfeeding,” says Isabel Crowley. The
classrooms at a certain age, ensuring all children receive the
need for vaccination does not stop after childhood. Regular
preventive medicine. In spite of many lamenting the lack of
updates are recommended, particularly against seasonal
preventive culture in Mexico, vaccination seems to be an area
viruses and in older people. Armando Ahued of the Mexico
Mexico is excelling at. According to the OECD, 98 percent
City Ministry of Health stresses: “In October, we will start
of children in Mexico are vaccinated against measles within
vaccinating against influenza. There is a vaccine, it is free
the recommended timeframe. By comparison, 90 percent
and people need to come and get it.”
PERCENTAGE OF CHILDREN VACCINATED AGAINST MEASLES IN 2014 CHILDREN VACCINATED AGAINST MEASLES IN 2014 (percent) 100 80 60 40
Poland
Mexico
Brazil
Canada
Turkey
Norway
Chile
Switzerland
Australia
US
France
0
India
20
Source: OECD PERCENTAGE OF CHILDREN VACCINATED AGAINST DIPHTHERIA, TETANUS CHILDREN VACCINATED AGAINST DIPHTHERIA, TETANUS AND PERTUSSIS INAND 2014PERTUSSIS (percent) IN 2014
100 80 60 40
Source: OECD
Poland
France
Turkey
Canada
US
Norway
Brazil
Chile
Switzerland
Source: OECD
Australia
0
Mexico
20
India
148
Most vaccinations occur during childhood. Some countries
| VIEW FROM THE TOP
STRONGER, TALLER, HEALTHIER
JUAN TAMAYO President of Mexican Committee for the Prevention of Osteoporosis (COMOP)
Q: How has your unique collaboration with the WHO led
treatment side. In 2012, we had explored all the areas
to results for your company?
that interested us so we closed it down and opened
A: We launched the NiĂąos y Adolecentes +Fuertes, +Altos,
Accessalud. What has survived since 1994 is the NGO,
+Sanos program to prevent osteoporosis from the womb
COMOP. The organization turned to clinical research
onward. This has given us an enormous amount of data,
and Osteosol expanded its focus on chronic, non-
and parents appreciate seeing how their children are
transmittable diseases through Accessalud. The areas
growing. We do all of this to make children strong, tall and
that have developed are epidemiology, and clinical trials
healthy. This program has led us to collaborate with many
for pharmaceutical companies. Many Mexican pharma
organizations such as Danone and Save the Children, and
companies ask us to be their CRO because we have
we are working with Mexicoâ&#x20AC;&#x2122;s Infantile System Telethon
several contacts in biotechnology and in generics, and we
and with Save the Children, with the Primary School of
know people in touch with administrative processes. We
the State of Mexico and the Center of Medicine, Physical
have also begun participating, and have learned a great
Activity, and Sports of the UAEM. The program generates
deal in biogenetics.
much interest. Three years ago we began the Oseograph, a patented method that uses a series of data to produce a
Q: What other collaborations allow COMOP to influence,
graph showing people the state of their bones.
and learn from the sector? A: Recently, the INSP held a forum in which the deans of
Q: How have your operations evolved from a non-profit
the 10 biggest virtual education institutions participated,
into a private entity?
such as Johns Hopkins University, Harvard, MIT, the
A: We began as an NGO in 1994, such that all the patrimony
University of California in San Francisco, two European
of COMOP is property of the nation. This poses several
universities and Coursera. Now we provide Massive
difficulties for growth and interaction with stakeholders.
Online Open Courses (MOOCs) specializing in the health
Certain players in the health sector preferred to interact
sector because we believe that everyone has the right
with private enterprises so we created Osteosol in 2000.
to education. We ran our first month-long course from
This company invited a group of eight members, four
October to November in 2015, and an incredible 15,000
of whom were from the pharmaceutical industry, and
people signed up. Nevertheless, we encountered several
four were investors. This was our first operational health
difficulties. In the first week the platform director changed
business model focused on obtaining quality outcomes
five times so it was difficult for students to get answers
for citizens. We modified our offices to be able to receive
to their questions and our participation rate dropped to
walk-in patients. Compiling a database was a good
11,000. However, 4,000 people completed the course in
experience bearing in mind that we did not have laptops,
spite of teething problems.
smartphones, or tablets back then. It allowed us to expand on what we could do as an NGO. We have had international
COMOP aims to gain experience with 60,000 patients
reach since COMOP joined the International Osteoporosis
in two years to be able to give the Ministry of Health
Foundation in 1999 but our experience from 2000-2012
and Seguro Popular quality clinical outcomes. Notably,
contrasted greatly with the financial expectations we
the WHO and the UN participated in the Millennium
had. We saw the world of health fluctuate. Today, bone
Development Goals containing an area dedicated to good
diseases are recognized as dangerous for public health
health and wellbeing. This program tries to fight obesity,
and the health sector.
and anorexia without stigmatizing people involved as few individuals are in the correct weight range. Whether we
Through Osteosol, we researched the effects of weak
expand through venture capital or franchises we have the
bones on the nation and have since turned to the
model in place and the association is more ready than ever.
149
| VIEW FROM THE TOP
DIGITALIZING MEXICAN DIAGNOSTICS CARLOS HERNÁNDEZ Hispanic America Regional Director, Diagnostics Division of Siemens Healthineers
150
Q: How has the health system digitalized and automated
solutions, like combining our ultrasound platform in the
since last year? Is there more cooperation between
diagnosis of prostate cancer combined with our PSA
entities in terms of sharing information?
laboratory test.
A: The healthcare sector is aware of the importance of digitalization and automation. Customers look forward to
Q: What products have you launched since we spoke with
having better results at lower costs and technology is the
you last year?
driver to accomplish that.
A: One of the most important projects we launched was with the Hospital Juárez, which has been a success story
Even though there is a sense of awareness about this
for us and where our APTIO and CentraLink solutions
issue, not everyone can update or change operations the
have been working to benefit thousands of patients daily.
same way at the same time because of different dynamics,
With this solution the laboratory now is connected and
but as time goes by there are more and more institutions
optimization of test processing has decreased by up to
implementing this way of work. We want to be a partner
40 percent. So we are talking about one unified solution
to help them accomplish that. Trends like diabetes,
that transforms lab operations, unifies and accommodates
cardiovascular diseases and cancer, in addition to an aging
current and future needs.
population, pose a huge care challenge to both the private and public health systems.
Q: Awareness of the importance of early detection and diagnosis is a problem in Mexico. What can be done by
We work hard to develop solutions to meet customers’
the industry to promote this?
expectations not only with our products but with related
A: Early detection and prevention is the way to go and we
services and systems. One example is the APTIO total
see that our healthcare authorities are gradually moving
automation system and CentraLink middleware solution
toward this direction.
that help laboratories have only one system which process most of their needs with maximum efficiency
It is important to keep in mind that in vitro diagnostics
and productivity, reducing risks, maximizing output and
account for around 2-3 percent of the total of healthcare
quality, providing real-time visibility of the process and
costs internationally but affect 70 percent of all critical
information flow. There is still a long way to go but we are
clinical decisions. By detecting predispositions, laboratory
convinced there is no way back. In Siemens Healthineers
diagnostics can improve disease prevention and will
we believe in the power of innovation and technology as
become more important, reducing cost of care with
the future of the business.
higher possibilities of success. Of course patient education and changing behaviors and habits are fundamental to
Q: Last year you told us that in vitro diagnostics such as
improving the general population´s health.
tumor markers and vitamin D tests were underutilized in Mexico despite their usefulness. How has this evolved and
Q: How has Siemens Diagnostics division been affected
what benefits could they bring to Mexican diagnostics?
by recent health budget cuts?
A: We have seen some changes but modifying these trends
A: We see these cuts as an opportunity to position our
requires long-term effort, which starts with training of
solutions, which generate efficiency and productivity.
healthcare professionals in universities and communication
Budget constraints and cost cutting are megatrends
of the clinical benefits of these tests for patients and
around the world and Siemens Healthineers solutions
doctors to achieve earlier and more accurate diagnostics.
are designed to help our customers cope with increasing
Siemens Healthineers is starting to promote the joint use
demand for services, reduced staffing and budgeting and
of our technologies and we are promoting total diagnostic
more stringent Key Performance Indecators.
| VIEW FROM THE TOP
MIROCULUS STARTS DETECTION ON STOMACH CANCER JORGE SOTO CTO of Miroculus
Q: How have the public and professionals received
sample from people, which can detect many illnesses.
Miroculus in Mexico?
There are already very good prevention campaigns for
A: The response has been positive. We are looking at better
breast, cervical and prostate cancers. We need to add lung
and easier ways to diagnose diseases and allow patients
and stomach cancers to that list as they are the deadliest
access to a state-of-the-art diagnostic tool that is easy to
in Mexico.
use, and affordable. We are focusing on demonstrating our technological, biological and clinical results.
Q: The Mexican public sometimes mistrusts vaccinations, such as that against cervical cancer. How can Miroculus
We presented our product and results at the Liquid Biopsy
and early detection help change this view?
Summit in San Francisco. We completed a study with 650
A: It is very important to demonstrate the device works,
people for stomach cancer detection. This will be the first
and to show sensitivity levels and its predictive value.
application. We have associated symptoms in patients
We mostly plan to work with institutions, and MDs
across five hospitals in three different countries with
to build this. The machine is not something we can
stomach cancer, gastritis, atrophic gastritis and intestinal
build independently since they are the experts who
metaplasia. We still need to validate these results but we are
can advise us on the best course of action. We joined
collecting new samples in other countries like Guatemala,
many medical institutions and research labs such as the
and Chile among others for data corroboration. We hope
Catholic University Hospital of Chile, and UCSF or Johns
to market our product by 2018.
Hopkins University in the US. We aim to build together, to understand the medical needs and the information
We have approached several institutions such as private
doctors need. We aim to have Miroculus ready as soon
hospitals in Mexico City and public institutions such as the
as possible so we can detect, and diagnose earlier and
INCAN and IMSS. Both are keen on potentially conducting
more efficiently.
a clinical study. Mexico is definitely one of our priority countries. We really want to test Miroculus in Mexico, and I
Q: Your device detects a certain number of cancers. How
believe we will do so by the end of 2016.
long will it be before it can detect all known cancers? A: Our device currently focuses on detecting microRNAs
Q: What steps do you think we can take to create a culture
while other labs, and researchers are validating the
of prevention and early detection in Mexico and how can
presence of microRNAs and specific diseases. Our
your device help?
company is focusing on discovering the validity and
A: The World Health Organization (WHO) stated that to
clinical utility of stomach cancer detection and microRNAs
tackle cancer we need to develop a better understanding of
first. The validation process is not particularly simple. It
preventive measures. This benefits patients, the economy,
is rigorous. Miroculus technology does not stand alone.
health institutions, and the government. Public health
Other specialists are developing technologies to detect
systems like those in Mexico need to start addressing the
several types of cancer. I am sure that within the next 10
most prevalent and the deadliest diseases in the country
years we will see technology that detects several types of
and encourage early detection.
cancer with one single blood sample.
Certain cancers are associated with lower recovery rates,
The design of our technology will be open to all. We
such as stomach cancer, the second deadliest cancer in
have several prototypes. The instrument we are building
Mexico, and it is difficult to detect at an early stage. It
to better understand the needs of hospitals and doctors
requires an endoscopy and it is impossible to provide all
will be very different. It should be available by late 2017
the population with one. It is possible to take a small blood
or early 2018.
151
DIGITAL HEALTH
7
Digital advances are impacting every sector and Mexicoâ&#x20AC;&#x2122;s health industry is no exception. The Ministry of Health is working on a national electronic registry for health information that would digitalize patient records and prevent duplications of registrations and payouts between IMSS, ISSSTE and Seguro Popular. While public institutions are striving to digitalize and streamline processes, private companies are working on technology to help the individual user, with a particular focus on mobile apps. International institutions such as UNICEF are also ramping up their IT focus, working with the government and telecoms to gather data targeting improved conditions for the most vulnerable sectors of the population.
Many digital apps are educational in nature, targeting the distribution of preventive information on subjects such as controlling diabetes, preventing obesity and best practices in antenatal and postnatal care and breastfeeding. The ease of access helps these programs succeed, although more can be done. There are also companies specializing in big data, collecting statistics on the Mexican healthcare system to help hospitals and medical practitioners analyze the needs of the population and holes in the system to improve the care and services they provide. This chapter introduces the pioneers of digital health in the public and private sectors.
153
| CHAPTER 7: DIGITAL HEALTH 156
VIEW FROM THE TOP: Xavier Valdéz, IMS Health for Mexico and Central America
157
VIEW FROM THE TOP: Álvaro Duque, Novartis
158
VIEW FROM THE TOP: Fermín Valenzuela, QBD Consulting
159
VIEW FROM THE TOP: José Alarcón, PwC
160
VIEW FROM THE TOP: Mónica Domínguez, Smile Train
Pamela Sheeran, Smile Train
David Almanza, Palindromo
162
VIEW FROM THE TOP: Pablo Pantaleoni, Medtep
164
VIEW FROM THE TOP: Roberto Tapia, Fundación Carlos Slim
165
VIEW FROM THE TOP: Javier Cardona, 1DOC3
166
VIEW FROM THE TOP: Alejandro de la Parra, Astrum Salud
168
VIEW FROM THE TOP: Xavier Boadas, Avinent
168
INSIGHT: Ana Pulido, Digitalizatxt
170
VIEW FROM THE TOP: Jaime Archundia, UNICEF
172
VIEW FROM THE TOP: Gabriela Allard, Mexican Diabetes Association
172
VIEW FROM THE TOP: Guillaume Corpart, Global Health Intelligence
155
| VIEW FROM THE TOP
MOBILE INTELLIGENCE FOR BETTER HEALTH DECISIONS XAVIER VALDÉZ Director General of IMS Health for Mexico and Central America
Q: What can you tell me about your new app?
156
Of this, 26 percent represents institutional purchasing of
A: One of the key products IMS integrated to its portfolio
medicine and 74 percent is due to pharmacy sales. We
through
(Mobile
are interested in being present in both sectors to have a
Intelligence) our customer relationship management
complete vision of the pharma market. We have a panel
platform, a fundamental piece to multiply our client’s
of over 2,000 doctors we interview regularly, from which
competitiveness in the health market. In today´s business
we obtain information on the principal diagnostics, what
environment immediate communication and decisions are
treatments are being applied and which products are being
critical to compete, which is why IMS recently launched
prescribed. This provides us with a national picture of how
REPWear & MGRWear apps for the AppleWatch as a
illnesses are evolving, what medicine is being consumed
convenient MI functionality, allowing immediate attention
and the treatment being applied. In the future we would like
to issues that impact business. All our platforms and apps
to have a more precise vision of the management process
are interoperable, not just in a technical sense but also
of high-cost illnesses such as oncology. Public institutions
in the analysis of the data we produce and include. We
certainly are developing digital systems at varying levels
process more than 5 million daily medicine sales in Mexico.
of implementation. Private hospitals are also developing
We can include analytics of our own sources and/or many
this, but there are smaller institutions with more limited
data sources in each device to allow our clients immediate
resources that are not at the same level.
the
Cegedim
acquisition
was
MI
access, such as you can do with a wearable device. All our developments have a series of applications with the ability
Q: What is IMS Health working on to ensure the safety of
of being connected.
sensitive data? A: We have a code and a series of algorithms that
Q: What information have you gained on the health
anonymize the information. A user would only be able to
situation of Mexico?
trace what treatment has been given and what the results
A: We are seeing a period of innovation in terms of
were. This is important information for health providers to
integrating the health system. The directors of IMSS
figure out which treatment works and what side effects
and ISSSTE are looking to optimize the use of existing
occurred. There is much value in this and we do this on
facilities. This is a good idea, but implementation will
a global level. It would be ideal to bring this to Mexico.
be complex. We aim to know the cost of treatment in
For this to happen, we need to be able to enter clinical
different institutions so patients have the possibility to
files and databases. Larger institutions are implementing
move between them, but it will take time. We work in three
digital systems but smaller clinics may not be up to speed.
areas of business: information, technology and consulting.
There will be a moment when this matures and companies
We gather information on public and private consumption
such as IMS Health will be able to enter the market.
of medicine and on the treatment of illnesses. As for
Some institutions are already working on a database of
technology services, we provide much support and
oncological patients through the INCan. Some states, such
integrate hospital information, production and efficiency
as Colima and Jalisco, have begun to digitalize.
indicators. Finally, in our consultancy practices we can help define the basic measures of medicines and which
Q: What will we see from IMS Health going forward?
are the most used types of medicines.
A: We are in the midst of a merger with Quintiles. They bring services such as clinical research and sales force
Q: What are the main partnerships you want to create in
services. From this merger you will see a company with
those areas? Are they public or private?
a much greater capacity to give integral services to labs
A: We are looking for both as the Mexican pharma market
and hospitals alike. The merger may conclude by the end
was worth around MX$209 billion (US$11.2 billion) in 2015.
of the year.
| VIEW FROM THE TOP
BIG DATA A PILLAR IN DIGITAL ERA ÁLVARO DUQUE Digital Marketing Leader of Novartis
Q: Digitalization is changing the healthcare industry.
trend is swiftly spreading throughout the pharmaceutical
How is Novartis restructuring its internal processes to
industry and results will soon be presented. Although
take advantage of progression in both clients and end
governmental agencies have not caught up to the latest
consumers?
technology trends, we must always consider a country’s
A: Our efforts focus on providing better solutions and
health regulations. Novartis’ digital interaction methods
differentiated drugs to our patients. Companies are subject
must run parallel with Mexico’s legal framework at all times.
to external market pressures, as pre-established consumer
Data privacy is a huge concern in the industry and we base
trends must be followed. According to the Mexican Internet
our work around enforced regulations. Marketing law is
Association (AMIPCI), Mexico will see 60 million Internet
quite intricate and Novartis is adhering to it verbatim.
users in the short term, creating enough pressure to get companies moving. Mobility should be kept in mind as the
Q: What developments will we see from Novartis’
number of smartphones has surpassed the volume of PCs
collaboration with Google?
owned by consumers. All things considered, companies
A: After its digital transformation initiative was put in
must adapt their communication mechanisms to patients,
place the company began creating strategic alliances
doctors and end consumers.
with key players. The Internet tycoon and its Google Glass development was a perfect fit. Novartis is tackling
Q: What opportunities are there for pharmaceutical
ophthalmological conditions creating a medical device
enterprises in emerging markets?
application with Google Glass that can measure some
A: The market is undergoing an important change. The
clinical parameters. We find eye pressure and glucose
digital era is considered a crucial time in the fourth
readings among those. These initiatives will give life to
industrial revolution and Novartis has benefited from it.
new health and technology applications, which will serve
A few years back the company implemented its digital
as the foundation to the future of the industry. Big data is
transformation initiative. Although it involved multiple
a pillar in the digital era and we have partnered with data
areas, it primarily focused on the company’s marketing
management enterprises. The amount of analytics needed
division. Also, the creation of a digital drug portfolio has
in this segment is overwhelming. Partnering with them was
placed Novartis at the forefront. We will tackle this new
a natural progression. Even at its most basic layer, sales
digital inclination from multiple perspectives but mainly
representatives have a significant amount of big data to
through strategic alliances, technological platforms and
manage and process, especially as multi-communication
digital laboratories and marketing. Virtual congresses
channels shift the face-to-face perspective.
have become the industry’s latest communication and capacitation format. Through virtual platforms, thousands
Q: Novartis Mexico invested US$50 million in R&D
can access the same information.
activities. How will the company benefit from this type of investment and how will it impact the company’s global
Q: How has digitalization impacted both consumer
operations?
behavior and Novartis’ operations?
A: Novartis bets on R&D, which translates to the number
A: We find ourselves disrupting previous technology
of product developments in the company’s pipeline.
implementations. We are adapting to new working patterns
It is the largest of its kind. Mexico is one of the leading
with patients and doctors and they are trying to acclimatize
countries in our headquarters’ global strategy not only
to the new technological wave. Although webpages are
because of its large demographics but also due to the
nothing new, the market was lacking a comprehensive
interests the company has in the country. We are looking
digital ecosystem to face a new and broader operational
to maintain our position as an R&D leader and Mexico will
modality. It is still too early to have reliable hard data but the
help us keep on track.
157
| VIEW FROM THE TOP
TIME FOR A REINVENTION
FERMÍN VALENZUELA Director at QBD Consulting
158
Q: After 11 years of managing pharmacological and
satisfy the needs of our clients. We propose process
biopharmaceutical research, what pushed you toward
analyses to pinpoint problems that are not seen by the
consulting?
organization, such as redundancies, lax controls and a lack
A: It was time for a reinvention. Research, especially
of communication between areas. Many holes in the fabric
clinical,
The
of the trials become apparent and we can begin to search
incorporation of new technologies and new approaches
for solutions. IT can optimize many processes and QBD
became necessary. QBD Consulting began proposing
Consulting looks for solutions tailored to each client’s
new approaches to clinical research while using new
specific needs.
tends
to
follow
the
same
patterns.
technologies and operating under a risk management approach. Collaborative efforts from players in the clinical
We implement electronic solutions for clinical trials. These
research and IT arenas gave life to QBD Consulting. In
can include eCRFs, eCH, and ePOR. All these solutions
return, we have given the industry a new approach to
are provided by our strategic ally Digitalizatxt and offer
how CROs and pharmaceutical laboratories can conduct
the advantage that monitoring can be done in real time
clinical studies. As most IT platforms used in clinical trials
to detect any kind of anomaly immediately. Master file
are provided by sponsors, we collaborate with CROs and
integration is done almost automatically. These solutions
Mexican pharmaceutical companies, since Big Pharma
allow the sponsor to reduce the time of study, follow
only uses their own solutions.
advances online, oversee all sites’ behavior and decrease the number of physical visits to the sites. This translates to
“We propose process analyses to pinpoint problems that are not seen by the organization, such as redundancies and
a decrease in time and costs. Having control of the study assures clean and verified data and compliance. Q: How open are clinical trial sites to acquiring technology solutions to manage their processes? A: If all stakeholders participate in the first phase, people discover the advantages of new models and
lax controls and a lack of
approaches. Concerning clinical trials, if you are able to
communication between areas”
solutions, and convince them they do not imply double
Fermín Valenzuela, Director at QBD Consulting
accept the reduced paperwork. Acceptance only happens
clearly communicate the benefits of using electronic the work but a simplification of all red tape, they happily after a period of reluctance. The results are what make
Q: What are the biggest needs of the clinical research
them accept the change following a long and complex
industry in terms of quality and process optimization?
educational process.
A: Although most sites and clinical research organizations have correct and orderly procedures, few have performed
Q: What certifications endorse the quality of QBD
in-depth analyses of their processes. This is the main tool
Consulting’s technology?
to see if procedures are in agreement with regulations
A: All our solutions have been developed following
and to identify risk factors. Analysis also identifies which
GAMP5, and they comply with Mexican regulations as well
processes could be automated. This allows times and costs
as CFR21. Some of the solutions developed by Digitalizatxt
of clinical studies to be brought down and helps us assure
have been analyzed and approved by COFEPRIS. The
quality and compliance. One of the value propositions
company also participates at academic events to promote
of QBD Consulting is the use of novel technology to
our solutions among industry experts.
| VIEW FROM THE TOP
DIGITALIZING THE MEXICAN HEALTHCARE SYSTEM JOSÉ ALARCÓN Partner and Leader of Health Services of PwC
Q: What are the advantages for the Mexican healthcare
Q: How do you think we can make digital healthcare
system becoming more digitalized?
providers more aware of cybersecurity risks and how do
A: One big advantage to using digital technology is that
we assure clients that their data will remain confidential?
it can enable health rights to become immediately more
A: The most mature in terms of cybersecurity are the
transportable. There also need to be the right incentives
insurance companies and the least mature are the health
for the health sector to make health records electronic
providers. The pharma and medical device companies
and make sure this is implemented correctly. INEGI has
are in between. At PwC we have some workshops for
a lot of information but there needs to be more efficient
healthcare providers’ boards to show them worst-case
ways to analyze data. The Ministry of Health’s National
scenarios, yet since there are no known such cases, it is a
Basic Health Information System (SINBA) is taking solid
slow process to get them to that level of awareness about
steps toward building a platform for all the incoming data
cyber threats.
from different health sector members so that it can be used by the public and private health care systems. They
Q: How can we use mobile health to prevent and fight
would also like to add all newborns into the electronic
many of the diseases we see in Mexico, like diabetes?
system from the moment their birth certificate is issued.
A: Prevention is very difficult but it is easier to help
This pilot program will take about a year and a half to
prevention
be fully implemented and is a step in the right direction.
marginalized, who are more concerned with other
Another relevant need is to create with the help of the
priorities. There are about 35 million middle class
Association of Insurance Companies (AMIS), and the
Mexicans. If we assume 5.2 million are privately insured,
Association of National Private Hospitals (ANHP) a
then there is a large marketplace for insurance, and
database where performance indicators of private and
a huge opportunity for wellness programs. There are
public hospitals is accessible to everybody. This will
around 25 companies that insure accidents and diseases,
help patients make educated decisions based on public
and there are only 10 health-specialized insurers (ISES).
information.
By law, ISES have to sell preventive and integrated care
efforts
for
the
middle
class
than
the
products but this model was not developed correctly due Meanwhile, on the digital side we are showing the
to the political problems that arise from having to give
Mexican health system a model sponsored by PwC and
IMSS’s resources to someone else. So now there are only
the University of Texas (UT). A community was created
four ISES that are focused on integrated health and six
for the relatively high diabetic population in Brownsville.
focused on dental services. Major accidents and health
Members are registered in the system, and if they are
insurance companies are allowed to provide preventive
diabetic or have a high risk for diabetes they are put into
care but only with reimbursements
a program to help them control it. This type of model could be brought here by insurance companies in alliance with pharma companies to manage costs and improve
“There need to be the right
health.
incentives for the health
Bodylogical is also an innovative digital tool we use
sector to make health records
to model the physiology of your body to give an individualized profile. This helps insurance companies determine
high-cost
customers
and
gives
them
electronic and make sure this
predictions of future risks, and programs on how to
is implemented correctly”
reduce it and lower costs.
José Alarcon, Partner and Lead, Health Services of PwC
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| VIEW FROM THE TOP
UNIQUE APP MITIGATES CLEFT PALATE IN CHILDREN
Mónica Domínguez Program Director Mexico and Central America at Smile Train 160
Pamela Sheeran Vice President of Smile Train
David Almanza Project Leader at Palindromo
Q: How does your unique app for children and physicians
PS: We have worked with a local partner called "Hablarte
software support patients’ therapy?
e Integrarte", a Mexico City-based speech therapy
MD: Smile Train is an app focused on cleft lip and
program. Dr. María del Carmen Pamplona launched the
palate that was established in 1999 and was brought to
program in 2001 gathering expertise until 2012 when the
Mexico in 2001. Today, we are in 85 countries and we
program was transformed into an app. Therapists have
work closely with local centers providing medical care
been extremely receptive to the app, and have shown
to children with this condition. We have 26 partners in
great enthusiasm at the prospect of its incorporation
Mexico, including ABC Hospitals. We provide funding for
into their practice since they consider it a creative and
the instruments, materials and any other components
unique form of support for patients. As mentioned,
needed for the complementary treatment of children
many children face difficulties in attending speech
affected by the condition.
therapy consultations, so the app allows therapists to help more children. Smile Train is all about increasing
Smile Train has also grown to cover a broader spectrum of
accessibility and empowering local programs by offering
services that goes beyond just surgery, such as follow-up
these services at no cost. Children who have used the
treatments and consultations. The comprehensive care
program have responded extremely positively to the
children require includes speech therapy, orthodontics,
dynamic therapy sessions it provides.
dental treatment and psychological care, among others. Speech therapy plays an extremely important role
Q: How does the app engage children to encourage
because patients with cleft palate tend to develop a way
them to use it long term?
of speaking in a nasal manner. They need post-surgery
MD: The app includes some songs, stories and drawings
treatment to modulate their voice and develop correct
and focuses on specific phonemes that are difficult to
pronunciation of several phonemes. This therapy should
pronounce for children that were born with cleft palate.
be administered twice a week for significant impact to be
Developing correct pronunciation also depends on the
witnessed but many of these children live in rural areas
technique and skills of the surgeon. The development
and cannot visit their therapist on such a regular basis.
of the app was a long learning curve. We needed to
We aimed to develop a digital tool to facilitate at-home
collaborate with speech therapists in a unique and
speech therapy. This results in fewer hospital trips for
creative way to develop something new. Speech
families, mitigating cost and transportation expenditure.
therapists piloted the app and realized the potential it had to bridge some of the most significant gaps in the
“Many children face
field, such as follow-up treatments.
difficulties in attending
We initially launched the interface on tablets. The
speech therapy consultations,
receptive toward the songs and games related to
so the app allows therapists to help more children” Pamela Sheeran, Vice President of Smile Train
team quickly discovered that children were incredibly phonemes. The app provides a significant educational value since the voice recognition system only allows the user to move to the next game if words are pronounced correctly. It has different areas to work on for children to advance through the various stages.
Our next challenge was to develop more material, activities and phonemes and to tackle greater challenges. For instance, speech therapy centers on patients’ abilities to articulate phonemes and integrate them into their daily speech from a cognitive standpoint. Sometimes they are able to articulate a phoneme correctly during the therapy but cannot use it in a word as part of a sentence. We posited that recording children’s voices while they were singing would provide valuable information about their progress. Q: What technical issues did you encounter in the development of the app and how did you resolve them? DA: The project initially included stories and songs. Then
“Speech therapists piloted the app and realized the potential it had to bridge some of the most significant gaps in the field, such as follow-up treatments” Mónica Domínguez, Program Director Mexico and Central America at Smile Train
we incorporated an update wherein the child could hear his or her own voice and the app evaluates the way in which
outset, we developed a virtual surgery training CD to provide
the child articulates phonemes. This was an interesting
education to doctors. We also realized it was necessary to
challenge because the software did not previously exist, so
create a medical database and patient records for all the
we used the Google voice recognition app to develop three
children we are helping. This allowed us to monitor the
songs, with one voice exercise per song. As Smile Train
quality of the surgeries. The speech therapy app received
wanted to increase the number of stories and activities,
solid support from our board of directors and the staff in
they requested six stories with different voice exercises.
Palindromo, especially since this is a philanthropic venture.
We also created another engine that recognizes one word
The database was developed by a well-known company in
and generates six more, which gave greater flexibility to
the US, for whom security is of the utmost importance. A
the app instead of recycling a fixed set of words. A narrow
limited number of people have access to patient records
list of words would reduce the app’s usefulness and if the
and therapists can only access their own files. The database
child stumbles on a certain word, he or she can become
only gathers information regarding surgeries but it will
frustrated.
soon include voice recordings from the app.
MD: Initially, we were working with seven kids using tablets,
DA: Palindromo has supported Smile Train in designing
but we soon developed a cellphone version too because
the website and creating social media content. With this
it is more likely that children in rural areas have access to
digital healthcare project, Palindromo is committed to
such a device. Voice recordings are sent to and stored in
helping people overcome physical limitations. Through
the cloud. These are evaluated by therapists, for whom we
this experience, we can see ourselves supporting other
developed a complementary app. When the patient returns
initiatives in the healthcare field. Nonetheless, there are
for a follow-up session, the therapists are already aware of
several barriers, such as the platform technology, the media
the areas in need of development. This represents a more
and Mexico’s lack of data transfer infrastructure. Creating a
accurate way to guide the children’s progress.
voice recognition app was a huge challenge but a rewarding experience for Palindromo.
To date, the app has been downloaded more than 4,000 times, of which 3,500 were children. We have not carried out a wide promotion of the therapists’ app because it is still undergoing testing. In terms of the timeline, we developed and started testing the children’s app in 2012 and 2013. Subsequently, we carried out all the upgrades in 2014 and separated the content between the children’s app and the therapists’ app. We have been testing the pilot release of the therapists’ app, while the children’s app is in its second stage of release and has been downloaded in 15 countries so far. Q: How does Smile Train fund its initiatives and charity activities? PS: Smile Train values and prioritizes the use of technology to help children around the world. From our operations’
161
| VIEW FROM THE TOP
KEEP IN TOUCH, STAY IN CONTROL PABLO PANTALEONI CEO and Founder of Medtep
162
Q: What opportunities does Medtep see in digital health
has sparked apps related to healthcare and wellness that
in Mexico and worldwide?
could provide valuable information for physicians about
A: Digital healthcare is one of the market segments
their patients.
that has been growing the most in the last three to four years, with extraordinary development in recent months.
We offer treatment plans for physicians to give to patients.
Healthcare and education are the two sectors with the
Through agreements with medical societies and reference
most promising opportunities because they suffer from
medical institutions, we ensure validations of all medical
inefficiencies. In Silicon Valley, we see many initiatives
content and our platform can cover treatments for any
in digital health and the Mexican market enjoys unified
disease. Our app also has a high degree of personalization,
information systems so technology can close many gaps
meaning physicians can adapt the treatment plan or
in the country. One of the main drivers of this trend is
create a new one according to the requirements and
the global economic crisis leading governments to reduce
needs of each patient.
expenditures. The implementation of technology is lagging in healthcare, but those solutions that have been
Q: What impact has Medtep had in both Spain and the US
introduced to the sector have produced excellent return
since its foundation?
on investments. We expect to see more applications in
A: The company was founded in Spain as an initial step
this area in the future.
to do some pilot tests at the lowest cost possible and then it was scaled up. Medtep was moved to the US last
Perfect timing does not exist in this market, it is difficult
year, with headquarters in San Francisco and offices in
to predict acceptance of this type of technology. We
Barcelona and Mexico. The company is growing through
have a hand in three very different markets. The US is
strategic alliances in the US and we have seen the greatest
mature and we have many competitors, but the market
growth of our operations in Mexico in recent months. We
is not saturated. It is dynamic and has the ability to
have operated for a year in Mexico and we already have
reinvent itself frequently. Medtep knows the European
some projects with pharmaceutical companies, insurance
market perfectly, and it is extremely segmented across
firms, and the government. We are planning to further
the biggest three markets in the UK, Germany and Spain.
expand this year and invest more resources to support
Mexico was chosen as the most relevant country in Latin
our growth.
America and as the first step toward penetrating the region. This market needs our health planning technology
Q: How does this tool improve treatment adherence?
urgently and we have already witnessed digital health
A: Patient adherence is perhaps the most important area
success stories.
of opportunity for digital health. Many entrepreneurs are obsessed with getting more clients, users and sales,
Q: Can you provide a technical description of your
but this is pointless if the actual value of the tool is not
services?
authenticated.
A: Our services represent an excellent way to follow
improving patient outcomes. We have conducted clinical
up with patientsâ&#x20AC;&#x2122; treatment. Physicians prescribe diet,
trials for hemophilia, asthma and borderline personality
exercise or medication for a certain period or for the
disorder. The study for hemophilia found that patient
rest of a patientâ&#x20AC;&#x2122;s life, but they can run into difficulties
adherence improved 60 percent with savings of US$5,300
following treatment. Our platform provides patients with
per year. We are focused on validating this tool in our three
the opportunity to keep in touch with their physician
markets. In Mexico, we are managing a plan for obesity
and control their disease. Physicians rarely know exactly
alongside medical societies and the government. We are
what patients are doing outside the consultation, which
also developing a treatment plan for respiratory diseases.
We
are
completely
oriented
toward
Q: How are you combatting resistance from technologyreluctant physicians and educating patients about these tools? A: Physicians do not always welcome new technologies when first introduced to them. They realize through using the tool that it simplifies following up with patients instead of representing more work for them. This tool can
“Our growth will be sustained through collaborative efforts with telemedicine firms and wellness companies” Pablo Pantaleoni, CEO of Medtep
reduce the number of phone calls and emails from their patients, diverting follow-up through the platform where everything is automatic. This kind of application is not for
in Mexico in the short term. Most of our Mexican projects
everyone but the acceptance among physicians has been
have started in Mexico City but we are running some pilot
excellent. We proudly discovered that age is not a limit
tests in rural areas where we see plenty of opportunities.
for the platform since we have seen both young and older physicians using it. This can differ in patients and depends
Q: What do you feel led you to receive the ‘30 under 30’
on the treatment they are receiving. Young people
award from Forbes?
between the ages of 13 and 25 are using the hemophilia
A: There are few Hispanics on the list and I see this award
solution, while our COPD users are above 50 years old.
as recognition for all the members of Medtep’s team. The award also reflects the trust of the American market in
We are engaged in training and educating patients on
our operations and the expectations of our customers
these kinds of platforms and tools. The development of
and investors. We want to continue capitalizing on the
the platform was a joint effort with both physicians and
many opportunities in digital health and try to reach as
patients. Patient associations, having been told about the
many people as possible. There are plenty of ways to
platform, are interested in receiving more information
collaborate with new industry players and we are open
and frequently contact Medtep. This is valuable for rare
to do so.
and chronic diseases, for which follow-up and treatment adherence are critical.
Q: What else do you envision for your company’s tools in Mexico in 2016?
Q: For which other diseases do you want to create
A: Medtep was founded in Spain but moved to the US
platforms?
last year. Our headquarters are in San Francisco and
A: We are focused on rare and chronic diseases and
our offices in Barcelona and Mexico. We are growing
there are many yet to be explored. We are also tapping
through strategic alliances in the US and we have seen
into mental health and prevention. The latter will not be
the greatest growth in our Mexican operations this last
a wellness app but a treatment plan to prevent diseases
year. We already have some projects with pharmaceutical
or their progression, such as pre-diabetes. We want our
companies, insurance firms and the government. We are
platform to be the basis for the development of many
planning further expansion this year and to nvest more
more treatment plans, and to stay as flexible as possible so
resources to support our growth.
that any healthcare practitioner can develop a treatment. This opens up many opportunities, and our growth will be
Our platform could be an exceptional tool for research
sustained through collaborative efforts with telemedicine
in clinical trials as it keeps a record of the lifestyle habits
firms and wellness companies. We are collaborating with
of patients. We have worked with the pharmaceutical
telemedicine companies so that physicians can follow up
industry but not during clinical trials per se because there
with patients after diagnosis through our platform.
are many good systems and competitors and we are not limiting ourselves to just one kind of segment or clinical
Q: How do you expect telemedicine to transform
application. The platform is flexible and open for use
healthcare in areas with few hospitals and limited
throughout patients’ treatment.
medical attention? A: I am completely certain that we have only seen a small
We
part of the great potential of telemedicine. Many doctors
establishing more agreements and creating synergies
still think they need to have contact with the patient to
with companies. We also aim to scale up the pilots that
examine him or her but a plethora of medical visits are
are already running in the country, which will be achieved
not necessary, they simply consume time and money
with the help of exterior units to gather evidence of the
that is limited in these communities. Follow-ups through
functionality and effectiveness of our platform. We will be
telemedicine platforms are effective and they are growing
investing significant resources this year and in 2017, which
significantly. I am optimistic that we will see this booming
will also contribute to job creation in Mexico.
want
to
consolidate
our
commercial
position
163
| VIEW FROM THE TOP
CONNECTING PEOPLE AND INFORMATION ROBERTO TAPIA Director General of Fundación Carlos Slim
164
Q: App-prende was recently released as a platform for
how these applications are useful for people’s daily lives.
teachers, students, parents and the general public. In
The bulk of access has been through the online platform,
what ways will it impact the health industry?
yet the smartphone growth in the market is increasing.
A: The app, app-prende, also found online as aprende. org, has three main components. The first is aimed at
Q: How does Fundación Carlos Slim collaborate with the
strengthening content to ease the learning process for
public sector to achieve its goals?
students in areas such as math and science, particularly
Universal health coverage is one of the most relevant
in elementary and middle school. The second provides
topics in Mexico. Fortunately, the Health Ministry is
training for high-demand employment from technology
striving to expand their system through solid actions. We
and food production to other service areas. The point is to
collaborate with the institution to implement our non-
make courses available for anyone, no matter their level of
communicable disease (NCD) program Casalud, which
education, which can connect them to the job market and
looks at re-engineering the first level of attention. Our
improve labor opportunities. Self-employment is promoted
philosophy emphasizes the importance of strengthening
as well, as we offer training courses such as beauty salon
the foundation of the health system.
management. The third element we offer concerns health. The app provides easy to digest information created for
Technology allows us to start all of these projects as we
the general public. Navigation allows people to reach
collaborate with public institutions that are promoting
everyday information through video lessons related to
our program nationally such as MIDO, an integrated
basic information on areas such as skin care, tattoo care
measurement for opportune detection of NCDs. The
and bullying. Plus, the app and website provide calculators
project
that can provide measured information like the Body Mass
diabetics, pre-diabetics and those free of chronic illnesses.
Index (BMI).
We are finding that the exam can be applied to people
implies
entering
communities,
and
finding
on the street in only nine minutes. It allows us to do a The Foundation deeply believes that health is a shared
preliminary evaluation and find unaware pre-diabetics who
responsibility between the individual and agencies that
can benefit greatly from our guidance. Lifestyle changes
can provide support in case of health loss. However, people
are essential to avoiding diabetes and can improve the
should not wait till they are ill to take care of themselves
life quality of many people at risk. We find that half of
and should prevent as much as possible. App-prende is
diabetics are completely in the dark about their condition
informative, preventive, educational and accessible. The
while the other half, aware of their condition, are not
platform is completely free to all Telcel users as there is no
taking care of themselves adequately. The latter can cause
charge for navigating the website.
eye, circulatory and kidney damage.
It was created with the Foundation and Carlos Slim’s
Another program being developed is based on paradigms
philosophy, which emphasizes the importance of taking
that worked for infectious diseases and that need to be
advantage of the information era and its ability to eliminate
modified for chronic diseases. Health units that focus on
access barriers through connectivity.
obesity and diabetes need their patients to be monitored and not just tended to for a specific period of time. The re-
Q: What are the target audience goals for the app?
engineering of the system is then coupled with technology.
A: The idea is to reach millions and to continue promoting it.
Mido Mi Salud is an app that was developed to promote
In the first week we were able to reach thousands. Growth
the fluidity of communication between the patients and
has been quick and it is already positioned as a high-level
service providers. Treatment and medicine follow-up will
app. The number of downloads gives us a good sense of
be easier.
| VIEW FROM THE TOP
HEALTH INQUIRIES, THE DIGITAL WAY JAVIER CARDONA CEO and Co-founder of 1DOC3
Q: Under what circumstances was 1DOC3 founded and
properly update current policies. Our platform also serves
what were the market opportunities you visualized to
as a digital channel for healthcare authorities to reach
start the company?
consumers. We work closely with other health institutions
A: Four years ago, while living in the Middle East, I suffered
to prevent the zika and chikungunya virus spread through
a serious injury. I did not know where to find a doctor in
content-based campaigns.
Dubai, so I searched online with little success. Thereafter, we came up with the idea of creating a platform similar
Secondly, we work with the pharmaceutical industry in
to TripAdvisor with a health approach, in which finding
two ways. We carry out disease awareness campaigns
physicians with excellent credentials would be easy. We
for companies like Novartis. Our job is to disseminate
realized rating doctors with stars was not the best approach,
information about Alzheimer’s, multiple sclerosis and
as fatalities can happen and grades could become biased.
other relevant diseases. We also deliver reports on people’s
We kept evaluating people’s Internet habits and found out
beliefs about certain health conditions in specific regional
that almost everybody googled their inquiries. As such, the
contexts, which can be structured by topic, gender, age
question-answer mechanism connected worried would-
and health condition, among other categories.
be patients with physicians lacking an online presence. Our platform was born as a medical recommendation site
Finally, health insurance companies are 1DOC3’s third
that became a place where people could get accurate
business line, as we serve as a first filter to their clients.
answers from real doctors, while the latter earned a digital
Many medical consultations are just informative; our
reputation.
digital platform can solve some of the enquiries before an insured patient visits their physician.
Q: How does 1DOC3 work and what are its main differentiators?
Q: What kind of growth has the company seen?
A: 1DOC3 is a multichannel platform that can be accessed
A: We launched our platform in June 2014. Since then, we
through our webpage, mobile applications developed for
have oriented 17 million Latin American people, half of them
both Android and iOS systems, SMS, and through Internet.
in Colombia, and 20 percent in Mexico. We have grown in
org. In Mexico, it’s already available on Telcel, allowing
an organic manner, without major marketing investments
people to use our service even without a balance on their
and through good positioning in online search engines.
account. 1DOC3 is quite easy to use. People simply write
We have close to 3 million users in Mexico so we decided
their questions and the system looks over the 100,000
to open local operations. Mexico is the largest market we
inquiries that have already been answered. If you want a
could aspire to reach in Spanish-speaking countries.
personalized answer, the system detects the type of doctor that should be answering the question. In an average of 90
Q: What can you tell us about the endorsement by the
minutes, users will get a concise answer. Our platform is
Inter-American Development Bank (IADB)?
not a medical chat, it is asynchronous.
A: The IADB named 1DOC3 as the startup with the highest social impact in Latin America for 2015. The institution’s
Q: Who are your main clients?
endorsement has helped us validate our operations with
A: We have three main clients. Firstly, we provide the
governments and other authorities. In February 2016, the
Colombian government with general information, helping
bank released a paper that showed how a startup like ours
them build and update public health policies based
aids governments in reducing communication campaign
on in-depth reports containing the general public’s
costs. The cost difference between reaching 10 million
most common questions and concerns. With this data,
people through a push approach, rather than through
authorities can improve education, training manuals and
online searches, is phenomenal.
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CONSULTATIONS CLICK ON IN DIGITAL ERA ALEJANDRO DE LA PARRA Director General of Astrum Salud
166
Q: What are the main advantages and disadvantages
Our solutions encompass these three benefits of digital
of digital health for the patient and how can it improve
health, as we are complementing our teleconference
patient outcomes?
services with a series of mobile apps focused on attending
A: Patient information security is an extremely important
health concerns separately. We provide relevant software
issue when speaking in terms of global healthcare. As the
solutions, one of which is an app that reminds people to
digital health era extends its reach, offering solutions to
take their medicine, thereby contributing to medicine
almost every corner of the world, the new health paradigm
adherence. We aim to combine our telecommunications
contributes a myriad of benefits. Technology can support
platform with our mobile development, to create a fully
both health professionals and patients to give and obtain a
integrated solution.
reliable medical service when handled appropriately. Q:
How
does
the
technology
support
healthcare
A solid digital health infrastructure eases communication,
providers?
as well as remote patient monitoring. Mobile technologies
A: Our technology provides treatment beginning with an
have established robust wireless solutions, wearable
initial consultation at an online pharmacy, generating a
technology and mobile devices that automatically keep
digital prescription. The teleconference business model
records of monitoring. Keeping patient records for on-
offers patients the ability to purchase time blocks within
demand cloud access empowers the healthcare and assists
a doctor’s calendar, which makes scheduling easier for
care providers across medical disciplines. This saves time
patients and doctors. Patients pay a lower fee for medical
and money. In Mexico, this is essentially groundbreaking
consultations, while doctors increase their earnings as
as the public has almost no access to their personal health
they can charge more for 15-minute appointments than
record. As most rural areas suffer from lack of access to
their typical hour-long consultation.
quality medical services, digital solutions can be a barrierbreaker as telemedicine and teleconference in particular
We are opening our technology to different sectors,
offer the ability to close that gap. As elderly, disabled and
such as education, legal advice and financial advice, to
remotely located patients struggle to attend a doctor’s
complement our medical solution. This year, we aim to
office, our model facilitates patient preparation, treatment,
build a complementary solution for general doctors,
second opinions and follow-ups.
psychologists and nutrition professionals to incorporate technology into their processes. We are also launching
“As most rural areas suffer from lack of access to quality medical services, digital
online courses related not only to health but also business and sustainability to empower the digital era in Mexico and Latin America. Our goal is to provide intuitive digital tools attuned to our society’s healthcare system. Q: How can you ensure that diagnosis is as accurate
solutions can be a barrier-
online as in person to the extent that a prescription can
breaker as telemedicine and
A: Our services for providers are by invitation only. We
teleconference (...) offer the
be given? cannot offer a digital office for someone who does not meet our strict credential validation, in addition to completing
ability to close that gap”
our training sessions before attending patients. Not every
Alejandro de la Parra, Director General of Astrum Salud
are distinct situations wherein medical tests can provide
medical consultation can be conducted online, but there
support. The decision to treat a patient from a distance
as we can contribute to governments saving money on
has to be that of the medical provider and patient. Both
disease prevention and facilitating medical consultation.
will discuss whether the treatment is suited to remote care. We contribute to preventive spaces for health-
There is a blurry regulatory framework at the moment
conscious individuals and on patient follow-up, which do
but data protection laws do apply to our technology, and
not necessarily require patients to be present. A study
we comply with them in their entirety. We are exploring
conducted in the US of these types of services confirmed
regulatory options alongside the government to generate
that patients believe that online therapy is almost as
a new law-abiding protocol for such technological
beneficial as face-to-face appointments. A great number
implementations. It is our job to ensure that medical
of diagnoses can be carried out without the doctor ever
professionals reach certain standards. There have been
coming into contact with the patient.
some important data breaches in the US, such that we are closely monitoring and updating our encryption
Q: How do you ensure your physicians have had the
standards. This requires us to work hand-in-hand with
correct digital health training?
medical providers and patients to reinforce the importance
A: We are incorporating our technology into university
of data security in their day-to-day operations as we all
programs, helping professionals acquire the skills to
incorporate digital technology. This is a collaborative
operate online. Our requirements for becoming an
effort, as all high-impact industries understand. The
Astrum
robust
success of our technology is undoubtedly a matter of
background checkups, as well as confirming their medical
education and although we can identify mistakes in past
training. We are carrying this out manually, but we are
implementations, these are far from being considered
imitating regulatory authorities as they incorporate
failures. They are part of the learning curve.
digital
digital
healthcare
infrastructure
into
provider
their
rely
on
operations.
Besides
technology adoption, there are doctors who already
Q: What are your main priorities for 2017 and beyond?
offer consultations over platforms such as WhatsApp and
A: In 2017, we aim to prioritize education, health and
Skype so bridging the gap is easier. These efforts support
social development through the data we receive from
the process as adoption of Astrumâ&#x20AC;&#x2122;s technology grows
our technology. Our company hopes to incorporate
organically.
the social media factor into technology development to enrich our usersâ&#x20AC;&#x2122; experience while learning what
Q: How are you expanding your market within rural areas
people want from our solutions. We are moving into the
to ensure connectivity that will allow communities to use
non virtual digital realms, where massive events hold
your products?
a strong position. Sports, science fairs and continuing
A: We recognize the issues surrounding connectivity.
medical education through seminars and congresses
As
complement our online solutions.
we
are
not
telecom
hardware
manufacturers,
we see the need to collaborate to solve this shared predicament. Social entrepreneurship combined with
For the next five years, our goals are to provide an
telecommunications is already an emerging trend for
integrated IT solution moving into Artificial Intelligence.
business and we envision healthcare in that interaction.
We aim to integrate our content and technology into
In Mexico, people with low incomes are increasingly
university courses throughout the Spanish-speaking
acquiring technology to access the Internet and interact
community, as well as joining forces with our Brazilian
on social media. Mexico has seen some impressive
and Portuguese colleagues to produce similar solutions
developments in telecommunications, following the entry
in their language. We hope to provide a complete
of AT&T for example. Where the population demands
content delivery infrastructure, where we can provide a
sophisticated connectivity, pricing is inevitably catching
one-stop marketplace for health and medical science for
up and attuned to local needs. Our focus is on private
all our users.
medicine, followed by exploring the public health sector once we lower our costs even more. We face a serious problem in Latin America with technology adoption, but are confident that these issues will be solved as the cost of telecom infrastructure drops. This paves the way for cheaper and better technology. The rising importance of telecommunications and its impact on business demonstrates that our service is one of the most economically viable projects that exist today,
US study confirmed patients believe that online therapy is almost as beneficial as face-to-face appointments
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| VIEW FROM THE TOP
GOOGLE GLASS APP VIRTUALLY GUIDES IMPLANT SURGERIES XAVIER BOADAS International Department of Avinent
Q: How has your collaboration with Google Glass
technologies such as guided surgery or customized
influenced surgical procedures?
prosthetics are applied. These recent medical advances
A: The development of Avinent App for Google Glass
could make it possible to plan a surgery virtually.
has been a fantastic tool to show how technology can
168
improve our sector. The app is ready to use and can be
Q: How important is Mexico in the trend toward dental
helpful for doctors during surgery. It guides them step-
medical tourism?
by-step through the surgical procedure. The application
A: Mexico is one of most important markets in which
works with a QR code attached inside the packaging of
we have to invest. We are starting with Colombia, and
an implant that when detected, automatically leads the
Mexico will be the next step for us. Another reason for
doctor through the appropriate drilling protocol.
this is that we are already well positioned in Canada and beginning operations in the US. It makes sense for us
Avinent has contributed to new developments, having
to enter Mexico in the very near future. The size of the
created an innovative implant system to which new digital
market is a contributing factor, since it is the largest in
| INSIGHT
DIGITAL TOOLS STREAMLINE CLINICAL TRIAL PROCESSES ANA PULIDO Director General of Digitalizatxt
developing the trial master file solution. It is important to highlight that our solutions are integral and interoperate among them meaning our customers do not have to deal with individual tools.” Integral solutions allow users
Even though IT tools serve a broad spectrum of areas in
to have access to information on all platforms instead of
different industries, Mexico’s clinical research segment is
importing and exporting data from one platform to the
still highly under-attended. International CROs are forced
other. According to Pulido, this is a software solution that
to bring solutions from foreign providers as there are no
uploads data to the cloud instead of relying on a server
local digital and electronic solution developers for Case
so customers do not need to invest in sophisticated,
Report Forms and clinical trial management systems
expensive
(CTMS). This is mainly due to local authorities requiring
technology
paper records of all data generated by clinical trials. “Users
worldwide. If appropriate security measures are taken
are continuously seeking solutions that can adapt to study
to protect confidential information such as clinical data
requirements so we develop specific solutions for them
companies become more competitive as they can focus
including support and training,” says Ana Pulido, Director
on their core activities and avoid maintenance of expensive
General of Digitalizatxt. International platforms often
hardware, software, IT staff and infrastructure. Companies
require stable and innovative infrastructure in the clinical
can save up to 30 percent with digital solutions and even
site to run effectively. However, this is not always true for
if the set-up cost can represent a significant investment
all clinical sites in Mexico.
for them relying on paper can be more expensive in the
infrastructure is
gradually
and
technical
replacing
staff.
electronic
Digital systems
long term, considering time, quality and productivity. Data “The development of the eCRF took us two years,
analysis is much easier when the information is generated by
electronic data transfer (EDT) one year and the CTMS
clean and organized digital sources, which improves decision
is taking us three years,” says Pulido. “We are also
making and data integrity and reduces approval times.
Latin America after Brazil. Dentistry in Mexico is highly
Q: How is your registration with COFEPRIS progressing?
qualified and competent. Many doctors from the north
A: We are still at the very beginning of the process.
of South America studied at the National Autonomous
We have held some meetings and our product was
University of Mexico (UNAM), which trains high-quality
well received. COFEPRIS does not provide information
professionals. Doctors from Colombia, Ecuador and
directly, it is received through third parties and we have
Venezuela study in Mexico due to the excellence of its
already heard some good news. Having FDA approval and
institutions. Our product is aimed at professionals that
approval in Canada and Japan will certainly help to speed
want a high-quality product, which is why Mexico is an
up the processes.
important market for us. Q: What opportunities do you see in Mexico? Q: What are the biggest differences you have seen
A: This second registry with the Mexican equivalent of the
between Mexico and Colombia?
FDA is an opportunity. When we return to Barcelona our
A: Colombia will be a lucrative market for us as it has
regulatory affairs department will study strategic ways for
qualified dentists and, because aesthetics are trending,
us to enter the Mexican market. We also have the help of
odontology is a way to tap into that market.
the ACCIÓ office (Catalonia Investment and Trade Agency) here in Mexico. Even with all this support, we expect it to
We are seeing this trend replicate itself increasingly in
take nine or 10 months to obtain approval. Although we do
Mexico. People want functionality and those that require
not plan to manufacture our products in Mexico, I cannot
intensive dentistry work want teeth that fit well and are
make that as an unequivocal statement as we do not know
aesthetically pleasing. The population is more familiar
how customized products will be classified by customs. It
with implants and their purpose and functionality as
may become necessary to produce them in the country for
information is readily available for everyone.
local sales.
