Orphan rules finally in place

OXFORD - The European Commission last week adopted rules for obtaining orphan drug designation, allowing companies to apply to the European Agency for the Evaluation of Medicinal Products (EMEA) to designate their candidate medicines as "orphan medicinal products" for patients with diseases that affect fewer than 5 patients in every 10,000 of the population in the European Union. Successful orphan drugs could receive up to 10 years of market exclusivity in the EU.

The rule implements European Parliament and Council Regulation 141/2000, which came into force on Jan. 22, but could not be implemented until the Commission had adopted the necessary definitions and implementing criteria...