Health in UNASUR: Challenges and Responses

Health in

UNASUR:

Challenges and Responses

Health in UNASUR: Challenges and Responses

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Health in

UNASUR:

Challenges and Responses

FILE GENERAL SECRETARIAT OF UNASUR Secretary-general Ernesto Samper Pizano

Director of Citizen Security and Justice David Álvarez

Chief of staff Yuri Chillán Reyes

Head of the Office of Legal Counsel Tania Arias

Minister – Ministry of Foreign Affairs Argentina Enrique Vaca - Narvaja

Head of Administration and Human Talent Dolly Arias

Brazilian Diplomatic Adviser to the General Secretariat Camila Mandel

Head of Technology and Informatics Andrés Carrasco

Representative of Bolivia to the General Secretariat Rubén Saavedra Chilean Adviser to the General Secretariat Juan Salazar Representative of Colombia to the General Secretariat Luz Stella Jara Ambassador Representative of Ecuador to the General Secretariat Diego Stacey Representative of Paraguay to the General Secretariat Martha Moreno Adviser of the Embassy of Uruguay to the General Secretariat Nicolás Rodríguez Representative of the Bolivarian Republic of Venezuela to the General Secretariat Pedro Sassone Director of Economic Affairs Pedro Silva Barros Director of Social Affairs Mariano Nascone Director of Political Affairs and Defence Mauricio Dorfler Director of International Cooperation and Technical Agenda Ricardo Malca

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Head of the Communication and Information Centre Erubys Chirinos Head of Press and Institutional Relations Ana María Serrano M. www.unasur.int www.facebook.com/unasur www.twitter.com/unasur

SOUTH AMERICAN INSTITUTE OF GOVERNMENT IN HEALTH Executive Director Carina Vance Mafla Head of Administration and Human Resources Gabriela Jaramillo Coordinator of Information and Communication Management Flávia Bueno Coordinator of International Relations Luana Bermudez South American Ministries of Health in February 2016 Jorge Daniel Lemus Argentina Ariana Campero Nava Bolivia Ricardo Barros Brazil

Text Edition Alessandra Ninis, Angela Acosta, Flávia Bueno, Luana Bermudez Translation review Angela Acosta, Flávia Bueno, Luana Bermudez Translation Gonzalo Ibañez Photography Acervo ISAGS y Acervo Secretaría General de UNASUR Graphic project Humponto Design e Comunicação Support Aline Fontainha, Beatriz Nascimento, Bruno Macabú, Felippe Amarante, Laura Santana, Manoel Giffoni

Carmen Castillo Taucher Chile Alejandro Gaviria Colombia

Acknowledgments

Verónica Espinosa Ecuador

Agencia Nacional de Vigilancia Sanitaria de Brasil (ANVISA)

Volda Lawrence Guyana

Centro del Sur/South Centre

Antonio Carlos Barrios Paraguay Patricia García Funegra Peru Patrick Pengel Suriname Jorge Basso Uruguay

Drugs for Neglected Diseases Initiative (DNDi) (and not unattended) Ministerio de Salud Pública del Ecuador Organización Panamericana de la Salud / Organización Mundial de la Salud (OPS/OMS)

www.isags-unasur.org www.facebook.com/isagsunasur www.twitter.com/isagsunasur

Antonieta Caporale Venezuela

Health in UNASUR: Challenges and Responses

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INDEX PRESENTATION Unasur Health Week: from vision to action Ernesto Samper Pizano – Secretary-general of UNASUR Carina Vance – Executive Director of ISAGS/UNASUR

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Progress and challenges on the South American agenda Mariano Nascone – Director of Social Issues of UNASUR

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MEDICINES Introduction: access to medicines in south america

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Second Workshop of the Medicines Price Bank of Unasur

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Executive Report Tomás Pippo – Coordinator Technical Group on Universal Access to Medicines of UNASUR (GAUMU)

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High Level Meeting on: Strategies to combat Hepatitis C in South America Introduction: Jorge Bermúdez – Vice President of Production and Innovation in Health Oswaldo Cruz Foundation – Fiocruz

Executive Report

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Extended abstract “Strategies against Hepatitis C in South America” Germán Velásquez – Special Adviser for Health and Development, South Centre, Geneva

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Summary high level meeting: Strategies for Hepatitis C in South America Round Table: United Nations High Level Panel on Access to Medicines and its Impact for the Region Jorge Bermúdez - Vice President of Production and Innovation in Health Oswaldo Cruz Foundation - Fiocruz

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Lorena Di Giano – Grupo Efecto Positivo Foundation Argentina (GEP)

27 Germán Velásquez – Special Adviser for Health and Development, South Centre, Geneva Bernard Pecoul – Drugs for Neglected Diseases Initiative (DNDi)

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Second Session: Prospects for the Elimination of Hepatitis C Bernard Pecoul – Drugs for Neglected Diseases Initiative (DNDi) DNDi’s Proposal and its Public Health Approach

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Tomás Pippo – Coordinator of the Technical Group on Universal Access to Medicines of UNASUR (GAUMU) Access Challenges and Responses to Hepatitis Treatment in the Region

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Third Session: Addressing Regulatory and Intellectual Property Barriers Hernán Núñez – Executive Director of the Ecuadorian Institute of Intellectual Property Experience of the Ecuadorian Institute of Intellectual Property

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Carlos Correa - UBA / South Centre Use of TRIPS Flexibilities to Promote Access to Medicines

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Jorge Costa – Oswaldo Cruz Foundation – Fiocruz, Min. of Health, Brazil Initiative for the Production of Direct-Acting Antivirals in Brazil

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Lorena Di Giano –GEP Foundation, Argentina Reasons for Opposing the Patent on Base Compound of Sofosbuvir

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Pedro Villardi – GTPI, Brazil Reasons for Opposing the Patent on Base Compound of Sofosbuvir

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Open Panel: Possible Scenarios of Coordinated Strategies for the Elimination of Hepatitis C Virus 40 Conclusions and Recommendations

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Health in UNASUR: Challenges and Responses

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NUTRITION Introduction: Nutrition and food security in South America

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Associate Institutions

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REPORT International Conference Integrated Policies and regulation in food and nutritional security

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Extended Summary Gerardo Lorbeer – Director of the National Food Institute, Ministry of Social Development, Uruguay. glorbeer@mides.gub.uy Food and Nutritional Security Network UNASUR – GTSAN

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Abstracts: Presentaciones de la Conferencia Internacional Políticas Integradas y regulación en seguridad alimentaria y nutricional Consuelo Santamaría - Undersecretariat for Health Promotiom of the Ministry of Public Health of Ecuador Keynote Conference: Advances in the prevention of noncommunicable diseases through the implementation of healthy public policy / health promotion strategies

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Ricardo Uauy - Professor of the Nutrition Institute, Universidad de Chile Keynote Conference: Nutrition Transition: a review of the South American profile

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Forum on Integrated Policy and regulation for food and nutritional security Fabio Gomes - Advisor on Nutrition and Physical Activity, PAHO/WHO Regulatory and scal policies in the prevention of obesity and NCDs

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Yanci Guadalupe Urbina - President of the Consumer Protection Office of El Salvador Protection policies against the marketing of foods and drinks harmful to health

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Luisa Brumana - Regional Health Advisor, UNICEF Latin America and the Caribbean Review of practices and regulations on the labelling of industrialized foods and beverages for children and adolescents

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Healthy Municipalities Forum

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Stephen Whiting – Technical Of cer (Diet and Physical Activity) Surveillance and Population-based Prevention Unit Policies for the promotion of physical activity, Stephen Whiting

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Adriana Pavón - National Director of Health Promotion of the Ministry of Public Health of Ecuador Healthy Municipalities Program: the Ecuadorian case

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Nicolás Cuvi - Department of Development, Environment and Territory, FLACSO Ecuador Urban Agriculture and its impact on Health and Food Sovereignty

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Forum Front-of-pack Labelling (FOP) as a mechanism for promoting health Sue Davies, Chief Policy Adviser, UK Consumer Association

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María Rosa Curutchet – Director of the Observatory of Food and Nutrition Security, National Food Institute – INDA, Ministry of Social Development Jane Martin - Executive Manager of the Obesity Policy Coalition (OPC), Australia

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Forum Successful experiences of food labelling in South America Andrea Bravo, Department of Health Promotion and Citizen Participation of the Ministry of Chile and Representative of the Latin American and Caribbean Network of Health Promotion Managers Cristian Cofré, Technical Advisor, Ministry of Health of Chile/Representative of the Chilean Agency for Food Quality and Safety, ACHIPIA, Chile Gabriela Rivas - Specialist Coordinator of Internal Management for the Promotion of Nutrition, Security and Food Sovereignty at the Ministry of Health of Ecuador

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Forum Role of Regulatory Agencies in the national public policies of food labelling Thalita Antony de Souza – Head of the Food Of ce of the Brazilian Agency of Health Surveillance, National Health Surveillance Agency of Brazil – Anvisa

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Cristian Cofré - Technical Advisor, Ministry of Health of Chile/ Representative of the Chilean Agency for Food Quality and Safety, ACHIPIA, Chile

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Dayana Donoso - Technical Director of Good Manufacturing Practices, National Agency for Health Regulation, Control and Surveillance of Ecuador ARCSA Lynn Silver – Senior Advisor for Chronic Disease and Obesity. Public Health Institute, EEUU and University of California San Francisco

List of Acronyms

82 84 86

Health in UNASUR: Challenges and Responses

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Health in UNASUR: Challenges and Responses

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UNASUR HEALTH WEEK:

FROM VISION TO ACTION South America is committed to ensuring health for all! The health of the more than 420 million South Americans has been one of the main priorities of the 12 member countries of UNASUR since its creation.

This clear commitment placed achieving universal access to social security and health services among the main objectives of UNASUR, in a global context where, for a large part of the world’s population, access to health services is a privilege limited to those who can afford them.

Health is central in the context of South American regional integration. The Health Council of UNASUR, made up of the Ministers of Public Health of the region, was one of the first two Sectorial Councils created by the leaders of the member countries of the bloc, understanding that health problems and challenges transcend borders and that there are shared values and interests between countries. One of this understandings bears the idea that health is a fundamental right for achieving a harmonious life in the region, strengthening the position of member countries in the global scenario and promoting a regional sustainable development based on equity.

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The principle of health as a fundamental right is what has guided the work of regional integration in health in recent years, not without posing complex challenges: How to make universal health systems sustainable?

How to improve the quality standards of the services? How to strengthen surveillance systems in order to protect the population from new communicable diseases? How to act on the social determinants of health such as poverty, discrimination and the lack of access to education? And one of the most outstanding challenges: How to move forward together to achieve our common goals in health at the regional level?

Between November 28th and December 1 , 2016, the “Health Week” was held at UNASUR headquarters to address these questions and to assess the progress of the region in high priority issues such as access to medicines and policies to prevent overweight and obesity as risk factors for chronic noncommunicable diseases, which have currently become the main cause of death of the South American population. The meeting, organized by the South American Institute of Government in Health – ISAGS and the General Secretariat of UNASUR, st

with the support of the Ministry of Health of Ecuador and other partners, made it possible to see how political agreements among countries in health issues result in tangible and effective advances for citizenship.

The Medicines Price Bank will strengthen the bargaining power of the states in order to obtain better prices for medicines; the coordinated action of the Group on Universal Access to Medicines will allow countries to know and share the most successful public policies to continue to progress together in strengthening health systems; and the strategies to improve prevention, diagnosis and treatment of Hepatitis C will allow us to dream of a region that eradicates the transmission of this disease, currently affecting more than 8 million South Americans. Likewise, regional strategies to prevent chronic noncommunicable diseases place the region at the forefront of the world with policies that have become role models, such as the labelling of processed foods, high in fat, sugar or sodium. The region is responding with effective measures to curb a worldwide trend of increased deaths from strokes, circulatory system diseases and diabetes that, according to the latest statistics from the 12 countries reported to the Pan American Health Organization (PAHO/ WHO), claimed almost 1 million lives in a year.

During the 4 days of events, was recurrent the recognition of the important advances made by the region, as well as

the leadership and the ability of countries in the South not only to have referents in the Northern Hemisphere, but also to be referents for each other, with effective strategies of their own. It was also clear that the South American region is characterized by their commitment to universal health systems and to achieving greater equity in a continent marked by deep inequalities. Our countries present a feature that strengthens them: the aspiration to have increasingly healthy populations along with the political conviction needed for implementing the changes required to achieve such objective.

For the General Secretariat of UNASUR and ISAGS, the “Health Week� marked a milestone in the concretion of ideas, efforts and desires for integration, through palpable policies aimed at improving people’s health. A region that faces its challenges together is a region that will see more and more progress and will progress faster and deeper, translating, in the case of health, into more lives and a higher quality of life, which is without doubt the greatest desire we can have as human beings. In health, from vision to action!

Ernesto Samper Secretary-general of UNASUR

Carina Vance, Executive Director of ISAGS/UNASUR Health in UNASUR: Challenges and Responses

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HEALTH WEEK AT UNASUR:

PROGRESS AND CHALLENGES ON THE SOUTH AMERICAN AGENDA Mariano Nascone, Director of Social Issues of UNASUR The Health Week at UNASUR is a response to the need of positioning and deepening the approach of various issues to be incorporated into the next Five-Year Plan of the South American Health Council. Concerns such as access to medicines policies; Hepatitis C; or malnutrition, accentuated by the increase in the consumption of ultra-processed foods and soft drinks1 with the consequent increase in childhood obesity, diabetes, hypertension in the context of Chronic Noncommunicable Diseases2 are some of the reasons that demand us to provide a comprehensive framework for the preparation of a large event such as this one3.