For Mexico to reach its full potential in the digital
As a consulting company for IT solutions, Digitalizatxt
healthcare field, authorities still need to modernize their
has several business units including Naat Solutions,
processes and requirements. “Regulatory authorities
Naat Health, Naat Knowledge, and Naat Mobile. Naat
still ask companies conducting clinical studies to keep
Solutions and Naat Health are dedicated to clinical
physical records of clinical data,” says Pulido. She
research and provide solutions such as the eCRF and
adds that a shortcut to a better competitive position
the CTMS. Naat Knowledge is focused on training for
in the healthcare and life sciences sector consists of
several sectors such as finance, education, medicine
incorporating digital solutions that help processes be
and law, among others. It consists of a learning platform
quicker, safer and more reliable.
for online programs. These platforms help save costs associated to logistics, and transportation incurred by
A number of companies have tried to enter the electronic
companies interested in training employees in different
records market in the last three years but only now
cities. According to Pulido, when employees are trained
is the business opportunity attractive. “In the past,
by different instructors they do not receive the exact
many companies used to see digital technologies as an
same information, which is something that can be
unnecessary expense but they are becoming aware they
avoided with online platforms. As for Naat Mobile, it
need to adapt to this global trend,” says Pulido. This digital
enables customers to have a broad range of educational,
platform already has been used by several CROs with
entertainment or business solutions in their smartphone
favorable feedback.
or tablet, which is also an important trend today. Business people spend much of their time travelling and the use
There are still many gaps to be closed in the clinical research
of mobile technologies has become quite popular and
industry such as eliminating manual data manipulation
useful for business management. Digital services are
because it can take weeks to transfer information from
changing the way companies develop new drugs in
devices to electronic databases. But the EDT solution can
terms of time and patient empowerment. Future plans
reduce the work of an entire week to three minutes. “Our
of Digitalizatxt include a patient diary where information
clients have become aware of the benefits of these tools.
regarding medicine intake and lifestyle changes can
But greater effort is needed to explain the importance of
be uploaded. “We expect digital healthcare to greatly
optimizing processes with the aid of digital solutions,”
increase in the next five years and we want to be there
says Pulido.
when the market starts booming in Mexico,” says Pulido.
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| VIEW FROM THE TOP
TEXTING FOR HEALTHIER BEHAVIOR JAIME ARCHUNDIA Innovation lead of UNICEF
170
Q: How is UNICEF’s partnership with the Mexican
RapidPro tool helps us obtain information from the
government contributing to the Prospera Digital strategy?
beneficiaries, which assists us on the catering of specific
A: The Prospera Digital strategy we are working on targets
solutions for their needs. For instance, we ask mothers
mothers and pregnant women. For Prospera Digital,
with babies of breastfeeding age how many times a day
UNICEF provides our rapid growth technology and original
they breastfeed their babies or how many times a day
content we have developed on breastfeeding, early child
they change the baby’s diapers. If we notice that it is less
development, signs of concern during pregnancy and so
than eight times we can allocate them to a group that
on. UNICEF has developed a technological tool called
has low rates of breastfeeding and we begin a process of
RapidPro, a development app we use for different kinds
sending messages that try to reinforce the importance of
of interventions and to create information flows from
breastfeeding and then track their progress.
and for people. Our experience on Communication for Development (C4D) and our technology is what makes us
The second treatment group receives the same kinds
an invaluable partner for the federal government on the
of messages but we also send messages to community
Prospera Digital strategy.
health promotors that participate with Prospera. We ask them to reinforce the messages the women in
The content we provide is designed jointly with users. We
their communities receive through their phones. These
conducted ethnographic research with the beneficiaries of
community health promoters also have the capability
Prospera, going to several communities to identify which
of sending more messages to the pregnant women that
were the main obstacles they faced in terms of healthcare.
help with reinforcement of the message we are sending.
Most of the time, the obstacles they face are related to
It is a mobile initiative with a strong health community
the long distances they have to travel to get to the closest
component aimed at reinforcing information.
health clinic. Sometimes when they have an emergency it takes them three or four hours to get to the clinic. Another
The third treatment group also receives the messages
difficulty they face is at the moment of child delivery.
but the mothers are also able to assess the quality of
Sometimes a women will get to the clinic but because she
the healthcare they receive in the clinics. The women
is not that far into labor she has to wait and is sent back
are asked for specifics regarding the attention they have
to her house.
received from their doctors and the treatment they need depending on their pregnancy stage or their baby’s age.
Prospera’s beneficiaries are a vulnerable group and
With this information we are able to shorten the route
unfortunately they suffer from the highest rate of stillbirth
of accountability, in which beneficiaries are directly able
and of high maternal mortality. Based on these situations
to evaluate the quality of the service they receive. With
we decided to create this intervention, working with the
all the information we gather we try to allocate positive
Mexican government and its National Digital Strategy
incentives for doctors’ good work, such as extra vacation
office. They provided us access to Prospera and to the
days. Our control group is also with Prospera beneficiaries
Ministry of Health.
but they are on the traditional Prospera plan and only receive their conditional cash transfers.
RapidPro has three different treatment groups and one control group. The first treatment is focused on sending
There are 3,000 beneficiaries on the three treatment
messages with content aimed at changing beliefs,
programs and 3,000 on the control group. Our 6,000
attitudes and practices during pregnancy and identifying
beneficiaries are being treated at 655 clinics. We are
different signs of concern. Our interaction goes beyond
deploying the program on the states of Mexico, Chiapas,
sending push notifications, or one-way messages. The
Hidalgo, Puebla and Guanajuato. These five states were
chosen because they present a mixture of the different
where we invite pregnant women to participate. In the
conditions in Mexico and because they present a high
workshops the team implementing the program explains
ratio of maternal mortality rates. With this information we
how it works, how to use their cellphones and if they do
will obtain data that will inform us on the scope of the
not have a phone we provide them with a basic cellphone.
program and after the implementation of the program we
We have found that in the first four months participation is
will have outcome results from the impact evaluation.
high because it is something new and they are enthusiastic.
The messages we send to all treatment groups cover an
Around 45 percent of the women who participate are
array of topics such as prevention during pregnancy, labor,
23 years old or under. Our strategy for maintaining the
breastfeeding, early child development and content to
participation rates of this particular group after the first
prevent accidents during the first two years, all aimed at
four weeks is to create Facebook Messenger multimedia
changing the mother’s behavior. The messages also ask
content. It is a strategy that we believe will increase
them if they know where their nearest clinic is and how are
participation rates. Our Facebook page also is filled with
they planning to get to the clinic when their baby is born.
interesting content created by UNICEF, the Ministry of
We ask them to design a plan for their delivery day and
Health and our partners regarding breastfeeding, child
a back-up plan for that day. We also ask them how much
development and anecdotes from people who have used
money they believe they are going to spend on delivery
the program. The goal is to make the program personal for
day and provide them with a money-saving plan so they
all the women who participate.
can have funds available when the time comes. Q: Which alliances did UNICEF forge to develop the Q: What participation and engagement rates are Prospera
program?
Digital seeing?
A: The President’s office as well as representatives from
A: The project was launched last December and we are
the National Digital Strategy helped us with the process of
still going through the implementation process. It has
bringing together private sector players. The equipment
been going for around seven months. In the next two
or hardware we give the women is provided by Alcatel
months we will have the first preliminary results and
and Samsung. Telcel and Movistar Telefónica are helping
at the end of the year we will get information on how
us with the text messaging. Telcel gave us 2 million free
the program is changing baby’s sizes at birth, weight,
text messages for an eight-month period and Telefónica
height and Apgar scores. Those are our final outcome
gave us 6 million free text messages for one year. Their
outputs. The midterm outcomes we have been tracing
participation has been crucial for us. That is why the
are engagement and participation rates. Our latest
partnership with Facebook is so important. Its Internet.
measurement shows an average engagement rate for our
org can definitely help us to achieve our goal of carrying
three groups of 87 percent.
information to a population group that has no access to other mobile technologies.
We send different kinds of messages. Some messages only provide information while other messages are questions designed for us to collect information so we can cater options to that mother’s specific needs. Our participation rate is based on the response to those questions. There is an average response to 85 percent of the messages we send. The preventive messages also have two variants, the informative ones and the ones that look for a response. With those messages we have a 70 percent response. For the messages we send that are looking for warning signs we receive around an 87 percent response. The messages asking for the quality of the healthcare they receive are having an 80 percent response. Our messages receive high response rates at the beginning but the engagement levels tend to decrease as time goes by. We are working on ways to maintain the participation rates. Prospera beneficiaries have to attend different workshops as part of the conditional cash transfers they receive and one of those workshops is Prospera Digital,
There are 3,000 beneficiaries on the three treatment programs and 3,000 in the control group. Our 6,000 beneficiaries are being treated at 655 clinics
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| VIEW FROM THE TOP
TECHNOLOGY INCENTIVIZES HEALTHY LIVING FOR DIABETICS GABRIELA ALLARD Director General of Mexican Diabetes Association
Q: What new efforts is the Mexican Diabetes Association
by a small percentage of the population but we will create
developing for diabetes awareness programs?
other platforms for more people to have access to these
A: Our main objective today is education so a factual
courses.
change can occur in society. We cannot put the solution
172
to diabetes in the hands of anyone else but the patient.
Technology plays an important role in healthcare, and this
Therefore, we created a new app that provides educational
app was fully developed by us with funding from Fundación
content about diabetes that can be downloaded with a
Chespirito and Boston Scientific. The app takes the user to
basic Internet connection. The information covers nutrition,
a webpage called Pacientes Como Yo (Patients like me), an
self-monitoring, exercise and the emotional management
online community in which patients share information on
to follow a successful treatment. We do not only want to
diagnostics and treatment, which is supervised by experts
provide information but we also want to transform lives
from Boston Scientific. We want patients to be proactive and
through education. It is true that physicians sometimes do
participate in discussions about their disease. It is important
not have time to educate patients so these tools are not
to highlight the app is not intended to either measure
meant to replace medical care but to help patients control
glucose or keep a food journal. It only has educational
their own condition. We are aware the app can be reached
content for diabetes type 2. Nonetheless, we will also cover
| VIEW FROM THE TOP
LEVERAGING BIG DATA FOR BETTER HEALTHCARE GUILLAUME CORPART Managing Director of Global Health Intelligence
Q: Global Health Intelligence has a focus on emerging
in Brazil than in the US, a whopping 7,000, while Mexico
markets. Why is it particularly interesting in Mexico?
has nearly 4,000. Together Mexico and Brazil account for
A: Emerging markets abroad are an attractive focal
two-thrids of Latin American hospitals. Consequently,
point thanks to their growth perspective. The healthcare
any business that wants to compete seriously in the
industry is expected to grow two to three times faster in
region must participate in these two countries. With this
emerging markets than in developed economies between
perspective, Latin America is a huge healthcare market
now and 2017. Any mature business that is striving to
that has been sidelined by many multinationals for the last
grow in global markets must plunge into the emerging
20 years.
market playing field. With that being said, Latin America differentiates itself with a large population, 625 million of
Q: How does GHI collect data in the region and specifically
which about 128 million live in Mexico.
in Mexico? A: We use health demographics to map hospital penetration
We are particularly interested in the fact that the Latin
across the region. We cover 11 countries, with 12,000 of the
American market has a complex healthcare system in which
region’s 16,000 hospitals. As a result, GHI has developed
there is no standardized government metric for measuring
the world’s largest hospital demographics database
hospital demographics. The region has 16,000 hospitals in
focused on Latin America. All data is collected, verified
total, more than all of Europe. There are more hospitals
and distributed by GHI. We have a call center and research
diabetes Type 1 and prenatal diabetes in the future. We are
glucose 8-10 times per day. Achieving this in the public
going to measure the acceptance level of the app among
system is not easy. Diabetes Type 1 is a catastrophic disease
the population and we will subsequently do the necessary
accounting for up to 30 percent of the total income of a
improvements. We are continuously looking for sponsors for
family and the industry is highly committed to supporting
the app and we are talking with several potential sponsors.
this initiative. Other Latin American countries such as
Many people are stuck in the same speech and activities
Argentina, Chile and Uruguay already cover full treatment for
around diabetes so we wanted to create something
diabetes Type 1. Glucose monitoring is also important during
innovative that could have a significant impact with the aid
pregnancy because women’s health can be endangered and
of technology.
babies could be born with many health problems.
Q: What concrete public initiatives have you supported to
Not all associations achieve tangible results or remain
improve patients’ quality of life?
active over the years. Sometimes we blame the Ministry of
A:
Patients
need
to
understand
they
can
prevent
Health or the Government for the populations’ health and
complications, and handle acute situations. The obligation
we are not assuming any responsibility ourselves. Diet and
to provide education to patients has been left entirely to
healthy habits are an individual choice so we have to work
physicians, the government and sometimes the industry. As
in conjunction with more parties to establish this mindset
a civil association we are also responsible for this. Treatment
with interesting initiatives to start making a change in
for diabetes Type 1 is not guaranteed in public institutions
society. In the Mexican Diabetes Association, we aim to teach
so we created an alliance with Fundación Mídete, Fundación
patients how to live healthy despite their condition, which
Fine and others, and submitted an initiative to the Senate
subsequently gives them hope and the power to manage
for children to have access to full treatment for this disease
their own health. Chronic diseases are difficult to bear
in public institutions. Some of them are already providing
because they affect quality of life for the rest of people’s
treatment but they do not cover auto-monitoring, which
lives. Patients feel good one day and the next day they are
is expensive since parents have to measure their children’s
at the hospital because glucose levels can easily fluctuate.
staff in Mexico to handle the majority of this work. The
stroke and diabetes. It is a massive long-term strain on the
first step of the process involves contacting government
healthcare system. Some of these diseases, like diabetes,
ministries across the region to obtain information about
are irreversible and need a lifetime of expensive treatment.
their healthcare network and infrastructure. In most cases, we receive a list of hospital contacts and addresses and
On a positive note, in 2013 Mexico had a diabetes
our call center continues the labor by contacting hospitals
awareness campaign that was the largest of its kind region-
to obtain additional information. We ask 106 questions to
wide. During this event, diabetes tests were provided, as
each hospital, gathering data from the number of beds to
well as information on the importance of eating well and
the type of equipment they use. GHI also delves into the
exercising. The event demonstrates that policies are being
human resource departments to inquire about medical
developed, even if the effects are yet to be seen.
staff and capabilities. Q: How has the government reacted to the incoming It is an incredibly challenging task, yet rewarding as we
reality of an aging population?
see positive collaboration from both hospitals and clients.
A: Latin America has the fastest aging population in the
We anticipate obtaining 85 percent regional coverage by
world. By 2055, the 45 to 60-year-old age group will grow
2017. We support the hospitals that are willing to give us
by 40 percent, while the over 60-year-old age group will
information by sharing information with them regarding
grow threefold. Investing in infrastructure and building
hospital infrastructure development. This is very much a
more hospitals is not an efficient solution due to high
collaborative task.
costs and limited lifespan of the use of infrastructure, much like building a large number of schools at a time
Q: What challenges does the sector need to face to
when people are having fewer children. We have to be
make growth happen in light of the increase in chronic
more innovative. One example is to focus on population
diseases?
health management, focusing on maintaining a population
A: Chronic diseases are the largest burden on the healthcare
healthy rather than on treating the ill. Digital health
radar regionally, and on top of that list is obesity. The
awareness is an element in this equation, which Latin
latter is a precursor to a wide range of complications like
Americans are adopting quite well.
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CLINICAL RESEARCH
8
Mexicoâ&#x20AC;&#x2122;s strict COFEPRIS regulations, ethnic and epidemiological diversity and relative stability have transformed the country into a burgeoning hub for clinical trials. International drug companies are turning to Mexico and contract research organizations (CROs) are carrying out Phase II and Phase III trials for those that may not have a direct presence. Working on drugs to treat the conditions that plague Mexico, such as diabetes and cancer, companies are working on innovative new molecules, combination drugs, biotechnology and generics.
To improve clinical trial sites, companies are improving compliance with strict regulations, actively seeking to earn certifications and competing to attract and retain medical talent. To do so, many partner with universities and offer internships and training to entice students into a career in clinical research. Despite the advances that have been made and its natural advantages, Mexico only attracts just over 1 percent of world clinical trials. Many industry insiders say further investment and faith in Mexicoâ&#x20AC;&#x2122;s scientific abilities are needed. This chapter provides an overview of clinical research underway in Mexico, relevant regulation, maintaining patient participation rates in trials and other challenges companies are facing.
175
The benefits are in the active substance #ItIsWhatInsideThatMatters Before going to market, generic drugs must meet strict bioequivalency, bio-dissolution and bioavailability tests to guarantee their effectiveness. Bruluart, we believe that everyone is In Grupo Bruluar entitled to a long, happy and healthy life. We are a mexican pharmaceutical group with over sixty years of manufacturing and marketing experience in high quality, affordable medicine.
| CHAPTER 8: CLINICAL RESEARCH 178
ANALYSIS: Mexico Fights for Bigger Clinical Role
180
INSIGHT: Cecilia Moreno, PPD
José Viramontes, PPD
182
VIEW FROM THE TOP: Melissa Rosales, RM Pharma
184
VIEW FROM THE TOP: Cecilia Padierna, LEI
185
VIEW FROM THE TOP: Yomana Khoury, inVentiv Health
186
INSIGHT: Annette Ortíz, EPIC CRO
187
VIEW FROM THE TOP: Israel Vega, PRA Health Sciences
188
VIEW FROM THE TOP: Karen Hahn, ICON
189
INSIGHT: Ciro García, Accelerium
190
VIEW FROM THE TOP: Arturo Rodríguez, Infinite Clinical Research
177
| ANALYSIS
MEXICO FIGHTS FOR BIGGER CLINICAL ROLE As the world´s medical and scientific communities hunt
percent of GDP in 2013, compared with an OECD average
for better and more efficacious drugs, Mexico is fighting
of 8.9 percent.
for a bigger role in the global clinical research sphere. Although dominated by the US, the realm of clinical
Khoury points out that one of the hurdles facing Mexico
research is expanding outward in the drive to bring
in attracting more clinical trials and research is cultural.
needed medicines to the public more rapidly.
Unlike in the US where clinical trials are a familiar force, Mexicans tend to be wary.
Globally, US$28 billion are invested in clinical research annually, according to Arturo Rodríguez, President of
“Culture plays an important role in the way clinical
ACROM and CEO of Infinite Clinical Research. Of that, Mexico
research is perceived among patients,” Khoury says. “In
receives US$200 million and 1 percent of clinical trials.
the US people are (…) willing to participate because they know their safety is never compromised. In Mexico more
178
That’s a small slice of the pie and researchers and industry
education of the public is needed about what a clinical
insiders believe Mexico is primed for a bigger piece. They
study is, how it is regulated, and the benefits. Many
cite a large and diverse population, a new cooperative
patients miss valuable opportunities to improve their
regulatory environment and the potential of the country’s
health due to ignorance.”
human capital. The country’s geography is also playing a significant role “Mexico has a broad patient population, qualified
as it targets a greater share of the clinical research market.
professionals, the right infrastructure, and supportive regulations for clinical research,” says Yomana Khoury,
“While we are officially part of Latin America, our
Manager of Clinical Operations and Strategic Resources
close proximity to the US has enabled our country to
at global CRO inVentiv Health, a worldwide leader in
incorporate practices, processes and procedures that
neuroscience clinical development, having supported
are similar to those of the US, making us familiar and
more than 507 clinical programs in over 60 countries and
comfortable with the way US companies work,” says Jose
over 45,000 patients in the last five years. “Mexico has
Luis Viramontes, Director of Remote Site Management &
reliable, well-trained researchers, and a strong patient-
Monitoring, Latin America, of PPD.
doctor relationship resulting in good compliance and “In practice, for companies having their corporate offices
high retention rates.”
in the US, sharing the same time zone has been a clear Mexico’s population stands at about 128 million, which
advantage to Mexico from a business perspective. Being a
gives it a broad base of potential trial participants and
Latin American country, we also can offer the international
makes it ideal for clinical research. But health spending
implementation of sites that most trials desire.”
overall lags. According to the OECD Health Statistics 2015 report, health spending in the country was 6.2
Cecilia
Moreno,
Associate
Director
of
Clinical
Management, Mexico, CA & Caribbean at PPD adds that
“All medicines can be considered matters of national
there are a number of steps clinical research professionals can take to attract investment.
security. Vaccines reach
“The Minister of Health in Mexico and the COFEPRIS
over 90 percent of Mexico’s
countries and reviewing their regulatory processes
population, having a larger impact on our society in the
are deeply interested in taking the benchmark of other to improve timelines,” she says. “As a country, we are more predictable, which is good for clients. The pharma industry will send more studies to Mexico if they see that the timeframes for regulatory approval are improving.”
event of a quality breach”
Moreno points out that cooperation with government
Cecilia Padierna, Research & Development
regulators has advantages, especially if the goal is
Manager of LEI
improving turnaround times.
“The Mexican Social Security Institute (IMSS) is evolving
population, having a larger impact on our society in the
to change its processes, but only a few clinical trials are
event of a quality breach,” says Padierna. “Another problem
underway so far. Usually the time needed to implement
arises as public health institutions lack vaccine availability,
and conduct a clinical trial is short and IMSS cannot always
which could be the result of providers not delivering
meet those deadlines. We need to continue working with
punctually, a lack of vaccines in their portfolio or COFEPRIS
them to shorten turnaround time as this institution serves
not releasing and distributing them quickly enough. LEI
an important part of the population.”
could contribute to improving these circumstances.”
Melissa Rosales, Director General of RM Pharma, agrees
She expects regulators like the new head of the IMSS,
there are issues yet to be resolved, especially as they relate
Mikel Arriola, to help change the landscape. “We expect
to the difference between Mexico, the US and Europe.
the federal government’s health sector to allocate more activities of this kind to third-party testing laboratories.”
“The timeframes are the main difference,” she says. “We know all randomized studies started in the US, followed
THE FUTURE
by Western Europe. That is a major difference. In the
For some, the future of clinical research is the domain
US clinics have several sponsors. On several occasions
of technology and the people who administer the trials.
because COFEPRIS took a long time to approve
Technology is constantly evolving and has changed
protocols, recruitment was completed by sites in the US
the way we monitor clinical trials and the way data is
and Europe and we could not participate, which reduces
processed,” says Israel Vega, Clinical Operations Manager
our competitiveness.”
at PRA Health Sciences.
THIRD-PARTY TESTING
“The activities of clinical research associates today are
Among the industry’s players, third-party testers say
very different from those in 1999 and 2009. We now
they also could play a larger role in attracting trials.
collect data in real time and share it with the client. This
Those companies add efficiency to the supply chain,
is the future of clinical research.”
support COFEPRIS in medicine and medical device assessments
and
analyses,
says
Cecilia
Padierna,
Behind the technology are the people that implement
Research & Development Manager of LEI (Laboratorios
the plans and carry out the work. “I think we need to
de Especialidades Immunológicas), a third-party testing
work with universities and institutions because many
company.
young people do not know how the industry works,” RM Pharma’s Rosales says.
They can help ease the commission’s saturation but thirdparty companies like LEI have not been able to take part
“They may want to focus only on the clinical side of
in the vaccination sector, which she thinks is an issue.
clinical research, so they may move on to private practice as they do not know what clinical research actually
“All medicines can be considered matters of national
consists of. They need more informative conferences and
security. Vaccines reach over 90 percent of Mexico’s
more training.”
MEXICO A COMPETITIVE PLACE FOR R&D ON CLINICAL TRIALS Country
MEXICO MORE AFFORDABLE DESTINATION FOR PRODUCT TESTING
Savings (percent)
Country
Savings (percent)
Mexico
38.8
Mexico
46.4
Canada
29.6
Canada
27.8
France
27.9
Netherlands
26.9
Netherlands
22.5
Australia
22.8
Italy
19.7
France
21.4
Australia
19.6
Italy
21.4
UK
16.7
Germany
18.2 14.4
Japan
9.7
Japan
Germany
8.9
UK
11.1
US
0.0
US
0.0
Source: ProMéxico
179
| INSIGHT
STRENGTH OF PEOPLE, QUALITY OF WORK clinical research investment. Cecilia Moreno Associate Director of Clinical Management, Mexico, CA & Caribbean at PPD
JosĂŠ Viramontes Director of Remote Site Management & Monitoring, Latin America at PPD
Q: What perception does the global arena have of Mexico in clinical studies? CM: Evidence was published that the quality of data
180
Q: What steps should clinical research professionals in
generated in Mexico for international trials is comparable
Mexico take to attract investment for clinical research?
to any other country. Over the past five years, more trials
CM: We have been working with different associations and
have been allocated to Asia Pacific and Eastern Europe
the government, mostly involving process improvement.
than to Latin America. As a sector, we need to become
The Minister of Health in Mexico and the Federal Protection
more competitive and attract more clinical trials in
Commission against Sanitation Risks (COFEPRIS) are
tandem with companies and governments.
deeply interested in taking the benchmark of other countries and reviewing their regulatory processes to
JV: We must become a household name among decision-
improve timelines. As a country, we are more predictable,
makers. Clear factors influence this: timeframes, costs,
which is good for clients. The pharma industry will send
the quality of the sites and market size. We should be
more studies to Mexico if they see the timeframes for
promoting our advantages in medical infrastructure,
regulatory approval are improving.
which is in place and supported by many professionals already prepared and interested in working in this area.
JV: As a country, Mexico has several characteristics that make it very attractive to conduct clinical trials, such as
Q: As a clinical research professional, what are the areas
its population of about 128 million people, predominantly
of opportunity in terms of human capital?
living in cities, and its wide epidemiologic profile,
JV: As with any profession, the Mexican clinical trials
which includes both acute and chronic conditions. The
industry is focused on education. We want to make sure
country has a large number of highly qualified health and
the people who are part of our industry have the correct
medical professionals and a well-established regulatory
preparation and understanding of our operations. A
environment, especially strong intellectual property
step was taken in that direction via collaborations with
protection. While we are officially part of Latin America,
universities to start the clinical research training process
our close proximity to the US has enabled our country
even earlier.
to incorporate practices, processes and procedures that are similar to those of the US, making us familiar and
CM: All of our industry in Mexico has been working with
comfortable with the way US companies work. In practice,
universities, both private and public, to raise awareness
for companies having their corporate offices in the US,
among those who are graduating with science degrees.
sharing the same time zone has been a clear advantage
Few students have access to information regarding clinical
to Mexico from a business perspective. Being a Latin
trials, so the burden falls on the Mexican clinical trials
American country, we also can offer the international
industry to promote the benefits of developing a career
implementation of sites that most trials desire.
in our line of work. There are courses for clinical monitors at the National Autonomous University of Mexico (UNAM)
PPD hopes to take advantage of these natural conditions
and the National Polytechnic Institute (IPN).
and for economic and political stability to grow in Mexico. We have the tools and favorable characteristics to attract
JV: PPD routinely hires many graduates straight out of
more clinical research investment to Mexico compared
universities. For junior positions, we need the right talent
to other countries. The company has made efforts to
as early as possible to teach them about clinical trials. We
replicate South Korean success to integrate the efforts of
also need to have qualified and well-trained professionals
the main stakeholders, namely academia, the authorities
at the sites to provide role models for graduates, not just
and industry, in a common strategic plan known as
working in the industry. Several companies in Mexico
KoNECT, Korea National Enterprise for Clinical Trials.
already have implemented internship programs. At PPD
This aims to place Korea among the first 10 countries in
Mexico we have junior positions that are similar in scope
and allow people to learn and grow with the company.
IMSS cannot always meet those deadlines. We need
Their daily work contributes to the development of
to continue working with them to shorten turnaround
better pharmaceutical products for those who need
time as this institution serves an important part of the
them. Every time a product is launched for which we
population.
conducted a clinical trial we celebrate because we are JV: Although the Mexican Association of Pharmaceutical
part of an important achievement.
Investigation Industries (AMIIF) works directly with IMSS Q: What methodology are you implementing to find
to improve how it implements clinical trials, we still have
new efficient ways to introduce drugs to the market,
progress to make with timeframes and the contract
differentiating your company from competitors?
template, as some terms are not accepted by the legal
JV: PPD is one of the most innovative companies in the
departments of the companies we work for. A local legal
clinical research industry. We are recognized for the
department understands the importance of working with
strength of our people and the quality work we do. The
IMSS and is more flexible working through the terms. As
enterprise has several global initiatives underway that
a CRO, we cannot have one template that fits all, so we
address key elements of the drug development process,
have a variety of plans, each tailored to different ways of
helping to make the process more efficient.
doing things.
CM: The use of technology is another of our strengths.
Q: What upcoming projects do you have planned at PPD
We have a strong database system that is useful
Mexico?
internally and for clients to review in real time and for
CM: We will be taking advantage of new technology and
sites to evaluate patients. These interfaces are one of our
biotechnology needs. Biotech companies are growing
differentiators.
and the clinical studies are changing so we need to adapt to this.
Q: What type of trials is PPD Mexico primarily conducting in Mexico?
JV: As a global CRO with a strong presence in Mexico,
CM: We often work with oncology, a rising trend in
we are responding to industry needs. PPD aims to satisfy
the industry. We also work on rare diseases, pediatric
every need, big or small. A substantial number of PPD
indications, diabetes and neurology, and we have some
research centers are operating and we are looking to
vaccine trials underway. A great advantage is a large
increase this number as needed. We focus on the sites
population concentrated in big cities, such as Mexico
with the greatest success and seek to replicate their
City, Monterrey and Guadalajara. These three cities are
achievements at all our sites.
about the size of the total population of some European countries. There are also branches of hospitals here such as national institutes or regional hospitals. JV: With a population of about 128 million people in Mexico, we know we can participate in almost any type of trial because we have the quantity of patients. Although we have more experience in conventional therapeutic areas, we try to participate in all kinds of trials. As a CRO, PPD has studies covering a wide spectrum of medical products. PPD works with a variety of clients, both big and small, as we are capable of responding and adapting to our clientsâ&#x20AC;&#x2122; particular needs. As a company, PPD has strategic relationships with some clients, frequently acting as their clinical research team. Q: What advantages does working with governmental institutions like IMSS offer? CM:
The
Mexican
Social
Security Institute
(IMSS)
is evolving to change its processes, but only a few clinical trials are underway. Usually the time needed to implement and conduct a clinical trial is short and
Mexico has a population of approximately 128 million people, predominantly living in cities, making it an ideal location for clinical trials
181
| VIEW FROM THE TOP
MEXICAN DIVERSITY IDEAL FOR CLINICAL TRIALS MELISSA ROSALES Director General of RM Pharma
182
Q: What have been your latest achievements?
Q: How important is FDA approval for you?
A: We have done well in recruiting patients. We have
A: We have not yet been inspected but everyone involved
two studies in place, the first of which is a phase 2 trial
in clinical trials respects an FDA and COFEPRIS approval.
concerning rheumatoid arthritis. RM Pharma was third in
We have quality certification ISO 9001:2008 and a
patient recruitment for that trial and we were very proud
quality-control program that involves preparedness
of this because we were competing with European and US
for inspection. You are not notified in advance and
sites. We randomized 14 patients in only six weeks. It was
given time to prepare for an inspection; rather we are
very competitive due to the short timeframe available,
ready at all times. We review our SOPs and have all the
since we started in December whereas other countries
data in place. When conducting a study, we adhere to
began in February.
protocol, to the GCPs, and we maintain patient safety in recruitment.
Q: What is the main differentiator between you as a Mexican company and a European or other North
Q: If everyone was FDA inspected in addition to
American company?
COFEPRIS inspected, how would the industry in Mexico
A: The timeframes are the main difference. We know all
change?
randomized studies start in the US, followed by Western
A: I think the FDA audits improve the quality of the science.
Europe. That is a major difference. In the US, clinics have
Industries must maintain the integrity of the data that is
several sponsors. On several occasions because COFEPRIS
submitted to the health authorities, otherwise it could
took a long time to approve protocols, recruitment was
jeopardize a study. Higher FDA involvement in Mexico
completed by sites in the US and Europe and we could
could improve trust in the quality of data generated from
not participate, which reduces our competitiveness.
Mexican sites. That is why it is important to have more audits. I can see companies having at least one audit in
Q: To what extent is the diversity of Mexican ethnicities
the future.
and genetics attractive to sponsors? A: It is attractive for disease study but this is why we
Q: To what extent can Mexico be positioned as a clinical
carry out feasibility questionnaires. Not every country can
study hub?
carry out each study. Lupus for example is much more
A: Trust in Mexico is increasing. Others have seen our
aggressive in Europe. These differences are important
potential to recruit many patients and to collect varied
when sponsors are writing the protocols.
data in a timely manner. I think sponsors need to focus more on sites and we need more people to professionalize
Q: In which particular areas do you conduct studies?
clinical research. Regulatory approval timeframes have
A: We are focused on rheumatology because my partner
shortened but this is not enough as after COFEPRIS
had experience in rheumatology and I had worked on
approval other permissions still need to be obtained,
rheumatology trials previously. We are diversifying in
which lengthens the time needed to initiate a protocol.
dermatology because there are biological products we know well and my staff is competent in rheumatology
Sometimes sponsors focus on the principal researcher,
and dermatology. We hold classes so that those with less
not on the site as a team, which is the problem. I think
experience can gain more knowledge and to keep everyone
they could improve the process by supporting sites.
up to date with advances. We are trying to include internal
Sponsors only see the problems so sites do not dare tell
medicine. There are many trials in oncology but it is an
sponsors what is happening and what problems they are
area that is very difficult and I would rather conduct those
having. Sponsors have an important role to play, so I think
trials in a larger environment such as a hospital.
this can change to a real integrated partnership model.
Q: Are there enough young students choosing to move into this field to cover the growing research demand? A: I think we need to work with universities and institutions because many young people do not know
“Not every country can carry out each study. Lupus is much
how the industry works. They may want to focus only on
more aggressive in Europe”
the clinical side of clinical research, so they may move
Melissa Rosales, Director General of RM Pharma
on to private practice as they do not know what clinical research actually consists of. They need more informative conferences and more training.
more studies with a high number of patients. Our next challenge will be in October when the first study will be
Q: How have you been working with institutions to push
conducted for patients with pain due to osteoarthritis
or even develop this type of academic program?
of the knee and hip. We have committed to recruiting
A: We have this type of program in mind but we have
around 300 patients, of which 100 should be randomized.
not gained support yet. We have tried to approach other
It is the project with the most patients in the company’s
professionals and heads of departments like IMSS Centro
history. Our highest so far has been 50 patients, 34 of
Medical Nacional La Raza. We tell them who we need,
which were randomized. We are trying to configure new
we conduct interviews and we explain about GCPs and
recruitment strategies. We need to decide how to refer
the process of getting a drug to a pharmacy. If we see
patients, how to reach out to the community and what
interest, we can get them involved in a study. Afterward
advertising approach to take. The agreement gave us
if all went well, we can consider continuing with that
money to configure all these strategies, which is new
physician.
for us as most sponsors do not assign money for patient recruitment.
Q: How similar are these training programs to the inhouse programs you have?
We also have four studies in rheumatology that will start
A: I would like to implement formal training for all health
this year, the first of which we are going to perform with
professionals should they wish to be coordinators or
biosimilars. The application of these is in rheumatoid
CRAs. I need to meet with many people to accomplish
arthritis. In addition, we continue to have meetings with
this goal. If I can succeed in pushing one, then hopefully
our clients to look for new projects.
I can replicate the success with others. Physicians think of clinical research as pre-clinical research with rabbits
Q: How do you think sites should sell themselves to gain
and rats and many have no idea about clinical research
a greater share of the segment?
sponsored by the pharmaceutical industry and GCPs.
A: We are discussing forming a national association of clinical sites. We are trying to achieve this in line with the
Q: What are the company’s short-term plans?
ITESM. We have had two meetings and we expect to have
A: I already have an agreement in place with a US
a formal association by this year with more than 20 sites
company called CCBR, a BioClinica company. We are
as members. This should lead to more interaction with
now part of the site’s network. I expect this will bring us
the Ministry of Health and sponsors.
183
| VIEW FROM THE TOP
TESTING BIOTECH DRUGS, IMMUNOGENICITY AND GENE THERAPY CECILIA PADIERNA Research & Development Manager of LEI
184
Q: What relevance do third-party testing laboratories
in sales. Our market share participation falls short at
have in the market and what position do they hold?
20 percent because COFEPRIS enabled investigation
A: Third-party testing laboratories add efficiency to
institutions in these types of studies, including the
the pharmaceutical supply chain, as companies like LEI
Biotechnology Institute, the National School of Biological
support COFEPRIS’ operations in medicine and medical
Sciences (ENCB), CIATEC and UNAM’s Chemistry Faculty.
device assessments and analysis as well as clinical
Although our market share took a hit, the positive effect
activity validation. LEI eases the agency’s oversaturation,
they will have on Mexico outweighs our own interests.
ensuring the availability of medicine, but it has not been
Unlike the institutions, LEI is subject to normal procedures
able to take part in the vaccination sector. All medicines
and protocols. Despite seeing a slightly reduced cash flow,
can be considered matters of national security and
the company established added-value mechanisms that
vaccines reach over 90 percent of Mexico’s population,
minimized negative impact on our business.
having a larger impact on our society in the event of a quality breach. Another problem arises as public health
Q: What innovations will LEI release in the midterm?
institutions lack vaccine availability, which could be the
A: We are working on different specialization fields,
result of providers not delivering punctually, a lack of
one of which advances methods to predict a drug’s
vaccines in their portfolio or COFEPRIS not releasing and
immunogenicity. A large proportion of biotechnological
distributing them quickly enough. LEI could contribute
drugs produce immunogenicity, such that the human
to improving these circumstances. With Mikel Arriola’s
body detects and adversely responds to them. In those
new position as head of the Mexican Institute of Social
instances, the biocomparables molecule must react with
Security (IMSS), we expect the federal government’s
the same intensity as the innovative molecule, otherwise it
health sector to allocate more activities of this kind to
could harm the patient. Traditionally, the immunogenicity
third party testing laboratories.
stage is evaluated as far as the clinical trial phase, but LEI is developing models that can predict the molecule’s
Q: What competitive advantages can the company offer
immunogenicity in preclinical trials. Gene therapy quality
over other testing labs?
control is another field of study in which LEI innovates.
A: We are the only laboratory in Mexico that analyzes
Only four gene therapies have been approved worldwide.
biotechnological and biological products on a regular
Locally, the same technology and expertise used in gene
basis. We structure our technology based on clients
therapy studies is applied in biotechnological products,
needs, who are mostly players in transnational industry. As
wherein we have a strong foothold. Finally, nanotechnology
such, the knowledge and technology that LEI has adopted
has become one of LEI’s focal points. We are working
follows first-world and top-notch standards, resulting
alongside our partner to develop a nanotechnology-based
in business retention from all companies that supply
medical device.
biotechnological products in Mexico. Q: What challenges is the company facing? Q: What specialization areas does LEI foresee to grow the
A: Regulations have become the industry’s bottleneck.
most and impact the company’s profitability?
Years ago, LEI created a proposal to evaluate quality-
A: From a trial number standpoint, the medical device
control processes in cellular therapies. To our surprise,
sector will see the biggest change as it is growing
we realized that Mexico lacked regulation in this matter.
exponentially. For instance, from 2014 to 2015, LEI saw a
Thereafter, LEI referred to the European Medicines
40-percent growth in medical device sampling. However,
Agency (EMA) and the FDA. We evaluated their regulatory
the biocomparables sector will have the most impact on
practices and their stance in such matters, which helped
LEI’s operations, representing a 10 to 15-percent increase
us build the guidelines to our proposal.
| VIEW FROM THE TOP
MEXICO OFFERS UNPARALLELED ADVANTAGES FOR CLINICAL RESEARCH YOMANA KHOURY Manager Clinical Operations, Strategic Resources of inVentiv Health
Q: As a global CRO, how did inVentiv Health initially
the demand for services at clinical research sites is
become attracted to Mexico?
increasing, which can provide patients with better services
A: Mexico has a broad patient population, qualified
and treatments.
professionals, the right infrastructure and supportive regulations for clinical research. It continues to offer
Q: Some physicians think that clinical studies sponsored
unparalleled benefits to any clinical development program
by the pharmaceutical industry are biased. What role do
including consistent regulatory laws, quality assurance
CROs play in making sure clinical trials are ethical?
through strong adherence to ICH-GCP norms and
A: Clinical research is not taught at medical schools but
adequate technology. Mexico has reliable, well-trained
it is an actual profession. Therefore, some physicians who
investigators and a strong patient-doctor relationship,
are not involved in clinical studies tend to ignore their
resulting in good compliance and high retention rates.
scientific background and the basis of their execution.
The population is mostly concentrated in metropolitan
To conduct a clinical trial, it is mandatory to have ethics
areas and there are many public and private hospitals with
committee approval. CROs do not profit from the sales
consistent standards of care, which guarantees patients
of drugs they help develop and our role is to maintain a
will easily attend their treatments.
neutral position during the trial. We have no interest in proving a medicine to be safe and effective but we are
Q: What needs to be done to take advantage of such
interested in conducting studies according to protocol
features and bring more investment in clinical trials to
and protecting patientsâ&#x20AC;&#x2122; safety.
Mexico? A: Culture plays an important role in the way clinical
Q: How can clinical research professionals and services in
research is perceived among patients. In the US, people
Mexico help the region improve its services?
are familiar with clinical trials and are willing to participate
A: Some countries in Latin America such as Argentina
because they know their safety is never compromised. In
and Brazil have more experience in clinical research than
Mexico more education of the public is needed about what
Mexico. However, the latter has significantly grown in
a clinical study is, how it is regulated and the benefits.
recent years and could replicate its success in other more
Many patients miss valuable opportunities to improve
immature countries. Guatemala has an attractive population
their health due to ignorance.
and good private clinical sites but not enough trained professionals and certifications. When our workforce visits
Q: How would you evaluate Mexicoâ&#x20AC;&#x2122;s infrastructure
those places it performs its ordinary activities and helps
capabilities for clinical trials?
them to improve. The same happens with our Colombian
A: Some public institutions are already working with big
CRAs visiting Panama or other countries that train
pharmaceutical companies and CROs and there are private
investigators and make sure the sites are compliant.
centers with solid infrastructure for trials. To comply with Good Clinical Practice, research sites have to ensure the
Q: What makes inVentiv Health a leader in clinical
right facilities. Some institutions are not aware of issues
research?
such as a lack of staff training, expiration of emergency
A: We have supported more than 507 clinical programs in
car medicines or lack of a civil protection plan. We let
over 60 countries and over 45,000 patients in the last five
them know what we are looking for and work with them
years. Also, 89 percent of cardiovascular drugs approved
to improve their practice, procedures and operations. This
by the FDA have been developed or commercialized
is certainly more common in less experienced sites so
by inVentiv. Seventy-eight percent of oncology drugs
they need to take courses and renew their certifications.
approved by the FDA have received assistance from
Physicians and professionals in Mexico should also know
inVentiv.
185
| INSIGHT
LOCAL EXPERTISE ENHANCES CUSTOMER SATISFACTION explained Ortíz. “Some people believe that complying with the regulatory package in Mexico is very easy but in fact companies need to plan ahead and consider the
ANNETTE ORTÍZ
time it will take to undergo the whole development and
Director General of EPIC CRO
registration process.” Risk management tools are effective in identifying milestones and they provide excellent data for strategic planning.
Two years ago EPIC CRO was created to entirely focus
186
on Latin America, though it already had nine-years’
According to Ortíz, a case-by-case analysis is done to fully
experience under its belt. In 2001, global regulatory
understand client needs. “We focus on several things such
requirements for clinical research were easier to comply
as the protocol design, the experts who will be conducting
with but now each regulatory agency faces different
the study, the regulatory strategy to follow and of
challenges, representing an opportunity for local CROs.
course the budget,” she says. EPIC CRO strives to have
EPIC CRO has capitalized on Mexico’s evolving position in
customized services not just for the company but also for
the global pharmaceutical and clinical research industry
each product, which is the secret to its success. With a
through its local expertise. “I am proud of Mexico’s
Clinical Trial Management System (CTMS) in place, the
current position as the second largest pharmaceutical
company is able to manage the progress of all its studies.
market in the region, and its regulations are following international standards,” says Annette Ortíz, Director
There are several advantages for small local CROs. “While
General of EPIC CRO.
large international CROs are oftentimes more expensive than smaller local ones,” says Ortíz. “They often look
Efficient and supportive regulation has been key to
for local partners because either they do not have the
improving
internationally.
expertise in a particular area or have huge workloads
Now that the country has world-class regulation for
and limited resources.” Therefore, clients often negotiate
biotechnology drugs Ortíz is confident clinical research
directly with small CROs, which provide local expertise
will grow. Other countries in Latin America are developing
and excellent customer service, making value delivery
independent regulations hardly aligned to international
and customer satisfaction easier. In addition, clinical trial
standards, while others are completely lacking. Both
management is easier, more direct, and faster, increasing
situations are not desirable since companies want their
customer trust. Small CROs have less rotation and more
products to be protected by intellectual property laws and
employee loyalty, which is highly cherished. However, they
entering those markets could represent a risk. Excessive
also look for CROs with complete infrastructure so limited
regulation could also deter product entry into domestic
technology remains a challenge. When it comes to budget
markets. “I would say Mexico is in the middle,” says Ortíz.
allocation large CROs have the advantage of being able to
“The regulation is clear and has proven to support the
subsidize small trials with larger ones.
Mexico’s
competitiveness
industry. Therefore, companies are prone to bring more clinical trials to the country.” Mexico’s proximity to the US is
EPIC CRO aims to increase the amount of clinical trials
also a benefit since they share time zones, which facilitates
it manages and become one of the top CROs in Mexico.
clinical trial logistics and sample and supplies shipping.
“We will be focusing on that over the next three years and at the same time we will further increase our capabilities
Ortíz believes companies need to understand Mexican
in Brazil, Argentina, and Colombia so we can become a
regulatory requirements for pharmaceuticals for clinical
stronger clinical research player in the region,” explains
research investment to potentially triple. New molecules,
Ortíz. EPIC CRO will expand its technological capabilities
combination drugs, generics and biopharmaceuticals all
and is determined to stand out for clinical trials
require different registration processes and clinical trials.
management service and risk control. With quality being a
Companies also have to be realistic about timelines – the
high priority for all the staff, it is aiming to provide better
submission process of a new study protocol can take
services than larger CROs. “As a local CRO we provide
three to six months. “When a company manages to fully
scientists and professionals with opportunities to develop
understand the regulation and prepares submissions
their careers and I am proud to say we employ 20 Mexican
correctly it is closer to a successful product launch,”
professionals now,” says Ortíz.
| VIEW FROM THE TOP
THE FUTURE OF CLINICAL TRIALS: SHARING ISRAEL VEGA Clinical Operations Manager of PRA Health Sciences
Q: What are your goals as the new Clinical Operations
Department. Many people think this is a staffing service
Manager of PRA Health Sciences?
but it is more complicated than that because it consists
A: We are determined to reinforce our quality and
of hiring an individual that is trained, adaptable to the
efficiency, which is why our clinical research associates are
companyâ&#x20AC;&#x2122;s needs and able work with the infrastructure of
constantly looking at how we can improve and accomplish
the company.
our goals with a quicker turnaround time. Business renewal gives us valuable information on customer happiness
Q: What role do IT systems and digital platforms play in
and we are doing really well. Internally, as a CRO we
clinical research today?
have several qualitative objectives we want to achieve
A: PRA Health Sciences invests a lot in technology, which
and are continuously monitoring. PRA Health Sciences
is continuously evolving and has changed the way we
differentiates from other big CROs through creating
monitor clinical trials and the way data is processed. The
partnerships with customers to conduct specialized
activities of clinical research associates today are very
clinical studies. It is much more difficult to find and recruit
different from those in 1999 and 2009. We now collect
patients for oncological and rare disease clinical trials.
data in real time and share it with the client. This is the
New therapies have been developed for oncology in
future of clinical research. Immediate detection of risks
recent years with no precedents, so expertise is needed
will be possible and corrective actions will therefore be
but is hard to find.
implemented in a shorter time. We used to provide clinical sites with computers so they could access electronic case
Q: What are the drivers of double-digit growth in the CRO
reports, while now there are prototypes for accessing
industry despite stagnant pharmaceutical pipelines?
electronic forms from mobile devices. Remote monitoring also significantly reduces costs since monitors do not
A: Working with CROs can have different pros and cons
need to visit clinical sites as much as before.
depending on whether it is a Big Pharma, midsize or small innovative company. Resourcing clinical development
Q: How can clinical trials adopt a broader scope to
activities has several advantages, such as cost efficiency,
provide more knowledge of drugs during clinical trials?
and we help them to optimize R&D activities through
A: Clinical trials are the standard scientific method
highly qualified professionals taking charge of them.
to obtain information about a new molecule but full
CRO´s decision to hire depends on geographical presence
knowledge of the drug can only be obtained when
and commercial interests. Most pharmaceutical companies
the drug is taken by many patients worldwide. When
have preferred vendors, achieved by gaining customer
pharmaceutical companies partner with CROs they gain
satisfaction through high-quality services, efficiency and
specialized knowledge and services. CROs have extensive
meeting budgets. We do not only provide services for
experience in different therapeutic areas, giving us the
innovative companies, we also provide services for the
expertise to identify adverse events and when a study
development of biosimilars. Biosimilars undergo the same
has successfully met its primary and secondary endpoints
four clinical phases and pivotal studies and they require
through a validated, repeatable scientific method.
the same quality procedures as innovative drugs. Q: How do you envision PRA Health in the short term? Q: What is the difference between the CRO full service
A: Improving quality and efficiency will remain at the
model and staffing services?
center of our agenda. Mexico has the necessary capabilities
A: RPS (a unit of PRA) was one of the first CROs to
and key elements. We have excellent sites and proper
implement the embedded model in Mexico and it became
infrastructure and regulations are supportive. Patients are
the leader in this. Now it is part of our Strategic Solutions
also increasingly willing to participate in clinical trials.
187
| VIEW FROM THE TOP
STANDARDIZED PROCEDURES ATTRACT NEW TRIAL KAREN HAHN Director of Clinical Trial Management of ICON
188
Q: Mexico receives US$200 million in clinical research
the investigator’s engagement. The company is expanding
investment. Some believe this amount could triple within
its geographical outreach of sites and no longer focuses
five years. How can this be accomplished?
on large cities. We have found a niche in small towns that
A: The government is modernizing its regulations. By
are accustomed to following our metrics, which shows the
analyzing the measures implemented by first-world
new found willingness of the market.
markets, we can expedite clinical trial approvals without jeopardizing the quality of our products. The Federal
Q: With IMSS’ willingness to engage in clinical trials, what
Government, specifically COFEPRIS, learned that sharing
type of relationship does ICON have with this parastatal?
local procedures in international forums can expand
A: Over the past five years, ICON has conducted clinical
their understanding and improve efficiency in protocol
studies with IMSS. But that is completely up to our
approval. ICON is part of a CRO association that aims
clients. Although committing to IMSS takes time it is not
to standardize the segment’s processes. Rather than
impossible. Timelines are different, and so is the type of
competing to retain new clients or businesses the market
work that is conducted within the institute. Contracts
is collaborating to establish standardized procedures to
may take longer to secure but the patient volume our
attract new trials.
clients have access to far exceeds any other clinical site. In addition, the number of specialists and therapeutic areas
Q: How does the world perceive Mexico in terms of
within the organization provides added benefits. Given its
quality and infrastructure for clinical studies?
willingness to engage in these types of activities, IMSS is
A: Pharma and Biotech client companies have increased
keener to comply with procedures previously established
trust in Mexico. The levels of enrolment have always
by CROs. The retention rate is also an advantage as
been high but they are now supported by precise
patients are treated with the utmost attention.
inspections performed by either the FDA or the European Medicines Agency (EMA). COFEPRIS has improved its
Q: How is ICON incorporating new technology into
own internal procedures leading to the emergence of
clinical trials to transform the face of clinical research?
Mexico as a world leader in vaccines. The Pan-American
A: ICON combines best in class processes and industry
Health Organization’s (PAHO) recognition has opened
leading technology, delivering impact and performance
the doors for Mexico. With ongoing audits by clients
to its clients. Paper case report forms (CRFs) and clinical
Mexico has proven capable of high quality. There are
trial files are a thing of the past. ICON in collaboration
multiple opportunities that will advance our position. We
with
can channel our energy and resources to studies that
eConsent accreditation through Firecrest, which will
are affecting our community. In the past, we attracted
improve treatment compliance and expedite results in the
whatever study fell in our lap but we must be shrewder.
near future.
global
pharmaceutical
companies
gained
the
The government has asked us to attract studies that run parallel to therapeutic needs in the country like obesity,
Q: What goals has ICON set for 2016?
cancer and degenerative diseases.
A: Growth is always in our sight. ICON’s Mexican operations are the largest in Latin America with almost
Q: How does ICON decide which clinical sites it will do
200 employees. Considering six years ago there were 40
business with?
employees, our systemic growth has been noteworthy.
A: ICON’s internal system evaluates sites in Mexico based
In 2016, ICON Mexico was awarded a large contract
on available data. With it we can evaluate the site’s
enabling the company to grow its staffing division by
performance through metrics and forecasts. For instance,
45 employees. Historically, ICON Mexico has focused on
ICON has specific metrics around monitoring visits and
phase II and III studies.
| INSIGHT
MEXICAN EDGE IN CLINICAL TRIALS The development process of innovative pharmaceutical and biotechnological products is widely known to be long and expensive. Time scales and costs are extensively
CIRO GARCÍA
documented and identified in multiple industry analyses.
Director General
According to Bain & Company, these costs range between
of Accelerium
US$900 million and US$1.7 billion. Discovering and commercializing a new medicine takes an average of 1015 years. As the pharmaceutical industry’s profit margins
Centers for clinical investigation that have the adequate
are subject to increasing pressure, biotechnological and
infrastructure and human capital that is qualified to
pharmaceutical laboratories turn to outsourcing for many
manage clinical studies effectively will be a key element
aspects of their growth strategy. This pressure is predicted
for the success of R&D. The ideal research center provides
to rise in the near future. Contracted research companies
necessary resources to carry out these studies in line with
together with clinical testing centers are taking on greater
internationally established guidelines. Accelerium Clinical
importance and have become strategic associates for the
Research’s services understand the clinical investigation
biopharmaceutical industry to protect profit margins.
phases through access to large groups of patients and skilled medical researchers, operating under the strictest
Clinical trials play an increasingly critical role in light of
parameters
a growing number of procedures and in the complexity
procedures and the rules stipulated by the International
of
quality
management,
standardized
of investigation protocol. Testing now requires a more
Conference on Harmonization (ICH) and Good Clinical
diverse mix of patients globally but within specific criteria.
Practices (GCP).
These factors continue to push testing globalization, resulting in the solidification of these trends and inevitable geographical dispersion. In the past, clinical trials were principally carried out in the US. However, high demand for trials and insufficient access to patients led the biopharmaceutical industry to look to other regions. The demand for research services in Mexico is an overriding tendency, largely thanks to COFEPRIS’ interest in positioning Mexico as a global leader in the industry. Formal training programs for medical researchers also contributed to this trend.
Discovering and
commercializing a new medicine takes an average of 10-15 years
189
| VIEW FROM THE TOP
CLINICAL TRIAL INVESTMENT DEPENDENT ON STAKEHOLDER EDUCATION ARTURO RODRĂ?GUEZ President of ACROM and CEO of Infinite Clinical Research
190
Q: What activities are you planning to strengthen the
make it easier to start and conduct clinical trials in public
clinical research industry in Mexico as the new President
institutions. Better communication and simpler policies
of ACROM?
are vital to formalizing collaboration.
A: The main priority for ACROM is to consolidate the clinical research industry in Mexico. While we all agree the
Q: What needs to be done to improve the international
regulatory agency has significantly improved approval
perception of Mexico regarding clinical trials?
times for clinical study protocols. It is important to know
A: Promoting clinical research in Mexico is another
how long it takes CROs to recruit the first patient after
priority for ACROM. Little more than 200,000 clinical
receiving a new protocol. There are several processes that
trials are being conducted worldwide, of which only
could be improved between both milestones, and which
2,500 are brought to Mexico accounting for just above
could help increase the productivity of R&D for new
1 percent. We used to compete against Brazil and
drugs and medical devices. A private ethical committee
Argentina to attract clinical trials but we realized that
usually takes one month to issue an approval letter while
attracting protocols to Mexico also benefits the rest of
an institutional one can take up to three. In terms of
Latin America, and vice versa. The region has two main
intellectual property protection, many pharmaceutical
hubs - Mexico and Argentina - and both should join forces
companies have historically refused to conduct clinical
and keep protocols in the region instead of competing
trials in IMSS due to the institution having a policy
against each other. Stakeholders abroad know little about
that stated it was entitled to claim property rights of
the region and the advantages of conducting trials here.
all products that resulted from any research project conducted within its walls. Paradoxically, the lack of
Clinical trials in Mexico can provide valuable information
pharmaceutical clinical studies conducted in IMSS is one
regarding drug effects on the US Hispanic population.
of the barriers for including new drugs in the institutional
When we tell international stakeholders about our
basic formulary.
capabilities to conduct studies for drugs, biotechnology products and medical devices they are skeptical. They are
Q: Do you believe CROs and pharmaceutical companies
not aware that Mexico City has 20 million people making
are more interested in conducting clinical trials in IMSS
it ideal to execute studies and recruit patients.
after it revised its policies over possession of property rights?
