Introduction

This book is about how medicines are controlled in the European Union (EU), with particular emphasis on the sociology and political economy of medicines regulation. It is written to be accessible to specialists and non-specialists in academia, government agencies, industry, the medical profession and consumer organisations. The focus is on the safety and effectiveness of drug products themselves, rather than on the pricing of medicines. Problems concerning the risks and benefits of medicines are inevitably part of such regulation and involve medical scientists and scientific expertise. Hence, the book may also be seen as an exploration of the relationship between regulation and science. Some may read it as a case study of the pharmaceutical sector in the politics of regulation or European studies, others may read it as a study of regulation within medical sociology, and still others will see it simply as an addition to the literature on medicines policy.