Regulating Medicines in Europe

This Book 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,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for 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. Introduction; Chapter 1 Science, technology and regulation; Chapter 2 Opening the black box of European medicines regulation; Chapter 3 National regulation in Europe; Chapter 4 The Europeanisation of medicines regulation; Chapter 5 The politics of scientific expertise; Chapter 6 Competition, harmonisation and public health; Chapter 7 Democracy, technocracy and secrecy; Chapter 8 Conclusions and political implications;