It is important to convey the right message and prove that
A: We want to enter into a strategic alliance with IMSS as
Mexico has a mature clinical research industry delivering
we gradually see more companies working there due to
great results. In the last decade a great emphasis was
modified policy. At Infinite Clinical Research (ICR) we have
placed on the professionalization of clinical research in the
three protocols we wish to carry out in IMSS. But there are
country. We have professional, institutional and private
other factors affecting the actual opening of the protocol
sites, ethics committees protecting patients safety and a
such as the number of patients recruited worldwide
strong regulatory agency.
and the time it takes to start a protocol in Mexico. Pharmaceutical companies, CROs, and the government
Q: As Director of ICR, in what areas will there be more
want to work together but collaboration agreements need
clinical trials and what services represent promising
to be structured and formalized.
business opportunities? A: There are many clinical trials for dermatology,
ACROM is engaged in this kind of discussion and it
cardiovascular, metabolic, gastro and medical devices.
has several divisions designated to work with public
This changes on a regular basis as two years ago the
institutions. We want to devise templates and processes to
cardiovascular area was the largest segment while this
year dermatology is number one. One of the advantages
pharmacodynamics, while bioequivalence studies basically
of ICR is that we are a general CRO. This allows us more
consist of obtaining pharmacokinetic curves.
flexibility to manage clinical studies of any therapeutic area and we always train the team in particular areas so
There are three sites in Mexico that can actually conduct
it is qualified to coordinate the study. ICR has already
phase I studies. The demand for phase I clinical trials is
tapped into the pharmacovigilance area, in which we are
not growing in the short term because they are usually
able to design risk management plans for protocols and
performed in clinical sites near headquarters or scientific
methodologies for hospitals and doctors.
groups of pharmaceutical companies â&#x20AC;&#x201C; most of them located in the US and Europe â&#x20AC;&#x201C; and only when they are
Hence, they can follow up on the drug for a certain period
saturated do they migrate to other places.
as required by COFEPRIS. In the past, a report was drafted every six months and many companies used to present
Q: Last year you mentioned you had plans to enter the
reports with zero findings regarding adverse events.
Central American and Caribbean region. What have you
Now the authority requires higher quality reports and
achieved in this respect?
the implementation of collection methods for accurate
A: We established a partnership with another CRO and
information regarding safety. We are also participating
now we can provide services in the region, including
in research projects for cell therapies, an area that is
Brazil, Argentina, Chile, Colombia, Central America
not new in Mexico but still lacks clear regulation. We
and the Caribbean countries. Both our partner and
are closely working with a Senate Commission to attain
ICR have business development departments and the
it and prevent the loss of clinical studies given that last
agreement consists of sharing a protocol to represent
year 15 were not approved by the authority due to a lack
the whole region. We have already homogenized
of regulation.
standard
operational
procedures
and
established
communications lines. Q: Why do you think it has taken so long to have a clear regulation for cell and gene therapy while COFEPRIS
Q: What are your main concerns?
quickly developed the new regulation for biotechnology
A: I am concerned that US$28 billion is invested globally
drugs?
in clinical trials, of which Mexico only receives US$200
A: Cell therapy was initially included in the regulation for
million or 1 percent of clinical trials. Thirty percent
the use of tissues. However, there are some preparation
of global clinical trials are being managed by CROs.
methods that include cells in a solution and the
Considering the development of one molecule costs US$1
regulation did not cover the use of animal cells, plant
million, US$200 million is very little investment. Clinical
cells and autologous implants of stem cells. Cell therapy
trials are also a great opportunity to benefit patients with
has a promising future but we are in the initial stages
new treatments and is also a good source of revenues.
of its development and we have to wait and see its full
Last year, 10,000 patients were enrolled in clinical trials
potential.
conducted by member CROs of ACROM, which account for 60 percent of the all clinical trials in the country.
Some countries such as Japan and Panama already have a clear law for this kind of product and their commercialization is authorized. Protocols for cell therapy are needed to generate conclusive information. Mexico closed the door to cell therapies last year but also identified a group working in this area so we expect cell therapy protocols to be on the agenda for the next five years. Q: Some CROs have shown interest in conducting phase I clinical trials in Mexico. To what extent does the country have the necessary infrastructure and specialists to do so? A: Most clinical trials conducted in Mexico are phases II and III and most people do not understand the difference between phase I studies and bioequivalence ones. The quality, precision and standardization of processes are completely different. Phase I requires a high degree of detail, including toxicology, pharmacokinetics and
US$28 billion is invested globally clinical trials,
of which Mexico only receives US$200 million or 1 percent
of clinical trials
191
9
INNOVATION & BIOTECH
Biotechnology has a considerable number of applications and improves treatments that not so long ago were considered risky or impossible. Stem-cell research, controversial and even banned in some countries, is being developed in Mexico to treat auto-immune diseases and to help slow the aging process. Others are focusing on developing drugs to help patients cope with mental disorders, which can be as debilitating as a physical disability. Fertility treatment is leaps and bounds ahead of where it was 10-15 years ago and allows older couples a greater chance of conceiving and for women to delay having children by freezing ovules.
Many biopharmaceuticals are in the pipeline and companies continue to invest in R&D. Industry insiders expect the biopharmaceutical market to specialize further in Latin America over the next three years. Mexican academia has been keen to join the sector, offering state-of-the-art facilities and recruiting more talent into these efforts. This chapter will look at the fascinating advances that are being made, the growth expectations companies have of the market and how the regulation regarding biotech has evolved.
193
| CHAPTER 9: INNOVATION & BIOTECH
196
ANALYSIS: Biomedicine Stealing the Spotlight
198
VIEW FROM THE TOP: Franz Schubert, BIOSKINCO
Sergio Villa, BIOSKINCO Mexico
199
VIEW FROM THE TOP: Ernesto Gutiérrez, World Stem Cells Clinic
200
INSIGHT: Óscar Parra, Lundbeck
201
VIEW FROM THE TOP: Mauricio Vidales , Croda
Christian Escandón, Croda
202
VIEW FROM THE TOP: Mario Cervantes, CareFusion/Becton Dickinson
205
VIEW FROM THE TOP: Octavio Tonatiuh, IBt
206
VIEW FROM THE TOP: Thomas Cantor, Scantibodies
207
VIEW FROM THE TOP: Edna Álvarez, Malvern Instruments
208
VIEW FROM THE TOP: José Islas, IVINSEMER
209
VIEW FROM THE TOP: Joel Osorio, RegenerAge
195
| ANALYSIS
BIOMEDICINE STEALING THE SPOTLIGHT As technology evolves so do the options for treating
Group and published in The Journal of the American
disease. While the world waits on the next big cure or
Medical association showed US government research
treatment in medicine, pioneers in the field are working
funding from 2004-2012 fell to 50 percent of the global
to deliver just that. To do so, they are increasingly turning
total from 57 percent. US companies also spent less,
to advanced technology and innovations to find solutions
posting a drop to 41 percent from 50 percent in the same
for complicated puzzles.
period, according to the study. At the same time industry accounted for 58 percent of US research funding in 2012,
This is the world of biological medicine, where cutting-
compared with 46 percent in 1994.
edge treatments are on the market or in development for
196
everything from infertility to cancer. Instead of chemically
As the US slowed its spending, Asia picked up the slack.
synthesizing drugs, these researchers and innovators are
The study showed China tripling its research funding
looking into stem cells, gene therapy, blood components
to US$4.9 billion from US$1.6 billion. The total for Asia
and tissues, among others. It is an area that is growing
jumped to a whopping US$14.6 billion from $1.6 billion
and for companies big and small, Mexico is increasingly
in the period.
on the radar.
A GROWING NICHE Amgen, among the world’s leading biotech companies
Biosimilars, or drugs that are similar to already approved
with an array of products on the market, came to Mexico
biological products, are an area that companies like
in 2006 and invests 19 percent of its global revenue in
Croda view favorably. “Over the next few years we will
R&D. It sees a growing trend for biological drugs, citing
be looking into biosimilars, a growing niche believed to
a COFEPRIS report that said 35 percent of the drugs
be the future of the pharmaceutical industry,” Croda’s
approved in Mexico are biologics.
Commercial Manager Christian Escandón says.
“We assume this to be a sustainable trend,” says Elvin
Penn, at Amgen, agrees. “Amgen is committed to
Penn, Director General of Amgen. “Biologics account for
developing and launching biosimilars since they can cover
around 30 percent of the products undergoing clinical
a wider population, hence helping the healthcare system,”
development.”
Penn says. “These medicines require a significant effort to be developed because their comparability and effect
This growth has come rapidly, as technology overtakes
has to be demonstrated through clinical studies, not only
more traditional methods of drug development. Mauricio
through physicochemical characterization methods.”
Vidales, Director General of Croda, points out that “in 2004, just one of the leading global drugs was a so-
Edna
Álvarez,
the
Latin
America
Manager
of
called big molecule or biologic with nine others being
Malvern Instruments, a leading provider of scientific
developed through more traditional means. Ten years
instrumentation, says the sector is actively growing.
later, seven of the top 10 new drugs approved in 2014
“Three technologies are seeing the highest demand,”
were biologics.”
she says. “These are laser diffraction for particle size characterization and distribution, dynamic light
The US is the traditional leader in biomedical research
scattering and nanoparticle tracking analysis focused
funding but it appears to be slowing as others climb into
on nanoparticles, and image analysis solutions for
the arena. A 2015 study led by The Boston Consulting
characterizing the shape of particles.”
“Over the next few years
Mexico has a number of advantages that help it attract
we will be looking into
involvement in a number of free-trade agreements like
biosimilars, a growing niche believed to be the future of the pharmaceutical industry” Christian Escandón, Croda’s Commercial Manager
investment, including its close proximity to the US and NAFTA that make it easier to do business here for foreign companies. Equivalency agreements signed by COFEPRIS with agencies like the US FDA and Europe’s EMA are also important because they can quicken the process of getting drugs to market.
“Regulatory recognition among countries is evolving and
Gutiérrez adds that understanding of the possibilities for
will certainly play a much more relevant role in upcoming
biologics such as stem cell therapies is another factor
years,” Penn says. But there are problems and hurdles
to consider. “There is still a long way to go in terms of
that need to be overcome, among them is local expertise.
understanding everything we can achieve with stem cell
To overcome these, many industry players are looking at
technology and how to do it.”
partnering with academic institutions.
THE NEXT FIVE YEARS “A key problem is the expertise in the industry regarding
As the industry develops and grows to the extent of the
state-of-the-art biotechnology,” says Octavio Ramírez,
that of the US and Europe, it is possible to imagine what
Director of UNAM’s Instituto de Biotecnología (IBt).
lies ahead. UNAM’s Ramírez looked five years out to give
“Lack of expertise and knowledge results in foreigners
an idea of what biopharma applications might be on the
often selling suboptimal or outdated technology to
horizon.
the Mexican industry, which, in general, is not capable of differentiating them from true valuable state-of-the-
“Biopharmaceuticals aimed at attending the particular
art technology. The industry is gaining more and more
needs of the Mexican population, would be the ideal
knowledge, but they need to trust the academy as allies
niche for the industry segment to be able to compete
on technology assessment.”
with translational companies. I believe that personalized and genetic medicine is a key field that the Mexican
But it’s a two-way street, he says. “Academics need to
biopharmaceutical industry could focus on. Diagnostics
make a better work in collaborating with the productive
is also a field of particular importance for Mexico,
sector and gaining their confidence.”
and again, particular niches can be exploited by the pharmaceutical industry.”
PERCEPTION PLAYS A ROLE Perception also plays a big role as foreign companies
To create a healthy biopharmaceutical market that can
look to Mexico. Thanks in part to medical tourism, the
thrive in the short term, Ramírez sees an important role
country is seeing an improvement in how it is viewed
for COFEPRIS in bringing new opportunities.
from abroad. “The increased strength of COFEPRIS is an important area “It is slowly changing, and medical tourism has influenced
of opportunity. Mexico has become a leading country by
this,” says Ernesto Gutiérrez, President of World Stem
approving state-of-the-art treatments in an expeditious
Cells Clinic. “World trends, especially regarding US
manner, with a strict scientific review,” he says.
and European patients, have made healthcare systems almost unaffordable for big population segments, giving
“An example is the approval of the dengue vaccine. I
way to insurance companies. The social gap between
believe this is an important area of opportunity, as the
those using Medicaid and Medicare, and others that can
table is set for the evaluation of new approaches to
afford private health services in the US is quite sizeable.
improve health. Mexico needs to stop being a follower
As such, Mexico offers them an affordable solution to
and continue down a leadership track, with strong
their needs.”
support from the scientific community in the country.”
MEXICO IN FIFTH SPOT FOR EXPORTS TO US MARKET
MEXICO A COMPETITIVE PLACE FOR R&D ON CLINICAL TRIALS
US imports of life-sciences products in 2015 (US$ millions)
Country
Ireland
12,129
Mexico
5,515
UK
Savings (percent) 46.2
Netherlands
27.0
4,383
Canada
26.6
Switzerland
4,253
Australia
22.5
Mexico
3,974
Italy
China
2,446
France
Germany
21.3 20.6
Japan
1,734
Germany
17.2
Singapore
1,639
Japan
12.6
Belgium
1,529
UK
10.3
India
1,474
US
0.0
Source: ProMéxico
197
| VIEW FROM THE TOP
MEXICAN DRUGS AND EUROPEAN HURDLES
Franz Schubert CEO of BIOSKINCO
198
Sergio Villa Director General of BIOSKINCO Mexico
Q: What has been BIOSKINCO’s development in other
avoid being labeled as a low-quality product from Mexico
countries such as Germany given your success in Mexico?
it is being redeveloped in Europe and we are in the process
FS: We are taking the first steps and the process of
of creating a European company. In the meantime, we are
registering a product in Europe will take at least three
working with a Spanish company that will be in charge
years. BIOSKINCO is opening an affiliate in Germany which
of the manufacturing in Europe under European GMP
will create several possibilities for developing a portfolio of
standards. We are now transferring technology from
products. The registration process of Epifast®, BIOSKINCO’s
Mexico to Europe which we are very proud of.
blockbuster product, is ongoing but it will take more time. Q: BIOSKINCO recently announced an increase in Epifast® Q: What barriers have you encountered to launch Epifast®
production by 50 percent. How are you planning to
in Europe?
achieve that from an industrial point of view?
FS: The regulation in Europe is different from that of
SV: We have already scaled up the production of
Mexico and the US. In Europe, Epifast® has to be submitted
Epifast® by 30 percent for next year. To continue scaling
as a pharmaceutical and that is why it's taking so long.
it up by 25 percent per year, we will have to invest in a
However, in Mexico, Epifast® is registered as a medical
new facility between 2017 and 2018. In Mexico, we have
device.
COFEPRIS certification that is supported by the Ministry of Health. Having the certification gives us the possibility
There is a worldwide trend in which new therapies that have
to go to other places in the world but we are required to
a sophisticated pathway and include an interaction with
show the authorities of the new region that we comply
the body can be registered as Advanced Therapy Medicinal
with the standards of each country. For instance, the
Products (ATMP). Epifast® is to be considered an ATMP in
authorities could come visit our facilities and check for
Europe because it promotes healing of the wounds by the
their standards. As for Europe we have two options,
interaction of keratinocyte cells delivering growth factors
either comply with their requirements and accept their
to the cells remaining in the patient´s wound. This product
visit or produce it in Europe under its regulation and
requires a lot of knowledge to be transferred to doctors so
best practices.
they can learn how to use it. FS: There are many pharmaceutical companies that In Mexico, the production of Epifast® could be developed
want to commercialize products in Europe. But, it
and done in a university but in Europe this is not allowed.
seems
The product has to be manufactured at Good Manufacturing
quality assurance and regulatory compliance. We are
Practice (GMP) facilities. To have it manufactured in a
expecting a new regulation stating local manufacture is a
hospital would require an average investment of €5 million
commercialization requirement. Therefore, we are planning
(US$5.4 million) plus maintenance that no hospital can
to manufacture Epifast® in Europe with GMP certification
afford. This high investment would make the unit price of
despite higher production costs. At this point, the product
Epifast® very high.
is under development in Europe including animal and
authorities
are
becoming
stricter
regarding
clinical studies. Authorities recognize that we have done a Q: What is your strategy to ensure the quality of
good job in Mexico, especially after presenting them with a
manufacturing at a greater scale to serve those markets?
retrospective study and evidence of the positive outcomes
SV: Epifast® already complies with the internationally
the product has had in over 10,000 patients. Data also
accepted standard GMP and therefore can be sold in
shows that 50 percent of the patients who received the
Europe. Nevertheless, we have to review our production
product are children and no other company is producing
conditions and comply with European GMP auditors. To
such an excellent product for them.
| VIEW FROM THE TOP
NEW ERA OF HEALTHCARE IS BORN ERNESTO GUTIÉRREZ President of World Stem Cells Clinic
Q: Stem cell treatments have the potential of treating
channeled its efforts to various orthopedic conditions that
chronic conditions, which have now become the greatest
are an everyday occurrence.
obstacle for healthcare systems around the world. How are they improving the stance of Mexico’s health?
Q: Where will we see regenerative treatments in the
A: Stem cells are able to treat and improve patients’ health
future?
but they cannot cure any type of illness. In short, they
There is still a long way to go in terms of understanding
help the body heal itself. They are the human body’s own
everything we can achieve with stem cell technology
repair mechanism regardless of the ailment. Stem cells are
and how to do it. Through its parent company DaVinci
“generic” cells that can become different tissues such as
Biosciences, World Stem Cells Clinic is developing tissues
bone, muscle or even pulmonary or cardiac tissue to name
for the pharmaceutical industry, relieving them from
a few. Clinics like ours have the capability of identifying
running preclinical studies in humans. Through our work,
these specialized cells, retrieving, storing, multiplying and
Big Pharma companies will be able to test their products
applying them where needed. Instead of allowing stem
on real cardiac tissue grown in our lab, thereby minimizing
cells to identify the issue themselves we can place them
costs and expediting results. When we finally learn how
where we need to in order to expedite the healing process.
to manipulate and influence the differentiators of each cell, as well as their specialty, we will see enormous
For the general population stem cell treatments are
leaps in health outcomes. For instance, instead of
normally thought of as either miracle solutions that can
applying synthetic components for wound closure we
cure everything or complete scams. The reality is that stem
can implement combinations of biodegradable polymers
cell therapies fall in between the two. Our therapies merely
with stem cells that can heal while sealing an injury. The
help the body heal itself through its own repair mechanism.
preclinical research work World Stem Cells Clinic is doing
Some physicians and patients still cannot grasp this
in Mexico is far ahead of our closest competitors.
therapeutic approach as it differs from the pharmaceutical approach we are all familiar with. There is no question that
Q: With a renowned position in the field, what
pharmaceuticals are of the utmost importance for society.
collaborations has World Stem Cells Clinic created in
Nonetheless, regenerative medicine through stem cell
Mexico and abroad?
treatment adds options and complements health solutions.
A: There are many international MDs that collaborate with
Stem cells have a myriad of applications contrary to drugs
us, especially in the autism field. They have sent several
that are focused on a single condition. In fact, drugs are
patients to our facility and followed up with them, which
developed and manufactured in this way to minimize the
further helps us in our data-gathering process. On the other
number of tissues they act upon and consequently the
hand, we will soon receive sport medicine doctors from
number of adverse effects they may have.
the US and Europe to facilitate an introduction of stem cell therapy to their field. This type of collaboration has
Q: What are the treatments foreign patients come to
helped us increase the number of treatment applications.
World Stem Cells Clinic for?
A big part of my job is to continue educating both patients
A: World Stem Cells Clinic has focused on an array
and doctors on the benefits of stem cell treatments. After
of applications in both its treatments and research
specialist physicians realize what stem cells can do they
activities. These include autism, cerebral palsy and
are the ones who come up with specific challenges in
neurodegenerative diseases, such as Parkinson’s, Charcot-
their fields, which could be overcome with stem cell
Marie-Tooth disease (CMT) and multiple sclerosis. We have
therapeutics and together we begin brainstorming and
also treated a vast number of autoimmune diseases like
developing new applications. Combined, a new era of
rheumatoid arthritis and lupus. World Stem Cells Clinic has
healthcare delivery is born.
199
| INSIGHT
LUNDBECK TO FIGHT DEPRESSION IN MEXICO so difficult for people to understand because they affect individual emotions and behavior,” explains Parra. In Mexico, development of proper diagnosis and advanced
ÓSCAR PARRA
knowledge on the impact of such diseases is necessary.
General Manager of Lundbeck
Mexico has a demographic bonus expected to drive economic growth and prosperity but Parra agrees on the impossibility to grasp this opportunity without a healthy
200
There are few companies in the world dedicated to bringing
population.
Untreated
depression
severely
impacts
innovation to central nervous system (CNS) diseases, which
individual productivity and can reduce thousands of
are often neglected due to societal stigma. CNS disorders
productive hours due to absenteeism, as diabetes already
are debilitating to the extent that patients end up unable
does. Lundbeck is engaged in this kind of constructive
to take care of themselves at all, impacting the lives of
discussion with the authorities and is committed to
relatives. Despite being well known, depression is still an
providing continuous medical education for physicians in
underdiagnosed disease and recent findings indicate that
direct contact with patients. Digital tools available online
it will be among the most debilitating diseases in the world
are also offered to create awareness about this issue.
in the next decade, even more so than diabetes and with a detrimental effect on quality of life and productivity.
At this point, Lundbeck is focused on prescription
Lundbeck is committed to providing solutions to 60 million
medicines in the private market. “Of course the public
people worldwide suffering from depression, Parkinson’s
sector is relevant to us and currently there are a great
disease, Alzheimer’s, sleep disorders and schizophrenia
deal of discussions regarding market access,” says Parra.
through cutting-edge research and new products. This will
When a medicine is approved by COFEPRIS it is ready to
improve the lives of many people who would otherwise
be commercialized in the private market but it still has a
lose years if not decades of good quality of life.
long way to go in the public sector. This does not mean the company discards entering this segment. The private
Mexico is one of the top regions for the company and
sector has its own hurdles. Most psychiatric disorders are
often provides invaluable input for its global strategy.
not reimbursed by private insurances and as explained
For instance, Mexico was involved in a project related
by Parra, depression is one of the diseases that will most
to the development of an anti-depressant two years
impact productivity in the private sector.
before it was launched on a global scale. Lundbeck is not exempt from the wave of patent expirations taking
With Mexico’s progress in the clinical research field,
place in the pharmaceutical industry and its strategy to
Lundbeck has conducted several clinical trials in both
mitigate this is through a stronger focus on innovation.
private and public research centers. For innovative
In the next couple of years it will launch a new drug
companies the southern area of Mexico City is highly
for sleep disorders followed by an anti-psychotic. “I
attractive due to the extraordinary density of highly
am confident that we have many interesting growth
specialized physicians and healthcare companies. “As for
opportunities in the future,” says Óscar Parra, General
the role clinical trials play in improving new drug approval
Manager of Lundbeck Mexico. The central nervous
processes and inclusion to basic formularies, conducting
system segment is flooded with generics – just one of
a clinical trial in public institutions does not provide
Lundbeck’s molecules competes against 20 generics.
any benefit for admittance of new drugs into basic
Therefore, Parra continues working with a business
formularies,” Parra says. Clinical trials and drug inclusion
model that includes visits to physicians and information
are two very different processes but could greatly improve
exchanges. In the last five years, the acceptance of
if they were connected. Moreover, Lundbeck might
generics has grown significantly among the population,
benefit in the future from COFEPRIS’ recognition by other
leading
regulatory agencies in Latin America where Lundbeck has
multinational
companies
to
maintain
their
competitive position through innovation.
a direct and indirect presence. “I think there are two ways to look at things," Parra says. "Compared to the past,
People with mental disorders are still stigmatized in
things could look rather difficult now but examining the
Mexico, which is a harsh reality to accept. “We are used
situation of other countries Mexico has fewer challenges
to seeing people in leg casts but mental disorders are
in comparison and has copious business opportunities.”
| VIEW FROM THE TOP
THE RISE OF BIOLOGICS
Mauricio Vidales Country Director of Croda
Christian Escandón Commercial Manager of Life Sciences at Croda
Q: Why did you feel that Mexico was a good place to
Q: What niches do you operate in?
establish a subsidiary?
CE: In oncology we have a wide range of ingredients
MV: We have been in Mexico for over 40 years. Although
suitable for use in parenteral applications. Consumers
the company began in the personal care market, we have
expect high-quality transparent liquids without any
seen great growth in the pharmaceutical industry in the
particles or sediments. If a patient sees a strange particle
last decade. I think Mexican customers really value the
in a product particularly in a liquid or an injectable liquid,
ingredients and expertise we can offer to help them get
they will rightly not trust the medicine. We also have a
the best performance from their active ingredients.
wide range of ingredients for topical application and expertise in the area of oral liquids.
Q: What is the market outlook for the world of pharmaceuticals?
Q: How do you see your position in Mexico over the next
MV: The pharma market is changing. In fact, it has already
several years?
changed with biopharmaceuticals playing an increasingly
CE: The Latin American management of Croda is indeed
important role. In 2004, just one of the leading global
looking at Mexico as a growth hub. Considering that our
drugs was a so-called big molecule or biologic, with nine
specialties are applicable in a few niche specialties we have
others being developed through more traditional means.
very aggressive growth targets in those segments. This
Ten years later, seven of the top 10 new drugs approved
growth does not exactly match the growth of the market
in 2014 were biologics. This increased development of
as the market will grow mostly in solids. Over the next few
biologics is shifting R&D development toward injectables,
years we will be looking into biosimilars, a growing niche
not just needles but increased sophistication led by
believed to be the future of the pharmaceutical industry. We
devices such as pens and autoinjectors. Croda’s wide
also produce high-purity Omega 3 fish oil concentrates that
range of Super Refined ingredients, and especially our
provide clinically supported health benefits for nutritional
high-purity Polysorate range are well suited to meet the
and pharmaceutical use. Our Incromega™ and OmeRx™ fish
needs in this area.
oil concentrates are produced using proprietary PureMax™ technology.
Q: What can you tell us about your Super Refined™ range of ingredients and how they help overcome industry
MV: We have a skincare lab in Mexico and have been
challenges?
looking into claim substantiation, which is related to
MV: One of the main challenges faced by pharmaceutical
the technical aspect of hair care or skin rejuvenation.
formulators
drug
We pride ourselves on our technical expertise and have
formulations. Many active pharmaceutical ingredients
invested several million dollars in our Mexican offices and
(APIs) can respond unstably to oxidation, moisture or pH,
laboratories as part of our continued investment.
is
the
ability
to
produce
stable
affecting the both the stability of the drug and the final formulation.
Q: Based on your experience so far, do you foresee further investment in Mexico?
To create products with both superior quality and purity,
MV: Yes we are certainly hopeful to grow our footprint.
Croda developed a proprietary flash chromatographic
Croda Mexico is composed of three major divisions: Life
process called Super Refining. This process physically
Sciences, which oversees both crop care and pharma,
removes impurities from pharmaceutical excipients without
Personal
altering their fundamental structure. The removal of these
Industrial Chemicals (PTIC), which focuses on market
polar impurities helps reduce API interaction, maintaining
segments such as Home Care, GeoTech (Petroleum &
both the stability of the drug and the final formulation.
Gas), Mining and Polymer Additives.
Care,
and
Performance
Technologies
and
201
| VIEW FROM THE TOP
TIJUANA A CRITICAL HUB FOR US HOSPITALS MARIO CERVANTES VP of Manufacturing of CareFusion/Becton Dickinson
202
Q: How do CareFusion products contribute to improving
A: We are a global company and we need to comply
the service at Mexican hospitals?
with many regulations. We live in an extremely regulated
A: BD offers a wide array of products to hospitals
environment. We need to comply with the FDA, European
around the world. In particular, in Tijuana, CareFusion
regulation, ISO and COFEPRIS for products sold in
manufactures IV sets and related products used to
Mexico. Over the past few years we have witnessed the
deliver fluids and medication to patients. We produce
homogenization of regulations. COFEPRIS regulations are
over 1 million IV sets per day. That makes us one of the
similar to those required for pharma but not so much for
largest manufacturers of this type of product in the world.
medical device manufacturing. This is an area in which as
We supply IV sets to Mexico as part of a bundle of BD
a country we could improve by segregating COFEPRIS
products, including syringes, needles, diabetes care and
regulations so they could have two branches, one focused
medication management solutions.
on pharma and another branch dedicated to regulate and control medical device manufacturing.
Q: What is your best-selling product in the Mexican market?
Q: What percentage of the market in Mexico do you
A: That would be the Alaris pump, the pump that is
occupy?
compatible with the IV sets we manufacture at this site.
A: Mexico and Latin America are vital for the development
It is widely used in hospitals because of its precision in
of BD. We have grown dramatically in Mexico, the secret
dispensing doses through computerized control. The
to which is our Mexican associates. We have the best
pumps can interact with computers in the hospital to
personnel to work with. Our direct labor is dedicated,
insure the correct fluids and drugs are being dispensed
of high quality and with a consciousness for quality
to the patient. One of the main issues hospitals face is the
like nowhere else in the world. Our professional base
dispensing of incorrect medication formulas and doses.
is comprised of engineers, administrators and finance
Our infusion systems devices work both independently
specialists.
and together to accurately deliver infusions while helping protect each patient.
Everyone is highly specialized and qualified in what they do. Previously, I tried to set up manufacturing sites
Q: What recent innovative products have you brought to
in Eastern Europe, North Africa and Asia but we were
Mexico?
limited by the number of professionals available. In Baja
A: A key element of our product is the type of connector
California, we are blessed with a large cluster of medical
valve we use. It allows physicians to access the IV set
device manufacturers that employ between 40,000-
without using needles. Connector valves can be classified
45,000 people. This is a large pool of professionals
as positive displacement no displacement or negative
already
displacement according to doctorsâ&#x20AC;&#x2122; needs. The importance
validation and new production introductions. Anyone can
of this product lies in the elimination of needles as they
buy machines and buildings but Mexican associates are
need to be disposed of afterward, which creates a health
an insurance for success.
knowledgeable
about
sterilization,
product
hazard for nurses. Patients are mostly medicated alongside the IV sets and the drugs sometimes attack the resin the IV
Q: How are universities and companies working together
sets are made of. The valves are designed to withstand even
to ensure human talent is optimal and willing to stay in
the most aggressive chemicals in chemotherapy sessions.
Mexico? A: There are almost 35 public and private universities in
Q: What are the main regulatory challenges in Mexico for
the area. We have close relationships and agreements with
pharma companies?
them to prepare professionals with the necessary skills.
We have 25-26 paid interns working for us as part of
as 90 percent to 95 percent of patients admitted to
the agreement. This allows them not only to complete
hospital will receive some type of intravenous therapy.
the number of work experience hours needed for their
We also sell our products in Australia, New Zealand
degree but also to learn something valuable. We forbid
and Europe. BD believes in manufacturing close to
interns from performing clerical jobs as that is not
the market, so products destined for the Asian and
what they are here for. They come to complement their
Eastern European markets are manufactured near to
education and we want to make sure they get valuable
those regions. We expect to see both organic and non-
experience during their time with us. Quite often, these
organic growth. Organic growth has been at 7-8 percent
interns return to work with us as engineers. We recently
year on year in which acquisitions have also played a
hired a young lady who completed her internship with us
significant role. BD recently acquired CareFusion but
and then graduated at the top of her engineering class.
even before, CareFusion was acquiring other companies such as Medegen Inc. and others. Combined organic
We also invest heavily in our employees on technical
and inorganic growth would be around 12 percent for
aspects such as process validation abilities, but also
Tijuana.
on the soft skills a well-rounded professional always needs. We have many seminars and training sessions on
Q: What are the most relevant projects you are working on?
supervisory skills, emotional intelligence, how to deal
A: We continue to grow tremendously. We are investing
with difficult people, among others. These well-balanced
heavily on automation, injection molding machines,
professionals eventually will be managers; people skills
molds and extrusion.
make them promotable. We believe in promoting from within and in developing talent.
Q: What percentage of production remains in Mexico and what percentage is exported?
We have a very good program to help our employees
A: 100 percent of production goes to the US and 85
through high school and through professional education.
percent is consumed within the US. The remaining 15
We have 16 employees in elementary school, almost 30
percent goes to Australia, New Zealand, Italy, England,
in secondary school, 10 are completing a bachelorâ&#x20AC;&#x2122;s
France, Latin America and Spain.
degree and five or six are working on a masterâ&#x20AC;&#x2122;s degree. Every year we hold a party for those that graduate. We
Q: What can we expect to see from CareFusion over the
also have other kinds of classes for our employees, such
next year?
as salsa dancing or health cooking, singing and guitar
A: You will see products that continue to improve lives,
lessons. We offer about 10 different programs, English
they will be easier to use by nurses and doctors, safer
lessons included.
for patients and more resistant to the new drugs being administered to patients in chemo sessions. There will
The country in general, and Baja California in particular,
also be much advancement in the software that comes
needs to continue to invest in talent development. We
with our pumps and how they interact with computers
seem to be growing faster in the industry than the
in hospitals to track drug use and ensure the medication
talent pool is, so although we invest in developing
is correct. It would for example prevent an infant from
our associates we also need the participation of the
being supplied with an adult dose.
government. The three government levels must make it easier for the young population to enroll in schools and to obtain scholarships to be successful professionals. We also need to promote technical education for those that decide not to pursue a professional degree. Q: What growth has CareFusion seen in recent years and what growth do you expect to see? Is this expected to be via acquisitions or via organic growth? A: CareFusion is now part of BD and our site in Tijuana has grown from 2,000 employees six years ago to 5,800 employees today. This shows dramatic head count growth and we have seen it also in terms of exports from Mexico. Right now products from Tijuana are valued at close to US$900 million in global sales. This site is critical for hospital operation in the US and Latin America
The medical devices industry in Baja California employs
40,000-45,000 people
203
| INNOVATIVE DRUG SPOTLIGHT BRINTELLIX (VORTIOXETINE) FROM LUNDBECK
sexual dysfunction, cognitive function, comorbid anxiety
Lundbeck has developed Brintellix® (vortioxetine). It is one
and insomnia. Brintellix® is an effective and well tolerated
of very few novel antidepressants approved in past years
antidepressant in short-term as well as long-term treatment
for treatment of adult patients with major depressive
clinical trials, with a low level of discontinuation symptoms.
disorder (MDD). MDD is related to significant cognitive
Brintellix® was approved by the FDA in September 2013
deficits such as psychomotor speed, attention, visual
and the European Medicine Agency (EMA) in October
learning and memory, involving all aspects of executive
2013 for the treatment of MDD. It was approved for the
functioning, and this is a milestone for Brintellix®.
same indication by COFEPRIS in July 2014.
Vortioxetine is the result of an approach based on a thorough understanding of the disease and its consequences over the quality of life of patients with MDD. Brintellix® is a multimodal antidepressant with two modes of action, receptor modulation and reu-ptake inhibition, which moderate several key neurotransmitter systems known to be involved in mood 204
disorders and their related cognitive deficits. Brintellix is part of a new therapeutic class of antidepressants, which is different to previous families of the established classes of SSRI’s, SNRI’s, tricyclic antidepressants and monoamine oxidase inhibitors. Its unique mode of action is thought to result in the effects observed in clinical studies, both in terms of efficacy and the benign safety/tolerability profile – such as mood,
Chemical structure of vortioxetine hydrobromide
| VIEW FROM THE TOP
TRAINING PROFESSIONALS FOR THE BIOPHARMACEUTICAL INDUSTRY OCTAVIO TONATIUH Director of UNAM’s Instituto de Biotecnología (IBt)
Q: What efforts has the institute made to push for more
at IBt, national regulatory authorities and industrial
and better trained local professionals covering a growing
partners. Thus, LAMMB supports industry throughout
market demand for biotech services?
various critical areas during biopharmaceutical product
A: The Institute has focused on four main strategies for
development and also supports government agencies with
promoting biotechnology. First, we held two open house
detailed independent characterization reports that sustain
events, during which visitors of all ages visit our Institute
quality, safety and efficacy claims required during product
to learn about biotechnology and our day to day work.
registration. The fourth strategy has been the publication
More than 100 different activities are designed by our
of a new magazine called “Biotecnología en Movimiento”
community including guided visits, seminars for amateurs,
or Biotechnology in Movement. The purpose of this
photographic exhibitions, hands-on demonstrations and
magazine is to describe in simple and friendly language
other activities. In 2016 584 members participated and
the on-going research at our institute as well as publishing
2,400 people attended, doubling the number of people
select information on relevant and new developments in
that attended in 2014. Most were undergraduate students,
all areas of biotechnology.
many of which applied for admission to our graduate program. This effort is complemented by visits from
Q: Which types of research are Big Pharma companies
different universities and elementary schools throughout
looking for the most and what are the main reasons
the school year.
behind this? A: At this point the industry is looking for expert advice and
Our second strategy focuses on the productive sector. We
highly specialized knowledge on product characterization
host seminars, ad hoc courses and private visits for the
during clinical and preclinical phases, process transfer and
industry, government and NGOs. In the last five years the
scale up. Mexican biotechnology still needs to advance
Institute has signed agreements with 40 different entities.
toward the development of new products and at this point
We aim to create bonds between the industry and our
the route to get products developed by Mexican academia
students many of which already work at key positions in
to the market is being paved.
non-academic institutions. Q:
What
companies
has
IBt
helped
to
develop
The third strategy has been the establishment of specialized
biotechnology practices and what makes the UNAM the
infrastructure to support not only academic activities but
best partner of choice for these types of activities?
also governmental and industrial needs. Central to this
A: IBt has worked with over 50 institutions. We have
effort has been the launch of the National Laboratory for
worked with companies in Mexico, Brazil, the US and
Production and Analysis of Biopharmaceuticals (LAMMB).
Australia, helping them in a variety of matters. New
This laboratory has state-of-the-art infrastructure and
drug development, product characterization, process
highly experienced and qualified scientists and technicians
scale-up, preclinical and clinical testing are all within the
in all areas related to the production and analysis of
expertise of the institute. With 100 researchers, many
recombinant proteins employed as active ingredients in
of whom are world leaders in their fields, the Institute
vaccines and therapeutics.
of Biotechnology is a unique place that conjoins a very strong basic science group with an equally strong
These areas include gene synthesis and transformation into
technology development and applied science group.
suitable cell hosts, cell culture or fermentation, downstream
Moreover, the IBt has been collaborating with the
processing and formulation and a thorough analytical
industry since its foundation. The Institute has a deep
characterization of the particular recombinant product.
understanding of the needs of the industry that has been
LAMMB acts as a link between basic research performed
acquired throughout the years.
205
| VIEW FROM THE TOP
BRINGING BEST PRACTICES TO MEXICO THOMAS CANTOR Founder and President of Scantibodies
Q: Who are Scantibodies’ main competitors?
lowered the price to only US$950 for the PET scan, which
A: The main competitor for the diagnostic kit manufacturing
is very reasonable.
is in-house producers. We want to extract that production
206
out of their company and do it ourselves. We have to show
Q: Which partnerships do you have with the medical
management the advantages of outsourcing with us. The
diagnostic community?
core of our imaging therapy is the PET scan and we don’t
A: After two years in Baja California, we have created three
really have much competition because we are the only
main partnerships. Our first is with insurance companies
supplier north of Monterrey.
all over Mexico, cancer clinics and hospitals because they need to get PET scans to monitor their patients, and the
Q: What services and products do medical tourists and
third is with private medicine in which our sales people
domestic patients most often require?
visit oncologists and doctors to show them the new
A: I got cancer in 2010 and used my personal experiences
technology in town.
to help learn about other people. After the initial shock, the patient asks what can they do to take care of themselves
Q: Is there a single breakthrough to be proud of in
and how do they monitor their progress after the cancer. I
diagnostic medicine by Scantibodies?
have witnessed that some doctors and hospitals, especially
A: In-vitro diagnostics, like blood testing, is something
in the US, follow the same guidelines for treating patients
the company has been doing successfully for decades
that are not necessarily catered to or are the best options
but nowadays people are more concerned with heart and
for that specific patient. Therefore, I have created here
cancer diagnostics. There are certain limitations for heart
a type of sanctuary where a patient can consult with a
diagnostics because the enzyme markers only tell you if
doctor for an hour and receive their options for treatment.
you have had a heart attack or damage to the heart, but there are not markers for your risks. Another breakthrough
Most of the services that medical tourists and domestic
that we are proud of is the profusion study with the MRI.
patients require are for cancer, diabetes or other diseases
For example, instead of getting a biopsy of a lump in a
like Lyme disease. The services they receive here center
woman’s breast, which could risk spreading the cancer
on the advantages of IV high vitamin-C doses and ozone
with the needle, the profusion study in the MRI shows us
therapy, which has been around for a long time and offers
in the video if the blood supply to the lump is set up for
many curative benefits.
cancer or not.
Part of our therapy is also J-27 juice. Years ago, I learned
Q: Scantibodies has no investors. How does this affect
about Dr. Max Gerson from Germany, who created the
your operations and how do you finance your business?
Gerson Therapy Juice that cured patients with tuberculosis
A: God has taken care of the financing of the business. For
and cancer. We then improved this juice recipe by fixing the
25 years I was in charge of my business and let God come in
microbe problem to make it more stable and we tested it to
and out of helping. After a lawsuit, I agreed that God was in
find that it shrank cancerous tumors in lab mice. We are not
complete charge of the business. I consciously asked God
quite sure how it works but it is a staple in our therapies.
to take the site in Tecate and make it His own and I believe He has kept us out of debt and without investors. This is
Imaging like CT, PET and MRI scans are also very important
a great advantage to us because investors want to make
in our treatment. Usually, a patient will be scanned at a
the decisions for the company and are just concerned with
high expense in the beginning and end of their treatment,
money, which is not our goal. So I feel blessed because I
but here we scan the patient throughout their therapy
have a purpose to be in this business, which is the business
to monitor its effectiveness. Because of this, we have
of helping patients.
| VIEW FROM THE TOP
THE RISING IMPORTANCE OF MEXICAN BIOTECH EDNA ÁLVAREZ Latin America Manager of Malvern Instruments
Q: How do Malvern’s activities solve predicaments for
Key
their clients?
absorption rates and content uniformity can all be
The past decade has seen biopharmaceuticals become the
affected by the particle size distribution of various
fastest growing class of therapeutic agent with increasing
components of a drug product. For example, reducing
numbers of novel molecules entering development every
particle
year. Underlying this is a fundamental shift in pharmaceutical
formulation of New Chemical Entities (NCEs) with poor
industry investment and emphasis. The challenges of
water solubility; thus getting a drug into pre-clinical or
moving from the development of small molecule drugs
clinical
to dealing with more complex biological materials are
attributes of pharmaceutical products in conjunction with
considerable and wide ranging. Malvern’s Bioscience
their chemical structure is also of great value.
performance
size
parameters
can
trials
speed
quicker.
up
such
as
dissolution,
pre-formulation
Understanding
and
morphological
Development Initiative (BDI) is an independent, agile and entrepreneurial organization. It partners with industry and
The morphology of drug particles, granules, topical
academia to rapidly identify and assess analytical problems
and
and bottlenecks within biopharmaceutical development
formulations provides information about bioavailability
and manufacture, and to prototype, develop and deliver
(BA) or bioequivalence (BE). Measurement of particle
solutions. Even though the company has presence in a wide
size and shape of the correct particle must be achieved
range of industries and countries the market determines
and techniques such as Raman spectroscopy, in tandem
Malvern Instruments’ approach and specialization. Latin
with image analysis, can provide an accurate, objective
America has just begun to demand life science applications,
and automated means to do this. Malvern Instruments
in line with the US and Europe. In return, we expect far more
has specialized technical personnel who are in regular
specialization in LATAM over the next three years.
dialogue with government agencies, such as COFEPRIS
Orally
Inhaled
Nasal
Drug
Products
(OINDP)
or the FDA in the US. This allows us to showcase new Q: How have the Malvern Bioscience Initiative’s (BDI)
technologies and explain best practices for the use of
efforts supported its parent company?
specific technologies and advise on data interpretation.
Malvern’s Bioscience Development Initiative (BDI) is an independent, agile and entrepreneurial organization. It
Q: How important is the Mexican market for Malvern’s
partners with industry and academia to rapidly identify
global strategy?
and assess analytical problems and bottlenecks within
In a move that reflects continued sales growth in Mexico,
biopharmaceutical development and manufacture, and
Malvern Instruments has opened a new office in Mexico
to prototype, develop and deliver solutions. The initiative
City. Operational since August 2013, the Mexico office
was established in 2012 to meet the evolving needs of a
provides both pre and after sales support to a growing
sector that is undergoing rapid change.
customer base. It is also the venue for an increasing number of advanced training courses and seminars and
Q: How does Malvern Instruments contribute to the
is part of Malvern’s operational expansion in Mexico and
Mexican pharmaceutical industry?
throughout Latin America. The opening of the office in
The particle size distribution of active ingredients,
Mexico comes just a year after the establishment of a
excipients,
important
sales and applications laboratory in Sao Paulo, Brazil.
physical characteristic of the materials used to create
Our investment continues with the launch of a Spanish
pharmaceutical products that have the right Quality
website earlier this year. There is great demand for our
Target Product Profile. It can affect product performance,
products and services within Mexico and strong customer
manufacturing scale up, processability and stability of the
relationships and exceptional service are the cornerstone
final drug formulation.
of Malvern’s business.
granules
and
droplets
is
an
207
| VIEW FROM THE TOP
DEVELOPING PROGRAMS TO COUNTERACT INFERTILITY JOSÉ ISLAS Director General of IVINSEMER
208
Q: One of IVINSEMER’s goals for 2016 was to increase
are the first company in Mexico to have brought life from
infertility awareness in Mexico. How has the company
a frozen ovule which was from a cancer patient. Through
moved forward in this regard and what communication
the Preserva program we bring awareness to woman that
mechanisms has it implemented?
will undergo oncology treatment that our treatment will
A: IVINSEMER has worked strongly on technological
eventually allow them to become mothers.
advancements as becoming pioneers in the reproduction field is contingent on our investments. This led us to an
Q: What is the strategy behind the Compromiso
alliance with the Valencian Institute of Infertility (IVI), a
IVINSEMER initiative?
global solution leader. Our merger has put IVINSEMER
A: IVINSEMER has developed an accumulated pregnancy
at the forefront in both technology and human capital
statistic throughout the years. As such, we know that
considering IVI’s Valencian foundation systemically works
couples that were successful in the treatment have a 90
in the creation of new fertility treatments. By joining their
percent probability of having a healthy baby. Compromiso
platform our services have improved while gaining an
IVINSEMER is divided into three sessions where we analyze
additional capital flow.
different parameters and adapt our treatments. If couples do not reach their goals after following IVINSEMER’s
Last year, IVINSEMER was comprised of six clinics. We now
medical orders the company partially reimburses them.
have a network of 12 with superior services. Some of them are equipped with an assisted reproduction laboratory as
Q: What is the price range of your services?
is the case in Mexicali, Guadalajara and Colonia Anzures
A: High complexity treatments go for US$9,000 including
in Mexico City. Franchising our brand has resulted in
drugs, doctor fees, diagnostics and blood tests. In the event
significant expansions in collaboration with MDs that have
of insufficient capital, we structure down payments and
received IVINSEMER’s training. Future expansions include
financial solutions. Unfortunately, public health institutions
Tuxtla Gutierrez, San Luis Potosi and Oaxaca.
servicing infertility are oversaturated as the government’s agenda is not focused on the problem. Besides their lack
Q: What new treatments from IVI’s technological platform
of service availability, their infrastructure and technology
have been implemented in Mexico, and how have they
is sub-par. Infertility remains a non-addressed public
been accepted in the local market?
health issue in Mexico, giving way to private clinics like
A: Preimplantation genetic diagnosis has had positive
IVINSEMER.
results in the market. It allows MDs to diagnose a wide range of diseases before transferring embryos to the
Q:
womb, improving its success rates by approximately 25
considerably more affordable than in other countries, will
Considering
fertility
treatments
in
Mexico
are
percent. In the past, we operated with a 50-55 percent
this service increase the medical tourism influx?
success rate. This technology has minimized disease
A: Fertility services are attracting patients from all over the
transfer from parent to child, such as hemophilia, anemia
world, which we are mostly benefiting from in our Mexicali
and cystic fibrosis to name a few.
facility. We are negotiating with medical facilitators in Phoenix and San Diego to further strengthen our clinic’s
We will soon see the entrance of the EmbryoScope
reputation. As members of the Latin American Network
solution to Mexico. It will allow us to record embryo
of Assisted Reproduction (REDLARA), IVINSEMER has
division in real time. The incubator stores and captures
proven its worth and quality. Mexico is lacking certificating
their evolution taking pictures every 30 seconds and
institutions, which has led to small companies with poor
facilitating our selection process. This technology is new in
procedures that negatively impact the industry by offering
Mexico and IVINSEMER will pioneer its establishment. We
deficient services.
| VIEW FROM THE TOP
REGENERATIVE MEDICINE: REJUVENATION AND DISEASE CURE JOEL OSORIO Director General of RegenerAge
Q: What led to the creation of RegenerAge, and what
with patients suffering from ALS, diabetes, hypertension,
main health problems can you prevent?
rheumatoid arthritis, sclerosis, scleroderma and lupus. Not
A: Smart prevention is the best treatment for any disease.
only can we treat different illnesses but we can also treat
Once an illness is part of a person’s life, human regeneration
patients at a variety of different stages.
is a great option for health to restructure damaged tissues and cells. Biotechnology advances provide a chance
Q: How can you expand your business to the more
to improve outcomes when a patient needs diverse
preventive end of the spectrum for patients who are not
medical treatments. Using a unique biopharmaceutical
yet sick or are only just beginning to show symptoms?
product, Bioquantine (BQ-A®), in combination with stem
A: The more a patient’s health deteriorates the costlier
cells we are able to offer an option for those who would
treatment will be. There are three ways we can convince
like their own bodies to activate the healing process
otherwise healthy patients to seek preventive treatment,
or keep themselves as healthy as they can for as long
the first of which is functional nutrition. Secondly, there is
as possible. We have created a system of different
bioidentical hormone replacement treatment for women
treatments including functional and regenerative based
and men over 45 and by maintaining a healthy hormone
diets, Bioidentical Hormone Replacement Treatments,
level in one’s body a patient can stay young for as long
skin regeneration and aesthetics. From this point, we
as possible. Finally, we offer aesthetic medicine derived
can guide the patient into adopting a functional style of
from PRP, which can revitalize and regenerate skin all over
nutrition because regeneration is borne from a specific
the body. This includes treatment of cellulite and adipose
diet plus bioidentical hormone replacement treatment,
deposits as well as skin tightening.
which is the proper use of Human Growth Hormone. Prior to a patient’s regenerative medical performance I have
Q: Given the fact that regenerative treatment is a new
to order different lab tests to decide which patients are
technology, how are you working to make its incorporation
candidates for each treatment. Platelets Rich Plasma
into healthcare plans possible?
(PRP) is one option - from the skin surface to knees joints.
A: Approved stem cell treatments have been on the
Another is a stem cell booster or stromal cells, made of
market for at least seven years. The use of human
the live cells from human placenta. This one has to be
placenta to boost stem cells is also an old technique that
implanted within the subcutaneous tissue of the patient’s
was discovered about 75 years ago in Russia. In terms
body. The company’s recent human regeneration project
of mesenchymal stem cells (MSC) treatments, the new
has attracted worldwide media attention after announcing
feature we are adding in our system is BQ-A. Our extract
BQ-A extract is going to be used to treat deep coma or
itself has been researched for around 30 years and is
brain dead patients. BQ-A contains 93 polypeptides,
derived from an amphibian that is able to regenerate itself.
proteins that work on the development and repairing of
It is only now that research has become state of the art,
human DNA.
which is why we have recently targeted it.
Q: What have been some of the results you have seen and
Q: What are your priorities for 2016-2017?
what cases demonstrate your success?
A: We will start working in different locations in Mexico,
A: I was treating a patient suffering from stage 4 pancreatic
and are in talks with private hospitals that are extremely
cancer, which is one of the most aggressive cancers one
interested in the project. This could be implemented
can contract. After treatment over a few months of using
in Puerto Vallarta, Ciudad Juarez, Cancun, Mexico City,
BQ-A, the patient’s lifespan was increased by one year.
Puebla and Cuernavaca. We need to initiate protocols and
When I first started treating the patient her prognosis
the first step will be the ReAnima project, which deals with
was three to four weeks. I have had positive outcomes
neurological regeneration.
209
10
AESTHETIC MEDICINE & SKINCARE
The global dermatology market was valued at US$20 billion in 2015, according to PRnewswire, and is projected to grow. Investment in new products and strategies continues. The sector accounts for 6 percent of the pharma market, say industry experts who expect the dermatology market to grow 3-4 percent this year and next. Worldwide, the aesthetics and cosmetic segment is enjoying growth, with Mexico in fifth place for the number of surgical and nonsurgical procedures performed annually. To stay ahead of the crowd, companies are investing in newer and more innovative technology.
Demand for natural or vegan products and ingredients is an emerging opportunity and an increasing number of companies in Mexico are choosing to specialize in this niche. Although regulations already are tight in certain areas of natural and vegan products, some foresee stricter controls to come with the change in COFEPRIS leadership. This chapter will present insights from the Mexican aesthetic medicine and skincare industries and will look at expected challenges in addition to growth expectations.
211
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| CHAPTER 10: AESTHETIC MEDICINE & SKINCARE 214
ANALYSIS: Growing Opportunities in Aesthetic Care
216
VIEW FROM THE TOP: Carlos Berzunza, CANIPEC
218
VIEW FROM THE TOP: Ricardo Spinola, Farmapiel
219
VIEW FROM THE TOP: Geraldine Waked, Sesderma
220
VIEW FROM THE TOP: Carlos de Kruyff, CDM Labs
221
VIEW FROM THE TOP: Corrado De Gennaro, Galderma
222
VIEW FROM THE TOP: Alejandro Grisi, Grisi
223
VIEW FROM THE TOP: Alejandro López, IM Natural
224
VIEW FROM THE TOP: Ariel Díaz, Kaloni Holding Group
225
VIEW FROM THE TOP: Víctor Anaya, Merz Pharma
226
ANALYSIS: High Growth Potential for Aesthetic Surgery
227
VIEW FROM THE TOP: Fernando García, Tijuana Bariatrics
213
| ANALYSIS
GROWING OPPORTUNITIES IN AESTHETIC CARE In 2015, Mexico occupied fifth place globally in the
at US$1.3 billion, says CANIPEC. Considering market
total number of cosmetic procedures, stacking up an
fluctuations and the depreciation of the peso against
impressive 907,913 elective surgeries, according to the
the dollar, this shows a strong industry poised to grow.
International Society of Aesthetic Plastic Surgery. The
Carlos Berzunza, Director General for CANIPEC, says
country fell behind the US, Brazil, South Korea and India.
that on average the sector grows 4-5 percent annually and this year will be no exception.
With an obesity problem plaguing Mexican society as well as the transformation of the country into a medical
In the past decade the country has attracted US$300
tourism hub for bariatric surgery, there is no doubt
million in foreign direct investment annually, thereby
Mexico’s aesthetic industry is thriving. According to
creating an industry that provides more than 200,000
Fernando García, Director of Tijuana Bariatrics, 98
direct and indirect jobs, he adds.
percent of his patients are international and only 2 Berzunza says 96 percent of Mexican personal care
percent are domestic.
products exported stay in the continent, with over half 214
Data from the National Chamber for the Cosmetic
going to the US. This creates a multifaceted market
Products Industry (CANIPEC) states that personal care
with a large catalogue ready to cater to international
products represent 1.2 percent of Mexico’s GDP, which
markets.
makes it the second largest beauty market in Latin The industry’s exports are driven by numerous treaties
America after Brazil.
the country already has including the Pacific Alliance, In an official statement, Expo Feria de la Belleza y el
its negotiations for the Trans-Pacific Partnership (TPP)
Estilismo or Expo EBIO 2016, one of the industry’s
and the Panama Free Trade Agreement. CANIPEC
leading events, states that only 20 percent of Mexican
is also negotiating tariff reductions and commercial
households own at least one personal care product and
facilitation for beauty products through the Economic
that 70 percent of all merchandise available is directed
Complementation Agreement with Brazil, says Berzunza.
to females. This leaves significant room to grow the Mexican beauty industry from a mere US$10.5 billion in
Skincare is also an important issue that is being targeted
2015 to USUS$14 billion in 2020, according to Mordor
by the market. Corrado de Gennaro, General Manager
Intelligence.
