ABSTRACT
Research on the Europeanisation of medicines regulation must, of course, analyse the appropriate institutions which operate at the level of the EU. However, it is important not to lose sight of national institutions and their development within individual European countries. It is our contention that, in the case of European medicines regulation, it is desirable to examine not merely the transnational EU systems or, say, the UK-EU interface, but also to compare different European countries in order to appreciate the nature of the interaction between European regulation, scientific expertise and public health. The reasons for adopting such an approach are that a national position towards medicines harmonisation may have influenced, and been influenced by, the positions taken by other EU countries; and that explanations of differences and similarities in regulatory priorities and practices across different Member States can provide valuable insights into why harmonisation takes one particular route rather than another. Furthermore, a defining characteristic of the ‘Europeanisation’ of medicines regulation is that some powers remain with Member States, and the utilisation of those powers can only be examined if some analysis focuses on the national level.
