Constitutional asymmetry and pharmaceutical policy-making in the European Union

Abstract

This paper offers a theoretical perspective on pharmaceutical policy-making in the European Union, and shows the lack of a single European market in medicines to be the result of a clash between the supranational free movement rules and national healthcare policy competencies. The paper considers the roles of the European Commission, the member states, the industry and consumer interests (patients) as the main stakeholders, and frames the discussion within an integrated macro- and meso-level approach. Here we draw on Wilson's ‘politics of (regulatory) politics’ typology, tying it to Scharpf's ‘constitutional asymmetry’ perspective on EU policy. This enables the development of a broad sphere of analysis, allowing us to make observations on the EU regulatory arrangement for medicines as a whole. Specifically, the paper shows the extent to which industrial rather than health(care) policy interests have driven the development of regulatory policy in the sector, and seeks to understand the political dynamics shaping the on-going evolution of the regulatory framework.