Mexico & Central America for Nestlé’s Galderma, says 70 percent of the Mexican population is afflicted by
Last year beauty exports surpassed US$2.5 billion
some variety of skin disease, which would explain the
while imports amounted to a little more than half that
company’s emphasis on R&D and the registration of 55 new patents since 2014. According
to
Euromonitor,
dermatologicals
are
anticipated to increase by a value compound annual growth rate (CAGR) of 3 percent at constant 2015 prices, to reach MX$6.6 billion (US$358.1 million) by 2020. According to Carlos Kruyff, Partner and Managing Director at CDM Labs, this growth includes dermocosmetic and skin disease medicines and it still barely covers inflation. Kruyff says, though, that in the past dermatologists sneered at the aesthetic and corrective industry but the tide has changed as proven
Mexico ranks fifth globally for aesthetic procedures, with over 4 percent of the
world’s total
by growth percentages. Farmapiel plans to launch 13 new products this year, adding to the 18 launched in 2014, says Ricardo Spinola, CEO of the company. “Beauty is becoming a relevant topic and today we see people in their 60's and 70's looking like 50-year-olds.”
MEXICO PERSONAL CARE TRADE BALANCE (US$ millions) MEXICO PERSONAL CARE TRADE BALANCE (US$ millions) 2,500
2,230
2,000
2,191
1,776
1,089
1,164
1,500
1,341
978
915
781
562
1,000 500
2,106
1,894
996
780
0
2010
Imports Imports
1,065
979
2011 Surplus Surplus
2012 Exports
1,102
2013
1,128
2014
2015
Exports
Source:CANIPEC Source:CANIPEC
He emphasizes though that chemotherapy patients are
provided by the company lasts 14 months they welcome
also pushing the market, looking for products to counter
their clients for lifelong follow-ups.
the effects the treatment has on their skin. Diabetes, one of the leading conditions in Mexico, is also a driver for
Euromonitor states that in 2015 Procter & Gamble
skincare.
Mexico continued to lead hair care, accounting for a 21 percent value share. The company owns several brands
To ensure success, Sesderma focuses its sales strategy
including Head & Shoulders and Pantene, which are in
on medical practitioners as they represent 80 percent
the top five hair care brands in the country.
of their revenues. The company has only added 20 sales points for over the counter (OTC) products, which
CDM Labs is investing most of their capital in capillary
strategically cater to the practitioners' preferences.
care and hair products, pigmentation skincare and
“Sesderma had to lower pharmaceutical points that
skin blockers hoping to grow domestically and put off
were no longer profitable such as Sanborns, which
exports, says Kruyff.
was dropped from 40 to 20, and San Pablo, cut from 50 to 30,” says Geraldine Waked, Director General of
However, in the baby shampoo market Grisi is still
Sesderma.
leading the pack after launching Ricitos de Oro, the country’s blockbuster shampoo, 26 years ago. According
Merz Pharma is focusing on bringing to Mexico a new
to Alejandro Grisi, the company’s Director General, the
cellulite correction device known as Selfina, which
star chamomile product still represents 40 percent of
has already been approved by the Federal Drug
the national market share.
Administration (FDA) and exists in the US market, says Victor Anaya, CEO. The company is also proud of its
Grisi is focusing on the development of natural-based
botulinum toxin, which is the only one in the market
products including soaps, which are now made from
that does not contain complex proteins, minimizing side
vegetable oil. Alejandro López, Director General of
effects.
IM Natural, says the company prefers to invest in the quality of their natural products instead of marketing,
In 2015, the largest market dermatological competitors
and therefore they focus on multilevel programs and
were Genomma Lab Internacional with a 35 percent
catalogue sales for their revenue. Their high-quality
value share and Bayer de Mexico with an 11 percent
mascaras are also conquering new grounds in the male
share, claims Euromonitor. Both have continued double-
grooming sector.
digit growth. López foresees that the beauty products market could Hair loss is another trend driving the market in Mexico.
be growing at rates of about 11 percent by 2019, propped
As in the rest of the world, this is the number one
up by research efforts to find new ingredients and
aesthetic concern for men and one of the main concerns
solutions and more professionals entering the sector.
for women, says Ariel Díaz, Co-founder of Kaloni Holding
“Mexico is an attractive investment and distribution
Group. Up to 40 percent of men suffer from some kind
destination adding to the positive outlook we have on
of alopecia, he adds. Therefore, though the treatment
the future.”
215
| VIEW FROM THE TOP
BUSINESS PUSHES FORWARD VIA TRADE AGREEMENTS CARLOS BERZUNZA Director General of CANIPEC
216
Q: What specific strategies is CANIPEC enforcing to gain
Q: How do you make sure that the personal care and
more competitiveness in the Mexican market?
household care product industries take advantage of the
A: Our aim is to gain competitiveness in the personal care
export opportunities Mexico provides?
and household care products industry. Our products play
A: Mexico has a solid investment platform being Latin
an important role in the daily lives of Mexican consumers.
America’s largest exporter of personal care products.
Improving conditions for doing business in the Mexican
Our industry has achieved exports diversification. Around
arena is important. We are pursuing many initiatives with
52 percent of our exports go to the US and the rest go
a priority being the communication between the industry
to other Latin American and Caribbean countries, which
and the consumer.
means that a total of 96 percent of our exports stay on the continent. However, we still have work to do to make sure
Besides complying with the authorities’ regulations
that the conditions in which Mexican exports happen are
regarding
self-
the best possible. We maintain constant communication
regulation code called COSMEP, which includes ethics
advertising,
CANIPEC
developed
a
with Mexican trade agreements negotiators to make sure
guidelines for the advertising of affiliated enterprises.
our products receive the best possible treatment regarding
However, it is not an exclusive code and is open to any
tariffs and market access. We have a very active industry
other company that might want to adhere to it. Several
on the exports market. Cosmetic products exports amount
associations such as AMAP and CONAPEC have accepted
to US$2.8 billion. When added to household care products
our COSMEP code. These agreements help enterprises
we arrive at a total of US$3.6 billion with a trade surplus
maintain communication among them but also make them
of US$1.7 billion.
vigilant of each other making sure everyone complies with the regulations. Complementing authorities’ regulations
We have done many things to achieve high export figures.
with self-regulation has been an interesting experience.
Our most recent accomplishments have been the Pacific
Thanks to this, we have been able to develop better
Alliance negotiations. For this particular agreement, we
advertising, which has evolved into increased confidence
wanted to take advantage of the opportunities the free
from our clients and improved communications with the
product flow segment offers. Cosmetics chambers in
authorities.
the four countries involved proposed a common agenda for eliminating tariffs, flexible origin rules, homologated
The personal care and household care products industry
regulations and a document with international best
was recognized by the Ministry of Economy as a key
practices for the industries. Around 90 percent of our
sector for the Mexican economy, so we have been working
proposals were accepted by our governments. The idea
with them very closely to identify opportunities for
behind this joint effort was to eliminate requisites that
strengthening supply chains and to raise awareness among
do not provide added value to consumers’ safety and are
consumers about the benefits that come from using our
time-and-resource consuming.
products. There are several products we sell that improve life quality but do not have the consumption levels they
We took the same approach in the Trans-Pacific Partnership
should have, like hair conditioning and sunscreens. That
(TPP)
is why it is so important to promote an informed and
countries wrote position papers in which we proposed a
responsible usage of products, encouraging consumers
common agenda for negotiators. At the moment we are
to adopt products from formal establishments rather than
participating in talks for the extension of the Economic
informal venues where there is no institution or authority
Complementation Agreement with Brazil, the largest
that takes responsibility if the product causes an adverse
market for beauty products in Latin America, so we need
reaction.
to work on tariff reduction and commercial facilitation.
negotiations.
Chambers
from
the
involved
Q: What are the positive economic effects CANIPEC has
our consumers with more sources of information. But
on the Mexican Industry?
consumers also need to inform themselves regarding the
A: Our industry has an extensive catalog that adapts
products they use. Maintaining an open communication
to consumer needs and possibilities. There are many
channel with the government is vital. Fortunately, we
affordable products and several premium products. Our
have established a relationship of trust and constant
products amount to more than US$9 billion. This magnitude
communication, especially with the Health Ministry
of product consumption generates an important effect on
and COFEPRIS. They have accompanied us on our self-
the countryâ&#x20AC;&#x2122;s economy. Our estimations show that over
regulation processes and in our efforts to negotiate our
200,000 jobs are created, either directly or indirectly, by
free trade agreement regulations. Another important
our industry.
authority we maintain constant communication with is the Ministry of Economy. Government support is
Our growth in the local market has attracted investment.
fundamental to many processes, for example trade
Personal and household care have grown at rates of 4
agreement negotiations. We are partners with the
percent and 5 percent per year, respectively, In the last
government regarding the observance of applying
decade the industry has attracted more than US$300
existing regulations and upgrading them. We have had
million in foreign direct investment annually. We have
openness from the federal government, we have been
seen significant amounts of investment in the past five
able to maintain communication and we have generated
years in plants and research centers. That is why our
agreements.
goal is to achieve a solid double-digit growth. This can
creating synergy with the government is vital for the
be done by maintaining the growth of products that are
success of the industry.
Communication
with
consumers
and
already being consumed and increasing the consumption of products that have yet to be accepted by the market. The 68 enterprises that make up CANIPEC are having an impact on the economy. To increase our impact we are developing new services to help small enterprises that develop artisanal products. Additionally, we believe there are some enterprises in the chemical and manufacturing
â&#x20AC;&#x153;Personal and household care have grown at rates of 4 percent and 5 percent
industry we could affiliate in the next years.
per year, respectively. In the
Q: What steps are you taking to improve opportunities in
last decade the industry has
the Mexican market? A: Improving consumer culture is important. Mexican consumer habits are influenced by their beliefs. If people believe that hair conditioning triggers hair loss they are definitely not going to buy it even if it is not true. Erasing these myths is a double responsibility. We are doing what we can to improve our communication and provide
attracted over US$300 million in foreign direct investment annuallyâ&#x20AC;? Carlos Berzunza, Director General of CANIPEC
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| VIEW FROM THE TOP
CAPITAL COOPERATION IS KEY TO EXPANSION RICARDO SPINOLA CEO and Founder of Farmapiel
218
Q: What are the latest trends in the dermatological segment
of this venture have been positive. We have been able to
and how does Farmapiel capitalize on them?
take some opportunities that would otherwise have been
A: Mexico has an aging population, more effective medicines
out of reach such as product acquisition, technologies,
to treat chronic diseases and a population that wants to
the manufacturing plant, brands, trademarks, product
look young and healthy. Beauty is becoming a relevant
registrations and company investment. Last year we
topic and today we see people in their 60s or 70s looking
launched 18 products and this year we will launch 13 more.
like 50-year-olds thanks to the growing trends in esthetic
We expect to maintain this aggressive strategy to continue
medicine, such as plastic surgery and corrective medicine.
growing mainly in the prescription market. Some of the new
People are interested in taking care of their skin, which is
products were in the market before and we will relaunch
driving the growth of skin protection products and raw
them. Others are new formulas we released in the US and
ingredients, such as emollients, vitamins, clarifying agents
Europe and we are now bringing to Mexico.
for spots and active compounds for conditions like acne. Ten years ago, it was uncommon for adolescents or the
Exports certainly take time but we are moving ahead and the
general population to attribute much importance to acne
regulatory process requires patience. When looking at Latin
whereas today treatment is a priority. Moreover, there are
America, Mexico is one of the biggest established productive
many patients living with cancer who require more skincare
markets and is also economically and socially stable, which
products to counteract the side effects of chemotherapy
is not the case for other major countries in the region. This
and conditions like diabetes serve as another driver for
represents a competitive advantage for Mexico so it is just a
specialized skin products. We are focusing on product
matter of seizing the opportunity. Our plant in San Juan del
development to create differentiated products through
Rio has the installed capacity and expertise to participate
specialized technology to capitalize on these trends. New
in other markets. At the moment we have not explored
formulations are developed within the company, and we
options such as support from ProMĂŠxico because we are still
have a laboratory in San Juan del Rio where we carry out
focusing on consolidating the business in the country but we
this activity. We are constantly seeking new ingredients and
are aiming to grow into other markets this year.
materials that provide differentiation not only for our own production but also for third-party manufacturing where we
Q: To what extent will funding from EMX Capital pave
offer high-quality raw materials.
the way for other companies looking for this kind of opportunities in Mexico?
Q: Last year, you invested in the manufacturing site in San
A: I truly believe this is setting a precedent for companies
Juan del Rio in an attempt to reach new markets like the US
willing to raise funding. This is a matter of learning how
and Latin America. To what capacity is the plant operating?
to work together. We are experts in launching products
A: We received COFEPRISâ&#x20AC;&#x2122; approval last July to manufacture
and acquiring technology while the capital was provided
semi-solids, oral solids and liquids including dermatological
by EMX Capital along with their knowledge on corporate
liquids, creams, ointments and gels. In addition, we obtained
governance and their business and banking contacts at the
a Good Manufacturing Practices (GMP) certificate and we are
international level. It is important for us to always see the
already carrying out third-party manufacturing. Farmapiel is
big picture and realize that increasing our capabilities with
about to obtain registration for semi-solid products and we
the support of someone else enables us to expand more
are starting to manufacture dermocosmetics in the plant.
easily together. This is a promising path to follow not only for dermatological and pharmaceutical companies, but EMX
We received funding from EMX Capital for the overall
Capital covers many other industries. EMX Capital stands
project including the expansion of our operations and
out due to its corporate governance, formal organizational
establishing the manufacturing site and so far the results
structure and relationship with capital markets.
| VIEW FROM THE TOP
MEXICAN BEAUTY MARKET PROVES ATTRACTIVE GERALDINE WAKED Director General of Sesderma
Q: From 2014 to 2015, Sesderma’s consolidated sales
Q: Which products have had a bigger impact in the
reached 38 million euros (US$42.19 million). What role
Mexican market?
did the Mexican market play in these numbers?
A: So far, our genocosmetic products have had the most
A: Since we entered the Mexican market three years ago,
impact in 2016. This treatment draws from DNA to prolong
sales have shown positive growth. In 2014 business in
the life of telomeres and consequently cells. Sesderma’s
Mexico doubled and we are hoping that 2016 will follow
biggest innovations of the year include our retinol
the same trend. Our sales derive from two areas: doctors
development that stimulates elastin and collagen to
and pharmacies. Sesderma prioritizes practitioners as the
reduce wrinkles with few applications. Reti Age and Factor
company is made by and for dermatologists.
G were launched last year at the Dermocosmetic Congress and have been particularly successful in terms of volume.
The company collaborates closely with doctors to solve
Factor G incorporates plant-based growth elements. Reti
common dermatological issues centered on beauty and
Age reduces wrinkles up to 80 percent and causes almost
health for both men and women. We have earned the trust
immediate changes upon application.
of doctors who feel comfortable prescribing our products. Q: What is Sesderma’s strategy for points of sale? The most attractive aspect of our brand is our OTC
A: Overall, we have added 20 points of sale since last year.
product range that can be found in pharmacies. Our
The growth is not massive and carefully adapted to the
products range from medical peels that need to be
preferences of practitioners. Sesderma has had to lower
applied by professionals to complimentary products such
pharmaceutical points that were no longer profitable such
as face washes and creams found in pharmacies. Our OTC
as Sanborns, which was dropped from 40 to 20, and San
products have active ingredients and basic concentrations
Pablo, cut from 50 to 30. On the other side, Derma is a
that doctors prescribe for continuous treatment.
consistent sales outlet and we make sure to be present in as many branches as possible. Our marketing objectives
The world and Mexico in particular is starting to pay more
are targeted to medical practitioners as they do 80
attention to the skin as it is the most exposed organ to
percent of the work in sales. Practitioners are our forte as
external factors like pollution and stress. The country
people trust and believe their recommendations.
is starting to worry more about spots, wrinkles and aesthetic issues.
Q: Transnational companies tend to use Mexico as a platform to enter Latin America. What other countries in
Q: As mentioned Sesderma has two distribution channels,
the area is the company interested in entering?
pharmacies and doctors. Where is the market driving
A: Sesderma is already widely spread in the region. We
these channels?
affiliated with the US at the same time as we entered
A: Mediderma and Sesderma are our two lines. Despite
Mexico. The brand opened branches in Panama, Dominican
the fact that practitioners are our main pillar, we make
Republic, El Salvador, Costa Rica, Ecuador, Guatemala,
sure that our retail market is as strong as our medical one.
Peru, Guatemala and Brazil. The company is participating
Pharmacies have a strong drive as not all doctors provide
in even more countries as a distributor. Sesderma entered
medicine at consultancies and rely on prescriptions.
Panama, the Dominican Republic and Ecuador. These
Sesderma accounts for 70 percent of our sales while
branches were recently turned over to their country
Mediderma represents 30 percent, because our OTC
managers. We believe that our Mexican branch will be as
products have a general purpose like hydration, night
big as our Colombian one in two years. It is an ambitious
treatments and face washes while our medical products
goal considering that Colombia has a 10-year advantage
serve a more defined purpose such as peels.
and a double-digit market.
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| VIEW FROM THE TOP
FOREIGN PRODUCTS SUPPORT LOCAL GROWTH CARLOS DE KRUYFF General Manager of CDM Labs
220
Q: CDM Labs is looking to expand its participation
A: Natural products are increasingly demanded around
into different markets. What new opportunities is the
the world, taking the form of phytopharmaceuticals. This
company targeting?
type of pharmaceutical has been clinically proven and is
A: The dermatology field has three different branches:
backed up by most physicians. As such, it has specific
clinical dermatology, which focuses on skin disease
therapeutic effects on conditions like rosacea and atopic
treatment, all other dermocosmetic fields serve as
dermatitis (AD). The latter has huge market opportunities
coadjutants to the aforesaid conditions, and surgical
as children contract the disease at high frequency. But
procedures covering both the aesthetic and dermatology-
there are some who remain skeptical about the benefits
related fields. CDM Labs is merely involved in the clinical
of phytopharmaceuticals and it is crucial the rest of the
area of dermatology, but the company is looking to expand
population understand their importance. On a positive
its scope into surgical and aesthetic-related procedures
note their success in European markets will most certainly
as it is the fastest growing segment in dermatology. Last
permeate into Mexico and Latin America.
year, the pharmaceutical market as a whole grew by 6 percent. Contrarily, the dermatology market, which involves
Q: Which socioeconomic spheres is CDM Labs targeting
desmocosmetic, and skin disease medicines fell short at 3
the most?
percent, which is barely enough to cover yearly inflation. In
A: CDM Labs covers most market segments but a large
the past, dermatology specialists were against the aesthetic
volume of our products are destined to the C+, upper
and corrective industry but the tide has changed as proven
middle
by growth percentages.
services the A/B and C+ social spheres. Nonetheless,
socioeconomic
class.
Our
luxury
portfolio
some of our products fit different demographics with Through mergers and acquisitions companies have
different consumption capabilities. We have evaluated
inorganically grown in this segment, concentrating their
the possibility of commercializing generic products that
efforts somewhere else. Big pharma companies with major
could further expand our market reach, however, nothing
market presence have some participation in dermatology
has materialized. What is certain is that lowering prices is
while those who do not are still holding back believing
essential as all types of societies need solar protection. A
it is responsible only for minor market volumes. In the
way to accomplish this is by cheapening packaging costs
pharmaceutical industry, dermatology accounts for 6
mainly by using environmentally friendly materials.
percent of the market share. This represents considerable opportunities for CDM Labs as we are solely focused on
Q: What products commercialized by CDM Labs see the
this. Bringing new and innovative medical solutions to
most success?
the market is not an easy task as COFEPRISâ&#x20AC;&#x2122; regulations
A: We commercialize a large number of products but
continue to tighten. As a result, we are bringing foreign
we are investing most of our capital in three categories
medications to the market, especially from countries
of products, including capillary care and hair products,
with high standards, and certification requirements such
pigmentation skincare products and skin blockers, which
as the US, Canada, France, Germany and Italy. Currently,
is a very congested market with multiple players. There
dermocosmetic
sanitary
are high margins for opportunity in Mexico putting a
registration, which allowed us to boost our portfolio.
products
do
not
require
hold on our export endeavors. There is a lot of room to
However, we foresee that Julio SĂĄnchez y Tepoz, the newly
improve domestically and our efforts will be channeled
appointed Commissioner of COFEPRIS, will change this.
into meeting our expectations. CDM Labs is looking to help Mexican society by commercializing state-of-the-art
Q: What are the current market trends in the dermatology
and innovative solutions in-house. There is a long way to
care arena?
go in terms of product coverage.
| VIEW FROM THE TOP
MEXICO SKINCARE MARKET LOOKING GOOD CORRADO DE GENNARO General Manager Mexico & Central America of Galderma
Q: What role does Mexico play for the global strategy of
rates encountered in lower socioeconomic spheres. At
Galderma?
the very least, 3,000 skin diseases are thought to exist.
A: Mexico is considered a strategic priority for Galderma.
Mexico continues to fall short when compared to mature
Gaining recognition as a worldwide pre-eminent authority
markets in the skincare and dermatology fields, such as
on skin health is a priority. Since its establishment in
Europe, North America or other Latin American countries
1995, Galderma Mexico has partnered with healthcare
like Brazil and Argentina. However, the country’s low
professionals (HCPs) providing medical solutions in the
penetration poses growing opportunities moving forward.
skin health field. This has contributed to Galderma’s steady
The needs and expectations of consumers change as
and systemic double-digit growth, becoming one of the
mortality rates drop worldwide. Global trends show that
top players in the dermatological arena. The company
consumers seek to feel and look better. The attention
competes in three specific market segment including
placed in skin senescence is growing as most people want
prescription (Rx) and OTC drugs, as well as aesthetic and
their skin to overcome the challenges of time. As such,
corrective treatments.
looking and feeling better while playing an active role in society is becoming more critical.
They all deliver sustainable growth exceeding average market rates, and positioning our brands among the
To achieve emotional and physical stability, consumers
preferred ones by healthcare professionals. In terms of
are looking for solutions that will get their skin back to
revenues, Mexico is within the top 10 countries in the world
its best natural look. Although Mexico’s demographics are
for Galderma and among the top emerging markets.
mostly comprised by younger people they will eventually age, increasing the market’s demand for skin health care.
Q: What is the importance of Nestle’s acquisition of
As the demand for dermatology services increases the
Galderma and what transformation has it brought to the
role of HCPs will consequently evolve. Considering the
business?
dermatologist to patient ratio in Mexico is of approximately
A: Nestlé is the leading nutrition, health and wellness
1:75,000, other medical practices such as pediatricians,
company in the world. Acquiring full ownership of
geriatricians and general practitioners will be expected to
Galderma helped the group create Nestlé Skin Health,
deal with mild to moderate skin conditions. Meanwhile the
further solidifying its vision of enhancing society’s quality
demand for dermatologists will continue to rise.
of life by delivering science-based solutions over the course of people’s lives in skin, hair and nail health. This
Q: What kind of investment does Galderma direct to its
will expand the reach of Galderma’s services and products
R&D operations?
not only for healthcare professionals and patients but
A: Galderma’s R&D operations focus on growing needs
also for everyday consumers. Under Nestlé Skin Health,
within the self-medication and esthetic and corrective
Galderma will continue to leverage its strong heritage
dermatology fields. Although R&D centers have not
and competencies, meeting the requirements of the
been established in Mexico so far, our facilities in France,
pharmaceutical and medical device environments with the
Sweden, Switzerland, the US and Japan continue to help
help of its prescription and self-medication divisions, as
us in this endeavor. In 2014, Galderma ran 78 clinical
well as its aesthetic and corrective products.
studies in 275 sites spread around 14 countries. So far, 23 of them are in phase IV, with a total of 6,905 enrolled
Q: What growth have the skin care and dermatology
patients. In return, we saw 55 new patent registrations.
segments seen in Mexico?
We look to maximize capacity and boost our efficiencies,
A: Up to 70 percent of Mexico’s population is affected
delivering high quality and safety while improving costs
by some variety of skin disease with higher exposure
due to larger production volumes.
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LEVERAGING PAST EXPERIENCE FOR FUTURE STRENGTH ALEJANDRO GRISI Director General of Grisi
222
Q: What would you say is Grisi’s biggest strength in the
respective bioequivalence and dissolution test have been
Mexican market and what is its commercial structure?
performed. This process can take up to nine months
A: Grisi supplies almost every supermarket and pharmacy
excluding the component evaluation period where we
in Mexico. In addition, the government is responsible
identify the market’s demands. We cover a wide range
for a small part of our generic product sales. We do not
of applications like anxiolytics, vasodilators and calcium
sell directly to them but through distributers that orbit
related products.
the segment. On the other hand, the company’s US commercialization activities are mostly supported by
Q: What are the most relevant trends in the personal
Midway Importing, of which we own 52 percent of shares.
and skin care market and what is your fastest growing
Midway Importing is responsible for 80 percent of Grisi’s
product line?
sales in the US market.
A: The personal care market segment is extremely broad, and is mostly comprised by transnational companies.
Q: Grisi has a tradition of developing products from
Local market tendencies initially come from Europe and
natural sources. Has it been difficult to remain loyal to
the US, followed by Mexico. Dermocosmetics has become
your basis in an industry highly dependent on chemically
the latest trend as it follows hygiene and beauty formulas
synthesized substances?
while
A: Grisi’s R&D department continuously modifies and
alongside its European brand Maja, is positioned in El Corte
implementing
pharmaceutical
practices.
Grisi,
advances the company’s formulas for its pharma, hygiene
Inglés. Both have higher degrees of active ingredients
and
for
adding product functionality. Maja was acquired four
natural-based products are tighter than before, forcing
years ago and it specializes in perfumery. Although it is
us to systemically modify and improve our formulas.
not a premium brand its greater quality positions it in the
Considering less impactful ingredients are needed Grisi
masstige category. Our Mexican blockbuster is Ricitos de
partnered with international companies focused on
Oro, the country’s baby shampoo market leader with more
raw material production and jointly developing the best
than 40 percent of the market. With 26 years in the market
possible formulas for its products. In terms of natural
Ricitos de Oro resulted from Grisi’s original chamomile
extracts we purchase them from multiple regions in the
shampoo. The company also has a strong presence in the
world, such as the chamomile that is later processed in-
neutral soap segment, which is the highest selling soap in
country. Soaps, on the other hand, are now made from
Mexico. We are also leaders in the minimarket veterinarian
vegetable oil instead of animal fat. The trends behind
segment with our Perro Consentido and Perro Agradecido
natural product manufacturing have become stricter,
product lines.
beauty
segments.
The
industry
standards
especially as companies misrepresent and falsely promote their goods. Evidently, it is near impossible to have 100
Q: Grisi invested MX$100 million (US$5.3 million) on a
percent natural products as some types of chemicals are
new distribution center. What are the highlights of this
used for their preservation. We do our best to keep in line
investment?
with the company’s vision. Grisi’s active, natural origin
A: We will move our operations by mid-2016 to gain
ingredients must be of the utmost quality.
connectivity with our client’s distribution centers. Grisi’s distribution center services its warehouses in Guadalajara,
Q: What generic products is Grisi developing?
Monterrey and Tijuana. But more space is greatly
A: Grisi produces tablets and capsules. Our portfolio
needed. We are also refurbishing and strengthening
also includes salt compounds like epinastine, tamsulosin,
the infrastructure of our manufacturing facilities. Large
alprazolam and imiquimod. We research nearly expired
investments have been channeled to this endeavor, which
patents further filing product registrations once the
has positively impacted the quality of our pharma products.
| VIEW FROM THE TOP
GROWTH ON TAP FOR NATURAL BEAUTY PRODUCTS ALEJANDRO LÓPEZ Director General of IM Natural
Q: What inspired you to create IM Natural, a Mexican
Catalog sales are also an important commercial channel for
cosmetics company that creates its products with natural
the company representing a good portion of its business.
ingredients?
It is necessary to point out that through these efforts we
A: Twenty-five years ago, natural ingredients became the
are helping segments of Mexican society activate the
newest market trend. As a result, creating a cosmetics
economy. The multilevel program has proven to potentiate
brand with natural raw materials was something we felt
sales in the cosmetic and wellness industry.
223
a strong pull toward but we also understood that adding preservatives was necessary. IM Natural and its staff also
Q: How are market trends shifting considering cosmetic
worry about nature and its integrity. What we first thought
products are now also demanded by males?
would be a passing trend actually became a way of life for
A: Male consumption of cosmetic products is on the
consumers as can be seen in the market’s consumption
rise. In fact, our mascara portfolio has a transparent eye
habits. Back in the day, only a few nature shops could
liner for men that want to improve their features. Even
be found in the city, making for our first commercial
though this is a product that we export, for the most part
clients. In fact, the well renowned brand Nutrisa became
Mexican consumers are also joining the trend. There is
our first partner, later becoming the chain that it is
an uncanny amount of male-directed cosmetic products
today. Natural shops have since multiplied, opening up
and they vary in type and application. IM Natural’s
commercialization channels across the country. What is
transparent mascara was released in Mexico but it was
undeniably true is that natural, organic and vegan trends
not well accepted by consumers. Contrarily, its demand
have overtaken the market and companies with a long
in Costa Rica continues to grow, making for our largest
trajectory in these types of activities are one step ahead
consumer market.
of the curve. Q: How are IM Natural’s products reaching larger Q: As of today, international brands take up most of
population
the world’s cosmetic market share. How is IM Natural
product awareness?
positioning itself to overcome these challenges?
A: It is predicted that in a five-year period the cosmetic
A: Through a few star products IM Natural has captured an
market will grow exponentially and IM Natural will
important share of the market. This is especially true in our
certainly secure some of the growth. Even though
mascara range considering it is the leading portfolio in the
the pharmaceutical industry has only reached single-
natural arena. Consumers in our line of business not only
digit growth in the past few years we believe the tide
know what they want but also understand the intricacies
will change. Although this may be true there is a huge
of a solid cosmetic product. Keeping this in mind, IM
difference between the pharma and wellness industry, as
Natural’s biggest challenge has been securing sustained
well as in the challenges that they face.
segments
and
helping
increase
natural
growth. Rather than investing heavily in marketing our strategy has been to develop high-quality products and
Q: What future goals and ambitions does IM Natural
let consumers spread the word. Granted, transnational
expect to fulfill in the short term?
companies with long histories lead the way. But IM Natural’s
A: By analyzing available market data, we can foresee future
strategy has divided the Mexican market into different
market trends. We know that Mexico’s beauty industry
segments mostly based on their consumption capabilities.
employs 250,000 professionals. By 2019, the segment will
The brand can be found in multiple supermarket chains,
grow by 11 percent with an overall market value of MX$154
from Walmart to Farmacias Benavides, and everything in
billion (US$8.3 billion). Multiple research efforts are being
between. Finally, we have a presence in natural cosmetic
channeled into finding new ingredients and solutions. The
shops, as we did from the beginning.
quality and effectiveness of our products will grow.
| VIEW FROM THE TOP
HAIR RESTORATION: LOOK GOOD, FEEL GOOD ARIEL DÍAZ Co-founder of Kaloni Holding Group
224
Q: Kaloni’s international recognition is the result of
Q: How big is the market for your services? How do
its hair transplant technique. What is the registered
Kaloni’s services improve the quality of life of its patients?
Técnica Kaloni and why is it the most advanced in the
A: The size of the market is what attracted us toward
marketplace?
the hair business. It is the number one aesthetic concern
A: Our technique is the result of years of experience and
for men and one of the main concerns for women. This
innovation. From the very beginning we set ourselves the
problem is a source of depression, stress and even shame.
goal of creating the most pleasant and technologically
That is why we are really pleased to hear how we have
advanced technique for the benefit of our patients. It is
changed the lives of our patients. They come to us with
constantly evolving and we have become faster, more
stories about how they feel more secure or how they are
efficient and more successful than the competition. We
doing better with their partner or their job. Because it is
have even incorporated techniques from other medical
such a delicate matter the market has always existed and
areas such as platelet rich plasma, which we were one of the
according to some reports at least 40 percent of men
first to introduce to the hair restoration industry. We like to
suffer from some kind of alopecia. The hair restoration
focus on our surroundings, on what is outside the company,
services we offer are not only for balding men. We also
what other people are doing and what technology is being
help fill beards and eyebrows, and we can even cover scars
developed. We have to remember technology is advancing
that left an area devoid of hair, for example a cleft lip.
at an exceptional pace and we do not want to become the “old guys”. We want people to come to us for the latest and
Q: Lifelong follow-up is marketed by Kaloni. How does
best services in the world. The differences of our product
the company ensure this added service and what are the
are vast and they range from first contact with the patient to
incurred costs?
when they return for a check-up. The recovery time is one of
A: Lifelong follow-up is one of our biggest advantages.
the greatest accomplishments in hair restoration. In the past
The patient is usually under supervision for 14 months but
there was a technique called the strip method or FUT that
they can return anytime. We like to keep our doors open
consisted in removing a piece of scalp in order to collect
for them because Kaloni is not only a business but also
the follicles from there. This evolved into the FUE technique,
a medical center that takes care of everyone involved. It
where the follicles are collected one by one. This is much
is free of charge because we like to keep it simple and
more comfortable for the patient as the wounds are minimal
motivate people to come to us for help.
and they heal rather quickly versus the strip method, a surgical procedure that involves more recovery time.
Q: How are Kaloni’s new technology implementations – such as the ARTAS robot – improving patient outcomes
“The size of the market is
and the overall customer experience? A: Kaloni’s fixation with improvement has led us to some
what attracted us toward the
fruitful alliances. The ARTAS robot is the latest. Technology
hair business. It is the number
When we first started we only knew how to do procedures.
one aesthetic concern for men
products and we have multiplied that knowledge. We like
and one of the main concerns for women” Ariel Díaz, Co-founder of Kaloni Holding Group
has always helped medicine so we do not shy away from it. Now we have machines, cutting edge tools, bio-intelligent to make the patient comfortable with the range of options we can offer. We have something for everyone, and we like to keep expanding this. If a patient comes to us with mild alopecia there is no need for the robot and we can give him topical treatment instead.
| VIEW FROM THE TOP
AESTHETIC MARKET SPROUTS STEADY GROWTH IN MEXICO VÍCTOR ANAYA CEO of Merz Pharma
Q: How does Merz Pharma replicate its German success in
sheer population size of Mexico and Brazil, will ensure it
Mexico and the region?
remains significant. When talking about the new line of
A: Merz Mexico has been one of Merz’s most successful
energy products Merz has the most advanced technology
subsidiaries worldwide. We have been working in the
for performing non-invasive lifting, which is also growing.
country for almost 14 years. We began with a focus on
More and more small spas and clinics offer this. In Mexico
neuroscience, although recently as part of our global
plastic surgeons consider themselves owners of the
strategic direction change we have moved toward
aesthetics business and in reality they are the experts.
aesthetics and the neurotoxin business. We have also reorganized locally because our former CNS line
Q: Aside from your formidable resource allocation for
has already lost its patent in most parts of the world.
R&D, what other factors differentiate Merz?
The aesthetics business has been growing greatly in
A: Our goal is to be recognized as the most innovative
Mexico mostly among middle to upper income people.
aesthetics company, which means we invest heavily. Our
Worldwide women represent 80 percent of the market
botulinum toxin is the only one that does not contain
and men only 20 percent. In Mexico this also stands
complex proteins, which is a significant advantage. A
true. We are targeting consumers, promoting ourselves
product with proteins can cause side effects, notably
and we hold medical events for plastic surgeons and
the development of antibodies that results in an allergic
dermatologists.
reaction. As our product does not contain proteins clinical evidence shows more units can be used on patients.
Q: What made your Mexican subsidiaries so important for global operations?
That is an important factor for patients just like spasticity
A: The market, market conditions and demographics
for multiple sclerosis, cerebral palsy or an EBC. To aid
all contribute to Mexico’s importance but also Merz is a
with spasticity the muscle must be relaxed to achieve
private health company and decided against opening
movement and begin rehabilitation. Ours is the only toxin
subsidiaries widely. We have been selective and Mexico
that does not require a cold chain. There are still many
was one of our first subsidiaries outside of Europe, which
power outages in Mexico, which could compromise the
has given Merz Mexico a boost. It opened in 2002 and
product and result in a wasted investment for physicians.
was the only subsidiary in Latin America until 2015. The recent reorganization and refocus has also contributed
Q: How has the company achieved such growth, and what
to our success. Most of the revenue from Latin America
will it do to ensure the trend continues?
comes from Mexico but not exclusively. We are growing
A: We will continue to invest heavily in R&D to obtain
with double digits, which is great.
products with the highest quality. Selfina is a device that has been approved by the FDA. It corrects cellulite
Q: What would you say are the specifics that make the
and is already in the US market and we hope to bring
Mexican pharmaceutical market so fruitful or on par with
it to Mexico soon. Cellulite is a condition that is not
other foreign markets?
determined by exercise or diet and our device is the only
A: Mexico occupies the 15th–16th place in the pharma
one approved by the FDA that guarantees elimination
market. We have Merz OTC products, derma-cosmetic
of cellulite for two years. We believe it will be a huge
products,
medical
success. Fortunately, the Mexican regulatory authorities
equipment for lifting and medical devices. Merz has a
medicines
and
energy-equipped
have accelerated the process for medical equipment that
diverse product portfolio. Each product has a different
is already approved in Europe, Canada, the US or Japan.
reason for being successful. Other Latin American countries
We remain cautious though as every market is different
may be more well-known for cosmetic procedure but the
and we prefer not to rush.
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| ANALYSIS
HIGH GROWTH POTENTIAL FOR AESTHETIC SURGERY With the advancement of modern medicine, many are
But it is not just the locals turning to surgery to fix their
now going under the knife to satisfy their aesthetic
appearance, providing an opening for the industry.
desires. Mexico is no exception, carving out fifth place
Mexico is a growing hub for medical tourism, second
for total cosmetic procedures performed globally in
behind Thailand, but it lags in performing aesthetic
2015, according to the International Survey on Aesthetic/
procedures on foreigners. The ISACP shows that in 2015
Cosmetic Procedures Performed in 2015 (ISACP) by the
on average only 17 percent of total aesthetic procedures
International Society of Aesthetic Plastic Surgery.
were performed on medical tourists, compared to 12.2 percent worldwide and 24.7 percent in Colombia, which had the highest rate of the countries surveyed. Despite
Mexico, representing 4.2 percent of the worldwide
Mexico’s success with foreign patients, it still has room to
total and split almost 50-50 between surgical and
grow in terms of attracting more foreigners to undergo
nonsurgical (461,544 and 446,369, respectively). It is no
non-elective aesthetic procedures.
surprise that in a country ranked second worldwide in terms of adult obesity, two of the most popular surgical
There is also potential to grow for companies providing
procedures were liposuction and abdominoplasty, and
nonsurgical procedures. Mexico provides only 3.0
one of the most popular nonsurgical procedures was
percent of the world’s hyaluronic acid treatments, 2.7
skin tightening. Despite the health industry’s efforts
percent of hair removal procedures and a paltry 1.7
to cut obesity rates and promote healthier lifestyles,
percent of chemical peels.
surgery is still a top option for achieving weight-loss goals.
US patients are the main foreign clients of Mexican doctors, yet the US ranks number one in all of the most
More teenagers are also undergoing surgical procedures
common nonsurgical procedures. Given its geographical
to change their looks before they reach 18 years of age.
proximity, many industry insiders see potential to grab
In 2015 in Mexico, 44.7 percent of breast augmentations
more of the market. In Mexico, much of the medical
performed on women 17 years or younger were for
tourism talk centers around dentistry and cancer
purely cosmetic reasons, a higher percentage than
treatments. There is room for aesthetic and cosmetic
Colombia, the US and Brazil.
procedures to join the conversation.
AESTHETIC AND COSMETIC PROCEDURES PERFORMED IN MEXICO IN 2015 (thousands) Surgical Procedures SURGICAL PROCEDURES
Non-Surgical Procedures NON-SURGICAL PROCEDURES
80
200
70 60
150
50 40
100
30 20
50
Source: Source:ISACP ISACP
Source: ISACP
Nonsurgical Skin Tightening
Hair Removal
Cellulite Treatment
Hyaluronic Acid
0
Botulinum Toxin
Abdominoplasty
Rhinoplasty
Eyelid Surgery
0
Breast Augmentation
10 Liposuction
226
Last year, 907,913 procedures were performed in
| VIEW FROM THE TOP
AESTHETIC SURGERY TO COMPLEMENT WEIGHT LOSS FERNANDO GARCĂ?A Director of Tijuana Bariatrics
Q: How can your surgery help with the severe Mexican
A: We are seeing an increasing number of aesthetic surgery
obesity crisis?
patients. Around 15 to 20 percent of our revenue could be
A: Obesity is a public health problem, for which Mexico
attributed to plastic surgery. This is due to patients returning
holds the top spot after the US. It is a risk for the
for a second surgery. Generally, we do not do plastic surgery
development of diseases previously known as hereditary
at the same time as bariatric surgery as they are different
but that we now know are directly related to obesity,
specialties. Dental services represent around 5 percent of
such as diabetes mellitus, hypertension, respiratory
our revenue. Most probably 98 percent of our patients are
and cardiovascular diseases. In addition, there is the
international and only 2 percent are domestic. Our business
psychological effect on patients that as doctors we do not
is geared toward foreign patients, all our publicity is aimed
always take into account. Surgery is not the complete cure
at helping people come to Mexico and making their stay
but a tool to cause lifestyle changes in patients.
easier. Most are from the US but we also get patients from Canada, New Zealand, Australia and Dubai.
Q: How popular is the follow-up plastic surgery after bariatrics surgery? How many patients choose to undergo
Q: What differentiates you other than the insurance you
this additional surgery?
offer?
A: It gives us great pleasure when a patient requires
A: As a company and as a team, we have been working
aesthetic surgery because our principal objective is for
together for many years. We believe we offer a service
people to lose weight, so when a patient turns to plastic
of higher quality and it is based on the experience and
surgery it is because they have already reached a point
attitude of the staff. We give patients the confidence and
where they have lost 30, 40, 100 kilograms and are ready
sense of comfort necessary to come to Mexico: we send a
for aesthetic surgery. About 70 percent of patients will
chauffeur to the airport, we communicate with them even
require aesthetic surgery after their bariatric procedures.
before they come, they know where they will stay, the
This is an extra service we can offer to patients, of the
timetable, we agree on flights and we respond quickly on
same excellence and quality, and we recommend it be
social media. We have a nutritionist who visits them twice,
performed after 18 months to two years after the bariatric
once in the hospital and once in the hotel. This is necessary
surgery so that their bodies have time to adapt and
because lifestyle changes need to be made after surgery.
recover after the procedure, which is major surgery.
We call them over Skype, we have an online support group where patients support each other and answer each otherâ&#x20AC;&#x2122;s
Q: How do your dentistry services fit in with the bariatric
questions and this has been a great success. The group and
services and how does it impact your operations?
the nutritionist have been our greatest assets.
A: Our dental service is high quality and can be aesthetic or reconstructive. It is slightly less frequently required but
Q: What plans do you have for 2017?
we offer a complete service to the patient and their family
A: We would like to expand Tijuana Bariatrics, in which case
members. We offer dental services to bariatric patients
we would require more surgeons to ensure we maintain
when it does not detract from their principal objective.
quality of service and the human touch. It is a project of
We offer services such as cavity cleaning, oral hygiene
ours to grow to other cities, especially as some patients
appointments and dental prosthesis. We have a dental
wish to go to a touristic spot where they can recover. We
surgeon specialized in these areas.
have been thinking of Cancun and also Puerto Vallarta, as it is an international port. Although we aim to expand to
Q: What percentage of your revenue can be attributed to
other touristic areas, our principal objective remains the
each area such as aesthetic and dental? What growth do
quality of care. We would rather strengthen the three
you foresee in the coming years?
areas we already work in than expand to new areas.
227
11
NUTRITION & WELLNESS
In 2015 the OECD reported that over 70 percent of the Mexican population was overweight or obese, the highest level for OECD countries. Mexico ranks first worldwide in child obesity and second in adult obesity. The nutrition and wellness of the population is increasingly important as this crisis is bringing many more health problems such as hypertension and diabetes, which in turn causes glaucoma and can lead to amputation.
It is a heavy burden for public institutions as 80 percent of the IMSS budget is spent on 20 percent of the Mexican population suffering from preventable conditions. Many recommend improving nutrition and physical activity habits, creating new areas of opportunity such as corporate wellness.
Breastfeeding, a vital part of nutrition, also has been in decline. Rates of babies fed exclusively breastmilk for six months have reached lows of 14 percent in Mexico, the lowest in Latin America. NGOs such as UNICEF are working with the public sector to improve child nutrition. This chapter provides an overview of how companies are responding to the obesity challenge in Mexico.
229
| CHAPTER 11: NUTRITION & WELLNESS 232
ANALYSIS: Mexico Banks on Multipronged Approach to Awareness
234
VIEW FROM THE TOP: Isabel Crowley, UNICEF in Mexico
235
VIEW FROM THE TOP: Gabriela Allard, Mexican Diabetes Association
236
VIEW FROM THE TOP: Francisco Rodríguez, Productos Medix
237
VIEW FROM THE TOP: Javier Luna, Nestlé
238
VIEW FROM THE TOP: Fabián Bifaretti, Sports World
239
VIEW FROM THE TOP: Fernando Núñez, Grupo Body Systems
240
VIEW FROM THE TOP: Jorge Vergara, Omnilife
242
VIEW FROM THE TOP: Bensi Levy, The Green Corner
243
VIEW FROM THE TOP: Luis Suárez, SANAR
244
ANALYSIS: Obesity in Mexico
245
VIEW FROM THE TOP: Jorge Treviño, Anti-Obesity Center
231
| ANALYSIS
MEXICO BANKS ON MULTIPRONGED APPROACH TO AWARENESS Faced with a myriad of health issues, especially obesity
is very poorly treated at the population level: 24.7 percent
and related diabetes and high blood pressure, Mexico is
of diabetics were found to be at high risk of complications
taking a multipronged approach to reduce the impact on
such as strokes, heart attacks, renal failure or loss of vision
the public health system. Education to promote lifestyle
and 49.8 percent at very high risk.”
changes and prevention awareness campaigns are a priority as entities in the public and private sector look to
It is not a pretty picture but efforts are under way to
put the population on a healthier path.
spread healthier practices. Isabel Crowley, Representative for UNICEF Mexico, says one way to improve health is to
232
The OECD points out that Mexico has attracted attention
start at the beginning, by focusing on breastfeeding. “In
for its comprehensive approach to tackling diabetes and
Mexico only 14 percent of mothers exclusively breastfeed
other chronic diseases through reforms such as prohibiting
for six months, which is the lowest rate in Latin America,”
unhealthy foods in schools.
she says.
A LONG WAY TO GO
During the 2015 World Week for Breastfeeding, Minister
“Secondary prevention (i.e. the early detection and
of Health José Narro pointed out that between 2012
adequate treatment of chronic diseases) is much less
and 2015 breastfeeding had increased from 14.4 percent
well delivered,” the OECD states in its Review of Health
to 30.8 percent. Still that remains the lowest number in
Systems Mexico for 2016. It continues: “Data from
the region and puts the country barely above Indonesia,
ENSANUT (Mexico’s National Health and Nutrition Survey)
Taiwan and Cape Verde, he said in a statement.
show that, of those found to have high blood pressure (an important and treatable risk factor for strokes and
Higher breastfeeding rates could have a solid impact on
heart attacks), 47.3 percent were unaware that they had
children’s well-being because it helps reduce obesity and
the condition. Of those aware, only 73.6 percent were
other problems since maternal milk adapts to the children’s
receiving treatment and less than half of these had their
growth and acts as a first vaccination, according to
blood pressure adequately reduced. Similarly, of those
Crowley. There is also a financial impact as switching from
known to be diabetic, 14.2 percent (almost 1 million
powdered milk to breastmilk creates savings, she says.
Mexicans) had not seen a doctor for routine management
UNICEF has partnered with TV Azteca on a breastfeeding
of the condition in the past year. This means that diabetes
promotional campaign and Crowley says the government could make further improvements through extended maternity leave and baby-friendly hospitals. Improving infant health is also a target of the private sector. Nestlé, for one, is adding probiotics to its infant formula product line. Javier Luna, Nutrition, Regulatory and External Affairs Sr. Manager for LATAM at Nestlé, says that thanks to probiotics the company’s clinical trials focused on improving infant health have registered a 90 percent success rate. He says Nestlé has already added probiotics and prebiotics to 150 of its products and he
Diabetes is very poorly treated at the population level: 24.7 percent of diabetics were found to be at high risk of complications such as strokes, heart attacks, renal failure or loss of vision
projects this number will increase. Groups like the Mexican Diabetes Association are actively implementing strategies to encourage healthy eating, which can reduce obesity and diabetes. Their program “Restaurantes por la Salud” already has 22 affiliates. Gabriela Allard, President of the Association, wants people to read labels and buy products that will enhance their health. Chronic disease can be a huge burden on the healthcare system and severely impact the productivity of companies. Allard says it may take two or three generations
to get people in the right mindset but she believes Mexico
“In Mexico only 14 percent
is going in the right direction.
of mothers exclusively
EDUCATION IS KEY
breastfeed for six months,
According to the National Health and Nutrition Survey, diabetes costs the country US$3.87 billion in health services alone, which amounts to US$707 per person. Doctoralia Mexico says 15.5 million people suffer from this disease in Latin America but Mexico is home to 10.6 million. This translates to 87,000 deaths a year.
which is the lowest rate in Latin America” Isabel Crowley, UNICEF Representative Mexico
Education is the key to obesity prevention, says Jorge
help clients reduce fat, firm and tone muscle and skin and
Treviño, President of the Anti-Obesity Center. Mexican
remove expression lines.
society is too tied to its eating habits and obesity can lead to diabetes, high-blood pressure, cardiovascular
Food supplement firm Omnilife, in the middle of a global
problems, fatty livers, varicose veins and many other
expansion push, believes results can be achieved faster by
health issues, he says. Treviño believes that insurance
aiding diets with products such as theirs. “There are habits
companies authorizing obesity surgeries could help solve
that are part of the Mexican culture, such as traditional foods,
the problem.
which tend to have a high caloric and fat content with a low nutritional contribution that could be harmful to people.
Getting more people to the gym would also help. Sports
People are more receptive to us when we show them results
World, a growing fitness club chain, is seeing impressive
that habit changes can provide when they supplement their
churn rates of less than 2 percent as of March this year,
diet,” says Jorge Vergara, the company’s CEO.
says Fabián Bifaretti, the company’s CEO. This follows the company’s decision to invest in its personnel and train them
Omnilife also has a program, called Reto 90, to address the
in hospitality. “We encourage a community feel so that our
need to change people’s eating habits with the target of
clients integrate to a social group that will encourage them
reducing weight. “It is a challenge in 90 days, which aims
to stay,” he says. The company hopes to reach 70 clubs
to ingrain the habits change. The winner gets a monetary
within the next four years, 20 more than they have now.
prize. It is a whole package and includes dietary practices and recommended exercises. It is also used to help teach
According to the 2014 International Health, Raquet and
people better habits so that they can continue the positive
Sportsclub Association (IHRSA) Global Report, annual
changes,” Vergara says.
revenues for the fitness sector in Mexico amounted to US$1.5 billion with nearly 8,000 clubs open around the
It may be true that the fastest route to health is through the
country. On the downside, this only represents 2.2 percent
stomach, with healthy eating. Bensi Levy, Director General
of the population.
of the Green Corner, says that newly attained social consciousness has led to exponential market growth in
Companies also have a vested interest in the health of their
the organic food sector, despite the rough financial patch
workers. Grupo Body Systems has successfully entered
the country is experiencing. Raw, vegan and gluten-free
the corporate wellness sector, helping their clients create
products are new, and encouraging, trends in the sector.
savings by lowering work absenteeism, attendance and personnel rotation. By minimizing sedentarism in workers
“It is important to keep in mind that a balanced lifestyle
it has also helped reduce insurance costs, says Fernando
is vital for a healthy body,” says Levy. “Therefore, organic
Núñez, the company’s Director General. Grupo Body
foods must be supported by consistent exercise and stable
Systems' Wellness 360 program provides nutritional,
sleep cycles. Unfortunately, the market is shifting to an
physical and mental support for employees. The group’s
industrialized organic pattern, which takes away from the
success is leading it to 40 percent growth this year, he says.
basic principle of creating a rich biodiverse environment.”
Medix’s consumer division opened two brands -- 180°
Integrative medicine is another avenue to pursue. Luis
and SlimCenter -- in Mexico, focused on weight loss.
Suárez, CEO of SANAR, says acupuncture and ozone
180°, which opened in February 2016 and became
therapy are among the services in demand in Mexico.
profitable within a month, is equipped with some of the
“Every mother and grandmother knows how to use herbs
same medical devices found in hospitals, says Francisco
and plants,” says Suárez. “This is a more formalized version
Rodríguez, Consumer Division Director. These devices
of that and it has been very well received.”
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| VIEW FROM THE TOP
BREAKING BREASTFEEDING MYTHS IN MEXICO ISABEL CROWLEY Representative of UNICEF in Mexico
234
Q: What has UNICEF achieved through its breastfeeding
is with the baby after birth and that breastfeeding is
program in Mexico?
initiated immediately. What we recommend doesnâ&#x20AC;&#x2122;t cost
A: We have done many things. In Mexico only 14 percent
very much. The State of Mexico is making great savings
of mothers exclusively breastfeed for six months, which is
by switching from powdered milk to encouraging mothers
the lowest rate in Latin America. We could see the negative
to breastfeed. We also have to ensure that there is a code
impact on the health of children in terms of obesity and
for breastmilk substitute for the industry to adhere to and
other problems and so this would be a way to reduce
comply with, but it is a big business and they have not
government cost in the medium and long term and spread
been adhering to this. This is something the government
the benefits for breastfeeding for mothers and children. For
must enforce. There are a lot of interests involved but
breastfeeding mothers there is less incidence of cervical
the constitution tells us that the best interest of the child
and breast cancer, they lose weight more rapidly and are
should override any other concerns. Last year there was a
less prone to being depressed. For children it is extremely
gathering of the three main groups that deal with childrenâ&#x20AC;&#x2122;s
important because breastmilk adapts to the age of the child
health:
and the first milk that the mother gives is like a vaccination,
Federation, the Mexican Pediatrics Association and the
it has all a newborn child needs. They will be healthier and
Mexican Confederation of Pediatrics. It was the first
they will not get as sick. This is why we are working hard
time they worked together and they signed a historical
to change the status quo so children are not negatively
agreement to increase breastfeeding in the country.
the
Mexican
Obstetrician
and
Gynecologist
impacted. Over the last 20 years women have been increasingly incorporating themselves into the workforce.
It is very important to create awareness. At first we were
Over 50 percent more are working now than in the past
not getting any traction so we created a viral video about
but laws have not changed to help them breastfeed. We
a woman breastfeeding in a park arrested for showing her
ran a campaign with TV Azteca to promote breastfeeding.
breast. We wanted the public to start talking about it. An
We are trying to educate and break the myths about
important task of UNICEF is to create awareness and then
breastfeeding.
the environment for public policy to change. We feel that in the last 2 1/2 years we have done a lot but it will only be
Policy improvements have been made, women no longer
successful when we start seeing the results for children.
need to take six weeks pregnancy leave before having their baby. This does not have an additional cost to the
Q: What do you attribute to the drop of breastfeeding
employer but is beneficial to the mother. Other simple
rates in indigenous communities?
solutions that make huge differences would be to give
A: Breastmilk is the best. It comes with the right nutrients,
mothers a place to breastfeed and store their milk. We are
at the best temperature and itâ&#x20AC;&#x2122;s free. It was a major
also working on increasing maternity leave. We will have
human rights problem when we decided that powdered
an active campaign during International Breastfeeding
milk is better than breastmilk, which is precisely why the
Week to help the government and the general population
government should be implementing health codes for
realize the importance of breastfeeding and increase the
tinned milk and promoting breastfeeding. Of course tinned
percentage of mothers exclusively breastfeeding in the
milk is a good option for mothers unable to breastfeed but
first six months.
it should be the last resort instead of the first. It is difficult to compete against the industry, especially when they invest
Baby-friendly hospitals are another strategy of the
about the same amount to advertise their tinned milk in a
government, discontinued many years ago but starting
day that we invest to promote breastfeeding in the whole
again. The hospitals must comply with certain regulations
year. Campaigns by the government and support from
to get the certification. These include ensuring the mother
hospitals will help educate and raise breastfeeding rates.
| VIEW FROM THE TOP
HEALTH IS EVERYONE'S RESPONSIBILITY GABRIELA ALLARD President of Mexican Diabetes Association
Q: What has “Restaurantes por la Salud” and “Feel Healthy”
and we are pushing for resource allocation from these taxes
achieved in the last year?
focused on improving access to water.
