Contributions to evaluation of regulatory processes: the case of electronic cigarettes in Brazil

Vigil Sanit Debate, Rio de Janeiro, 2024, v.12: e02213 | Published on: 20/02/2024

Abstract

Introduction: The Electronic Nicotine Delivery Systems, represented by electronic cigarettes (e-cigarettes), are object of a global dispute in public health. In Brazil, they are forbidden but this interdiction is currently under a debate steered by the Brazilian Health Regulatory Agency (ANVISA, by its acronym in Portuguese). Objective: Characterize the regulatory model of ANVISA, in the case of e-cigarettes, and debate its implications for evaluations that have the regulatory process as object. Method: The documental research supported the timeline construction entailing publications about the regulatory process in ANVISA’s website, from 2009 to 2023. Results: The timeline presents the critical events that lead to consequences and reconfiguration of the analyzed process. Besides 31 news stories, 10 normative and non-normative publications compose the process. 2019 was the year with most publications, followed by 2022 and 2018. The Resolution of the Collegiate Board (RDC, by its acronym in Portuguese) n° 46/2009 was the first ANVISA opinion, prohibited the commerce, import and marketing of the devices. In 2019, the topic was included in the Regulatory Agenda based on a new regulatory model that promoted social participation. During the regulatory process, diverse stakeholders took their stances around the RDC, and started to signal a flexible opinion in face of new evidence. Conclusions: The Brazilian case, which includes diverse stakeholders and interests, contributes to the identification of approaches that allow exploring the regulatory processes as evaluation objects, re-signifying as a devices network that emerge from strategic crises.