Norris P
Health Services Research Centre, Victoria University, Wellington, New Zealand.
Health Policy. 1998 Jan;43(1):65-81. doi: 10.1016/s0168-8510(97)00083-3.
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.
尽管挪威并非欧盟（EU）成员国，但由于欧洲经济区（EEA）协议，它是欧洲内部市场的一部分。1994年之前，挪威在药品许可和分销方面有着一套独特的安排。由于欧洲的协调统一，其中许多安排都发生了重大变化。本文描述了先前的安排以及欧洲协调统一对它们的影响。由于“需求条款”的丧失和价格控制的变化，挪威的市场授权体系发生了重大变化。本文对此进行了描述，并试图评估其影响。平行进口的发展以及私人批发公司的引入，导致挪威药品市场出现了新的参与者，药品分销链各层级内部以及各层级之间的竞争都有所加剧。新的合作社也应运而生，以增强采购方（尤其是医院）的谈判能力。未来，挪威制药行业可能会发生进一步的重大变化。挪威的案例研究为审视欧洲协调统一对特定监管安排的影响提供了契机，也揭示了在国家层面实施欧洲政策的困难。
