With a reliance on the U.S. for up to 40 percent of our human blood plasma needs, Europe faces a major challenge: we simply do not collect enough plasma. Some 300,000 rare disease patients depend on plasma-derived medicinal products (PDMPs) to treat a wide range of serious and life-threating conditions, including hemophilia and primary immune deficiency (PID). What’s more, this number is growing fast, as improved diagnostic techniques, heightened awareness of treatable diseases among physicians, and broader indicated use drive growing patient need for PDMPs. Indeed, for many rare disease patients, PDMPs are often the only treatment option to keep patients healthy.
Some 300,000 rare disease patients depend on plasma-derived medicinal products.
Europe now has the opportunity to address this: the proposal for a Regulation on Substances of Human Origin (SoHO). As it makes its way through the EU legislative process, it will fall to the rapporteur, MEP Colin-Oesterlé, and her shadow rapporteur colleagues, MEP Casares, MEP Glück, MEP Metz, MEP Kopcińska and MEP Konečná, to put forward meaningful and ambitious amendments to the European Commission’s original proposal for a SoHO Regulation, safeguarding donor health, boosting plasma collection and potentially improving supply of medicines made from substances of human origin, such as plasma-derived therapies, sustainably across Europe. There is an opportunity to focus on working toward greater strategic autonomy for plasma collection in Europe and increasing patient access to plasma-derived medicines.
This can be achieved by addressing specific, key aspects in the SoHO text.
The language in the current proposal, for example, references: “Donations of […] plasma should be considered to imply a significant risk.” This is not the case and, in fact, the opposite can be attested to by a range of well-founded and comprehensive scientific studies, including one involving more than 12 million plasma donations. Source plasma donation — donation via a process called apheresis, in which plasma is taken from the donor and white and red blood cells are returned to the body — has a low risk of adverse events, similar to that of blood donation.
It takes between seven and 12 months to transform plasma for fractionation into a safe and efficacious life-saving therapy.
That said, there are some fundamental differences between blood used for transfusion and plasma used for fractionation — the process used to turn plasma into different PDMPs — and a welcome distinction has been made clear in the Commission’s proposal. A plasma donation takes up to four times as long as a blood donation and while a blood transfusion may help a patient in a matter of hours, it takes between seven and 12 months to transform plasma for fractionation into a safe and efficacious life-saving therapy. Recognizing differences such as these will lay the foundation for science-based policies that will support the increased availability of plasma in Europe for the manufacturing of life-saving PDMPs.
Compensating donors for the expenses and inconveniences related to a donation is another element that would remove the disincentives to donate and boost plasma collection sustainability. Most European countries have some form of monetary or non-monetary compensation in place. In this respect, we welcome the clarification in the SoHO proposal that compensation with a ‘fixed-rate allowance’ — with conditions to be determined by the member countries — is compatible with ‘voluntary unpaid donation’, a principle accepted by all EU member countries.
It’s important that any form of compensation takes into account the specificities of the type of SoHO donation and the inconvenience to the donor related to it. However, the proposed legislation should eliminate references that suggest, mistakenly, that voluntary and unpaid donation alone can contribute to ensuring a high-level protection of public health. It has been shown that plasma-derived medicines coming from remunerated donors are as safe as those from non-financially compensated voluntary donors.
Over the past 20 years, growth in plasma collection in the EU was achieved largely by the four countries (Germany, Austria, the Czech Republic and Hungary) that allow both the public and private sector to collect plasma. This number could be increased further if the EU were to be more ambitious in the SoHO Regulation and recommend that more member countries establish proactive national plans, calling on them to collect more plasma through plasmapheresis, which is the most efficient means of doing this. Historically, the public sector has mainly collected blood for transfusion, and plasma recovered from whole blood donations rather than through plasmapheresis. Consequently, over the past 20 years, the public sector has been collecting less plasma than it could. If the public, private and third sectors, such as NGOs, were permitted to work in tandem to secure the EU’s plasma supply, we’d likely make much faster headway — and do so sustainably. This would help to improve long-term reliability of the supply of PDMPs for patients, in line with the European Commission’s ambition to achieve and secure strategic autonomy in critical raw materials.
A collaborative approach to plasma collection involving both the public and private sectors would reduce our dependency on the U.S.
The data show that a collaborative approach to plasma collection involving both the public and private sectors would reduce our dependency on the U.S. and lead to the strategic autonomy that the EU seeks. Let’s build on the lessons from the COVID-19 pandemic, which saw unprecedented levels of public-private partnerships to tackle a priority global health issue. It is only through an open and constructive dialogue with all policymakers and relevant stakeholders that the SoHO Regulation will contribute optimally, via its provisions — appropriately implemented across the member countries — to preserving the health and safety of donors, increasing plasma collection in the EU and, ultimately, to improving patient access to essential life-saving PDMPs across Europe.
