The Plasma Protein Therapeutics Association (PPTA) recognizes the substances of human origin (SoHO) regulation as an important step toward enhancing plasma collection and increasing donor safety in the European Union (EU).
The compromise text from the co-legislators (European Commission, European Parliament, and European Council) recognizes that all forms of compensation, including a fixed-rate allowance with conditions set by Member States, are compatible with the principle of voluntary unpaid donation. This model has been successfully implemented for plasma donation in Austria, Czech Republic, Germany, and Hungary. In these countries, plasma collection is four times higher than the EU average and is based on safe, efficient, state-of-the-art plasmapheresis programmes that contribute to the collection of more plasma for European patients.
Pending official ratification from the three EU institutions, the regulation provides Member States with the flexibility to optimize plasma collection while safeguarding donor health. Co-legislators gave prominent attention to plasma, acknowledging that it is a critical SoHO, thus encouraging Members States to establish plasmapheresis programmes. PPTA and member companies call for governments to recognise this opportunity for action around improving efficient and resilient supply of plasma for fractionation. Bringing together the efforts of the public, private,and non-profit sectors to increase plasma collection in the EU is not only crucial to address the growing patient need, but also to enhance European self-sufficiency in plasma.
While the extent of progress across Europe will depend on the implementation of SoHO at national levels, PPTA looks to a future of committed collaboration with stakeholders, policymakers, and members to ensure a reliable supply of plasma for fractionation and patient access to PDMPs.