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Guest article by Robin Doeswijk and Gauthier Quinonez, European Hematology Association

Plasma Shortages

Plasma-derived medicinal products (PDMPs) are used to treat various rare, chronic, and potentially life-threatening conditions including immune deficiencies, immune-mediated peripheral neuropathies, hereditary angioedema and haemophilia among other bleeding disorders. 

In Europe, we face a shortage of PDMPs, particularly immunoglobulins. Non-profit blood establishments from voluntary non-remunerated donors, conduct a substantial part of plasma collection in the EU. But these organizations cannot supply the volumes needed. This means that Europe is dependent on plasma imports from the U.S which is responsible for around 60% of the plasma global supply chain. However, the US is facing its own plasma and blood shortage, as a result, the American Red Cross foresees a shortage of plasma for the creation of PDMPs.  

Thanks to active advocacy by patient organizations, blood establishments and medical societies, the European Commission has recognized the need to tackle plasma shortages and build a more robust European plasma supply chain.  

The SUPPLY Project 

As part of the EU4Health program, the European Commission awarded funding to a project composed of diverse stakeholders led by the European Blood Alliance (EBA), national blood establishments, European Universities, and the European Hematology Association (EHA). The “Strengthening voluntary non-remunerated plasma collection capacity in Europe” (SUPPLY) project will start in September 2022, and will last 18 months. 

SUPPLY will: 

• Evaluate current legal frameworks and policies on plasma collection in Europe; 
• Assess current strategies to recruit and retain voluntary non-remunerated plasma donors. 
• Develop practical recommendations to improve plasma collection for blood establishments, competent authorities, medical societies and other professional stakeholders. 

These outputs should help drive an increase in public sector plasma collection in the EU, and improve the availability of plasma medicines for patients, therefore contributing to the EU becoming more strategically independent in its need for plasma medicines.   

Recently, the European Commission published a proposal on standards of quality, and safety for substances of human origin (SoHO) intended for human application. This new proposed EU regulation will set updated rules applying to plasma donation shortages. Given the importance and scope of the upcoming regulation, it is crucial for SUPPLY to advise EU institutions on plasma shortages with sound expert input and evidence-based recommendations. 

Conclusion 

The COVID-19 pandemic has significantly tested the resilience of blood and transplant systems and has strongly reduced the supply, availability, use, and access to these therapies. There is a need to improve resilience, ensure the continuity of supply, and increase access, safety and quality of therapies, particularly in times of infectious disease outbreaks. Since plasma demand increases with the use of immunoglobulins, it is vital that its use is appropriate and prioritization is properly guided. Thanks to its multi-stakeholder consortium, blend of critical expertise, and timeframe SUPPLY is ideally placed to take the lessons from the COVID-19 pandemic and ensure a resilient supply chain of PDMPs as a core component of the new European legislative framework on blood, tissues and cells.