The current revision of the EU Blood, Tissues and Cells (BTC) legislation brings an opportunity to strengthen this legal framework. The revised EU BTC can encourage new approaches to increase plasma donations across the European Union which are needed to manufacture plasma-derived medicines.
The EU’s original legal framework for blood and blood components was not developed with the need of increasing plasma collection in mind. New clinical uses for plasma-derived medicines have expanded significantly in the past two decades. This, combined with Europe’s increasing reliance on plasma from the U.S., requires a policy change in how we collect plasma in Europe. Changes in the new EU Blood Directive will help increase plasma collected from European donors.
PPTA’s position paper highlights how the EU Blood Directive can be strengthened to benefit patients relying on plasma-derived medicines and donors across the EU.
The Blood Directive, related European legislation, and national public health regulations need to:
The renewed EU Blood Directive should: