Law and the Regulation of Medicines

1. Auflage 2012
ISBN: 978-1-84946-179-5
Verlag: Bloomsbury 3PL

Buch, Englisch, 308 Seiten, Paperback, Format (B × H): 156 mm x 234 mm, Gewicht: 488 g

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.

Autoren/Hrsg.

Jackson, Emily

Fachgebiete

• Rechtswissenschaften Ausländisches Recht Common Law (UK, USA, Australien u.a.)
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinrecht, Gesundheitsrecht

Inhaltsverzeichnis

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

Über Autor(innen)

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