Health policy and regulatory authorities: challenges of technology regulation in Public Health Emergencies. / Política de saúde e Autoridades Reguladoras: desafios da regulação de tecnologias nas Emergências em Saúde Pública.

Public Health Emergencies (PHE) have had repercussions on health systems on a global scale, and timely access to new health technologies is a challenge for health policy. The national regulatory authorities (NRA) play a key role in the evaluation and regulation of these technologies. The present study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the health system's effective response during a PHE. This research, based on WHO and Brazilian NRA norms and documents, considered dimensions related to strategies for strengthening regulatory activities and regulatory instruments used to accelerate access to technologies, especially during PHEs. International cooperation between the NRA and the WHO were important strategies for strengthening the NRA, with emphasis on the use of reliance, regionalization, accelerated assessments, and work/information sharing, as well as the processes of regulatory harmonization and convergence. In addition to the use of existing regulatory instruments, efforts were also identified in order to implement new ones.

As Emergências em Saúde Pública (ESP) têm repercutido nos sistemas de saúde em escala global. O acesso às novas tecnologias em saúde em tempo oportuno é um desafio para a política de saúde. As autoridades reguladoras nacionais (ARN) têm papel fundamental na avaliação e regulação dessas tecnologias. O estudo objetiva analisar as principais estratégias e instrumentos regulatórios utilizados para lidar com os desafios da regulação de novas tecnologias necessárias à resposta do sistema de saúde durante as ESP. Trata-se de uma pesquisa normativa e documental, tendo como fonte a OMS e a ARN brasileira. Foram consideradas as dimensões relacionadas às estratégias para o fortalecimento das atividades regulatórias e os instrumentos regulatórios utilizados para acelerar o acesso às tecnologias, especialmente durante as ESP. A cooperação e a colaboração internacional entre as ARN e com a OMS foram importantes estratégias para o fortalecimento das ARN, com destaque para o uso de confiança, regionalização, avaliações aceleradas e compartilhamento de trabalho/informações, bem como os processos de harmonização e convergência regulatória. Identificou-se, além da utilização de instrumentos regulatórios já existentes, esforços na implementação de novos, com destaque para Autorização de Uso Emergencial.

[Asymmetries between national articulation and the autonomy of state governments in implementing health technologies to fight COVID-19 in Argentina]. / Asimetrías entre la coordinación nacional y la autonomía de los gobiernos estatales en la adopción de tecnologías sanitarias frente a la COVID-19 en Argentina.

Argentina, as other countries, showed several public policies related to the health technologies implemented to fight and treat the COVID-19 pandemic. This study sought to analyze how articulation vs. cooperation and autonomy vs. division of powers between entities occurred in Argentina, exploring asymmetries between several entities in implementing public policies related to health technologies during the pandemic and the influences of other actors. For this, a documentary research was carried out related to 2020-2021 (technical reports published by the World Health Organization, national agencies and scientific societies, laws, court decisions, press, and research and in-depth interviews with members of the Argentine Ministries of Health). The processes and results of decision-making in the Ministries of Health were analyzed, outlining the coverage and orientations of each technology and the political party in power in the province. This study found heterogeneous results and processes between Ministries and disputes within them. It also observed the poor adherence to official guidelines due to technical-political criteria (power relations, social, media, academic, judiciary, and legislative pressure). Some cases showed a strong tension between the government and its opposition over the discussion of technologies. Each province in Argentina has autonomously defined its policies on health technologies for COVID-19, and decision-making in public administration was disorderly, complex, and non-linear during the pandemic.

En pandemia, en Argentina y en otros países se observó variabilidad en las políticas públicas implementadas sobre tecnologías sanitarias para prevención y tratamiento de la COVID-19. El objetivo fue analizar cómo se procesaron en Argentina los movimientos de coordinación vs. cooperación, y de autonomía vs. reparto de autoridad entre entidades, explorando asimetrías entre diferentes entidades en la implementación de políticas públicas sobre tecnologías sanitarias en pandemia y las influencias de otros actores. Se realizó una revisión documental del período 2020-2021 (informes técnicos publicados por la Organización Mundial de la Salud, organismos nacionales y sociedades científicas, leyes, fallos judiciales, prensa, encuestas y entrevistas en profundidad a miembros de los Ministerios de Salud de Argentina). Se indagó sobre procesos y resultados de la toma de decisiones en los Ministerios de Salud, mapeando la cobertura y recomendación de cada tecnología y el partido político provincial gobernante. Hubo heterogeneidad en resultados y procesos entre los Ministerios, y disputas en el interior de los mismos. La adherencia a recomendaciones oficiales fue baja, influyendo distintos criterios técnico-políticos (relaciones de poder, presión social, de los medios, académicos, poder Judicial y Legislativo). En algunos casos se observó una fuerte tensión entre oficialismo y oposición al partido gobernante a partir de la discusión sobre tecnologías. Cada provincia argentina definió sus políticas sobre tecnologías sanitarias para COVID-19 con autonomía, y la toma de decisiones en la administración pública en pandemia fue desordenada, compleja y no lineal.

