Contributions to inclusive evaluation processes: Social participation in the regulation of electronic cigarettes in Brazil

Abstract

Electronic Nicotine Delivery Systems (ENDS), especially electronic cigarettes, are a subject of debate in public health. Drawing on the ‘Social Participation Menu in Regulation’ developed by the Brazilian Health Regulatory Agency (ANVISA), this study aimed to characterize the social participation mechanisms mobilized in the regulatory process of ENDS in Brazil. This exploratory study was based on a documentary review of activities related to the regulatory process, using data from ANVISA’s official website (2019–2024). The analysis followed an adapted model based on the participatory approaches of Cousins and Whitmore and Cousins and Chouinard. Five social participation mechanisms were identified. The model’s dimensions proved interconnected and sufficient to explain disputes between the interests and values of stakeholders and the regulatory authority, although limited in examining interactions among participants. The model reinforces the importance of understanding the regulatory system itself, yet it does not fully capture the relationships among those involved and their interaction with ANVISA. The theorization of these mechanisms as a network of dispositives highlights the dynamics of the State in the control of health policies. The Brazilian case may contribute to theoretical approaches examining the role of social participation in negotiated and transparent valuation processes central to inclusive and democratic evaluations.