Law and the Regulation of Medicines (Paperback, 1st)

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 Medicines V Conclusion 2 Clinical Trials I What are Clinical Trials? II Regulating Trials III Ethical Review IV Trials and Industry V The Global Trials Industry VI Conclusion 3 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 Conclusion 4 Pharmacovigilance and Liability for Dangerous Drugs I Post-marketing Surveillance II The Consequences of Identifying Drug Safety Hazards III Liability for Drug Injuries IV Conclusion 5 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 Conclusion 6 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 Conclusion 8 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Confidentiality III Resource Implications IV Cost-effectiveness and Orphan Patients V Clinical Trials VI Licensing VII Withdrawn Medicines?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