Open Exceptions: Why Does the Brazilian Health Regulatory Agency (ANVISA) Exempts RIA and Ex Post Reviews?

Abstract

Abstract In this article, we examine the evolving landscape of Regulatory Impact Assessment (RIA) decisions made by the National Health Regulatory Agency (Agência Nacional de Vigilância Sanitária [Anvisa]), a prominent federal agency leading RIA implementation in Brazil. We quantify Anvisa’s RIA usage rates, exploring the influence of emergency and other justifications for RIA exemptions both pre and post the enactment of detailed procedural requirements in a recent Presidential Order No. 10,411/2020. Our quantitative analysis shows a sharp decline in RIA usage after Presidential Order No. 10,411/2020 came into force in April 2021, as well as a diversification of the justifications given in decisions not to use RIA (exception decisions). This effect is present even if we take into consideration a large proportion of exception decisions tied to Anvisa’s regulatory stock review and to urgent measures prompted by the COVID-19 pandemic. Additionally, we conduct a qualitative analysis of exception decisions due to emergency, post-Presidential Order. We find that Anvisa failed to provide compelling justifications for exempting RIA in emergency regulations in several cases and avoids ex post reviews when RIAs are waived due to emergencies. We conclude the article with recommendations to enhance the scrutiny and transparency of Anvisa’s exception decisions to conduct RIA.