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Vol 23 No 5 May/June 2018

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Law and the Regulation of Medicines

ISBN13: 9781849461795
Published: March 2012
Publisher: Hart Publishing
Country of Publication: UK
Format: Paperback
Price: £36.99

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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.

While the UK's regulatory regime is the principal focus, the question of global access to medicines is addressed not only because of its political importance, but also because it is an issue which places the question of whether medicines are a private or a public good in particularly stark focus.

Two further specific challenges to the future of medicines regulation are examined separately: pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and the possibility of using medicines to enhance wellbeing or performance, rather than treat disease.

Throughout, the emphasis is upon the role of regulation in shaping and influencing the operation of the medicines industry, an issue which is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

Medical Law
1. What are Medicines and why are they Special?
2. Clinical Trials
3. Licensing
4. Pharmacovigilance and Liability for Dangerous Drugs
5. Marketing
6. Funding and Access to Medicines in the UK
7. Funding and Access to Medicines: A Global Problem
8. The Future of Medicines I Pharmacogenetics
9. The Future of Medicines II: Enhancement