Joint Task Force on Orphan Medicinal Products and Rare Diseases Meets in Brussels

BIO Deutschland has been working for several years in the European trade associations’ joint task force that aims to improve the conditions for medicinal products for rare diseases (“orphan drugs”). At the beginning of March, the group held its first meeting of 2015 in Brussels. The agenda included discussion on a possible revision of the EU Regulation on Orphan Medicinal Products (141/2000/EC). The terms “additional benefit” and “significant benefit” are to be revised as a result of current developments. The aim remains to introduce stricter regulations for similar medicinal products with the same therapeutic field of application.

The members of the joint task force also discussed which topics should be addressed in 2015. Project teams were set up to deal with health technology assessment and joint procurement, as well as to draw up guidelines on the terms “additional benefit” and “similar medicinal products”.

The agenda also included discussion on the planning for the event to mark the fifteenth anniversary of the Regulation on Orphan Medicinal Products. An event will be held in the European Parliament on the morning of 26 May 2015.