Na Argentina, assim como em outros países, houve uma variabilidade de políticas públicas relacionadas às tecnologias de saúde implementadas no combate e tratamento da COVID-19 durante a pandemia. Este estudo buscou analisar como ocorreram a articulação vs. cooperação, e a autonomia vs. divisão de poderes entre as entidades na Argentina, explorando assimetrias entre diferentes entidades na implementação de políticas públicas relacionadas a tecnologias de saúde na pandemia, bem como as influências de outros atores. Para tanto, realizou-se uma pesquisa documental para o período de 2020-2021 (relatórios técnicos publicados pela Organização Mundial da Saúde, agências nacionais e sociedades científicas, leis, decisões judiciais, imprensa, pesquisas e entrevistas em profundidade com membros dos Ministérios da Saúde da Argentina). Os processos e os resultados da tomada de decisão nos Ministérios da Saúde foram analisados, traçando a cobertura e orientações de cada tecnologia e o partido político no poder na província. Observou-se uma heterogeneidade nos resultados e processos entre os Ministérios, e disputas em seu interior. Houve uma baixa adesão às orientações oficiais, influenciada por diferentes critérios técnico-políticos (relações de poder, pressão social, midiática, acadêmica, do poder Judiciário e do Legislativo). Em alguns casos, observou-se uma forte tensão entre governo e oposição a partir da discussão das tecnologias. Cada província da Argentina definiu suas políticas sobre tecnologias de saúde para a COVID-19 de forma autônoma, e a tomada de decisões na administração pública foi desordenada, complexa e não linear durante a pandemia.

Política de medicamentos y otras tecnologías de la salud de la República de Guatemala: acuerdo No. 276-2019 / Policy on medicines and other health technologies of the Republic of Guatemala: agreement No. 276-2019

Bajo la premisa de que para contribuir al acceso universal a la salud y la cobertura universal de salud, es necesario desarrollar políticas y estrategias que aseguren el acceso a medicamentos de calidad, seguros y eficaces que se utilicen adecuadamente, la presente ley es un instrumento político estratégico, orientador de las acciones que se realicen en este ámbito, para garantizar una vida sana y promover el bienestar para toda la población guatemalteca.

The regulation and adoption of health technologies under Brazil's Unified Health System: barriers to access to medicines for diseases of poverty? / Registro e incorporação de tecnologias no SUS: barreiras de acesso a medicamentos para doenças da pobreza?

The study aimed to examine the regulation and adoption of health technologies for the diseases of poverty in the Brazil's Unified Health System (SUS). An exploratory, descriptive study was conducted between January and May 2016 consisting of the search and analysis of relevant documents on the websites of Brazil's National Health Surveillance Agency, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Commission for the Adoption of Technologies by the SUS, and Saúde Legis (the Ministry of Health's Legislation System). The 2014 version of the Brazilian National List of Essential Medicines (RENAME, acronym in Portuguese) contained 132 medicines for diseases of poverty. Over one-third of these (49) had only one national producer, while 24 were not registered in the country. The number of medicines contained in the RENAME dedicated to this group of diseases increased by 46% between 2006 and 2014. Despite advances in the regulation and incorporation of technologies by the SUS, given the lack of market interest and neglect of diseases of poverty, the government has a vital role to play in ensuring access to the best available therapies in order to reduce health inequalities. It therefore follows that Brazil needs to improve the regulation of medicines that do not attract market interest.

Registro e incorporação de tecnologias no SUS: barreiras de acesso a medicamentos para doenças da pobreza? / The regulation and adoption of health technologies under Brazil´s Unified Health System: barriers to access to medicines for diseases of poverty?

Resumo O presente trabalho buscou verificar os aspectos relacionados ao registro sanitário e à incorporação de tecnologias no SUS para as doenças da pobreza. Trata-se de estudo exploratório, descritivo, desenvolvido entre janeiro e maio de 2016, em que foram realizados levantamentos e análises de documentos nos sítios eletrônicos da Anvisa, FDA, EMA, Conitec e Sistema Saúde Legis. Verificou-se um total de 132 medicamentos elencados na Rename 2014 para atendimento específico das doenças da pobreza, sendo que mais de um terço (49) possuem apenas um produtor nacional e outros 24 não possuem registro no país. No período de 2006 a 2014 houve crescimento de 46% do número de medicamentos na Rename para tais doenças. Apesar dos avanços do SUS nos campos da regulação e incorporação de tecnologias, dado o desinteresse de mercado e a condição de negligência para as doenças da pobreza, a atuação do Estado é imprescindível para garantir o acesso às melhores terapias disponíveis, visando à redução das iniquidades em saúde. Infere-se que o Brasil precisa avançar na regulação e incorporação de medicamentos sem interesse mercadológico, agenda inconclusa que pode gerar barreiras de acesso às tecnologias para as populações vulneráveis.

