Law and the Regulation of Medicines

Emily Jackson

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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 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. The book will be of interest to medical lawyers and scholars interested in medical law, as well as those who deal with the regulation of medicines on a professional basis.

Book Details

Publisher: Hart Publishing
Publish Date: Mar 1st, 2012
Pages: 308
Language: English
Edition: UK - undefined
Dimensions: 9.10in - 6.20in - 0.60in - 0.80lb
EAN: 9781849461795
Categories: • Medical Law & Legislation• Administrative Law & Regulatory Practice• Ethics

About the Author

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

Praise for this book

"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." --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..." --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." --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." --Modern Law Review