EC's orphan drug proposal
OXFORD - Europe took a step closer to having its own orphan drug legislation. After seven drafts and years of delay, the European Commission last week unveiled its proposal for a European orphan medicinal products regulation.
European pharmaceutical and biotech executives gave the proposal a qualified welcome.
Commission officials are proposing incentives to support companies developing compounds to treat diseases that affect fewer than 1 in 2000 European citizens or are life threatening or seriously debilitating communicable diseases for which products would not be developed without incentives to provide sufficient returns.
Orphan drug status will