[Orphan drugs].
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.
Kolár
J
J
Ustav aplikované farmacie Farmaceutické fakulty Veterinární a farmaceutické univerzity, Brno. kolar@vfu.cz
Chalabala
M
M
Srámková
H
H
D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D006291:Health Policy; D007564:Japan; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence*; D014481:United States