One of the most relevant issues is the Policy on Access to Medicines in UNASUR since the disproportionate prices of these products act as a double vicious process.

On the one hand, it forces States into a situation of economic vulnerability, since they must make great efforts to comply with the obligations assumed in their national legislations added to the expenditures for lawsuits in cases of non-compliance. On the other hand, the situation of vulnerability is felt by the citizens who allocate more income to

1 In Latin America, sales of ultra-processed products increased 48% and purchases of fast food per capita 40% between 2000 and 2013. Source: Document circulated at the event.

2 Main causes of death in the region along with smoking and alcoholism 3 “The UNASUR’s Health Week gathered 4 events in 4 days, brought together more than 150 participants and covered about 54 hours of exhibitions, debates and consensus searches”. See: http://www.isags-unasul.org/it_materia.php?lg=2&ev=3504

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the acquisition of medicines, a condition that can be aggravated by a growing coverage deficit by public health systems. As a result, the levels of incidence of social determinants on health conditions increase, generating a vicious circle that mainly harms the most deprived sectors of society and weakens the state capacities, as they are both at the mercy of the pharmaceutical industry, i.e. the rules of the market. This is why the role of the States as the main guarantor of access is irreplaceable and, in this sense, the joint purchase of medicines through the UNASUR Medicines Price Bank will allow to negotiate with the pharmaceutical industry the lowest reference price for all countries. An exercise presented by UNASUR’s Universal Access to Medicines Group showed that, taking into consideration a certain amount of purchases and the lowest price paid by the countries, it could have possible to generate an estimated potential regional saving of USD 950 million. If the lack of access is understood as a violation of a fundamental human right, penalties would be imposed on pharmaceutical companies due to excessive charges, strengthening the role of States and their negotiating capacities.

At the same time, regarding food-labelling policies – and in line with what was previously developed – it was possible to visualize that South America is at the forefront, given that among the six of the world’s existing experiences, three are from countries of

4 events in 4 days the region1. If we take into consideration the progress made by Uruguay, Peru, Argentina and Colombia, we can offer a hopeful message as a region regarding the commitment of the States to the implementation of policies for combating malnutrition that, as in the case of medicines, require strong negotiations with the private sector (in this case, the food industry) but mainly political will of their governments and a citizenship with greater levels of awareness and participation. In addition, these policies cover areas such as healthy municipalities programs, fiscal policies, advertising regulations, and involve various actors (ministries, citizenship, levels of government, private sector, etc.) demonstrating the importance of their treatment for the improvement of citizens’ health conditions.

In short, these are some of the results of the Health Week in UNASUR, so all the actors together with ISAGS are invited to redouble their efforts in this area of 1  Ecuador, Chile and Bolivia have implemented CNCDs prevention policies such as food labelling.

150

participants

54 hours

of presentations, debates and consensus building

regional consensus as a joint response to a more multipolar globalized world in the management of power relations. Faced with a scenario of economic recession in the region, health should not be the adjustment variable. Because a healthier region is more inclusive and presents greater possibilities for development.

Because WE ARE ALL UNASUR.

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INTRODUCTION:

ACCESS TO MEDICINES IN SOUTH AMERICA It is the responsibility of the States to establish the operating parameters of markets such as the pharmaceutical in order to protect the public interest and guarantee the right to health. However, there are barriers to this free exercise of South American States, such as the lack of bargaining power vis-Ă vis bidders, trade agreements that establish a disproportionate extension of medicines patent periods, and the unjustified use of judicial exception mechanisms that demand medicines that affect the therapeutic and financial rationality of our health systems.

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ISAGS, following its purpose of facilitating the exchange of knowledge and generating innovations in health public policies, has been supporting the implementation of the 2010-2015 Five-Year Plan of the South American Health Council. In this sense, the Institute has participated in various strategic areas for the Region, such as the formulation of the strategic plan for the production and distribution of medicines proposed in Argentina. Similarly, today the ISAGS is the executing body responsible for the two projects developed by the

SG/UNASUR

Members of GAUMU/UNASUR and BPMU focal points with the UNASUR Secretary-General, ISAGS Executive Director and others

Technical Group on Universal Access to Medicines of UNASUR (GAUMU) and financed by the UNASUR’s Common Initiatives Fund (FIC): Medicines Price Bank of UNASUR (BPMU) and Mapping of Regional Medicines and Health Supplies Manufacturing Capacities and mapping of medicines policies.

Regarding the medicines financing and coverage difficulties faced by our health systems, there are other strategies currently under way in some of our countries, such as the use of patenting flexibilities. There are models incorporating these and other measures, such as regional technology transfer.

This section dedicated to the topic of medicines presents some of the work that is currently under development in the regional context of UNASUR, as well as proposals and possible scenarios to underpin to the development and

implementation of the comprehensive drug policy in our region. Within the framework of Health Week in Ecuador, on the one hand, the II Workshop for the Implementation of the BPMU was developed in order to train and have some feedback with those responsible for loading information on the purchase of medicines by each country. In addition, an ordinary GAUMU meeting was held where FIC projects and the next frameworks for technical and political action were followed up. Finally, the High Level Meeting “Strategies against Hepatitis C in South America” provided an adequate environment to identify strategies useful for the therapeutic approach to Hepatitis C, recognizing the particular situation of the countries of South America in relation to the patenting of direct-acting antivirals useful in the treatment of the disease.

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RECENT RESULTS OF NEGOTIATION PROCESSES AND PURCHASES OF MEDICINES IN

SOUTH AMERICA

Actual accumulated savings until 2014:

Accumulated savings:

US $38.8 million

US $25.9 million

Medications for the treatment of:

Source : http://comisca.net/content/negociaci%C3%B3n-conjunta-de-preciosy-compra-de-medicamentos-para-centroam%C3%A9rica-y-rep%C3%BAblica

cancer, haemophilia, epilepsy, hypertension, kidney transplantation, autoimmune diseases

Projected Savings event 1-2015:

US $12.9 million

THE CASE OF ECUADOR Total Savings for the State thanks to the last Reverse Auction Process in 2016:

US $322

million

Amount of savings in the auction process:

US $205

million (45% compared to the reference budget)

Amount of specific savings due to the application of new methodology:

US$117

million

(about 27% compared to the reference budget)

745

medicines Of a total of in the National Basic Medicines Chart,

425 (57%) were acquired

*The new methodology includes reference prices for medicines related to the main causes of death in countries of South America Source: SERCOP’s Institutional Data, Dec. 2016

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SECOND WORKSHOP OF THE

MEDICINES PRICE BANK OF UNASUR Good governance, strong and concrete accountability mechanisms and greater transparency are key drivers of the United Nations 2030 agenda. An important factor behind the coherence between human rights, trade, intellectual property and public health lies in the diversity of accountability mechanisms and levels of transparency in these spheres that, although different, often overlap. Traderelated matters and intellectual propertyrelated liability mechanisms are usually resolved by the WTO’s Dispute Settlement Body. On the contrary, human rights and mechanisms of public health accountability are characterized by inaccuracies in legal force and limited applicability.

To have a fair return on public investment, government actors and public funding providers require clear information on the costs of innovation and introduction of specific health technologies to the market.

There are some public databases of prices for medicines, vaccines and medical devices that are generally referenced to those of multilateral organizations or civil society organizations, but which account for very specific conditions, different from real situations in the countries of South America.

One of the mechanisms that some regions have implemented to confront the economic power of the pharmaceutical industry is public procurement. Central America, for example, already has a

common tool through the Executive Secretariat of the Council of Ministers of Health of Central America (COMISCA) for the joint purchase of 64 drugs through what has been called “aggregate purchasing”.

The ISAGS signed an agreement with this Regional instance to take advantage of its experience and to join efforts in the future.

Awarded Medicines

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Purchase estimate for 2016

US $45.7 Millions

Actual Savings Achieved 2010 to June 2015

US $25.9 Millions

Projected Savings Event 1-2015

US $12.9 Millions

Savings accrued to 2016

USD $38.8 Millions

Source: COMISCA, 2016.

A South American country, Ecuador, with the initial purchase through reverse auction of 326 medicines to supply the country’s public health system over the next two years, saved USD $ 320 million in 2016. This process included an analysis of the prices of those medicines used for treating the leading causes of death in the region, revealing that a same firm sells the same medicine in different countries with price variations that can reach 300% or even 600%.

More than 160 companies participated in the Ecuadorian auction; including 27 Latin American companies, of which 7 were adjudicated.

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52%

TOTAL SAVINGS FOR THE STATE

322

AVERAGE SAVING IN ADJUDICATED PROCEDURES

MILLIONS OF DOLLARS

165

Affiliated suppliers

57%

Contracted suppliers

49 nationals 8 foreigners

Procedures awarded by suppliers with preference MIPRO

124 nationals 41 foreigners

326

Bidding procedures

96%

Average number of bidders per procedure: 8

AWARDED PROCEDURES Procedures through negotiation

49%

Awarded amount

4%

133 MILLIONS OF DOLLARS

Source: Documentos Institucionales SERCOP-Ecuador, 2016

As part of the progress towards a comprehensive medicines policy, since mid-2015 the Union of South American Nations (UNASUR) set itself the task of creating a bank with the prices of medicines public procurement in all the countries of the region as a strategy for pressuring for their reduction.

The objective of the Medicines Price Bank of UNASUR (BPMU) is to strengthen

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the management capacity of medicines procurement processes by the actors of the health systems responsible for managing public resources, as well as reinforce the prices control capacity by the competent authorities (where applicable), through the availability of a computerized system with information on medicines procurement prices and related data in the Member States of UNASUR. The BPMU is a reservoir of information on the prices obtained through government negotiations, acquisitions and/or contracting of medicines carried out by the countries that make up the UNASUR region. Governments, taking into consideration previously agreed common definitions provide the information periodically. For this purpose, during the Second Workshop held in Quito, a number of technical issues related to the loading of information from 10 countries were reviewed for a total of 30 medicines, including oncology drugs and vaccines.

This regional effort seeks to generate transparency and support the decisionmaking related in principle to the acquisition of medicines. Today BPMU becomes a strategic facilitator for the bloc. With the implementation of BPMU, Secretary General Ernesto Samper announced that countries will be able to save up to 600 million dollars.

EXECUTIVE

REPORT Tomás Pippo – Coordinator Technical Group on Universal Access to Medicines of UNASUR (GAUMU) With the presence of the delegations of Argentina, Brazil, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Uruguay and Suriname, as well as representatives of ISAGS and the General Secretariat of UNASUR, the II Workshop for the Implementation of the Medicines Price Bank of UNASUR (BPMU) was held at the headquarters of the General Secretariat of the bloc, located in the City of Quito, Ecuador, on November 28th and 29th, 2016.

As already mentioned, the objective of the BPMU is to strengthen the management capacity of the medicines public procurement processes through a computerized system containing information on the medicines procurement

prices and related data in the Member States of UNASUR. Its development is part of the 2010-2015 Five-Year Plan of the South American Health Council, corresponding to the Technical Group on Universal Access to Medicines of UNASUR (GAUMU), and it refers in particular to the Outcome “Formulation of a price policy proposal to strengthen access to medicines”, Activity “Implementation of a medicine price bank of UNASUR”.

With this second workshop, we made significant progress in optimizing the information platform and the characteristics of the information that we are going to share regionally. The platform provided for these purposes is now a reality; during this session were presented the procedures and the platform’s operating manual.

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HIGH LEVEL MEETING ON:

STRATEGIES TO COMBAT HEPATITIS C IN SOUTH AMERICA Introduction: Jorge Bermúdez – Vice President of Production and Innovation in Health Oswaldo Cruz Foundation – Fiocruz Viral hepatitis, including Hepatitis C, represent a public health problem, affecting millions of people around the world. Since late 2013, direct-acting antiviral drugs (DAAs) represent a concrete hope for the cure of Hepatitis C, but there are also access barriers, given their high prices. This barrier is present not only in poor countries; highincome countries have not incorporated these drugs into their health systems yet.

The problem of the high prices of these drugs is in tension with the right to health

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and prevents access to these medicines as a fundamental human right. The recent publication of the Report of the United Nations Secretary-General’s High-Level Panel identifies access barriers to medicines, especially those related to intellectual property, monopolies and speculative and extortive prices. In this sense, the South American countries approach demands the confrontation of the regulatory and protection barriers related to these products, not only with the expectation of protecting them from the patents, but also of identifying and building together a regional action plan that effectively contributes to improving the health and life conditions of the population and ensures access to medicines.

EXECUTIVE

REPORT One of the strategic issues prioritized by the Health Council of UNASUR in its Five Year Plan is Universal Access to Medicines.

With regard to treatment for Hepatitis C virus infection, a new class of direct-acting antiviral oral medications (DAAs) have recently shown safety and effectiveness.

These new drugs have a high cure and safety rate with great potential for the elimination of the disease. However, their prices are extremely high, especially in middle and high-income countries, where the epidemic burden is higher. This fact has forced Ministries of Health to rationalize DAAs, prioritizing the treatment of people with an advanced degree of the disease.

