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SUMMARY 10 14 22 MARKET Health Investment Scenario in Brazil
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ECOSYSTEM Innovation in Health based on Brazilian Biodiversity HEALTHCARE The Importance of the Brazilian Unified Health System (SUS) INNOVATION Brazilian Public Laboratories as a Foundation for Science, Technology and Innovation CANCER Precision Oncology: What Does It Mean for the Patients and Where Are We? HEPARIN New Opportunities for the Brazilian Market REGULATIONS Cannabis sativa: Access to Medication and/or Product COVID-19 International Trade and Investment in Response to the Pandemic
BIO Br Project Management by: Reporter: BIOMINAS Brasil / Project Manager: Camila Molinari / Planning, Control and Operation: Carolina Sellani and Natalia AraĂşjo Art Editor: Daniel Guedes / Contact us at: marketing@abiquifi.org.br / Visit our site: bph.org.br
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Innovation in Health based on
Brazilian Biodiversity 10 bioBr
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ccording to the Convention on Biological Diversity (Article 2), biological diversity (Biodiversity) is “the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.” Therefore, Biodiversity underpins the ecosystem functioning and the provision of goods and services that are essential to human health and well-being.
When it comes to Biodiversity, it is known that Brazil has a fundamental role in the global scenario, being at the top of 18 megadiverse countries. It is estimated that the country hosts between 15-20% of the world’s biological diversity, with the greatest number of endemic species on a global scale. It contains two Biodiversity hotspots (the Atlantic Forest and the Cerrado) with more than 4,000 plant species. Although this rich Biodiversity puts us in a privileged position, our responsibility is enormous. The sustainable use of natural assets is critical to Brazil’s present and future generations. To protect this powerful Biodiversity, the law nº 13.123 was created in May 20th,
It is estimated that the country hosts between
15-20% of the world’s biological diversity)
2015, which became known as the “Biodiversity Law” or the “New Legal Landmark for Biodiversity”. This law, although already published, depended on regulations for the implementation of several of its instruments. Thus, it only effectively came into force with the Decree No. 8.772/2016, which defined the regulations for such law. According to João Emmanuel Lima, partner at the law firm Nascimento & Mourão Advogados, this law has substantially simplified the rules for research and development with species from Brazilian Biodiversity - activities that the law technically calls “access to genetic heritage and/or associated traditional knowledge”. Additionally, this new scenario created by the law, tends to attract companies that had abandoned research on Brazilian Biodiversity due to the regulatory complexity in force at the time, encouraging more investments in this area. Although João Emmanuel Lima believes that there are some challenges to be faced such as the continuously improvement of the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SISGen) – which is an electronic system elected as one of the pillars for implementing the legislation to access Brazil’s genetic heritage – as well as the setting up of the National Benefit Sharing Fund – a fund originated by resources from products
developed based on Brazilian Biodiversity, which could be applied in relevant projects for the Brazilian society – the benefits are much higher and relevant for the country. As João Emmanuel says “the advancement of research in this area tends to generate relevant environmental benefits. The biggest one is undoubtedly the recognition of the value of Biodiversity, whose conservation is sometimes seen only as a burden when direct economic benefits cannot be associated with it.” According to the World Health Organization (WHO), health is “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. Therefore, Biodiversity and human health are interlinked in various ways. This intrinsic relationship can be seen, more directly, in the areas such as biomedical/pharmaceutical discovery, nutrition, mental health, infectious diseases, and others. However, impacts on Biodiversity also indirectly affects human health, since the Biodiversity loss results on habitat loss, over-exploration, pollution, climate change, and many other problems that impact society’s health and well-being. As stated in the report Connecting Global Priorities: Biodiversity and Human Health, the Biodiversity has been an irreplaceable resource for the discovery of medicines and biomedical breakthroughs. Drugs derived from
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natural products may perhaps be the most direct bond between Biodiversity and health. Brazil has innovative initiatives for developing the productive sector of medicinal plants sustainably, and pharmaceutical industries have also been developing new medicines from these natural products. Below, we present some of these initiatives.
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BRAZILIAN BIODIVERSITY INFORMATION SYSTEM – SIBBR The Brazilian Biodiversity Information System - SiBBr is an online platform that aggregates and makes data and information about Brazil’s Biodiversity available openly and freely. It was developed under the coordination of the Ministry of Science, Technology, Innovations and Communications (MCTIC), with technical support from the UN Environment (UNEP) and financial support from the Global Environment Facility (GEF). SiBBr is the first national database of information on Brazilian Biodiversity. This platform aims to gather and give access to data and provide information to support public policies, conservation, and sustainable use actions, as well as to promote knowledge of the Brazilian Biodiversity. Thus, the SiBBr platform contributes both to basic research and to applications in development or production chains in progress in the country. According to the MCTIC’s General Coordination for Biomes, since its implementation, in August 2019, the platform is capable of providing information on more than 165 thousand species from Brazilian Biodiversity in an interoperable way. Additionally, more than a hundred institutions constantly publish on SiBBr, enabling to make more than 15 million records of occurrence of Brazilian species available. SUSTENTEC Sustentec is an associative entity whose objective is to develop the sustainability in the sector of medicinal plants and herbal medi-
cines from Brazilian flora. Founded in 2003, the association has been working in the articulation between the public and private sectors and farmers with a focus on developing herbal medicines to supply to the Brazilian Unified Health System (SUS). Sustentec’s work ranges from training farmers/family members, structuring rural properties, developing and producing seedlings of medicinal plants, and developing new technologies in drying and processing medicinal plants. Additionally, Sustentec has also been developing pharmaceutical inputs/plant extracts. Euclides Lara Cardozo Junior, Sustentec’s President, points out that one of the most relevant association’s initiatives is “The Medicinal and Phytotherapic Plants Project” which is being developed in the city of Toledo, in the south of Brazil. This project is a partnership with Toledo’s health secretary. The project aims to guarantee the population safe access and rational use of medicinal and phytotherapeutic plants via SUS. It also aims to carry out clinical and pharmacotherapeutic follow-up of patients in the initial phase of diseases such as hypertension, diabetes, mental health, and other pathologies. This project was financed by the Brazilian Ministry of Health and it is in accordance with the National Policy and Program for Medicinal Plants and Herbal Medicines, which proposes the expansion of therapeutic options and the improvement of health care for users of the SUS. This project has contributed to the generation of direct and indirect jobs as well as to the generation of income for the producing families in this region. CENTROFLORA GROUP The Centroflora Group, from São Paulo and Piauí, works with the production of natural products for the Pharmaceutical Industry. Most of their raw materials are supplied by small family farms. According to Cristina Dislich Ropke, Innovation Director at Centroflora and CEO at Phytobios, the Group has invested signifi-
cantly in initiatives that aim to boost the development of medicines based on Brazilian Biodiversity. Among these initiatives is the construction of the Centroflora Inova Research, Development and Innovation Center in Campinas. The center has modern R&D laboratories and a pilot plant for scaling up extracts under GMP (Good Manufacturing Practices) conditions. Centroflora Inova will act as a catalyst for technological innovation connecting the dots between research institutions, partners, and national and international pharmaceutical companies. To enhance the generation of innovation from the Brazilian Biodiversity, the Centroflora Group also started the creation of a digital platform called InovafitoBrasil to further integrate the agents of the sector. In addition to access the genetic heritage for the discovery of new molecules, access to associated traditional knowledge through ethnobotany studies has also proved to be a winning strategy in the discovery and development of innovative phytomedicines. The InovafitoBrasil platform gathers information on ethnobotany from our rich Biodiversity as a strategy to leverage the development of innovative phytomedicines. Another initiative from the Centroflora Group, through its radical innovation company Phytobios, is the Molecular Powerhouse project, in partnership with the Brazilian Center for Research in Energy and Materials (CNPEM). The project is aimed at discovering new molecules from Biodiversity to develop novel medicines for unmet medical needs. For more than 4 years Phytobios has been collecting and studying samples in four different Brazilian biomes and preparing extracts for the project. ACHÉ The Brazilian pharmaceutical company, Aché, also has an innovation platform that intents to discover and develop innovative
