Análise de Impacto Regulatório: uma nova ferramenta para a melhoria da regulação na Anvisa

Abstract

Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefi ts of regulation as well as solutions to current issues to enhance the decision-making process. This article discusses the importance of Regulatory Impact Analysis in the context of the National Agency for Sanitary Surveillance performance as well as the agency's current phase of regulation improvement and strengthening. Also, the main defi nitions related to the regulatory fi eld as well as some international case experiences are presented.

Regulation and development: Theoretical contributions and empirical lessons from Latin America

“…Parrado and Salvador (2011) have analyzed the meritocratic patterns of 72 regulatory agencies in 18 Latin American countries. Alketa Peci and her colleagues (Neves & Peci, 2011;Peci & Sobral, 2011) have studied the potentialities and difficulties of the implementation of regulatory impact analysis in Brazil.…”

Proteção à saúde no Brasil: o Sistema Nacional de Vigilância Sanitária

“…The regulatory agencies, in Brazil, were created with administrative, financial and technical autonomy, and their purposes, as well as correction of market failings, include: monitoring of the relevant economic agents; guaranteeing of the effectiveness of the State's public policies; the issuance, and monitoring of compliance of specific legislation and other regulatory actions 24 . The regulation carried out by Brazilian Agency (Anvisa) is of importance for the structuring of the Brazilian Unified Health System, because its actions have an impact on the development of productive sectors, on the regulation of industries, on prevention of risks to the health population and on the organization of the health market 25 . However, the creation of this federal agency took place in the midst of the reform of the Brazilian state, in the 1990s, under the aegis of neo-liberalism.…”

Regulatory policy choice in post‐reform contexts: The case of industrial safety regulation in Mexico's oil and gas industry

“…Despite advances in the study of regulatory governance in Latin America, there have been few attempts at empirical single‐country case analyses aimed at gaining a greater understanding of the complexity of how regulatory processes are affected by a country's specific administrative, political, and economic context. Studies that focus on a single‐country analysis of regulatory agencies include González (2018) and González and Verhoest (2020) in Colombia, Elizondo and Dussauge‐Laguna (2018, 2019) in Mexico, and Cunha et al (2017), Alves and Peci (2011), Peci and Sobral (2011), and Peci et al (2020) in Brazil. In this paper, we contribute to the study of how systemic features of developing countries shape regulatory policy design by analyzing the regulation strategy adopted by Mexico's then recently created Safety, Energy, and Environment Agency (the Agencia de Seguridad, Energía y Ambiente , or ASEA).…”