Monday, September 29, 1997
Officials at the European Commission are expected to unveil proposals for the long-awaited orphan drug legislation in November. Patrick Deboyser, head of the commission's pharmaceuticals unit, confirmed that proposals are being finalized that will provide drug developers with an exclusive right to market designated orphan drugs for 10 years.
At present, the commission blueprint defines an orphan drug as a medicine for a disease that affects 1 in 1,200 people. This compares favorably with the U.S definition, which describes orphan diseases as those affecting about 1 in 1,300, or fewer than 200,000 Americans.