Orphan law on target for 2000

OXFORD - Europe moved closer to a final set of rules on orphan drugs last week, as the European Parliament adopted without amendments a proposed regulation on orphan medicinal products. The proposal now heads back to the European Council of Ministers for final approval early next year.

The proposal would apply to products for life-threatening, seriously debilitating or serious and chronic conditions affecting not more than 5 in 10,000 persons, and where no diagnostic, preventative or treatment exists, or where a new product would provide significant benefit over existing products...