Optimizing plasma collection and donor safety – POLITICO

With a reliance on the United States for up to 40% of our human blood plasma needs, Europe faces a major challenge: we simply don’t collect enough plasma. Some 300,000 rare disease patients rely on plasma-derived medicinal products (PDMPs) to treat a wide range of serious and life-threatening conditions, including haemophilia and primary immune deficiency (PID). Moreover, this number is growing rapidly, as improved diagnostic techniques, increased physician awareness of treatable conditions, and wider indicated use are driving a growing patient need for PDMPs. Indeed, for many rare disease patients, PDMPs are often the only treatment option to keep patients healthy.

Europe now has the opportunity to tackle it: the proposed regulation on substances of human origin (SoHO). As it progresses through the EU legislative process, it will be up to the rapporteur, MEP Colin-Oesterlé, and his fellow shadow rapporteurs, MEPs Casares, Glück, Metz, Kopcińska and Konečná, to propose significant and ambitious proposals. amendments to the initial European Commission proposal for a SoHO regulation, protecting the health of donors, strengthening plasma collection and potentially improving the supply of medicines made from substances of human origin, such as plasma-derived therapies , sustainably across Europe. There is an opportunity to focus on finding greater strategic autonomy for plasma collection in Europe and to increase patient access to plasma-derived medicines.

This can be achieved by addressing specific and key aspects in the SoHO text.

The wording of the current proposal, for example, refers to: “Donations of […] plasma should be considered to involve a significant risk. This is not the case and, in fact, the opposite can be attested to by a series of well-founded and comprehensive scientific studies, including one involving over 12 million plasma donations. Source plasma donation – donation via a process called apheresis, in which plasma is taken from the donor and the white and red blood cells are returned to the body – has a low risk of adverse events, similar to that of donating blood.

That said, there are fundamental differences between blood used for transfusion and plasma used for fractionation – the process used to transform 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 longer than a blood donation and although a blood transfusion can help a patient within hours, it takes between seven and 12 months to turn the plasma to be fractionated into a therapy safe and effective that saves lives. . Recognizing such differences will lay the foundation for science-based policies that will support the increased availability of plasma in Europe for the manufacture of life-saving PDMPs.

Compensating donors for the expenses and inconvenience associated with donating is another element that would remove barriers to donation and enhance the sustainability of plasma collection. Most European countries have some form of monetary or non-monetary compensation in place. In this regard, we welcome the clarification in the SoHO proposal that compensation with a “lump sum indemnity” – with conditions to be determined by member countries – is compatible with “voluntary unpaid donation”, a principle accepted by all EU member countries.

It is important that any form of compensation takes into account the specificities of the type of SoHO donation and the associated inconvenience to the donor. However, the proposed legislation should eliminate references which incorrectly suggest that voluntary and unpaid donations alone can contribute to ensuring a high level of public health protection. Plasma-derived medicines from paid donors have been shown to be as safe as those from voluntary unpaid donors.

Over the past 20 years, the growth of plasma collection in the EU has been driven largely by the four countries (Germany, Austria, Czech Republic and Hungary) that allow both public and private sector to collect plasma. This number could be further increased if the EU were to be more ambitious in the SoHO regulation and recommend to more member countries to establish proactive national plans, inviting them to collect more plasma by plasmapheresis, which is the most effective means. to do this. Historically, the public sector has primarily collected blood for transfusion and recovered plasma from whole blood donations rather than plasmapheresis. Consequently, over the past 20 years, the public sector has collected less plasma than it could. If the public, private and third sectors, such as NGOs, were allowed to work in tandem to secure EU plasma supply, we would likely move forward much faster – and in a sustainable way. This would help improve the long-term reliability of PDMP supply for patients, in line with the European Commission’s ambition to achieve and secure strategic self-sufficiency in critical raw materials.

The data shows that a collaborative approach to plasma collection involving both the public and private sectors would reduce our dependence on the United States and lead to the strategic autonomy sought by the EU. Let’s learn from the COVID-19 pandemic, which has seen 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 optimally contribute, through its provisions – properly implemented in member countries – to safeguarding health and donor safety, increase plasma collection in the EU and ultimately improve patient access to essential life-saving PDMPs across Europe.