The actual practice of agency autonomy: Tracing the developmental trajectories of the European Medicines Agency and the European Food Safety Authority

Abstract

In recent decades, a series of regulatory agencies has been created at the European Union (EU) level. The existing literature on EU agencies focuses either on autonomy as reason for their creation or on the autonomy that they are granted by design. As a result, we do not know much about how EU agencies’ de facto autonomy comes about. This paper therefore probes into the development over time of two particular agencies. On the basis of document analysis and interviews with agency officials and external actors, it explores why in practice the European Medicines Agency (EMA) seems to have developed a higher level of autonomy than the European Food Safety Agency (EFSA), whereas on paper EMA appears to be similarly autonomous as, or, if anything, less autonomous than EFSA. The paper demonstrates the importance of tracing the developmental trajectories of EU regulatory agencies for understanding the actual practice of their autonomy.