Law and the Regulation of Medicines

Informationen zum Autor Emily Jackson is Professor of Law at the London School of Economics. Klappentext The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK! from the definition of a medicine! through clinical trials! licensing! pharmacovigilance! litigation! marketing and funding. Zusammenfassung The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK! from the definition of a medicine! through clinical trials! licensing! pharmacovigilance! litigation! marketing and funding. 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Confidentiality III Resource Implications IV Cost-effectiveness and Orphan Patients V Clinical Trials VI Licensing VII Withdrawn Medicines?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 ...

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.

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

Texte du rabat

The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from the definition of a medicine, through clinical trials, licensing, pharmacovigilance, litigation, marketing and funding.

Contenu
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