Agnieszka Zimmermann, Rafał Zimmermann
Sieroce produkty lecznicze
2009-03-25
The rare diseases constitute serious problem for the public health. The legislature provides a definition of orphan medicinal products used in the treatment of rare diseases. The article describes the rules of classifying a medicinal product as an orphan medicinal product and presents the system of incentives for researchers and medicinal products manufactures introduced by the Regulation 141/2000. Furthermore, the article describes the rules of financing the treatment of patients in Poland within the frame of therapeutic programs.Keywords: Orphan medical products, rare diseases, legal acts, market exclusivity, clinical superiority.