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[Orphan drugs]
J Kolár1, M Chalabala, H Srámková
1Ustav aplikované farmacie Farmaceutické fakulty Veterinární a farmaceutické univerzity, Brno. kolar@vfu.cz
Abstract:
The paper discusses the problems of orphan drugs from the standpoint of the attitude of state authorities in the USA, Japan, and particularly Europe (the European Union) to their definition and the formation of appropriate legislation--financial provision for the development, production, provision of exclusive sale rights--which warranties the availability of the drug to every patient suffering from a rare disease.