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

Autores

  • Natasha Schmitt Caccia Salinas Escola de Direito da Fundação Getúlio Vargas (FGV Direito Rio), Rio de Janeiro – RJ, Brazil s https://orcid.org/0000-0003-1012-1132
  • Lucas Thevenard Gomes Escola de Direito da Fundação Getúlio Vargas (FGV Direito Rio), Rio de Janeiro – RJ, Brazil https://orcid.org/0000-0001-5011-4960

Palavras-chave:

reforma regulatória, análise de impacto regulatório, Agência Nacional de Vigilância Sanitária, Anvisa, pesquisa empírica

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.

Downloads

Não há dados estatísticos.

Biografia do Autor

Natasha Schmitt Caccia Salinas, Escola de Direito da Fundação Getúlio Vargas (FGV Direito Rio), Rio de Janeiro – RJ, Brazil s

Professora do Programa de Pós-graduação (Mestrado e Doutorado) em Direito da Regulação e do curso de graduação em Direito da FGV Direito Rio. Doutora e mestre em Direito pela USP. Master of Laws (LL.M.) pela Yale Law School.

Lucas Thevenard Gomes, Escola de Direito da Fundação Getúlio Vargas (FGV Direito Rio), Rio de Janeiro – RJ, Brazil

Mestrando em Direito da Regulação pela FGV Direito-Rio, pesquisador do Centro de Pesquisas em Direito e Economia (CPDE) da FGV Direito Rio, MBA em Relações Internacionais pela FGV.

Referências

Alves, F. N. R., & Peci, A. (2011). Análise de Impacto Regulatório: Uma nova ferramenta para a melhoria da regulação na Anvisa. Revista de Saúde Pública, 45(4), 802–805. https://doi.org/10.1590/S0034-89102011000400023

Atienza, M. (1997). Contribución a uma teoria de la legislación. Civitas.Baldwin, R. (2010). Better Regulation: The Search and the Struggle. In R. Baldwin, M. Cave, & M. Lodge, The Oxford Handbook of Regulation. Oxford Handbooks Online.

Bana e Costa, C. A., de Corte, J.-M., & Vansnick, J.-C. (2011). MACBETH (Measuring Attractiveness by a Categorical Based Evaluation Technique). In J. J. Cochran, L. A. Cox, P. Keskinocak, J. P. Kharoufeh, & J. C. Smith, Wiley Encyclopedia of Operations Research and Management Science. John Wiley & Sons, Inc. https://doi.org/10.1002/9780470400531.eorms0970

Casa Civil. (2018). Diretrizes gerais e guia orientativo para elaboração de análise de impacto regulatório—AIR. Governo Federal. https://www.gov.br/casacivil/pt-br/centrais-de-conteudo/downloads/diretrizes-gerais-e-guia-orientativo_final_27-09-2018.pdf/@@download/file/diretrizes-gerais-e-guia-orientativo_final_27-09.pdf

Chevallier, J. (1992). A Racionalização da Produção Jurídica. Cadernos de Ciência da Legislação, 3, 9–23.

Coglianese, C., Kilmartin, H., & Mendelson, E. (2009). Transparency and Public Participation in the Rulemaking Process. Faculty Scholarship at Penn Law. https://scholarship.law.upenn.edu/faculty_scholarship/238

Costa, C. A. B. e, Vieira, A. C. L., Nóbrega, M., Quintino, A., Oliveira, M. D., & Costa, J. B. e. (2019). Collaborative Value Modelling in corporate contexts with MACBETH. Procedia Computer Science, 162, 786–794. https://doi.org/10.1016/j.procs.2019.12.051

Guerra, S., Salinas, N. S. C., & Gomes, L. T. (2020). As agências reguladoras em resposta à crise da COVID-19. Revista de Administração Pública, 54(4), 874–897. https://doi.org/10.1590/0034-761220200321

McCubbins, M. D., Noll, R. G., & Weingast, B. R. (1987). Administrative Procedures as Instruments of Political Control. Journal of Law, Economics, & Organization, 3(2), 243–277.

Medauar, O. (2008). A processualidade no direito administrativo (2a. ed. rev., atualizada e ampliada). Editora Revista dos Tribunais.

Meneguin, F. B., & Saab, F. (2020). Análise de Impacto Regulatório: Perspectivas a partir da Lei da Liberdade Econômica [Texto para Discussão no 271]. Núcleo de Estudos e Pesquisas/CONLEG/Senado.

Moe, T. M. (1989). The Politics of Bureaucratic Structure. In J. E. Chubb & P. E. Peterson (Orgs.), Can the government govern? (p. 267–329). Brookings Institution.

Morall, J. (1997). An Assessment of the US Regulatory Impact Analysis Programme. In OECD, Regulatory Impact Analysis: Best Practices in OECD Countries (p. 71–87). OECD Publishing.

National Health Surveillance Agency - ANVISA. (2008). Governo escolhe Anvisa para projeto piloto de regulação. Anvisa’s news page.

National Health Surveillance Agency - ANVISA. (2013). Análise de impacto regulatório: Anvisa é referência para agências. Anvisa’s news page.

