The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good.
Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease.
Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.
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