Abstract The study aimed to examine the regulation and adoption of health technologies for the diseases of poverty in the Brazil’s Unified Health System (SUS). An exploratory, descriptive study was conducted between January and May 2016 consisting of the search and analysis of relevant documents on the websites of Brazil’s National Health Surveillance Agency, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Commission for the Adoption of Technologies by the SUS, and Saúde Legis (the Ministry of Health’s Legislation System). The 2014 version of the Brazilian National List of Essential Medicines (RENAME, acronym in Portuguese) contained 132 medicines for diseases of poverty. Over one-third of these (49) had only one national producer, while 24 were not registered in the country. The number of medicines contained in the RENAME dedicated to this group of diseases increased by 46% between 2006 and 2014. Despite advances in the regulation and incorporation of technologies by the SUS, given the lack of market interest and neglect of diseases of poverty, the government has a vital role to play in ensuring access to the best available therapies in order to reduce health inequalities. It therefore follows that Brazil needs to improve the regulation of medicines that do not attract market interest.

A systematic review of the process of regionalization of Brazil's Unified Health System, SUS. / O processo de regionalização do SUS: revisão sistemática.

This review focuses only on specific studies into the SUS regionalization process, which were based on empirical results and published since 2006, when the SUS was already under the aegis of the Pact for Health framework. It was found that the regionalization process is now underway in all spheres of government, subject to a set of challenges common to the different realities of the country. These include, primarily, that committee-structured entities are valued as spaces for innovation, yet also strive to overcome the bureaucratic and clientelist political culture. Regional governance is further hampered by the fragmentation of the system and, in particular, by the historical deficiency in planning, from the local level to the strategic policies for technology incorporation. The analyses enabled the identification of a culture of broad privilege for political negotiation, to the detriment of planning, as one of the main factors responsible for a vicious circle that sustains technical deficiency in management.

O processo de regionalização do SUS: revisão sistemática / A systematic review of the process of regionalization of Brazil's Unified Health System, SUS

Resumo Nesta revisão foram incluídos apenas estudos específicos sobre o processo de regionalização do SUS, baseados em resultados empíricos e publicados a partir de 2006, já sob o referencial do Pacto pela Saúde. Foi evidenciado que o processo de regionalização é hoje uma realidade em todas as esferas de governo, sujeito a um conjunto de desafios comuns às diversas realidades do país. Entre os principais, os colegiados são valorizados com espaços de inovação, mas ainda em busca da superação da cultura política burocrática e clientelista. A governança regional é ainda prejudicada pela fragmentação do sistema e, em particular, pela histórica deficiência com planejamento, desde o nível local às políticas estratégicas de incorporação tecnológica. As análises permitiram implicar a cultura de amplo privilégio para negociação política em detrimento do planejamento como uma das principais responsáveis por um ciclo vicioso que sustenta a deficiência técnica da gestão.

Abstract This review focuses only on specific studies into the SUS regionalization process, which were based on empirical results and published since 2006, when the SUS was already under the aegis of the Pact for Health framework. It was found that the regionalization process is now underway in all spheres of government, subject to a set of challenges common to the different realities of the country. These include, primarily, that committee-structured entities are valued as spaces for innovation, yet also strive to overcome the bureaucratic and clientelist political culture. Regional governance is further hampered by the fragmentation of the system and, in particular, by the historical deficiency in planning, from the local level to the strategic policies for technology incorporation. The analyses enabled the identification of a culture of broad privilege for political negotiation, to the detriment of planning, as one of the main factors responsible for a vicious circle that sustains technical deficiency in management.

Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states.

Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. "Regionalization"-an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems-may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative's concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

Technological incorporation in the Unified Health System (SUS): the problem and ensuing challenges / Incorporação tecnológica no SUS: o problema e seus desafios

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.

Technological incorporation in the Unified Health System (SUS): the problem and ensuing challenges.

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.

Ata da ducentésima décima segunda reunião ordinária do Conselho Nacional de Saúde ­ CNS / Minutes of the 212th ordinary meeting of the National Health Council - CNS

Aprovação das atas das 210ª e 211ª reuniões ordinárias do CNS e da 46ª reunião extraordinária do CNS.

Resumo executivo da ducentésima décima segunda reunião ordinária do Conselho Nacional de Saúde / Executive summary of the 212th ordinary meeting of the National Health Council - CNS

Aprovação das atas das 210ª e 211ª reuniões ordinárias do CNS e da 46ª reunião extraordinária do CNS.