Law and the Regulation of Medicines

Emily Jackson is Professor of Law at the London School of Economics.

• 1 What are Medicines and why are they Special? I Why Medicines are Special II The Development of a Special Regulatory Regime for Medicines III What is a Medicine? IV Complementary and Alternative MedicinesV Conclusion2 Clinical Trials I What are Clinical Trials? II Regulating TrialsIII Ethical Review IV Trials and Industry V The Global Trials Industry VI Conclusion3 Licensing I The Significance of a Marketing Authorisation II Applying for a Marketing Authorisation III Grounds for Licensing Decisions IV Relationship between Regulators and Industry V Classification of Medicines VI Buying Prescription Drugs Online VII Conclusion4 Pharmacovigilance and Liability for Dangerous Drugs I Post-marketing Surveillance II The Consequences of Identifying Drug Safety Hazards III Liability for Drug Injuries IV Conclusion5 Marketing I Direct to Consumer Advertising II Selling Diseases III Patient Groups IV Public Relations V The Relationship between Doctors and the Pharmaceutical Industry VI Conclusion6 Funding and Access to Medicines in the UK I The Costs of Prescription Medicines II The Pharmaceutical Price Regulation Scheme III Value-Based Pricing IV The National Institute for health and Clinical Excellence (NICE) V Exceptional Case Review VI Judicial Review VII Top-Up Payments VIII Conclusion 7 Funding and Access to Medicines: A Global Problem I The Problem of Unaffordable Medicines II TRIPs, Doha and Generics III Incentives to Develop and Supply Treatments in Low-income Countries IV Humanitarian, Charitable and Philanthropic Initiatives VI Conclusion8 The Future of Medicines I: Pharmacogenetics I The Limitations of Genetic Testing II An Expansion in Genetic Testing: Consent and Confidentiality III Resource Implications IV Cost-effectiveness and Orphan Patients V Clinical Trials VI Licensing VII Withdrawn Medicines? VIII Improved Post-licensing Surveillance? IX Liability for Harm X Conclusion 9 The Future of Medicines II: Enhancement I The Line between Treatment and Enhancement II A Pharmacological Fix? III Enhancing Sporting Ability and Cheating IV A Parallel with Education? V Distributional Justice VI Coercion VII Prescription Drug Abuse VIII Transhumanism and Posthumanism: Utopia or the End of History? IX Conclusion Concluding Remarks

Although it is written by a legal scholar, this is not a book that focuses solely upon the narrowly 'legal', and it certainly does not concentrate almost exclusively on case law, as is the case with many books in the field of medical law. Rather, the case law, and the relevant legislation (both UK and EU), is placed firmly in its various contexts. This law-in-context approach contributes significantly to the success of the book, as does its interdisciplinarity. The book is hugely rich and varied in terms of the literature to which it refers. Law journals or books are very much in the minority in the bibliography, and there is an impressive array of works written by medical sociologists, some ethicists, and philosophers, and a wide range of different medical professional specialists. In short, Jackson's book should be the reference point of choice in the field of UK pharmaceuticals regulation.