By Mike Ward
Editor, Europe

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.

Approved orphan products would have 10 years of market exclusivity, which could be reduced to six years based on the product's profitability. Orphan protection also could be lost if a following product were shown to be clinically superior (see Online Links, A4).

Pending a budget allocation from the European Parliament, a Committee for Orphan Medicinal Products could be operational as early as late February, said Anthony Arke, general secretary of EuropaBio.

Scientific oversight in Europe