Brazil contains two Biodiversity hotspots (the Atlantic Forest and the Cerrado)
WITH MORE THAN 4,000 plant species
medicines from natural sources, named Bioprospera®. The platform is structured to be sustainable in the broad sense of the term. Bioprospera® is based on two research approaches to discover active molecules and extracts from nature: (i) Ethnopharmacology and (ii) Bioprospection. Using scientific rigor, the former unravels the pharmacological and toxicological effects described for medicinal plants. This platform has been obtaining important results based on Ethnopharmacology. One of the successful results it is the Acheflan, a phyto-medication based on Cordia verbenacea extract for inflammation treatment. Acheflan was launched in 2006 in the Brazilian market and recently it was also launched in México, Eastern Europe and Asia, reaching out to 20 countries. Another potential success case of Bioprospera®, based on an innovative plant extract, is a first-in-class oral therapy for the treatment of vitiligo disease. At the beginning of this year, this potential phytotherapeutic received approval from the U.S. Food and Drug Administration (FDA) to begin the clinical trial phase II. Additionally, there are other three potential bioactive compounds, also from Brazilian Biodiversity, which are under development (pre-clinical phase). These bioactive compounds have been showing promising results for acne, alopecia treatments and one of them has been presenting potential anti-aging effects. According to Stephani Saverio, Innovation Head of Aché, the company has been developing expertise in innovative medicines from plant extract since 1998. However, just after some technological, infrastructure advances, and mainly because of the Biodiversity Law (Decree No. 8.772/2016), it was possible to leverage and accelerate the development of the programs. Currently, in synergy with the Bioprospera® Platform, Aché is open to interact and establish partnerships with researchers from different institutions for the development of new medicines from Brazilian Biodiversity. ●
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The Importance of the Brazilian Unified Health System (SUS)
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he Brazilian Unified Healthcare System (SUS) is one of the largest and most complex public health systems in the world. Implemented in the 1988 Constitution, it has since guaranteed full, universal, and free access for the entire population of the country. Comprehensive healthcare, and not only assistance care, has become a right for all Brazilians, focusing on health with quality of life, aiming at prevention and health promotion. Brazil is a continental-sized country, with many regional, cultural, and socioeconomic differences, so guaranteeing SUS principles can be challenging. According to Fernando Pigatto, president of the National Health Council, (CNS), SUS is one of the greatest achievements of the Brazilian people, and is the result of a historic process of struggle in the Brazilian society,
including redemocratization, health reform and a constituent assembly. Brazil is the only country in the world that has a free health system that serves more than two hundred million people. It is through SUS that Brazil has the largest immunization and transplantation program in the world, that provides treatment for various chronic conditions and guarantees antiretroviral treatment for HIV/ AIDS. Fernando Pigatto says SUS has over 60% primary care coverage. In 2018 alone, the Brazilian Ministry of Health financed 20 billion radiotherapy procedures, Mobile Emergency Care System (SAMU) achieved coverage of over 80% and more than 42,000 basic health units, which shows that SUS takes care of people and also contributes strongly to the economy and quality of life in the country. The World Health Organization (WHO) points out that the system is used exclusively by 78.8% of the Brazilian population. The rest of the population uses the private care sys-
tem and 70% of hospitalizations in the private sector are financed by the public sector. Brazil’s public health system has brought quality healthcare to millions of poorer inhabitants who were previously denied even basic care. Brazilian government invests approximately 8% of its Gross Domestic Product (GDP) in public health. Of that, 45% of expenses are paid with public funds and the remaining (55%) comes from the private sector. Certainly, Brazil, just as the rest of the world, is being heavily stricken by the COVID-19 pandemic. Having a population of over 200 million people, the spread of the disease is a big concern. Less than 10% of counties have ICU beds, and they are unevenly distributed throughout the country, being more concentrated in the Southeast, the richest region of Brazil. Even before the pandemic, ICU beds had a 95% rate of occupation in SUS, and 80% in the private sector. With the arrival of the new coro-
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navirus, the health system is overloaded. COVID-19 is exposing social, economic and health problems in Brazil. We know that Health is transversal, so we need a great mobilization in defense of the life of our people. It is necessary to value and strengthen the SUS. The National Health Council defends a great union of the sectors of society to find quick answers and solve problems, ensuring the right that is established in our constitution: the right to Health”, declares Fernando Pigatto. Considering that approximately 70% of the Brazilian population does not have a healthcare plan, and even for those who do, if they are in debt with the private plan the service is denied, Brazil would certainly be facing a much more tragic moment than what is presently happening if there was no SUS. Certainly, in a pandemic situation, it is necessary to take public and articulated action to reduce damage and ensure greater access to protection for the population as a whole. Therefore, the public health system needs to always use science to think about how to incorporate technologies, inputs and procedures that strengthen the SUS. It is necessary to act with resolution and effectiveness in order to expand the access to promotion, prevention, diagnosis, and rehabilitation. For SUS to be able to accomplish that and attend patients more efficiently, it needs to invest in technologies that can make the whole process more agile. One of these improvements would be the unification of health data. The health system fragmentation is a challenge to be overcome, considering the coordination among the various levels of managers. SUS is decentralized, hierarchical and regionalized. Therefore, much of the information is recorded where it happens. Fernando Pigatto argues that the government should search for information in just one place. “I think there has been a lot of progress in that direction, but we need to integrate more, and we cannot forget our regional dif-
ferences. There are places that do not even have access to internet. So, I believe that management should think about expanding the integration between the information systems that exist to better plan health policies. Health information and communication should be at the service of better planning health policies in Brazil.” Considering the importance of a single view of an individual’s health data, the National Regulatory Agency for Private Health Insurance and Plans (ANS) has been working towards the unification of health data for a long time. We can mention, for example, the adoption of the National Health Card (CNS) to identify the beneficiaries of Supplementary Health, provided for in RN 295 of 05/09/2012. Another fundamental aspect to achieve this unified database is the use that ANS makes of the National Register of Health Facilities (CNES) to evaluate the structure of the network of service providers of the operators. In this sense, ANS is coordinating with the Brazilian Ministry of Health so that the occupation of beds in private hospitals is monitored by the same platform used for notification of SUS beds, the “eSUS Notifica”. More recently, ANS has been working with the Brazilian Ministry of Health to make the National Health Data Network (RNDS) a reality, a national health data integration platform. Throughout its development, this platform will integrate citizen health information into a large data network. As a result, health professionals and managers will be more efficient in care, allowing the transition and continuity of care in the public and private sectors. The RNDS project was already in the development phase and its implementation initially included a pilot phase in the state of Alagoas, scheduled to start in March 2020. However, to