Meeting during the last days of UNASUR Health Week on November 30th and December 1st, the General Secretariat of the bloc and the ISAGS, with the support of the Drugs for Neglected Diseases Initiative (DNDi) and the South Centre of Geneva, Switzerland, held the High Level Meeting on Strategies to Combat Hepatitis C in

South America. The event was attended by the medicines focal points of the countries of the bloc, representatives of national intellectual property offices, representatives of the medicines regulatory agencies and representatives of civil society in the region, as well as the then Minister of Health of Ecuador, Margarita Guevara, and the Minister of Colombia, Alejando Gaviria.

This meeting was proposed in October 2016 in the context of an important partnership between ISAGS and UNASUR with DNDi and the South Centre that seek to identify opportunities of South-South cooperation for the development of new strategies towards the elimination of the disease in the region. The development of its agenda sought to discuss barriers and challenges of HCV treatment at the regional level, as well as to develop common strategies to overcome intellectual property (IP) barriers.

Then Minister of Heath of Ecuador, Margarita Guevara, the UNASUR Secretary-General Ernesto Samper Pizano and Alejandro Gaviria, Colombia’s Minister of Health

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“STRATEGIES AGAINST HEPATITIS C IN SOUTH AMERICA”

EXTENDED ABSTRACT Germán Velásquez – Special Adviser for Health and Development, South Centre, Geneva The overall framework of the High Level Meeting on Strategies against Hepatitis C in South America was the High Level Panel, made up of prominent personalities from around the world, convened by the United Nations Secretary-General at the end of 2015. The terms of reference that were set for this group of experts was to study “the inconsistency between inventors’ rights, international law on human rights, trade rules and public health”.

This inconsistency or failures of the current model of research and development of medicines are located at three levels: 1) lack of transparency in the costs of research; 2) decrease of innovation; and 3) prices that block access. Inconsistencies or failures that can only be addressed through a multisectorial approach.

New ways of dealing with mass treatment of Hepatitis C programs are necessary. If drug companies refuse to lower prices, it will be necessary to resort to the flexibilities allowed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO), i.e. compulsory licenses and parallel imports. Another possibility could be using the money from tax evasion to pay for treatments, or even sue the industry for these practices as a violation of human rights. Finally, promoting the local manufacture of generic medicines is undoubtedly the most durable solution that can be promoted at the national and regional level.

Joel Keravec, DNDi Latin America Regional Executive Director, and Germán Velasquez, Special Advisor for Health and Development at South Center, Switzerland

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SUMMARY HIGH LEVEL MEETING:

STRATEGIES FOR HEPATITIS C IN SOUTH AMERICA Round Table: United Nations High Level Panel on Access to Medicines and its Impact for the Region

Jorge BermĂşdez - Vice President of Production and Innovation in Health Oswaldo Cruz Foundation - Fiocruz The exorbitant and extortive prices of medicines recently launched on the market, as well as those not so recent, reveal an excessive greed of segments of the pharmaceutical industry. The new DAAs for Hepatitis C and cancer products, among others, represent the same problems for high-income countries as well as low- and middle-income countries. These high prices pose a threat to both patients and health systems. We should build on the lessons learned from HIV/AIDS, in which generic competition led to a reduction in the prices of ARVs, making it possible for us to currently have 18,2 million people under treatment in the world.

The recent progress achieved by the United Nations General Secretariat following the adoption of the 2030 Agenda for Sustainable Development and the appointment of the High-level Panel at the highest level of the United Nations shows the importance of this issue. This is the opportunity for a global discussion process. In recent months, there have been several meetings and 2 hearings in London and Johannesburg and 181 contributions from governments, the private sector/

industry, civil society, academia and international organizations. In addition, intergovernmental organizations such as WIPO, UNIDO, WTO, WHO and the Office of the High Commissioner for Human Rights also submit their contributions to the Commission.

The Report released in September 2016 presents a series of recommendations aimed at ensuring that access to medicines can be considered as a fundamental human right: full use of the flexibilities of the WTO TRIPS Agreement; the rejection of the TRIPS-plus clauses in free trade agreements; the right to knowledge generated with public funding; the uncoupling of the costs involved in the research and development from the final product’s prices; as well as governance and transparency mechanisms throughout the innovation chain are some of the elements mentioned in the report. We believe that some elements are not present in the report due to a lack of consensus among the members of the Group, especially those issues related to bold proposals in terms of a new intellectual property regime for pharmaceuticals products and future measures.

Health in UNASUR: Challenges and Responses

27

Regarding the next steps, we believe it is necessary to widely disseminate, discuss and debate the UN Panel report

in order to discuss the results and build a plan of action for the region.

HLP Recommendations: IP and Access • WTO members must maximize their use of Article 27(1) of TRIPS towards real innovation; • Governments must adopt and implement a legislation that makes it easier to issue Compulsory Licences • WTO members must review Doha’s Paragraph 6

• Governments involved in trade negotiations shouldn’t compromise the right to Health with TRIPS-plus measures • Governments must assess the impact to Health before subscribing to trade and investment deals.

Carina Vance Mafla, Executive Director of ISAGS, and Jorge Bermudez, Vice-President of Production and Health Innovation of Fiocruz

28

Lorena Di Giano – Grupo Efecto Positivo Foundation Argentina (GEP) Contributions to the High Level Panel’s discussion focused on innovation models, ratified the problem of medicines prices and inaccessibility to medicines and highlighted the low percentage of genuine innovation and abuse of the medicines patent system.

The chapters of the panel’s report include innovation in Health Technologies and Access, intellectual property laws and access to medical technologies, new incentives for R&D in health technologies, governance, accountability and transparency.

A potential alternative to favour access in the region is the possibility of using the TRIPS safeguards and consolidating the report of the High Level Panel on Access to Medicines as a framework document.

Research and development strategies should be developed, the granting of patents should be restricted and the issuance of effective and automatic compulsory licenses could be facilitated.

R&D costs - a wide range of estimates

KEY PWC1 Tufts2 PhRMA3 Light & Warburton4 DNDi5

$4.2 billion

$2.56 - $2.87 billion

$2.6 billion

$180 - $231 million

$100 - $150 million

1. PWC (2012) From vision to decision: Pharma 2020. Available at: http://www.pwc.com/gx/en/pharma-life-sciences/pharma2020/assets/pwc-pharma-success-strategies.pdf 2. DiMasi, J.A., et al. 2016 Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 22 (2003): 151 - 185.

Available at: http://fds.duke.edu/db?attachment-25--1301-view-168 3. PhRMA (2015) Profile bio pharmaceutical research industry. Available at: http://www.phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf 4. Light, W & Warburton, R. (2011) Demythologizing the high costs of pharmaceutical research. BioSocieties. Available at: http://www.pharmamyths.net/files/Biosocieties_2011_Myths_of_High_Drug_Research_Costs.pdf 5. DNDi (2014) An innovative approach to R&D for neglected patients: Ten years of experience and lessons learnt by DNDi. Available at http://www. dndi.org/images/stories/pdf_aboutDNDi/

Health in UNASUR: Challenges and Responses

29

Germán Velásquez – Special Adviser for Health and Development, South Centre, Geneva The deficiencies of the current medicine research and development model could be summarized in three main statements: lack of transparency in research costs, pharmaceutical innovation has declined significantly in recent years and high prices that impede access.

Gilead’s philosophy seems to be the search for the highest price that governments can afford. To complete this scenario, on July 13th, 2016, the Washington Post published that the company, using Ireland as a tax haven, is evading taxes in the United States for U$S 10 billion3.

In 2014, the Gilead Company introduced Sofosbuvir in the market, a medicine against Hepatitis C, at a price of 84,000 dollars for a 12-weeks treatment. English scholars 1 found that the production costs of the 12-week treatment is $ 62 (already including a 50% profit margin), but Gilead has managed to negotiate with several governments prices with large differences from country to country. This company purchased the enterprise that developed the aforementioned medicine for a total de 11 million dollars.

The problem is global, it is no longer about diseases that disproportionately affect developing countries, nor is there a difference between communicable and non-communicable diseases. For the first time in history, there are medicines that industrialized countries cannot afford to finance – as is the case of Sofosbuvir – and for that reason, they also begin to have difficulties in ensuring supply.

This means that Gilead, on its first year, has already fully recovered its investment, what leads one to wonder why there is a 20-years exclusivity in the patent system.

Prices that have nothing to do with production costs fluctuate as follows: 50.426 euros in Germany, 41.680 euros in France, 13.000 euros in Spain, 6.000 euros in Brazil, 3.465 euros in Australia2.

Everything seems to depend on the bargaining power of each country, and

1 Gotham D, Barber M, Fortunak J, Pozniak A, Hill A. Abstract number A-792-0516-01639, presented at AIDS2016, Durban.

2 Price of the 12-weeks treatment.

30

The complete elimination of this disease is only possible if the drugs can be purchased at low prices within the health budgets. New ways of dealing with mass treatment of Hepatitis C programs are necessary. Anyway, if pharmaceutical companies refuse to lower their prices, one would have to think about compulsory licensing, parallel imports, using the money they are evading in taxes to pay for treatments, promote the manufacture of generics, or attack the industry in court as a violation of human rights.

3 http://www.corpwatch.org/article.php/article. php?id=16083

40.556 € UK

Price Germany: €50,426 Cost: €55

37.936 €

41.680 €

45.000€

Sofosbuvir (Sovaldi)

France

288 €

55 €

India

Target

3.435 €

15.000€

6.008 €

30.000€ 13.000 €

price in Euros for 12-week course

60.000€

50.426 €

Price of sofosbuvir in some countries (12 weeks)

Australia

Brazil

Spain

Canada

Germany

0€

Sofosbuvir prices: 1. Canada (Quebec): http://www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/liste_med_2016_10_03_fr.pdf 2. France: http://www.medecinsdumonde.org/actualites/presse/2016/09/29/mdm-soppose-au-brevet-sur-le-sovaldir-decision-le-5-octobre-2016 3. Germany: medizinfuchs.de 4. Spain: http://politica.elpais.com/politica/2016/04/05/actualidad/1459873421_480033.html?id_externo_rsoc=TW_CC 5. UK: British National Formulary 2016 6. Brazil: http://www.portaltransparencia.gov.br/despesasdiarias/empenho?documento=250005000012015NE801493 7. Australia: Based on total annual government expenditure (AU$200 million) and 40,000 treated in 2016 8. India: http://hepcasia.com/wp-content/uploads/2016/03/31-Jan-2016-Indian-generic-sofosbuvir.pdf

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Bernard Pecoul – Drugs for Neglected Diseases Initiative (DNDi) In 2003 the Drugs for Neglected Diseases Initiative (DNDi) was created with the participation of founding members such as Oswaldo Cruz (Fiocruz) Foundation of Brasil, Indian Council of Medical Research, Kenya Medical Research Institute, Malaysia Ministry of Health, and Pasteur Institute of France; A humanitarian organization: Medecins Sans Frontieres (MSF); and a research international organization, WHO Special Programme for Research and Training in Tropical Diseases (TDR) as permanent observer. The success of DNDi is possible thanks to the collaboration of partners including international organizations, pharmaceutical companies, universities and research groups and biotechnology development companies.

Among the achievements of the organization, it is possible to highlight 30 projects for 8 diseases, 15 completely new chemical entities, more than 160 partners – most of them in endemic countries, € 400 million raised from public and private funding sources, 4 networks/platforms for specific clinical trials for neglected diseases and several technological transfers.

The DNDi’s strategy for addressing the Hepatitis C problem consist of making available to the Ministries of Health a pangenotypic, safe and affordable treatment for all those affected by the disease under a broad Public Health approach. South-South strategies started successfully. For instances, Egypt has already been spreading treatment and a partnership with Southeast Asia has also been established.

Hepatitis C: exorbitant prices undermine a public health approach Prices vary considerably The benefits of pharmaceutical companies depend on the negotiating capacity of each country 90000

U$80,000 a 100,000

80000 70000 60000 50000 40000 30000

Objective of DNDi for 2020:

20000

U$10,000 a 20,000

10000

U$900

U$300

India

Egypt

0

United States

32

Latin America

U$100 treatment

Second Session: Prospects for the Elimination of Hepatitis C Bernard Pecoul – Drugs for Neglected Diseases Initiative (DNDi) DNDi’s Proposal and its Public Health Approach About 130-150 million people are chronically infected with hepatitis C – between 5 and 6 million of them are citizens of the 12 UNASUR member countries, most of them with the disease’s genotype 1, followed by type 3. Of the world total, about 26-30 million have F3-F4 levels of fibrosis. Something extraordinary, taking into account that recent therapeutic advances in the development of DirectActing Antivirals (DAAs) – sofosbuvir being the most important currently – transformed hepatitis C into an essentially curable disease. The prohibitive price of these treatments makes them inaccessible, especially in countries with a high hepatitis C burden.

The Drugs for Neglected Diseases Initiative (DNDi) is a non-profit research and development (R & D) organization that exists to address the needs of forgotten patients, of neglected people. For this reason, the DNDi project for HCV focuses on offering combinations of accessible DAAs that are optimized for their use in public health. The project seeks to establish

a pan-genotypic therapeutic regime– to treat the disease all around the world, in an accessible way, and with a short and safe cycle.

A partnership with the Egyptian pharmaceutical company Pharco and with Presidio, a biotechnology company in the United States, allow DNDi to test the new sofosbuvir regimen along with ravidasvir, a promising developing DAA that has shown to be effective in the genotype 4. The two drugs combined have showed cure rates of 100% and 94% in non-cirrhotic and cirrhotic patients, respectively. Clinical studies of the combination of ravidasvir and sofosbuvir have begun in Malaysia at a cost of U$S 300 per treatment cycle.