A: This program has been very successful with 22 restaurants participating. We want to offer healthy food options for
Q: Some experts think healthcare is not a priority in the
people and we want this to become a prevalent and massive
government’s agenda. What are your thoughts on this?
initiative such as smoke-free spaces. When a restaurant
A: I believe it is the exact opposite and that many public
decides to participate we provide the necessary guidance to
offices are working to improve the population’s health.
create healthy options on the menu. There are many people
But it is not that easy and we should not leave the entire
who believe that healthy food is not delicious and we want
responsibility to the government. We should team up with the
to let them know this is not true. We are not against any
public sector and they should develop new communication
type of food but we want people to learn healthy eating
channels through which they can convey recent advances
and have a balanced diet. There are no good or bad foods
in healthcare promotion. There are a lot of initiatives of
and everything depends on people’s lifestyle and habits.
which people are not aware. Changes cannot be made
Chefs are also invited to join these restaurants and learn to
overnight It can take two or three generations to see actual
cook healthy food. “Feel Healthy” has been successful with
changes in the population. Chronic diseases can become an
effective patient adherence to the exercise programs that
unbearable burden for society and the healthcare system.
are tailored according to their condition. We are also working
The productivity of companies is also impacted by chronic
with Tonalli support association in which we take children to
diseases so we need to make people realize the importance
nutritional camps and teach them how to inject themselves
of prevention. In the past, diabetes type 2 was a disease seen
with insulin and count their carbohydrate intake.
in people over 45 years old and today there are children suffering from it, and Mexico is one of the countries with the
Q: What has been the reaction to the Mexican Diabetes
highest levels of children obesity in the world. I think people
Association Guarantee Stamp from the industry?
have the power to decide what to eat but much more effort
A: Responsible consumption and production has also
is needed to get the right message across.
reached the industry. There are some pharmacies interested in selling products that are acceptable for diabetics and our
Q: What is your final message to our readers?
stamp guarantees the use of healthy ingredients. Additives,
A: We all should be involved in promoting healthcare
such as sweeteners, are under continuous scrutiny and there
and raising awareness. We should all be responsible for
is a lot of updated information about their safety and health
preventing obesity and diabetes on an individual basis,
impacts. We are interested in making people read labels
and we cannot leave the full duty to the government and
and buy acceptable products. A validated product is not
schools. Every person has to be completely in charge of
necessarily a carbohydrate free product but a balanced one.
their own health.
Q: To what extent do you think taxation on sugary beverages
“People have the power to
contributes to improving the diabetes crisis in the country? A: I think it has been an excellent initiative. Contrapeso is a network of associations coordinated by the Director of Fundación Mídete. In Mexico there are millions of people hydrating with soft drinks. We are not against the beverage industry but we are pushing for these people to have access
decide what to eat but much more effort is needed to get the right message across”
to water in their communities and schools. This measure
Gabriela Allard, President of Mexican Diabetes
has raised awareness on the importance of drinking water,
Association
235
| VIEW FROM THE TOP
WEIGHT-LOSS CENTERS SURGE IN MEXICO FRANCISCO RODRÍGUEZ Consumer Division Director of Productos Medix
Q: How has the Medix Consumer Division evolved
this. Some 180° centers have integrated fitness circuits
throughout the years?
that help clients complement their fat reduction efforts.
A: Medix’s Consumer Division was created one year ago
236
and is divided into three brands, two of which are in Mexico.
Q: What are the main services that 180° provides?
180° and SlimCenter are brands specifically targeting the
A: We have a wide range of services. These include body
Mexican market and our Become Yourself Centers brand
fat reduction, firming and toning muscle and skin and
can be found in the US. Even though 180° is Medix’s luxury
expression line removals, as well as nutritionist services
brand, our SlimCenters are almost up to par. The latter was
that follow up and compliment our services. Our SlimUp
recently acquired by Medix and had no investments in any
device tones all types of muscles while our Thermage
of its seven centers for more than 30 years. Its previous
treatment removes facial marks by stimulating lower
owners developed such an effective treatment method
dermis layers where collagen is found. Its effects help the
that a COFEPRIS certification was secured, with which we
body create its own natural collagen after a three-month
can now advertise and guarantee a seven-kg weight loss
period, achieving a real rejuvenation process. All of our
after only 20 sessions.
services have a scientific basis with no collateral effects. For us to make our clients feel better we must help them
A little over a year ago Medix acquired 20 centers in the US
reach their optimal weight. Therefore, our nutritionist
that were owned and branded as Medifast Weight Control
services are complementary.
Centers. Back in the day, Medifast sold 70 percent of its volumes through direct mechanisms called Take Shape for
180° is an integral solution for clients. We are there to
Life, 20 percent through e-commerce and the remaining
help them reach a certain weight and to ensure the best
10 percent at the control centers. Thereafter, we decided
results before undergoing our treatments. Our nutrition
to rename the brand Become Yourself while keeping our
plans with the use of Medifast products account for 40
previous business plan intact.
percent of our sales, proving their extraordinary success and effectiveness.
Medifast eatables remains as the nutritional foundation and we subsequently implemented the machinery found
Q: What has allowed Medix’s Consumer Division to
in our Mexican centers. After implementing our added
successfully position itself in such a congested market
services sales grew by 47 percent, which shows the
through its 180° concept?
effectiveness of our integral business model.
A: Our centers are equipped with the latest technology. A nonsurgical procedure, the CoolSculpting device acts
Q: What was the idea behind 180° centers?
similarly to liposuctions and eliminates the accumulation
A: We needed to create integral centers covering most
of adipocytes in the body. Even though it has a clinical
of our client’s concerns. We are equipped with medical
use, the technology is also used by plastic surgeons,
devices also found in hospitals and specialized clinics.
dermatologists and wellness spas. Given the benefits and
We have a DEXA bone densitometry scanner that also
success of our treatments we create clients for life. We
produces a muscle and body fat report, which we call
cover a wide range of needs most of which can be serviced
BodyScan. This type of equipment needs a specialized
at any given occasion. We understand the concept may
technician to operate and we have hired a professional
be new to Mexican consumers but our indicators show
in the field. In addition, our centers have physicians that
that it's gaining traction. Our first 180° was inaugurated
perform an overview of our clients’ health before providing
in February 2016, immediately followed by two others in
any type of treatment. We must provide scientific support
the same month. All our centers, regardless of their brand,
for everything we do and our physicians help us achieve
became profitable after the first month.
| VIEW FROM THE TOP
NESTLÉ FOCUSES ON PUBLIC HEALTH ISSUES JAVIER LUNA Nutrition, Regulatory, and External Affairs Sr. Manager for LATAM at Nestlé
Q: What role does innovation play in Nestlé’s corporate
be denied. Consumers must first understand the health
strategy?
benefits of these additives. Thereafter, the market will
A: Mexico’s public health issues are one of Nestlé’s biggest
reshape itself. As of today, Nestlé has added probiotics
concerns. Our new corporate agenda focuses on reducing
and prebiotics to 150 of its products and we see the trend
the levels of sodium and sugar in several products of our
rising.
portfolio. We are finding better and healthier ingredients that will increase our client’s options. Consumers must
Q: To what extent has COFEPRIS’ seal of quality helped
make informed decisions and we are helping them in
Nestlé and its products?
the process. Nestlé continuously innovates and assesses
A: We are quite pleased and extremely optimistic about this.
product releases. This is the spirit of the company.
Countries like Japan have implemented similar measures
With a 150-year history, Nestlé has always emphasized
which have had a tremendous impact on companies that
and stressed innovation practices. There are instances
were granted this recognition. Even though only some
where renovations are the only logical step forward,
of our products have received the nutritional seal from
but fulfilling emerging market needs with new product
COFEPRIS, we are working on spreading this across our
releases is crucial as well. To date, Nestlé is innovating in
portfolio. Before Nestlé’s accreditation, LICONSA was the
the food supplement and infant formula segments. We
only entity with such recognition and it helped put the
are producing better products with advanced health and
company on higher ground.
nutrition traits for consumers. Q:
What
collaborations
with
organizations
and
Q: How relevant is the infant nutrition portfolio for the
associations have you created to promote a healthy
company and what gaps is Nestlé aiming to close in this
lifestyle and a balanced diet?
segment?
A: Nestlé has a worldwide social responsibility initiative,
A: Infant nutrition is an important segment to Nestlé. The
collaborating with multiple stake holders around the world.
whole industry, alongside government and academia, is
We have established relationships with Mexican medical
working on ways to minimize breastfeeding complications.
and nutrition societies on a local, state and federal level.
We were the first company in Mexico to innovate in this
In addition, Nestlé has implemented internal programs
regard by adding probiotics to our infant formula product
to promote healthier lifestyle habits in Mexico, Nestlé’s
line. As a result, Nestlé leads the market in probiotic
global initiative led us to their development, but they must
administration. Our clinical trials have had a 90-percent
be regionalized. We are allocating economic resources
success rate positioning us at the top of the herd. In
and human capital to this endeavor, which reiterates our
addition, Nestlé’s OPTIPRO® innovation optimizes protein
commitment to the programs. Mexico has growing issues
intake by creating an equivalence to breast milk, which has
with obesity, malnourishing and breast feeding, which
been implemented in our GOOD START and NAN brands.
calls for an action plan to promptly come into force. We are always looking to partner with the government and
Q: How much is the probiotic market growing in Mexico?
academia, share our efforts, grow our scope and reach our
A: Components that add value to products are increasingly
goals at a faster pace.
demanded by consumers. For instance, 10 years ago nucleotides were administered to different types of
Nestlé wants to become a nutrition leader by thoroughly
products. Even though they were poorly received at first
understanding people's lifestyle and dietary intake. In
due to price increments they later became mandatory
addition, we must secure our position as industry leaders
worldwide. I foresee that probiotic implementation will
in nutrition and health research with the help of internal
behave similarly as their positive effect on children cannot
programs and external collaborations.
237
| VIEW FROM THE TOP
INVESTMENT LIFTS RETENTION RATES AT GYMS FABIÁN BIFARETTI CEO of Sports World
238
Q: How have Sports World’s specific efforts to increase
until we have reached our full potential. Fifty clubs are
customer retention been reflected in the company’s
not enough, thus growth will improve our position in
market position?
terms of stocks. The sector itself could grow considerably
A: The company has reached a record high, reversing last
and while industry players continue to make moves that
year’s low retention record. In March 2016, we registered the
intrigue investors we will see a general increase in market
lowest churn rate since we started operating. Today, less than
penetration.
2 percent of members drop out from the club. The market’s average is between 2.5 percent and 4 percent depending on
As the dollar strengthened the cost of our equipment rose.
the type of business and country but below 2 percent is very
Nonetheless, we have not lowered investment. In fact,
rare. Thus, we are proud of our work and attribute much
instead of waiting eight years to replace machines we now
of the success to our strategy of continuously improving
make routine changes every five to six. Cardiovascular
customer service. The whole company has undergone
machines in particular must be changed frequently as
training sessions in hospitality, specifically to be able to
they receive the heaviest use. Therefore, rather than
personalize service to different kinds of clients. Excellent
cutting investment in these imported products we have
service philosophy must be maintained and passed on to
found savings in other areas such as reducing the cost of
new people that enter the company.
infrastructure of new clubs. By negotiating better deals with construction companies we have been able to keep
Analysis of classes we offer led us to identify the variables
the same level of investment in maintenance to benefit our
that encourage or limit attendance. Within peak hours, we
members.
identified that popularity of most classes depended on the trainer leading the class. In response, we launched a
Q: In what areas is Sports World geographically targeting
program called Start Trainers so that our 20 best trainers
growth and club inaugurations with the projected
could guide 150 staff members to give even better classes.
investment this year?
We encourage a community feel so that our clients
A: Our growth has been organic, tending to open five or six
integrate to a social group that will encourage them to stay
new clubs per year. Per year, the average cost of new clubs
in a specific gym. Those that attend two or three classes
is MX$200 million (US$11 million) plus a further MX$30
per week are less likely to cancel their membership.
million (US$1.6 million) approximately for maintenance of existing gyms. However, we aim to optimize the building
We started 2015 poorly, but in 2Q15 we balanced it out to
costs by square meter following some positive offers from
the point that we saw positive results at the end of the year.
construction companies. While we have investigated and
The recovery that we saw in the final quarter was partly due
are negotiating inorganic growth opportunities few have
to market trends but also due to a focus on service. Aiming
matched our expectations and tend to be more expensive
to optimize our overheads, we delayed some unnecessary
than constructing from scratch.
renovations. However, this influenced our retention levels. We have switched the focus to correct this and we are now
Every year we concentrate less on the capital city. Of the 50
benefiting from increased efforts, reaching almost 70,000
clubs operating, 35 are in the city and 15 in the rest of the
members.
country. We are now focusing on balancing the quantity of clubs in and outside the capital 50/50. Three new
Q: How has corporate pushed to raise their value and
locations will be opened in Guadalajara this year, another
stabilize the brand?
in Merida and in the future we will continue to increase the
A: The company’s marketability is low although our results
concentration in other states. In total, we hope to reach 70
have been excellent. We do not expect to see a change
clubs in Mexico within the next four years.
| VIEW FROM THE TOP
EMPLOYEE WELLNESS DRIVES PROFITABILITY AND PRODUCTION FERNANDO NÚÑEZ Director General of Grupo Body Systems
Q: With over 12 years of experience in the wellness sector,
them were companies such as Seguros Monterrey, New
what were the market opportunities that led to the
York Life, KPMG, CMR, Pepsi Co., all of which have an
creation of Body Systems?
assigned budget for this type of corporate program.
A: Grupo Body Systems includes four companies. We
We seized the opportunities the market had to offer.
started by targeting clubs and gyms and offering high
Every company has a budget allocation for training
quality group fitness classes. Back then, this segment
courses, which is the approach we are taking through
offered huge opportunities as few companies offered
stress management, meditation, nutrition or mindfulness
specialized classes like ours. Five years later, our CEO
courses. There is a newfound interest for services like
envisioned the opportunity of spreading into corporate
ours helping us significantly expand our operations. Our
wellness. As such, he was summoned to be a founding
prospect client pipeline is quite robust.
member in the Wellness Council board, which allowed him to better assess the available market opportunities.
Grupo Body Systems is part of the American Chamber of Commerce, which has further strengthened our
By focusing on corporate wellness we realized that
capabilities. Growing at the same pace as the market
companies were saving large amounts of money by
is an important challenge. The quality of our corporate
minimizing work absenteeism, attendance and personnel
service far exceeds our competition, making us segment
rotation. Therefore, insurance costs dropped significantly
leaders. Our operational program allows us to train and
as primes were lower than the average. Our Group Fitness
retain instructors much more efficiently while offering
model offered different classes to companies with the
better remuneration for their services. Through systemic
right infrastructure, such as fitness centers or gymnasiums.
surveys we have realized that the quality of our courses
So far, we provide an estimated 800 worth of weekly
is far greater than our competition. Grupo Body Systems
instruction hours. Back in 2014, the company widened
is working on attaining international certifications, further
its services by devising an integral human development
advancing its institutional accreditation.
model that covered each part of an employee's life. For instance, we have instructors that activate employees at
Q: What benefits can a company receive by hiring your
different times during the day, which has paid off through
Integral Human Development Program?
productivity increments.
Q: We diagnose a company’s operations further offering a service that fits their specific requirements. The Wellness
Generating our own data is probably our biggest area of
360 program offers an integral solution to an institution’s
opportunity. Data belongs to our clients and employees.
problems covering nutritional, physical and mental
However, we are finding ways to use this information and
aspects of its human labor. Being sedentary is one of
consequently improve our programs. The company has
the biggest problems the market is facing. This type of
realized that results are not only trackable in the long
behavior can produce hypertension, diabetes and other
term but in the short term as well. Institutions implement
conditions.
measurements based on the expected ROI, coupled with their inherent interest in providing employees with added
Q: What are the key objectives you want to fulfill by the
benefits and compensation.
end of the year? A: Grupo Body Systems has a growth expectation of over
Q: How do you approach companies and how do you
40 percent, which the company is on track with. With time
differentiate from other businesses?
our clients are requesting more and better paid services,
A: Our approach led us to target transnational companies
which impacts our profitability. The market opportunities
first, which is Grupo Body System’s strong suit. Among
will continue to grow.
239
| VIEW FROM THE TOP
RESULTS-ORIENTED SUPPLEMENTS TO CHANGE BAD HABITS JORGE VERGARA President and CEO of Omnilife
240
Q: What are the distribution advantages that you have at
on a cruise. The young people also organize their own
Omnilife?
trips, like one they did recently to a music festival in Brazil.
A: We work directly with our distributors who in addition
We also seek to take some advantage of the technological
to using the product have the advantage of directly
era through bonuses and incentives in which distributors
approaching the consumers, which gives us a personalized
can win a tablet or smart phone to help their business to
treatment. We offer courses related to human development,
grow faster. We have a close relationship with them and
business administration, finance and the basic business
this helps retention rates.
tools to be successful as an Omnilife distributor. We also have direct telephone lines for different questions that our
Q: What are the regulations implemented by COFEPRIS
distributors and consumers may have about our products
that affect your business?
or business. Our top-selling products in Mexico include
A: We have a good working relationship with COFEPRIS
Omniplus, Power Maker, Magnus, Optimus, Thermogen
because when we started the company there were no
coffee and tea, Chiva Cola, Aloe Beta and Dolce Vita.
other supplement companies in the market in Mexico. Since then we have had a close relationship with the
Q: What is the difference between Omnilife and similar
authorities. Omnilife has been closely involved in the
competitors?
regulation of the dietary supplements industry, a situation
A: The only thing we have in common is that we do
that has influenced countries such as Colombia, Costa
supplements. We make powders and liquids and our
Rica and others in which Omnilife is present. We continue
competitors mostly do tablets. We also focus on the
working and promoting the improvement of the regulatory
special needs of the population, in this case Mexico and
framework for our category, which allows technological
we are chasing results instead of money. We make sure
progress in the development of new products.
to cover all our customers needs before they spend all their money on goods that are not necessary for them. We
Q: How is Omnilife trying to help with Mexicoâ&#x20AC;&#x2122;s problem
have many differences in what we teach, how we teach
of chronic diseases, like diabetes and obesity?
and of course, in our products. Another important thing is
A: Our philosophy is that rather than changing bad
we respect the culture and flavors of the country we are
habits drastically, we could orient them to nutrition by
working in.
consuming our products. There are habits that are part of the Mexican culture such as traditional foods, which tend
Q: What are the strategies for recruiting distributors from
to have a high caloric and fat content with a low nutritional
ages 18-25?
contribution, that could be harmful to people. People are
A: Our group, NFuerza, was created when we saw there
more receptive to us when we show them results that habit
were many young family members of distributors that also
changes can provide when they supplement their diet with
wanted to become independent distributors. Young people
our products, which is why we are convinced that the best
have realized that we appreciate their talent and that they
way to motivate people is by showing results rather than
can start their own business through this company. Today
just preaching to them.
we have about 300,000 young distributors in different countries, and we expect this number to double by the
When I started the company, I was fat and sick and I
end of this year.
wanted to lose those habits that were harming me. I believe that people start learning through results. Education
Q: What strategies do you use to retain this talent?
is very important but it is not enough. For example, the
A: First, we use their language. We make a yearly trip
educational campaigns against smoking have not really
where we take about 4,000-5,000 of the biggest sellers
accomplished much. The people also need to witness the
241
results for themselves before they make any long-term,
manufacture in Mexico, Colombia and Ecuador. We plan to
real changes in their habits and lifestyle and this spreads
manufacture products in Russia and India, especially since
to other people.
the flavors and products will be tailored for those cultures.
Q: Omnilife is already present in many Latin American
Q: What is the program Reto 90?
countries. To which other countries would you like to
A: Reto 90 is a program to help people change their eating
expand?
habits, having consequently some weight loss. It is a 90-
A: We will expand to Russia by September of this year, India
day challenge that aims to ingrain the habits change.
and Nigeria by next year and Australia by the beginning of
The winner gets a monetary prize. It is a whole package,
2018. These are countries that I take a personal liking to
including dietary practices and recommended exercises. It
and I feel comfortable approaching them and attending
is also used to help teach people better habits so they can
to each culture.
continue the positive changes.
In five years, we expect to be in at least 10-12 more
Q: What are the new products you are planning to launch?
countries, especially in Asia and other countries that we
A: I cannot tell you! twenty-five years ago, we revolutionized
feel a connection to. it is also important to keep in mind
the industry with liquid vitamins and we plan to do
that we will manufacture the products near the country
something similar in a couple of months. We spend a lot
they are being distributed in, since it is more expensive to
of research and development to produce original products
transport than manufacture in some cases. Right now, we
that cover the specific needs of that country.
| VIEW FROM THE TOP
SOCIAL CONSCIOUSNESS LEADS TO ORGANIC FOOD BOOM BENSI LEVY Director General of The Green Corner
242
Q: How has society responded to your products in a time
employment and positively impacting the region’s crime
where food has become a focal point in people’s lives?
rate, which we take great pride in. Our workforce has grown
A: At first we thought convincing people would be the
throughout the years as our sustainable development
hardest task, which was certainly not the case. Even though
model works year-round contrary to the season-based
the turnout was much lower, there was always a demand for
approach of industrialized enterprises. The latest organic
organic goods. We saw people from Cuernavaca, Queretaro,
industrialization trend has blueprinted their working
San Miguel de Allende and Aguascalientes, to name a few,
mechanisms and although products are healthier than
coming to our store looking for better alternatives. It is also
the average they do not cover the whole environmental
true that The Green Corner went through an education
spectrum. There is little waste from The Green Corner’s
process, taking part in organic tianguis, back when they
end as organic matter in the process of turning bad is used
were not popular. In 2005, the company participated in
for either juice production or to feed livestock. This way
an enormous organic fair launched at Mexico City's Zócalo
we close natural life cycles and reduce costs. We have a
in celebration of World Environment Day. At this event,
rain capture pond used in our irrigation processes differing
producers and distributers got to know each other while
from wells that need foreign sources of energy to extract
also assessing the number of consumers in the city. The
water. Once implemented we decided to introduce bream
Green Corner’s initiative also led the company to schools
that feed off mosquitoes. Given their quick reproduction we
and hospitals, educating the general public of the benefits
now harvest fish meat as well. Our pond water is filled with
that organic products had. In return, physicians started
nutrients derived from fish waste so it is used in our fields
sending their patients to us for viable preventive solutions.
to enrichen the soil. We are creating an intricate ecosystem that the industrial model previously wiped out.
Q: Where does this market segment stand and what are the newest trends that The Green Corner has perceived?
Q: How does the Green Corner pick the producers it does
A: Newly attained social consciousness has led to
business with and what are the company’s distribution
exponential market growth. Although there has been a
channels?
demand upsurge over the last six years the segment is going
A: There were no pre-established norms when we first started
through difficult times due to Mexico’s economic crisis. As
our operations. We took it upon ourselves to make sure
such, growth has not continued as strong as before. But
that our partners followed our philosophy. As the industry
new niches have emerged, such as raw, vegan and gluten
grew bigger the NOM-037 came into force. To date, around
free products, to name a few. Having a wide variety of
95 percent of producers are certified. However, this is not
nonprocessed goods is the segment’s goal. It is important
enough to ensure good practices. Organic industrialized
to keep in mind that a balanced lifestyle is vital for a healthy
companies have enough distribution channels with large
body. Therefore, organic foods must be supported by
supply chains. Small producers need stores like The Green
consistent exercise and stable sleep cycles. Unfortunately,
Corner to survive. We also help small producers obtain
the market is shifting to an industrialized organic pattern,
certifications as we have close relationships with certifying
which takes away from the basic principle of creating a rich
agencies. So far 37 farmers have been certified with the
biodiverse environment.
help of The Green Corner.
Q: What can you tell us about The Green Corner’s
Q: Where will we see The Green Corner in 2016?
production mechanisms?
A: We expect to open more stores in Mexico City,
Our production practices keep the environment in mind
commercialize larger product volumes, and consequently
at all times including the impact we are generating and
help small farmers. In parallel, we will lower the volume of
the influence we have on our community. We are creating
imported products in our shelves.
| VIEW FROM THE TOP
INTEGRATIVE MEDICINE ON THE RIVIERA MAYA LUIS SUÁREZ CEO of SANAR
Q: How did you decide to focus on integrative medicine
often already searched for it online and reviewed all the
and why did you decide to do so here in particular?
conventional and alternative therapy options open to
A: When I was younger I had asthma and I often saw
them. This drive for knowledge and global awakening
doctors and ended up in hospital. Then one time an
to the effects of chemicals on the natural environment
acupuncturist treated me and I never had asthma again.
has contributed to people being more open to these
It prompted me to study general medicine in Mexico and
techniques. Mexico has always had traditional medicine,
to specialize in Acupuncture and Phytotherapy. I then
and every mother and grandmother knows how to use
studied integrative medicine in the US. This used to be
herbs and plants. This is a more formalized version of
called alternative medicine but that is a misnomer as it
that and it has been very well received. Sadly there are
gives the impression the patient has to make a choice
many snake-oil vendors who give this type of healing a
between the two. This field of medicine has grown the
bad reputation. I would love for integrative medicine to
most in oncology. An oncology patient will receive
be officially sanctioned here in Mexico but the discussion
radiation therapy, surgery or chemotherapy. Other
is still difficult as most do not realize that it is not a fight.
techniques are now administered hand in hand with those
It should be a collaborative effort between integrative and
conventional therapies. Ozone therapy is administered
conventional medicine.
while receiving chemotherapy as it heightens the body’s tolerance to chemotherapy, which improves results. We
Q: How can the integrative movement in Mexico be
also aim to improve the patient’s mindset by giving him
strengthened?
mindfulness and yoga exercises because a depressed
A: It can be strengthened through the diffusion of
patient has less chance of recovery. These techniques
information. We need to show that we want to work
contribute to improving the patient’s quality of life and
together for it to be more accepted by authorities such
the final prognosis.
as COFEPRIS. We then need to organize ourselves in a conference and hold an event to gather us all together but
Q: Which are the treatments most in demand and what
sadly there are no resources for integrative medicine. From
can they help with?
a normative point of view, the formalization of integrative
A: Acupuncture and ozone therapy are the most
medicine would allow institutions like COFEPRIS to extend
demanded. Acupuncture can help with many problems
its umbrella over practices that are not yet regulated.
like stress, panic attacks and pain, and it has applications
We are creating an event ourselves that will take place
in gynecology and pregnancy as there is no need for
on October 1st and to our knowledge it will be the first
medicines that may hurt the baby. We recommend
regional integrative medicine event. Unfortunately, it is
acupuncture for almost every patient we see as no matter
true the field lacks professionalism. I am lucky enough to
what ails them acupuncture can help as part of their
go to Europe and North America to attend courses and
treatment. Ozone therapy can also be applied for chronic
conferences but not everyone has that opportunity, which
pain and viral infections such as those that are caused by
results in undertrained people wrongly administering these
chikungunya and dengue fever.
treatments. The press only reports the cases that went wrong and this tarnishes our reputation.
Q: To what degree have you seen the stigma of alternative medicine reduced in other parts of the region?
Q: Where will we see you in the future?
A: With all the information available nowadays on the
A: We have begun to look into medical tourism as many
Internet patients are already in possession of an impressive
patients come from abroad looking for this type of
amount of knowledge when they come for a consultation.
therapy. In general, regenerative medicine is expensive
No matter what the patient suffers from he or she has
and inaccessible in other countries.
243
| ANALYSIS
OBESITY IN MEXICO Mexico’s worrying obesity epidemic has become a priority
4th highest proportion of overweight adults in the Americas,
for both local authorities and international organizations
as per BMI (Body Mass Index) measurements, behind the
such as the World Health Organization (WHO), which
Bahamas, the US and Canada. The country had the worst
stated in a 2014 report that the country suffered from the
index for Latin America, followed by Chile and Venezuela.
XXX (in PCT) AND OBESE ADULTS IN THE AMERICAS IN 2014 (percent) OVERWEIGHT 80 70 60 50 40 30 20 10 Haiti
Paraguay
Honduras
Nicaragua
Bolivia
Guatemala
Belize
Guyana
Brazil
Ecuador
St. Vincent & Gr
Colombia
Dominican Rep
St. Lucia
El Salvador
Peru
Grenada
Dominica
Cuba
Suriname
Jamaica
St. Kitts & Nevis
Uruguay
Costa Rica
Trinidad & Tobago
Panama
Argentina
Venezuela
Source: WHO Source: WHO
Antigua & Barbuda
Chile
Barbados
US
Mexico
Canada
Bahamas
0
Child overweight rates show that almost one of every
equivalent to MX$1 (US$ 0.05) per liter and an 8 percent
three children in Mexico is overweight, compared to rates
tax on the price of every non-basic food with a caloric
of around 23 to 21 percent for Organization for Economic
density equal or greater than 275 calories per 100
Cooperation and Development (OECD).
grams. Professor Alfonso Miranda of Mexico’s Center for Economic Development Research (CIDE) says in an
The problem has become a government priority and in
article for research center CONACYT that this tax reduced
2014 President Enrique Peña Nieto implemented a new
consumption of sugary drinks by a rate of 6 to 12 percent
tax on high-caloric-density foods and sugary drinks,
in its first year.
OVERWEIGHT CHILDREN PER SELECTED OECD(in COUNTRIES (percent) OVERWEIGHTAND ANDOBESITY OBESITYIN DATA PER SELECTED COUNTRIES PCT) 30
boys girls
25 20 15 10 5
Source: OECD estimates based on national health surveys. Note: Measured height and weight in Australia, England, Korea, Mexico and USA; self-reported data in other countries.
boys Source: OECD
girls
Brazil
India
Australia
Canada
Chile
France
Norway
Poland
Portugal
Switzerland
US
Mexico
0 OECD average
244
| VIEW FROM THE TOP
EDUCATION CENTRAL TO ANTIOBESITY EFFORTS JORGE TREVIĂ&#x2018;O President of Anti-Obesity Center
Q: What actions can be taken to avoid reaching the
focusing on social media and our webpage. Working
alarming obesity levels we are experiencing in Mexico?
with brokers is also important, as they usually promote
A: The only thing we can do is to reinforce education.
our services with many more possible patients. Another
Unfortunately, our social lives revolve around eating
important source of patients comes from referrals from
rituals, we go out to eat with friends and we close business
US colleagues. As of today, most patients coming from
over dinner or drinks. If we do not teach our children the
abroad are in need of obesity-related services. Often, our
correct eating habits, it is easier for them to suffer from
patients have already undergone an obesity surgery that
obesity the rest of their lives. People need to be aware
did not go as planned, so we perform revision surgeries.
of the risks obesity involves. Prevention is crucial. There
We expect that eventually the rest of the procedures we
are many health problems associated with obesity and
offer will also be in demand. In Canada, we have seen that
people sometimes are not aware of them. A patient with
unless it is a medical emergency, people experience long
obesity is more likely to present diabetes, high-blood
waiting periods to have medical procedures done.
pressure, cardiovascular problems such as heart attacks, chest angina, strokes, fatty liver, varicose veins and many
Q: Which are the characteristics you consider when
more health complications that could develop. There
deciding who is suited to a specific procedure?
are some forms of cancer related to obesity, particularly
A: You have to be very cautious for several reasons. First,
gynecological cancers.
the patients visit with a limited amount of time, usually periods of no longer than a week. Secondly, many have
Having insurance companies authorizing obesity surgery
not been correctly assessed by doctors and may have pre-
would be very helpful and in the long run this course
existing conditions that could make their surgeries riskier.
of treatment would be more economical than treating
To avoid having risky situations we ask our patients to
diseases such as diabetes or high-blood pressure. Their
perform the necessary studies in their country of origin
argument is that obesity surgeries can easily be abused.
and to have them sent to us for evaluation.
When not performed by a correctly trained physician there can be many complications. Certain insurance companies
If we perform a risky surgery we talk to our patients and
cover obesity operations but it would be ideal if more
explain to them the many possible outcomes and make
enterprises included this kind of surgery.
suggestions regarding their preparation and the time they would need to spend in Mexico to have a successful
Q: Which were Cancunâ&#x20AC;&#x2122;s specific market conditions that
recovery. When risky procedures are requested by US
drove you to open the Anti-Obesity Center?
citizens we sometimes ask our US colleagues to give them
A: When we first arrived in Cancun, we noticed the city
pre and post-surgery attention. Throughout the years, we
lacked medical infrastructure and no one offered our
have consolidated important relationships. We combined
specific service. We are a multidisciplinary model clinic
efforts with doctors in the US for development of the
that
medicine
Full Sense stent that is placed on the patientâ&#x20AC;&#x2122;s stomach.
physicians, surgeons and dieticians. I trained on obesity
provides
psychological
care,
internal
Unlike other devices used in bariatric surgery, this stent
surgery and laparoscopic surgeries in the US but in
will prevent patients from feeling hungry by creating a
addition to obesity procedures, we offer gastrointestinal
sensation of pressure on the stomach. It is extremely
surgery, colonoscopies and endoscopies to name a few.
safe to put it on the patient since it is done through an
A high percentage of our patients are foreigners. If you
endoscopic procedure that does not take more than 20
search the words obesity and Cancun on the Internet
minutes. We developed it on 2009 and now we are in
our webpage is on the first page of results. A special
the latest experimental phases and waiting for Mexican,
department in our center is in charge of digital strategy,
European and FDA approval.
245
12
LOGISTICS & SUPPLY CHAIN
A growing pharma and health market has increasing logistics and distribution challenges. Companies have been improving their technological offerings to attract a bigger portion of the logistics industry and meet its highly specialized needs. They also are racing to reach remote geographies more efficiently. Mexican distribution companies now use thermo-technology and pressure gauges to maintain cold chains and protect delicate products, such as biological samples moving between hospitals and clinical research sites. Satellite tracking ensures the chain of custody is unbroken and products are delivered as quickly as possible, even with blockades and strikes.
Products are transported safely and seamlessly across regional and international borders with reduced waiting times for permits. Industry leaders are looking to secure certification and attract and train talented human resources. The industry is also concerned with the proper disposal of medical products and waste and some companies are now offering delivery services direct to patient homes. This chapter provides insight into how distribution and logistics companies keep the wheels turning in the health industry from behind the scenes and how they are overcoming the challenges the health logistics and distribution industry is facing.
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| CHAPTER 12: LOGISTICS & SUPPLY CHAIN 250
VIEW FROM THE TOP: Daniel Pardo, BOMI de México
252
VIEW FROM THE TOP: Juan Aguirre, Brudifarma
253
VIEW FROM THE TOP: Jaime Castro, ValidPro
Fausto Hernández, ValidPro
254
VIEW FROM THE TOP: Rubén Vargas, NTA
256
VIEW FROM THE TOP: José Aedo, SINGREM
257
VIEW FROM THE TOP: Patrick Troop, Pharma Tycsa
258
VIEW FROM THE TOP: Víctor Soto, Distribuidora Levic
259
VIEW FROM THE TOP: Rudolf Hess, R.H. Shipping
261
VIEW FROM THE TOP: Carolina Galicia, World Courier
262
VIEW FROM THE TOP: José Peña, Grupo Marzam
264
VIEW FROM THE TOP: José Mora, Farmalisto
265
VIEW FROM THE TOP: Rodrigo Amor, Marken
249
| VIEW FROM THE TOP
HEALTHCARE LOGISTICS FOCUS ON PATIENT SAFETY DANIEL PARDO Director General of BOMI de México
250
Q: What challenges are you facing as the new CEO of
fully tracked and controlled and which could represent a
BOMI de Mexico?
threat for patient safety. We are identifying how we can
A: There are several challenges in the healthcare and life
ensure that drugs are delivered to the recipient at the
sciences sector in Mexico that no company has been able
right temperature. The other line of action is developing
to fulfill. For instance, big companies are oftentimes limited
new products and services the market requires. We
by their own corporate processes and there are potential
are listening to laboratories, marketers, clinicians, to
customers that are not their typical target because they
understand what the gaps are so we can improve, be more
do not have the required qualifications or certifications.
efficient and take their brand and sales to the next level.
However, there are many things to be done to be closer
We are coming up with new solutions with their input –
to the patient and end-users while reducing the cost of
not only reducing overall costs, which is the main issue for
healthcare. There are still many inefficiencies along the
third-party logistics (3PL) but understanding what needs
overall supply chain that could be improved for patients
to be done differently. We are reaching new locations our
and healthcare companies and this is exactly what BOMI
competitors cannot warrant a visit due to a low number of
aims to solve. We want to bring the industry closer to
clinics and low volumes. For instance, it is very expensive
patients and clinics and solve some of the industry’s
for medical devices companies to service the southeast of
complexity to ease things for manufacturers and patients.
Mexico but by bringing them together we can make things more efficient and make sure we can get there faster and
Q: What are your plans to become a more relevant player
cheaper. Clinics could start providing some specialized
in the healthcare industry?
services there and patients would no longer need to travel
A: We have two parallel lines of action to achieve this.
400 kilometers to have a surgery.
We are looking for additional growth by several added value services that distinguish us from our competitors
Q: What role should logistics providers play to actually
and allow us to target additional customers while making
put patients at the center of the healthcare system?
the logistics process more efficient. We are the only
A: Patients are at the center of BOMI’s operations.
logistics company in Mexico focused 100 percent on the
They are what we live for and our slogan is “Saving
healthcare industry – with its own fleet, drivers, certified
and Improving Lives”. This is not about moving cases in
trucks, certified cold chain and certified packaging. This
warehouses, healthcare logistics are more difficult, so our
allows us to widen our market share. Cold chain is a big
checkpoint system is robust and identifies errors allowing
opportunity as it has several milestones that are not
us to service customers in a timely manner. A patient who has to get his or her monthly dose cannot skip his
“A patient who has to get his
medication because of logistic mistakes so that has to
or her monthly dose cannot
serve patients the best we can. We cannot be 99 percent
skip his medication because
have to ensure this 1 percent is covered by our backup
of logistics mistakes, so that has to be part of the culture
be part of the culture of the organization, working to accurate, 1 percent of inaccuracy is unacceptable. We processes before they occur. Q: How could integral services be further improved and regulated?
of the organization”
A: I truly believe that everything has room for improvement
Daniel Pardo, CEO of BOMI de México
Integral services cover some gaps at clinics, which are the
not because things are wrong but because of evolution.
point where end consumers receive the products and these facilities are not only managing supplies, they manage lives. Therefore, clinics need to partner with companies that can take full responsibility of materials and supplies and ensure lower costs, maintain minor inventories and ontime deliveries. Integral services to clinics, hospitals and laboratories will become more regulated on quality and compliance, and this needs to be reinforced in the entire value chain. As new clinics providing subrogated services open they must have the right licenses and comply with all requirements to operate guaranteeing patient safety. Discussions about the cost structure of integral services at clinics are not that relevant because in the end no manufacturer discloses how much it is charging for a certain active compound or material in the medication they commercialize, which is also true for healthcare services. Instead, costs become more important when they are charging lower prices for something that is not certified. Buyers need to question if some part of the delivered
A: Today customers want information and visibility
drugs come directly from the manufacturer and if some
about what they are getting and the need to get real-
could be counterfeit. Serialization and pedigree for drugs
time information is increasing significantly. This is why
and medical devices can reduce these risks. There have
we have a web platform on which our customers can
been several efforts to develop and implement regulations
track the shipment in a mobile app that allows for the
for serialization in countries such as the US and Brazil but
creation of digital signatures and picture taking of their
they are still a work in process. When this becomes reality
shipment. We allow customers the possibility to visualize
several players could leave the market due to the lack of
what is going on inside the warehouse. They have access
compliance. Yet I am sure BOMI is ahead of the curve. We
to a webpage where they can access information about
are the only logistics provider certified with ISO 9001 and
our quality system, track our processes and procedures
ISO 13485 in the healthcare industry.
for compliance, know how inventories are being handled, follow preventive and corrective actions and so on. We
Q: What led BOMI to win the National Award of Logistics?
also have an e-learning tool used by each of our employees
A: We were not doing home deliveries for dialysis in the
when a new process is implemented and it stores training
past but we started doing it with a new customer and
records. In the past, only providers could know about their
evolved from there. Therefore, we had to implement a new
own operations.
process, service and scheduling to make sure every patient was getting his or her monthly kit for dialysis. This not only
BOMI is completely focused on healthcare and our main
means ensuring patients get their kit but also having a
differentiator is that we do not replicate operations and
highly flexible agenda as every month new patients receive
knowledge from other sectors. Patients are what we live
the kit while others pass away. Some are located in remote
for and we want to make sure that our services are a
areas, which makes it more challenging. We literally had
valuable part of the chain. Helping the system to provide
to put kits on boats and horses to reach some patients so
better healthcare services is also our mission and we are
we were the first 3PL to achieve thorough integral service
determined to keep on growing with this in mind. Most
from start to end.
companies have more challenges to face than the year before. From the exchange rate pressure in finished goods
Public healthcare institutions are not able to reach all the
to raw materials, we have to work with our customers in
patients directly and that is why they are subrogating
order to do more with less. Another differentiator is that at
services. Even so not all patients are being reached.
a corporate level, big companies have a lots of processes
Remote and low income regions also require healthcare
coming from headquarters and we do not have all those
and we should develop a better structure for subrogation
guidelines that sometimes become obstacles. To deliver
to reach them.
bottom line results, you need to be fast and flexible. Our team is ready to make things happen and quickly start a
Q: What does BOMI offer through its business intelligence
new operation with procedures that are well defined but
solutions?
flexible at the same time, so we are leaner and faster.
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| VIEW FROM THE TOP
BUILDING A SOLID FOUNDATION OF COMPLIANCE JUAN AGUIRRE Commercial Manager of Brudifarma
Q: What new policies would you like to see implemented to
set up and have an interest in growing and doing things
create a more sophisticated market?
the right way. Our challenge is helping these independent
A: The changes that have been made so far have been
pharmacies comply with all the new requirements.
good for the industry but maybe the time frame should be
252
expanded. It is difficult and somewhat unrealistic to ask an
Q: How are you looking to increase your profit margins
industry to change the way it has been doing things in six
despite the drop in commodity prices?
months. Only the committed companies that have a long-
A: For Brudifarma, the name of the game in 2016 and 2017
term plan and are determined to invest will prevail and the
is regulation, not profit. We are looking to set up all kinds of
public will be sure that whatever product they get will be
workshops and information booths to help our clients and
top quality.
theirs. We sell to many small distributors that then sell to their own clients. We have to be ready for COFEPRIS’ new
Q: How do you select what products you will distribute and
rules in July-August.
what are your quality control processes? A: COFEPRIS’ new regulations allow us to access information
Q: What new technologies are you integrating into your
about new suppliers from that same institution. If we comply
processes?
with them, we can then move on to the next step. Since last
A: We have been working with SAP to transfer our clients
year, we have been sampling products and analyzing them
from an email-based order system to a CRM one. Once they
in our warehouse, requiring us to implement a whole new
are registered with us and we have certainty when it comes
quality control system in-house. We know and work with
to their files being in order and up to date, then they can
the top companies in Mexico and do not expect this order
start using a sort of online ordering process.
to be disrupted any time soon. Previously, there used to be a defined line between patent and generic medicine. Now
Q: What allows you to be positioned within the top three
there is a grey area in between. Many of the Big Pharma
main distributors of generics in Mexico?
companies are approaching us and starting to work with us.
A: Our first approach is to keep our customers happy, which allows us to help them grow. Lately, we have also
“If a new regulation is to come
been focusing on keeping COFEPRIS and the Ministry of Finance happy. We want to comply with the rules and be
into effect in July, we will be
one step ahead. If a new regulation is to come into effect in
compliant six months prior”
our customers also have to comply with the rules early on.
Juan Aguirre, Commercial Manager Brudifarma
to customers what we are doing, why and how we are
July, we will be compliant six months prior. This means that We have workshops every Friday during which we explain complying, allowing them to comply.
Q: Are there any risks that could impact your supply chain ? A: The biggest risk was financial and we passed that hump
Q: How does Brudifarma wish to impact the pharmaceutical
about five years ago when companies that could not keep up
and generic industry and what are your goals for the
started closing, leaving distributors unpaid and also leaving
coming years?
us unpaid. Now the biggest risk is compliance. There are
A: We want to be the best option for customers. We do
many pharmacies that do not want to or cannot comply with
not see ourselves as only a supplier but rather as a partner.
COFEPRIS. We have to shift from these small independent
We want to provide our clients with the best products and
pharmacies that were set up from one day to the next to
best prices as well as workshops to help them comply with
small local or regional chains. These have infrastructure
COFEPRIS and the Ministry of Finance.
| VIEW FROM THE TOP
VALIDATION SERVICES FOR THE PHARMA INDUSTRY
Jaime Castro Operations Manager of ValidPro
Fausto Hernández Business Manager of ValidPro
Q: What are the main challenges surrounding validation
validates computerized equipment. Our services cover the
practices in the pharmaceutical industry?
whole validation spectrum regardless of division or area.
JC: Validation services are expensive and even more so if
We must understand the industry undergoes systemic
a company allocates a whole division to it. This is not only
regulation restructuring, forcing companies to adapt to
true due to human capital training but also to the number
the changes. Therefore, there is always business to be
of devices and appliances needed in reading an analysis
secured and companies to be helped.
processes. As such, subcontracting validation services from companies like ValidPro is a better fit for most
Q: Considering the importance of securing competent
laboratories and companies. Our job consists of unveiling
human capital, to what extent does ValidPro have special
the company’s shortcomings, wrongdoings and areas of
relationships with academic institutions?
opportunity. As such, creating strong relationships and
JC: Even though we do not have specific alliances we
ties with our clients is crucial, especially as they will define
have worked with academic institutions through courses
the project’s success. Our first challenge is to be perceived
and conferences. We do not see these conferences as
as the entity that can help them solve their issues rather
a way to develop future ValidPro workers considering
than be seen as the enemy. Secondly, we must push for
the validation field of study is new in schools and
total compliance with the country’s regulatory framework,
universities. The company normally retains the services
which calls for added efforts, work and resources.
of
chemists,
pharma-biological
chemists,
chemical
engineers and pharmaceutical engineers due to their Q: What are the internal processes of validation? How do
underlying understanding of the manufacturing process of
you differentiate yourselves?
medicaments. When someone does not fully understand
FH: We have an internal system of quality control that
what a particular validation field of work entails then they
assures the quality of our services in a constant and
are called in for further training by ValidPro. The learning
permanent manner. This system is updated on an ongoing
curve for a trainee to become an A-level engineer is
basis. In the commercial area, we have created a new team
somewhere between one and one and a half years.
that caters to clients and gives them the attention they need. This has led to a sales boost that caused exponential
Q: Where do you see Mexico’s legal framework evolving
growth over the past three years.
and what are the trends that will push for this transition? JC: Trends will not only be defined by industrial
JC: We launch products with alliances and this has brought
technicalities but also by external factors like the country’s
great benefits to us. ValidPro is a company that has not
socioeconomic landscape and its politics. For instance,
been afraid to make alliances. We do not see competitors
COFEPRIS is receiving the ISO 9001 certification changing
as opposition but as complementary. This has allowed us
its perspective as a sanitary regulator and consequently
growth alongside other businesses.
shifting the way companies work.
Q: Who are ValidPro’s most relevant clients and what
The NOM-059 will enter into force by mid-2016 and we
services do they ask of you?
must all fall in line with it. The industry will be under more
FH: We work with top tier clients such as Boehringer
scrutiny due to the country’s economic environment but
Ingelheim,
Merck
its strength and importance on a global level will allow it
Sharp & Dohme, Pisa and Praxair. The services they
to minimize adverse effects. The instability of the Mexican
demand vary but we can provide a broad spectrum of
peso and other international currencies has impacted
services from the validation of entire manufacturing plants
manufacturing activities and its industries. But the market
to equipment and area qualifications. ValidPro also usually
continues to behave similarly to how it did in the past.
Laboratorios
Valdecasas,
Ulsatech,
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| VIEW FROM THE TOP
NEW DRUGS REQUIRE NEW TRANSPORT METHODS RUBÉN VARGAS Director General of NTA
Q: How many of your competitors engage in similar
is not accounted for, we cannot ensure the integrity and
services to NTA’s new medicine delivery, medical and
efficiency of molecule components.
laboratory equipment services and materials for clinical
254
research and what impact has this transition had on the
Q: According to NTA, what are the new market tendencies
company’s profitability?
of the pharmaceutical industry?
A: NTA is a logistics company specializing in the health
A: For years, big pharmaceutical laboratories have either
industry, including clinical research and everything that
merged or acquired other laboratories to expand their
it entails. We have structured our distribution scheme in
portfolio. Others however, are specializing from within by
such a way that specialized infrastructure and machinery
creating specialty drug divisions. Chronic diseases such as
was needed. We also developed a distribution network
diabetes and cancer have become a pandemic problem
that could easily help us reach our clients as our drop-off
around the world and therefore major pharmaceutical
points are hospitals, clinics and research centers. We do
companies have turned their attention to them. In the
not only deliver manufactured products but also clinical
past, companies would strategize their sales by season,
analysis and biological samples. The latter represents
developing gastroenterology solutions for the summer
the most intricate part of our operations as it can refer
and respiratory drugs for winter. This is no longer true with
to organs requiring quick delivery times and adequate
chronic diseases. Suppliers are now expected to deliver to
temperature, humidity and handling control.
hospitals and clinical sites as well as private homes and offices.
We continue to lead the way in specialization services and the number and size of our clients is the best indicator of
Q:
this as we now service multinational giants like Johnson
regulatory framework?
How
have
these
transitions
affected
Mexico’s
& Johnson and Fisher Clinical. Not everyone can offer
A: It has influenced the distribution channel of the
comparable services, which include warehousing, portfolio
pharmaceutical industry. Previously, through the NOM-
control and distribution services, as well as terrestrial and
059 COFEPRIS only regulated drug integrity with
aerial delivery supervision. OTCs are the only product we
manufacturers and healthcare sites without watching
do not deliver as distribution volumes are high and do not
over the distribution phase. COFEPRIS now demands
fit our business model.
that laboratories oversee service providers’ compliance, ensuring product integrity throughout the supply chain.
Q: Considering OTC products represent a significant
As a result, from 2017 onward all distribution units must
proportion of the pharmaceutical industry, why did NTA
be equipped with temperature control mechanisms. Since
decide to exclude them from its operations?
our creation in 2000, regulations have evolved on a yearly
A: In today’s world, groundbreaking laboratories are
basis. We have seen the way the market has evolved,
focusing on biotechnological specialty drugs in line with
where laboratories merged with each other, growing their
health trends. The volumes of these products coupled with
production and distribution volumes. In return, NTA has
the desire of businesses to keep inventory numbers low have
learned how to become flexible in the way it works. In the
given way to our services. Maintaining a balance between
past, we only reacted. As of today, we can foresee what
low distribution units and low inventory numbers is tricky.
will happen further along the line.
However, the price of specialty products keeps economic performance up. Nonetheless, to ensure healthy profits,
Q: Last year, you were the only company with SMTC
precise and timely distribution is of the essence. We must
01 certification (service, handling, transportation and
also take the packaging and transportation temperature
custody certification). How does this differentiate your
levels into consideration, which must be set at 2-8°C. If this
services from others?
A: The SMTC 01 is a security certification implemented to service pharmaceutical companies. As the only company in Mexico that has secured it NTA can guarantee products will arrive safely. The certification covers the new subsections the NOM-059 is aimed at tightening. Our clients' patrimony is at stake during the distribution process, and the SMTC 01 reflects our ability to keep dangers to a bare minimum including damaged, lost or stolen goods. By complying in terms of safety we achieve the quality of service expected by our clients. With the enforcement of the NOM-059 sub regulations, companies will have to catch up. Even though we will see more competition from an expertise standpoint, we remain the first. There is a five-year history behind our accreditation,
“Suppliers are now expected to deliver to hospitals and clinical sites, as well as private homes and offices. In return, providers give their operators more responsibility as they must make sure the drugs’ integrity is not tampered with” Rubén Vargas, Director General of NTA
which has allowed us to further understand what our clients want and the challenges they need to overcome.
among others. Exterior audit programs are also put in
As such, NTA continues to understand the market’s
place by our clients, which can happen at any given time.
needs and evolve its capabilities. In addition, some
Through both, NTA systemically improves any deficiencies
small distribution companies with insufficient financial
and tightens its strongholds. Finally, we are measured
capital will not be able to comply with new temperature
and graded by Good Manufacturing Practices (GMP),
requirements.
which controls quality practices of the pharmaceutical industry and by the Mexican Society of Standardization
Q: In which ways does NTA ensure innovative means of
and Certification (NORMEX) that evaluates both safety
transport and quick responses?
and quality. As such, our results speak for themselves,
A: NTA has an in-house auditing program that takes place
securing between 96 percent and 98 percent compliance.
twice a year, overviewing every affair of the company. This
If we expect to service the health industry we must run
includes transportation, security, quality and delivery time,
parallel with what authorities expect of laboratories.
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| VIEW FROM THE TOP
WASTE DISPOSAL REACHES 26 STATES JOSÉ AEDO Director General of SINGREM
Q: In 2008, CANIFARMA created SINGREM. What was the
waste to an authorized company that will destroy
strategy behind this?
the product. We receive a certificate of destruction
A:
256
The
law
states
that
manufacturers,
distributors
and elaborate reports for the authorities and the
and sellers of motor oil, batteries and cooking oil are
companies that are collaborating with us. The law
responsible for managing hazardous waste. In relation
states that all companies must either have a disposal
to medicines, pharmaceutical companies are obliged to
plan of their own or adhere to an existing one. We are
destroy the drugs used by households, hence a company's
the only program carrying out this activity. The most
obligation is not limited to when the drug is sold but
common disposed products are analgesics and anti-
until it reaches the expiration date. CANIFARMA decided
inflammatories, as well as antibiotics and products for
to create the National Waste Management System for
diabetes such as metformin. Unfortunately, only 100
Packaging and Drugs (SINGREM). Our aim is to provide
out of 200 pharmaceutical companies use this plan so
the necessary logistics to collect the product from
we are practically collecting waste for those that are not
consumers and ensure an adequate disposal. SINGREM is
attached to us yet. Sometimes companies incorrectly
financed by pharmaceutical companies. The pilot test took
believe that if they are not part of CANIFARMA they
place in 2008 and in 2009 more containers were set in
cannot be part of SINGREM. We serve companies like
several states. It was not until 2010 that the project began
Procter & Gamble, which is not part of CANIFARMA but
to operate at its full capacity. We started with a presence
belongs to the program because it sells OTC products.
in four states, then we established ourselves in Mexico City
At this point, 15 of the top 20 largest pharmaceutical
and we now cover 26 states.
companies are already in the program.
Q: How hazardous is medical waste compared to oil
Q: What are the main motivations for companies to
and industrial waste and what was the pharmaceutical
participate in the program?
industry’s main concern in this respect?
A: European and American companies in particular are
A: Lack of proper drug disposal increases the likelihood
more prone to joining us as they are usually extremely
of them ending up in the black market. This is particularly
responsible when it comes to complying with global
true for expired medication since packaging can be
regulations requiring them to implement waste disposal
easily counterfeited. Another concern is pollution when
programs. Local companies such as Liomont, Sanfer,
medicines reach the ground, rivers and lakes. We collect
Hormona, Psicofarma and Chinoin, just to mention a few,
about 40 to 45 tons a month. Northern states such as
are attached to the program as well but generic producers
Chihuahua, Sonora and Tamaulipas are not covered yet,
are still not incorporated. Given that generics represent
while the city of Monterrey was included in 2015. I believe
more than half the volume we collect, the situation is
we can collect 1,000 tons annually but at this point we do
aggravating.
not have the capacity or infrastructure to manage it. In 2008 we collected eight tons and this year we are going
Q: What expansion strategies are you considering for the
to be close to 500.
future? A: Next we are planning to cover Chiapas and subsequently
Q: What is the added value SINGREM provides and what
Tabasco. Logistical issues in terms of distance for northern
are the most common products found in your sampling
cities still limit our expansion plans in the medium term.
results?