join forces in the fight against the COVID-19 pandemic, the RNDS project was redirected to receive and share information that could give due support to citizens and health professionals in the fight against the new coronavirus. Thus, the Ministry of Health, with support from public and private laboratories, will allow reception and sharing of test results related to COVID-19. After the completion of this fight against COVID-19, RNDS will resume its initial strategy. It is worth mentioning that the RNDS is a network under construction, whose continued evaluation will enable the implementation of new products and services for the evolution of the Digital Health Strategy, such as the integration of: other types of health establishments (specialized clinics, imaging diagnosis services, among others); interoperability with Supplementary Health; Telehealth; consolidation of the use of clinical terminologies; Smart Regulation of Healthcare; and of new information services using Artificial Intelligence, Analytics, Big Data, Internet of Things (IoT) and other emerging technologies for knowledge extraction in health. Another initiative that is part of the strategy of integrating public and private health data is the Minimum Data Set (CMD), which is the public document that collects healthcare data in each assistance contact, performed at any health facility in the country, public or private. Assistance contact data from Supplementary Healthcare are sent to ANS through the Exchange of Information on Supplementary Health (TISS), which was established as a mandatory standard for the electronic exchange of healthcare data of plan beneficiaries, among Supplementary Health plan operators. The objective is to standardize administrative actions, subsidize the evaluation and monitoring of economic, financial and assistance actions of the operators of private healthcare plans and compose the Electronic Health Record.
These initiatives have the benefits of improving service, monitoring the patient, favoring continuity of care, as well as promoting efficiency in resource management and innovation in health. All of these points are essential for coping with situations such as the current COVID-19 pandemic. Regarding solutions to tackle the pandemic, ANS has sought to quickly make adjustments to legislation that would allow operators to focus their efforts on actions to combat the pandemic. One of them being the possibility of operationalizing telehealth care through messages from the TISS Standard. In this sense, in order to better enable and monitor the use of remote assistance to health plan beneficiaries, in view of the emergency measures adopted as a result of the COVID-19 pandemic, ANS decided to adapt the TISS Standard, with the inclusion of a new type of care: telehealth. As a result, healthcare operators and service providers will exchange more accurate information about procedures performed at a distance. The use of this change in the TISS will start immediately. Still, in order to enable the immediate implementation of telehealth in the sector and to guarantee the necessary legal security, ANS decided to apply the understanding that the use of telehealth does not depend on contractual amendment to comply with the rules for the conclusion of contracts between operators and service providers, especially those set out in Normative Resolutions No. 363 and 364, 2015. However, for such healthcare assistance to be made through telehealth, there must be a prior adjustment between operators and the service providers of its network, through any instrument, as for example the exchange of email and exchange of electronic message on the operator’s website that allows: the identification of the services that can be provided, by that particular provider, through telehealth; the pricing that will remunerate the ser-
The World Health Organization (WHO) points out that Brazilian Unified Healthcare System is used exclusively by
78.8%
of the Brazilian population
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vices provided in this type of telehealth assistance, and the rites to be observed for billing and payment for these services. The Brazilian Association of Group Medicine (Abramge), that represents institutionally the private healthcare companies from the Group Medicine sector, understands that telehealth is a worldwide evolution, adopted by several countries. It brings great progress and promotes greater safety for medical practice and has enormous potential to promote the health of the population, especially at this time of the COVID-19 pandemic. It provides access to adequate guidance, reducing risks of exposure to diseases for both the health professional and the patient who needs care. It is possible to promote a safe relationship between health professionals and patients in a digital way, through responsible telemedicine, solving a patient’s momentary need. In this sense, telehealth is also essential in the most remote regions of the country, where in some cases there are no permanent doctors, thus providing correct medical guidance. According to the latest opinion poll carried out by IBOPE on health plans, access to a health plan is the third biggest desire of Brazilians, second only to own housing and education; moreover, 73% of people who do not have a private health insurance say that they would like to have it within their family budget. In light of this, Abramge defends the updating of the Health Plans Law (nº 9.656) because it believes it is necessary to bring the obligations of the public and private health sector to the current reality of the country and the world, so that the law may be really effective and balanced for all involved. The current model of health insurance has become inaccessible and, in view of the population itself, it is important to have new product options. All of this, so that the contractor can choose the items and coverages he wishes, respecting the principles of ANS. In relation to the care with the COVID-19,
Abramge advises people to maintain maximum caution at this time and informs that it has been following the initiatives led by the Brazilian Ministry of Health, since the novel coronavirus exceeds the operating limits of the health plan operators. It has also guided member operators to act in line with the best public policy practices, with the aim of mitigating the impacts of the disease. The recommendation to health plan operators and hospitals is to, when possible, provide two different entrances: one for suspected cases of COVID-19 and another for other urgent and emergency care needs and also continuous care. One of the health systems in the world that presents the most agility and data unification is the National Health System (NHS) from the United Kingdom (UK), the role-model system based on which SUS was created. Founded in 1948, the NHS has been an inspiration to Brazil when it comes to structuring a public health system, which was implemented to all the population in 1988. Both systems were implemented after two big political events (the Second World War, in the UK case; and the military dictatorship, in Brazil’s case), with the hope of giving better health structure and welfare to its population. A similarity between NHS and SUS is in the way citizens are served. They go to hospitals in urgent cases and do not pay for drugs and consultations when prescribed by professionals in the system. Both SUS and NHS are systems financed through tax collection. In this sense, one of the biggest differences between the systems refers to the availability of services for the population, due to the difference in population size between both countries. For this reason, a private health system has been developed in Brazil, which serves about ¼ of the population. Private health plans exist in the UK, but they are small and restricted (used by only 3% of the population), chosen by people who want to choose their doctors not because of geographical proximity. An-
other difference between both systems is that in the UK people have family doctors, meaning their primary care is done by the same doctor, whilst in SUS the population is attended by any doctor available at the moment. The NHS is extremely important to the British people and their government. This is seen in the statements by Prime Minister Boris Johnson, who was recently serviced by the system in his treatment of COVID-19 and thanked it for his life. Despite the difficulties posed by COVID-19, there is appreciation by all for the services that NHS professionals have offered, especially for the work of nursing professionals - a profession that was created in the United Kingdom. The system is overloaded, but the evaluation of the work carried out is positive, in particular the remote care of patients by assistive technologies. The NHS is an important driver of new technologies for the British health sector because it articulates different initiatives in relation to health, with partnerships with academia, companies, or non-governmental organizations. The NHS has its own acceleration program for those technologies that are considered important for the System, such as digital health appliances. The System also ar-
ticulates the development of clinical trials with its own patients, given the epidemiological profile of different regions of the country. As it was possible to see through this article, SUS still has innumerable challenges and room for improvement, whether in terms of system fragmentation, in terms of the quality and scope of services provided, in terms of the incorporation of technological innovations, among others. And just as the NHS served as an inspiration for the creation of SUS, it can continue to serve as a model for future improvements. Other than that, the data unification was shown to be important to improve the health system and is something that is being worked on by several players. Telehealth is definitely a trend to what healthcare will look like in the next few years, and Brazilian institutions are working on implementing it. This process has been speeded up by the COVID-19 pandemic and is being approved by its users. Despite all the challenges ahead of SUS, Brazil should be proud to have the largest public health system in the world, whose relevance and service capacity have become even more evident in the current context of COVID-19. â—?