The goal is to reach a $ 100/treatment cost by 2020. Nevertheless, beyond the issue of price, the path to addressing and combating hepatitis C requires synergy of all key actors and stakeholders and, in this context, public leadership to improve the treatment and care level of this disease is key to enable a large-scale expansion in affected countries.

Health in UNASUR: Challenges and Responses

33

Tomás Pippo – Coordinator of the Technical Group on Universal Access to Medicines of UNASUR (GAUMU) Access Challenges and Responses to Hepatitis Treatment in the Region The situation of the region in terms of Hepatitis C is not different from that of other countries: it presents high prices and a differentiated price offer.

The production cost (including R&D) does not explain the high price, and price differentials are neither explained by the countries’ income level. These characteristics determine limited access and coverage while threatening the financial sustainability of health systems.

access and coverage and discourage investment in research and development on actual inventions that solve public health problems. Likewise, the application of TRIPS flexibilities, the strengthening of incentives to the generic industry (credits, subsidies, etc.) and the strengthening of the rational use and administration of medicines should be considered as measures that complement each other within the framework of an access policy.

Among the measures that could be explored is the prevention of patenting practices of developments without inventive step (Guidelines, Prior consent, oppositions). These practices may be considered a disincentive to socioeconomic development as they limit

International coordination, such as the case of UNASUR, may favour price negotiations, joint purchases, the use of tools to facilitate decision-making (such as the Medicines Price Bank) and possible coordinated licenses.

Carolina Batista, Medical Director of DNDi Latin America, and Tomás Pippo, coordinator of GAUMU/UNASUR

34

Fig 2. Relationship between PPP-adjusted price, GDP per capita, and estimated market size for Sofosbubir and ledipasvir/Sofosbubir.

Fig 2 shows the relationship between PPP-adjusted price (y-axis), GDP per capita (USD PPP) (x-axis), and estimated market size (circle size) for (A) Sofosbubir and (B) ledipasvir/Sofosbubir. Solid circles indicate countries where insurance agencies/reimbursement organisations are likely to obtain confidential rebates/price reductions for the medicines, and thus have a 23% rebate in the analysis. Unfilled circles indicate countries that have special pricing arrangements and are unlikely to obtain additional price reductions, and therefore have no further discounts in the analysis. The estimated market size for each country is based on the point estimate of the viraemic population reported by Gower et al. [1]. http://dx.doi.org/10.1371/journal.pmed.1002032.g002. Fuente: Iyengar S, Tay-Teo K, Vogler S, Beyer P, Wiktor S, de Joncheere K, et al. (2016) Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis. PLoS Med 13 (5): e1002032. doi:10.1371/journal.pmed.1002032

Health in UNASUR: Challenges and Responses

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Third Session: Addressing Regulatory and Intellectual Property Barriers Hernán Núñez – Experience of the Ecuadorian Institute of Intellectual Property The recently approved Organic Code of the Social Economy of Knowledge, called the Ingenios Code, provides for a balance in terms of access to medicines, allowing the State to adopt measures that seek to guarantee health and nutrition. Intellectual property rights, undisclosed information, clinical trials data for pharmaceuticals and chemical-agricultural products are goods that guarantee fundamental rights; therefore, they are goods of public interest and that is the reason why, in addition to limitations and exceptions, other uses are allowed without the authorization of the patent holder.

ARE NOT INVENTIONS

• •

INGENIOS CODE

ARTS: 4, 87 Y 91

• • • • • •

36

The following shall not be considered as inventions: biological material existing in nature or which may be isolated (genes, genome), new form of substance (salts, ethers, etc.), polymorphs, metabolites, pure forms, particle size and isomers, and genetic resources containing biodiversity and agro-biodiversity.

Regarding the use of TRIPS flexibilities in Ecuador, 8 compulsory licenses have been granted and three are currently under process, with ARV and immunosuppressive medicines being favoured.

Discoveries, scientific theories, mathematical methods; Biological material existing in nature or that may be isolated (genes, genomes); New form of substance (salts, ethers, etc.); Literary and artistic works; Plans, rules and methods for the exercise of intellectual activities; Ways of presenting information; Polymorphs, metabolites, pure forms, particle size and isomers; Genetic resources containing biological diversity and agro-biodiversity.

Carlos Correa - UBA / South Centre Use of TRIPS Flexibilities to Promote Access to Medicines Flexibilities in the TRIPS agreement refer, inter alia, to the definition of the concept of invention and the criteria for examining patent applications, exceptions to patentability, exceptions to exclusive rights, parallel imports, compulsory licenses and the (non-exclusive) protection of the clinical trial data.

Prior to the entry into force of this agreement, countries had wide discretion to determine their intellectual property policies, including patent terms and patent exclusion (as occurred in Latin America until the 1990s). With the implementation of TRIPS, this discretion was significantly reduced, but WTO member countries retained the possibility of implementing measures that, among other things, mitigate the effects of patent monopolies.

Such measures include, in particular, the right to define what an invention is (excluding, for example, metabolites and materials isolated from nature) and the lesser or greater rigor with which the novelty, inventive step and industrial application criteria are applied.

Governments may, for example, restrict

the scope of the so-called ‘Markush’ claims and not apply the novelty fiction used by some patent offices to consider that a generic disclosure does not imply specific disclosure of a particular compound.

In addition, the inventive step can be judged with rigorous criteria in order to avoid the patenting of routine developments, such as salts, formulations, polymorphs, etc., of already known products. Various patent applications on sofosbuvir exemplify the use of the patenting strategy known as ‘evergreening’.

Another important flexibility is the granting of compulsory licenses and government use for non-commercial purposes. Several countries – as is the case of Brazil and Ecuador among UNASUR countries – have used these tools to promote access to medicines at affordable prices. In countries that grant patents these tools may be used if necessary in relation to sofosbuvir. There have been no claims in the context of the WTO against countries that have granted such licenses or decided for governmental use, since these are legitimate measures recognized by TRIPS Article 31.

Patents related to insulin WIPO Patentscope Abstract search term

Assignee: “Lilly”

Assignee: “Novo” Assignee: “Pfizer”

Assignee: “Sanofi”

insulin*

254

839

179

444

analog*

334

485

126

142

analog* OR insulin*

472

1090

279

516

analog* AND insulin*

126

234

8

70

Source: Warren Kaplan and Reed Beall Insulin Patent Profile, Technical Report, ACCISS, HAI, March 2016, available at file:/// Users/carloscorrea/Downloads/ACCISS-PatentReport-FINAL.pdf

Health in UNASUR: Challenges and Responses

37

Jorge Costa – Oswaldo Cruz Foundation – Fiocruz, Min. of Health, Brazil Initiative for the Production of Direct-Acting Antivirals in Brazil The Oswaldo Cruz Foundation (Fiocruz) is an institution of public law linked to the Ministry of Health (MS) of Brazil that aims to promote health and social development, generate and disseminate scientific and technological knowledge, and be an agent of citizenship. Through its Institute of Technology in Pharmaceuticals (FARMANGUINHOS) Fiocruz develops, produces and supplies medicines designed to meet the demand of the Ministry’s strategic programs.

The Workshop Access to health and medicines, a fundamental human right was held in April 2014. A group of national and international specialists met to reflect on the world scenario and discuss access to high-cost products and services for health, focusing on the local production of the drug Sofosbuvir for Hepatitis C treatment.

Fiocruz established a partnership with Brazilian companies in the pharmaceutical and pharmacochemical sector with the aim of developing Sofosbuvir 400mg.

Nowadays, this development is in its final

38

phase and stability studies are in progress.

The studies of pharmaceutical equivalence and bioequivalence are expected to begin in January 2017.

Regarding the following steps, it is necessary to define the strategy related to the patents of the Sofosbuvir and other DAAs prioritized by the MS. An analysis of Fiocruz’s partnership model with private initiatives, the definition of a strategy for the preparation of the registration dossier and the submission of the file for ANVISA registration during the first half of 2017 are also part of the next necessary steps.

Following all these stages, starting in 2017, we will be able to make Sofosbuvir available in the Unified Health System (SUS), as part of a progressive plan for treating Hepatitis C. We seek to reduce the vulnerability of the SUS, contributing to the access policy’s sustainability and regularization of prices. In the end, this will help to potentially reduce the vulnerability of health systems in other countries, prioritizing those of Latin America and the Caribbean.

Model flow chart for R&D R&D and local production of sofosbuvir NATIONAL PHARMACOCHEMISTRY

IQ/UFRJ

2014

Development of the synthesis process 2015

NATIONAL PHARMACOCHEMISTRY

Industrial production Sofosbuvir (IFA)

FARMANGUINHOS

1st semester

NATIONAL PHARMACOCHEMISTRY

2015 / 2016

ANVISA

2017

Development of the formulation 400 MG Tablet

Registry

FARMANGUINHOS / NATIONAL PHARMACOCHEMISTRY

2017

1st semester

Industrial production Sofosbuvir 400 MG 2017

2nd semester

Access

SUS

Health in UNASUR: Challenges and Responses

39

Lorena Di Giano –GEP Foundation, Argentina Reasons for Opposing the Patent on Base Compound of Sofosbuvir The voice of civil society in activism for the right to health accounts for cases such as Sofosbuvir in Argentina in which the GEP filed an opposition to the patent in May 2015. “There will be no universal access to medicines as long as these continue to be legally considered as commodities”, “We cannot rely on the patent system and let

companies define health needs: behind the development of medicines, due to the very design of the patent system, are the speculative funds that only seek for profit”.

Countries are urged to use TRIPS flexibilities and to use the High-level Panel’s report as a framework document.

Sofosbuvir in Argentina Sofosbuvir Patent Applications SOFOSBUVIR PRODRUG

AR066898A1

SOFOSBUVIR BASE COMPOUND

AR044566A1

SOFOSBUVIR DIVISIONAL

AR082064A2

SOFOSBUVIR DIVISIONAL

AR082067A1

SOFOSBUVIR DIVISIONAL

AR82068A2

SOFOSBUVIR DIVISIONAL

AR082066A2

Lorena di Giano, Executive Director of FGEP, Argentina

40

Pedro Villardi – GTPI, Brazil Reasons for Opposing the Patent on Base Compound of Sofosbuvir The Working Group on Intellectual Property (GTPI) is a collective of civil society organizations, coordinated by the Brazilian Interdisciplinary AIDS Association. The GTPI is dedicated to mitigating the negative effects of pharmaceutical patents on medicines access policies in Brazil and in the Global South.

Although in Brazil the company Gilead has not charged the $ 84.000 dollars price, the $ 6.900 dollars price for the 12-weeks treatment has serious consequences for the policy and for access. By comparison, if Brazil continues to pay the price offered by Gilead, it will only be possible to treat all people with HCV in Brazil around the year 2075. In contrast, if Brazil achieves the lowest international price ($ 300 dollars) already in 2019 Brazil could treat all people living with HCV1.

If the Gilead patent is granted, the American company will have a monopoly

1 http://deolhonaspatentes.org/apoie-o-manifesto-contraos-altos-precos-da-cura-da-hepatite-c/

over the exploitation of Sofosbuvir in Brazil and will be able to charge the price it wants.

To prevent this from happening, GTPI in coordination with civil society groups from Argentina, China, the USA, Ukraine, Thailand and Russia filed an opposition to the Gilead patent, offering the Brazilian patent office technical arguments proving that the patent must be rejected. However, it is essential to look at the issue of patent examination.

In Brazil, we have the model of Previous Consent, considered a good model by many international organizations. The Brazilian examination is conducted in two steps: two different agencies – the National Institute of Industrial Property (INPI) and the National Health Surveillance Agency (ANVISA) – analyse the requirements of patentability; ANVISA carries out a more rigorous analysis from a public health perspective. However, Brazil has not been able to enjoy the benefits of this mechanism since transnational pharmaceutical corporations do not accept the Previous Consent decisions and appeal or challenge them in court.

The challenges •

• •

SOF - Base Compound, prod drug - 4 Divisional - Complement Daclatasvir The exam - HLP: as strict as possible • Brazil: Previous Consent • Challenges

www.deolhonaspatentes.org/contestacao-patentes-2

Health in UNASUR: Challenges and Responses

41

Open Panel: Possible Scenarios of Coordinated Strategies for the Elimination of Hepatitis C Virus This last session discussed possible actions against four current scenarios

in countries of the Region regarding the Sofosbuvir’s patent status.

Sofosbuvir patents are the biggest obstacle for accessing the treatment

UNASUR Countries: 12 Total Population: ~400 millones Total cases Hep C: ~5-6 million, G1 predominance

SOF patents granted NO SOF patents granted SOF primary patents pending Only SOF secondary patents pending

42

CONCLUSIONS AND RECOMMENDATIONS This meeting leaves a road map on both the local approach by the countries of the region as well as possible regional agreements that may favour not only the pharmacological treatment, but also the integral management of the disease, following the constitutional act of UNASUR under a perspective of health systems universality.

The Ministers present and the Secretary General of UNASUR made an urgent appeal: the regional agenda must incorporate all those actions that mitigate the impact of the disease, including regional political agreements in the use of patents’ flexibilities, such as compulsory licenses. Alejandro Gaviria, the Colombian Health Minister, called for changes in the current state of affairs and his Ecuadorian counterpart, Margarita Guevara, reinforced the urgency and need of these changes, because what is at stake is the health of the people.

