Law and the Regulation of Medicines

Description

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.

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

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 *