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

Thomas Gehring, Sebastian Krapohl

Research output: Contribution to journalReview articlepeer-review

55 Scopus citations

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.

Original languageEnglish
Pages (from-to)208-226
Number of pages19
JournalJournal of European Public Policy
Volume14
Issue number2
DOIs
StatePublished - Feb 2007

Keywords

  • Delegation
  • EMEA
  • Pharmaceuticals
  • Regulatory agencies
  • Single Market regulation

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