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The text presents an updated proposal for a Health Science, Technology and Innovation Policy in Brazil, following the huge political turmoil in the country since 2019 and the COVID-19 pandemic since 2020. The proposal is presented in five sections: Scientific Research; Productive Innovation; Health Technology Assessment and Incorporation; Intellectual Property in Health; New challenges posed by the Pandemic. The authors take part in the Advisory Committee in Science, Technology and Innovation of the Brazilian Association of Collective Health.O texto contém uma proposta atualizada de política de Ciência, Tecnologia e Inovação em Saúde no Brasil e a pertinência da atualização decorre do desastre nas atividades nesse terreno verificadas no país desde o início do atual governo federal em 2019, bem como dos desafios colocados pela emergência da pandemia COVID-19 desde 2020. Ele está organizado em cinco seções, a saber: Pesquisa em Saúde; Inovação Produtiva; Avaliação e Incorporação de Tecnologias em Saúde; Propriedade Intelectual em Saúde; Novos desafios colocados pela Pandemia. Os autores fazem parte do Comitê de Assessoramento em Ciência, Tecnologia e Inovação da Abrasco.

The text explores the theme of Brazilian sufficiency in vaccines. It presents the ways practiced in the two most important Brazilian institutions in the development and production of vaccines - the Butantan Institute and the Institute of Technology in Immunobiologicals (Bio-Manguinhos). These paths are the pure and simple purchase, the purchase of the product with technology transfer commitment, partnerships that include the fulfillment of phase 3 trials by the buyer, the new path announced by Instituto Butantan in which the partnership includes for the realization of trials in phases 1 and 2 and, finally, the invention, development and local vaccine production. The latter is only mentioned as a possibility currently not achieved. Finally, the text presents data on the chances of success in vaccine development.O texto explora o tema da suficiência brasileira em vacinas. Apresenta os caminhos praticados para a capacitação nas duas instituições brasileiras mais importantes no desenvolvimento e na produção de vacinas - o Instituto Butantan e o Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Esses caminhos referem-se à compra pura e simples, à compra do produto com compromisso de transferência de tecnologia, às parcerias que incluem a realização de ensaios da fase 1 pelo comprador, o novo caminho anunciado pelo Instituto Butantan no qual a parceria prevê a realização de ensaio nas fases 1 e 2 e, finalmente, a invenção, desenvolvimento e produção locais de vacinas. Este último caminho é apenas mencionado como possibilidade. Apresenta dados sobre as chances de sucesso no desenvolvimento de vacinas e louva a iniciativa do Butantan nessa nova modalidade de parceria.

The text presents and discusses the main aspects related to the current dynamics of the vaccine industry in the world and in Brazil, focusing on the demand created by the pandemic of COVID-19. At the global level, it briefly exposes the place currently occupied by Brazil within the scope of the BRICS and sets out and analyzes the options - identities and differences - of industrial policy in Brazil, China and India in the field of vaccines. Next, it analyzes the displacement of the vaccine industry, from a situation of exclusive production of immunizers to a majority control by the large pharmaceutical industry. Further on, it recovers recent fundamental aspects of the vaccine industry in Brazil, with an emphasis on Biomanguinhos / Fiocruz and the Butantan Institute. Finally, it discusses the successes and limitations of the technology transfer mechanism used by the two institutions, as well as the relevance of their historically assumed commitment to public health policies.O texto apresenta e discute os principais aspectos relacionados à dinâmica atual da indústria de vacinas no mundo e no Brasil, com foco na demanda criada pela pandemia da COVID-19. No plano global, expõe brevemente o lugar ocupado atualmente pelo Brasil no âmbito dos BRICS e expõe e analisa as opções - identidades e diferenças - da política industrial de Brasil, China e Índia no campo das vacinas. A seguir, analisa o deslocamento da indústria de vacinas de uma situação de produção exclusiva de imunizantes para um controle majoritário da grande indústria farmacêutica. Mais adiante, recupera aspectos fundamentais recentes da indústria de vacinas no Brasil, com ênfase em Biomanguinhos/Fiocruz e no Instituto Butantan. Finalmente, discute os sucessos e limitações do mecanismo de transferência de tecnologia utilizado pelas duas instituições, bem como a relevância do compromisso historicamente assumido pelas mesmas com as políticas públicas de saúde.