Gaviria also highlighted the lack of transparency in medicines price information: “clearly, there is a divorce between value and price”. He reaffirmed the need for unity between the UNASUR countries “to buy, unite to negotiate and to fight for intellectual property. This has to be a joint effort.” Several of the countries representatives agreed with Gaviria’s emphasis and with the importance of insisting at the regional level on the joint work for regional purchases of medicines, as well as the support required for implementing other types of interventions, particularly in the diagnosis and screening phase of the disease.

intervention related to the treatment of Hepatitis C. Facilitating decision-making of the member countries is now a reality thanks to the work that the Group on Universal Access to Medicines of UNASUR (GAUMU) has been developing, with such concrete results as the BPMU. Likewise, the results of compulsory licenses in two countries of the region, as well as new regulations of patent approval that contemplates all those public health protection safeguards like the recent experience of Ecuador.

Proposals involving the use of flexibilities in conjunction with research and development and the transfer of medicines’ technology, such as that presented by the DNDi, are also part of the possible horizons for countries in the region.

All this will allow drawing a roadmap that contemplates several possible interventions from an integral perspective of the management of the disease and the problems evidenced in the treatment and approach of Hepatitis C. This without ignoring, as stated by the PAHO/WHO resolution CD54/INF/5 of 2015, the need to understand the therapy, the focus on integrality and to promote universal access through a rational use of resources.

On the other hand, progress has been made regionally in various instances of Health in UNASUR: Challenges and Responses

43

44

Health in UNASUR: Challenges and Responses

45

INTRODUCTION:

NUTRITION AND FOOD SECURITY IN SOUTH AMERICA At a global level, as human race we have been able to recognize the enormous problem that we face regarding chronic noncommunicable diseases (CNCDs).

Currently, these diseases are the leading cause of death in South America and in much of the world and are closely related to social determinants of health as broad as urban planning, access to education and information, socioeconomic conditions, among many others.

A process that much of the world is currently experiencing compounds this previous scenario: the so-called “nutritional transition”. According to the Food and Agriculture Organization of the United Nations (2014) 1, this concept refers to dietary changes produced by the large supply of ultra-processed

1 Food and Agriculture Organization of the United Nations (FAO). Panorama of Food and Nutritional Security in Latin America and the Caribbean. Hunger in Latin America and the Caribbean: approaching the Millennium. 2014. Available in: http://www.fao.org/docrep/019/i3520s/i3520s.pdf

46

industrialized products with high levels of sugars, fats and sodium, in detriment of healthy food such as fruits and vegetables.

This has a direct impact on the increase of overweight and obesity, coexisting with malnutrition problems.

This phenomenon is the result of structural changes in individual lifestyles; true. But it mainly has to do, for example, with the accelerated pace in which people live, especially in urban areas, where mobility is often a problem that affects the time spent exercising, while at the same time distancing people from the process of production and preparation of food. Furthermore, we can also take into consideration the lack of suitable information for healthy eating and the advertising of industrialized foods in the media that promotes harmful products.

According to WHO (2016)2, obesity has

2 World Health Organization (WHO). Obesity and overweight.

Fact sheet No. 311. 2016. Available in: http://www.who.int/ mediacentre/factsheets/fs311/es/

more than doubled between 1980 and 2014, a year in which 41 million children in the world under the age of five were overweight or obese.

At the same time, we have not yet overcome the challenge of ending hunger and promoting food security, as set out in Objective 2 of the 2030 Agenda for sustainable development. Poverty and the consequent lack of access to basic services, safe water and quality food contribute significantly to malnutrition in children, causing child development problems such as low growth and learning difficulties. In 2013, malnutrition caused 45% of child deaths worldwide3.1In that sense, it is worth emphasizing the essential role of breastfeeding, which can save up to 823.000 children lives and prevent 20.000 deaths from breast cancer each year4.2 In this context, the South American Health Council, made up of the 12 ministers of health of the region, has prioritized since its inception the generation of regional strategies that seek to improve the health conditions of the population through comprehensive approaches.

Within the framework of the Five Year Plan (2010-2015)5,3besides specific objectives to prevent CNCDs, one of the driving forces

3 Rome Declaration on Nutrition, 2014. Available in: http:// www.fao.org/3/a-ml542s.pdf

of the document is “health promotion and actions on social determinants”, which are directly related to the reduction of inequities in health and highlight life conditions that lead to totally preventable health problems, such as malnutrition. In that sense, the Health Council urged its bodies to develop within the scope of the Five-Years Plan the issues of hunger, food, nutrition and food sovereignty.

Following these guidelines, ISAGS, with the support of the Brazilian Health Surveillance Agency, the Secretary General of UNASUR, the Pan American Health Organization and the Ministry of Public Health of Ecuador, organized the “International Conference on Integrated Policies and Regulation For Food and Nutrition Security”, which aimed at deepening the existing knowledge about innovative, comprehensive and high-impact policies. It is very clear that good nutrition, non-consumption of alcohol and tobacco products and physical activity contribute to improving health, reducing NCDs. However, it is also clear that in order to expand these healthy practices in the population the role of the State, in articulation with civil society, is crucial. South America is at the forefront in implementing several policies that favour people’s health against companies’ strategies that only seek to generate more and more profits.

4 Victora, C. G. et al. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. The Lancet , 387(10017), p.475 – 490, 2016.

5 South American Health Council. UNASUR. Five-Year Plan (2010-2015). 2010. Available in: http://www.isags-unasur.org/ uploads/biblioteca/1/bb[67]ling[2]anx[147].pdf

Health in UNASUR: Challenges and Responses

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ASSOCIATE INSTITUTIONS ANVISA: According to the World Health Organization (WHO), around 36 million deaths in 2008 were caused by noncommunicable chronic diseases (NCD).

NCDs relate to many risk factors such as unhealthy diets, specially involving the consumption of the following nutrients: industrial trans fat, saturated fat, sugar and sodium. One of the WHO’s recommendations to reduce their consumption is by making precise, standardized and understandable information on the composition of food available to consumers. The Codex Alimentarius, an organism linked to the WHO and the Food and Agriculture Organization (FAO), reinforces the role of food labeling as an incentive to a healthy diet and advises its improvement. Therefore, front of package labeling emerges from a solution to make information accessible and practical, 48

considering the needs of consumers and the specificities of each country.

ANVISA, the Brazilian regulatory agency responsible for food control and regulation, supports the organization of this Conference aiming at exchanging experiences on the models of food and nutritional labeling adopted in order to contribute to the effectiveness of regulatory actions that will be implemented in Brazil.

PAHO: “Our Region, like the rest of the world, faces an epidemic of chronic diseases, overweight and obesity, strongly associated with changes in eating patterns and sedentary lifestyle. In order to face this situation – which produces suffering and premature deaths in our population,

Thalita Antony de Souza, Head of ANVISA’s Food Office, Veronica Espinoza, then Vice-Minister at Ecuador’s Public Health Ministry, Margarita Guevara, then Health Minister of Ecuador, Yuri Chillán, UNASUR General Secretariat’s Chief of Staff, Carina Vance Mafla, ISAGS Executive Director, Adrián Díaz, PAHO/WHO Advisor on Family, Gender and Course of Life

in addition to a constant increase in the costs of medical care – it is necessary the coordinate action of the countries of the Region regarding the implementation of regulatory measures to overcome the different obstacles present in some sectors of our countries’ food industry. Meetings such as the one recently convened by ISAGS contribute precisely to this process of harmonization and consensus of public policies that far from being against anyone are in favour of the health and quality of the population of our Region”.

MSP Ecuador Modernity has marked a change in the agro-food chain, which has been affected in its social, ecological and sanitary dimensions due to the tendencies towards the industrialization, homogenization and growth of international trade. As a

consequence, people’s eating habits have turned to large supermarkets, eating out meals or fast food. Thus, especially from the cities, consumers disconnect from the origin of food as well as producers, those who can put a face to the food we consume.

Not knowing not only the origin, but how the food is modified, makes imperative the need to establish mechanisms such as food labelling to inform the components of processed foods. This single strategy that has been recognized as an achievement in public health by PAHO / WHO can greatly help the prevention of overweight and obesity and chronic noncommunicable diseases such as hypertension, diabetes and certain types of cancer, since there are critical components (sugar, fat and salt) in processed products that may be conducive to these conditions.

Health in UNASUR: Challenges and Responses

49

REPORT International Conference Integrated Policies and Regulation for Food and Nutrition Security November 29 and 30, 2016

Gathered on November 29 and 30, 2016 in Quito, Ecuador, representatives of UNASUR member countries, international organizations, academia and civil society from South America and countries outside the region participated in the International Conference “ Integrated Policies and Regulation for Food and Nutrition Security�.

50

In order to share international and intra-regional experiences on issues such as food and nutritional security and food labeling, and to propose common actions among UNASUR countries, the participants present the following results:

1 – Progress • South American governments are promoting the implementation of ECNT prevention policies to address increased consumption of processed foods high in fat, sugar and sodium.

• Governments of Ecuador, Chile and Bolivia have been pioneers in the implementation of food labeling in the region, facilitating the understanding of nutritional information by their population.

• In the same way, governments of Colombia, Peru and Uruguay are currently in the process of formulating

and implementing a policy of front of pack labeling.

• Several countries have school feeding policies prohibiting the supply, sale and advertising of ultra-processed foods.

• Within the framework of the Habitat III Declaration, several countries have made progress in implementing policies for healthy municipalities and promoting physical activity.

• The Chilean government has made notable progress in restricting food advertising to children under the age of 14.

Health in UNASUR: Challenges and Responses

51

2 – Challenges • To avoid expanding the consumption of industrialized products that contributed in the last decades to the epidemiologic transition in the region: from malnutrition to obesity with malnutrition.

• Control the permanent pressure against the implementation of regulation by the processed food industry.

• Eliminate advertising of ultra-processed and high in fat, sugars and sodium foods, mainly the ones focused on children and the sponsoring of sporting events.

• Promote citizen participation in the construction and implementation of policies.

• Maintain healthy life cycles, with consumption habits that are preserved for generations.

• Promote the construction of comprehensive and intersectoral legislation and policies, involving food, transportation, land use, and others.

• Incorporate into the policies the perspective of national sovereignty, with respect to intercultural issues.

• To have evidence-based policies, including studies on the costs of ECNT treatment for health systems and to avoid conflicts of interest that override the public health interest.

52

3 – Recommendations • Taking into account the centrality of the debate and the progress made by South American countries in the promotion of food and nutritional security, we recommend the Health Council of UNASUR to incorporate in its new FiveYear Plan actions that promote these policies at the regional level .

• Promote research for the generation of evidences to base integral policies of food and nutritional security.

• Establish indicators to measure the impact on health of the implementation of labeling or advertising restriction policies.

• Promote initiatives that involve civil society, such as the formation of conscious consumer groups.

• • Promote the exchange of good practices for food advertising aimed at vulnerable groups.

Quito, November 30th, 2016

WHO estim that the co reducing the gl burden of Chr Non-communic Diseases (CNCD

In Latin America, sales of ultra-processed products increased by and purchases of fast food per capita increased by almost

11,2

48%

m do

per year: an an investme

1-3

do per ca

40% between

(WHO,

2000 and 2013 (PAHO/WHO, 2014)

The governm of Ecuador, C have become regional pione on the area by implementing Front-of-Pack Labelling poli and Bolivia co with an appro law under cur implementati

The most obese countries in South America are: Venezuela (31%), Chile and Argentina (29%), Ecuador (22%), Brazil (20%), Paraguay (19%),

ECUADOR 2014

Bolivia (19%), and Colombia (18%)

CHILE 2016

(PAHO/WHO, 2014)

ALTO EN AZĂšCARES

ALTO EN CALORĂ?AS

ALTO EN GRASAS SATURADAS

Ministerio de Salud

Ministerio de Salud

Ministerio de Salud

Chile and Ecuador have implemented fiscal measures on the marketing of sugary beverages and Colombia is also in the process of implementing a fiscal policy

ALTO EN SODIO Ministerio de Salud

Argentina, Brazil and Paraguay are advancing important works in the reduction of salt in processed foods

Many countries have school feedin and food marketin control policies an in their consume protection codes recognize the spec vulnerability of children in relatio to advertising

Health in UNASUR: Challenges and Responses

53

EXTENDED SUMMARY Gerardo Lorbeer – Director of the National Food Institute, Ministry of Social Development, Uruguay. glorbeer@mides.gub.uy Food and Nutritional Security Network UNASUR – GTSAN The increase in the consumption of ultra-processed products (PUP) in Latin America has had, in addition to the known negative impacts on the health of the population (with a considerable increase in overweight and obesity and chronic noncommunicable diseases), other negative impacts on the food system seen from a global perspective.

There is a notable reduction in the demand for various foods and in the typical preparations of local or regional culture (which implies a globalization of flavours), a loss of culinary skills and intergenerational transmission of habits and customs and a substitution of food 54

purchases in small local markets for the purchase in large commercial areas.

The large areas in several countries of the region have contributed to the precariousness of work, since they employ labour with low specialization and training, who in many cases come from other productive sectors, even former rural workers or young people who have not completed their studies and depend on these low-wage labour sources for their livelihood. This implies, among other things, loss of skills for food production, a situation of dependency and vulnerability, with reduced wages and extended working hours. This social, economic and cultural

conditions of a considerably large size of the population has not been analysed on its real dimension, due to the fact that usually, when analysing the change in dietary habits, in the productive system and in people’s as a result of an increase in the sales and consumption of PUP, this component of high relevance is relatively unknown.

