ABSTRACT
When considering the control of medicines in Europe, two distinct but related sources of government regulation need to be taken into account: the national legislation and institutions of the Member States; and the supranational bodies and laws of the EU. While the Europeanisation of medicines control has undoubtedly been a supranational and transnational phenomenon, it has been built on existing national systems of drug regulation. This process of Europeanisation did not start from a blank slate; it was partly shaped by the socioeconomic and political contexts of EU nationstates. The historical timing of regulatory developments may also be significant because different European countries may influence each other or even dominate ‘regulatory space’ (Hancher and Moran 1989b: 284-5). Hence, to understand Europeanisation, we must examine the nature of modern national regulation and how it has come about. This must, of course, go beyond legislation because, as Dukes (1985: 32) notes, the interpretation put upon the law by regulatory agencies and other parties involved is of great significance.
