Orphan Designation

Providing drugs for rare disease was not profitable, but still they were in need. With the support of government assistance and incentives such as tax credits, fee exemptions and protection on the market, the development of orphan medicinal products (= drugs) has been made more attractive for pharmaceutical companies. The medicine must fulfill certain criteria as an orphan drug to be recognized as such by the authorities. 

In the European Union, the Orphan Medicinal Product Regulation (EC) No 141/2000 requires that the sponsor seeking to obtain or having obtained the designation of a drug as an orphan medicinal product must be established in the EU.