Drug selection in a regulated society: the Norwegian experience.

Norway has strictly regulated the introduction and marketing of drugs for more than 50 years. The system is a state owned whole-sale monopoly with nationwide distribution. Marketing approvals must satisfy a medical "need" clause and are granted and reviewed every 5 years by the " Specialties ' Committee." Although clinical trials are not mandatory for drug approval, relative efficacy and benefit/risk considerations make them desirable. Assessment of clinical data is based on reviews by outside consultants. Because of such strict regulation, the total number of drug products available is smaller than other Western European countries, however, only a few therapeutic classes are not represented. The impact of regulation on the drug market and the therapeutic armamentarium available for health care in Norway are discussed.