Assessing the Generic Drug Regulatory Process in the 2000s: Governmental Intervention, Market Demand and Local Pharmaceutical Industries

  • Elize Massard da FonsecaEmail author
Part of the SpringerBriefs in Political Science book series (BRIEFSPOLITICAL, volume 26)


This chapter explores the development of the generic drug policy. We know that generic drug regulation persisted even after Serra left the government, but we know less about how this happened. In what ways has the generic drug regulation influenced the governance of the pharmaceutical sector in Brazil? The first part presents the economic outcomes of this regulatory policy, reviewing the vitality of generic drugs in the pharmaceutical sector. The second part assesses how government advocacy for generic evolved after the Serra administration and the market demands for generic drugs. Governments have been less politically active on this matter, and there is controversial and conflicting information about how health professionals and the population received these products. The third part of this chapter discusses the role of suppliers. Private local pharmaceutical producers have been leading the rank of the generic drug sector. Particularly puzzling is that, as demonstrated in the previous chapter, local pharmaceutical producers repealed this government intervention in their business. This chapter concludes by summarising how the new institutional context empowered local pharmaceutical producers and the structure of the interest group in this sector in Brazil.


Generic Medicine Generic Drug Similar Drug Pharmaceutical Sector Bioequivalence Test 
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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Center for Public Administration and Government Studies, São Paulo Business SchoolGetulio Vargas FoundationSão PauloBrazil

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