We have a presence in Tijuana, where several destruction
A: We are authorized in the Handling Program and our
companies are based but it is still difficult to reach La Paz
responsibilities include placing containers in pharmacies,
and Los Cabos due to distance. We plan to have more
removing
containers in retail stores and pharmaceutical chains.
disposal,
sampling
and
finally
delivering
| VIEW FROM THE TOP
ADDED VALUE SOLUTIONS OPTIMIZE MEDICINE DELIVERY PATRICK TROOP Director General of Pharma Tycsa
Q: What is unique about Pharma Tycsa?
high prices and institutions have no option but to accept
A: The healthcare industry is looking for distributors with
them. This is something that should be regulated in the
proper infrastructure, systems, ethical practices and a
short to medium term.
strong transparency policy, which translates into a huge opportunity for us. In our first three months of operations
Q: How could public institutions further optimize their
we closed a contract with a public institution to which
processes and how are you helping to do so?
we distributed products and also created value for our
A: Our added value services always try to put patients
suppliers by managing the delivery of therapies to patients.
at the center. I believe the system is moving toward
To do so, we incorporated professional pharmacists in
cost optimization through consolidated purchases. The
the customer drugstores, something rather uncommon
next step for cost reduction is to manage inventories
in Mexico. The difference between having clerks and
and to keep track of where medicines go and how they
pharmacists in pharmacies is that the former just deliver
are delivered. The process to provide medicines to
prescription medicines, while the latter actually analyzes
patients in public institutions consists of purchasing
the prescriptions and makes sure they are in accordance
medicines, warehousing, distribution logistics, delivering
with patientsâ&#x20AC;&#x2122; records. This is a highly valuable service for
products to pharmacies and then giving them to
our customers because it adds a clinical component to
patients. There is a great opportunity to reduce costs
deliver better attention to patients. We have also developed
along this chain. We can get involved in some parts of
a new service called Clinical Breast Cancer Integral Service
it while institutions are fully responsible for others, like
aimed at delivering high-quality services to patients.
ISSSTE, that has subcontracted warehousing and logistic services while IMSS has not. Data collected from a 10-
Q: How are integral services transforming the way
year period worldwide show that more than 30 percent
healthcare services are delivered?
of prescriptions are done or processed incorrectly by
A: The definition of integral services should be clarified
physicians, nurses, clerks, among others. In Mexico, the
because some providers could use the term as a way to
rate of error is even higher. We have hired pharmacists in
avoid disclosure of the full range of services and costs
a public oncology hospital in the State of Mexico, where
they are charging. Integral services comprise a set of
we have already implemented some systems. Last year,
products, services, experience and information to take
we detected 2,000 incidences in a 40-bed oncological
full responsibility of a certain activity the government
hospital so we now have statistics representing the first
does not know how to do or should not invest in doing.
step to transforming the way medicines are delivered in
Whereas the private sector uses its resources more
the country. If drugs are administered to cancer patients
efficiently, public hospitals do not have enough budget
incorrectly the efficacy and safety of the treatment can
to acquire, maintain and repair equipment, which could
be compromised.
easily result in expensive and underutilized equipment. Integral solutions are therefore intended to provide better
Q: Where do you see the company at the end of the year?
services to patients, have more positive clinical outcomes,
A: We want to incorporate pharmacists in at least two
reduce bureaucracy in institutions and manage resources
more oncology hospitals and we want to expand our
more efficiently as a single, expert provider. Actually, some
Clinical Pharmacy Integral Service in some others. We
surgeries cost more for public institutions than for private
are also planning to launch a project for hospitals to
hospitals so there are more than enough opportunities
incorporate a system that was developed by us to track
to optimize processes in the public system. On the other
the actual number of prescriptions delivered to patients.
hand, the bargaining power of integral service providers
This will make the process more transparent and help
has reached a point in which they are capable of charging
public institutions reduce unnecessary costs.
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| VIEW FROM THE TOP
LEVIC GROWS INFRASTRUCTURE TO EXPAND REACH VÍCTOR SOTO Director General of Distribuidora Levic
Q: How do you ensure the quality of products is
operations as we take this health alternative to pharmacies
maintained during transportation?
and homes. It is our raison d’être.
A: Medicine is delivered in containers to avoid damage to
258
the secondary packaging to the greatest extent possible.
Q: What is being done to minimize losses in times of
Our vans have combined temperature and pressure gauges
strikes and blockades and how do you continue to ensure
and air conditioning for warm climates. We ensure a cold
product quality?
chain for products that require special temperatures.
A: Products and supplies are made ready for delivery and
In both cases the temperature is constantly monitored
channeled through our logistics area, which uses satellite
assuring that even when products are transported over
location to determine an efficient route. In zones of conflict,
long distances, all safety, quality and trust standards are
we use satellite to permanently monitor the delivery on top
maintained.
of the standard means we use to maintain product quality.
Q: Who are your principal clients?
Q: What challenges is the distribution industry facing and
A: Our principal clients are independent pharmacies,
how is Distribuidora Levic overcoming them?
hospitals and clinics, regional distributors and some
A: The greatest challenge the industry is facing is being
government offices.
able to cover medicinal needs in every corner of the country. Levic has growing infrastructure that allows us
Q: What are your most important alliances?
to reach further and further away, satisfying the medicinal
A: We work with different pharmaceutical associations such
needs of our clients and commercial partners.
as UNEFARM, Farmacias Tradicionales and ANAFARMEX. Q: What rates of growth have you seen and what growth
“The greatest challenge the industry is facing is being able to cover medicinal needs in every corner of the country” Víctor Soto, Director General of Distribuidora Levic
do you foresee? A: There is much talk of growth in the pharmaceutical market. We have seen sustained double-digit growth and we wish to continue in this way to enter new markets. Q: In light of the wave of expansion of Mexican companies in the world, has Levic spotted an opportunity to expand to other zones such as the Caribbean or Central or South America? A: We are already working on this with our commercial
Q: What are your best-selling products?
expansion department. We aim to enter the Central
A: It varies, as we sell high volumes of pharmaceutical
American and Caribbean markets.
products for respiratory diseases, infectious and chronic illnesses.
Q: What plans do you have for 2016/2017? A: A new distribution center in Monterrey is underway.
Q: What effect will the government budget cuts have on
We
your operations?
distribution center to its maximum potential and we are
A: The fewer resources that are allocated to health, the
also opening two more secondary distribution centers,
more the population will be forced to buy the best quality
which will allow us to reach states in which we do not
medicines they can by their own means. As one of the
have a physical presence and enter Central American
main distributors of generics, this strengthens our area of
markets.
are
working
in
developing
the
Mexico
City
| VIEW FROM THE TOP
STRUCTURE AND EXPERTISE KEY TO GROWTH RUDOLF HESS President and CEO of R.H. Shipping
Q: How does R.H. shipping ensure the adequate
perishables have allowed us to be part of the logistics
transportation of delicate samples for the health industry?
of many important companies inside and outside
A: We follow and monitor the temperature of shipments
Mexico. We offer many transport solutions for general
through thermo-sensors in accordance with negotiated
and specialized cargo, maintaining our position in the
space with airlines and maritime shipping companies that
market for over 20 years and strengthening bonds with
have refrigeration and temperature control services.
our clients. This has positioned us, a Mexican company, as one of the top five freight forwarders in the various
Q: How do you ensure the chain of custody?
industries in which we operate.
A: Through the sensors in the cargo, we keep the client informed of any event or diversion.
Q: T21MX reports that R.H. Shipping is expecting 20 percent growth this year. To what extent is this true and
Q: What expertise have you gained from the perishables
what are the drivers behind this growth?
industry that can be applied to the transportation of
A: In 2016 R.H. Shipping showed a significant increase
goods for the health industry?
in the volume of air exports. According to IATA, we
A: We ensure the management and monitoring of the
are in the top five freight forwarders in Mexico every
cold chain and temperature control to maintain optimal
month. This reflects the excellent work accomplished
conditions, to preserve the hygiene of the product and to
by the perishables division and the general division,
offer clients the best service in the pharmaceutical and
and R.H. Shipping hopes to close 2016 with even better
perishables sector.
rankings. We hope that 2017 will position us within the top three freight forwarders in IATA rankings. Besides,
R.H. Shipping is a leader in handling perishable cargo. The
our maritime shipping sales have also grown in a manner
company is looking to apply the know-how obtained in
that has enhanced our negotiation power with shipping
perishables to the pharmaceutical industry and wants to
lines.
become a reference within the next year in the logistics industry for handling pharmaceuticals.
Q: What is the importance of the health industry for R.H. Shipping?
Q: What places you ahead of your competitors in the
A: It is important for R.H. Shipping due to the high demand
Mexican distribution industry, specifically for biological
that it represents globally. The expectation is that it will
samples and medication?
continue to grow in the future. As a logistics operator
A: We guarantee the correct handling of the cargo,
R.H. Shipping will be able to offer high-quality services
helping to reduce risks, costs and transportation time.
according to our customer needs. We have the structure,
We give personalized professional advice for our team of
expertise and capable staff to grow in alliance with the
dedicated professionals. We also have technological tools
pharmaceutical industry.
that allow us to innovate to offer more efficient channels of communication including visualization and generation of reports for our personnel and clients.
â&#x20AC;&#x153;We hope that 2017 will position us within the top
Q: How important are your Mexican operations for you globally? A: Mexican operations are extremely important for
three freight forwarders in
the company as the high volume of imports and
IATA rankingsâ&#x20AC;?
exports from other industries such as oil and gas and
Rudolf Hess, President and CEO of R.H. Shipping
259
260
| VIEW FROM THE TOP
GROWING DEMAND FOR SPECIALIZED STORAGE FACILITIES CAROLINA GALICIA Director General of World Courier
Q: How is the change in pharmaceutical company and
embedded controller interface (HECI) specifications.
clinical trial budgets affecting World Courier’s business?
Our clients expect this. We are frequently audited in line
A: It has definitely affected all those in the industry and
with the high standards required by GxP. Our clients are
everyone is looking for more value for money. Fortunately
constantly looking for more options, weighing costs and
as we have a great deal of experience, particularly in
benefits together with adherence to protocol and study
clinical trials and we follow Good Manufacturing Practices
specifications.
(GMP), good distribution and clinical practices, this has not resulted in serious difficulties for us or our clients. We
Q: What are the greatest risks in pharma at the moment?
have 14 warehouses dedicated to clinical studies. We have
A: As the industry employs extremely high-quality
more than 140 offices in over 50 countries. We are more of
products, shrinking budgets may be the biggest risk
a partner than a vendor to clients.
for everyone to maintain standards for patient safety. Processing times, permits and changes in government all
Q: Are you still growing in Mexico?
affect how we can do business. Recruitment and retention
A: Yes, in spite of market difficulties we hope to continue
rates of patients for studies are critical and failure to
our growth in the coming years. We are looking to grow at
maintain these will affect the industry greatly.
around 20 percent and offer more exclusive services. The clinical services market on Mexico is consolidating, which
Q: What is driving your business in Mexico and what will
is why we are focusing in other sectors too. Growth of the
we see in years to come?
market in general is difficult to measure and our numbers
A: Right now, the greatest demand is in storage and
do not correlate exactly with the market.
distribution in contrast to transport. Mexico is a vast country and we are interested in entering other states, like Jalisco.
Q: Why is Mexico becoming a more attractive market for
We will continue to specialize in pharmaceuticals. Our new
clinical trials and how is this trend growing?
invention, Cocoon™, is a type of packaging designed for
A: In the past, regulatory framework impeded us from
larger bulk supply shipments. This was created for use in
doing many things, including clinical trials, because many
pallets, with specific temperature requirements. Cocoon
companies lacked COFEPRIS’ authorization. This has
is a game changer for us as it is extremely light when
stabilized and the number of protocols we are working
compared to other packaging options on the market.
with has grown. Our location also makes Mexico an
Weight is typically reduced by 25 percent. Within the
attractive country to work in, with a diverse population
pharma supply chain, we offer a service called “Direct to
that is ideal for studies helped, by our close proximity to
Patient” where deliveries go to the patient at home or into
the US.
the hands of a medical professional caring for them. This is already in place in around 40 countries including the US.
Q: What are the tendencies in pharma logistics in Mexico?
We have the regulations in place to roll this out in Mexico.
A: Storage is definitely a trend, as we have seen across
What often causes patients to withdraw from a study is
our 14 depots. Standardization of services and having
that they cannot easily attend the place where the study is
strategic locations in emerging markets, particularly in
being held, particularly when they are sick.
Latin America, is very important. Either direct distribution or depots are needed. Depots must adhere to the
ASD Healthcare, also a part of our parent company
conditions required by the client and the regulators.
AmerisourceBergen, offers myCubixx, a small refrigerator
Any company providing such a service must have the
that can be kept in a pharmacy or in a patient’s home,
necessary
scans the medicines inside and automatically orders new
staff,
processes
and
documentation
and
control the temperature, with demands such as host
supplies when specific stocks are low.
261
| VIEW FROM THE TOP
EFFICIENCY DRIVES GROWTH FOR DISTRIBUTION JOSÉ PEÑA Director General of Grupo Marzam
262
Q: What does your recent decision to take a new
companies expect from distributors. I think more synergies
professional direction, moving from the pharmaceutical
could be created between the pharmaceutical industry,
sector to the distribution industry, mean for you?
points of sale and the government. We must also make an
A: I want to implement different ideas and practices
effort to emphasize the importance of distributors in the
from the pharmaceutical industry and provide insights
healthcare supply chain. The healthcare system cannot
on what the industry requires from distributors. I
function without distributors, so strengthening the image
think there are more synergies to be created between
of Grupo Marzam as an essential actor in the value chain is
pharmaceutical companies, the points of sale and the
a priority. We have the opportunity to position ourselves
government regarding distribution. I also believe we must
as a truly critical and unique provider for the industry.
make a concerted effort to emphasize the importance of distributors in the healthcare supply chain. The
Q: What does Münch Cooperatif owning the majority
healthcare system cannot function without distributors,
shareholding of Grupo Marzam represent for the
so strengthening the image and value of this segment of
company’s future?
the value chain is a huge priority. With this in mind Grupo
A: Münch Cooperatif purchased 51 percent of Grupo
Marzam has the opportunity to position itself as a truly
Marzam shares and our intent is to be a strong actor in
critical and unique provider for the healthcare system.
pharmaceutical distribution in Mexico. This is a long-term project that represents both a challenge and opportunity
Q: What are your immediate plans as the new Director
to take the company to the next level and become a major
of Grupo Marzam?
player. In the long term we are committed to increasing
A: Innovation in the distribution segment has been
our stake in the company. We will introduce several
lacking in the past decade, therefore, we are excited to
innovations to Grupo Marzam’s structure, business scope
start looking at things disruptively, hoping to provide new
and technological capabilities to become the supplier of
services. Customers want new things so we plan to focus
choice, not necessarily the largest one, but the smartest one.
on efficiency. Considering that margins in distribution
Grupo Marzam is also determined to become a strategic
differ greatly from those of pharmaceutical companies,
partner for our customers regarding business development
implementing the right organizational structure and
and execution. It is essential to think differently. Looking at
capabilities will certainly help us optimize our processes
the distribution sector today, the vacuum left by Casa Saba
and costs. Today, about 96 percent of our profits come
has already been filled by three major distributors and by
from the private market and this will continue to be the
companies developing their own distribution channels. We
priority for the next five to 15 years. However, we still want
have moved into a new stage for the industry. There are a
to grow our public sector customer base. Multinational
lot of things we can learn from Casa Saba so that we do not
pharmaceutical companies are increasingly focusing
follow the same path.
on specialized medicines such as biotechnology and oncological drugs, which are mostly bought by public
Q: How does fragmentation of Mexico's healthcare
institutions. The public sector represents 44 percent of
system impact the distribution segment?
the pharmaceutical market, therefore, we cannot afford to ignore it.
A: Mexico is considering healthcare universalization, which I think is still at a conceptual stage. The country’s healthcare system is complex because there is no single
Q: What role do you think distributors should play in
healthcare provider and having a highly fragmented
today’s healthcare industry?
system makes it difficult to implement an effective
A: Having spent 25 years in the pharmaceutical industry
strategy across the country. Having a single healthcare
has allowed me to fully understand what pharmaceutical
provider could certainly make operations more efficient
but it could represent fewer opportunities for players used
the industry and end user. This could lead to reducing the
to negotiating with different institutions. Consolidated
gap between manufacturers and the final client by using
purchasing, for instance, makes supply of goods difficult
strategies such as home delivery. Grupo Marzan is known
to a certain extent because of the large volumes
for its deep understanding of the industry, which results in
demanded and negotiating with a single supplier is riskier
trust building and strong client relationships.
for institutions. We have to closely analyze procurement methods and evaluate their success in providing medicines,
Q: How are you facing the changing landscape in the
devices and diagnoses to the population.
retail market? A: The market has seen a significant amount of changes,
Increased collaboration between the private and public
including pharmacy chains consolidating. As some
sector is worth our attention. There are nearly 30,000
expand there are fewer independent pharmacies, but this
pharmacies in Mexico that could be pivotal in drug
trend will shrink. In terms of distribution we still need to
dispensation for the public sector. Private hospitals
mind the different channels. Supermarkets and pharmacy
could also become more relevant in supporting public
chains require different services than independent
institutions by overcoming their weaknesses. There
retailers or private hospitals. Independent pharmacies
are a lot of private and public partnerships involved in
will continue to rely on large distributors and represent 25
building new hospitals but more partnerships are needed
percent of our sales, while pharmacy chains constitute 30
to deliver higher quality services to the population. It is
percent and are currently establishing direct commercial
important to visualize how the healthcare sector is going
relationships with pharmaceutical companies.
to move forward.
263
They will never purchase medicines from a single The dominant model today is cutting prices but there
company though, so the role of distributors is still
is a limit to it. Grupo Marzam needs to focus on being
extremely relevant. Grupo Marzam has 10 distribution
a reliable supplier and offering appropriate distribution
centers and 30 sub-distribution centers across the
solutions. In the past, there was no significant focus
country, supplying 420,000 units of medications per
on efficiency, margins were greater and there was less
day and covering 18,000 pharmacies so there is robust
pressure on pricing. This has completely changed and
infrastructure to capitalize on.
prices of both generic and innovative medicines in Mexico are among the lowest in the world. Efficiency in all
Q: What role does digital technology play in improving
activities could be one of the major factors contributing
distribution efficiency?
to success.
A: Our customers want to know in real time the status and location of their products to make quick decisions. IT
Q: What growth strategy would you consider efficient
platforms are an area where we can grow and differentiate
given the different sectors and market segments?
ourselves to provide more effective solutions to our clients.
A: Product segmentation is essential to devise effective strategies for tackling the different sectors. We must
We have several IT projects at advanced stages aiming
make sure that we have a clear strategy for generics in
to optimize times, resources, routes and follow-ups. We
both the public and private markets since Mexico is the
are looking forward to implementing them in the short to
top consumer of generics worldwide as they comprise
middle term.
84 percent of all drugs distributed. We must also focus growth on the distribution of specialty products, such as biotechnology drugs, oncology and orphan drugs, since these areas are evolving and sustaining the importance of delivering value to our customers. One of our priorities is to deliver quality services that will differentiate us from a simple logistics provider transporting cargo from point A to B. We must ensure client satisfaction by optimizing processes and working closely with our commercial partners in implementing new business models such as shared risk and pay for performance. These are becoming increasingly important
“Prices of both generic and innovative medicines in Mexico are among the lowest in the world. Efficiency in all activities could be one of the major factors contributing to
given public sector budget constraints, so we should
success”
master their implementation to become a catalyst between
José Peña, Director General of Grupo Marzam
| VIEW FROM THE TOP
MEDICINE ON DEMAND
JOSÉ MORA CEO of Farmalisto
264
Q: What are the market conditions and opportunities that
they will eventually need. Farmalisto contacts its clients
led to the creation of Farmalisto?
a few days before they run out of medicine as to prevent
A: Farmalisto started operations in Colombia more than
them from enduring any complications. We have recently
two years ago. We are an online company that operates
focused on patients with hypertension, diabetes and high
in Mexico as much as it does in Colombia, making its way
cholesterol, all of which need close follow-up. Offering
to the local market in 2015. E-commerce is the newest
the lowest market price is one of Farmalisto’s business
trend in business and Farmalisto is taking advantage of
promises. If clients find better listings Farmalisto matches
new technology and available distribution channels for
the price and deducts double the difference in their next
prescription and pharmaceutical products. Farmalisto
purchase. That is to say, clients get a MX$10 (US$0.5)
saw an upsurge in e-commerce opportunities especially in
discount if there is an initial MX$5 (US$0.27) difference.
large cities where mobility is an issue. Traditional pharmacy stores also have limited storage space, which could
Q: What led Farmalisto to come into the Mexican market
mean product scarceness. Farmalisto’s goal is to provide
rather than expanding into the South Cone?
ongoing support and comfort to the clients that need it
A: There are two key reasons why Mexico made sense
the most. Some of our clients suffer from chronic diseases,
to us. Firstly, it is the second largest Latin American
forcing them to purchase their medications on a monthly
market following Brazil. Secondly, the out-of-pocket drug
basis. As such, Farmalisto follows up on the status of its
payment percentage in Mexico is nearly 80 percent.
clients, making sure the right dose was purchased at the right time. By knowing our clients have properly followed
As such, Farmalisto foresaw that Mexico was essential to
their treatment, side effects are kept to the lowest point.
its success. Our strategy is to attract direct consumers rather than state institutions, which perfectly fits Mexico’s
Q: How does Farmalisto comply with its three-hour
market conditions.
delivery promise in an environment such as Mexico City? A: Farmalisto has specialized in logistics operations since
Q: How did the Farmalisto Esencial program get started
birth. Creating demand, having efficient purchasing
and what results have you reached from this initiative?
schemes and becoming experts in logistic operations are
A: Patients constantly look for added information regarding
three main elements to the company’s business model
their medical conditions especially in therapeutic areas.
success. If Farmalisto does not have sufficient logistics
Therefore, we created categories for Mexico’s largest
power, creating high service demand is pointless. We have
market segments, where clients have the opportunity to
a fleet of 15 motorcycles that service inner-city customers,
ask questions and get a referral to companies that can
coupled with key partnerships with FedEx and DHL
further provide information. Patients value information and
that cover the rest of the country. On average 30 inner-
our program has helped them in their efforts. If patients
city orders are delivered daily in our around-the-clock
have not found a good supplier Farmalisto Esencial helps
schedule while keeping flexibility at the top of our agenda.
them purchase the drug they need.
Although Farmalisto does not operate day-and-night outside of Mexico City, we are evaluating the possibility
We provide optimal information while helping clients
of doing so in the near future. If demand grows our fleet
reach the medicine they truly need. By receiving this type
will grow too.
of support from the pharmaceutical industry clients have more inclination to use our services, creating brand loyalty.
Our SugarCRM database enables Farmalisto to keep close
Our business model calls for constant evaluations in each
track of its client’s treatment, as doses and intakes are
operational activity. The Farmalisto Esencial program has
recorded allowing it to assess the number of packages
positively impacted our sales with a clear ROI.
| VIEW FROM THE TOP
STRATEGIC ALLIANCES IMPROVE THE SUPPLY CHAIN RODRIGO AMOR Branch Manager of Marken
Q: Marken is within the top 3 medical commercialization
and it was common to use on-board couriers to collect
and logistics companies. What strategies have you
these. This came at a high cost. The development of a
implemented to maintain your position and business in
more efficient logistics network with dedicated personnel
Mexico?
and strategic alliances has allowed the creation of better
A: Marken opened a large Good Manufacture Practices
and less expensive routes, facilitating the transportation
(GMP) depot two years ago and just rolled out Marken
of goods. These strategic alliances include airlines, a great
Allegro, an online booking tool for all research sites
advancement for the industry. We have a strong alliance
in Spanish. We have moved to offer direct to patient
with Aeroméxico, which has allowed us to increase the
services and are leaders in this area. We are now heavily
efficiency of routes while reducing transit time as well as
investing in the supply chain services for cell, gene and
costs increasing visibility and quality.
immunotherapies as a key focus of our industry demanding high-quality services with GPS tracking and full chain of
Q: Why were airlines not part of the supply chain before?
custody.
A: This was mainly because of a lack of knowledge surrounding biological samples. The majority of samples
Q: How has this tracking system contributed to a reduction
we transport are at room temperature or frozen with dry
in costs of your internal operations and was it developed
ice, and Marken provides the proper type of packaging per
in association with another company?
temperature for shipment, which facilitates transportation
A: The software was initiated by a developer and Marken
and reassures airlines into being part of the supply
acquired the rights to it before it was finalized. This was
chain. We worked closely with them, showing our
extremely convenient as we were then able to adapt it
secure transportation of samples and demonstrating the
to our requirements. It allows us to monitor costs more
packaging is specifically made for this use. We explained
closely and helps with our visibility. Regional operative
that dry ice might be at risk if it is packed in an airtight
directors were also involved in the development phase.
container but the industry has now developed ventilated
We made sure it offered optimal traceability, letting our
ones. These sorts of technological advantages play a big
customers know when the product was shipped and when
part in bringing airlines into our supply chain.
it is expected to land so they can plan for its reception with minimal time lost. We enter routes into the system
Q: What areas of opportunity do you see within Mexico’s
and then assign a cost per shipment. We can thus see
legal framework that would facilitate and improve
what cities or routes provide better costs and find ways to
business without compromising quality?
improve the situation in those that don’t.
A: One area of opportunity may be the excessive fiscal controls that companies with international transactions
Q: One of the industry’s most important objectives is
such as Marken are subject to. Certain controls are
cost reduction. What are the biggest challenges these
undoubtedly necessary and a new trend has emerged in
companies will have to overcome to succeed?
making them electronic. Commercial and shipping invoices
A: Companies want cost reductions but they are also
will soon become digital, putting our transit times at risk.
managing more complex projects. The strategies that we
Instead of having the customs broker or Marken produce
have put together to respond to this involve making our
this document we will have to reach each CRO to generate
processes as efficient as possible in addition to creating
this digital receipt with their complement and they do not
strategic alliances with commercial partners. A few years
necessarily have the time or knowledge. In this respect,
ago, the routes to transport drug product and biological
the transport of biological samples is treated by fiscal
samples were much less developed, leaving companies
authorities as a commercial product. The industry is actively
with few options. Recovering samples was a challenge
working to avoid this disruption in cooperation with SAT.
265
MEDICAL TOURISM
13
The medical tourism market continued to grow in Mexico over the past year. Globally, Mexico occupies second place for medical tourism, behind Thailand. Many opt for Mexico due to its affordability and high-quality medical care and many doctors have trained both in Mexico and abroad in the US or in Europe. Institutions are actively seeking both local and foreign certification to bolster their appeal to tourists.
According to ProMĂŠxico, nine hospitals and one medical complex in Mexico are accredited by the Joint Commission International (JCI) and 96 are certified by the Ministry of Health. Others have relocated their facilities to medical tourism hubs such as Tijuana, Cancun, Merida or Monterrey and use brokers to attract more foreign clients. Many insist their staff speak English so patients feel secure at all times and understand the steps of their medical treatment or surgery. These services are increasingly attractive as healthcare centers arrange complete holiday packages for their patients, making a procedure performed abroad the least complex possible.
This chapter looks into the evolution of medical businesses to adapt to this inflow, what strategies they are implementing to attract more clients from abroad and how local government entities are aiding clinics and hospitals.
267
| CHAPTER 13: MEDICAL TOURISM 270
VIEW FROM THE TOP: Servando Acuña, Quintana Roo Medical Travel Association
271
VIEW FROM THE TOP: Regina Garza, Parque TecniA Universidad Anáhuac
272
VIEW FROM THE TOP: Eduardo García, Clúster Ciudad de la Salud and UDEM
273
VIEW FROM THE TOP: Mario Estrada, UROSUR
274
VIEW FROM THE TOP: Rogelio Villarreal, Centro de Oftalmología Monterrey
276
VIEW FROM THE TOP: Alexis Acuña, Cancun Oncology Center
278
VIEW FROM THE TOP: José Gaytán, Fertility Center Cancun
279
VIEW FROM THE TOP: Mayra de la Garza, IREGA
280
VIEW FROM THE TOP: Alma Orozco, Tijuana Bariatrics
282
VIEW FROM THE TOP: José Claros, Videre
284
VIEW FROM THE TOP: Javier Flores, Hospital San José & Hospital Zambrano Hellion
285
VIEW FROM THE TOP: Ricardo Segovia, CostaMed
286
VIEW FROM THE TOP: Javier Loria, Dentistar
287
VIEW FROM THE TOP: Alejandro Laguna, Coral Dental Center
269
| VIEW FROM THE TOP
A GROWING MARKET OF EXPAT RETIREES SERVANDO ACUÑA Director General of Quintana Roo Medical Travel Association
Q: How did medical tourism begin its development in
that per year he or she will spend US$48,000. A hundred
Quintana Roo?
US citizens living in the city will spend approximately
A: In Cancun, medical tourism started because of numerous
US$4,800,000 per year. A percentage of this amount
time-share ventures. People came on vacation for a week,
would be spent on doctors and hospitals. This is why the
got sick, had to go to a doctor or a hospital and they liked
retiree population is an attractive market for us. When
the service so much that next year they came for vacation
retirement enterprises visit us, the first thing they ask
and decided to schedule a doctors’ appointment. Coming
about is our health system.
on a vacation became an excuse for going to the doctor. 270
This is what we call informal medical tourism. Organized
Q: Why should patients choose Cancun or Cozumel over
medical tourism involves actively planning and promoting
other medical tourism destinations?
the advantages of medical services offered in Mexico.
A:
Unlike
many
other
places,
in
Cancun
medical
responsibility is mainly in the hands of the hospital as an Five or six years ago, we noticed the health situation in
institution. Those taking responsibility for patients’ lives
the US was reaching a critical point. Private healthcare
are medical institutions. Cancun depends completely
prices had increased enormously and public health
on the tourism industry, which is why we are so
services had various limitations. Around that time, we also
professionally committed to positive outcomes for our
discovered that Canada’s health system is insufficient to
patients. Our hospitals and doctors’ certifications are
cover Canadian needs in a timely fashion, indicating an
an important selling point. To obtain a certificate from
important window of opportunity. We needed to identify
the General Health Council (CSG), hospitals need to
the most common medical procedures people were in
comply with requisites as measurable as quality results,
need of and if they were elective or non-elective. We
patient safety and clinical outcomes. This involves a long
identified at least five different areas to focus on. Bariatrics
checklist of requirements. An important thing to take into
procedures were a natural option, as Mexico and the US
consideration is that CSG and the JCI have homogenized
have an increasingly overweight population creating a
their certifications. Mexico is the only country to have
niche market. Orthopedics treat many patients for knee
homogenized its certification. This means that if you
and hip replacements due to the aging society. The third
approve the Mexican Certification then you have already
market opportunity was cosmetic surgery. We also treat
approved around 80-90 percent of the US certification.
patients in dentistry, which is a sought after specialty.
Having this accreditation is commercially important.
Fertility clinics were also an important opening. Finally, we
Without the JCI seal of approval, insurance companies
want to investigate stem cells procedures. R&D facilities
will not pay for procedures. Therefore, we worked actively
are contributing to this area. Bio-cellular medicine has
to comply with their conditions.
become an important niche and is considered the future of medicine.
Q: How have the cities benefited from the development of the medical tourism industry?
Q: Is there a specific niche market in which you expect
A: Medical tourism not only creates job opportunities but
Cancun to thrive?
also contributes to the improvement of medical services
A: We have a growing market regarding medical tourism
for foreigners and nationals. Due to the constant influx
services, but we would like to attract a bigger retirement
of foreign patients, hospitals are being provided with the
community. There are more than 1 million US citizens living
resources they need to modernize their facilities to offer
in Mexico. Each of these retired citizens has an average
higher quality health programs for the least wealthy. We
income of US$3,500-4,500 per month. A US citizen living
are extremely proud of our certifications because we can
in Cancun will spend US$4,000 monthly, which means
offer quality medical services to national patients.
| VIEW FROM THE TOP
MEDICAL COMPLEXITIES FROM ACADEMIA REGINA GARZA Director General of Parque TecniA Universidad Anรกhuac
Q: Why does the university see value in becoming part of
university, as we must provide adequate training, not only
the trend of medical tourism in the region?
in terms of the medical profession but also in terms of
A: Previously, healthcare was about the social aspect and
customer service for patients.
caring for patients, but tourism has come along and made healthcare into more of a business. This can bring a great
Q: How has Universidad Anรกhuac strengthened the value
deal of economic advantages. It is our job to teach about
chain with medical training?
these kinds of trends and to identify areas where we can
A: We are working extremely closely with the Ministry
create value. One of the first contributions made by the
of Tourism (SECTUR), to form various forums. The first
university to this industry was in innovation.
platform we organized was with an international partner that focused on understanding generic concepts like
In 2008, we completed a specific analysis of medical
that of Medicare and funding for healthcare costs. I am
tourism in Mexico and we found that in the Baby Boomer
also a consultant for COPARMEX, which has a mandate
generation, many were looking to move to a different
to promote medical tourism, so we have been working in
location, so more than medical tourism, there was a type
collaboration. We have recently had a proposal approved
of assisted living. Naturally, Yucatan became the nucleus
by the National Council for Science and Technology
of this activity and many people moved from Canada or
(CONACYT) to carry out an analysis in terms of both
from very cold states in the US to spend their winters or
business and the value chain of medical tourism, and we
their retirements here. Obviously, these people needed
have an agreement with the Universidad Iberoamericana,
healthcare and they began to bring their friends and
which is working on some other projects.
family to take advantage of the quality and the low cost of medical treatment in Mexico. The question at that
We must first break paradigms. The main way we would
point became whether or not we had the facilities to
be able to obtain hard data on these indicators is by
accommodate this demographic, which prompted another
going to the source, which is of course the medical
analysis. We began to make small changes in terms of
records held at clinics and hospitals. It is astounding that
infrastructure, hygiene and access. At this point, the
so many people seek dental attention, yet no records
Mexican system was strengthening because a great deal
are kept because the clinics do not consider patients
of focus was placed on safety and security, so locations
that come from other countries. We must also make
like Merida began to be considered more as a place to live
the difference between medical tourism and tourism
or for a second home.
for purposes of wellbeing. For this reason, municipal authorities must be present to outline a proper definition
Q: Can you break down the value chain of medical
of medical tourism.
tourism, especially related to Yucatan? A: We have the hospital infrastructure, which is at the
Q: How are you spreading the message about medical
center of the chain. Clinics provide support for primary
tourism to different markets abroad?
levels of attention. However, the value chain is not strictly
A: Our main aim has been to spread the message that
limited to medical practices but also includes hotels,
medical tourism is not only the concern of one sector but
logistcs, transport services and restaurants that provide
several, including tourism, health and academia. We have
food to aid patient recovery. The role of the facilitator
been present at various international events and we have
in this sense is relatively new and is not well understood
been gradually raising the profile of Merida and putting it
because we are not talking about a travel agency that sells
on the map. We must all make an effort as a group. We are
a package deal. Rather, there are more components that
also trying to develop a degree in Medical Tourism to align
need to be considered. We also have a role in this as a
with the concepts of the new industry.
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HEALTH CITY SETS THE GOLD STANDARD EDUARDO GARCÍA President of Clúster Ciudad de la Salud and School of Health Sciences Dean of UDEM
Q: How many foreigners from abroad come to Monterrey
hospitals in Chile and are entering the Colombian market.
in search of private health care?
This helps patients move back and forth. They also have
A: The security crisis that occurred in 2010-2012 challenged
hospitals in the US that show how hospitals in Monterrey
Monterrey’s health industry and the number of foreigners
look. Monterrey's ITESM also has a good reputation and is
dropped. Now the numbers are starting to grow again.
well known in the US and Latin America.
Around 30,000 foreign patients receive treatment but we
272
are not yet at the levels previously seen. The cost-benefit
Right now the Committee for Promotion is working on
in being treated in Monterrey is attractive, especially
designing a strategy to relaunch the Monterrey brand as
with short driving distances or direct flights to major US
a health service city internationally and also to strengthen
cities. Many of the hospitals’ doctors comply with the JCI
Monterrey’s position in the internal market.
regulations. As a matter of fact, our accreditation process in Mexico is aligned with the accreditations process of JCI,
We have to understand that both segments are important
which helps attract people from overseas. The number of
and we cannot overlook the fact the public sector is
foreign patients coming into the country will quickly grow
an important player in this role. Someone that comes
in the near future.
to social security here will talk about the quality of Monterrey’s hospitals. They will help broaden the scope of
Q: Why choose Monterrey over Tijuana in the north or
opportunities that people may have. If you consider that
Cancun in the south?
in Mexico half of the service payments are out-of-pocket,
A: There are several reasons. First of all, you have a city
people will actively search for alternatives.
here that is dedicated to ethical standards in hospitals, which was written in the Declaration of Monterrey 10
Q: Is this rebranding of Monterrey as a health city also
years ago. As part of the cluster, there is the Committee of
being done through the state government?
Ethics, which reviews how well the different institutions are
A: It is supported by the state government and they
working. They are not judging, just trying to build a culture
are part of the cluster. The concept of the cluster is
that provides safety and security for the patient. The
government, academia and industry. So they are involved
technology in Monterrey is always up-to-date. Although
through the Ministries of Economy and Labour, Health
we are in the health business we also are aware of safety
and Tourism. They are trying to support our efforts. Also,
and security, which are not the same thing. Safety is the
we have the involvement of the government through the
well-being of the patient. Security is the well-being of the
hospitals and public sector. Hospital Ángeles for example
person in the city and in the institution.
is a relatively new hospital in the city and it is expanding its infrastructure effectively.
Q: How are you targeting markets other than North America, specifically through the committee of promotion
Q: Where will we see the city in the future? What new
in the cluster? How does that committee promote
projects does the cluster have at hand?
Monterrey’s health services?
A: By the end of 2016, we will be in a similar position but with
A: First we try to understand the needs of the market,
higher numbers of people from Mexico and overseas tended
especially in the US, which is closest to us. But some other
to at our health institutions. You will see a city with more
Latin American citizens choose to receive services here
demanding health-related organizations and academia
because of the equipment we have. The health sector
concerning ethics, transparency, honesty and integrity. We
has entered into the process of globalization and this has
are working a lot on credibility. Last but not least, I hope that
helped place Monterrey on the map. For example, Christus
we will see a government that is understanding, supporting
Health is the holding of Christus Muguerza and they have
and working along with the sector.
| VIEW FROM THE TOP
UROLOGY SPECIALISTS FOR LOCALS AND TOURISTS MARIO ESTRADA Medical Partner of UROSUR
Q: What were the opportunities you foresaw that led you
Q: What new treatments or technological advances are
to open the first integral urology clinic in Merida?
there in urology that put you one step ahead?
A: We wanted to create an environment where patients
A: We use laser technology to break kidney stones, which
with any urology-related problem could find a solution.
is one of the main problems here in Merida. We also now
We made sure we had the infrastructure in place, without
have new surgical reconstructive techniques, which few in
sending people from place to place. Many problems in
the southeast adopt. We are trying to change all the old
urology are multidisciplinary, so we needed many experts
techniques that are now obsolete. People are responding
in the different urologic branches in one place.
to these new techniques, including minimally invasive surgery that did not exist 20 years ago. We also have other
Q: How do you guarantee best practices that meet
new technologies like Urodynamics.
international standards? A: At an administrative level, our clinic has certification.
Q: How do you do think medical tourism will evolve in the
Federally, we are certified by the Certificación de Clínicas de
short and long term?
Atención Primaria y Consulta de Especialidades. All personnel
A: Mexico is a solid destination in which to seek an
is bilingual and we have a national certification given by the
operation, especially for the infrastructure that is present
National Council of Urology, which is structurally linked to
and the city is safe. People may prefer to recuperate by
the American Urological Association (AUA). This ensures
the beach. Also, as our currency has a certain position in
that Mexican urologists also have the latest knowledge, as
comparison with others, prices are attractive to people
would an urologist practicing in the US. We try to stay up to
who come from other countries. They can recuperate very
date with technology and advancements.
well after a first class operation that will guarantee results. I think these are the factors that will increase medical
Q: Who are you joining forces with to educate about
tourism.
prevention? A: One of the associates in UROSUR is the medical
Q: Where will we see the company in 2016-2017?
residencies teaching chief in one of the IMSS hospitals.
A: We are very interested in having an impact on a local
Training residents with a culture of prevention will have
level in Yucatan, Campeche and Quintana Roo. We are
an impact. Another associate is the chief of the Hospital
looking to expand but we are a young company, we are
Regional de Alta Especialidad de Mérida. From that position
still looking and learning. I think in a few years’ time, we
we can launch campaigns. For these campaigns, we can
will develop an even stronger team and more specialized
distribute packets of preventive urology medicine. The
equipment. We are looking to acquire a surgical theater.
government has many projects and plans but I think this is
We will likely remain at the local level with a more
the path to follow. We also cooperate with IMSS and ISSSTE.
advanced clinic, even better services and with the desire to expand our patient reach. We will also explore holding
Q: What makes you different from other multidisciplinary
consultations via video, as we have patients who contact
clinics in the city?
us from states that are far away and from South American
A: I believe we are the first to truly work as a team. If I
countries. We need to find a way to reach these patients.
have a colleague with a greater ability in an area of need,
We have a clip that greatly improves the lives of male
I will work with my colleague for the good of the patient.
patients with incontinence. This is the type of product
We have the medicine needed to ensure there are no
we can help with from a distance by carrying out online
complications. We have a nutritionist who is an expert in
consultations and online sales. We did not design the clip,
lithiasis, a sexual psychologist and a specialist in the pelvic
but we made the necessary contacts to obtain exclusive
floor, among others.
distribution rights in Mexico.
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PIONEERING EYE SURGERY IN "CITY OF SIGHT" ROGELIO VILLARREAL Director General of Centro de Oftalmología Monterrey
274
Q: You were the first surgeon in the world to perform
the future. Mexico’s eyesight health is lagging, resulting
farsightedness laser surgery. How has this helped change
in over 1 million people with poor or nonexistent vision.
the world’s perception of Mexican physicians?
Between 60,000 to 80,000 people join them on a yearly
A: Our Monterrey operations began in 1992. Centro
basis. Monterrey has always had top quality human capital
de Oftalmología Monterrey was the first center where
in the medical field but technological advancements
ocular laser surgery took place for both eyestrain and
were still lacking. Once we secured the latter, the city
farsightedness conditions. Soon after, the city’s research
saw a significant increment of patients. We have received
in laser performance exponentially increased, creating a
multiple patients in our facilities, whether foreign or
booming interest in eyesight correction. Laser precision
domestic. Most international patients come from the US,
far exceeds previous surgical techniques, guaranteeing
considering their closeness and connectivity to the city.
greater success. Thereafter, we continued our efforts
We have seen full charter flights with patients arriving to
in
Monterrey, going back to their country of origin only hours
short
sightedness
and
astigmatism
correction.
Monterrey’s involvement in the ophthalmological laser
after their procedure.
surgery field was so great the city imparted the first courses, gathering surgeons from all over the world. In
Q: What is the price range of eye laser surgical procedures?
addition, we received the support of the industry’s largest
A: This type of surgery has greatly evolved since 1992.
medical device manufacturers, further positioning the
Medical advances happen almost on a daily basis and so
city as a hub for eye care. Multiple ophthalmologists
does the technology that follows. Centro de Oftalmología
have come out of Monterrey, treating patients around
Monterrey is equipped with the latest medical devices,
the world. As a result, the city has positioned itself
which has changed our procedural approach. We now
as the “city of sight”, becoming a pioneer in eyesight
engage in minimally invasive surgery called, allowing us to
correction procedures. We also pioneered the cataract
correct the issue with little damage to the eye structure.
correction field with the implementation of bifocal
Our prices range from US$1,000-4,000 for both eyes,
intraocular lenses.
depending on the condition we are treating. Even though this type of treatment is yet to be certified by the FDA,
Q: How did you foresee the opportunity of implementing
the COFEPRIS has already accredited it. Under these
laser surgery in eye correction?
circumstances, we are attracting greater volumes of
A: Laser surgery can take as little as 20 seconds, contrary
foreign patients.
to the hour-long procedure that traditional methods take. We understood that if we wanted to quickly bring
Q: How have eyesight conditions evolved throughout the
back the eyesight of our population, laser surgery was
years and which ailments affect Mexico’s population the most? A: Society has become more attached to cellphones
“With the help of stem cells,
and computers, which has a greater impact on sight.
we will be able to create
ophthalmologists around the world concur that spending
artificial corneas, eliminating
Even though we lack the scientific proof to allege this, so much time in front of a screen impacts eyesight. This has resulted in an ailment increase, especially in children.
the need to wait for donors”
Scientists in Japan and China have also proven that keeping
Rogelio Villarreal,
impact on eye health. This has led to different teaching
Director General, Centro de Oftalmología Monterrey
models, where stepping outside and seeing nature helps
children in a classroom for long hours can have a serious
reduce nearsightedness rates. Under these circumstances,
to our communities, receiving funding from sponsors.
we are expecting an increase in ophthalmological care. We
I personally assembled a team of ophthalmologists
must also take into consideration society’s life expectancy.
that had the same concerns as I did, bringing the
Since people live longer, older members of society have
latest technology and procedures to marginalized
natural sight regression. For them to become active
communities and making it available to them. We do not
members of society, our farsightedness, cataract and
only treat patients from Nuevo Leon, as families from
eyestrain solutions are crucial.
the whole country come to us, including from Chiapas and Oaxaca.
Q: Centro de Oftalmología Monterrey is working with stem cells to develop advanced solutions in the eye care
Cataract and diabetic retinopathy conditions impact
field. What has resulted from your efforts?
Mexico’s society the most and although we offer
A: We have worked with adult stem cells alongside the
treatments, we mostly focus on educating and creating
University of Monterrey (UDEM) and its re-engineering
a preventive culture. Our most recent study shows a 5
laboratory. These are stem cells with specific applications
percent glaucoma prevalence in people over 40 years
and are directed to the organic tissue where they
of age. It is important to mention that symptomless
originated from. However, adult stem cells can now be
glaucoma, where the eye pressure is not affected, can
programed and used for other purposes. We are looking
strike patients.
to create treatments for eye conditions with no solution. As such, the disease advances to much more complicated We are still in the earliest stages of our research,
stages that need larger investments. With the help of
understanding how to manipulate and direct the cells at
UDEM, Fundación Ojos para México has developed
will. We also want to limit the scope of ailments to treat,
new screening mechanisms for glaucoma and diabetic
concentrating on retinitis pigmentosa (RP), glaucoma
retinopathy. If we can detect the condition in its earliest
and corneal opacities. With the help of stem cells, we
stages, the incurred costs will plummet for patients and
will be able to create artificial corneas, eliminating the
the public healthcare system will benefit from it.
need to wait for donors. Finally, we can also administer stem cells in all laser surgical procedures.
Finally, Fundación Ojos para México has international alliances, expanding its sphere of influence to other
There is a direct correlation between stem cells and
regions in the world. For instance, the Barzilai Medical
the time of recovery from laser surgeries. Nowadays,
Center in Israel and Spain’s Barraquer Ophthalmology
surgery patients can go back to their daily activities
Center have allowed us to further our field of knowledge,
after 24 hours, but the time will be reduced to one hour
understanding ophthalmological conditions that affect
with the use of stem cells. We are yet to define the
the global population.
concise date when our developments will be ready, as some unexpected events arose. For instance, we did not foresee the extent of our investment, which has put a toll on our development times. Be that as it may, we are working to present these solutions to the general public in a four-year timespan. Q: For the time being, the Fundación Ojos para México is one of your biggest projects. What results have you obtained and how is it helping your community? A: Ophthalmologists are becoming more aware of the problems that presently overwhelm Mexican society. There is a large population segment that is unprotected, as the government’s public healthcare system cannot cover them all. We must find alternative means of treatment that can ensure their health. For this reason, the Fundación Ojos para México came to life. We began our project in 2006, treating patients below the poverty line completely free of charge. We are an altruistic organization that wants to bring health back
About 285 million people are visually impaired worldwide. In Mexico, close to 1.3 million inhabitants have some sort of visual
impairment
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| VIEW FROM THE TOP
BRINGING ONCOLOGY EXPERTISE TO CANCUN ALEXIS ACUÑA Director General of Cancun Oncology Center
Q: Why did the company decide to establish its operations
We have built a one-stop shop clinical model for oncology
in Cancun and what were the market conditions that led
patients, following the operational plan of US and
to its establishment?
European cancer care units. All of our patients, regardless
A: Cancun Oncology Center began operations in 2013.
of their initial diagnosis, receive the attention of at least
It is part of the MRC International Oncology Center
three of our specialized oncologists.
Group comprised of US, Mexican and European investors
276
whose approach was to target emerging economies with
Q: How is Cancun Oncology Center helping marginalized
insufficient oncological units. The group has invested
communities receive cancer treatments?
in Cancun and Queretaro in Mexico, as well as in the
A: Cancun has grown exponentially over the last
Dominican Republic. MRC International recognized that
10 years, attracting wealthier communities as time
Mexico and specifically Cancun had a shortage of
passes. The city has an average population of 1 million
oncological services. In the past, regional patients had to
inhabitants. However, the project originated from a
travel to Yucatan, Campeche, Monterrey, or Mexico City to
wider angle, trying to service all socioeconomic spheres.
receive some types of treatment.
The company offers discounts to those in need by conducting socioeconomic studies, coupled with free
High-quality care units with international certifications,
treatments for children through partner foundations.
like Hospital Galenia, also opened their doors making
One of our main purposes is to service all of our patients
for potential partners in the local market. Large volumes
equally, regardless of status or financial capabilities. For
of foreign patients coming to the city added to the
example, we are equipped with the best linear accelerator
attractiveness of Cancun. Even though the oncology field
(LINAC) in Mexico’s southeast region, providing both
is not a focal point in medical tourism, we still attract
radiotherapy and radiosurgery services depending on
demand.
what our patients need.
Q: How is Cancun Oncology Center divided and what
Q: What sets Cancun Oncology Center apart?
services can it offer?
A: As I previously mentioned, our integral solutions set
A: Cancun Oncology Center’s business and medical
us apart from our competitors. In the past, excellent
attention model, as well as its infrastructure, is focused on
oncology practitioners could be found in Cancun but
an interdisciplinary approach that includes radiotherapy,
there was no cohesion in their services. After diagnosis,
chemotherapy and surgical treatments, the three general
patients were normally referred to other states, which
ways to treat cancer. We have two internal oncologists
left a lot of unexploited opportunities in the market and a
who focus on radio and chemotherapy, coupled with an
deficiency in the quality of medical attention. In addition,
affiliate group of oncologists with different specializations.
marginalized communities could rarely make the trip and receive treatment.
“Like fingerprints, each cancer
Like fingerprints, each cancer case is unique. As such,
case is unique. Patients need
patients need multiple specialists to define the best
multiple specialists to define
of Mexican oncologists, Cancun Oncology Center has
the best approach”
physicians. These physicians are leading experts in
Alexis Acuña, Director General of Cancun Oncology Center
approach and type of treatment. Besides the support also created alliances with highly renowned US-based the oncology field, all of which have developed new technology and cancer treatments.
We understand that we can achieve more positive
Q: How is the state government helping Cancun Oncology
outcomes through cooperation. Therefore, we open our
Center achieve its social purpose?
doors to independent oncological practitioners that want
A: We keep open communication channels with the
to use and support their work through our infrastructure.
government at all times. Some of our physicians work in the public sector as well, serving as the governmentâ&#x20AC;&#x2122;s on-the-
We treat our patients with affection, personalized care and
field analysts, helping it understand what is happening in
the latest scientific advancements. Similarly, we expect all
the market. Cancun Oncology Center has monthly lectures
our doctors and affiliates to follow suit. Their credentials
on prevention and public institution agents are always
alone are not enough. For us to retain their services,
invited. Cancun Oncology Center also works with private
we must make sure they believe in our philosophy and
charity institutions. In both instances, they help us spread
respond accordingly.
the information. Finally, we are undergoing negotiations with the state government as to subcontract some of our
Q: How is cancer evolving and how has it affected the
services to it.
number of patients you see come through your doors? A: Breast and cervical cancer are affecting female
Q: How much of your business is from medical tourism
populations all over the world, not only in Quintana Roo.
and foreign patients?
Male patients, on the other hand, are affected by lung,
A: On average, 20 percent of our patients come from
prostate and gastric cancer the most. When comparing
abroad. Numbers fluctuate depending on the month, but
these numbers to the US and the rest of the country, similar
that is average. Most of these patients come from Canada
results will follow. Unfortunately, the state government is
and the US. But Hospital Galenia is referring some of
still in the process of creating indicators that will allow us
its Belizean patients, as they created a link-up program
to better understand the situation in Quintana Roo. On
with private national institutions. We also have seen
a positive note, the stateâ&#x20AC;&#x2122;s public healthcare system is
patients from Germany, Italy, Colombia, Venezuela and the
systemically improving its quality, especially in oncology.
Caribbean.
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| VIEW FROM THE TOP
FERTILITY CLINICS GUARANTEE PATIENT SAFETY JOSÉ GAYTÁN Director General of Fertility Center Cancun
Q: What differentiates you from other clinics?
at the same rate. In the past, families were formed before
A: We are focused on the local population and we opened
the age of 26. The second cause is contraceptives, which
with the intention of attracting local clients and fell into
have given people more sexual freedom. People who do
medical tourism. We are also much bigger. We have 132
not protect themselves are more prone to infections, which
staff members whereas the clinic opposite us has six. The
can affect the genital tract and cause infertility. There are
other clinics have space of around 200m whereas we
other causes, like the chemicals we consume, pollution and
have around 700m2. Almost all of our staff members are
our lifestyles. Testicles have to be at a certain temperature,
bilingual. We are not associated with a hospital, as infertility
which is why they are outside of the body. We spend most
is not a disease as such. We prefer to be independent.
of the day sitting down and our eating habits are not
2
278
the same. There have been developments in ultra-rapid Many profit from the fact that infertility treatment here
freezing in vitro treatments. Before, for every 10 ovules
costs US$6,000 whereas in the US it costs US$16,000-
frozen, nine died. Now, 9.5 unfreeze well.
18,000.
Surrogacy,
which
internationally
can
total
US$60,000-70,000, costs US$120,000-130,000 in the
Q: What does your high rate of success depend on?
US. It is understandable that people come to Mexico as
A: Age is an important factor. The donation of ovules is
they would save around 50 percent on treatment. We also
the most successful treatment with a success rate of 70-
get many European clients with North American visas.
80 percent. This compensates for women aged 39-40 who
It is sometimes difficult to get treatment in Europe and
have in vitro treatment and of which only 25-30 percent
surrogacy is banned in Spain. We also offer a wide range
become pregnant. In vitro treatment for a woman of 28
of services, the most complex of which is monogenic
would result in pregnancy in over 60-65 percent of cases. So
detection. We are now treating an Indian patient whose
on average, for every 10 women we treat, six get pregnant.
daughter has Epidermolysis Bullosa. This is an extremely painful condition in which the skin lacks a certain protein
Around 70 percent of our clients are over 36 and most
and so any rough contact would break the girl’s skin and
visit with their spouse or partner. We did a study in Spain
lead to infection. The client wishes to have another child
that showed a couple with fertility problems waits around
without this gene and so in coordination with Spain and
a year and a half to come to a fertility center. In Mexico, the
Miami we have the embryo ready to transfer without the
average is six to seven years.
affected gene. This treatment can be found in the US and in Europe but it is still difficult in Mexico because there are
Q: What is this long wait due to?
very few cases. We have many mixed race people, which
A: The lack of centers available and the cost, as the
protects against monogenetic diseases.
treatments were extremely expensive. The price has not changed much, and the money it costs was worth a lot
Q: What are the infertility levels in Mexico?
more previously than it is now. In addition, doctors did not
A: Infertility is a special condition that affects people
have the habit of referring people to specialists.
equally, no matter where he or she is from. The percentage of couples with fertility problems is consistently around 14-
Q: How do these services improve the lives of your
16 percent. It is mostly women who suffer from infertility. A
patients?
woman begins to lose her reproductive ability from the age
A: It does not improve peoples’ lives; it completely
of 35, and this accelerates from age 37. From age 42, the
changes them. Couples come after years of failure and
real possibility of having a healthy baby at home is around
are tired, worn-out and angry. People that arrive stressed,
5 percent. Today people wish to focus on their careers
nervous and angry, transform themselves after having
and not on having families but our genes do not evolve
their baby.
| VIEW FROM THE TOP
SHORTENING THE WAIT FOR NEW LIFE MAYRA DE LA GARZA Medical Director of IREGA
Q: What conditions in Cancun drove the opening of a new
treatments, while others might need to undergo a surgical
IREGA clinic?
procedure before they can begin fertility treatments.