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Brazilian Public Laboratories as a Foundation for Science, Technology and Innovation
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he Brazilian government is one of the biggest promoters of innovation in the country, funding R$ 7.4 billion (USD 1.2 billion) to science and technology in 2019. Brazil has a program called National Institutes for Science and Technology (INCT), promoted by the National Council of Scientific and Technological Development (CNPq), that gathers the best university research groups in a specific field, so that they can work together towards creating innovative solutions that can be internationally competitive. There are INCTs for different
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knowledge areas, from social and human sciences to health, chemistry, and agriculture. This is an example of an initiative that promotes research and development (R&D) in public laboratories, focusing on creating new products that can bring a financial return to the country, as well as foment science and innovation. Besides the INCTs, Brazil has the National System of Public Health Laboratories (SISLAB), comprising epidemiological surveillance, environmental health surveillance, health surveillance and medical assistance. The reference laboratories includ-
BUTANTAN INSTITUTE, LOCATED IN SÃO PAULO
ed in SISLAB work with the Brazilian Health Regulatory Agency (Anvisa), and articulate priority lines for the development of studies, research, analysis and other scientific-technical activities of interest to the Brazilian Unified Healthcare System (SUS). Through the Brazilian Ministry of Health, the federal government supports the Oswaldo Cruz Foundation (Fiocruz), located in Rio de Janeiro. Likewise, the Butantan Institute, located in São Paulo, is supported by the government of the state of São Paulo. Both of these research institutions produce vaccines for the entire country. Butantan also produces serum, while Fiocruz also produces diagnostic kits. Both of them carry out important research in several subjects within the health field. This means that a big part of the public healthcare system is supported by products and/or technologies either produced or developed by Butantan and Fiocruz. And this turns out to be advantageous for the government because it diminishes importation of these specific products and maintains a low price on the immunobiologicals and pharmaceuticals produced locally. The Butantan Institute is specialized in the production of immunobiologicals, and supplies the SUS with 90% of the antivenin and 65% of all vaccines distributed in the country. In particular, Butantan manufactures 100% of the influenza vaccine doses used by the Brazilian Ministry of Health. Presently, they are the largest flu vaccine manufacturer in the Southern Hemisphere. The institution is currently working in the constitution and coordination of the Laboratory for Diagnosis of Coronavirus. Integrated by 42 private and public laboratories (including one created in Butantan) and state uni-
versities in São Paulo, on May 15, this Network/Platform had already carried out 70 thousand RT-PCR tests across the state. The same Platform organizes and applies rapid tests (with availability of 2 million tests) in specific cohorts, to monitor the pandemic. A cohort of state military police officers and their families will be tested from May 15 through early June, as a tool for assessing prevalence. In addition, starting in May, the Platform also extended RT-PCR testing to all patients with flu-like symptoms - initially, only hospitalized patients were being tested. An assay is also being organized to evaluate seroprevalence in the population of São Paulo, using neutralizing antibody detection tests. All of this aims, in addition to diagnosis, to the production of data to inform pandemic mitigation policies. The pandemic did not interrupt the Butantan Institute preparation for increasing its vaccine production capacity, with an eye on Brazil and also on the rest of the world, with an emphasis on the supply of biological products to low- and middle-income countries. In May 2020, two actions by the Institute showed the determination of the current Board of Directors to achieve this global 23 bioBr
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objective: the establishment of a partnership with the pharmaceutical company Valneva for the production of a vaccine against Chikungunya, with collaboration in phase IV clinical trials; and the public call, on May 18, for the construction of its new Vaccine Manufacturing Center (CPV) vertical, in the Technology Commissioning modality. CPV will be the locus for the production of 7 new vaccines. In addition, the inauguration of the new monoclonal antibody factory is scheduled for the second semester. On its turn, Fiocruz as well has been working very intensively towards a solution for COVID-19, with diagnostic kits and R&D. Fiocruz is a foundation that is part of the Ministry of Health, and together they are currently working to find solutions regarding the new coronavirus. To name a few initiatives, Fiocruz has two internal calls in the innovation program Inova, which supports novel R&D projects. The institution has also promoted Hackovid19, a hackathon to develop solutions related to the COVID-19. The Oswaldo Cruz Foundation collaborates, with the Ministry of Health, of important strategies to combat the new coronavirus, and has provided 2 million diagnostic tests to public laboratories all over Brazil. According to Rodrigo Correa, Vice-president of Research and Biological Collections (VPPCB), they are sequencing the virus to better understand it, and providing the care of vulnerable populations throughout Brazil, by contributing with primary health care and modifying public policies. He also remarks that the collaboration with the private sector is going very well, and prepares us for situations that may happen in the future. Fiocruz has currently set a consortium with the medical diagnosis company DASA, the biggest in Brazil and Latin America, and believes the association between private pharmaceutical industries that are capable of producing vaccines is fundamental. Rodrigo Correa says that the vaccine for
coronavirus, as well as the increase of other vaccine production, cannot wait the end of the pandemic to take place. Brazil does not have a big capacity to produce vaccines, but adaptation has been significantly rapid for its production. Fiocruz continues to invest in the plant of immunobiologicals (such as vaccines), already under construction in Santa Cruz, a city in the State of Rio de Janeiro. Rodrigo Correa comments that it is a worldwide moment to build and make factories available, and public factories are important because they have a lower cost of production. Regarding the post-pandemic scenario, he argues that it will be a time when the population sees science as a necessary future path. “Science in Brazil today is being highly demanded and valued, and it should continue to be in the future.” Rodrigo Correa also points out that the population should demand government officials the resource to finance science. “Brazil has an enviable installed capacity, not only in the labs, but as people who have the ability to respond quickly. I hope that after the pandemic, people will continue to see the importance of science as they see it now, and that there will be investment in science as a whole.” The public laboratories play an important role in Brazilians health, and are essential institutions to fight against the new coronavirus in the country. The government’s support to those institutions (federal support in Fiocruz’s case, and state support in Butantan’s case) promotes advances in the R,D&I sector, and we have seen that partnerships between public laboratories and pri-
OSWALDO CRUZ FOUNDATION (FIOCRUZ), LOCATED IN RIO DE JANEIRO
