Policy diffusion in practice: the case of Brazilian medicines regulation

• Autor(a) principal: Sizukusa, Letícia Oyamada
• Data de Publicação: 2023
• Outros Autores: Fontoura, Yuna, Krieger, Morgana G. Martins
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Revista de Administração Pública
• Texto Completo: https://periodicos.fgv.br/rap/article/view/89368
• topic: policy diffusion; Anvisa; good manufacturing practices for medicinal products; regulation; difusión de la política; Anvisa; buenas prácticas de fabricación de medicamentos; regulación; difusão de política; Anvisa; boas práticas de fabricação de medicamentos; regulação

The present study seeks to contribute to a better understanding of policy diffusion processes, more specifically, of the diffusion process from a transnational arena that influenced the regulation of Good Manufacturing Practices (GMP) for medicines in Brazil in a context surrounded by international authorities. By conducting qualitative research, we analyzed the process of adhesion of the Brazilian Health Regulatory Agency (Anvisa) to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), initiated in 2010 and achieved in 2021. A process influenced by two diffusion constellations was identified, motivated by the national agency’s interests in maintaining its relevance and by actors that make up the National Sanitary Surveillance System, in which the PIC/S model of regulatory equivalence and convergence proved to be fundamental for the adaptation of the international reference to the national level, keeping the national system functioning. Such a policy diffusion process became even more relevant in the past years due to the expansion of regulatory convergence and potentially making the various health authorities’ GMP assessment of medicinal products more efficient.