Reforming pharmaceutical regulation: a case study of generic drugs in Brazil

Abstract

Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. As part of these reforms, the Generic Drug Act was introduced in 1999. This policy mandates that pharmaceutical products that are no longer protected by a patent must be interchangeable with an innovator (reference) drug. This thesis examines how and why Brazil promoted this large-scale regulatory policy. The literature on pharmaceutical policy often invokes international guidelines that inspire countries to reformulate their regulatory regimes or argues that regulations emerge in order to serve the interests of powerful interest groups. In contrast, this thesis examines how changes in the regulatory environment affect actors’ policy preferences. It argues that as actors adapt and respond to new regulatory environments, they also push the policy path further along the way.

This historical qualitative case study relies on in-depth interviews and documentary research to trace the policy process of generic drug regulation in Brazil. It finds that Brazil’s generic drug reform can be attributed to a convergence of the evolution of pharmaceutical regulation, unexpected events (AIDS epidemic and scandal of fake medicines) and political activity of the Minister of Health. In turn, this study demonstrates that the new regulatory development altered the preferences of local pharmaceutical firms, who now support and uphold a policy they once opposed because of the high costs associated with adapting their industrial plants and processes. The regulation of generic drugs has also culminated in other unintended consequences. Public pharmaceutical factories were still unable to fully adjust to the new regulatory environment and patient groups slowly became aware of these limitations.

Paradoxically, the generic drug regulation introduced in the name of patients and opposed by local pharmaceutical firms, is today opposed by important patient advocacy groups but solidified by the strong support of local and multinational pharmaceutical firms. These findings suggest although pharmaceutical firms strongly support the generic drug regulation today; they did not control the policy process that created it. Although Brazil’s norms resemble international guidelines, they were developed locally. Brazil’s case demonstrates that evolution of domestic political institutions were the most important determinant of the timing and direction of the regulatory policy. Thus, this thesis concludes that the state still matters for pharmaceutical regulation and that pharmaceutical regulation is only partially influenced by non-state actors.