vate companies can be fruitful for both parts. Public-Private collaboration is also key to the development of innovation in the healthcare sector. A crisis like the one we are experiencing now has brought that to the forefront even more and is demonstrating that close collaboration between private companies, public institutions, governments, and regulators can accelerate innovations. The collaboration of a private company like Sanofi Pasteur – the vaccines global business unit of Sanofi – with public institutions can extend throughout the whole value chain of innovation, from discovery (with co-development of new vaccines) and clinical trials, through to supply agreements and industrial support with technological transfer. Sanofi Pasteur has indeed a vast experience of longterm partnerships with governments and public institutions in different parts of the world. As a partner in people’s healthcare journey, Sanofi Pasteur believes that appropriate partnerships can generate a greater population’s access to medicines and vaccines. Sanofi Pasteur has been an important player, for the last 20 years in Brazil, and a partner in various projects of technological transfers and strategic cooperation, in areas of interest of the health authorities to help prevent public health diseases with impact to a broad population. “We remain committed to this type of partnerships in the future”, says Ana Garcia-Cebrian, General Manager of Sanofi Pasteur in Brazil. These partnerships have a direct impact in the reduction of disease burden and improvement of health status of the population, but also an indirect impact in the healthcare and industrial technological infrastructure development in Brazil. Sanofi Pasteur contributes to the Brazilian Unified Healthcare System (SUS) by being a reliable supplier of critical vaccines and new solutions to patients, helping the country find ways to enhance its technology and industrial capabilities. Ana Garcia-Cebrian affirms
The Oswaldo Cruz Foundation collaborates, with the Ministry of Health, of important strategies to combat the new coronavirus, and has provided
2 MILLION diagnostic tests to public laboratories all over Brazil
that “what is key, in my opinion, is keeping the dialogue and close collaboration with health authorities and public institutions in order to contribute to the Brazilian health challenges.” Regarding the current COVID-19 situation, Ana Garcia-Cebrian commented on Sanofi Pasteur’s acquired experience with Severe Acute Respiratory Syndrome (SARS), and how they are using their knowledge for the development of a vaccine candidate for this novel coronavirus, and how dealing with a pandemic as daunting as COVID-19 requires cooperation. The company has three lines of R&D where they are collaborating in search of a vaccine to COVID-19. The first one is a collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate, regarding the development of a recombinant, protein-based vaccine candidate against COVID-19. There is also the agreement with Translate Bio where Sanofi will collaborate to develop a novel mRNA vaccine for COVID-19. Lastly, this past April, Sanofi announced a collaboration with GSK to develop an adjuvanted COVID-19 vaccine, using innovative technology from both companies. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology, and will use the basis of the company’s licensed recombinant influenza product. Sanofi Pasteur is playing its part to fight this pandemic by cooperating with multiple institutions to provide a solution to this global public health issue. As we can see, collaboration is key to the development of new technologies in the healthcare system, be they between public laboratories and the public health system, or public laboratories and companies, or even companies amongst themselves. One cannot advance quickly and assertively without the help of other players. This is especially true in urgent health matters, such as the one we are currently living with the COVID-19 pandemic. ●
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CANCER
Precision Oncology: What Does It Mean for the Patients and Where Are We? Dr. Karina Eterovic, Director of R&D for Oncology Diagnostics at Viracor-Eurofins
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ancer is primarily a genetic disease where changes in DNA in a particular group of cells in our body lead to uncontrolled cell growth and originate tumors. The genetic alterations within a tumor might differ from patient to patient, even when their tumors look identical under a microscope, and that is one of the reasons why patients with the same type of tumor, for example, breast cancer, will respond differently to the same type of treatment. The goal of precision oncology is to provide a molecular characterization of the tumor of each patient and based on the findings make a decision on what is the best treatment for that patient. In other words, we want to give the right treatment to the right patient, at the right time. For the patients, this means we are significantly increasing the chances of a better outcome, as the treatment is tailored to their tumor profile and not chosen solely based on its histology. One of the most important tools that allowed for the implementa-
tion of precision oncology at scale was the development of modern, fast, and accurate sequencers that are now used to sequence the DNA of tumor cells. For comparison, the Human Genome Project, initiated by the United States (U.S.) in 1990, had the goal of completing a high-quality version of the human DNA sequence. The project took 13 years to be completed and the total cost was USD 2.7 billion. Today, sequencing one entire human genome takes less than a week and it can cost as low as USD 500.00 depending on the type of sequencer used. Using these next generation sequencers, for the past 10-12 years researchers around the globe have collected an immense amount of genomic information from tumor samples and made significant progress in understanding how tumors respond to treatment. Critical genomic alterations in tumors include mutations, copy number variations (CNVs), gene fusions, and rearrangements. And we have learned that they can guide treat-
ment decisions and reveal associations with sensitivity or resistance. For example, melanoma patients that present a BRAF_V600E mutation respond significantly better to a drug called Vemurafinib (a targeted agent) than patients that do not have the mutation. Therefore, identifying these genomic aberrations is crucial to decide what can be potentially the best drug for the patient. As we learn more about the molecular profile of tumors, we are able to develop new drugs that are more effective and less aggressive than chemotherapeutic agents. Drugs that are created based on molecular markers are known as targeted therapies. There are dozens of targeted drugs that have been approved by the U.S. Food and Drug Administration (FDA) in the past several years as they are proven to promote a better response when given to a patient that has a molecular marker. In parallel to these discoveries, several commercial genomic tests have been developed and are currently offered in clinical labs in-
side and outside the United States. These tests require a piece of tumor that can be obtained from the surgery during tumor resection or through a biopsy. A less invasive approach, known as liquid biopsy, has also been utilized to perform genomic testing. Liquid biopsies require only a blood sample instead of tissue - as tumor cells die, they shed pieces of DNA to the blood, which is called cell-free DNA (cfDNA) and this material can be sent to a lab for sequencing. However, the amount of cfDNA that is released into the blood is very small, so this type of test can be challenging, and extra steps need to be taken to avoid false positives or false negatives. Due to these challenges, tumor tissue remains as the gold standard for genomic testing, but liquid biopsies tests seem to be the future on precision medicine, due to its less invasive nature and significantly lower cost. The field of precision oncology is exciting and dynamic and fortunately has been evolving at a very fast pace. We should expect more
robust advances and discoveries within the next few years as new technologies and drugs are developed and we learn more about how tumors evolve and respond or resist to treatments. Equally robust efforts and investments should be also made focusing on making these new tests and drugs accessible to as many patients as possible. â—?
