The use and exemption of Regulatory Impact Assessment by the National Health Surveillance Agency

Resumo

Regulatory impact assessment—RIA—is increasingly important for Brazilian Administrative Law, especially after the ‘Economic Freedom Act’ (Lei de Liberdade Econômica) extended its scope of implementation to all public bodies and federal administration entities. This work analyses the evolution of RIA under the purview of the National Health Surveillance Agency (Anvisa), a federal agency that stands out for being at the forefront of RIA implementation in Brazil. To this end, data published on the legislation section of the agency’s website about the use of RIA to substantiate Directors' Collegiate Regulations (Resoluções de Diretoria Colegiada) and Normative Instructions (Instruções Normativas) between 2011 and 2020 were collected. The total number and proportion of cases in which the Directors' Collegiate approved the realization or dispensation of RIA, based on relevant normative acts collected in this period, are presented. It was found that, in most cases, there were exemptions from RIA, and this proportion was not reduced over time. Furthermore, in cases of exemption, it was observed that the urgency/severity of the process was used as justification in a high proportion of cases. Finally, it was also observed that the use of RIA and exemption justifications vary according to the subject of the regulatory norm in question. The results of this study advance the existing knowledge about the implementation of RIA in Brazil and suggest new avenues of qualitative research on the factors that influenced the use and exemption of RIA by Anvisa.

Ficha do documento

Tipo

Artigo científico

Ano

2021

Instituição

Escola Nacional de Administração Pública - Enap

Fonte

Revista do Serviço Público

Idioma

Inglês

Acesso

Não informado

Identificador

oai:ojs.pkp.sfu.ca:article/5954

Licença

http://creativecommons.org/licenses/by-nc-sa/4.0

Palavras-chave

reforma regulatóriaanálise de impacto regulatórioAgência Nacional de Vigilância SanitáriaAnvisapesquisa empíricaregulatory reformregulatory impact assessmentNational Health Surveillance Agencyempirical research