Enabling harmonization – Business actors and the eastern enlargement of the EU

Abstract

In recent years, most enlargement research has focused on theorizing the process of eastern enlargement and analysing the incentives of both the European Union (EU) and candidate member states to initiate a gradual process of legal and policy approximation with the prospect of eventual membership. Although the bulk of the literature draws on bilateral executive negotiations between the European Commission and central governments, there is little systematic account of the role of non-actors in the process of policy approximation with EU standards during the pre-accession negotiations. In light of the enormous economic, political and administrative challenges posed by the EU's eastern enlargement, we raise the question of the extent to which eastern enlargement has provided new opportunities to private actors from the Central Eastern European region to pursue their interests in the process of aligning domestic regulatory regimes to European policies. Drawing on empirical evidence from pharmaceutical harmonization in Hungary and Poland, the article analyses the extent to which enlargement has empowered non-state actors as shapers of success or failure in the efficient and effective adoption of and adaptation to EU regulatory requirements.