Regulating the (E)Uterus - Epistemic Communities in the European Medicines Agency and the case of ellaOne

Abstract

EU institutions increasingly rely upon opinions from scientific experts in decentralised agencies as the basis for EU-level legislation. At the same time, the role of private actors as drivers of integration is becoming more important as the availability of goods and services on the internal market depends upon proactive behaviour on their part. With regard to European governance, this expanding role of non-elected and non-governmental actors raises questions about democratic accountability and legitimacy. In early 2015, the European Commission modified the marketing authorisation for the emergency contraceptive brand ellaOne from prescription to non-prescription status. This decision was based upon a positive opinion from the European Medicines Agency (EMA) and effectively made emergency contraception available over the counter in five EU Member States (MS). This case illustrates the importance of the scientific experts employed in EU agencies and raises questions regarding the role and influence of expert communities in EU policy-making. Departing from the theoretical framework of Epistemic Communities as a specific type of expert group, this thesis aims to better understand the role of scientific experts in EU medicines regulation by analysing eight semi-structured interviews with members of the Committee for Medicinal Products for Human Use (CHMP) at the EMA.