Single market regulation between technocratic independence and political control: the European Agency for the Evaluation of Medicinal Products and the authorisation of pharmaceuticals

Abstract

"The paper explores the successful European scheme for the authorisation of pharmaceuticals within the Single Market. Theoretically, it argues that successful regulation requires the exclusion of parochial interests from the decision process and the strict limitation of the agency's opportunities to adopt arbitrary decisions. Empirically, it holds that these conditions are fulfilled in the European authorisation scheme. The European Agency for the Evaluation of Medicinal Products (EMEA) enjoys a strong agenda-setting power, while it is locked into a control arrangement that precludes arbitrary decisions. Moreover, all actors involved in the decision-making process are bound to a coherent and detailed set of legally binding decision-making criteria as well as subject to judicial review." (author's abstract)