Progress On European Orphan Drug Legislation

Orphan drug legislation came first to the USA, when the US Congresspassed the Orphan Drug Act in 1983. More recently, there has been a French initiative in this area, which resulted in the European Council of Ministers also addressing the problem in 1995, asking the European Commission to draft proposals for orphan drug regulations.

EU Parliament Examination Due Directorate G III, responsible for industrial matters, has been in charge of preparing the future European orphan drug regulation. This project is expected to be examined in the European Parliament this fall, according to Pharmaceutical Partners for Better Healthcare's publication The Patient's Network, with the first rulings expected in the first half of 1998. The following points are included in the draft bill:

- a committee on orphan drugs will be set up to determine which drugs will be designated as orphan. This committee will be assisted by the European Medicines Evaluation Agency;