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Informationen zum Autor Margherita Colangelo is Associate Professor of Comparative Law, Roma Tre University, Italy. Klappentext This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition laws, and public health in prescription drugs markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anticompetitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debate. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, emblematic case studies, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets. Vorwort An ambitious critical analysis of regulating pharmaceutical markets, drawing on the EU, US and international law frameworks. Zusammenfassung This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anti-competitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debates. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, significant cases, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets. Inhaltsverzeichnis Acknowledgements v Introduction 1 I. The Different Faces of Pharmaceutical Markets 1 II. Purpose and Scope of the Analysis 3 III. Methodology 7 IV. Structure of the Book 9 PART I 1. Regulating Entry 15 I. The Main Features of Pharmaceutical Markets: The Supply Side and the Demand Side 15 II. The Product Life Cycle and the Costs of Innovation 20 III. The Access to the Market: Regulatory Approaches 23 A. The European Regulatory Framework 23 B. The US Regulatory Framework 27 IV. Concluding Remarks 33 2. Regulating Exclusivity 34 I. The Interplay between Regulatory Exclusivities and Intellectual Property Rights 34 II. Intellectual Property Rights in the Pharmaceutical Industry: An Overview on the Role of Patents 35 III. EU Supplementary Protection Certificate and US Patent Term Restoration 41 IV. Regulatory Exclusivity 48 V. Research and Bolar Exemptions 52 VI. Exhaustion Doctrine and Parallel Trade 59 VII. Concluding Remarks 63 3. Regulating Prices 64 I. Pharmaceutical Pricing and Reimbursement Systems in Europe 64 II. The US System 70 III. Conclu...
