Law and the Regulation of Medicines

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VII Withdrawn Medicines?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