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Law and the Regulation of Medicines

By: Emily Jackson
Media of Law and the Regulation of Medicines
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Published: 01-03-2012
Format: EPUB eBook (?)
Edition: 1st
Extent: 308
ISBN: 9781847319098
Imprint: Hart Publishing
RRP: £35.09
Online price : £28.07
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About Law and the Regulation of Medicines

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.

Table Of Contents

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


“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.” –  Tamara Hervey, Medical Law Review

“...this was an exceptional book that left me much better informed and much better equipped than I had been before I read it, and I think it implicitly encourages the reader to think more deeply about fundamental questions...” –  Shawn HE Harmon, Social and Legal Studies 22(3)

“It is impossible in a short review to do justice to Jackson's rich and critically informed account of a drug's journey from synthesis through trials, licensing, marketing, pharmacovigilance, and approval by the National Institute of Clinical and Healthcare Excellence (NICE).
This is an excellent book. It is essential read for all medial lawyers, and anyone who wants a comprehensive understanding of the current regulatory framework of pharmaceutical industry, and the problems it faces, given the immense power and influence of the industry in shaping global healthcare.
” –  Phil Fennell, Journal of Law and Society, Volume 40(2)

“Jackson provides a meticulously argued, extensively researched and utterly compelling critique of the current regulation of pharmaceuticals.
This important new book should serve as a clear call to arms anyone who cares about patient health, NHS budgets and global justice.
” –  Sally Sheldon, Modern Law Review

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