The Plasma Protein Therapeutics Association (PPTA) welcomes the Council's negotiating mandate on the proposed EU Regulation to safeguard quality and safety standards of Substances of Human Origin (SoHO). The Council’s approach acknowledges the need for flexibility in the legislation for Member States to establish and maintain plasma collection models and infrastructure that reflect the particularities and needs of their individual healthcare systems. 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 needed to treat EU patients with plasma-derived medicinal products (PDMPs).
PPTA welcomes the Council’s approach on donor compensation practices, which recognises that EU Member States can have different approaches to suit their local circumstances, including having in place a fixed-rate allowance, which is compatible with the Voluntary Unpaid Donation principle (VUD).
PPTA also supports the Council’s proposals to allow for the implementation of national, European, and international guidelines based on latest scientific knowledge and evidence. These approaches would help ensure donor health while increasing plasma supply to meet growing clinical need for PDMPs.
However, more can be done to meet this growing patient need through greater EU strategic autonomy in plasma supply for the manufacturing of plasma-derived medicinal products (PDMPs). While PPTA welcomes measures that protect donor health, including the proposals to increase donor monitoring, the statement that plasma donations imply a ‘significant risk’ or a ‘non-negligible risk’ is not supported by science or any evidence. Scientific studies[i] and EU haemovigilance reporting[ii] have consistently shown that plasma donation is a safe procedure and presents a low risk to donors, comparable to blood donation. This reference is not consistent with well-established international risk principles and could impact Member States’ willingness to put in place the necessary infrastructure for plasma collection and donors’ willingness to donate.
“The bottom line is that plasma donation is safe. All data generated on the subject, including the data most recently published in Transfusion, show that repeat plasma donation is safe and does not adversely impact donor health. Every donation is important to ensure reliable and adequate supply.” says Maarten Van Baelen, PPTA Executive Director Europe.
PPTA is committed to supporting greater strategic autonomy for Europe in plasma to manufacture PDMPs and to meeting growing patient need for PDMPs. Throughout the upcoming trilogue negotiations, we hope that the co-legislators will work together to ensure a sustainable and flexible regulatory framework that allows Member States to establish an effective plasma collection ecosystem that would protect and increase patient access to life-saving plasma-derived medicinal products (PDMPs), while ensuring the health and safety of SoHO donors.
References
[i] Fransen, M, Becker, M, Hershman, J, Lenart, J, Simon, T, McCausland, K, et al. Effects of donation frequency on U.S. source plasma donor health. Transfusion. 2023; 63(10): 1885–1903. https://doi.org/10.1111/trf.17523
Schreiber GB, Becker M, Fransen M, Hershman J, Lenart J, Song G, et al. 2021 “Plasmavigilance – Adverse events among U.S. source plasma donors.” Transfusion 2941-57
Gustafson M. Source Plasma Donor Hemovigilance Activities and Results. Available from: https://assets-global.website-files.com/638f893112c6eac0e46ac576/645391e5ed98576842df695e_%231Gustafson_PlasmaVigilance100817.pdf (Pilot study).
Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF. Personalized collection of plasma from healthy donors: a randomized controlled trial of a novel technologyenabled nomogram. Transfusion. 2021;61:1789–98.
Cho JH, Rajbhandary S, van Buren NL, Fung MK, Al-Ghafry M, Fridey JL, et al. The safety of COVID-19 convalescent plasma donation: a multi-institutional donor hemovigilance study. Transfusion. 2021;61(9):2668–76
Cho JH, Hiskey M. Plasmavigilance: Source plasma joins the call to arms. Transfusion. 2021 Oct;61(10):2803-2805. doi: 10.1111/trf.16668. PMID: 34605562
[ii]https://www.basg.gv.at/fileadmin/redakteure/04_Marktbeobachtung/H%C3%A4movigilanz/Haemovigilanz_Bericht_2020.pdf