Prohibition and regulatory authority: a documental research about drugs categorizing administrative process

Abstract

This work aims to map the decision making process and identify actors and foundation of regulatory normative acts within public policy about drugs, consubstantiated with the edition and updates of Portaria SVS/MS nº 344/1998, which defines rules to substances under special control and forbidden substances in Brazil, and complement the meaning of Law 11.343/2006. A documentary research was made to elucidate the following issues: compliance of the acts of National Agency for Sanitary Vigilance - ANVISA to the actualizations of the lists of the international conventions about the theme; actors who have initiative of the inclusion process of substances; steps of the process; use of social participation, decisional transparency and accountability mechanisms; consulted sources to subsidize the decision and main reasons related in the technical reports. The results shows that there’s not total compliance to the international parameters with the inclusion of substances in the Brazilian controlling lists and that the prohibition is more related to public security reasons than health damages, probably due to asymmetric influence of interest groups in the administrative process.