It is necessary to advance in the regulation of PUP, we need the scientific knowledge necessary for guiding us in the decision-making, because it is imperative to have global perspectives on this problem that transcends the actions that can be developed by the health sector.

Public Health, as a human right, requires

global and intersectoral perspectives in order to achieve better results. We must continue to work for our governments to continue this strengthening process, with instances such as these that allow us to learn together, share successful experiences and learn about our failures, as we face the enormous responsibility of defending our food systems in order for them to be healthier and more sustainable, and thus contribute to the well-being of people.

Health in UNASUR: Challenges and Responses

55

ABSTRACTS Presentaciones de la Conferencia Internacional Políticas Integradas y regulación en seguridad alimentaria y nutricional

Consuelo Santamaría - Undersecretariat for Health Promotiom of the Ministry of Public Health of Ecuador Keynote Conference: Advances in the prevention of noncommunicable diseases through the implementation of healthy public policy / health promotion strategies Given that the concept of health as well-being transcends the idea of healthy lifestyles, health promotion is not an exclusive concern of the health sector.

In this sense, the Ministry of Public Health of Ecuador, through the National Undersecretariat for Prevention, Health Promotion and Equality, is dedicated to encourage health promotion strategies as a mechanism for improving the general health and welfare of the citizens with broad social participation and community organization.

Ecuador faces an accelerated increase in overweight and obesity in all age groups: children, adolescents, adults and seniors. In 2016, about 7 500 000 people in Ecuador, or 1 in 2 Ecuadorians, have these conditions. Based on this evidence, Ecuador in its National Plan for Good Living 2013-2017 includes as one of its goals “to reverse the incidence of overweight and obesity in schoolchildren”.

56

In the Shanghai Consensus on Healthy Cities 2016, ten priority areas of action were established for healthy cities. Areas 8, 9 and 10 address the risk factors for CNCDs. Area 8 is to promote sustainable urban mobility. Physical inactivity can be addressed in this area. Area 9 is Policies on food safety and sustainability that enhance access to healthy and affordable food and safe water, reduce sugar and salt intake, and reduce harmful alcohol consumption.

This area addresses poor diet and alcohol.

Area 10 is Smoke-free environments. This area addresses tobacco.

In this sense, the Ministry of Public Health of Ecuador presents two lines for combating CNCDs: the implementation of processed food labelling, as a measure based on the right of consumers to clear, complete and not misleading information at the time of making decisions that protect their; and the implementation of Healthy Municipalities.

Health promotion for the prevention of CNCDs in Ecuador: Policies and strategies Noviembre, 2016

Benefits of Labeling in Ecuador

The industry has formulated healthier products: 23% of big companies changed their components; 40% have formulated new products with medium and low content.

Ecuador was the pioneer in implementing mandatory labeling, gaining international recognition.

BOLIVIA February 2016 In the region, Bolivia and Chile joined the initiative to implement a labelling system similar to Ecuador’s.

CHILE 2016

CHILE June 2016

HIGH IN SUGAR

HIGH IN CALORIES

HIGH IN SATURATED FATS

HIGH IN SODIUM

Ministerio de Salud

Ministerio de Salud

Ministerio de Salud

Ministerio de Salud

Health in UNASUR: Challenges and Responses

57

Ricardo Uauy - Professor of the Nutrition Institute, Universidad de Chile Keynote Conference: Nutrition Transition: a review of the South American profile Household availability of ready-toconsume food and drink products in Chile: impact on nutritional quality of the diet Recently, a team of researchers from the University of SĂŁo Paulo in Brazil, chaired

by Prof. Carlos Monteiro has developed a classification of foods according to the nature, extent and purpose of processing.

This new classification divides food into three groups: 1) food as such, which may be unprocessed or minimally processed (e.g., grains, legumes, fruits, vegetables, eggs, fish, meat and milk); 2) processed culinary ingredients (e.g., oils, sugar, flours, animal fats and salt); 3) ready-to-eat food products that can be processed (e.g. canned fruits and vegetables, dried or dehydrated meats, cheeses) or ultra-processed products (pastry products, sausages, hamburgers, soft drinks).

58

This classification has been adopted in several countries of the world in order to analyse the level of consumption of readyto-eat food products and their impact on the quality of the diet. Studies in Brazil and in Chile, show that the products ready for consumption are characterized by their low nutritional quality, are higher in sugar, salt, fat and more energy dense, compared to non or minimally processed foods combined with culinary ingredients used in the preparation of dishes and meals. There is evidence that some ready-to-eat products are associated with a higher prevalence of obesity and metabolic syndrome.

The notable changes in diet in the Latin American region since the 1980s have affected the health of the population of the region, with a clear increase in the proportion of ready-to-eat food products and a significant contribution to food expenditure.

Prevention of CNCDs through Life

Development of CNCDs

Foetus

NSE Maternal Nutrition Growth Weight at Birth

Infants and Children

Adolescents

NSE Infections DPE Micronutrients Growth Physical activity TV Nutrition

Obesity Sedentary lifestyle Inactivity Tobacco

Adult life Risk behaviors in adults Diet / Physical Activity, Tobacco, Alcohol Biological Risks Socioeconomic level Environmental conditions.

Accumulated risk Genetic susceptibility to CNCDs Age

Health in UNASUR: Challenges and Responses

59

Forum on Integrated Policy and regulation for food and nutritional security Fabio Gomes - Advisor on Nutrition and Physical Activity, PAHO/WHO Regulatory and fiscal policies in the prevention of obesity and NCDs In October 2014, the Member States of the Pan American Health Organization (PAHO) unanimously approved the Plan of Action for the Prevention of Obesity in Children and Adolescents. The Plan is organized into five strategic lines of action, including: Primary health care and promotion of breastfeeding and healthy eating; Improvement of the environment regarding nutrition and physical activity in schools; Fiscal policies and regulation of food advertising, promotion and food labelling; Other multi-sectorial measures; Surveillance, research and evaluation.

Fiscal policies and other regulatory measures are part of one of these key lines of action, without which it is not possible to effectively reduce the demand for nonrecommended food and beverages as part of a healthy diet. The PAHO Nutrients Profile Model presents criteria that define products that are high in health-critical nutrients (e.g. free sugars, fat, sodium) and that should be subject to regulations aimed at reducing their demand and supply.

The most effective and cost-effective measures to reduce the demand for these non-recommended products include the application of taxes, the regulation of advertising, with particular restriction to those aimed at children and adolescents, and the regulation of labelling, including the introduction of front-of-pack warning systems of quick and easy comprehension and the prohibition of the use of persuasive elements in the label that generate deception and promote non-critical purchase and consumption decisions.

One of the key challenges for implementing these policies is the protection of the policy cycle from the interference of actors who oppose public health. In this sense, it is fundamental to discuss and establish safeguards capable of protecting scientific independence and the different stages of the policy cycle from interactions with opponents and thus preventing the emergence of conflicts of interest.

5 STRATEGIC LINES OF ACTION

60

1. Primary health care and promotion of breastfeeding and healthy eating;

3. Fiscal policies and regulation of food advertising, promotion and labelling;

2. Improvement of the environment regarding nutrition and physical activity in schools;

4. Other multisectoral measures; 5. Surveillance, research and evaluation.

Yanci Guadalupe Urbina - President of the Consumer Protection Office of El Salvador Protection policies against the marketing of foods and drinks harmful to health The Consumer Protection Office of El Salvador proposes actions for the promotion and protection of consumers’ right to a healthy diet and to receive full, clear, truthful and timely nutritional information from the supplier to ensure that consumers can choose healthier and safer diets versus the processed foods market, high in sugar, sodium (salt) and fat.

The Consumer Protection Office also promotes the knowledge and reading of nutritional labels. It as well encourages

the reduction of sugar, salt and fats consumption in order to contribute to the health and good life of the consumers.

The “Mi Plato Saludable” (My Healthy Meal) strategy is a basic food guide to encourage a change in consumption habits, such as the consumption of more water and vegetables and fresh fruits, instead of food products with a high content of sugar, sodium and fats. It also promotes the practice of more physical activity.

PROTECTION POLICIES AGAINST THE MARKETING OF FOODS AND BEVERAGES HARMFUL TO HEALTH QUITO, ECUADOR 2016 YANCI URBINA PRESIDENT OF THE CONSUMER PROTECTION AGENCY

CAMPAIGN: HEALTHY CONSUMPTION, RESPONSIBLE CONSUMPTION

“My Healthy Plate” basic food guide to encourage a change in consumption habits, such as the consumption of more water and fresh vegetables and fruits, instead of foods high in sugar, sodium (salt) and fats; As well as practicing more physical activity.

Health in UNASUR: Challenges and Responses

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Luisa Brumana - Regional Health Advisor, UNICEF Latin America and the Caribbean Review of practices and regulations on the labelling of industrialized foods and beverages for children and adolescents In order to contribute with scientific evidence on food labelling, UNICEF and the National Institute of Public Health of Mexico (INSP) carried out the “Analysis of regulations and practices for the labelling of foods and beverages for children and adolescents in Latin America (Argentina, Chile, Costa Rica and Mexico) and recommendations to facilitate consumer information�.

The study revealed the importance of having simple and comprehensive front-of-pack labelling that is consistent, striking and can be interpreted by the entire population quickly and easily. Key labelling models, regulated or voluntary, were identified, among which the

62

preferred ones by the population were: the traffic-light label of Ecuador and the warning octagons of Chile.

Finally, we detailed a series of recommendations and actions to improve the regulations and practices of the labelling of industrialized foods and beverages aimed at children and adolescents, such as harmonized regulations for the region and the strengthening of educational and public social campaigns.

Having more informed consumers, both adults and children/adolescents, is an indispensable step for them to change their habits and make responsible decisions when choosing a product.

Results: Systematic Review Impact / effect of food and beverages nutrition labelling 612 articles were identified and 42 were included

Identified studies (n=612) Excluded/duplicate studies (n=410) Studies excluded by title (n=294) Studies excluded by abstract (n=77) Medline (n=346)

Studies excluded by full text (n=5) Selected studies (n=415)

Academic search premier (n=171) MedicLatina (n=1) Studies evaluated (n=44)

Literatura Gris (n=23)

Total of studies included (n=39)

COCHRANE (n=71)

Health in UNASUR: Challenges and Responses

63

Healthy Municipalities Forum Stephen Whiting – Technical Officer (Diet and Physical Activity) Surveillance and Population-based Prevention Unit Policies for the promotion of physical activity, Stephen Whiting Physical inactivity is now the fourth leading risk factor for global mortality, causing approximately 3.2 million deaths per year. As populations age, annual NCD deaths are projected to rise to 52 million in 2030. Rising global physical inactivity has major implications for population health, particularly as an NCD risk factor.

In addition to being an independent risk factor for NCDs, physical activity is also related, either directly or indirectly, to other leading risk factors including high blood pressure, high cholesterol, and overweight and obesity. NCDs are not only a major public health burden, but also have broad, significant social and economic impacts.

The Global Action Plan for the Prevention and Control of NCD specifies nine voluntary global targets including a 10% relative reduction in insufficient PA. One of the policy options outlined to help Member States achieve this target is the ‘development of policy measures in cooperation with relevant sectors to promote physical activity through activities of daily living including through active transport, recreation, leisure and sport.

In addition, actions to support and encourage ‘physical activity for all’ initiatives for all ages and creating supportive built and natural environment have also been promoted.

As part of it’s secretariat role, WHO is developing a physical activity technical

64

package and toolkit to support countries in developing and implementing policies and interventions to increase population physical activity and progress toward achieving the Global NCD Action Plan targets. These resources are being developed based around the seven key areas for action to promote physical activity: i) Community-wide programmes; ii) Environment (including urban design, transport, land use etc); iii) Schools; iv) Healthcare; v) Sports; vi) Workplaces; vii) Communication and mass media.

The technical package specifies the key policies and interventions for promoting physical activity in each of these sectors, based on reviews of the evidence and with technical input from a global network of experts. The policies and interventions are intended to be implemented as a comprehensive package as there is evidence that they are synergistic, complementary and will help to increase physical activity levels across the lifespan among all population groups. The package is currently being field tested in countries and a toolkit is being developed which will provide guidance on how to implement the policies as well as case studies and other resources to support countries to adapt to their own local context

Policies for the promotion of physical activity Stephen Whiting Technical Officer (Diet and Physical Activity) Surveillance and Population-based Prevention Unit Prevention of NCD Department WHO Headquarters

7 key areas for physical activity promotion

1. Environment (urban design and transport) 2. Schools 3. Healthcare 4. Sports 5. Workplaces 6. Media 7. Community-wide programmes

Health in UNASUR: Challenges and Responses

65

Adriana PavĂłn - National Director of Health Promotion of the Ministry of Public Health of Ecuador Healthy Municipalities Program: the Ecuadorian case In the 9 th World Conference on Health Promotion held in Shanghai from November 21 st to 24 th, attended by more than 100 mayors from around the world, who committed with health and sustainable urban development, recognized that health and well-being are in the basis of the United Nations 2030 Development Agenda and its Sustainable Development Goals. Local governments have a key role to play in achieving the sustainable development goals.

The 3 pillars of health promotion established in Shanghai have been: Good governance, health knowledge and healthy cities, in order to meet the goal of “Health for all and all for health�.