A: IREGA’s first clinic opened in Acapulco. Our decision to open a clinic in Cancun was partly a response to specific
The tests we perform help us to be realistic about our
health needs in the region. Around 20 percent of the
patient’s opportunities. It is vital to always tell them the
population in the state is affected by fertility problems.
truth regarding their chances of success. However, we
When we opened in 2011, there were no fertility clinics in
have very high success rates. Our strict quality controls
Quintana Roo. If people needed treatment they had to
help us achieve an 80 percent fertilization rate. Once the
travel to Merida or Mexico City.
eggs are fertilized we wait for embryonic development and we freeze the eggs so that couples can use them in the
Q: How do medical tourism trends impact IREGA’s
following months. Most of our patients are 34 or 35 years
strategy and operations?
old and our in vitro procedures have a success rate of 80
A: Around 30 percent of our patients are medical tourists,
percent. If a couple does not get pregnant after two clinical
which is a very high percentage. When we opened our
attempts they are required to perform follow-up studies
clinic we were focusing on local population but we started
to determine which problems they might be encountering.
receiving requests from people from the US and Canada that were looking for treatment options outside their
Q: What are the reasons behind increasing infertility
countries. Economic reasons and long waiting periods
rates?
are the main elements when people decide to come to
A: Lifestyle and professional goals are prompting young
Cancun. We have received patients from many places
couples to postpone parenthood. This takes a toll on
including Europe, Latin America and Russia, but most of
their ability to become parents. The older women get the
our patients come from the US and Canada. We promote
harder it is for them to get pregnant. After women turn
ourselves using digital media and our webpage acts as
35 years old, their fertility rates begin to decrease and
a communication portal. We also participate in medical
are drastically reduced after the age of 40. But age is not
congresses and events. Part of our service for foreign
the only setback. Pollution, environmental and chemical
patients is a logistics team that helps them get all the
agents and toxic particles are also to be blamed.
information they need for planning their trip and provides transportation for them once they are in Cancun.
A healthy couple has an 8 percent monthly opportunity of getting pregnant naturally. After the age of 35, this
Q: What processes do couples have to go through when
percentage drops to 6 percent and after the age of 40,
they go to an IREGA clinic?
it declines 4 percent more. Age plays an important role.
A: When a couple comes for the first time we ask for their
The success rate for getting pregnant with assisted
clinical history. We study their family background and if they
reproduction techniques is 60 percent but after the age of
have undergone any previous treatment. We look for signs
40 the percentage drops to 15-20 percent. There are two
of diseases that might affect their reproductive ability such
main conditions related to women’s age. As we get older,
as endometriosis, pelvic and inflammatory diseases and
our ovarian reserves and our oocyte quality are reduced
STDs. We assess the uterus and ovaries. All of this is done
and our risks of miscarriage increase, especially after the
in the first visit. Follow-up studies are required to evaluate
age of 40. Men also face fertility problems. There are many
hormones, the uterus cavity and fallopian tubes as well as
factors that decrease sperm production. Being exposed to
a sperm sample, for which we assess its' volume, mobility,
high temperatures is not conducive for sperm production,
morphology and concentration. We have to estimate the
as is smoking and being exposed to pesticides or chemical
course of treatment. Some couples only need stimulation
agents. Men are also affected by age.
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| VIEW FROM THE TOP
FOREIGN BARIATRIC SURGERY DEMAND ON THE RISE ALMA OROZCO Director General of Tijuana Bariatrics
Q: Tijuana Bariatrics has a unique operational structure
evaluation process to decide whether fertility medicine
with its main offices in San Diego. Can you further
is something we want to take part in as demand from
explain the reasons why you opted for this location?
medical tourists is high.
A: Tijuana Bariatrics was registered in the US and it
280
is considered a medical tourism facilitator. We link up
Q: How does Tijuana Bariatrics manage its patient flow?
US and Canada-based patients with Mexican medical
A: Our onsite coordinators are very important, as they
practitioners and we arrange the logistics for their stay.
serve as Tijuana Bariatrics’ initial and final point of
From the moment patients register on our webpage we
contact during the patients’ stay. Part of our patients’
begin to plan their trip and provide prospective patients
success is contingent on their follow-up process, thus
with detailed information of their procedure, services
Tijuana Bariatrics accompanies its patients through
and the physicians who will take care of them. Once
their weight loss journey, monitoring new behaviors
they are informed about our services and the patient
and helping them with their new eating habits and
has made a final decision, we charge an initial deposit
supplement requirements. We send a reminder every
to secure their place in the schedule. It is important to
three months for a year to our patients to recommend
mention that patients coming to Tijuana fly into San
they undergo a checkup. Thereafter, once a year will
Diego, which is a faster, more affordable domestic flight
suffice. We have an onsite doctor and nutritionist
and from then on they are under our watch. We send
in charge of post-operatory care, key factors to the
a driver to pick them up, take them to their hotel and
success of the patient.
the following day they are driven to their pre-operatory checks. Once there, they will meet their medical team,
We see an estimated 100 surgeries each month, which
their nutritionist and all the staff that will be in charge
requires a lot of attention. We have developed and
of their procedure.
implemented a database that automatizes patient care and their consequential attention. Following patient
Q: Considering the specific procedures your patients
registries, systemic information packages are sent to
undergo, how long do they normally stay at your
them, helping us ensure their safety and successful
facilities?
treatment. Our database management system also
A: It depends on the procedure they are interested
includes travel info, pre and post op diet information,
in as we offer a great number of bariatric and plastic
payment information, dates, bank information, medical
surgeries. For instance, when recovering from gastric
tourism policies and patient consent forms. Medical
sleeve surgery patients remain two days in the hospital
tourism insurance policies are an important part of our
and can leave Mexico on the seventh morning. All
operations. In the rare event of a complication, these
gastric bypass surgeries including mini bypass, bypass
policies will cover additional expenses needed by our
and duodenal switch require three days of hospital stay,
patients, according to their coverage, helping patients
leaving on day six. Among them, gastric sleeve surgery
feel more secure being treated abroad.
is the most popular. Nowadays, gastric band surgery is not as frequently demanded due to a lesser success rate
Q: What alliances have allowed you to operate under
than alternative procedures but it is still an option. We
your plan?
also offer revisional procedures to improve on previous
A: Throughout the years, Tijuana Bariatrics has created
bariatric surgery results, which can be a different
multiple alliances. Hotel chains, like the Tijuana Marriott,
procedure to better fit needs. Finally, the company
offer special fees to our clients, improving our prestige
has expanded its procedural scope to take part in the
in customers’ eyes. Hospitals are also a key component
orthodontics and plastic surgery fields. We are in an
for Tijuana Bariatrics. We have collaborated with a newly
established hospital, the CER Hospital. Their top-notch facility ensures success and the peace of mind we need to treat patients from around the world. Rather than only focusing on specialized services, CER is equipped with intensive care units and laboratories, further attracting patients from abroad. CER has given Tijuana Bariatrics a whole floor for its operations and refers all bariatric procedures to the company. We also have the flexibility of having the rest of the facility on hand if we happen to be oversaturated. Q: How has your position in Tijuana helped the
“We have our sights set on the city of Monterrey once again. Its infrastructure and capable professionals have helped it gain the name 'health city' ” Alma Orozco, Director General of Tijuana Bariatrics
company’s overall operations? A: Our proximity to the border has worked in our favor.
patients to find the company that better fits their
Tijuana Bariatrics is positioned on the border in one of the
needs. By categorizing facilitators based on their types
city’s nicest areas. In return, it has helped our logistics,
of services, efforts can be channeled more effectively
travel affordability and connectivity between sites. Even
further strengthening the medical tourism market. We
though our orthodontics facility is not in CER, it is just
can also pinpoint and evaluate a hospital’s and doctors’
around the corner in a state of the art institution with
performance, thus helping them build their international
English-speaking personnel, further improving the way
reputation.
we work. Because most of our patients come from the US,
281
Tijuana-based professionals must speak English, which all
Q: What other markets does Tijuana Bariatrics plan to
of our drivers, onsite coordinators and doctors do.
cover in the near future? A: We have our sights set on the city of Monterrey once
Q: How has the medical tourism sector in Mexico
again. Its infrastructure and capable professionals have
evolved throughout the years?
helped it gain the name “health city”, demonstrating its
A: Mexican physicians are becoming more specialized in
importance for the medical tourism segment. Cancun has
their fields considering that most of their competition
also emerged as a medical tourism paradise pushing us to
comes from US doctors, with the advantage that patients
consider the city as our next destination.
are very cost-conscious. Mexico remains a better choice due to the high-quality services at affordable prices.
The natural economic and demographic landscape of the city makes it ripe for opportunities and we are making
Tijuana Bariatrics, alongside the nation’s health clusters
sure that Tijuana Bariatrics patients are able to take
and the Mexican health authorities, has detected
advantage of these medical travel advantages. Obesity
multiple areas of opportunity. They are looking to include
has increased incredibly globally, making bariatric surgery
facilitators in a regulatory framework to standardize
a determining factor for patients to obtain the quality of
service clusters and categories to make it easier for
life they deserve.
| VIEW FROM THE TOP
HELPING LONGER-LIVING PATIENTS SEE BETTER JOSĂ&#x2030; CLAROS Director General of Videre
Q: How did you obtain so many certifications and what
in Mexico, so we also operate on diabetic retinopathy,
were the circumstances that aided you in this?
cataract and glaucoma.
A: We started in ophthalmology in Mexico City over 20
282
years ago. When I came to Merida, I created the clinic with
Q: What technological advances do you make use of?
the aim of it serving as a highly specialized center where
A: One of our strengths is cataract surgery. Even with the
patients could be truly satisfied. Obviously moving out
highest quality technology and doctors, results depend
of the capital entailed certain consequences because in
on the lens that we use so we must use the most precise
Mexico City, everything was easily accessible whereas in
machine possible. We have just purchased a machine
Merida the lack of a supply chain made it more difficult
that allows us to operate with the highest precision in the
to implement quality. We fought for excellence and in this
calculation of lens size. Every new update to machines
way when inspectors came, we already had the highest
improves results and this keeps us well above the average.
quality equipment and personnel in place and we were able to obtain certifications. We are proud to say we can
Q: What are the reasons for cataract being the most
compete with any national or international center.
common ailment here in Mexico? A: It is because, thankfully, we live longer. There used to be
Q: How has the health system evolved here in Mexico?
hardly any cataract as people died young, at age 45 at the
A: We are pioneers in cataract and refractive surgery,
most. Nowadays, cataract is routine for people aged 75
which is recuperative surgery in older adults who want
and fewer and fewer people want to wear glasses so there
to correct vision impairments that require glasses. Merida
is an increasing number of operations.
has high standards in surgery and we are up to date in the latest advancements in technology and human capital.
Q: How has medical tourism impacted your operations? A: I operate on anyone that comes to me. We started to
Q: What are the specificities of medical tourism?
hear about medical tourism about 5 years ago but for it to
A: More than anything, we work with the idea that
really take off infrastructure such as hotels and transport
everything has to be in English. All of our consent forms are
needs to be in place to receive tourists. Now that more and
in English, all the pre-operation instructions are in English
more companies are working on this, the opportunity is
and the staff speaks English, be it those in the reception,
more appealing. We are in contact with Belize, Canada and
in surgical coordination or those involved in the rest of
the US. Yucatan is an important national center of medical
the trip. Patients should feel that even though they are
tourism and many people come to Merida for health
in Mexico, they understand what is happening and where
services. We are starting to create different packages so
they are. This makes them more comfortable and safe.
that people can come for three days and undergo surgery without having to worry about the details.
Q: What is the most common ophthalmological disease that you treat here in Merida?
Q: What type of alliances have you created, especially in
A: Nationally and even internationally cataract is the most
terms of promoting prevention?
common ailment of eye patients. Nowadays, the most
A: Since our inception, we have always campaigned for
common type of surgery is refractive surgery. A typical
this. One month per year we hold a diabetes month with
patient would be aged around 50, seeking to eliminate
the Mexican Diabetes Association during which we hold
his or her dependence on glasses. I can operate on these
free checkups for diabetics and their families. We are in
patients and restore their short and long sighted vision.
contact with the Yucatan Health Foundation and we hold
For young patients, we often carry out laser treatment and
talks on diabetes with the aim of motivating people to
corneal transplants. There are many people with diabetes
take interest and participate.
283
| VIEW FROM THE TOP
A FOCUS ON QUALITY FOR PATIENTS JAVIER FLORES Director of Hospitals and Clinical Services at Hospital San José & Hospital Zambrano Hellion
284
Q: How many surgical procedures do you perform on
Q: What certifications do you currently hold?
foreign patients?
A: Hospital San José has recently undergone an audit
A: We do not perform a great deal of surgical procedures
from Mexico’s General Health Board (CSG). Hospital
on foreign patients, although we attract international
Zambrano Hellion's audit is scheduled for July. We hold
patients, mostly from the US and Canada. The foreign
a JCI certification that we obtained in 2012. For reasons
patients often live or work here but seek treatment under
of safety, the commission did not want to come to Mexico
a foreign address, which is why they are considered
to carry out the evaluation so we had a robot that went
medical tourists. Although we do not look to receive
around the hospital. We are hoping that by December
foreign patients specifically, we do get some.
2017 we will be re-evaluated and gain another certification, either by the JCI or another international organization.
Q: To what extent are you using alliances with doctors abroad to attract foreign patients?
Q: How has the affiliation with Houston Methodist
A: Usually the patients come through a broker, which
increased your patient influx?
mostly originates in the US. Most conditions that we treat
A: The affiliation was set up with the intention of exchanging
here require surgery. The patients plan this ahead and
best practices. This entity is much bigger than us in terms
decide whether to have it done here or in their country of
of patients, space and capital. We both take advantage of
origin. There are also a few cases of trauma, most of which
the exchange of knowledge on diseases and services.
require high levels of specialty. Some begin their treatment here and the follow-ups are performed in their home
Q: What projects do you have in mind for 2016/2017?
country. Often patients could be treated there but they
A: We are focused on highly specialized services. For the
come because they have international medical coverage.
past few years we have declared our intention of focusing on cardiology, oncology and neurology. We will continue
Q: Why do you have this brokerage system with the US
to work on projects of high quality, service and safety for
but not with other countries such as Canada?
the patient. Both hospitals are general hospitals so we still
A: Canada has a public healthcare system, as do some
tend to all ailments. We have a program called CUIDO,
European countries like Denmark. They do not see the
which covers all topics related to the health and safety
need to pay for medical services because they are free.
of a patient. We have all the certifications needed for
It is from countries that require the population to pay for
Hospital San José and Hospital Zambrano Hellion will be
services themselves or to pay for private healthcare that
audited soon. We are getting ready to obtain international
we see the most foreign patients originate from.
certification as a medical center in 2016/2017. We are also working on a cultural transformation project called VIVO,
Q: Why would an international patient choose you over
which aims to improve the patient experience.
another hospital? A: The conditions of our facilities are excellent and many of
Q: Why are your main areas of focus?
our doctors studied abroad in the US and Europe. Patients
A: We have great patient care facilities, research labs and
have confidence in us. Those that come are impressed by
academic links. We want to boost these areas as we are
the quality of our medical services and facilities. Patients
one of the few institutions in Mexico that has those three
imagine a different scenario but they start to feel more
elements. It is part of our vision to help create medical
comfortable once they see our webpage and eventually
professionals the Mexican healthcare system needs.
our facilities. We have testimonies on our website where
We know more than anyone the need for good medical
people have said the reality of treatment here was
professionals. For this we concentrate on quality and
completely different from what they had imagined.
security for the patient and academic training.
| VIEW FROM THE TOP
ONE-STOP SHOP FOR MEDICAL NEEDS RICARDO SEGOVIA General Surgeon of CostaMed
Q: What is the history behind CostaMed?
Caribbean, capable of simultaneously fitting nine people.
A: Before establishing Cozumel’s Medical Center, I was a
Our personnel is extremely qualified, all certified by their
partner and medical member of Clínica Cozumel. Back in
respective medical counsels. CostaMed is the only hospital
1995, Chris Schumacher, who is now my most important
in Cozumel that has been certified and recertified by the
business associate, approached me about new technology
General Health Council.
implementations. Although I was interested in acquiring new and unavailable technology for Cozumel’s market,
Q: What technology implementations has the hospital
there was little to no expansion room in the facility. Partners
undergone?
at Clínica Cozumel had already planned on creating a new
A: The imaging diagnostics division is equipped with
center and machinery would be required. After a year, not
a fourth dimension ultrasound, a 1.5 Tesla MRI and a
only did we not go through with the project but the whole
16-slice CT that will soon transition to a 64-slice CT.
Clínica Cozumel team began dissolving.
Foreign patients demand multiple procedures from us. Plastic surgeries, gastroenterology procedures, cardiac
Under those circumstances, I planned to open Cozumel’s
catheterization and pacemaker placement, among others,
Medical Center, but was lacking some of the initial capital.
top the list. Our capabilities in orthodontics have also
After further discussions with Schumacher, we became
increased the demand for such services. In fact, they are
partners and established our operations in a 900m2
commonly promoted by cruise staff.
piece of land on January 3, 1998. Since then, we have had progressive and sustained growth, now covering 3,800m2
Q: Have you seen more foreign patients coming to
in Cozumel alone. Expansions to Playa del Carmen, Tulum
Cozumel?
and Mahahual followed.
A: The cruise ship industry is Cozumel’s main economic motor, so our operational focus is mainly on this segment.
Q: What market conditions led to its establishment in
Nonetheless, through this scope we can offer top-
Cozumel?
notch medical infrastructure to Cozumel’s 100,000 local
A: My trajectory as Felipe Carrillo Puerto’s Social Security
inhabitants. In the past, people went to other cities to
Director and later as Social Security Director of Cozumel’s
receive medical treatment. Now, they travel to Cozumel,
port, allowed me to clearly assess the healthcare
which includes foreign patients as well. Between 60-70
shortcomings of the island. The system’s evolution in
percent of our admitted patients come from abroad. They
recent years has been quite radical. For instance, treating
now look for our services online and arrange their arrivals
patients with craniocerebral trauma was unthinkable in the
from all corners of the world.
past but it can now be done with our onsite neurosurgeon. Q:
What
alliances
has
CostaMed
developed
with
Q: How have CostaMed’s operations evolved throughout
governmental institutions to promote its services?
time?
A: We developed a medical tourism initiative that
A: We have gone from offering basic medical services to
showcases Cozumel as an important player in healthcare
specialized tertiary care. CostaMed is equipped with the
services in local and international congresses. CostaMed
latest technology. We have one of the best intensive care
is also a member of Quintana Roo’s Medical Tourism
units in the region. We have successfully performed five
Association as one of the region’s main hospitals. We have
open-heart surgeries, the only hospital in Quintana Roo
close contact with the state’s Ministries of Tourism and
to achieve this. CostaMed is a pioneer in gastrointestinal
Health as well as the National Institute of Entrepreneurship
and therapeutic endoscopy. Finally, our Cozumel facility
(INADEM). Medical tourism has been a fundamental
is equipped with the largest hyperbaric chamber in the
initiative for President Enrique Peña Nieto.
285
| VIEW FROM THE TOP
ATTRACTING BUSINESS THROUGH DENTAL TECHNOLOGY JAVIER LORIA Director General and Founder of Dentistar
286
Q: How have your operations evolved since opening?
Q: Where is medical tourism going in the next few years?
A: I started with a consultancy practice and then realized I
A: It will increase. There are more and more people coming
needed a clinic and it has grown from there. I had a problem
to Mexico. I think we will start to see more complex
in that the maker of my prosthesis, dentures and crowns
procedures that require two or three visits a year or a visit
was located in Merida. There were no dental laboratories
every six months. I think that due to the tax and insurance
in Cancun. Patients that come from abroad only come
US doctors pay, they will continue to raise their prices. A
for a week, so in that short time the work needed to be
doctor of my specialty in the US is a millionaire. Here, we
completed in full. Due to this, I decided to invest in opening
belong to the middle-high income bracket. I would like to
my own laboratory to satisfy the needs of my patients. That
see Mexican doctors raise their prices so we can be more
has been running since mid-2011. In addition to covering my
equal with our counterparts in the US. All the material and
own needs, I supply to 10 other orthodontists in the area.
machines I use are imported from the US. I have to pay
Thanks to technology, I can have a product ready in three
tax and it costs me almost double what the material costs
days. Patients want few appointments and a job well done.
over there.
Q: What differentiates you from your competitors?
Q: What pushes medical tourism in Mexico?
A: Primarily, I guarantee my work for life. It is highly unlikely
A: The patient wants good quality or acceptable quality
to break or falter in quality. If something were to happen, I
work at a much lower price. Some are too afraid to come
would repair it at no extra cost to the patient. If it is due to
to Mexico despite the quality and lower price of our
a fault in the patientâ&#x20AC;&#x2122;s bone that causes the damage to my
work. Little by little, through references of my patients,
work, I also inform the patient. I cannot control their bone
others come.
structure or oral hygiene habits such as tobacco usage. Even so, I have only two lines of dental implants, which are
Q: What certifications do you have that help you win
the best in the world. In some cases, patients know I can
prospective patients' trust?
put in the implants and they can have the work finished in
A: The certifications we can obtain are through the
the US if needed, as the provider gives me support. They
Mexican Dental Association. We attend many classes, talks
replace their products at no cost if they are faulty or have
and forums for which we do not receive any certificates.
a problem.
Any doctor that goes to a class and pays can obtain a piece of paper that certifies he went; it does not mean
Q: What other key alliances do you have that allow you to
he is capable of doing a good job. Sadly, there are many
operate in this way?
cases of work done by certified doctors that did not work.
A: I do not have alliances as such, but if a doctor from
I would like international certifications.
another country has doubts, we speak over the phone. My only alliances are with the suppliers. I do not ally myself
Q: What are your short-term projects?
with companies that come offering discounted products,
A: We are in the middle of a project of making personalized
as I know they do not have the background.
braces with a 3D printer. We are also working on making surgical guides to operate on patients with implants by
Q: What are the treatments that you offer?
feeding data into a radiograph. It is already happening in
A: In orthodontics, we have patients that come for regular
Merida but I want to do it a little differently. My wife is
checkups. Some foreign patients come for braces and
an orthodontist, so we want to buy a machine that does
their local dentists do the follow-up treatments. I get more
both things. Such a machine was only recently launched in
and more patients with no teeth at all who come for a
Chicago this February and it is not yet available for sale.
complete set of implants or veneers.
We hope to have it in a few months.
| VIEW FROM THE TOP
DENTAL TOURISM IN THE RIVIERA MAYA ALEJANDRO LAGUNA Director of Coral Dental Center
Q: What were the reasons that led you to establish your
A: When we first came to Playa del Carmen, we saw the
operations in Playa del Carmen, rather than in Cancun?
growth potential of the market, whereas companies that
A: We are originally from Mexico City. Even though we had
arrived prior to us may have evaluated it as just a small,
significant success in Mexico City, the poor conditions of
fishing town. Under these circumstances, Coral Dental
the city were too much and we were motivated to look
Center significantly invested in its facility, becoming
for better life quality. Playa del Carmen made more sense
a specialized service provider capable of performing
in that regard, rather than Tijuana or another medical
advanced procedures. Our goal has always been to
tourism hub. Our services have been greatly received in
provide the best quality services, without compromising
Playa del Carmen, considering orthodontics are needed
our prices.
regardless of the market segment. Since our arrival 12 years ago, we have created brand loyalty and preference
An important market segment is emergency procedures,
within the community.
where tourists unexpectedly require our services. In that regard, hotels are our key allies, as they know Coral Dental
Q: What is the potential of Playa del Carmenâ&#x20AC;&#x2122;s market?
Centerâ&#x20AC;&#x2122;s facility will offer the best solution. We always
A: Being a touristic paradise is one of its biggest
follow all federal and clinical requirements, such as having
advantages. The tourism flow throughout the year and
sterilized and clean facilities, and most importantly, our
specifically during the summer is extraordinary and
technological equipment sets us apart.
presents major opportunities for businesses. Patients living in countries with adverse weather come to Playa
Q: Considering medical tourism was the main area of
del Carmen for extended periods of time and they need
opportunity, what percentage of your clientele is foreign?
specialized services during their stay. Even though Cancun
A: Half of our patients come from abroad. This includes
remains the most attractive destination in Quintana Roo,
not only tourists but also foreigners living in the city.
Playa del Carmen is gaining ground and closing in. Coral
Most foreign individuals are retired and their purchasing
Dental Center has received patients from far-off countries
capabilities are superior to the average community
like Germany, China and Australia, among others, as well
member, adding value to the market. Our online platform
as from the US and Canada.
has also secured much business, where patients file previous studies and we assess the procedure to be
Climate conditions and scenery are not the only elements
performed. We need to keep in mind the recovery time
foreign patients factor in while looking for medical
needed so that patients can plan ahead and enjoy what
destinations. Price ranges are equally important. Dental
the city has to offer.
services can be extraordinarily expensive in other markets and Mexico offers great quality of service at affordable
Q: What can be done to further position Mexico and Playa
prices. As such, patients can spend the same amount
del Carmen as a medical tourism hub?
of money to vacation in Mexico and undergo the same
A: Even though the federal government has emphasized
procedure. Medical tourism is already responsible for
the importance of strengthening medical tourism, we need
substantial capital inflows, and although countries like
more governmental support. Los Cabos, for example, has
Costa Rica and Brazil have a slight lead on Mexico, we are
been greatly promoted in the past. The Ministry of Tourism
attracting more patients.
must push more promotion campaigns as private entities like Coral Dental Center would greatly benefit from those
Q: How did Coral Dental Center differentiate itself,
efforts. Mexico has sufficient capabilities to become the
becoming the service provider of preference in Playa del
prime destination for medical tourism in America and
Carmen?
perhaps the world.
287
DOING BUSINESS IN MEXICO & INSURANCE
14
When considering Mexico as an investment destination, its geographical proximity to the US, low costs and stable economy are key. The country also provides easy access to North America, the Caribbean and Central and South America. In 2012, COFEPRIS was recognized as a regulatory agency by the Pan American Health Organization (PAHO) and its strict regulation makes Mexico an ideal place to conduct clinical research trials.
According to the World Bank’s 2015 ranking of countries per GDP, Mexico is in 15th place but it is second in Latin America. Coupled with the country’s open economy and many trade agreements, Mexico is an appealing center for investment.
From legal advisers to business consultants, there is a wealth of firms at the ready to help foreign entrants to the market navigate the Mexican economy and establish successful operations, including manufacturing plants, research facilities and medical practices. This chapter provides an introduction to those who truly understand how to do business in Mexico’s health industry and the expected highlights and growth of the sector.
289
GET THE INSIDE PERSPECTIVE ON MEXICOâ&#x20AC;&#x2122;S MAIN INDUSTRIES Mexico Business Publishing supports business and political leaders in driving the development of Mexicoâ&#x20AC;&#x2122;s main industries by offering first hand industry intelligence and analysis based on face to face interviews with carefully selected stakeholders. As the independent publisher of comprehensive, high-level annual reviews, our mission is to accelerate the exchange of vital industry information that enables Mexico and its business community to capitalize on emerging opportunities.
www.mexicobusinesspublishing.com
| CHAPTER 14: DOING BUSINESS IN MEXICO & INSURANCE 292
VIEW FROM THE TOP: Angela Spatharou, McKinsey & Company
294
VIEW FROM THE TOP: Jorge Cueto, Deloitte
295
VIEW FROM THE TOP: José Alarcón, PwC
296
VIEW FROM THE TOP: Alejandro Luna, OLIVARES
297
VIEW FROM THE TOP: Christian López, Baker & McKenzie
298
INSIGHT: Justyna Kroplewska, Hays
299
VIEW FROM THE TOP: Moses Dodo, Bupa Global Latin America
300
VIEW FROM THE TOP: Ernesto Algaba, Hogan Lovells BSTL
Alfredo Pineda, Hogan Lovells BSTL
301
INSIGHT: Geraldine Rangel, Healthlinks
302
VIEW FROM THE TOP: Cristina Viruega, TAPVS
303
VIEW FROM THE TOP: Isidro Rodríguez, Entimem
304
VIEW FROM THE TOP: John Mitchell, Heidrick & Struggles
305
VIEW FROM THE TOP: Ignacio Pérez, Heidrick & Struggles
306
VIEW FROM THE TOP: Paul Doulton, Oriundo
306
EXPERT OPINION: Paul Doulton, Oriundo
308
VIEW FROM THE TOP: Dominik Bacher, Bacher Zoppi
309
VIEW FROM THE TOP: Louise Batchelder, SYNELOG MEXICO
310
VIEW FROM THE TOP: Jaime Cervantes, Grupo Vitalmex
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VIEW FROM THE TOP: Ángel Alonso, VecMedical
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HELPING BUSINESSES WITH BEST PRACTICES ANGELA SPATHAROU Partner at McKinsey & Company, Latam Healthcare Systems and Services Practice
Q: Could you give us a brief history of your Mexican
but we also work extensively within Latin America. Many
operations, how you got to Mexico and what success you
colleagues who lead healthcare programs with Mexican
have had here?
clients often work with clients in Colombia, Brazil, Chile,
A: McKinsey & Company started in Mexico in the '70s.
Costa Rica and the Dominican Republic.
We were one of the first management consulting firms
292
to develop a client base in Mexico City. We now serve
Q: How are you guiding your clients into complying
clients out of Mexico City and Monterrey. McKinsey is
with best practices in Mexico and also how are you
a globally incorporated firm, so we work closely with
collaborating with institutions to create this legal
colleagues internationally including in Spanish-speaking
framework?
Latin America and North America. In Mexico we offer
A: Bringing the best practices within Mexico and
services across different sectors such as energy, financial
internationally to our clients is an intrinsic part of the
services and private equity, consumer goods, healthcare
value we hope to contribute. At the same time, we are
services,
devices,
not a law firm and do not engage on issues around
telecommunications and automotive, among others. We
the legal framework, nor do we provide legal advisory
offer a broad range of functional services like strategy,
services. Our observations in general are that there is
corporate finance, operations, technology and digital
sufficient legislation across the general Mexico system,
sales and marketing.
but there may be lack of clarity in some areas, or a fair
pharmaceuticals
and
medical
amount of process in others. When we work with a client In the early days, we supported pharmaceutical and
in Mexico, we are trying to make sure that there is as
medical devices companies, often large multinationals
much transparency as possible on the legal context and
setting
in
rules applicable, so they can pursue legitimate strategies
strengthening their local strategy and operations, but
within the context of the legal system and contribute to
also Mexican-owned operators, both in pharmaceutical
Mexican society.
up
operations
in
Mexico
or
interested
production and distribution. Q: How are you able to input your opinion and change Our Health Systems and Services practice followed a few
the healthcare system in Mexico?
years ago, initially focusing on strategy and operations.
A: As a company we try to have a positive impact through
In recent years, we have served Mexican health systems
the programs we support directly, working with clients
on issues around service design, financial sustainability,
in different systems. We may also have the opportunity
or developing different models of care for specific patient
to organize conferences where decision-makers come
segments, such as patients suffering from diabetes and
together and discuss priority issues across the system,
other chronic conditions.
expressing their ideas openly. Two years ago we held a conference on chronic disease management where we
We have also helped clients on a variety of programs
brought a select number of industry people together and
in terms of scale and resources. For example, we have
created a forum where system leaders could exchange
supported
ideas on topics of great importance to Mexico.
whole
system
transformation
efforts,
in
which Mexican health systems launch multi-year national programs to increase patient access to services by
One of the areas we are passionate about is care
improving operations. We have also supported individual
innovation. We hope that our work within this area, for
providers on quality improvement, clinician leadership or
example on chronic disease management, may help
the development of academic medical centers. Mexico is
set a precedent creating a dynamic for the system to
part of our McKinsey North American client service group,
introduce more integration across levels of care and
leverage
cutting-edge
technologies
and
advanced
analytics to significantly improve quality of care and
“Over the last few years, we
patient outcomes.
have worked with health
Before I came to Mexico, I worked in the UK and supported
systems in Mexico, helping
clients within the English NHS. One of the topics I worked extensively on was defining a truly integrated care model for chronic disease management. As we know, chronic patients need tailored support to keep symptoms under control and avoid unnecessary complications that may lead to loss of quality of life, dependency and often emergency hospitalizations. Complications do not only affect the individual patient, but also put the health system under enormous strain. Putting an integrated system of care in place means that primary, secondary and tertiary care have a single view of the patient and work in a holistic way to improve his or her health.
them develop their models, improve the business case for investment in services, and put in place the mechanisms that will allow them to care for patients differently” Angela Spatharou, Partner at McKinsey & Company, Latam Healthcare Systems and Services Practice
Over the last few years, we have worked with health systems in Mexico, helping them develop their models,
of care. In a year with more macro-economic pressures,
improve the business case for investment in services and
healthcare leaders are focused on finding ways to extract
put in place the mechanisms that will allow them to care
more value from what they already have, not spending
for patients differently. We know this produces better
further but providing more services.
results and allows for a more sustainable management of care.
Overall the reactions seem more incremental than a “step change” or a major radical shift. In some cases, there
Q: What have you accomplished for the healthcare
may be more renegotiation around older contracts that
system or the health of patients?
are in US dollars because the exchange rate has a strong
A: We have worked with several public healthcare systems
impact. We cannot predict what will happen in the next
and private providers in Mexico and across Latin America.
year or two but we would not be surprised if we see a
Models such as the integrated care model have resulted
more extreme response from organizations than we have
in reductions of clinical complications of around 20-25
seen thus far.
percent, depending on the patient segment. We have also achieved a reduction on cost per patient close to 15
Q: Where are we going to see the company this year, in
percent, an important step for many systems struggling
terms of new projects, new clients and growth?
to provide services sustainably. We have worked with
A: We are continuing to be involved with major Mexican
a number of individual hospitals on operations and
healthcare systems on topics around operational efficiency
performance improvements where we have seen increases
and whole system transformation. We would like to bring
in numbers of patients treated within existing resources
the topics of quality and standardization of services
between 15-20 percent on average. In particular, we have
back to the agenda as well. In addition, we have started
seen through operational “lean” type improvements in
investing across McKinsey and specifically in Mexico in
surgical theaters and better planning of surgical capacity,
advanced analytics and digital, which in our experience is
leading to up to 30-40 percent of additional surgical
key for Mexican systems to unlock growth in some areas
capacity within existing resources. This has significant
and efficiency in others. Many systems struggle with the
impact on patient access to services but also significant
fact that they do not have a consolidated view of their
financial impact on the organizations because they can
own resources, patient outcomes and associated costs.
manage their costs much more sustainably. There are hospitals where leadership cannot cite how Q: Has the Mexican healthcare industry been impacted by
many people they employ. Digitalization and advanced
macro-economic conditions, particularly the exchange
analytics can be powerful tools to help create a distinctive
rate with the dollar? How are institutions responding?
view of what is happening and to aid decision-making
A: In a typical year healthcare leaders often review a
for policymakers and hospital directors alike. We have
broad agenda of topics covering quality improvement,
already built this in other markets and are very excited to
leadership development, productivity and new models
do so also in Mexico.
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| VIEW FROM THE TOP
STEERING THROUGH MEXICO’S HEALTHCARE INVESTMENT ENVIRONMENT JORGE CUETO Lead Partner of the Healthcare Sector at Deloitte
294
Q: What are your plans to consolidate and expand the
Q:
healthcare and life sciences practice in Deloitte?
perspective on efficiency and how is Deloitte supporting
A: Healthcare and life sciences is one of the most
them in this endeavor?
relevant industries for Deloitte’s global operations.
A: There are two different things happening in Mexico.
Today, it is the fastest growing industry for Deloitte in
Firstly, multiple M&A activities in both the pharmaceutical
the US. We are expanding our services and capabilities
and provider spectrum are unfolding, which denotes
in
segments,
the consolidation efforts Mexico’s healthcare system is
including pharmaceutical, bioscience, medical devices
undergoing. Secondly, many players in the healthcare
and healthcare systems. We provide our customers
arena are focusing on its efficiency. Public institutions
with valuable solutions for their local and regional R&D,
are finally beginning to understand the importance of
manufacturing, commercial and operation processes.
indicators, metrics and their performance in comparison
Collaborations
to local and foreign hospital data.
Mexico,
covering
with
multiple
industrial
COFEPRIS
and
third-party
How
are
healthcare
providers
changing
their
authorized units are fundamental to devising effective strategies
for
product
registrations.
Go-to-market
Q: What do you think is necessary to improve technology
strategies also are relevant to our solution portfolio,
adoption in public institutions?
advising companies on how to enter the country with
A: Clinical outcomes not having a direct impact on the
a strong understanding of its economic, fiscal and labor
ROI is a great challenge for healthcare providers. When
issues. We are experts in the industry’s entire value chain
patients go to hospitals, providers get paid regardless of
with an important focus on innovation and technology.
the clinical outcome. As such, there is still some industry resistance to invest in technology, considering the revenue
Q: While there are global trends shaping the industry,
of public institutions does not grow from positive clinical
what would be the regional issues companies have to
outcomes. We expect the tide will change over the next
adapt to be successful?
couple of years. Pay for performance is a way of risk
A: Optimizing healthcare costs is one of the most
sharing, where companies get paid only if expected
important challenges globally and locally. There are
outcomes are reached.
many initiatives taking place in this regard. As such, we advise our customers on developing trends and proper
Q: How can pharmaceutical companies be supported in
ways to implement them. We see many healthcare
attracting direct foreign investment to the country?
systems interested in devising prevention strategies;
A: I think that Mexico has a great opportunity to leverage
nevertheless, effective implementation has not taken
what COFEPRIS achieved in recent years. Nowadays,
place. Instead of focusing on a fix and break model
many states are open to provide incentives to companies
burdening the healthcare system, providers are shifting
in this industry. Moreover, with the certifications and
toward investing significant resources in prevention, self-
recognitions COFEPRIS has earned from WHO and
care and education. Getting these programs properly
PAHO, Mexico is now among the 44 countries with a
implemented remains one of the industry’s biggest
fast track in place. For instance, by performing R&D and
challenges. These efforts will see technology platforms
manufacturing activities in the country, companies will
and industrial clusters playing an important role in the
have access to other regional markets. Firstly, the cost-
system’s development. The economic reality of each
effectiveness of manufacturing activities in Mexico is far
individual country is yet another regional challenge. In
greater than other countries in the region. Establishing
Mexico, 20 percent of the population retains 80 percent
plants in Mexico from the legal and fiscal standpoint is
of the country’s wealth, which has resulted in a strong
also much easier. Secondly, Mexico is close to the US, one
market penetration for generic drugs.
of the biggest markets in the world.
| VIEW FROM THE TOP
STRIKES AND BUDGET CUTS COULD PROVE BENEFICIAL JOSÉ ALARCÓN Partner and Lead Health Services at PwC
Q: Considering the recent dual budget cuts in the
is positive as long as the public sector sees it as a sign
healthcare sector, what challenges do you expect the
for improvement. As for private spending, it is too much
industry will have?
out-of-pocket.
A: You can see it in an optimistic or pessimistic way. Pessimistically, you can say that healthcare is cut and
The public sector does not have the resources to comply
it is frozen, in which the only way to move forward is
with everything and an alternative is to shift to an
with pressure from organized society, the private
innovative public-private partnership, which would lead
sector, or even international organizations from the
us to negotiations with insurance companies. Only 8.2
outside. Optimistically, considering the intellingence of
million people are privately insured, which leaves plenty
our government leaders, such as Mikel Arriola at IMSS
of space for collaboration.
and José Narro, Minister of Health, we may now be more united and integrated. Using an integrated view,
Q: What do you foresee for the furure of Mexican
you can use the pressure originated by the budget
healthcare?
cuts as an opportunity to change things for the better,
A: In the near future, I do not think there will be anything
meaning being more efficient. If politicians and leaders
revolutionary, just evolutionary things to maintain the
in the public sector share this view these cuts can be
status quo and maybe some relevant steps focused
used as leverage for improvement. New models can be
on efficiency on the public sector side. In the private
introduced using public-private cooperation such as
sector, I see a more united voice pushing to have it seen
pay for results, risk-sharing agreements and developing
as a competitiveness tool for the government and the
strategic demand linked to consolidated purchases.
country as a whole, which is the right way to see it, and hopefully driving the big reform in the early years of the
Q: We have seen the beginnings of a universal healthcare
next administration.
reform this year along with doctor strikes. What do you think is the significance of this first step? A: Fortunately, these strikes have not been as broad as in other countries. While they did not have a major impact on our health service provisions they are still not a good sign because it means we could reach a crisis. We should
“Strikes should not be used as a political weapon” José Alarcón, Partner and Lead Health Services at PwC
understand them as a call to action and comprehend that the process from student to practicing physician needs
After the next eight years, I think reform will be
to change. We must tread carefully as strikes should not
implemented and the focus will shift to trying to stabilize
be used as a political weapon. As long as their demands
a united national health system until 2030. Most of this
are focused on genuine improvement of physicians’
will be employed through Public Private Partnerships
quality of life then I think they are positive. On the other
(PPPs) since resources will be scarce on either side of
hand, no matter the amount of strikes we must be careful
the spectrum. Afterwards by 2034, a better healthcare
not to stop changes that must really happen.
system may be a reality with some room for improvement. Another way to view it is in terms of supply and demand.
Q: Are pharmacy doctors an appropriate alternative to
To avoid a crisis, the supply must be increased by being
delayed services in public hospitals?
more efficient and the demand must be lowered with the
A: I think it has been a good alternative for society,
help of innovations. We must get the reform right so the
however, by taking that alternative the population is not
gap between supply and demand does not become a
receiving access to public healthcare as is their right. It
predicament.
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| VIEW FROM THE TOP
MEXICO A KEY STAKEHOLDER IN THE TRANS-PACIFIC PARTNERSHIP ALEJANDRO LUNA Partner at OLIVARES
296
Q: What are the most common administrative violations
into the market. Indeed, Mexico was a leader in these
in industrial property in the life sciences industry and how
discussions on this highly debated topic which led to the
does the Trans-Pacific Partnership (TPP) aim to regulate
inclusion of a transitional period for Mexico before being
them and strengthen the intellectual property system in
obliged to adopt the obligations of TPP. My opinion is that
Mexico?
such a transitional period was not necessary and in the
A: Nowadays, the most common violation to intellectual
case of data protection for example, it will only delay the
property (IP) rights is the infringement of patents.
fulfillment of Mexico's obligations which are now Mexican
Patent linkage has reduced patent infringement for
court orders based on other international treaties such as
pharmaceuticals but it only prevents the infringement of
NAFTA and TRIPS.
compound patents. Other patents within the life sciences industry either do not fall under patent linkage regulation
Q: Some stakeholders argue the TPP would limit the
or are disregarded by the corresponding authorities. The
entry of up to 5,000 generic medicines in the next five
claims may be unjustified and thus disregarded by the
years; yet some others believe it will bring further foreign
Mexican Patent Office and COFEPRIS, or they may be
direct investment to the pharmaceutical industry. Will the
prevented from patent linkage to avoid the granting of
TPP help improve the perception of Mexico among other
marketing authorizations in violation of these patents.
countries regarding support and protection of innovation?
There is no reason to exclude medical patents from the
A: There is no basis to say TPP obligations alone would
linkage regulation but the authorities do.
hinder the entrance of generics to the Mexican market. Statistics show penetration of generic products in the
The TPP includes certain obligations: country members
Mexican market is growing year on year and this trend is
should accept as patentable subject matter the new uses
not going to be changed by the TPP, as indeed there is
of known products to avoid in all aspects the discrimination
nothing in the TPP that would ban the entrance of generic
of these patents, including patent linkage. The TPP will
pharmaceutical products. The various legal instruments
also clarify data exclusivity for biologic products.
in place in Mexico are only recognized or clarified in the TPP, for example patent linkage, data package exclusivity
Q: It has been said that Mikel Arriola, Commissioner of
for new molecules and second-use patents is a matter
COFEPRIS at that time, negotiated a balanced agreement
within the Mexican office. The few new matters contained
for the Mexican industry, protecting both the innovative
within the TPP such as data exclusivity for biologics
and the generics’ industry. To what extent do you agree
and compensation of patent terms are not bans to the
with this perception?
entry of generics, only the necessary recognition of a
A: Due to my participation in the so-called “cuarto de
longer period of protection for biologic products, which
junto” I witnessed Mikel Arriola and the Mexican delegation
is recognized by generic companies when requesting a
defending and looking for better conditions on behalf of
Roche-Bolar exception of eight years for bio-comparable
the country. It is no secret the IP Chapter in TPP, specifically
products.
the issues related to pharmaceutical patents and data package exclusivity, were highly debated during the
In general terms, the TPP will provide a higher degree
negotiations, precisely due to the irreconcilable position
of certainty for investment in Mexico compared with the
of some generics companies which pushed against the
current legal framework in various aspects of IP. I am
measures to protect innovation. Mexican negotiators
convinced proper and effective protection of IP is a driver
addressed these conflicting interests by trying to reconcile
for innovation. In the life sciences sector, the opportunities
them and establish a balance between the need to protect
and expectations of the TPP on IP protection were higher
and promote innovation with the need to launch products
than the final result.
| VIEW FROM THE TOP
INTEGRAL LEGAL SOLUTIONS FOR HEALTHCARE INNOVATION CHRISTIAN LÓPEZ PhD, Partner and Head of Pharmaceutical & Life Sciences at Baker & McKenzie
Q: You have mentioned that Baker & McKenzie is Mexico's
Q: In which way do evolving regulations impact your
largest and most advanced regulatory practice. How have
client’s operations?
you retained that position in an extremely competitive
Let us take a look at medical products. By official
field?
accounts, the area that has gone through more profound
B&M keeps generating synergies between our different
regulatory changes in recent years has been the sector of
groups of practice, finding new opportunities to integrate
medical devices. Not only were new provisions developed
health regulation to previously unconnected areas, which
(e.g. techno-vigilance rules), but also old provisions were
has resulted in value-added services for the life sciences
completely revised and resulted in a deregulation and
industry. For instance, we integrated regulatory work with
simplification of the approval process of these products.
privacy law and information technologies, resulting in our
Moreover, international recognition plans were agreed
Digital Healthcare Initiative, which places us well ahead in
with other countries, which has not only expedited the
the market of legal services, particularly for our clients in
approval in Mexico of products already authorized by
the medical devices sector. Likewise, we have increased
other foreign regulators, but has also made it possible for
the integration of our regulatory and litigation capabilities,
approvals obtained in Mexico to be recognized in other
winning several cases against regulatory decisions for our
countries.
clients in the pharmaceutical sector. Q: How does Baker & McKenzie help its clients stay ahead Q: How is the firm’s internationalization and understanding
of the herd in a growingly competitive environment?
of global markets reflected in its client’s operations?
We have designed legal strategies to manage the
Our global view and regional experience has been
regulatory, antitrust and compliance implications of
appreciated by our clients. One visible indicator is that
Patient Support Programs. Companies in the life sciences
we have increased the number of Latam-wide projects.
industries are moving away from a product-only business
For instance, we are implementing a regional project to
model and moving into a more product-plus-service model,
develop compliance policies for every country in Latam
which is making a reality today what others expected to
where a pharmaceutical client has a presence. We are
take place in the future. Also, we are constantly preparing
also executing, for a global cosmetics company, a regional
specialized content and reports in the Life Sciences sector,
mapping exercise of individual countries, aimed at
which is made available to our clients in new ways. The
identifying available mechanisms to accelerate access to
best example of this is our recently launched mobile app,
the whole regional market. We are also helping a pharma
called MapApp, which puts key legal content literally at
client create a mobile app to generate information about
the fingertips of our clients. This covers every country
regulatory developments in Latam in the area of biosimilars.
where we operate and more.
Q: How does Baker & McKenzie ensure its involvement
Q: How can we improve the legal environment of Mexico,
through the whole life cycle of a drug or medical device?
making it more attractive and desirable for foreign
What does this mean to the company and its clients?
enterprises to set-up-shop in the country?
Being a full-services law firm gives B&M a privileged
For many years several regulators in Mexico were
position to assist during the whole life cycle of regulated
accustomed to the fact that their main decisions were
products. For example, we are currently developing a
not regularly challenged in courts. This has slowed down
Licensing & Regulatory Initiative for Drugs in Latam, which
the emergence of legal precedents that are much needed
integrates the different regulatory, intellectual property
in several aspects. This is unfortunate since being able
and corporate law aspects that derive from technology
to challenge decisions is a crucial component towards
transfer projects and M&A transactions.
achieving a true and effective rule of law.
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| INSIGHT
MEXICO UNEVEN ON TALENT SUPPLY AND DEMAND As for the brain drain trend that Mexico has seen with
JUSTYNA KROPLEWSKA
scientists leaving the country seeking better opportunities,
Head of Life Sciences and
still relatively limited in Mexico. “It is a shame to lose the
Human Resources at Hays
talent we have in the country because we are not ready to
Kroplewska affirms that opportunities in this arena are
offer solid career development options,” she says. “While we support exchange programs, it is also important to Talent management is undoubtedly crucial to business
retain Mexican talent in Mexico.” Hays has a global reach
strategy and firms are not only defined by their products,
while looking for specific profiles and its huge professional
services, corporate strategy and prestige but by the people
database includes Mexicans living abroad who might be
who are actually making decisions, contacting customers
interested in returning to the country to continue with
and running the business on a daily basis. “Companies
their career path.
are not fully dedicated to finding the right talent so most
298
of our clients reach out to us when they need to find the
Kroplewska considers the most important part of her job is
most qualified candidate at a given time or under certain
finding the right match between companies and candidates,
circumstances,” explains Justyna Kroplewska, Head of Life
which can be challenging. Although the human resource
Sciences and Human Resources at Hays. In today’s ever-
firm provides services for many multinational companies
changing and complicated landscape in the healthcare and
operating in the same sector in reality they have different
life sciences industry understanding client needs is a must,
values, policies and procedures. Before an employee
which is why Hays has a division completely dedicated to
requirement even arises the values, core activities and
this sector. The life sciences division has been one of Hays'
future plans of the company must be deeply understood
most important ones since it started operations in Mexico
because these differences will determine if a candidate will
City in 2001. “We are aiming to invest more in this area and
fit with a certain ethos and vice versa. “At Hays we believe
become more specialized to provide the best recruitment
the right job can transform a person’s life and the right
consulting services for companies,” says Kroplewska.
person can transform a business,” she states.
In collaboration with Oxford Economics, Hays releases a
Employee turnaround issues are not unique to the
publication called Hays Global Skill Index annually, which
pharmaceutical industry but they actually are a global
presents a ranking that evaluates the supply and demand
phenomenon across many sectors. Kroplewska observes that
for talent at a global level. According to Kroplewska,
commercial positions rotate the most in the pharmaceutical
Mexico presents uneven levels of supply and demand
and medical devices industries. People are continuously
when it comes to human capital, which results in significant
looking for different challenges. “Gone are the days when
difficulties when looking for specialized talent. “The only
people stayed in a company for 10, 20, or 30 years,” she
thing companies can do is focus on retaining talent
explains. “Today, we see a lot of movement every two, three,
through several human resources management strategies,
or four years.”. When candidates cannot find new challenges
such as offering global mobility, international exposure,
in the companies they are working at they start looking
training and development and attractive compensation
for opportunities outside. For Kroplewska, this has both
packages,” she adds. Companies in the life sciences
advantages and disadvantages since companies actually
industry are looking for a different skillset than before.
spend considerable amounts of resources in training and
As explained in the Labor Market Analysis conducted by
developing staff and when talent leaves, businesses suffer
Hays, pharmaceutical companies used to focus on hard
from knowledge gaps. However, a company would certainly
skills, technical knowledge and educational background
lack innovation should it retain the same personnel for 20
but today soft skills are more relevant. “Communication,
years. She believes receiving talent from other companies
leadership and talent management abilities are more
can be enriching because people incorporate best practices
important as managers need to cultivate teams and not
and values from previous experiences. Yet, having a high
having this particular skillset makes failure more likely
turnaround in a short period of time could be damaging for
within the organization,” says Kroplewska. She believes
sales positions because the sales cycle requires people to
the government should foster exchange programs so that
stay for a set time to create a strategic plan, implement and
professionals can enrich their experience.
obtain the return on investment.
| VIEW FROM THE TOP
HEALTHCARE FOR GLOBAL BUSINESS TRAVELERS MOSES DODO General Manager of Bupa Global Latin America
Q: To what extent are your Mexican customers looking for
programs, corporate insurance is also a solid benefit for
a product with specific features?
employees and has proven to be successful in retaining
A: We are present in 190 countries and we have found the
talent. Replication of healthcare coverage is also a common
profile of our customers is similar regardless of geographic
issue in the region and this has been addressed by several
location. We target clients who have a need for international
countries such as Brazil, where the public system can
coverage, such as frequent travelers and those whose
actually charge private insurance companies. Retirement
lifestyle transcends country borders. Customers might
is also a concern for both private insurance companies
need this for different reasons, for instance expatriates
and public institutions, because people are living longer
seek coverage in both their host and home countries. Non-
and healthcare providers should be ready to face this
expat customers want to have the peace of mind of access
colossal challenge, especially considering that many
to medical care and treatments elsewhere in case of serious
public institutions have not modernized their processes
health problems and this is important for people living in
and operations in decades. When these institutions were
countries where high-quality healthcare services are scarce.
created in the '40s and '50s life expectancy was 50 years.
In addition, there is a global wave of medical tourism. After
Retirement age was 45 years. Today, life expectancy is
10 years of having a direct presence in Mexico, we now have
between 75 and 80 years depending on the country and
30,000 customers and the potential is probably 200,000
people are still productive at the age of 65. Prevention is
to 300,000. Mexico was the first country in Latin America
vital for both individuals and governments. Every dollar
where we launched this suite of global health plans after
we invest in prevention represents three dollars saved in
conducting thorough market research showing that the
the long term.
behavior of our customers in Mexico does not differ from that of our Chinese or American customers. Frequent
Q: What are the factors contributing to the rise of medical
travelers and international citizens do not want to be told
insurance costs?
where to obtain treatment.
A: As people age, their risk of becoming ill increases and we are one of the few companies in Mexico willing to
Q: How important is corporate insurance for your
provide insurance for people up to 75 years old. Population
commercial strategy?
aging is extremely important today. It has been said the
A: We do not approach large companies to offer them
first person who will live 150 years has already been born.
insurance for their employees because we do not offer
While increasing life expectancy is highly desirable, it
quantity, but a product richer in benefits and with
certainly represents a burden for the healthcare budget.
international coverage. Medical insurance is one of the
Thirty years ago, people used to die from factors such as
key benefits that employees seek and can receive while
infections, accidents, or heart attacks, but such events are
working in a company and this is true in a global context,
now controlled and life expectancy is prolonged. A stage-
although the spectrum of needs among employees is
four cancer patient can survive three or five years today,
relatively broad. Some positions require an excellent
but medical care has a cost.
local coverage as a risk management measure, while top positions need comprehensive international coverage if
Q: What are your priorities in Mexico?
they are frequent travelers.
A: We are re-launching our travel product in Mexico, which is a very attractive option for those seeking international
Q: What should be done in order to increase the number
protection. Customers can buy it online or with distributors
of people with private insurance in the country?
and customize it. It is also convenient for corporate
A: Corporate insurance is driving the growth of the private
agencies, which can buy a thousand days and cover their
insurance market in Mexico. With the rise of wellness
employees when they travel.
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| VIEW FROM THE TOP
NEW RULES TO BRING INVESTMENT TO MEXICO registrations being granted to someone else despite the Ernesto Algaba Partner and Head of Life Sciences at Hogan Lovells BSTL
Alfredo Pineda Senior Associate for Intellectual Property at Hogan Lovells BSTL
product or technology being patented, as well as public complaints over third party conducts that may constitute a health risk for the population. This may include the import and/or commercialization of counterfeit products
Q: How has the evolution of the pharmaceutical legal and
subject to health regulations.
regulatory framework in Mexico contributed to improve
300
the country’s global competitive position?
Q: How will TPP impact the Mexican pharmaceutical
EA: Regulatory improvements have made Mexico an
market and when can we expect companies to adopt the
attractive investment destination for the pharmaceutical
new regulations it encloses?
and health industry. Significant changes in COFEPRIS’
EA: Due to the relevance of the agreement, we believe
administration, its international certification by the PAHO
the legislative pathways should be accelerated. Given
and recognition by WHO as a Functional Regulatory
enhanced
Agency have aided this. The international recognition of
opposition from the generics industry is expected, thus
certain Mexican drug registrations and the removal of
resulting in delays. TPP would allow its members to grant
regulatory barriers for market entry have pegged the local
a sui generis protection term in addition to the patent
industry as a highly competitive and sophisticated engine.
term to compensate innovators for the non-justified
The new health environment in Mexico encompasses the
delays derived from the health registration grant. In our
population’s access to innovative health products due to
perspective, the aforementioned provision may have a
the Agreement for the Promotion of Innovation and the
positive impact on improving COFEPRIS’ proceedings
Recognition of GMPs Certification, as well as the successful
related to health authorizations and registrations.
timelines
for
data
protection,
a
strong
harmonization and cooperation of COFEPRIS with other leading sanitary agencies, such as the FDA, Health Canada
Q: What does stronger protection of clinical data
and the Japanese regulatory body through Equivalence
represent for both innovative and generic companies?
Agreements.
