EU encourages marketing of orphan products:
This article was originally published in Clinica
Executive Summary
The European Parliament has approved the EC regulation on orphan medicinal products, giving exclusive marketing rights for 10 years to products that would be unlikely to generate sufficient returns without such incentives. The regulation will cover products that diagnose, prevent or treat, life-threatening, seriously debilitating or serious chronic conditions and will include some products on the drug/device borderline, such as contrast media. Orphan status will be decided by a new committee set up at the European Medicines Evaluation Agency and companies will benefit from a range of incentives, including a reduction in, or a waiver of, registration fees.