Product Description

This book presents a critical appraisal of medicines regulation policy and exposes the influence of the pharmaceutical industry in the acceleration of drug approvals.

Product Details

• Amazon Sales Rank: #1154343 in Books
• Published on: 2000-09-28
• Original language: English
• Number of items: 1
• Binding: Paperback
• 256 pages

Review
'This book breaks new ground through interrogating European and global practices associated with the development of new drugs - the book deserves and demands a wide readership,' - Andrew Webster, Professor of Sociology University of York and Director of the (ESRC's) Innovative Innovative Health Technologies Programme

`We are entering a period when a book like this will be immensely important - it provides a much needed new look at regulating medicines. Commendably calm and nicely structured, the book will also induce a strong stimulus to further research.' - Graham Dukes, Emeritus Professor of Drug Policy Studies, University of Groningen

From the Back Cover
Regulating Medicines in Europe explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations, John Abraham and Graham Lewis provide the first major critical examination of the new Europeanised systems of medicines regulation. They argue that the drive to produce and approve drugs more quickly on to a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.
The authors demonstrate that national regulatory agencies now compete in an internal EU market for fees from pharmaceutical companies in the race to approve new drugs. The implications of this competition and European harmonisation of risk-benefit assessments for new drugs safety standards, industry-regulator relations and public accountability are carefully scrutinised.
Regulating Medicines in Europe will prove a valuable resource to all those concerned with medicine regulation.

About the Author
John Abraham is Professor of Sociology and Co-ordinator of the Centre for Research in Health and Medicine at the University of Sussex, and former Research Fellow in Science Policy at the University of Reading. Dr Graham Lewis is a wirte and cinsultant on European and international medicines regulation.