0061/2024 - Política de saúde e Autoridades Reguladoras: desafios da regulação de tecnologias nas Emergências em Saúde Pública Health policy and Regulatory Authorities: challenges of technology regulation in Public Health Emergencies
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) possuem 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 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 da 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, para agilizar o acesso às tecnologias em saúde, com destaque para Autorização de Uso Emergencial.
Palavras-chave:
Emergências, Política de saúde, Cooperação Internacional, Vigilância Sanitária, Agência Nacional de Vigilância Sanitária.
Abstract:
Public Health Emergencies (PHE) have had repercussions on health systems on a global scale. Timely access to new health technologies is a challenge for health policy. The National Regulatory Authorities (NRA) have a fundamental role in the evaluation and regulation of these technologies. The study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the response of the health system, 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 identified to implement new ones to speed up access to health technologies, with emphasis on Emergency Use Authorization.
Keywords:
Emergencies, Health Policy, International Cooperation, Health Surveillance, Brazilian Health Surveillance Agency.
Health policy and Regulatory Authorities: challenges of technology regulation in Public Health Emergencies
Resumo (abstract):
Public Health Emergencies (PHE) have had repercussions on health systems on a global scale. Timely access to new health technologies is a challenge for health policy. The National Regulatory Authorities (NRA) have a fundamental role in the evaluation and regulation of these technologies. The study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the response of the health system, 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 identified to implement new ones to speed up access to health technologies, with emphasis on Emergency Use Authorization.
Palavras-chave (keywords):
Emergencies, Health Policy, International Cooperation, Health Surveillance, Brazilian Health Surveillance Agency.
Oliveira, C. V. S., Pepe, V. L. E. Política de saúde e Autoridades Reguladoras: desafios da regulação de tecnologias nas Emergências em Saúde Pública. Cien Saude Colet [periódico na internet] (2024/Mar). [Citado em 05/10/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/politica-de-saude-e-autoridades-reguladoras-desafios-da-regulacao-de-tecnologias-nas-emergencias-em-saude-publica/19109?id=19109