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HNF
Heparin: New Opportunities for the Brazilian Market
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iscovered over a century ago in 1916, heparin, also known as unfractionated heparin (UFH), has been used medically since 1935. Heparin is a sulfated sugar polymer made up of a sulfated iduronic acid and sulfated glucosamine units. As a medication, heparin acts as an anticoagulant, preventing the formation of clots and extension of existing clots within the blood. It has been used in a wide range of surgical procedures, involving extracorporeal circulation such as cardiovascular surgeries and renal-dialysis 1. It is on the World Health Organization’s List of Essential Medicines, the safest and most effective medicines needed in a health system. Additionally, at this moment, there are no surrogates approved for the same use. Even today, the production of UFH on an industrial scale still relies on the extraction of crude materials from mammalian tissues (porcine and bovine) through chemical or enzymatic proteolysis followed by different methods of puriďŹ cations. The process of isolating and extracting heparin leads to partial degradation of the glycosaminoglycan chains that make it up, producing a drug formed by molecular fragments of heterogeneous molecular weights, ranging from 3,000 to 30,000 daltons, known as unfractionated heparin, conventional heparin or simply heparin. Currently, most of the unfractionated hepa-
rin consumed worldwide is sourced from porcine-mucosa (HPI), except for some countries, such as Brazil, Argentina, India, and some of the Islamic nations, which consume the UFH from bovine intestinal mucosa (HBI) concomitantly with the gold-standard HPI 2. In this context, the Brazilian production of animal-based pharmaceuticals has been rising, with heparin exports being one of those responsible for that increase. Brazil has the largest cattle in the world and the 8th biggest pig herd, which gives us ample access to raw materials. According to the Brazilian Industry Association of Active Pharmaceutical Ingredients - (Abiquifi), until June 2019, USD 20.7 million of this pharmaceutical input was sold to abroad. Today, China is the largest producer (more than 60%) of heparin based on porcine-mucosa preparations. However, Norberto Prestes, CEO of Abiquifi, points out that the China production has been recently compromised by Swine Fever aicting the Chinese pig herd, which represents an opportu-
nity for porcine heparin Brazilian production. Another competitive factor refers to Brazilian bovine heparin. According to Valentine Baigorria, President of Kin Master, which is one of the largest manufacturers of heparin in Brazil, the country occupies a privileged position in the world for the quantity, quality, control, and traceability of its cattle. Brazil also has sufficient installed capacity to process all heparin, both bovine and porcine sourced, with high technology, very well structured industrial parks and with approval through the Good Manufacturing Practices (GMP) Certification granted by the Brazilian Health Regulatory Agency (Anvisa), thus meeting all the requirements of international quality standards. Moreover, last year, heparins sourced from bovine and porcine mucosa have gained exclusive monographs in the Brazilian Pharmacopoeia. These monographs represent a pivotal step toward the safest use of porcine mucosa and bovine mucosa heparins as interchangeable anticoagulants and serve as a valuable template for the reformulation of pharmacopoeias of other countries willing to introduce the heparin sourced from bovine mucosa. Recently, heparin has been winning over the world media due to the COVID-19 pandemic. Studies carried out in different countries, including in Brazil, although preliminary, have been showing promising results from the use of heparin for the treatment of patients affected by the new coronavirus. According to a Brazilian study recently published on MedRxiv and led by Elnara Márcia Negri, a professor from the University of São Paulo and an associate pulmonologist at Hospital Sírio-Libanês, there is clinical evidence of the action of heparin when applied to critically ill patients, who develop hypercoagulation. COVID-19 patient autopsies have re-
vealed thrombi in the microvasculature, suggesting intravascular coagulation as a prominent feature of organ failure in these patients. The study results suggest the important role of disseminated intravascular coagulation as one of the main mechanisms of organ failure in COVID-19 and the potential response to early anticoagulation therapy with heparin. Although the initial study was carried out with only 27 patients, the results were very promising, and as the next step, a randomized study will begin to prove the effectiveness of treatment in these cases. There are relevant clinical studies ongoing in other countries, such as the USA, China, and Italy. In this context, the bovine heparin could be an excellent complementary to COVID-19 treatment. As Brazil is a world leader of this heparin type, currently, this puts the country in evidence. However, there is a consensus that some challenges need to be faced if Brazil is to consolidate itself as an important global supplier of heparin. Some of these challenges refer to regulatory issues and tax isonomy. According to Norberto Prestes “currently, Abiquifi and partners have been working with regulatory bodies to align legislation and build a regulatory framework that gives fluidity to the national market and facilitates the production and export of this product.” Valentine Baigorria also comments that it is important to apply rules of tax equality for imported heparin for the heparin produced in Brazil to become competitive. Nevertheless, this pandemic moment could be the perfect timing to accelerate and tackle these challenges. Thus, Brazil has a great capacity to serve the national market and even expand to other countries, to meet the current and future demand of this animal-based pharmaceutical. ●
1- Al Yami MS, Kurdi S, Abraham I. Direct oral anticoagulants for extended thromboprophylaxis in medically ill patients: meta-analysis and risk/benefit assessment. J Blood Med. (2018) 9:25–34. doi: 10.2147/JBM.S1 49202. 2- Keire D, Mulloy B, Chase C, Al-Hakim A, Cairatti D, Gray E, et al. Diversifying the global heparin supply chain. Reintroduction of bovine heparin in the United States? Pharm Technol. (2015) 39:28–35.
According to the Brazilian Industry Association of Active Pharmaceutical Ingredients (Abiquifi), until June 2019,
USD 20.7 MILLION of this pharmaceutical input was sold to abroad
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MARKET
Health Investment Scenario
in Brazil
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ccording to different economic analysis carried out in a pre-COVID-19 scenario, in 2019, Brazil presented itself as a global destination for investment. According to UNCTAD’s World Investment Report 2019, Brazil remains among the top 10 recipients of FDI in the world and is the only Latin American country on that list. Still in 2019, the study Investment Guide to Brasil 2019 has presented 10 key reasons for investing in Brazil, such as: leading regional economy; resilient domestic market and diversified economy; one of the biggest producers and exporters of agricultural and mining products; rich biodiversity; a gateway to Latin America, among other reasons. The fact is that there were solid proofs of the attractiveness of the Brazilian market, even during the economic and political crises that the country went through in recent years.
