The impact of European harmonisation on Norwegian drug policy.

Although not a member of the European Union (EU), Norway is part of the European internal market as a result of the European economic area (EEA) agreement. Before 1994, Norway had a distinctive set of arrangements for the licensing and distribution of medicines. Many of these have undergone considerable change as a result of European harmonisation. This paper describes the previous arrangements and the impact of European harmonisation on them. Significant changes have been made to the Norwegian marketing authorisation system because of the loss of the 'need clause' and changes in price control. These are described and an attempt is made to evaluate their impact. The development of parallel importing and the introduction of private wholesaling companies have led to the development of new players in the Norwegian drug market and an increase in competition both within and between levels of the pharmaceutical distribution chain. New co-operatives have also arisen to increase the negotiating power of purchasers, particularly hospitals. Further significant changes are likely to occur in the Norwegian pharmaceutical sector in the future. The Norwegian case study provides an opportunity to look at the impact of European harmonisation on a particular set of regulatory arrangements and sheds light on the difficulty of implementing European policy in a national setting.