AP: Extended protection of medical data will result in effective protection of exclusivity rights and data related
Q: How can Hogan Lovells BSTL support healthcare
to patents. Currently, exclusivity rights and data protection
companies in devising strategies and solving legal issues?
terms are affected by delays in patent prosecution and
EA: Scientific and regulatory developments, significant
examinations and in health registration proceedings
changes in the business models of our clients and increased
derived from different reasons including the authority’s
competition within the market are driving the demand
workload.
for strategic legal advice. We represent and provide regulatory advice for several transnational healthcare
Extended data protection may also have a positive impact
companies including pharmaceutical, medical devices and
on R&D investment, but biopharmaceutical manufacturers
biotechnology research projects, where we have acquired
are still uncertain about the final provisions, while
high specialization. Our services include legal assistance in
biosimilars producers might be reluctant to adapt to the
planning and conducting R&D projects related to business
new dispositions. We have to wait for the final protection
strategy. This comprises launching new products, adapting
terms in order to better assess these provisions and their
to
benefits and incentives for the development of biologics.
sophisticated
regulatory
structures,
restructuring
business operations, research projects involving stem cells and advanced technology applications, training programs
Q: What strategies is Hogan Lovells BSTL implementing
and highly specialized compliance matters. Hogan Lovells
to attract foreign and local clients?
BSTL also advises on litigation.
EA: Hogan Lovells BSTL was recently recognized as the fifth most renowned legal firm in the world. Expansion
AP: Litigation could go from an administrative matter to
of our operations and attracting more customers will
federal court. The most common services we render in this
come through integrating our services and a greater
area are related to linkage system conflicts, such as health
collaboration between our 47 global offices.
| INSIGHT
ADDED VALUE DRIVES TALENT ATTRACTION Mexico is among an elite group of countries in Latin America that continues growing in the midst of tough global finances. The country scores 60.6 in BMI’s Pharmaceutical
GERALDINE RANGEL
and Healthcare Risk/Reward Rating (RRR), making it the
Director General
fourth most attractive market in the Americas. This also
of Healthlinks
means the industry’s business and regulatory environment is stable, which along with robust patent protection and the removal of plant registration requirements, has
Biopharmaceutical companies are focusing on high specialty
enabled companies to commercialize drugs without
drugs. Rangel believes that marketing and promotion teams
having a manufacturing site in the country. All important
should undertake pharmacoeconomic studies to prove the
reasons for foreign companies to invest in Mexico but
efficiency of the drugs. They should have conversations with
success will only come with appropriate strategy. “Global
decision makers in which they can discuss the benefits for
executives are often extremely passionate about entering
patients and institutions such as savings, patient health and
Mexico as a first step to expanding their presence in Latin
minimal side effects. “It is important that companies develop
America,” explains Geraldine Rangel, General Manager of
reduced cost strategies aiming to save in manufacturing,
Healthlinks. “But to avoid stumbling, knowledge on doing
import and licensing and maximizing their resources,”
business in the country is essential.”
Rangel says. She advises local companies to find further competitive advantages and added value they bring to the
The main hurdles are not regulatory anymore since
Mexican healthcare sector.
COFEPRIS decided to speed the drug registration process. According to Rangel, companies now face the
Digital marketing is now playing an essential role in
challenge of understanding the tax system and building
delivering the right message in the right way. “We have
a corporate strategy that will help them gain access to
been discussing this with pharmaceutical companies for
the public markets. Evaluating the regulatory, pricing,
years,” says Rangel. “Just last year, companies started using
promotion and distribution aspects of a given product is
social media and digital marketing to connect to the final
important to decide whether or not to enter the market
customer especially for OTC products.” Social media can
before companies invest or spend valuable time and
also be exploited to better inform patients about therapy
resources. “If the company decides to enter the market we
or treatment. At Healthlinks, it is widely known that chronic
will help them build sustainable commercial platforms,”
patients use many digital tools and social media platforms
says Rangel. “The process starts by defining the staff
to connect to other people suffering from the same
profile we are seeking, then engaging in a strategic
condition. “We are in an era of better-informed patients and
recruiting process, training and monitoring closely their
the second opinion usually comes from Dr. Google,” she
performance in the field.”
adds. As for orphan drugs, digital platforms are a great way of finding patients always ensuring compliance with local
Companies should think about value proposition, including
and international regulations. The health industry is starting
product differentiation and a unique team of passionate
to use new tools to find loyal and detractor users based
people wanting to learn about the market and quickly
on what people post on the Internet, which is not new
adapting to their new surroundings. “The ability to hire
for other industries. “Pharmaceutical and biotechnology
and retain talent is a significant challenge for companies
companies should incorporate more of these digitally
today,” says Rangel. Healthlinks helps its clients by
focused marketing strategies,” she concluded.
building a high-performing marketing and sales team and in renewing their product portfolio so they can focus on future development plans. Recruiting and managing talent includes having a strong sales force, presence in the right territory, effective communication strategies among the team, setting and achieving sales goals and ensuring proper medical support for the team. Rangel claims these are all key factors for developing sustainable strategies aimed at increasing the company’s market share.
“Digital marketing is now playing an essential role in delivering the right message in the right way” Geraldine Rangel, Director General of Healthlinks
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| VIEW FROM THE TOP
LEADING THE WAY IN THIRD-PARTY REGULATION CRISTINA VIRUEGA Director General of TAPVS
302
Q: How has the company advanced in its certification
Q: What trends has TAPVS detected in the pharma sector?
processes since 2015?
A: We see a definite trend toward generic solutions.
A: After completing the authorization process with
Many patents became public in 2016 and we expect
COFEPRIS we focused on getting biotechnological,
more to expire in the following year. However, we also
vitamin and herbal products certification. It was a complex
see many new molecules coming into the country.
process and the commission was mindful of every
It is not widely known the national sector is investing
detail when testing our processes. As we are certified
considerably in new research. It is true that Big Pharma
in biotechnological products the first new molecules
is registering trends related to a drop in clinical studies,
have already been authorized via a pre-review process
but Mexico has all the necessary advantages to become
through TAPVS. The sector is increasingly moving toward
an international standard in this area. We have the right
biotechnological medicines and TAPVS is becoming a key
infrastructure, we have qualified doctors and we have a
partner in the process.
considerable genetic diversity, particularly in the north of the country.
Q: How have COFEPRIS’ latest changes in regulation affected TAPVS’ operations?
Q: What has been TAPVS’ development in the domestic
A: We always adapt to COFEPRIS’ standards and we have
market over the last few years?
seen many positive changes. The new regulations establish
A: We have maintained constant double-digit growth
a post-commercialization approach that forces companies
rates and although we previously reported rates of 40-
to really think about the inherent sanitary risks of any
50 percent we are now consolidating at 10-13 percent
product. As a result, there is a significant improvement
margins. We are not worried about this and we have always
in pre-commercialization norms leading to pharma and
considered competition as our best ally. We are now
technical vigilance. The government focuses on tracking
reinventing our business to adopt more advanced IT tools,
the behavior of the product once it reaches the market,
methodizing ruling processes, standardizing revisions and
more in line with how the international sector works.
making our operations far more efficient. This has also been a major advantage for our clients, since they know
Q: How could COFEPRIS incentivize further investment in
exactly what we need to follow up on their registrations.
projects similar to TAPVS’?
Through our Workflow platform, COFEPRIS can supervise
A: The vision of COFEPRIS’ new head, Julio Sánchez,
all our activities so there is no way we can make any
follows Mikel Arriola’s previous strategy to protect
mistakes. We have already implemented this solution. This
people from any sanitary risks, while taking into
is an excellent alternative in terms of sustainability as well,
consideration
since we can store all information digitally and delete it
the
economic
implications
for
all
players regulated by the commission. Making vigilance
once we do not need it anymore.
processes much more assertive and establishing clear regulations incentivizes newcomers to consider Mexico
We have even worked on specific ruling guidelines we
as an investment destination. Furthermore, it pushes
expect will help revolutionize the regulation process in
these companies to not only seek strategic partners but
the country. Furthermore, considering the benefits it has
also bring their full operations to the country. One of
brought to the pharma market, certification outsourcing
TAPVS’ main drivers has always been customer service
can be an excellent solution for other industries as long
and focusing on clarity and time efficiency so our
as the government establishes the proper regulation. The
clients can get their marketing authorizations as soon
oil and gas sector has already taken advantage of this
as possible. In the end, COFEPRIS’ trust makes our job
solution and the country is now looking to integrate this
much easier.
system in the industrial patent registration process.
| VIEW FROM THE TOP
CUTTING THROUGH PAPERWORK TO REACH THE MARKET ISIDRO RODRÍGUEZ Director General of Entimem
Q: In recent years the role of authorized third parties has
Q: What are the main services you provide and what is
been growing strongly in the Mexican healthcare sector.
the added value of the services provided by Entimem?
What specific needs do authorized third parties address?
A: We started working exclusively with medical devices.
A: In 2010, COFEPRIS announced the creation of third party
Afterward, we expanded to incorporate drugs, both in
authorized units for the pre-approval of medicines and
registration and modification of registries. At this point,
medical devices. COFEPRIS decided to create these units
there are 20 third party authorized units and all of them
taking into account the large backlog of registries they had
are able to do the same activities. To differentiate ourselves
at the time alongside new registrations. By law, COFEPRIS
we offer value-added services including our Solution
has to answer every submission. In some cases the products
Ecosystem which encompasses all services we provide to
are easily authorized, but much more information is required.
help companies to register their products in Mexico with
As COFEPRIS previously had to closely follow the entire
a network of companies that provide complementary
approval process and thoroughly review all the information,
services in the health industry such as translations, legal
granting approvals or rejections was a highly time-consuming
consulting, imports and distribution.
process. COFEPRIS gave third party authorized units the responsibility to ensure all information submitted is accurate
Q: What new services are you planning in the near future?
and correct, saving COFEPRIS´ time. COFEPRIS always has
A: We plan to expand our services to other areas of the
the final decision on every registration, since it has a large
economy, for example to provide certification for drivers,
responsibility in regulating medical devices and medicines
electric devices, biotechnology drugs, pesticides food
and we are held accountable if a product validated by us has
manufacturers and restaurants. COFEPRIS is also planning
negative health consequences.
to allow third party authorized units to regulate vaccines, which is a very interesting and challenging area as it
Q: What strategies have you used to position the company
requires working with the WHO.
in the Mexican market? A: We began by searching for companies needing to submit registrations in Mexico. The first step was to gain their trust, convince them that we have all the expertise they require and that we will not waste their time with unnecessary paperwork. As a third party, the most
“There is no room for error in healthcare” Isidro Rodríguez, CEO of Entimem
important thing we handle is our clients’ trust. Q: What strategies is Entimem implementing to attract Third party authorized units seem like a strange concept to
foreign and local clients?
foreign and local companies because they are usually not
A: At this point several companies around the world
aware that these are fully authorized by COFEPRIS. We
are under the impression that regulations in Mexico are
often have to explain to our clients that we are authorized
overly complicated, so our goal is to bring more foreign
by the council and the concept of third party authorized
companies. Next week, for example, we will go to
units is not new since it has already been utilized for other
Colombia to promote our services, as many companies
industries. The council applied this concept to medicines
in that country want to import to Mexico but they are
and medical devices, which was perceived as risky as it
unaware of the proper procedures. More companies, both
involved large responsibilities on public health. However
from Mexico and the rest of the world, are seeing Mexico
the system has worked correctly and we are able to
as a strategic country to enter the rest of Latin America,
provide the necessary drugs and medical devices much
and for that reason there are increasingly more registries
faster to the Mexican population.
for medical devices and medicines.
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| VIEW FROM THE TOP
HUMAN CAPITAL KEY TO GLOBAL COMPETITIVENESS JOHN MITCHELL Managing Partner of the Healthcare and Life Sciences Practice at Heidrick & Struggles
Q: How is the healthcare practice in Mexico different from
the local and global market. In Mexico there is a positive
your previous global experience?
attitude for the healthcare market especially after the
A: Our colleagues in Mexico tend to be more generalist,
growth of generics. Nowadays, Big Pharma is launching
enabling them to work across different practices. Even
considerably less innovative products and what we are
though they may not be as focused on healthcare and life
seeing from them is an increase in the number of mergers
sciences, they can work in consumer or industrial areas,
and acquisitions.
as the vast market size inhibits them from focusing on a
304
single specialization area. Notwithstanding, this type of
Q: How are you addressing the need for human capital and
behavior varies around the globe. For instance, in the US
the development of Mexican talent?
and certain European markets, in-depth specialization
A: Big Pharma used to bet on Mexican-bred leadership to
is the norm. The Mexican healthcare market is quite
oversee local operations and companies had a really strong
different from the rest of the world. In the past, foreign
Mexican leadership. Now, leadership comes from other parts
companies entered the country to manufacture their
of the world. However, what we are looking for in terms of
products, as the country offered high-quality standards at
quality and talent does not differ. We are looking for leaders,
competitive costs. In addition, Mexico’s strategic location
people who can inspire, who are culturally adaptable and
made manufacturing activities for specialty products and
who have strong experience and a proven track record of
generics much more appealing.
success. We are also looking for a flexible workforce.
“It is necessary to establish a
It is necessary to embrace diversity and be clear about
zero tolerance policy for
sector it is necessary to closely scrutinize safety and to
non-compliance”
which may be expensive and difficult to navigate. Thus, it is
John Mitchell, Managing Partner of the Healthcare and Life Sciences Practice at Heidrick & Struggles
business objectives, values and ethics. In the pharmaceutical ensure compliance with the entire regulatory environment, necessary to establish compliance policies and methods and to ensure that employees understand and follow them. The pharmaceutical industry handles products which deal with life and death.
Q: What are Mexico’s strong suits in the healthcare industry? A: Mexico’s talent pool is highly fluid, as people frequently
Q: Taking into account that Millennials are shaping their
explore
work environment, how should pharmaceutical companies
the
professionals
marketplace. to
acquire
This
allows
on-the-field
healthcare
experience
in
adapt to remain competitive?
multiple areas and markets, which is extremely important
A: The Millennial generation is extremely strong, and
and adds value to the industry. In markets where there
different from the Baby Boomers. They are the largest
is more specialization, employees will focus only on one
generation at this point. This segment is much more
area, such as medical technology or biopharmaceuticals.
interested in their quality of life and base their decisions
People are very polished in the healthcare industry. At this
on the work environment and experience. We have seen
point, there are strong concerns on the topic of the single
some companies completely change their workforce
payer system and what actions will the government take
and work environment for them. For instance, previously
to promote healthcare in the country. The government
personal offices for leadership roles would take about
may decide to follow the example of other economies
80 percent of the space in an office. Now, these offices
around the world where medicine is subsidized, leading to
only take 20 percent while the rest is open space to allow
a healthier workforce, which is in a better position to help
employees to communicate.
| VIEW FROM THE TOP
BUSINESS BACKGROUNDS ENHANCE HEALTHCARE SECTOR LEADERSHIP IGNACIO PÉREZ Managing Partner at Heidrick & Struggles
Q: What role does the life sciences industry play in
but oftentimes they are reluctant to come back. On the
Heidrick & Struggles’ strategy?
contrary, there are many foreigners in Mexico occupying
A: Founded in 1953, Heidrick & Struggles is the oldest top
leadership positions who do not want to leave when their
executive search firm comprising several practices such as
contract ends. Moving from one company to another
financial services, global technology, consumer, industrial
regardless of them being in the same market segment
and healthcare and life sciences. Each practice has different
requires adaptation and a cultural fit and this process
subsectors, the latter comprising the pharmaceutical
should not be minimized as it is necessary to learn the
industry, medical devices, biotechnology and healthcare
company’s priorities and the short, middle and long-term
which all comprise one of the largest practices in Mexico.
strategies. 305
We also offer consulting services such as top level assessment, top directors effectiveness and cultural
Q: What should be an executive’s focus on their first days
shaping. Thus, we have substantial experience providing
in a company to guarantee success?
pharmaceutical and medical devices companies with tools
A: The first 90 days are crucial for an executive’s success.
to develop strong leadership and organizational culture.
Learning about business trends, priorities, talent within
I believe talent in the pharmaceutical industry is scarce
the company and gaining industry expertise should be
and there is a need for hiring leaders with both medical
a priority. There are six factors the new manager should
and business backgrounds and skills. Hiring traditional
focus on. Culture is the first one. This means leaders need
doctors who lack knowledge on business strategy is not
to be fully involved in the company’s culture, including
a wise move in today’s pharmaceutical industry. Similarly,
the mission, values, strengths, weaknesses and drivers.
hospitals could hire people capable of making better
The second factor is talent, which is getting to know
decisions based on a clear understanding of the market
and building the team they are leading. The third is the
drivers and business environment.
business, which basically entails learning about it and its problems with products, providers and clients among
Q: What considerations should a company take into
others. The fourth factor is familiarizing with the local and
account when evaluating a candidate for an executive
regional expectations in a two-way sense: the company’s
position?
ideals, as well as the leader’s vision. The fifth is networking
A: We map the entire market across industries to find the
with internal and external providers and clients. The last
right talent. Some positions such as CFOs and CHROs,
one is thoroughly knowing the products and services
can be filled by people from other industries, which works
offered by the company and the pipeline.
smoothly when their previous work experience allows them to learn about pharmaceutical industry dynamics.
Q: Mergers and acquisitions are commonplace in the
Recruiting talent from abroad is another strategy being
pharmaceutical industry. How can cultural alignment
implemented by many companies and the number of
between two different companies be fostered and
Mexican and foreign executives in top managerial positions
achieved?
is equitable. We find candidates through a clearly defined
A: Aligning the culture of both organizations is extremely
search strategy and a cultural fit assessment. We also
important and it is necessary to define whether it is an
map second level managers in Mexico who might be
acquisition of products and/or services and then making
ready to jump to the top position and help them develop
the cultures merge and work together. Cultural shaping is
the necessary skills for it. In addition to ethical values
a continuous process since new people join the company
and skills, the cultural fit accounts for 80 percent of a
constantly. The acronym DURAM helps us remember to
leader’s success. When it comes to attracting talent from
Define the culture, Unfreeze to kick bad habits, Reinforce
abroad, we always consider expatriate Mexican leaders
the culture, Apply to the business and Measure it.
| VIEW FROM THE TOP
NAVIGATING LOCAL WAVES IN MEXICO AND LATAM PAUL DOULTON CEO of Oriundo
Q: In the context of the Mexican landscape, what do you
for risk in investment and the degree of control needed.
believe is Oriundo’s role and how was this accomplished?
We then find the right solution and most appropriate fit.
A: We help companies understand Latin America, with
Many companies try to do this alone but are rarely able to
its 22 countries and differing market dynamics. Oriundo
identify the most strategic alliances to meet their needs.
means “someone who hails from” and we channel this
306
by helping foreign companies navigate local waters. Our
Q: What role do Mexico and other Latin American countries
offices are all over Latin America including Argentina,
play in companies’ internationalization strategy?
Brazil, Chile, Peru, Mexico and Colombia. At Oriundo, we
A: We have been in business for about 15 years and we now
help our clients develop the right entry strategies into
have more work than we ever had before, which reflects
Latin America through licensing, distributors, partnering,
the increasing interest in the Mexican and Latin American
joint ventures, or acquisitions. One of the most successful
markets. This is due not to the market growing, and its
strategies has been outsourcing marketing, regulatory,
regulatory environment, which is highly supportive of the
medical and sales services and try before you buy, while
industry. In comparison, the regulatory framework in other
others prefer partnering with Mexican companies. The
countries, such as Brazil, is still extremely protectionist.
right strategy depends on the company’s portfolio, what
The policies introduced by Mikel Arriola in Mexico are
the customer wants to achieve, his appetite or reluctance
speeding the introduction of new molecules into the
| EXPERT OPINION
DOULTON SEES GROWTH FOR MEXICAN HEALTHCARE Latin America has a population of 500 million, with a
the low spending and reduced priority for healthcare on
pharmaceutical market of US$80 billion and it is expected
the political agenda.
to rise to US$150 billion in the medium term. Most of the economies in the region are growing, excluding
The amount of money that is spent is not the problem.
Brazil, Argentina and Venezuela but economies such as
Most healthcare budgets are fixed on expenditure and
Colombia, Mexico and Peru are implementing sensible
not on outcomes. Payer and provider are often the same
policies to promote growth. Healthcare spending rises with
entity, so money cannot flow to the most efficient provider.
GDP growth but out-of-pocket spending still outpaces
Healthcare decisions are taken from the patient and a
public provision. All this means growth for the pharma
dependency culture has been the unwanted result. The
industry and only by understanding where healthcare is
only system approaching viability is Colombia where the
headed, and the new rules it encompasses, can successful
government has set strict rules ensuring the separation of
strategies be devised.
payer and provider. In this case, the private sector is the funder, a separate provider comes from the private sector
The Latin American healthcare system faces similar
and the authorities simply oversee the process. In Mexico,
challenges to the developed world with funding running
healthcare coverage rose from barely 15 percent of the
out in the face of an aging population, especially older
population to close to 90 percent in about 10 years, all
populations such as Chile and Argentina, although the rest
managed by the private sector.
of the region has a positive demographic balance. Social security and public healthcare provisions differ widely
The Mexican system is suffering great fatigue not only
from country to country and much criticism is leveled at
because of duplication of coverage but also because of
country. It also makes the process more predictable,
business model by acquiring local generic companies and
fair, reduces the duplication of work and approval by
an issue they face after acquisition is trying to use their
other serious regulators such as EMA and the FDA. This
former business model by promoting to doctors, using the
is all being done without the need to relax standards
old wholesaler and pharmacy channel for generics too.
or
Mexicoâ&#x20AC;&#x2122;s
The only commonality between a patented medicine and
pharmaceutical and generics manufacturers now meet
its generic counterpart are its manufacturing and patient
global standards. Mexico benefits from a sound economy
consumption but the intermediate market dynamics are
and positive regulatory environment so many companies
entirely different. The more successful generics companies
are now choosing the country as a launching pad for Latin
are often managed by former fast moving consumer
America. At Oriundo, we have spent eight years studying
goods executives well versed in the channel dynamics and
healthcare systems across the region in order to ensure
who are focused on improving the value chain. As for local
that companies know where local policy and its execution
generic producers, pharmacy and supermarket chains are
is headed.
also promoting growth, especially private label generics.
compromise
patient
safety.
Contrarily,
These chains now represent more than 60 percent of all Q: How can both international and local companies drive
pharmaceutical product sales and are still growing. Local
growth in Mexico given the challenges they face?
producers, especially of generics, have traditionally been
A: International companies generally thrive in generating
flexible during manufacturing, which enables them to
and introducing new molecules. Major innovators are
meet market regulation, low-inventory and ever changing
losing their patents and have been unable to generate
requirements of the big chains just in time. Manufacturers
new ones fast enough. As a result, big pharmaceutical
in India, the US and elsewhere with large dedicated plants
companies are implementing new strategies such as
are not able to match these requirements at a distance.
the acquisition of smaller ones. For example, Merck
Therefore, local manufacturing, at least for high volume
(MSD) recently bought Schering Plough, Pfizer is buying
products, has gone from a regulatory to a strategic
Allergan, while Sanofi has incorporated 10 to 12 different
imperative. Price is indeed far from the most important
companies.
factor in Mexico.
International
companies
modified
their
vested interests, lack of competition, aging population,
and more recently Head of Harvard School of Public Health,
decisions taken away from the patient and interference in
tried to make the necessary changes to the social security
the doctor-patient relationship. Hope is around the corner,
system but faced great reticence from the sector, with its
however, with the creation of Seguro Popular, a funding
strong union and private interests. Therefore, he created
agency today covering more than half of the population. The
Seguro Popular with the goal of making this institution the
intention is to establish Seguro Popular as the unique funder
unique payer for medical services in Mexico but this has
for healthcare and purchase provision on a competitive,
not been accomplished. However, the institution is able to
outcome-focused basis from the array of social security
buy services from the main public healthcare organizations
hospitals and clinics, as well as from the private sector.
including IMSS and ISSSTE, therefore reducing duplication. Another problem with the social security sector is the long
To improve health and reduce expenditure, healthcare
distances patients have to travel in order to receive medical
should become a priority with the patient at the center.
care. Today, Seguro Popular has surpassed IMSS as the
The patient should decide how his medical savings are
institution with the largest number of affiliates so nearly 96
spent or saved with strong advice from his primary care
percent of the population now has some form of healthcare
doctor. This engages the patient in seeking wellness
coverage.
as they have been shown to be more careful with their money. There are indeed other successful examples
Mexico is a buoyant market, growing steadily if not
through medical savings in countries like Singapore,
spectacularly. The pharmaceutical market value is between
which has a healthy population, content doctors and
ninth and 11th globally, worth close to US$20 billion, with
government, while spending barely 4 percent of the GDP.
US$14-15 billion in the private sector and US$2-4 billion in
Finland is also headed down the same road. In healthcare,
the public sector. The North of Mexico is closer than ever
the source of the decision represents a direct indicator of
to becoming a developed market with sophisticated and
whether health will improve. Politicians should embrace
highly competitive manufacturing centers, as evidenced by
the patient-centric model as it circumvents acrid criticism
the continuous inward investment into new plants both for
about healthcare rationing. Julio Frenk, as Health Minister
small and large molecule manufacture and related services.
307
| VIEW FROM THE TOP
MEETING HEALTH MARKET NEEDS VIA TALENT DEVELOPMENT DOMINIK BACHER Director General of Bacher Zoppi
Q: What are the main gaps you want to close in the
Nowadays patients are more aware of costs and they
healthcare industry?
have new needs, such as better and more efficient
One of the main areas of opportunity is the point of
therapies and services. There is huge potential for
sale. The complexity of the market makes it necessary to
the pharmaceutical industry to consider, not only
establish business partnerships to ensure the availability
products but also more complete services. Patients are
of products at points of sale, to optimize the distribution
open to technology, generating a big opportunity for
of new products and to avoid the substitution of brands.
the development of new apps and systems that help connect patients with their doctors. This can have a
308
Bacher Zoppi has established three business areas or
major impact on prevention, diagnostic and treatments.
services lines: sales teams visiting physicians at their private
We have many pilot projects in this service area and
office and hospitals to generate sustainable demand; sales
we believe this field has enormous growth potential in
teams to optimize the distribution and attend the point
the next few years. Our clients are searching for data
of sale to guarantee the availability of the product; and
protection services and upgraded services focused not
finally services that offer added value to the patients. In
only on products, but on the provision of treatments and
many cases, especially for new brands, our customers
medical care in a collaborative way. The company also
ask for better access to patients and programs to ensure
has evaluated various projects of telemedicine because
adherence to the prescription or recommended treatment.
we are convinced that they have great potential to satisfy patient needs.
Q: To what extent do you agree with expertsâ&#x20AC;&#x2122; opinion that primary care at the point of sale needs to be regulated?
Q: How do you help your clients find the right talent
We see that primary care at the point of sale is a model
considering that Mexico does not have the necessary
that has been very successful in Mexico and in my view,
number of specialized professionals to satisfy all the
this is an irreversible tendency. The model allows easy
needs of healthcare services?
and comfortable access to primary care for the Mexican
We are searching for talent according to client needs.
population. Now the challenge is professionalizing medical
There are many levels of expertise and annually we
attention at pharmacies.
recruit over 1,000 pharmaceutical sales professionals and medical staff for specific projects. The evaluation
Q: Would you say that distribution is the main factor
method that Bacher Zoppi has implemented is designed
to consider in expanding the life cycle of a brand after
to reduce the gaps between what skills we are looking
patent expiration to maintain its competitive position in
for and the availability within the human resources
the market?
market. In addition, at Bacher Zoppi we have a platform
We believe and have experienced that it is possible to extend
to train and develop staff and we constantly certify
the life cycle of brands through optimized investment,
and re-evaluate our personnel. We also have built a
considering three key factors: a physician calling to remind
big data base with approximately 30,000 candidates
the brand, the distribution to make the therapy available
with different profiles that can be adapted to specific
and finally the price. At Bacher Zoppi we have experience
projects; so we find candidates with the profile our client
in helping industry reduce the impact on their revenues and
is looking for. However, we have noticed a reduction in
developing investment strategies for mature brands.
the size of the sales forces in pharmaceutical companies, as part of a worldwide trend to control expenses. Bacher
Q: What role do patients have in the healthcare system
Zoppi is focused on the commercial part of the industry,
and how are companies striving to put patients at the
meaning that our main expertise is recruiting and
center along with institutions?
managing sales talent
| VIEW FROM THE TOP
HEALTHCARE REQUIRES PUBLIC SECTOR PUSH LOUISE BATCHELDER CEO of SYNELOG MEXICO
Q: How are the recent tax reforms impacting the
national program, which aimed to have the private sector
healthcare industry?
finance new public hospitals. After a revision of PPP law
A: Tax reforms affect every economic sector including
other hospitals may still be built in the second half of this
healthcare. Under the new regime not only are taxes
administration.
higher but foreign investment will have to adjust to it. International companies used to be able to deduct certain
Q: What new entry strategies are pharmaceutical
payments from their local offices but the new reforms
companies implementing?
make them liable for more taxes, which is a disincentive
A: Eighteen months ago CANIFARMA and AMIIF generated
for new and continuous investment. Fiscal reforms affect
and implemented a new strategy called Shared Risk,
everyone including people who buy medicines and more
which meant pharmaceutical companies would provide
specifically people from the middle class. They drive the
innovative drugs to the public sector at no cost so that
demand for brand products. Therefore, a hit on their
patients could receive a trial period for their treatment. If
economy slows down demand for brands and innovative
the patient got a positive outcome the government would
medicines and increases generics being sold.
then be obliged to pay the price in full for the drugs.
Q: How is the government fostering the sector?
Though pharmaceuticals are not thrilled to be giving
A: The government has developed national programs for
away free medication these types of strategies prove the
every sector and they are available online for all to read.
willingness of the sector to overcome barriers.
But considering the effort made during the Energy Reform, I would say healthcare is not a priority right now. Public
Q: Has R&D in Mexico progressed?
officials have to prioritize according to budget availability
A: The link between research and commercialization has
and there have been significant cuts in the sector. Big
not changed significantly for the past 10 years. Back in
Pharma in Mexico has stated the government does not
2005, I was involved in a life sciences study and at that
perceive healthcare as a priority, much less innovation.
time we had many hopes that have not materialized due
Innovative medicines that are being brought into the
to financing problems. Angel financing does not exist in
country are the most significant challenge for subsidiaries.
Mexico. NAFIN and Bancomext are not prepared to take
The healthcare system has suffered budget constraints
risks, which is paradoxical as the purpose of a development
and a failure to implement an effective healthcare policy,
bank is to support the commercial banking system in
which has resulted in poor performance impacting the
handling risks. Other industrial activities may enjoy tax
pharmaceutical industry and R&D in Mexico.
breaks for undertakings such as building new plants or job generation. But given the limited risk the government is
Q: What can Mexico learn from other countries regarding
willing to accept for research there is a blockage between
Public Private Partnerships (PPPs)?
R&D and commercialization.
A:
Recently,
the
Minister
of
Health
said
in
the
administration’s first three years, PPPs have not been used
Q: What specific activities is SYNELOG MEXICO doing to
to their utmost potential. The UK, a world leader in these
promote innovation?
type of partnerships, advised the Mexican government on
A: SYNELOG provides consulting in healthcare, education,
how to use this tool and to this day Curry & Brown are
social development, science and technology, innovation
still the government’s tactical advisers. During the current
and competitiveness. At this point, I am interested in the
tenure only one PPP hospital has been built and the
lack of patenting offices in most Mexican universities. I am
procurement was led by ISSSTE Mexico City and not the
researching what structures could be set up so that any
Ministry of Health. This has paralyzed the health sector’s
university can set up their own in-house patenting office.
309
| VIEW FROM THE TOP
IMPROVING HEALTHCARE ACCESS FOR THE UNDERPRIVILEGED JAIME CERVANTES Director General of Grupo Vitalmex
310
Q: What would be the most relevant inefficiencies in the
and the potential target is 5 million. The opportunity is
healthcare system and how do you help in fixing them?
so important that it is almost impossible for one single
A: As in many other countries, there are inefficiencies in the
company to provide the required services. There are not
Mexican health system. The WHO suggests five indicators
enough companies with the quality standards to help the
that healthcare systems across the world should adhere
national health system implement the five WHO indicators.
to in order to fulfill their ultimate goal, which is to improve
We have five main competitors and are the pioneers of
public health. The first one is that the system has to be
integrated services. We are replicating our service model
humane, and we have incorporated this by ensuring that
in other nations. Mexico is the only country that has
we give dignified treatment to all. The second indicator
developed integrated services, while others, such as the
is availability, meaning all supplies and goods necessary
US, are surprisingly behind in terms of service delivery to
for patients should be available in a timely manner, which
hospitals. For this reason, we are targeting the American
requires significant logistic efforts. Accessibility is the third
market in the short and medium term.
indicator, and it is typical in emerging countries to see both protected and unprotected people, which is why Grupo
Q: How are you planning to mitigate the financial risk of
Vitalmex is creating a substitute infrastructure consisting of
offering healthcare services to the less affluent?
clinics to satisfy the demand for healthcare services for the
A: The only way we can mitigate such risk is by establishing
underprivileged. In the near future, we look to expand our
our clinics and hospitals in strategic locations. We are
reach to include clinics and hospitals. If we can do this in
planning to launch our model in Colombia, Peru and Mexico
collaboration with Seguro Popular we will be able to provide
simultaneously and I truly believe it will be a great project.
excellent options for patients.
This brings us back to the fourth indicator of the WHO, which is a timely healthcare system. People should receive
Q: Are there any indicators of hospitalsâ&#x20AC;&#x2122; performance
medical attention whenever and wherever it is required
improving due to your services?
and in reality many Latin American countries still do not
A: Our services reduce costs in the range of 12 percent to
have the infrastructure in place. The WHO indicators relate
20 percent, while increasing productivity of patient care
to an effective system and I would say the system that
and coverage by an average of 30 percent. Additionally,
exists today is relatively ineffective. However, if properly
surgeon and physician techniques improve significantly. We
implemented, the five indicators would help to transform
measure this indicator based on the rate of implementation
Mexicoâ&#x20AC;&#x2122;s healthcare system, which includes its three levels
of our services. The final goal is to improve the patient
â&#x20AC;&#x201C; private, social security and the base of the pyramid.
experience. A challenge we face is to merge our sales force with the vision of our partners, because the health industry
Q: What is next for Grupo Vitalmex in terms of expansion?
pushes hospitals and institutions to acquire the newest
A: We are also exploring possibilities in Germany and
technologies. There is a constant drive for innovation.
the Scandinavian markets. We aim to collaborate
Health institutions are interested in reducing costs; patients
in developing useful healthcare systems across the
want the most comprehensive medical attention possible
globe and our company has the experience and
and doctors are determined to improve their work. A
knowledge in healthcare to benefit our stakeholders.
balance of these three factors is necessary.
We are undergoing a process of vertical and horizontal integration to become one of the main healthcare service
Q: How significant is the opportunity to expand this kind
providers for the bottom of the pyramid, as poverty is
of service in Mexico and other countries?
still a relevant issue in Latin America. We have before
A: Mexico performs 2 million medical procedures per year,
us a solid opportunity to increase access to healthcare
including surgeries. At this point, we are covering 700,000
services through our clinics.
| VIEW FROM THE TOP
DEVELOPING MEXICAN-SPANISH PARTNERSHIPS ÁNGEL ALONSO CEO of VecMedical
Q: What type of participation does VecMedical have in
Q: When do you expect this cooperation with the IMSS
the Mexican market?
to happen?
A: We have a single Mexican distributor but we are
A: We have contacted some people, one of which worked
evaluating whether it is more advantageous to expand
in the hospital in Barcelona. We know her well and
our sales volume with them or whether to diversify our
worked on other projects with her, so communication for
efforts with others. Even though our product has received
future projects will be fluid. Now cooperation is simply a
the Conformité Europeéne (CE) certification from the
question of starting. There are two ways of working with
European Union, we are yet to secure a COFEPRIS registry.
the IMSS. They have been working for a certain amount of time on detecting the potential of projects and ideas
VecMedical is part of the Catalan Health Technology
that doctors have but perhaps do not find an opportunity
cluster. We are establishing a collaborative innovation
to develop. They have technological needs that we may
group, looking to create link-up partnerships with
be able to assist with, for example making prototypes. We
Catalan institutions from a clinical, industrial and
will concretely begin to contribute to a certain amount of
technological standpoint. Research is strong in Catalonia
projects. Other opportunities arise when are collaborating
but few products emerge from these efforts. As such,
on clinical research projects as we are doing in Barcelona.
we are looking to potentiate and secure these areas
The collaboration is bidirectional. We are about to sign an
of opportunity. Spain’s bilateral relations with other
agreement that will allow us to start work soon. Here at
countries have allowed us to expand our market reach,
VecMedical we are conducting clinical trials in Barcelona,
inserting our products in countries such as Mexico.
when finished we will send this to the IMSS.
We are holding meetings with the IMSS innovation department to jointly develop projects that will benefit
Q: What benefits will this collaboration bring other than
both parties. We are also looking to secure a framework
the great volume of patients?
agreement with ISSSTE, working on clinical research
A: Firstly, it will complete the feedback process as patients
and developing solutions, services and products. There
in Mexico may present different symptoms than those in
are other ways in which VecMedical and the Catalan
Germany or other countries. Secondly, if this collaboration
Health Technology cluster can potentiate the global
happens, we will have information directly obtained
participation of Mexican players. We can help them enter
in Mexico and I believe access to the market from a
the European market, which we have already done with
regulatory point of view will be simpler as the registration
Brazilian companies.
with COFEPRIS will be simpler.
Q: What are the conditions of the Mexican market
Q: To what extent have you considered opening a
VecMedical is adapting to?
subsidiary here in Mexico?
A: Market conditions are general, not exclusive to Mexico.
A: For our more mature products, we have two or three
Each area in the implementation and development of
distributors and so it would not make sense to open a
technology possesses a particularity of the Mexican
subsidiary. There is already an underlying basic framework
environment. When VecMedical develops a new product,
in place and registered producers. For new products in
we try to do multi-country clinical trials whereby we work
development it is interesting for us to have control of the
not only in the clinic and hospital of Barcelona and with the
registration, particularly for respiratory products. In this
IMSS and ISSSTE in Mexico but also in Denmark and other
area it would interest us to have a branch or an affiliate
countries. This gives us more positive and constructive
here. We have begun talks with some advisers here to
feedback and allows us to offer a more robust product
study the possibility of beginning with a branch and then
when we bring it to market.
an affiliate.
311
| GLOSSARY A-C ACRONYM
FULL NAME
AMEIFAC
Asociación de Médicos Especialistas en la Industria Farmacéutica (Association of Medical Specialists in the Pharmaceutical Industry)
AMID
Asociación Mexicana de Industrias Innovadoras de Dispositivos Médicos (Mexican Association of Innovative Medical Device Industries)
AMIIF
Asociación Mexicana de Industrias de Investigación Farmacéutica (Mexican Association of Pharmaceutical Research Industry)
ANHP
Asociación Nacional de Hospitales Privados (Association of National Private Hospitals)
APEC
Asia-Pacific Economic Cooperation
API
Active Pharmaceutical Ingredients
BPCIA
Biosimilar Price Competition and Innovation Act
CANACINTRA Cámara Nacional de la Industria de Transformación (National Chamber of the Manufacturing Industry) CANIFARMA
Cámara Nacional de la Industria Farmacéutica (National Chamber of the Pharmaceutical Industry)
CAUSES
Catálogo Universal de Servicios de Salud (Universal Catalogue of Health Services)
CDMX
Mexico City
CENSIDA
Centro Nacional para la Prevención y el Control del VIH/SIDA (National Center for the Prevention and Control of HIV and AIDS)
CETIFARMA
Consejo de Ética y Transparencia de la Industria Farmacéutica (Council of Ethics and Transparency in the Pharmaceutical Industry)
CIDEFARMA
Centro de Investigación y Desarrollo Farmacéutico (Center for Pharmaceutical Research and Development)
CINVESTAV
Centro de Investigación y Estudios Avanzados (Center of Investigation and Advanced Studies)
COFEPRIS
Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commision for the Protection Against Sanitary Risks)
COMECYT
Consejo Mexiquense de Ciencia y Tecnología (State of Mexico’s Council for Science at Technology)
COMOP
Comité Mexicano para la Prevención de la Osteoporosis (Mexican Committee for the Prevention of Osteoporosis)
CONACYT
Consejo Nacional de Ciencia y Tecnología (National Council for Science and Technology)
CONADIS
Consejo Nacional para el Desarrollo y la Inclusión de las Personas con Discapacidad (National Council for the Development and Inclusion of Disabled People)
CONCAMIN
Confederación de Cámaras Industriales (Confederation of Industrial Chambers)
| GLOSSARY C-S COPARMEX
Confederación Patronal de la República Mexicana (Mexico’s Business Owners Confederation)
COSMEP
Código de Autorregulación y Ética Publicitaria de Productos del Cuidado Personal y del Hogar (Code of Autoregulation and Publicitary Ethics for Personal and Household Hygiene)
CRF
Case Report Forms
CRO
Contract Research Organization
CSG
Consejo de Salubridad General (General Health Board)
CT Scan
Computed Tomography Scan
CTMS
Clinical Trial Management System
EMA
European Medicines Agency
FDA
Food and Drug Administration
FUNSALUD
Fundación Mexicana para la Salud (Mexican Foundation for Health)
GCP
Good Clinical Practices
GMP
Good Manufacturing Practices
IIIFAC
Instituto de Investigación e Innovación Farmacéutica (Pharmaceutical Innovation and Research Institute)
IMPI
Instituto Mexicano de la Propiedad Intelectual (Mexican Institute of Intellectual Property)
IMSS
Instituto Mexicano del Seguro Social (Mexican Institute of Social Security)
INCAN
Instituto Nacional de Cancerología (National Insitute of Cancerology)
INSP
Instituto Nacional de Salud Pública (National Institute of Public Health)
IPN
Instituto Politécnico Nacional (National Polytechnic Institute)
ISAPS
International Society of Aesthetic Plastic Surgery
ISO
International Organization for Standardization
ISSSTE
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (Institute of Safety and Social Services for Federal Workers)
ITESM
Instituto Tecnológico y de Estudios Superiores de Monterrey (Technological Institute of Monterrey)
JCI
Joint Commission International
LAMMB
Laboratorio de Análisis de Moléculas y Medicamentos Biotecnológicos (National Laboratory for Production and Analysis of Biopharmaceuticals)
LATAM
Latin America
MRI
Magnetic Resonance Imaging
MTA
Medical Tourism Association
NCDs
Non-Communicable Diseases
| GLOSSARY N-Z NOM
Normas Oficiales Mexicanas (Mexican Official Norms)
NORMEX
Sociedad Mexicana de Normalización y Certificación (Mexican Society of Standardization and Certification)
OECD
Organisation for Economic Co-operation and Development
OEM
Original Equipment Manufacturers
OTC
Over the Counter Products
PAHO
Pan American Health Organization
PET Scan
Positron Emission Tomography Scan
PIPCCM
Programa Integral de Prevención y Control del Cáncer en México (Mexico Cancer Prevention and Control Program)
PPP
Public-Private Partnership
R&D
Research and Development
REDLARA
Red Latinoamericana de Reproducción Asistida (Latin American Network of Assisted Reproduction)
Rx
Prescription Drugs
SALUD
Secretaría de Salud (Ministry of Health)
SEDENA
Secretaría de Defensa Nacional (Ministry of National Defense)
SEMARNAT
Secretaría de Medio Ambiente y Recursos Naturales (Ministry of the Environment and Natural Resources)
SINGREM
Sistema Nacional de Gestión de Residuos de Envases y Medicamentos (National Waste Management System for Packaging and Drugs)
SMAES
Sociedad Mexicana de Arquitectos Especializados en Salud (Mexican Association of Specialized Healthcare Architects)
SMSP
Sociedad Mexicana de Salud Pública (Mexican Society of Public Health)
SOP
Standard Operating Procedure
TPP
Trans-Pacific Partnershp
UAM
Universidad Autónoma Metropolitana (Autonomous Metropolitan University)
UANL
Universidad Autómoma de Nuevo León (Autonomous University of Nuevo Leon)
UDEM
Universidad de Monterrey (University of Monterrey)
UNAM
Universidad Nacional Autónoma de México (National Autonomous University of Mexico)
UNICEF
United Nations Children’s Fund
WHF
World Heart Federation
WHO
World Health Organization
| ADVERTISING INDEX 6 TAPVS
183 Qually
36
ABC Hospitals
189 Olivares
52-53
Mayoly Spindler
194 AMIIF
62
Pierre Fabre
204 LEI
71 Janssen
212 MBE
75
217
IM Natural
88 Hetlabs
Pharma Tycsa
230
Sports World
96
Aspen Labs
248 BOMI
108
Farmacias GI
255 NTA
127 BioSkinco
260
World Courier
136
APE Editorial
268
World Stem Cells
154
R.H. Shipping
281
Tijuana Bariatrics
176
Grupo Bruluart
290 MBP
| INDEX A-I 1DOC3 165
Coral Dental Center 287
3M 113
CostaMed 285
ABC hospitals 48
Croda 196, 201
Accelerium 189
Deloitte 294
ACROM 20, 178, 190-191
Dentistar 286
Alandra Medical 132
Digitalizatxt 168-169
Alfa Wassermann 77
Distribuidora Levic 258
AMEIFAC 19, 28
Dräger 112
Amgen 74-75, 81, 196
Entimem 303
AMIIF 20-21, 44, 181, 309
EPIC CRO 186
Anti-Obesity Center 245
Farmacias GI 104
Apotex 95
Farmalisto 264
ASMED 59
Farmapiel 214, 218
Aspen Labs 97
FENIN 30
Astrum Salud 166-167
Fertility Center Cancun 278
Avinent 168
Fundación Carlos Slim 24-25, 148, 164
Bacher Zoppi 308
FUNSALUD 20, 22-23, 74
Baker & McKenzie 297
Galderma 214, 221
B. Braun Aesculap 31, 118
GE Capital 110-111
BioMérieux 146-147
GE Healthcare 110-111
BIOSKINCO 198
Glenmark 94
Boehringer Ingelheim 68, 253
Global Health Intelligence 50, 115, 172-173
BOMI de México 250-251
Greatbatch 119
Brudifarma 100, 252
Grisi 215, 222
Bupa Global Latin America 299
Grupo Body Systems 239
Cancun Oncology Center 276-277
Grupo Marzam 262-263
CANIPEC 8, 216-217, 214
Grupo Neolpharma 98
Canon 116-117
Grupo Vitalmex 310
CareFusion/Becton Dickinson 202-203
Hays 298
CDM Labs 214, 215, 220
Healthlinks 301
Centro de Oftalmología Monterrey 274-275
Heidrick & Struggles 304-305
Cetifarma 78-79
Hetlabs 92-93
Clínica de Mérida 57
Hogan Lovells 300
Cluster Ciudad de la Salud 272
Hospital Galenia 56, 276, 277
Cluster Tijuana EDC 130
Hospital General de México 46-47
CODY 58
Hospital San Angel Inn 55
COFEPRIS 8, 10-11, 19, 20, 21, 30, 35, 38, 42,
Hospital San José 284
43, 44, 59, 61, 65, 68, 69, 74, 81, 85, 87, 92, 93,
Hospitaria 51
95, 98, 99, 100, 104, 105, 117, 120, 121, 128, 129,
IBt 197, 205
131, 132, 143, 158, 169, 175, 178, 179, 180, 182, 184,
ICON 188
188, 189, 191, 196, 197, 198, 200, 202, 204, 207,
IIIFAC 80
217, 218, 220, 236, 237, 240, 243, 252, 253, 254,
IM Natural 215, 223
261, 274, 289, 294, 296, 300, 301, 302, 303, 311
IMS Health 92, 95, 156
COMOP 149
IMSS 8, 14, 20, 21, 24, 30, 31, 35, 38-39, 41, 42,
ConvaTec 122-123
44, 45, 56, 57, 66, 80, 93, 112, 121, 133, 138, 145,
| INDEX I-Z 146, 151, 153, 156, 159, 179, 181, 183, 184, 188, 190,
Providien 126-127
229, 257, 273, 295, 307, 311
PwC 159, 295
INCAN 8, 112, 135, 138, 140, 151, 156
QBD Consulting 158
INSP 9, 26-27, 138, 144-145, 149, 313
Qually 105
Infinite Clinical Research 178, 190
Quintana Roo Medical Travel Association 270
inVentiv Health 178, 185
RegenerAge 209
IREGA 279
R.H. Shipping 259
IVINSEMER 208
RM Pharma 179, 182-183
Janssen 66, 70-71, 81
SANAR 243
Kaloni 215, 224
Scantibodies 206
Laboratorios Keton 99
Minister of Health of Mexico City 12, 13, 42
Landsteiner Scientific 69
SEFOTUR 32
LEI 178, 179, 184
Seguro Popular 14, 15, 20, 35, 40-41, 42, 45,
Liomont 90-91, 256
46, 85, 138, 140, 144, 149, 153, 307, 310
Lundbeck 81, 200, 204
Sesderma 215, 219
Malvern Instruments 207
Siemens 114, 138, 150
Marken 265
SignuFarma 81
Mayoly Spindler 102
SINGREM 256
McKinsey & Company 292-293
SMC 138, 142
Medisi 129
Smile Train 160-161
Medtep 162-163
SMSP 18
Medtronic 120-121, 132
Sports World 238
Merz Pharma 215, 225
Swiss Hospital 54
Mexican Diabetes Association 172-173, 235,
SYNELOG 309
282
Takeda 76
Miroculus 138, 151
TAPVS 302
MyHeart 143
Terumo 128
Nestlé 22, 214, 221, 237
The Green Corner 242
Novag 103
Tijuana Bariatrics 8, 214, 227, 280-281
Novartis 65, 157, 165
UDEM 54, 272, 275
Novo Nordisk 72-73
UNAM 11, 12, 42, 44-45, 47, 70, 78, 90, 91, 92,
NTA 254-255
98, 142, 169, 180, 184, 197, 205
NYCE 131
Unicef 16, 148, 153, 170-171, 229, 234
OLIVARES 296
UROSUR 273
Omnilife 233, 240-241
ValidPro 253
Oriundo 306-307
VecMedical 311
Össur 81, 124-125
Ventura 133
Parque TecniA Universidad Anáhuac 32, 271
Videre 282
Pfizer 64, 81, 307
WHO 10, 14-15, 76, 91, 98, 142, 149, 151, 244,
Pharma Tycsa 257
294, 300, 303, 310
Pierre Fabre 66-67
World Bank 27, 122, 289
PPD 178, 180-181
World Courier 261
PRA Health Sciences 179, 187
World Stem Cells Clinic 199
PROBIOMED 84-85 Productos Medix 82, 236
| PHOTO CREDITS 4
© Mexico Tourism Board: Photo/Ricardo
77 MBP
Espinosa-reo
78 MBP
10 MBP
80 MBP
12 MBP
80 MBP
14 MBP
81 MBP
16 MBP
82
Productos Medix
17 Dräger
82
Productos Medix
18 SMSP
84 PROBIOMED
19 AMEIFAC
86
20 MBP
90 MBP
21
91 Liomont
Productos Medix
Productos Medix
22 MBP
92 MBP
23 Dräger
94 MBP
24
95 MBP
Fundación Carlos Slim
25 Raystormxc
97 MBP
26 INSP
98 MBP
27
99 MBP
World Bank
28 AMEIFAC
100 Brudifarma
29 ProMéxico
101
30 FENIN
102 MBP
31
B.Braun Aesculap
103 MBP
32
Parque TecniA
104 MBP
Pierre Fabre
32 SEFOTUR
105 MBP
34 Dräger
105 MBP
38 MBP
106 Dräger
39 Dräger
110 MBP
40 MBP
110 MBP
42 MBP
112 MBP
44 MBP
113 3M
45
114 MBP
Centro de Oftalmología Monterrey
46 MBP
115
48 MBP
116 MBP
51 MBP
118
54
119 MBP
Swiss Hospital
Global Health Intelligence B.Braun Aesculap
55 MBP
120 MBP
56 MBP
122 MBP
56 MBP
124 Össur
57 MBP
125 Össur
58 MBP
126 Providien
59 MBP
128 Terumo
60
129 Medisi
Boehringer Ingelheim
64 Pfizer
130
65 MBP
131 MBP
66 MBP
132
Alandra Medical
67
133
Ventura Medical Technologies
68 MBP
134
Novo Nordisk
69 MBP
139 Sesderma
70 MBP
140
Instituto Nacional de Cancerología
72
Novo Nordisk
140
Instituto Nacional de Cancerología
73
Novo Nordisk
Pierre Fabre
Clúster Tijuana EDC
141
World Stem Cells
74 Amgen
142
Sociedad Mexicana de Cardiología
76 Takeda
143 MBP
| PHOTO CREDITS 143 MBP
220 MBP
144 INSP
221 MBP
146 BioMérieux
222 MBP
149 MBP
223
150
224 Kaloni
Siemens Healthineers
IM Natural
151 MirOculus
225 MBP
152 MedTep
227
Tijuana Bariatrics
156
228
Sports World
IMS Health
157 Novartis
234 MBP
158 MBP
235
159 PwC
236 MBP
160 MBP
237 Nestlé
160 SmileTrain
238 MBP
160 MBP
239
161
240 Omnilife
World Stem Cells
Mexican Diabetes Association
Grupo Body Systems
162 MedTep
241 Omnilife
164 MBP
242 MBP
165 1DOC3
243 MBP
166 MBP
245 MBP
168 MBP
246 Medtronic
168 MBP
250 MBP
170 MBP
251
172
Mexican Diabetes Association
252 Brudifarma
172
Global Health Intelligence
253 MBP
iStock, ProMéxico
174 Galderma
253 MBP
180 MBP
254 MBP
180 MBP
256 MBP
182
257 MBP
RM Pharma
184 MBP
258
Distribuidora Levic
185
Inventiv Health
259
R.H. Shipping
186 MBP
261
World Courier
187 MBP
262
Grupo Marzam
188 MBP
264 MBP
189 Accelerium
265 MBP
190 MBP
266 SEFOTUR
192
270
Novo Nordisk
Quintana Roo Medical Travel Association
198 MBP
271 MBP
198 MBP
272 MBP
199
273 MBP
World Stem Cells
200 MBP
274
201 Croda
276 MBP
201 MBP
277
Cancun Oncology Center
202 MBP
278
Fertility Center Cancun
205 UNAM
279 IREGA
206 Scantibodies
280 MBP
207 MBP
282 MBP
208 MBP
283
Centro de Oftalmología Monterrey
209 RegenerAge
284
Hospital San José
210 Sesderma
285 CostaMed
216 MBP
286 Dentistar
218 MBP
287
219 Sesderma
288 Hays
Centro de Oftalmología Monterrey
Coral Dental Center
292
McKinsey & Company
303 MBP
294 MBP
304 MBP
295 PwC
305 MBP
296 MBP
306 MBP
297
308
Baker and Mckenzie
Bacher Zoppi
298 MBP
309 MBP
299 MBP
310 MBP
300 MBP
311 MBP
301 Healthlinks
312 Avinet
302 TAPVS
| CREDITS EDITORIAL MANAGER: Tomás Sarmiento
PUBLICATION COORDINATOR: Marta Aguilar
JOURNALIST & INDUSTRY ANALYST: Sophie Murten
PUBLICATION COORDINATOR: Johanna Cronin
JOURNALIST & INDUSTRY ANALYST: Alicia Arizpe
JUNIOR PUBLICATION COORDINATOR: Franco Romero
JOURNALIST & INDUSTRY ANALYST: Ricardo Ibarra
COMMERCIAL DIRECTOR: Jack Miller
JOURNALIST & INDUSTRY ANALYST: Luis Vargas DESIGN DIRECTOR: Marcos González EDITORIAL DIRECTOR: Vanessa Buendía
GRAPHIC DESIGNER: Ailette Córdova
ASSOCIATE EDITOR: Mario Di Simine
GRAPHIC DESIGNER: Vanessa Rocha
COLLABORATOR: Nadine Heir
WEB DEVELOPMENT: Arturo Madrazo
COLLABORATOR: Sara Warden COLLABORATOR: Brenda Salas COLLABORATOR: Alejandra Gómez COLLABORATOR: Gabriela Mastache DIRECTOR GENERAL: Jeroen Posma PUBLICATION ADMINISTRATOR: Alena Lipková ADMINISTRATIVE ASSISTANT: Rebeca Garduño CIRCULATION MANAGER: Ana Cristina Garantón
| PRINTED BY Foli, Negra Modelo # 4 Bodega A Fracc. Cervecería Modelo, Naucalpan Estado de México T:. 9159 2100
$199.00 ISBN 978-0-9968026-3-5
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