In this sense, the Healthy Municipalities Program is an umbrella strategy to address food health from a local level and effectively attack the risk factors of CNCDs from a health determinants perspective.

The Ministry of Public Health of Ecuador leads the Healthy Municipalities Program in the country, which aims to encourage municipal GADs to address in a comprehensive way the determinants that influence the health status of the population, improving the well-being and quality of life of the population.

The Program presents four lines of action: 1. Promote the certification of healthy municipalities; 2. Provide advice and support to municipalities that are part of the Program regarding health issues; 3. Channel technical resources to the participating municipalities, in coordination with other entities; and 4. Promote

66

mechanisms for citizen participation within the framework of the Program.

Health awareness activities will be carried out with emphasis on promotion, support will be given to the development of spatial and development plans with an action approach on determinants, and the local authorities will have access to the Situational Health Analysis. The purpose is for municipalities to use the epidemiological profile of their locality as an input for the design and execution of actions within their competencies. The Program seeks to channel technical support to various issues of municipal interest (water, transportation, security, etc.) in coordination with the governing bodies through the formation of a National Technical Action Committee on Health Determinants.

It is possible to conclud that local governments have a key role in food health through actions such as the promotion of agro-ecological marketing, incentives to the creation of urban gardens, healthy markets, etc. In addition, cities can have positive and negative health effects.

However, it is necessary to understand the factors that influence health and to evaluate the circumstances and contexts in which one factor may be more or less important than other. Considering that urban planning has a strong impact on health, it is necessary to strengthen the urban-rural link as part of a common ecosystem and to deepen the analysis of problems related to socio-territorial inequality and exclusion.

Health in UNASUR: Challenges and Responses

67

Nicolรกs Cuvi - Department of Development, Environment and Territory, FLACSO Ecuador Urban Agriculture and its impact on Health and Food Sovereignty The urban and periurban food gardens strengthen food security and food sovereignty and provide healthy activity and food, spaces and communities for people and other species. In Quito, urban agriculture is practiced by thousands of families and people (especially women), most of them living in poverty or under situations of socioeconomic exclusion, unemployment or malnutrition, among other vulnerabilities.

This allows them to access food, improve their nutrition, reduce spending, have opportunities for socialization and training, generate income, among other positive notmonetary externalities.

In addition to helping to alleviate structural problems in the city, the food gardens were sustainable in the sociocultural, economic, environmental and technological

68

dimensions. The technological dimension presented greater sustainability as a consequence of the scale and philosophy of urban agricultural production in Quito, based on principles of agro-ecology or organic agriculture with agro-ecological basis.

Among the three projects/management and organizational models studied, AGRUPAR and PROBIO can serve as guidelines for the development of public and private urban agriculture projects.

The INTI case illustrates that for urban agriculture to be beneficial, permanent training and assistance, support in value added processes and marketing, formation of associations and groups, among other aspects, must be considered besides infrastructure.

Urban Agriculture and its Impact on Health and Food Sovereignty Nicolรกs Cuvi Department of Development, Environment and Territory, FLACSO Ecuador

Sustainability of urban gardens Index Dimension

PROBIO

AGRUPAR

Independents

INTI

Total

(4 gardens)

(69 gardens)

(4 gardens)

(5 gardens)

(82 gardens)

Economic

3,3

2,8

1,9

1,4

2,67

Environmental

3,2

3,0

3,1

2,2

3,04

Sociocultural

3,1

3,1

3,6

2,7

3,13

Technological

3,9

3,8

3,7

2,1

3,73

ISG

3,4

3,2

3,1

2,1

3,14

All the vegetables gardens were above the sustainability threshold, but certain aspects need to be reviewed to improve their performance, related to water, seeds, technical assistance, access to land, among others.

Health in UNASUR: Challenges and Responses

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Forum Front-of-pack Labelling (FOP) as a mechanism for promoting health Sue Davies, Chief Policy Adviser, UK Consumer Association Only around a third of people are a healthy weight in the United Kingdom (UK). A quarter of the population is obese, with disturbing rates in children. Across all population groups, people are failing to meet the recommended dietary goals. A range of measures are therefore needed to make it easier to eat healthily. This includes providing clear information and advice, but also actions to make products healthier, for example targets for reducing fat, sugar and salt levels and controls over the way that foods are marketed and promoted. Government policies, such as agriculture and trade, also need to be joined up with health initiatives.

Against this context, Which? campaigned for simplified front of pack nutrition labelling that includes ‘traffic light’ colour coding so that it is easier for people to make informed choices, particularly when buying processed foods. Around two thirds of products in UK supermarkets now have the traffic light labelling scheme which was developed by the Government in consultation with the food industry and consumer and public health groups .

It includes the nutrients that are of most public health significance: fat, saturated fat, sugar and salt, along with energy which is not colour-coded. Green or ‘low’ criteria are based on European Union (EU) definitions for nutrition claims, while ‘red’ is a proportion of the Reference Intakes (RI) set out in EU legislation: 25% for foods and 12.5% for drinks. Additional criteria for ‘red’ apply for larger portion sizes (over 100g or 150ml). The criteria apply across the board and are not category specific.

Information is also included on the amount per portion and the % RI.

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Under EU law, the scheme has to be used in addition to the mandatory back of pack information - and can currently only be a voluntary scheme. While all UK retailers have committed to use the scheme on their own label products and some manufacturers; other large producers do not use it. The scheme works alongside other forms of communication, such as the Government’s “Eat Well” plate, providing guidance on the balance of foods more broadly.

It evolved over many years and a lot of heated debate going back to around 2004.

While consumer research conducted by Which? and the Food Standards Agency showed that traffic lights worked best for most consumers, a separate scheme based on the % reference intakes with no traffic lights was heavily promoted by the main multi-national food companies and some retailers. Some retailers and smaller manufacturers did adopt traffic light labelling on front of pack in 2006, but they presented this in slightly different formats.

This meant that for some years, there were a variety of front of pack labelling schemes on the market, causing confusion, rather than simplifying choices for consumers.

Going forward however, it is important to ensure that the scheme is used on all products. The work that is now underway within Codex on front of pack labelling will be important in this respect - to ensure that it does not undermine traffic light nutrition labelling and ideally promotes it. While traffic light nutrition labelling alone will not solve the obesity crisis, it is an important step in order to make it clear to consumers what they are eating.

Each grilled burger (94g) contains

Energy 924 kj 220 kcal

Fat

Saturates

Sugars

Salt

13g

5.9g

0.8g

0.7g

11%

19%

30%

< 1%

12%

of an adult’s reference intake Typical values (as sold) per 100g: Energy 966kJ / 230kcal Table 2: Criteria for 100g of food (whether or not it is sold by volume Text

LOW8

MEDIUM

Green

Amber

Fat

≤ 3.0g/100g

Saturates

Colour Code

HIGH Red > 25% of Rls

> 30% of Rls

> 3.0g to ≤ 17.5g/100g

> 17.5g/100g

> 21g/portion

≤ 1.5g/100g

> 1.5g to ≤ 5.0g/100g

> 5.0g/100g

> 6.0g/portion

(Total) Sugars

≤ 5.0g/100g

> 5.0g to ≤ 22.5g/100g

> 22.5g/100g

> 27g/portion

Salt

≤ 0.3g/100g

> 0.3g to ≤ 1.5g/100g

> 1.5g/100g

> 1.8g/portion

Note: portion size criteria apply to portions/serving sizes greater than 100g

Health in UNASUR: Challenges and Responses

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María Rosa Curutchet – Director of the Observatory of Food and Nutrition Security, National Food Institute – INDA, Ministry of Social Development Four research projects were carried out by the Centre for Research, Food and Welfare, composed of Sensometric and Consumer Science researchers from the Technological Institute of Pando, Faculty of Chemistry, University of the Republic, Centre for Basic Research in Psychology, Faculty Of Psychology, University of the Republic and the Observatory of Food and Nutrition Security, National Food Institute, Ministry of Social Development.

on the content of key nutrients and classify them in low, medium or high. We investigated the time spent by the consumer in understanding different front-of-pack labelling systems, the healthy perception of products with different nutritional labelling systems, the preferences of schoolchildren according to the packaging label design and the applied labelling system, and the influence of the label design on children’s perception of healthy food.

There is sufficient evidence to affirm that the current system of nutritional labelling of foods in several countries of the region does not fulfil the function of empowering consumers so that they can make informed decisions about the nutritional characteristics of the products they buy, since label information is not understood by the consumer.

The research concluded that traditional nutrition labelling does not allow consumers to make informed decisions.

In this sense, the warnings system and the traffic light system improve the facility to find the relevant information. Additionally, the warnings system seems to have greater potential to improve the consumer’s ability to identify unhealthy products and discourage their choice in comparison with the traffic light system.

One of the alternatives for improving nutritional information is the inclusion of nutritional labelling on the front of the container (Hawley et al., 2013, Hodgkins et al., 2012, Grunert and Wills, 2007, Mackinson et al., 2010), since it easily captures consumer attention, facilitates interpretation, and increases the likelihood of consumers using nutritional information to make their decisions.

In the research, studies were conducted comparing three systems: Daily Dietary Guidelines (DDA), which only provide information on the content of key nutrients in absolute values or as % of Recommended Daily Value; Warnings, which includes warnings for each nutrient that is above the maximum acceptable range; and Traffic light, which communicate information

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It is important to note that cartoon characters, fruit drawings and nutrient statements influence the preferences of children. Therefore, the regulation of their use in product packages aimed at children is advised. In this sense, it is necessary to develop communication campaigns during the implementation of the front-of-pack labelling system. .

Healthy perception

The warning system decreased the perception of healthy compared to the GDA system in 3 of the 5 products and in 4 of the 5 with the traffic light system

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Jane Martin - Executive Manager of the Obesity Policy Coalition (OPC), Australia The Health Star Rating is a front-ofpack labelling system that rates the overall nutritional profile of packaged food and assigns it a rating from ½ a star to 5 stars.

It provides a quick, easy, standard way to compare similar packaged foods within a category, it is not designed to compare products across categories. The more stars, the healthier the choice overall.

In addition to the stars, nutrient content of the food may be shown directly below or to the side of the rating. This shows the quantity of nutrients, specifically energy (kilojoules) saturated fat, sodium (salt) and sugars that are in the product either per 100g, 100mL for liquids or per pack for single serve foods or per serve/portion (as specified). The label may also include one positive nutrient, such as protein, dietary fibre, certain vitamins or minerals.

The system is designed to provide key information that allows consumers to make at-a-glance comparisons of products within the same category. Further nutrient information is also available in the Nutrition Information Panel on food packaging. It is being implemented from June 2014

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on a voluntary basis by the food industry over the following five years, with a review of progress after two years. The Health Star Rating system was developed by the Australian state and territory governments in collaboration with industry, public health and consumer groups.

Many companies are using the scheme (115), some are not applying the stars to lower rating products, and some are not using them at all. So far stars appear on packaging for around 5,600 of about 20,000 lines. One thousand of those products receive two stars or lower, around 14% of unhealthy food receives 3 ½ stars or less.

There is also an online education campaign; which shows that so far almost 60% of people are aware of the scheme. For those who are aware of the scheme, one third has bought a product because it has a higher star rating than the product they usually buy. Nearly 8 in 10 of those consumers continue to buy the new product. Around 7 in 10 find it easy to identify healthier options, easy to understand, easy to compare products in the same section of supermarket

HEALTH STAR RATINGS range from 1/2 a star to 5 stars.

Compare similar packaged foods the more stars, the healthier the choice.

RISK NUTRIENTS - saturated fat, sodium (salt) and sugars. These are linked to increased rates of obesity and chronic disease if consumed in excess of recommended guidelines.

POSITIVE NUTRIENTS - such as dietary fibre, protein, calcium, or certain vitamins and minerals.

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Forum Successful experiences of food labelling in South America Andrea Bravo, Department of Health Promotion and Citizen Participation of the Ministry of Chile and Representative of the Latin American and Caribbean Network of Health Promotion Managers; Cristian CofrĂŠ, Technical Advisor, Ministry of Health of Chile/Representative of the Chilean Agency for Food Quality and Safety, ACHIPIA, Chile The Food Law is a response of the State of Chile to protect the health of the population against the alarming figures of obesity and noncommunicable diseases derived from poor diet. Its discussion began in 2006 in the National Congress and came into force in June 2016.

This law is part of a comprehensive policy to combat obesity, including advocacy, education, primary healthcare programs and other public health measures. Its purposes are to protect the health of the population, especially the children; decrease the consumption of foods with excess calories, saturated fats, sugars and sodium in the long term; promote the informed selection of food by means of a clear and visible message; improve the school environment by ensuring the supply of healthy food; and protect children and young people from excessive advertising.

The main axes of the Food Law are: i) The front-of-pack warning label on foods that exceed the limits set by MINSAL for

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calories, saturated fats, sugars and sodium; ii) The prohibition of advertising these foods directly to children under 14 years old; and iii) The prohibition of sale and advertising of these foods in pre-basic, basic and secondary educational establishments.

Through the activation of a territorial and regional health promotion network, it has been possible to achieve intra and intersectoral alliances, transfer of competencies, improvement of access and availability of healthy foods, communication strategies, as well as the implementation of citizen participation mechanisms, such as: Citizen Dialogues, Schools of Social Managers and Regional Public Health Forums. Through these instances, citizens have been actively involved in the design, implementation and evaluation of public policies and in the exercise of community control, all elements that contribute to the strengthening of governance and, ultimately, to the well-being and quality of life of individuals and communities.