The paper discusses the complex nature of the pandemic by highlighting the various intrinsic and extrinsic dimensions in the development of SARS-CoV-2 vaccines, with an emphasis on the two most advanced products in clinical testing, namely, the vaccine developed by the University of Oxford associated with the British pharmaceutical company AstraZeneca, and the one developed by Chinese company Sinovac. This choice also stems from the fact that both have testing activities, which, if successful, will lead to future production in Brazil, by Bio-Manguinhos/Fiocruz, Rio de Janeiro, and the Butantã Institute, in São Paulo, respectively. From a conceptual viewpoint, this paper builds on the reflection from the field of Collective Health that addresses the boundaries between the biological and the social spheres. It also seeks to show that, if successful and while important tools for coping with the pandemic, vaccines will not dispense with the continuity of other non-pharmacological measures already used.

Brazil has changed a lot since the enactment of the 1988 Federal Constitution. Although substantial advances have occurred in the health sector, old problems persist and new ones arise. The main goal of ensuring the universal right to health has not been achieved. The 16th National Health Conference will be held in 2019, an opportune moment to analyze the history, the present moment and the announcing trends. This text seeks to contribute to this analysis based on the results of studies on the developing health conditions of the population and the Brazilian health system in the last 30 years. It identifies the strengthening of the private sector and capital in the health sector, to the detriment of the public interest and the SUS. Finally, it discusses the strategies of the struggle for the right to health necessary and possible in the current context.Desde a promulgação da Constituição federal de 1988, o Brasil mudou muito. Na saúde, embora tenham ocorrido avanços importantes, persistem problemas antigos e novos têm surgido. O objetivo maior de assegurar o direito universal à saúde não foi alcançado. Em 2019, realiza-se a 16ª Conferência Nacional de Saúde, momento oportuno para analisar a história, o momento presente e as tendências que se anunciam. Este texto busca contribuir para essa análise, com base nos resultados de estudos sobre a evolução das condições de saúde da população e do sistema de saúde brasileiro nos últimos 30 anos. Identifica o fortalecimento do setor privado e do capital na área da saúde, em detrimento do interesse público e do SUS. Por fim, discute as estratégias de luta pelo direito à saúde necessárias e possíveis no contexto atual.

This opinion document is based on the contribution of ABRASCO and CEBES to the 8th National Symposium on Science, Technology and Pharmaceutical Assistance promoted by the National Health Council. It deals with the policy for Science, Technology and Innovation in Health and is part of the three pillars for a health development agenda: The Unified Health System; the productive base of health assets and services; and the installed capacity of science, technology and innovation in health.Este documento de opinião é baseado na contribuição da ABRASCO e do CEBES para o 8º Simpósio Nacional de Ciência, Tecnologia e Assistência Farmacêutica promovido pelo Conselho Nacional de Saúde. Trata da política de Ciência, Tecnologia e Inovação em Saúde e a inscreve nos três pilares para uma agenda de desenvolvimento em saúde: O Sistema Único de Saúde, a base produtiva de bens e serviços de saúde e a capacidade instalada de ciência, tecnologia e inovação em saúde.

Technological incorporation is a central topic among the concerns regarding health care systems. This paper discusses the role of technology dynamics in health systems' cost increases, suggesting two different approaches - a 'pragmatic-economic' approach and a 'rational-defensive' approach - as guidelines to explain the reasons for this centrality. The paper shows how judicialization results from this situation and discusses two doctrinal views - 'reserve for contingencies' and 'rational use' - as the views that usually guide the debates in the courts and among health policy makers. The paper suggests that the attitude currently prevalent in the Brazilian judiciary system can prejudice the principle of equity by improperly evaluating the principle of integrality. We present a brief genealogy of HTA and a timeline of HTA in Brazil. We also discuss the relevance and the impact of Law 12401/2011, which regulates the principle of integrality in the Unified Health System (SUS) and propose three challenges to the development of HTA actions aiming at technology incorporation in Brazil. Finally, we discuss the entry and the role of private health insurance companies, emphasizing changes in the scenario and in their position. A incorporação tecnológica é um tema atualmente colocado no centro das preocupações dos sistemas de saúde. O texto presente discute o papel da dinâmica tecnológica no aumento dos custos desses sistemas e sugere duas abordagens - 'pragmático-econômica' e 'racional-defensiva' - como orientadoras da explicação daquela centralidade. Aponta a judicialização como uma resultante dessa situação e discute duas visões doutrinárias - a 'reserva do possível' e o 'uso racional' - como as que habitualmente orientam o debate nas cortes e entre os formuladores/executores das políticas de saúde. Sugere que a postura predominante hoje no judiciário brasileiro pode ferir o princípio da equidade ao avaliar de modo inadequado o princípio da integralidade. Apresenta uma genealogia sumária da ATS e uma linha do tempo da mesma no Brasil. Discute a relevância e o impacto da Lei 12.401/2011, que regulamentou a integralidade no SUS, e propõe três desafios para o aprofundamento das ações de ATS com vistas à incorporação tecnológica no Brasil. Finalmente, discute a entrada e o papel da saúde suplementar nesse tema, enfatizando mudanças conjunturais de postura.

