Supranational regulatory agencies between independence and control: the EMEA and the authorization of pharmaceuticals in the European Single Market

ABSTRACT

The European Medicines Agency (EMEA) represents a new type of supranational regulation. Formally, it merely advises the Commission and a member state committee on the authorization of pharmaceuticals. In practice, however, it dominates decision-making and operates much like an independent agency. Based upon a brief discussion of the merits of independent regulation and the necessity to control regulatory activities, the article explores the institutional arrangement in which the EMEA is embedded and seeks to explain how tight oversight is compatible with quasi-independent action. It argues that the multi-tiered oversight mechanism restricts the non-scientific actors involved in the authorization of pharmaceuticals more than the agency – as long as the agency adheres to its mandate of producing scientifically convincing decisions.

Keywords:

• Delegation
• EMEA
• pharmaceuticals
• regulatory agencies
• Single Market regulation