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 pre-accession phase. By establishing a more decentralised and institutionalised mechanism Europeanisation, in which an agency (EMEA) is core actor pan-European forum (PERF) serves as main arena negotiation, European Commission has shown flexibility with regard to method it prepares candidates for implementation acquis. This new strategy "mutual understanding "learning" facilitated efficient adoption EU regulations complex highly standardised sector such pharmaceutical regulation. Expecting that future enlargements will even be sophisticated, solutions support efficiency conflict resolution phase are worth being considered.