کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
4198204 1609031 2010 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A comparative study of European rare disease and orphan drug markets
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی سیاست های بهداشت و سلامت عمومی
پیش نمایش صفحه اول مقاله
A comparative study of European rare disease and orphan drug markets
چکیده انگلیسی

ObjectivesThis article aims to compare regulatory aspects of rare disease and orphan drug markets in Belgium, France, Italy, the Netherlands, Sweden and the United Kingdom.MethodsInformation was derived from the international literature, analysis of legal texts, and a survey completed by national experts.ResultsThese countries adopted varying approaches towards regulating rare disease and orphan drug markets and, hence, the availability, pricing and reimbursement of orphan drugs vary between countries. Strategies to keep down prices include public procurement in Sweden, profit controls in the United Kingdom, and price comparisons with other countries. To gain reimbursement, the cost-effectiveness and/or budget impact of orphan drugs is considered in some countries. Other societal considerations, such as whether the drug treats a life-threatening disease, are sometimes taken into account.ConclusionsExtensive government intervention exists in rare disease and orphan drug markets in the countries studied. Our recommendations are to define priorities for research on rare diseases and orphan drugs at the European level, to set up disease and patient registries with a view to investigating the long-term effectiveness and cost-effectiveness of orphan drugs, to assess the profitability of orphan drugs, and to take into account societal considerations when evaluating orphan drugs.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Health Policy - Volume 97, Issues 2–3, October 2010, Pages 173–179
نویسندگان
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