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Author:   Emily Jackson
Publisher:   Bloomsbury Publishing PLC
Imprint:   Hart Publishing
Dimensions:   Width: 15.60cm , Height: 2.00cm , Length: 23.40cm
Weight:   0.454kg
ISBN:  

9781849461795

ISBN 10:   1849461791
Pages:   308
Publication Date:   01 March 2012
Audience:   Professional and scholarly ,  College/higher education ,  Professional & Vocational ,  Tertiary & Higher Education
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand  
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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Confidentiality III Resource Implications IV Cost-effectiveness and Orphan Patients V Clinical Trials VI Licensing VII Withdrawn Medicines?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

Reviews

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 FennellJournal of Law and SocietyVolume 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 SheldonModern Law ReviewMarch 2013

...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 March 2013

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 SheldonModern Law ReviewMarch 2013

Author Information

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

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