1 Queen’s Papers on Europeanisation No 8/2002 New Mechanisms of Europeanisation in the Process of EU Enlargement: the Example of Pharmaceutical Regulation∗

In the light of the enormous challenges imposed by the EU’s eastern enlargement, this paper examines, using pharmaceutical regulation as a case study, how the European Commission attempts to keep the candidate countries ’ demand for derogations from the acquis communautaire to a minimum, without deviating from the principle that future members have to accept all EU rules. I argue that a dual strategy of both institutionalising the process of regulatory adaptation and decentralising governance renders the enlargement process “smoother”, thus reducing the risk of conflicts during the pre-accession phase. By establishing a more decentralised and institutionalised mechanism of Europeanisation, in which an agency (EMEA) is the core actor and a pan-European forum (PERF) serves as the main arena of negotiation, the European Commission has shown flexibility with regard to the method by which it prepares the candidates for the implementation of the acquis. This new strategy of “mutual understanding ” and “learning ” facilitated a more efficient adoption of EU regulations in a complex and highly standardised sector such as pharmaceutical regulation. Expecting that future enlargements will even be more sophisticated, solutions that support efficiency and conflict resolution in the pre-accession phase are worth being considered