12 September 2023, Brussels - The Plasma Protein Therapeutics Association (PPTA) believes that today’s European Parliament vote on the EU Regulation to safeguard quality and safety standards of Substances of Human Origin (SoHO) is a missed opportunity to ensure the establishment of a truly effective plasma collection ecosystem that would protect and increase patient access to life-saving plasma-derived medicinal products (PDMPs).
As the PPTA affirmed in July, Member States should be empowered to implement approaches that are best suited to their national healthcare systems and distinct external environments, within a clear legal framework. This would help increase the amount of plasma collected in the EU and reduce its 40% dependency on third countries for this essential starting material.
Especially important is donor compensation, a topic that divided MEP’s in the plenary vote. Most European countries already provide some form of monetary or non-monetary donor compensation to blood and plasma donors. Therefore, maintaining a broad and open definition of SoHO donor compensation would allow Member States to choose whether and how to compensate donors within the framework of the Voluntary Unpaid Donation (VUD) principle.
PPTA Executive Director Maarten Van Baelen comments: “The restrictive amendments proposed by the European Parliament, permitting donor compensation only for “quantifiable” losses, is at odds with guidelines on donation ethics from respected organisations such as the Council of Europe and the Nuffield Bioethics Committee.”
Moreover, the rationale for this proposed change has no basis, with published data (most recently in Transfusion) showing that repeat plasma donation is safe and does not adversely impact donor health.
Today, Austria, Germany, Czechia and Hungary, where plasma donors are compensated with a fixed-rate allowance and private collection centres are part of the system, not only meet the plasma needs of their citizens, but they also contribute 46 percent of the total amount of plasma collected in the EU.
As the Council of the European Union finalises its position ahead of trilogue negotiations, PPTA and its Member companies stand ready to work together with legislators to help ensure that Member States are given both the clarity and flexibility to implement the optimal conditions for SoHOdonations in Europe aligned with their individual healthcare system and local circumstances to meet growing patient need for plasma therapies.
About the Plasma Protein Therapeutics Association (PPTA)
The Plasma Protein Therapeutics Association is the trade association representing the manufacturers of plasma-derived medicinal products (PDMPs) and the private sector plasma collectors, which includes more than 160 centres in Europe. As a trusted partner to health systems, PPTA drives broad and reliable access to high-quality plasma protein therapies, with a focus on the well-being of patients and plasma donors.