One of the most attractive areas for investments in Brazil is the life science sector, especially human health. Three main facts drive this market, one of them is the Brazilian population aging. According to Brazilian Institute of Geography and Statistics (IBGE) projections, in the year 2030 the number of elders will exceed the total of children between 0 and 14 years old. Another driver is the size of the Brazilian population: Brazil has one of the largest consumer markets in the world, with more than 210 million people. And one more relevant driver is the healthcare spending in both public and private services. According to Investment Guide to Brasil 2019, in 2028, Brazil is expected to remain amid the top 10 markets, with estimated health expenditures of USD 333.1 billion. Additionally, according to the Brazilian Research-based Pharmaceutical Manufacturers Association (Interfarma), Brazil ranks as the 6th largest pharmaceutical market in
the world, which is expected to move between USD 39 billion and USD 43 billion in 2023. In terms of revenues, the domestic market is expected to be well-balanced in terms of prescription drugs, similar medications, non-prescription drugs, and generic medications. Brazil is also an attractive country for clinical tests, because of its high degree of population heterogeneity. It is currently considered possible that Brazil could rise from the 24th place to the 10th place in the global ranking of clinical studies. It is also important to mention some public efforts to boost the Research, Development, and Innovation projects in the country, especially with the Legal Landmark for Science, Technology, and Innovation (Law No. 13,243/2016). This law seeks to increase the interaction between universities and companies by reducing bureaucracy. Additionally, according to Orbis Cross Border Investment, Brazil was the 10th-largest destination of foreign research and development centers projects between 2013-2018, with over USD 5 billion in estimated investment and more than 8,400 jobs created. This effort to boost the Research, Development, and Innovation is reflected, for example, by the growing numbers of Brazilian Health Techs, which can bring disruptive solutions aligned with global trends. In 2019, a healthtech report mapped 386 startups (98 more than mapped in 2018), distributed on different categories such as: Artificial Intelligence (AI) & Big Data, Information Access, Pharmaceutical and Diagnosis, Health management, Medical Devices, Marketplace, Wearables & IoT, Telemedicine and Patient
Relationship. Besides, according to the report Inside Venture Capital Brasil , in 2019 over USD 43 million were invested in health techs, a variation of 406% concerning 2018. Even in the face of the COVID-19 pandemic, there are strong reasons to believe that investment in Brazilian health, both public and private, will continue to grow and it will be essential to face this crisis. Currently, the fight against the new coronavirus in Brazil has been reinforced by different public initiatives. The Brazilian Industrial Research and Innovation Company (EMBRAPII) and the Brazilian Support Service for Micro and Small Enterprises (Sebrae) provide R$ 2 million for the development of technological solutions to help the country to face the advance of the new coronavirus in its territory. The contribution will be added to another R$ 4 million from EMBRAPII and the counterparts of companies and economic resources of accredited units. The expectation is to reach R$ 10 million in RD&I projects. The Brazilian Innovation Agency (FINEP), which is linked to the Ministry of Science and Technology and Innovation (MCTIC), has also launched calls for offering subsidized economic resources for the development of innovative solutions, involving significant technological risk, focused on personal protection equipment. The main goal of this initiative is to promote the biological safety and the protection of teams in the medical and hospital care chain during the COVID-19 pandemic. The Brazilian Trade and Investment Promotion Agency (Apex-Brasil), in its turn,
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MARKET
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is working to strengthen the investment scenario in this context. According to its Investment Manager, Roberto Escoto, in the short term, Apex-Brasil will focus on serving foreign companies based in Brazil, which in foreign investment jargon is called aftercare. It is understood that the moment requires us to be close to the companies that have already invested in Brazil, to find out their difficulties and challenges and to act in the best possible solution. Another strategy initiated by Apex-Brasil is to dialogue with the participants in the health system, and take their main difficulties to COVID19 to regulatory bodies. A strong point of this strategy is the creation of the Regulatory Agenda for Improvement of the Investment Environment through which the regulatory priorities (creation, revocation, review, and compilation) of normative acts that impact the investment environment in the health sector in Brazil will be indicated. According to the Brazilian Association of Private Equity and Venture Capital (ABVCAP), opportunities for Private Equity and Venture Capital in Brazil have increased since 2011. The report Impact Investing in Brazil - 2020 produced by ABVCAP, showed that the previous studies found 33 impact investors in Brazil between 2016 and 2017, of which 29 are considered active. The sectors with the largest number of operations were information and communication technology (ICT) with 23% of all operations, followed by education (14%) and health (10%). In this context, an opportunity for companies with the demand for investment resources to leverage the marketing of their products and services is the BIOTEC fund. Created in November 2019, the fund has approximately R$ 105 million in Committed Capital, based on institutional, corporate investors (including important players in the health sector) and entrepreneurs, and aims to reach up to R$ 300 million in resources in the coming months.
This fund is managed by FIR Capital, in partnership with HealthInvest, the first asset manager focused exclusively on the health sector. FIR Capital is one of the pioneers in Brazil in the capital market, with experience in structuring investment funds, financial advisory and venture building. According to AndrĂŠ Emrich, partner at FIR Capital and Manager of the BIOTEC fund, the fund aims to invest between 4-6 companies in the next 3 years. The first investment made in December 2019 was in VitaPart, one of the largest blood bank chains in the country, with operations in 7 states, more than 70 hospitals attended and more than 150 thousand blood transfusions per year. The fund is focused on life sciences and biotechnology applications, especially for the health market, which has attractive characteristics both for its size and impact, as well as for global social and technological trends. Even in a pandemic scenario, the BIOTEC fund continues to seek and analyze investment opportunities in the market. Its managers understand that the current moment has made the challenges and bottlenecks of the Brazilian health market even clearer, in the provision of specialized services and products, such as diagnostic systems, medications, and basic and sophisticated inputs. Additionally, the pandemic scenario naturally creates a favorable environment for sectoral consolidation processes in the market. Another investment alternative is the Corporate Venturing, which means any effort made by a corporation to create new entrepreneurial initiatives. Since 2014, the term has gained significant recognition in Brazil, being mainly related to the interaction of large companies with startups. Some Corporate Venture Capital (CVC) initiatives in the Brazilian health market are, for example, the Axon Venture Fund, which is a R$ 45 million early-stage CVC fund launched by the Brazilian pharmaceutical company
Eurofarma. Another fund is the Hypera Ventures launched by Hypera Pharma, which is their CVC program for investment in startups related to the health sector and that have synergies with the company’s business. The total amount to be invested in the program will be up to R$ 200 million. One of the most relevant players in the health sector in Brazil is Eretz.bio, an initiative started by Hospital Israelita Albert Einstein (HAIE), which is considered the best hospital in Latin America (2020). Erezt.bio is an HAIE startup incubator that fosters health tech startups offering them the technical know-how of HAIE spe-
In 2028, Brazil is expected to remain amid the top 10 markets, with estimated health expenditures of
USD 333.1 BILLION
