27 May 2024
The Plasma Protein Therapeutics Association (PPTA) welcomes the European Council's final adoption of SoHO Regulation which aims to strengthen the safety and quality of substances of human origin (SoHO) intended for human application. The Regulation provides flexibility for Member States to implement plasma collection models that reflect the particularities of their individual healthcare systems to increase plasma collection.
Additionally, it rightly recognizes that compensation is compatible with the principle of voluntary unpaid donation. The flexibility provided by SoHO to Member States is an important step toward enhancing plasma collection while ensuring the health and safety of SoHO donors in the European Union.
Maarten Van Baelen, PPTA Europe’s Executive Director, shared this in light of the SoHO adoption: “As stewards of safety, PPTA members uphold rigorous standards and protocols to ensure the safety of donors throughout the plasma collection process and are committed to continuously updating industry standards based on the latest scientific evidence to ensure the highest donor protection, thus going even beyond regulatory obligations.”
Ferdinando Borgese, PPTA’s European Board Chair, stated that, “The SoHO Regulation signifies a pivotal moment in securing the supply of plasma, a critical substance of human origin used to manufacture life-saving plasma-derived medicines. We remain committed to safeguarding donor health and fostering collaboration with plasma collectors and other stakeholders to sustain robust evidence on donor health. By doing so, the use of plasmapheresis can be scaled up to contribute to a resilient supply of life-saving plasma-derived medicines to patients across Europe.”
While the extent of progress across Europe will depend on the implementation of SoHO and other national policies, 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.