The Generic Drug Reform in Brazil

Abstract

This chapter traces the period of the generic drug reform in Brazil and its institutional antecedents. The first part provides background information about the local production of medicines to contextualise the pharmaceutical sector in Brazil. The second part assesses the three antecedent events to the Generic Drug Act that happened together in the 1990s: the initial attempts to introduce a generic drug regulation, the enactment of an intellectual property law, and the HIV/AIDS epidemic. Tracing these events helps in identifying the circumstances that led to this regulatory reform, the participants of the pharmaceutical sector, their preferences and demands. The third part deals with the critical period of generic drug reform between 1999 and 2002. It presents the contingent events that led up to the crisis in the pharmaceutical sector and thus triggering this regulatory transformation, and the political entrepreneurship of the minister of health, who used the opportunity to implement his ambitious regulatory agenda. This third section is divided into two parts for clarity purposes. First, it deals with the parliamentary bargain to enact the Generic Drug Act in 1999 and, second, assesses the Ministry of Health and the Health Surveillance Agency efforts to put this legislation into practice.