Contextualising Drug Regulation
This chapter aims to provide a critical analysis of the literature on policy studies on generic drug regulation and contextualise the Brazilian case. Very few studies of the political process to implement generic drug regulation were identified. This type of study is particularly important in clarifying how the drug policy is discussed, approved and implemented. Because of the limited supporting literature, this section expands the scope of the review to explore broad studies on the regulatory process of the pharmaceutical sector. The last part of this chapter focuses on contextualising the case of Brazil. The country has one of the most stringent regulatory regimes for generic drugs in Latin America and has promoted significant reforms in its pharmaceutical regulation. This section provides background information about this reform by revising previous studies on this topic and identifying avenues for investigation.