cialists, access to its extensive network of Brazilian and international scientific leaders and executives, and financial support. According to Cláudio Terra, Director of Innovation & Digital Transformation (CDO) of HAIE, the portfolio of startups in which the institution has invested, is composed mainly of digital startups, followed by those focused on solutions in diagnosis, treatments and medical devices. The institution’s investment thesis is fully aligned with major global trends in health, supporting innovations in big data, AI and genetics, among others. Over the past 3 years, the HAIE has invested in approximately 20 startups. It is important to note that the institution’s main objective is to support high impact solutions that meet the needs of patients and health professionals. For this reason, the institution seeks to reinvest future returns from these investments to continue supporting the development of science & innovation in healthcare. Cláudio Terra says that although the current crisis brings significant uncertainty and insecurity, it also presents opportunities. Whenever there are major changes in needs, habits and regulations, opportunities are also created. Some health services, for example, have already shown very rapid growth, such as diagnostics solutions, telemedicine, telenutrition, telepsychology, digital education, etc. Cláudio believes that Human Health, more than ever, is “the next big thing” and that both investors and entrepreneurs need to be in tune with the environment. They need to be agile and responsive to changes. For him, being inactive in the face of the crisis is not the solution. Agility should not only be the domain of startups: investors and large companies also need to get themselves moving! ● 1 - Distrito HealthTech Report 2019 – Available at: https://distrito.me/dataminer/reports/ 2 - Inside Venture Capital Brasil 2019 – Available at: https://distrito.me/dataminer/reports/
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REGULATIONS
Cannabis sativa Access to Medication and/or Product
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Dr. Margarete Akemi Counselor of the Federal Pharmacy Council / Director and Founding Partner of HGSM Regulatory Consulting
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he Resolution RDC 327/2019 by the Brazilian Health Regulatory Agency (Anvisa), came into force in Brazil in March 2020 and addresses a resolution that regulates the manufacture, marketing, and import of products derived from Cannabis for medicinal purposes. This led to the recent publication of the first health authorization for the sale of a phytopharmaceutical in the pharmaceutical form of an oral solution. It is important to understand that we now have in Brazil a specific medication - Mevatyl® - registered by RDC 24/2010, and a specific product based on Cannabis sativa. We then have to understand the differences between them, besides the form of registration in the health regulatory agency. Mevatyl® has 27mg of TCH and 25mg of CBD in its composition and has a specific indication - symptoms of adult patients who present moderate to severe spasms, due to Multiple Sclerosis (MS). The new product (based on
Cannabis sativa) is an oral solution containing pure CBD 200mg/ml. Cannabis-based products with a THC content of up to 0.2% should be prescribed with Prescription Notification “B”. On the other hand, Cannabis-based products with a THC content above 0.2% must be accompanied by the Prescription Notification “A” under the terms of Ordinance SVS/MS Nº 344, of May 12, 1998, and its updates. In the final packaging of Cannabis-based products with THC content, the following information must be in upper case: “SALE UNDER MEDICAL PRESCRIPTION” and “CAN ONLY BE SOLD WITH RETENTION OF PRESCRIPTION”, when the product falls into the category of Prescription Notification “A”; and “SALE UNDER MEDICAL PRESCRIPTION” and the “WARNING: USE OF THIS PRODUCT MAY CAUSE PHYSICAL OR PSYCHIC DEPENDENCE”, when the product falls into the category of Prescription Notification “B”. Cannabis-based products must be dispensed exclusively by pharmacies/drugstores without manipulation, and necessarily by the Pharmaceutical professional. Additionally, the transaction of such products must be registered in the National
Controlled Products Management System (SNGPC), in compliance with the RDC 22/2014, and its updates. WHAT REALLY CHANGES IN ACCESS TO THESE PRODUCTS? Since the publication of the RDC 17/2015, 14,000 requests have been made for the direct import, by the patient, of Cannabis-based medicines; In 2019 alone, there were 5,321 requests - data from Anvisa. And in 2020 we had the publication of the RDC 335/2020 to streamline the process of purchasing these products. With the RDC 327/2019, gained more popularity the idea of the possibility of national production and registration of products, as well as the treatment using products derived from Cannabis sativa. Although the projections are optimistic for the pharmaceutical market, we need to understand that, to date, with only two products, the access of the current 20 thousand patients is not guaranteed to meet all needs, pathologies, and also the underprivileged population. So, access remains the biggest challenge. We do have benefits with these new regulations, but until the national market effectively has the quantity and type of products that meets the majority of current and new patients, the number of direct import requests tends to continue to grow and, along with them, the number of lawsuits to authorize Cannabis-based products importation. ●
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COVID-19
International Trade and Investment in Response to the Pandemic Hanna Tatarchenko Welgacz Investment Officer FDI Health, Apex-Brasil Denys Martins Investment Officer FDI Health, Apex-Brasil
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ince the outbreak of the new coronavirus in Brazil, the Federal Government has been proactive in identifying and establishing adequate measures to ensure the supply of essential items to address the COVID-19 and to reduce the negative effects of the pandemic. The measures taken cover regulatory aspects, foreign trade rules and tax procedures. Regarding regulatory issues, the Brazilian Health Regulatory Agency (Anvisa) has issued a number of regulations that offer exceptions to regulatory requirements for medical devices and pharmaceutical products related to COVID-19. In addition, there is a commitment to swift analysis of connected products, but not directly associated with COVID-19. Ultimately, the Federal Government has enacted a law that allows for the waiver of public bidding procedures for the procurement of medications, medical devices, and medical supplies, in addition to reducing the formalities required for such purchases. Another decision of great im-
portance is about telemedicine services, allowed through Ordinance No. 467 (from the Brazilian Ministry of Health) and Federal Law No. 13,989/2020. These two new regulations provide for the possibility of telemedicine in both public and private health systems during the new coronavirus pandemic in Brazil. These regulations have contributed to a significant leap in digital prescription use among Brazilian physicians. As stated by Memed, a Brazilian telemedicine healthtech, on their platform alone there are more than 80 thousand physicians using a digital prescription. The Brazilian Patent and Trademark Office (INPI) made public that it will prioritize the examination of patent applications linked to processes, equipment and materials used in the diagnosis, prevention and treatment of COVID-19. Other available mechanisms are exception and relaxation of import and licensing restrictions. The Foreign Trade Board (Camex) reduced to zero the import taxes on 509 products that range from individual pro-
tection equipment, ethyl alcohol, respirators, substances with a wide field of therapeutic application, such as prednisone, indicated for the treatment of endocrine, osteomuscular, allergic and ophthalmic diseases. The new tariff reduction list includes more than 80 drugs considered critical by Brazilian municipalities. In Brazil, the dependence on medical equipment imports is quite high and represents more than 50% in certain sectors such as radiology, laboratory material, among others. Brazil, alike other countries, is dependent on imported pharmaceutical inputs. The question of how to strengthen local production chains is the discussion agenda of chemical and pharmaceutical companies that debate alternatives for the local production of inputs, products and equipment fundamental to the health sector, to reduce the high dependence on external suppliers. That is a great opportunity in a market that totals USD 171 billion. Despite the adverse circumstances, the Brazilian Trade and Investment Promotion Agency (Apex-Bra-
sil) continues to work hard to provide qualified information to investors. One of the results of this effort is a website that gathers several products and solutions that can help companies in the revision of their strategies. We have prepared a survey for international investors to identify the main difficulties they are facing at the moment. With this information, Apex-Brasil hopes to develop new solutions in order to mitigate the losses. As a national investment promotion agency for Brazil, our main goal is to help foreign companies and investors find their way to prosper in Brazil through great investment opportunities. We invite you to access our websites (www.apexbrasil. com.br and www.investinbrasil.com. br) and follow us on social networks (LinkedIn, Instagram and Twitter) and contact the team of health analysts at healthcare@apexbrasil.com.br. â—?
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ACCENTURE
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