Credible Commitment in Non‐Independent Regulatory Agencies: A Comparative Analysis of the European Agencies for Pharmaceuticals and Foodstuffs

Abstract

The creation of more and more supranational regulatory agencies has been one of the most significant institutional developments in the European Union during the last decade. Usually, these agencies evolve from EU committees and take over most of their structures. Accordingly, like most EU committees and the Commission, regulatory agencies are not independent, but act under the control of the member states. The question is, how far do they indicate a credible commitment of the Member States to long-term policy goals like health and consumer protection. This article compares the institutional structures and decision-making rules of the European Agency for the Evaluation of Medicinal Products and of the newly established European Food Safety Authority, in order to clarify the extent of credible commitment that the Member States show through the setting-up of these agencies. It concludes that the commitment of the Member States in the foodstuff sector is not as deep as in the pharmaceutical sector, and that the creation of the European Food Safety Authority will not lead to a success story similar to that of the European Agency for the Evaluation of Medicinal Products.

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

“…The European Medicines Agency (formerly the European Agency for the Evaluation of Medicinal Products, EMEA), which constitutes the cornerstone of the system, is among the most important supranational regulatory agencies founded in the EU during the last decade (Kelemen 2002;Krapohl 2004). It enjoys remarkably far-reaching competencies (Majone 1997) and may be conceived of as a blueprint for future agencies announced in the Commission White Paper on European Governance (COM 2001 [428] final).…”

The Rise of a European Public Administration: European Capacity Building by Stealth

“…They are often created on the basis of already existing organizational arrangements. Krapohl (2004) shows that several EU-level agencies have evolved from existing EU committees and take over most of their structures, like the European Food Safety Authority (EFSA) and the European Medicines Agency (EMEA). Similarly, Martens (2012) highlights that the organizational structures and standard operating procedures of the European Chemicals Agency (ECHA) to a large extent have been copied from the EMEA and the Commission framework through cut and paste.…”

The Politics of Information

“…This chapter explores agencies from an information processing perspective as a research strategy that it is hoped may contribute to filling this gap. We will do this by (re)investigating two intensively studied agencies in the EU -the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) -and by critically confronting some of the interpretations and claims made in the academic literature on EFSA and EMA (e.g., Kelemen 2002;Krapohl 2004;Borrás et al 2007;Gehring and Krapohl 2007;Groenleer 2011). Taken together, EFSA and EMA are interesting cases as their comparison presents a serious puzzle.…”