0263/2021 - Regulação sanitária e desenvolvimento tecnológico: estratégias inovadoras para o acesso a medicamentos no SUS Sanitary regulation and technological development: innovative strategies for access to medicines in SUS
A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes. Com base na análise documental,foram estudadas as interfaces entre as políticas sistêmicas e setoriais no campo do desenvolvimento tecnológico e da saúde, especialmente a partir da Política Nacional de Assistência Farmacêutica (PNAF), com impactos no campo regulatório sanitário e no estímulo à produção de medicamentos de interesse do Sistema Único de Saúde (SUS). As iniciativas para a produção nacionalizada do medicamento antirretroviral “efavirenz”, objeto de licença compulsória em 2007, bem como o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP), contribuíram para a definição de marcos e práticas regulatórias inovadoras, com destaque para os Comitês Técnico-Regulatórios (CTR) de acompanhamento das internalizações das tecnologias e registro sanitário dos produtos resultantes. Foi identificada a capacidade de permeação dos princípios e eixos estratégicos da PNAF no campo das políticas setoriais analisadas. A partir de 2014 não foram identificadas de macropoliticas ou politicas setoriais relacionadas à ampliação do acesso aos medicamentos no SUS com impactos no campo regulatório.
Regulatory science involves the articulation of knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. Based on documentary analysis, the interfaces between systemic and sectoral policies of health and technological development were studied, especiallythe National Pharmaceutical Policy (PNAF), with impacts on the health regulatory area and on stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of the antiretroviral medication “efavirenz”, which was the subject of a compulsory license in 2007, as well as the establishment of Partnerships for Productive Development (PDP), contributed to the definition of innovative regulatory frameworks and practices, with emphasis on the Regulatory Technical Committees(CTR) for monitoring the internalization of technologies and registration of the resulting products. Thepermeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies related to expanding access to medicines in the SUS with impacts on the regulatory area were identified.
Keywords:
Pharmaceutical Policy, Health Surveillance, Medicines.
Sanitary regulation and technological development: innovative strategies for access to medicines in SUS
Resumo (abstract):
Regulatory science involves the articulation of knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. Based on documentary analysis, the interfaces between systemic and sectoral policies of health and technological development were studied, especiallythe National Pharmaceutical Policy (PNAF), with impacts on the health regulatory area and on stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of the antiretroviral medication “efavirenz”, which was the subject of a compulsory license in 2007, as well as the establishment of Partnerships for Productive Development (PDP), contributed to the definition of innovative regulatory frameworks and practices, with emphasis on the Regulatory Technical Committees(CTR) for monitoring the internalization of technologies and registration of the resulting products. Thepermeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies related to expanding access to medicines in the SUS with impacts on the regulatory area were identified.
Palavras-chave (keywords):
Pharmaceutical Policy, Health Surveillance, Medicines.
Bonetti, Norberto Rech, Farias, Mareni R. Regulação sanitária e desenvolvimento tecnológico: estratégias inovadoras para o acesso a medicamentos no SUS. Cien Saude Colet [periódico na internet] (2021/Ago). [Citado em 18/09/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/regulacao-sanitaria-e-desenvolvimento-tecnologico-estrategias-inovadoras-para-o-acesso-a-medicamentos-no-sus/18162?id=18162
