The Politics of Pharmaceutical Policy Reform: A Study of Generic Drug Regulation in Brazil, explores the following:
· The politics of pharmaceutical regulation in Brazil over the last 25 years.
· The political negotiations to approve the Generic Drug Act, which involved a hard-to-reach agreement between the pharmaceutical industry (national and multinational), the Ministry of Health, and Congress
· The controversial decisions to regulate packaging and pharmaceutical equivalence.
· The surprising success of Brazilian pharmaceutical firms, which became market champions in a sector largely dominated by multinational firms.
· Comparative lessons from the Brazilian case for the political construction of regulatory standards to regulate generic drugs and its effects on global health.
This book will interest political scientists and health policy scholars concerned with the political conflicts in the pharmaceutical sector. It argues against well-established approaches to regulatory capture such as control of the regulatory process by interest groups and policy diffusion. It can be used as evidence for graduate courses in public policy, health policy and political science. Because Brazil is one of the largest markets for pharmaceuticals in the world, business leaders and consultancy firms would also be interested.
About the Author
Elize Massard da Fonseca is a postdoctoral fellow in Public Administration and Management at the Getulio Vargas Foundation (FGV) in Sao Paulo, Brazil. She holds a doctoral degree in Social Policy from the University of Edinburgh, United Kingdom, and a doctoral degree in Public Health from Fiocruz. Her research interests are in the areas of pharmaceutical regulation and health politics.
Table of Contents
Introduction.- Contextualising drug regulation.- The generic drug reform in Brazil.- Assessing the generic drug regulatory process in the 2000s: governmental intervention, market demand and local pharmaceutical industries.- Public production of medicines and HIV/AIDS activists: new actors in the generic drug regulatory process.- Conclusion.- Postscript.- Index.- References.- Annex - Notes on research methodology