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

Medical Law

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

By Sabrina Röttger-Wirtz
Hart Publishing March 2023

Specifications

ISBN-13
9781509943081
Publisher
Hart Publishing
Publication
March 2023
Format
Paperback
Jurisdiction
U.K. ? Countri(es) for reference only

Also available as

Hardback

Details

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy.

Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. 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 legal and policy framework, 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 European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Table of 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
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