Does licensing of drugs in industrialized countries guarantee drug quality and safety for Third World countries? The case of norplant licensing in Finland.
Norplant implantable contraceptives were developed mainly for use in Third World countries, but first were approved for marketing in Finland in 1983 and in Sweden in 1985. Since then Norplant has been approved in more than 40 countries, most of them in the Third World. The authors analyzed the clinical documentation submitted to the Finnish and Swedish drug control authorities, and the assessments made of the data. The Finnish review process lasted for three years, and the number of data increased substantially during that time. The authors have not been allowed to publish the clinical data submitted in Finland, but a reconstruction from the Swedish data showed that the clinical data were of poor quality and were mainly focused on assessing efficacy. Side effects, acceptability, and requirements of the health care system for proper use of Norplant were poorly studied. This example of Norplant licensing in Finland shows that licensing of drugs in industrialized countries is insufficient for guaranteeing their safety in Third World countries.
Ollila
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National Research and Development Centre for Welfare and Health, Health Services Research Unit, Helsinki, Finland.
Hemminki
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D003271:Contraceptive Agents, Female / Q000009:adverse effects / Q000592:standards*; D019049:Developed Countries; D003906:Developing Countries; D017277:Drug Approval; D005260:Female; D005387:Finland; D033161:Government Regulation; D006801:Humans; D033181:Information Dissemination; D038622:Internationality; D016912:Levonorgestrel / Q000009:adverse effects / Q000592:standards*; D011247:Pregnancy; D035842:Research Subjects; D018570:Risk Assessment; D013548:Sweden
D003271:Contraceptive Agents, Female; D016912:Levonorgestrel