WARNING FRONTAL LABELLING

HIGH IN SUGAR

HIGH IN CALORIES

HIGH IN SATURATED FATS

HIGH IN SODIUM

Ministerio de Salud

Ministerio de Salud

Ministerio de Salud

Ministerio de Salud

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Gabriela Rivas - Specialist Coordinator of Internal Management for the Promotion of Nutrition, Security and Food Sovereignty at the Ministry of Health of Ecuador BACKGROUND In the Ecuador’s National Plan for Good Living 2013-2017 stands out the implementation of processed food labelling as a measure based on the consumers’ right to clear, complete and non-misleading information to make decisions that protect their health. In 2012, the Ministry of Public Health (MSP) began a review and negotiation phase with the agencies involved, in particular representatives of the food industry and government agencies in the sector. This process demanded a thorough effort by the MSP, as leader, by other Ministries and the technical support of PAHO/WHO, resulting in the issuance of a new legal instrument, the Health Regulations for Processed Foods Labelling.

The first labelling regulation was approved and published in November 2013, and then several reforms were carried out until August 2014. The reforms that deserve more attention are those concerning the elimination of the ban on the inclusion of images and the last one that makes possible to include the nutritional traffic light either in the main (front) or in the secondary (back) panel of the package. In relation to the labelling

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implementation deadline, it is important to point out that due to the requests of the industry, this date had an extension from August 2014 to November 2014.

In November 2015, after a year of implementation of processed food labelling, the MSP proposed, together with PAHO and UNICEF, a qualitative evaluation. The objective was to assess the knowledge, understanding, attitudes and practices of the Ecuadorian population regarding the nutritional traffic light that became official in August 2014. The main finding of the research was that the “traffic light” is widely recognized and that there is a high level of information compression because it was presented in a simple way and with striking formats and colours, similar to a traffic light.

It is possible to concluded that in the area of food and nutrition at the international level, the traffic light labelling policy has allowed Ecuador to play a fundamental role in the Rome Declaration and the Framework for Action for better nutrition, as well as chair the negotiations on the Decade of Action on Nutrition and the World Nutrition Goals for 2025, within the framework of the 69th World Health Assembly this year.

QUALITATIVE EVALUATION OF PROCESSED FOOD LABELING METHODOLOGY

OBJECTIVE • To know the knowledge, understanding, attitudes and practices of the consumer regarding labelling

• 21 focus groups • Interviews with key informants • Large and medium national and international products • Structured Observation of Existing Regulations and Regulations

RESULTS

The nutritional traffic light was widely recognized by most participants in the Focus Groups due to its simple presentation, eye-catching colors, adequate text size and similarity to a real traffic light. No differences were observed by sex

CONSUMER PRACTICES REGARDING THE TRAFFIC LIGHTS

Reduction They perform physical activity

Compensation Replacement No change They stop consuming “HIGH” products

They drink water

Consume less

Decrease frequency of consumption

Practices of adaptation of the consumers before the traffic light

Increase consumption of products with artificial sweeteners

Consume to meet individual needs

Consume due to the lack of healthy offers

Avoid consumption in special conditions

They prefer medium and low products

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Forum Role of Regulatory Agencies in the national public policies of food labelling Thalita Antony de Souza â&#x20AC;&#x201C; Head of the Food Office of the Brazilian Agency of Health Surveillance, National Health Surveillance Agency of Brazil â&#x20AC;&#x201C; Anvisa The Brazilian National Health Surveillance Agency was created in 1999 by law n. 9782 and has its attributions the role of regulate, control and inspect product and services that involve risks to public health, including food and its labeling.

The regulations in force on general and nutritional labeling are harmonized among Mercosur member countries. Recognizing the need to improve the model of food labeling, the block has already started a review of its general labeling regulation (Resolution GMC n.26/03) and has already approved the review of the one on nutritional labeling (Resolution GMC n.

44/2003 and 46/2003).

Aiming at contributing to the speed of discussions, Brazil constituted, in 2014, a Working Group on food labeling, which worked from may 2014 to may 2016. The

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WG had as its goals identifying the needs to improve the current regulatory model on the matter and contributing to make an efficient proposal on the displaying of nutritional facts, proper to Brazil.

ANVISA is now in phase of building its Regulatory Agenda for the cycle 20172020, a regulatory tool which will make priority issues that will be regulated in the period visible to society. Therefore, the review of the nutritional labeling regulation is formally included in the list of themes of the Regulatory Agenda, reassuring the priority of this matter to ANVISA. At the same time, the agency will follow the discussions within Mercosur and the Codex Committee on Food Labeling, searching for convergence and alignment with international discussions.

Review of the Resolutions on Nutrition Labelling and Labelling • MERCOSUR / GMC / RES No. 26/03 review is ongoing.

• March 2012: At the request of Brazil, MERCOSUR approved the revision of the Nutrition Labeling Resolutions. Currently, availability to begin work is expected.

ANVISA ORDINANCE N. 949/2014 - NUTRITION LABELLING GT Objectives: • To help identify the main problems and limitations of the current regulatory model of nutrition labelling; • Propose alternatives to solve identified problems.

Composition: Government, universities, civil society, consumer representatives, the productive sector.

2 years (6 meetings + electronic discussions)

Next steps and perspectives • Continued discussions in Brazil, in accordance with Good Regulatory Practices (inclusion of the issue in the 2017-2020 Regulatory Agenda, analysis of regulatory impact, social participation); • Evaluate the frontal labelling model appropriate to Brazil; • Discussion in MERCOSUR; • Systematic review of scientific studies comparing the effects of different models of front-of-pack nutrition labelling on the perception, understanding and use of this information by consumers for healthier decision making; • Promoting research to explore the impact of these models on the Brazilian population.

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Cristian CofrĂŠ - Technical Advisor, Ministry of Health of Chile/Representative of the Chilean Agency for Food Quality and Safety, ACHIPIA, Chile It is understood that one of the roles of the agencies consist of developing comprehensive Public Policies for the management of Chronic Noncommunicable Diseases, based on social determinants.

Considering the cost efficiency of those strategies that may favour combating obesity and its related diseases.

It is important to strengthen citizen participation in policy debate and direct the process throughout the public policy

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cycle. In addition, it is essential to establish strategic alliances with key actors in each process, from design to evaluation.

The role of the agencies also includes participating actively in the international organizations relevant to the process and developing actions related to the national nutrition and food policy, as well as providing technical collaboration in the various international cooperation forums.

The Role of the Regulatory Agencies Food labeling policies CRISTIAN COFRÉ SASSO DEPARTMENT OF FOOD AND NUTRITION. cristian.cofre@minsal.cl

IMPLEMENTATION:Training

• EMCCS

• C and S Guidelines • SEREMIs Integrated Workshops • C and S Kits • Agreements • Intersectoral meetings • Meetings with Industry

• Citizen’s Dialogues • Health Forums • Schools for managers

Control and Surveillance

Promotion and Participation

• Educational material • National and local campaign • Guide kiosks and collations • Intersectoral work • Training

The successful implementation of this regulation goes beyond the control

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Dayana Donoso - Technical Director of Good Manufacturing Practices, National Agency for Health Regulation, Control and Surveillance of Ecuador ARCSA

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The Ecuadorian Agency for Health Regulation, Control and Surveillance (ARCSA) aims to contribute to the protection of the populationâ&#x20AC;&#x2122;s health, through the risk management of products for human consumption and use.

health surveillance actions; processed foods, additives, processed water, tobacco products, medicines, among others; and facilities subject to health surveillance and control established in the Organic Health Law.

The regulatory framework and the role of the Ecuadorian Agency for Regulation, Control and Health Surveillance (ARCSA) proposes regulatory, technical control and

The agency also controls that labels meet the requirements regarding sizes and phrases and reviews the control and management of results processes.

Para que tú estés bien, hacemos las cosas bien

CONTROL AND SURVEILLANCE INSPECTION PROCEDURE CONTROL LEVEL I Analysis of storage conditions, Labelling Review

PRODUCTS

• By risk-based planning • By request of the user

PRODUCTS TECHNICAL REPORT ISSUED BY THE CONTROL SYSTEM.

CONTROL LEVEL II Sampling for analysis in Reference Laboratory

• By control operation

http://postregistro.controlsanitario.gob.ec/

CONTROL LEVEL III Laboratory Specific Tests

2

3

4

BEGINING OF CONTROL

FIELD INSPECTION

SPECIFIC INSPECTION

MANAGEMENT OF NON-COMPLIANCE CONTROL RESULTS

ESTABLISHMENT

1

• By riskbased planning

Documentary review of the establishment

• By request of the user

(Operating License in force)

• By control operation

BACK CONTROL • Hygienic sanitary conditions; • Order and cleaning, clean floors, walls and ceilings, areas separated by type of product, functional and clean sanitary facilities;

IN CASES OF VIOLATION IT IS DERIVED TO THE RESPECTIVE ADMINISTRATIVE / SANCTIONING PROCESS

ESTABLISHMENT TECHNICAL REPORT ISSUED BY THE CONTROL SYSTEM http://postregistro.controlsanitario.gob.ec/

• Hygienic conditions of personnel; • Sale of products without current Sanitary Notification.

• Sale of expired products.

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Lynn Silver – Senior Advisor for Chronic Disease and Obesity. Public Health Institute, EEUU and University of California San Francisco It is considered necessary to emphasize the importance of the enormous social cost of inaction, which goes far beyond the costs of regulation. This social costs of inaction consist of direct costs to health systems that hinder the implementation of universal care, indirect costs for the families affected by expenses and loss of income and even cost for private companies due to the productivity losses.

a commitment to evaluation, such as the elimination of trans fats in the United States and the restriction hours of sale for alcoholic beverages in Diadema, Brazil.

It is worth noting the annual and increasing cost of haemodialysis in Brazil, US$ 970,354,600 in 2011, a good part of which is preventable and resulting from the diabetes epidemic. In addition to the high population reach and cost effectiveness of regulatory measures compared to individual health care interventions.

The results of sugary beverage tax assessments in Mexico and Berkeley, California, show reductions in sugar purchases of 6% in Mexico in the first year and 8.5% in Berkeley in the first six months.

It is important to draw attention to the fact that many innovative policies still lack complete evaluations of effectiveness and cost-effectiveness. However, we must act with the best evidence available to respond to health challenges, maintaining

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Likewise, in the field of nutrition and prevention of CNCDs, the most cost-effective interventions are fiscal interventions, such as taxes, food labelling, restrictions on the advertising of unhealthy foods, and reduction of sodium.

According to the former president of Finland, reflecting on smoke-free regulations – “Innovative ideas move over time from being perceived ‘ridiculous’ to being ‘possible’ and finally ‘normal’. Thus, it is possible to conclude that innovative regulatory practices to ensure healthy eating can also follow this path.

NCDs Costs for Different Sectors Table 1. Effects of NCDs in low- and middle-income countries Individuals and households • Premature death and disability • Loss of family income, possible impoverishment • Health expenditures, including catastrophic expenditures • Loss of savings and assets • Higher likelihood of children getting NCDs

Health Systems

National economy and governments

• Poor health outcomes

• Reduced labour force

• Reduced ability to meet other health needs

• Lower productivity and competitiveness

• Resources to reactivate health systems in the preventive care of chronic diseases

• Less tax revenue

• Health workforce demand and training • Increased demand for expensive medical interventions

• Higher expenditures on health and social welfare • Loss of demographic dividend • Political pressure derived from the unmet needs of the population

Source: Adapted from Council on Foreign Relations, 2014.

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LIST OF ACRONYMS

ACHIPIA

Agencia Chilena para la Calidad e Inocuidad Alimentaria (Chilean Agency for Food Quality and Safety)

ADPIC

Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (Trade-Related Aspects of Intellectual Property Rights – TRIPS)

ANVISA

Agencia Nacional de Vigilancia Sanitaria - Brasil (National Health Surveillance Agency – Brazil)

ARCSA

Agencia Ecuatoriana de Regulación, Control y Vigilancia sanitaria (Ecuadorian Agency for Health Regulation, Control and Surveillance)

ECNT

Enfermedades Crónicas No Transmisibles (Chronic Noncommunicable Diseases - CNCDs)

FAO

Organización de las Naciones Unidas para la Alimentación y Agricultura (Food and Agriculture Organization of the United Nations)

FOP

Front-of-pack labelling

GAD

Gobiernos Autónomos Descentralizados (Decentralized Autonomous Governments)

INSP

Instituto Nacional de Salud Pública de México (National Institute of Public Health of Mexico)

INPI

Instituto Nacional de Propriedade Industrial - Brasil (National Institute of Industrial Property – Brazil)

ISAGS

Instituto Suramericano de Gobierno en Salud (South American Institute of Government in Health)

MERCOSUR

Mercado Común del Sur (Southern Common Market)

I&D

Investigación y Desarrollo (Research and Development – R&D)

MSP

Ministerio de Salud Publica (Ministry of Public Health)

NCD

Non-communicable diseases

WTO

World Trade Organization

WHO

World Health Organization

UNIDO

United Nations Industrial Development Organization

PAHO/WHO Pan American Health Organization / World Health Organization

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PUP

Productos Ultra Procesados (Ultra-processed products)

UNASUR

Unión de Naciones Suramericanas (Union of South American Nations)

UNICEF

United Nations International Children’s Emergency Fund

USP

Universidad de São Paulo (University of São Paulo)