Now is the time

To strengthen the EU Blood Directive

To meet the needs of patients using plasma-derived medicines and plasma donors

The Directive can frame the unique aspects of human plasma more precisely

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.

Call to Action

The Blood Directive, related European legislation, and national public health regulations need to:

  • Explicitly recognize the unique nature of plasma used for manufacturing plasma-derived medicines. It is fundamentally different from whole blood and other labile blood components.
  • Support the EU’s policy of ‘Open Strategic Autonomy’ and address Europe’s reliance on plasma from the U.S. by encouraging the creation of a stronger European plasma donation ecosystem.

The renewed EU Blood Directive should:

  • Clarify the difference between plasma used for transfusion and plasma used to manufacture plasma-derived medicines. This is the foundation of policies that will encourage increased availability of plasma.
  • Support Member States as they establish dedicated programmes for direct plasma collection (plasmapheresis) and outreach to inform communities of the critical importance of plasma-derived medicines and the need for plasma donations.
  • Encourage plasma donations by clarifying that a fixed-rate allowance, of which the conditions are set by regulators, to compensate donors – for expenses and inconveniences related to donation – is in line with the principle of Voluntary Unpaid Donation, similar to the EU Tissues & Cells Directive 2004/23/EC, art. 12.1.
  • Promote the coexistence of public blood and plasma collection centres, together with private plasma collection centres.

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