OECD. (2008). Building an Institutional Framework for Regulatory Impact Analysis (RIA): Guidance for Policy Makers. OECD Publishing. https://www.oecd.org/gov/regulatory-policy/40984990.pdf

OECD. (2012). Recommendation of the Council on Regulatory Policy and Governance. OECD Publishing. https://doi.org/10.1787/9789264209022-en

OECD. (2015). Evidence-based policy making through Regulatory Impact Assessment. In OECD Regulatory Policy Outlook 2015 (p. 93–117). OECDPublishing. https://doi.org/10.1787/9789264238770-9-en

Proença, J. D., Costa, P. V. da, & Montagner, P. (2009). Desafios da regulação no Brasil. ENAP.

Radaelli, C., & De Francesco, F. (2010). Regulatory Impact Assessment. In R. Baldwin, M. Lodge, & M. Cave, The oxford handbook of regulation (Vol. 90, p. 563–564). Oxford University Press. http://doi.wiley.com/10.1111/j.1467-9299.2012.02049.x

Salinas, N. S. C., & Cerqueira, L. S. (2020). Análise de impacto regulatório na Lei Geral das Agências e na Lei de Liberdade Econômica: Fundamentos e tensões. Interesse Público, 22(124), 217–231.

Shapiro, S. A., & Schroeder, C. (2008). Beyond cost-benefit analysis: A pragmatic reorientation. Harvard Environmental Law Review, 32, 70.

Simon, H. A. (1997). Administrative behavior: A study of decision-making processes in administrative organization (4. ed). The Free Press.

Stodden, V. (2014). The reproducible research movement in statistics. Statistical Journal of the IAOS, 30, 91-93.

CITED LEGISLATION

National Health Surveillance Agency – Anvisa. Ordinance No. 354 of August 11, 2006. Available at: https://www.legisweb.com.br/legislacao/?id=197327. Last access on June 24, 2021.

National Health Surveillance Agency – Anvisa. Ordinance No. 422, of April 16, 2008. Available at: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/regulamentacao/guia-para-o-programa-de-melhoria-do-processo-de-regulamentacao-da-anvisa.pdf. Last access on June 24, 2021.

National Health Surveillance Agency – Anvisa. Ordinance No. 1,381 of September 16, 2011. Available at: https://www.legisweb.com.br/legislacao/?id=235139. Last access on June 24, 2021.

National Health Surveillance Agency – Anvisa. Directors' Collegiate Resolution - RDC No. 255 of September 10, 2018. Available at: https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/54522298/do1-2018-12-11-resolucao-de-diretoria-colegiada-rdc-n-255-de-10-de-dezembro-de-2018-54521871. Last access on June 24, 2021.

National Health Surveillance Agency – Anvisa. Ordinance No. 1,741, of September 12, 2018. Available at: https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/55220083/do1-2018-12-14-portaria-n-1-741-de-12-de-dezembro-de-2018-55219864. Last access on June 24, 2021.

National Health Surveillance Agency – Anvisa. Service Orientation – SO No. 56, of September 18, 2018. Available at: http://antigo.anvisa.gov.br/documents/10181/5087466/OS_56_2018_BPR_COMP.pdf/1e57cdc2-9597-4677-bc62-4a99ceae9d8e. Last access on June 24, 2021.

National Health Surveillance Agency – Anvisa. Ordinance No. 162, of March 12, 2021. Available at: http://antigo.anvisa.gov.br/documents/10181/6242211/PRT_162_2021_.pdf/43a711e9-4d53-4496-afc5-6eb3d7287a07. Last access on June 24, 2021.

National Health Surveillance Agency – Anvisa. Service Orientation – SO No. 96, March 12, 2021. Available at: http://antigo.anvisa.gov.br/documents/10181/6242211/OS_96_2021.pdf/09b1a87b-5d8d-4703-8696-d5ca361b9c7a. Last access on June 24, 2021.

Brazil. Law No. 95, of February 26, 1998. Available at: http://www.planalto.gov.br/ccivil_03/leis/lcp/lcp95.htm. Last access on June 24, 2021.

Brazil. Decree No. 4,176, of March 28, 2002. Available at: http://www.planalto.gov.br/ccivil_03/decreto/2002/d4176.htm. Last access on June 24, 2021.

Brazil. Decree No. 6,062, of March 16, 2007. Available at: http://www.planalto.gov.br/ccivil_03/_ato2007-2010/2007/decreto/D6062.htm. Last access on June 24, 2021.

Brazil. Decree No. 9,191, of November 1st, 2017 Available at: http://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2017/Decreto/D9191.htm#art59. Last access on June 24, 2021.

Brazil. Law No. 13,848, of June 25, 2019. Available at: http://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2017/Decreto/D9191.htm#art59. Last access on June 24, 2021.

Brazil. Law No. 13,874, of September 20, 2019. Available at: http://www.planalto.gov.br/ccivil_03/_ato2019-2022/2019/lei/L13874.htm. Last access on June 24, 2021.

Brazil. Decree No. 10,441, of June 30, 2020. Available at: https://www.in.gov.br/en/web/dou/-/decreto-n-10.411-de-30-de-junho-de-2020-264424798. Last access on June 24, 2021.

Downloads

Publicado

2021-12-06

Como Citar

Schmitt Caccia Salinas, N., & Thevenard Gomes, L. (2021). The use and exemption of Regulatory Impact Assessment by the National Health Surveillance Agency. Revista Do Serviço Público, 72(b), 8 - 33. Recuperado de https://revista.enap.gov.br/index.php/RSP/article/view/5954

Edição

Seção

Special Issue on Public Policy and Regulation (closed)