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New Arrival Regulation, Innovation and Competition in Pharmaceutical Markets: A Comparative Study

Regulation, Innovation and Competition in Pharmaceutical Markets: A Comparative Study

  • 作者:
  • 出版商: Hart Publishing
  • ISBN: 9781509965557
  • 出版时间 October 2024
  • 规格: Paperback
  • 适应领域: U.K. ? 免责申明:
    Countri(es) stated herein are used as reference only

List Price: ¥492.56

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  • 描述 
  • 大纲 
  • 详细

    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.

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    Student Edition ISBN 不可用
    Previous edition isbn 不可用
    Hardback edition isbn 不可用
    Paperback edition ISBN 不可用
  • 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. Concluding Remarks 76
    viii Contents

    PART II
    4. Competition Law Enforcement in Pharmaceutical Markets: An Introduction 79
    I. EU and US Antitrust Rules: An Essential Overview 79
    II. Antitrust Enforcement in the Pharmaceutical Sector 87
    III. Market Definition 95
    IV. Concluding Remarks 100
    5. Reverse Payment Patent Settlements 102
    I. The Recurrence of Reverse Payment Patent Settlements in Pharmaceutical Markets 102
    II. Reverse Payment Patent Settlements in the United States 105
    A. Earlier Case Law and the Actavis Ruling 105
    B. Critical Issues after Actavis 109
    C. Further Developments 113
    III. EU Case Law on Reverse Payment Patent Settlements 119
    A. Lundbeck 120
    B. Generics 123
    IV. Comparative Analysis 127
    A. Legal Frameworks 127
    B. The Antitrust Assessment 129
    V. Concluding Remarks 134
    6. Product Hopping 136
    I. Pharmaceutical Product Reformulations 136
    II. Product Hopping before US Courts 140
    III. The EU Experience 146
    IV. The Antitrust Assessment of Product Reformulation 151
    V. Concluding Remarks 155
    7. Excessive Drug Pricing 157
    I. The Resurgence of Excessive Pricing Cases in the Pharmaceutical Sector 157
    II. Excessive Pricing under EU Competition Law 161
    A. Aspen 165
    III. The US Approach 169
    IV. The Role of Antitrust Enforcement on Excessive Drug Prices 176
    V. Concluding Remarks 178
    Contents ix

    PART III
    8. Further Interactions: Pharmaceutical Markets, Intellectual Property and Human Rights 183
    I. The Right to Health and Access to Medicines and the Relationship with Intellectual Property Rights: An Overview 183
    II. Compulsory Licensing 191
    III. Concluding Remarks 196
    9. Public Health and Public Interest in Competition Law 198
    I. Public Health and Competition Law 198
    II. Competition Law and Non-competition Interests 203
    III. Concluding Remarks 208
    Conclusion 209
    Bibliography 213
    Index 233

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