تنظیم‌گری، نوآوری و رقابت در بازارهای دارویی: یک مطالعهٔ مقایسه‌ای

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. Acknowledgements Contents Introduction I. The Different Faces of Pharmaceutical Markets II. Purpose and Scope of the Analysis III. Methodology IV. Structure of the Book PART I 1. Regulating Entry I. The Main Features of Pharmaceutical Markets: The Supply Side and the Demand Side II. The Product Life Cycle and the Costs of Innovation III. The Access to the Market: Regulatory Approaches IV. Concluding Remarks 2. Regulating Exclusivity I. The Interplay between Regulatory Exclusivities and Intellectual Property Rights II. Intellectual Property Rights in the Pharmaceutical Industry: An Overview on the Role of Patents III. EU Supplementary Protection Certificate and US Patent Term Restoration IV. Regulatory Exclusivity V. Research and Bolar Exemptions VI. Exhaustion Doctrine and Parallel Trade VII. Concluding Remarks 3. Regulating Prices I. Pharmaceutical Pricing and Reimbursement Systems in Europe II. The US System III. Concluding Remarks PART II 4. Competition Law Enforcement in Pharmaceutical Markets: An Introduction I. EU and US Antitrust Rules: An Essential Overview II. Antitrust Enforcement in the Pharmaceutical Sector III. Market Definition IV. Concluding Remarks 5. Reverse Payment Patent Settlements I. The Recurrence of Reverse Payment Patent Settlements in Pharmaceutical Markets II. Reverse Payment Patent Settlements in the United States III. EU Case Law on Reverse Payment Patent Settlements IV. Comparative Analysis V. Concluding Remarks 6. Product Hopping I. Pharmaceutical Product Reformulations II. Product Hopping before US Courts III. The EU Experience IV. The Antitrust Assessment of Product Reformulation V. Concluding Remarks 7. Excessive Drug Pricing I. The Resurgence of Excessive Pricing Cases in the Pharmaceutical Sector II. Excessive Pricing under EU Competition Law III. The US Approach IV. The Role of Antitrust Enforcement on Excessive Drug Prices V. Concluding Remarks PART III 8. Further Interactions: Pharmaceutical Markets, Intellectual Property and Human Rights I. The Right to Health and Access to Medicines and the Relationship with Intellectual Property Rights: An Overview II. Compulsory Licensing III. Concluding Remarks 9. Public Health and Public Interest in Competition Law I. Public Health and Competition Law II. Competition Law and Non-competition Interests III. Concluding Remarks Conclusion Bibliography Index 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