The author discusses the challenges faced by the Brazilian graduate studies system with an emphasis on the human health sector. He identifies imbalances in the supply side of knowledge, a prime territory for graduate programs, while highlighting that a proper conceptualization of such imbalances is incomplete if it fails to incorporate the demands for scientific and technological knowledge coming from healthcare services, industry, and society. He draws on concepts from technology economics involved in the innovation systems approach. The article highlights the historical and current role of Brazilian Graduate Studies Coordinating Board (Capes), particularly its evaluation system, as an essential device for overcoming the existing challenges in Brazilian graduate studies. The author concludes by suggesting some conceptual adjustments in the agency’s work.

In Brazil, chronic noncommunicable diseases (CNCDs) are the leading cause of death and a major contributor to the national disease burden. This article describes CNCD research funded by the Ministry of Health Department of Science and Technology (DECIT) to support the production and dissemination of scientific evidence for the national health system, in accordance with the National Agenda of Priorities in Health Research, and within the context of Brazil's epidemiologic transition. Data were obtained from Ministry of Health database management systems. CNCD-related projects financed by DECIT from 2002 to 2009 were analyzed by research theme (cancer, obesity, hypertension, diabetes, cardiovascular diseases, CNCDs in general, and CNCD risk factors) and geographic region. In terms of funding and number of projects, the most-supported research theme was cancer, and the most-supported region was the Southeast. Project type varied widely, ranging from basic scientific studies to highly technological research and development. Results obtained included epidemiologic profiles and surveillance, cost, and quality-of-life data.

Recognition for the growing role of extra-academic demands and players in the dynamics of human resource training for the market and, in particular, for research is discussed. Their synergies with the movement towards maturation of the sectoral system of healthcare innovation and with the priorities of the Sistema Único de Saúde (Brazilian National Health System) are discussed. The methodological adequacy of the process for evaluating these trends used by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Coordination Office for Advancement of University-level Personnel) is analyzed. In a general manner, these trends mean adding new indicators for technological and social productivity to the predominantly academic criteria that already exist. The continuation and deepening of ongoing initiatives aimed at bringing in new formats for postgraduate programs and courses and new courses customized for the demands of the extra-academic market, among other markets, either of a social or technological-business nature, are discussed. In addition, the deepening of initiatives for stimulating postdoctoral training work, which is scarce in Brazil, is discussed.

The need for clearly-defined health research policies and priorities has been emphasized in the international scenario. In Brazil, this process began in 2003, when a group appointed by the National Health Council proposed 20 sub-agendas to account for the various health research specificities. The second step was to identify research priorities for each sub-agenda during national seminars involving 510 researchers and policymakers. The 2nd National Conference on Science, Technology, and Innovation in Health was held in July 2004. During the preparatory phase, 307 cities and 24 States organized local conferences, involving 15,000 participants. Some 360 health sector delegates were appointed during the local conferences, in addition to those from the education and science and technology sectors. During the Conference, the national policy was approved and 3 other sub-agendas were introduced and approved. The national policy and the priority agenda are currently guiding investments by the Ministry of Health for research and development, and to a certain extent those from the Ministry of Science and Technology as well. From 2003 to 2005, 24 calls for proposals were launched; as a result, 3,962 research projects were submitted and 1,300 financed. A necessidade de estabelecer uma política de ciência e tecnologia em saúde e prioridades de pesquisa em saúde foi destacada no cenário internacional. No Brasil, estes processos iniciaram em 2003, quando um grupo designado pelo Conselho Nacional de Saúde propôs 20 subagendas para abarcar as especificidades da pesquisa em saúde. O segundo passo foi identificar prioridades em cada subagenda, durante seminários nacionais envolvendo 510 cientistas e gestores. A 2ª Conferência Nacional de Ciência, Tecnologia e Inovação em Saúde ocorreu em julho de 2004. Durante a fase preparatória 307 municípios e 24 Estados organizaram conferências locais, envolvendo 15 mil pessoas. Do setor saúde foram indicados 360 delegados nas conferências locais, além dos indicados pelos setores de educação e ciência e tecnologia. Durante a conferência, a política nacional foi aprovada e três novas subagendas foram introduzidas e aprovadas. Atualmente, a política nacional e a agenda de prioridades estão guiando os investimentos de recursos para pesquisa e desenvolvimento do Ministério da Saúde e, de certa forma, do Ministério da Ciência e Tecnologia. Entre 2003 e 2005, 24 editais de pesquisa foram lançados, nos quais foram recebidas 3.962 propostas de pesquisa e aprovadas 1.300.

