Learning and interest accommodation in policy and institutional change: EC risk regulation in the pharmaceuticals sector

The purpose of this paper is to formulate hypotheses about the emergence of marketing approval regulation for human-use pharmaceuticals in the European Community since the beginning of the 1960s. Focusing on the developmental and institutional logic of the regulatory structures at different points in time, it highlights the way in which policy learning and actor interests have shaped the resulting regulatory policies and the way in which a variety of interests have been accommodated in the institutionalised procedures. At the same time, this analysis sheds light on the asymmetric distribution of influence especially in the implementation process...