The Interplay of Global Standards and EU Pharmaceutical Regulation: The International Council for Harmonisation

Description

This book analyses, and questions the impact and legitimacy of, the implementation of global pharmaceutical standards in the European risk regulation framework for pharmaceuticals. Global standards increasingly shape risk regulation law and policy in the European Union, and the area of pharmaceuticals is no exception. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU, the book questions the legitimacy of the Union’s reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the EMA, both as participants in global standard setting, and as the main gateway for global pharmaceutical standards being implemented in the European Union. Contents Introduction I. EU Pharmaceutical Regulation in a Globalised Market II. Global Standards: Questions of Legitimacy III. The Contribution of this Book: The Influence of Global Standards through the EU Lens IV. The Structure of this Book Part I 1. Regulating Pharmaceuticals in the European Union: Law and Administrative Rule-Making I. EU Pharmaceutical Regulation: Past and Present II. The Core of the Regulatory Framework: The Marketing Authorisation Procedures III. The Role of Administrative Rule-Making in EU Pharmaceutical Regulation IV. Conclusion: Incremental Integration, Extensive (Risk) Regulation and the Significance of Administrative Guidance 2. EU Risk Regulation in a Globalised World: Global Standards I. The Phenomenon of Global Standard-Setting II. The Institutional Landscape of Global Standard-Setting III. The Interplay between Global Standards and EU Risk Regulation IV. Conclusion: Institutional Diversity in the Face of Regulatory Complexity 3. The International Council for Harmonisation: Pharmaceutical Standard-Setting on the Global Level I. Pharmaceutical Regulation in a Globalised World: The History of the ICH II. The ICH: Mandate and Membership III. The ICH: Institutional Structure IV. The Standard-Setting Process V. Conclusion: The Reformed ICH in Perspective 4. The Implementation of ICH Standards in the European Union I. A Closer Look at the ICH Guidelines II. Implementing Global Standards in the EU: The Integration of ICH Standards in EU Pharmaceutical Law III. The Influence of ICH Guidelines on Legislation, Commission Guidelines and the Court of Justice IV. Conclusion: ICH Guidelines as Integral Parts of the EU Regulatory Framework for Pharmaceuticals Part II 5. Questioning the Legitimacy of Global Standards I. Why Should the Legitimacy of Global Standards Be Examined? II. What Constitutes Legitimacy on the Global Level? III. Administrative Law and Global Standards IV. Applying the Perspective of European Administrative Law V. Conclusion: In Search of Legitimacy 6. Examining the Legitimacy of the ICH Standard-Setting Procedure and Uploading EU Administrative Law I. The Principle of Participation II. The Principle of Independent Expertise III. The Principle of Transparency IV. Discussing Remedies: The Introduction of Ex-ante and Ex-post Procedures in the Process of Implementation V. Conclusion: Undermining and Uploading Procedural Standards 7. Global Pharmaceutical Standards as a Challenge for EU Law: Remedies within the EU I. Political Accountability Within the EU for Global Pharmaceutical Standards: A Remedy with Limits II. Legal Accountability: Judicial Review of ICH Guidelines within the EU III. A Broader Perspective: Global Standards as a Challenge for European Law – The Potential for Juridification IV. Conclusion: Accountability Gaps and Juridification Conclusion I. Pharmaceutical Regulation in a Globalised World II. The Legitimacy of Global Pharmaceutical Standards III. Lessons Learned from 'Uploading' EU Law to the ICH IV. The Implementation of Global Standards as a Legitimacy Challenge for the EU Bibliography Index