The Politics of Pharmaceutical Policy Reform

A Study of Generic Drug Regulation in Brazil
2015
ISBN: 978-3-319-12564-0
Verlag: Springer International Publishing

Buch, Englisch, Band 26, 117 Seiten, Format (B × H): 155 mm x 235 mm, Gewicht: 2117 g

Reihe: SpringerBriefs in Political Science

Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. This book innovates by analysing the generic drug  reform in Brazil, demonstrating that pharmaceutical regulation is only partially influenced by non-state actors. Little is known about the institutional antecedents and policy process that channeled this regulatory reform. This is particularly intriguing because a regulatory shift in the pharmaceutical sector requires the participation of a number of stakeholders and interest groups in the policy process. Fonseca examines the generic drug reform’s causes and consequences. No study has approached the generic drug regulation in Brazil from this perspective.

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.

Zielgruppe

Research

Autoren/Hrsg.

Massard Da Fonseca, Elize

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Rechtswissenschaften Recht, Rechtswissenschaft Allgemein Rechtspolitik
• Sozialwissenschaften Politikwissenschaft Regierungspolitik Wirtschafts- und Finanzpolitik
• Rechtswissenschaften Ausländisches Recht Mittel-/Südamerika
• Wirtschaftswissenschaften Volkswirtschaftslehre Wirtschaftspolitik, politische Ökonomie
• Sozialwissenschaften Politikwissenschaft Regierungspolitik Umwelt- und Gesundheitspolitik

Inhaltsverzeichnis

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

Über Autor(innen)

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.