PPTA Press Release on the EU Parliament's ENVI Committee Vote on the SoHO Regulation

The Plasma Protein Therapeutics Association (PPTA) recognises the efforts of the European Parliament’s ENVI Committee in their report on the EU Regulation to safeguard quality and safety standards of Substances of Human Origin (SoHO), adopted today. However, the Committee's efforts to secure the supply of critical SoHO, including plasma to manufacture life-saving medicines for some 300,000 patients across the EU, fall short. The measures in the report overlook evidence-based approaches on frequency of plasma donation, would introduce legal ambiguity on the subject of donor compensation and could ultimately undermine patient access to plasma-derived medicines.

Most European countries provide some type of donor compensation, which varies in form, ranging from paid days off work, to tax reductions, vouchers and fixed-rate allowances. In Austria, Germany, Czechia and Hungary, where plasma donors are compensated with a fixed-rate allowance and private collection centres are part of the system, they not only meet the plasma needs of their citizens, but also contribute 46 percent of the total amount of plasma collected in the EU.

PPTA considers the proposed, restrictive amendments, permitting donor compensation only for “quantifiable” losses, to be at odds with the recommendations of prominent guidelines on donation ethics, such as those from the Council of Europe and the Nuffield Bioethics Committee. Compensating for both financial losses, such as expenses and non-financial losses, such as inconveniences, is still considered to be altruistic and financially neutral.

PPTA believes the following measures in the EU SoHO Regulation have the potential to support plasma sufficiency and patient access, while safeguarding donor and patient health and well-being:

1. Refrain from stating that plasma donation implies a significant risk. Decades of evidence show that frequent plasmapheresis is a safe and effective procedure with low donor adverse events (DAEs). Plasma donation via apheresis — during which plasma is separated from other blood components, which are then returned to the donor — is associated with very few DAEs, while plasma donation can be undertaken more frequently than blood donation. An assessment of over 12 million plasma donations has shown that 99.84% of plasma donations are completed safely, without any adverse events, a number comparable with blood donation. To ensure donor safety is maintained, relevant health parameters are monitored regularly, as per national regulations, and frequency of plasma donation is set and regulated by national health authorities.

2. Ensure a broad and open definition of SoHO donor compensation that allows Member States to choose whether and how to compensate donors within the framework of the Voluntary Unpaid Donation (VUD) principle. Whichever sector collects plasma, be it public, private or third sector plasma collectors, compensation in the form of days off work, reimbursement of costs, meal vouchers, or a fixed-rate monetary allowance, is compatible with VUD and has no impact on the safety of donors or the quality of plasma for fractionation and PDMPs1. The restrictive and inconsistent definition of ‘compensation’, as proposed by the ENVI Committee, may lead to conflicting interpretations and legal uncertainty, thereby undermining existing plasma collection models across the EU Member States.

“The bottom line is that plasma donation is safe. Europe will only succeed in achieving strategic autonomy in plasma if it acknowledges that compensation via a fixed-rate allowance provides an important option to EU member countries,” says Maarten Van Baelen, PPTA Executive Director Europe. “Whether the public, private or third sectors (such as NGOs) collect plasma, compensation is a proven tool to reduce reliance on other countries, strengthen European healthcare systems, and make accessible and elevate the donation experience so that more people choose to donate plasma and save more lives.”

PPTA invites the co-legislators to consider, in the next phases of the legislative review, the need to ensure sufficiency of plasma to manufacture PDMPs and to increase the EU’s open strategic autonomy in essential SoHO. It is vital that the new Regulation is based on facts, and that agreed solutions for sustainable supply across Europe are grounded in reality, placing donor and patient well-being first.

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.

1 https://www.ema.europa.eu/en/documents/position/cpmp-position-statement-non-remunerated-remunerated-donors-safety-suply-plasma-derived-medicinal_en.pdf