The deficiencies in Brazilian science and technology policies with regard to the challenges of the twenty-first century are discussed, while acknowledging that these policies have in some respects been very successful. The importance of health research within the framework of general endeavors in science, technology and innovation in this country is also demonstrated. The distribution of research around the world is then summarized, and a specific position is claimed for Brazil, along with some other countries, within the global panorama. Some elements needed for maturation of the sectoral system for health innovation are discussed. Finally, the need for the presence of the Ministry of Health within the panorama of health research, for this maturation process to take place adequately, is discussed.

Descreve-se a pesquisa em epidemiologia no Brasil na atualidade. Utiliza várias fontes secundárias de dados, com ênfase na versão 4.0 do Diretório dos Grupos de Pesquisa no Brasil (2000) do CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico). O critério para o reconhecimento de grupo integrante da massa crítica em epidemiologia foi o desenvolvimento, pelo menos, de uma linha de pesquisa nessa subárea, conforme definido pelo líder do grupo. Foi identificado o universo da pesquisa epidemiológica, que se constituiu de 176 grupos e 320 linhas de pesquisa. Foram apresentadas e discutidas as relações entre o financiamento para a pesquisa, tendo como foco os programas de pós-graduação incluídos no sistema Capes (Coordenação de Aperfeiçoamento de Pessoal do Ensino Superior), e as pesquisas em saúde, em saúde coletiva e epidemiologia, a capacidade instalada de pesquisa em epidemiologia, sua distribuição geográfica e institucional, os pesquisadores e os estudantes que participam diretamente das linhas de pesquisa, os temas de pesquisa, os padrões de divulgação de resultados das pesquisas e os periódicos em que são publicados os artigos completos. The current epidemiological research in Brazil is described. Secondary data sources were consulted, such as the year 2000 database of the Brazilian Directory of Research Groups and the National Board of Scientific and Technological Development (CNPq). The criterion to identify a group as a research one relies on the existence of at least one research line in the field of epidemiology, as defined by the group leader. After identifying the defined universe of epidemiological research, which included 176 groups and 320 different research lines, the following issues were presented and discussed: the relationships between research financing and health research, focusing on CAPES (Coordination Center for the Advance of University Professionals) graduation programs, public health research and epidemiological research, geographic and institutional distribution and outreach of the current epidemiological research, the researchers and students directly participating in epidemiological research, research topics and patterns of disseminating research findings; the journals where papers in its fullness were published; the financial support of the epidemiological research focusing on the 23 officially recognized graduate programs in public health field.

CONTEXTO E OBJETIVO: O desenvolvimento científico e tecnológico é crucial para avançar o Sistema Único de Saúde e promover qualidade de vida. Analisou-se como o Ministério da Saúde (MS) apoiou a pesquisa clínica para proporcionar autonomia, auto-suficiência, competitividade e inovação no complexo industrial produtivo da saúde, segundo a Política Nacional de Ciência, Tecnologia e Inovação em Saúde. TIPO DE ESTUDO E LOCAL: Estudo descritivo baseado em dados secundários, realizado no Departamento de Ciência e Tecnologia, Ministério da Saúde. MÉTODOS: O banco de dados gerencial de pesquisas do MS, PesquisaSaúde, foi analisado de 2002 a 2009, empregando a palavra chave "pesquisa clínica" nos campos "sub-agenda principal" ou "sub-agenda secundária". Foram encontrados 368 projetos, classificados em seis categorias: pesquisa biomédica básica, estudos pré-clínicos, pesquisa clínica expandida, ensaios clínicos, infraestrutura e avaliação de tecnologias em saúde. A partir da revisão estruturada sobre "financiamento da pesquisa clínica", resultados de países selecionados são apresentados e discutidos. RESULTADOS: O total investido foi R$ 140 milhões. A maioria dos projetos apoiou "pesquisa biomédica básica" e os maiores investimentos foram em "ensaios clínicos" e projetos de "infra-estrutura". O Sudeste deteve a maior proporção de projetos e recursos financeiros. Em alguns aspectos, o Brasil está à frente de outros países do BRICS (Rússia, Índia, China e África do Sul), sobretudo no estabelecimento da Rede Nacional de Pesquisa Clínica. CONCLUSÃO: O MS assegurou investimentos para incentivar a pesquisa clínica no Brasil, contribuindo para promover a coesão entre os investigadores, as políticas de saúde e o complexo industrial da saúde. CONTEXT AND OBJECTIVE: Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. DESIGN AND SETTING: Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. METHODS: The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. RESULTS: The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. CONCLUSION: The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.