Market Insight - Rare diseases and changes for the common good
This article was originally published in Scrip
Executive Summary
An orphan medicinal product is defined as a product to treat life-threatening or serious debilitating conditions for which no, or no satisfactory, alternative exists. The current EU definition of rare diseases is a prevalence of less than five cases per 10,000 persons. The European Union Orphan Medicinal Product (OMP) Regulation was introduced in 2000 with the remit of providing timely and equitable access to therapies for patients with rare diseases, and to balance risk by providing economic and other incentives to industry to develop such therapies.