Commit to Plasma

A Call to Action for national and European authorities

Countries with plasmapheresis programmes (public and/or commercial) contribute proportionally more plasma to the manufacturing of PDMPs than countries without such programmes.

The new Regulation on Substances of Human Origin (SoHO) urges Member States to increase their collection capacity and donor base for plasma by investing in non-profit and public plasmapheresis programmes. We strongly believe that by increasing their funding towards public collection programmes, EU Member States will greatly improve the prospects of delivering a secure and resilient supply of plasma medicines for their patients in the coming years.

We, patients, donors, blood establishments, physicians and other healthcare professionals, hospitals, healthcare services and public sector industry representatives therefore endorse this manifesto and urge national and EU authorities to increase their political support and funding to public plasma collection programmes with a view to increase the public collection of plasma for fractionation in Europe by 40%, and at a minimum by 25%, by 2030. This would mean increasing the plasma contribution from Europe from 9 million litres in 2022 to at least 11 million litres in the next 5 years.

In line with the recently published EU SoHO Regulation, and articles 62 and 72 in particular,

We call on national authorities to:

• Publish National Plasma Plans by the end of 2026, with ambitious and clear commitments for national plasma collection goals;
• Earmark the resources required to achieve these goals;
• Establish or intensify their cooperation with the national representatives of all stakeholders supporting this call to work together in reaching these goals;
• Ensure optimal use of all available plasma.

We call on the European Commission, the European Parliament, as well as other relevant institutions such as EDQM, to:

• Work towards equipping Europe with a European Plasma Coordination Plan by 2027, building on the National Plasma plans and to be reviewed regularly.
• Urge national authorities to commit to increasing public plasma collection, as above, through all means at their disposal, be it through the future European Plasma Coordination Plan or more formal instruments at their disposal such as communications, reports or hearings;
• Collect and share national data and practices to accompany plasma-collection progress of Member States and Europe as a whole. Reliable, publicly accessible data is missing today;
• Engage with other regional and global organisations to exchange data, policies and establish a dialogue to address plasma shortages at a global level.

Plasma is the yellow-coloured liquid that makes up 55% of our blood. It’s mostly water but it also contains proteins and other components vital to our health. These proteins, when collected from human donors and manufactured into medicinal products, can then be used to treat several conditions to which, for the most part, there is currently no alternative. Most people born with primary immunodeficiencies will need life-long treatment. Others like cancer patients and patients with inflammatory auto-immune diseases, where the immune system may not be functioning properly, may need them to restore natural defences. 

The demand for plasma is increasing. In many cases, such as in the field of primary immunodeficiencies (PIDs) and neuro-immunological disorders such as chronic inflammatory demyelinating polyneuropathies (CIDP) or multifocal motor neuropathies (MMN), this growing demand is mainly due to improvements in patient diagnoses and in the identification of new conditions.

This growing demand contributes to today’s need for plasma, which far outweighs the amount Europe currently collects. Europe heavily depends on plasma imported from a single country, the US. This makes Europe, and its citizens, extremely vulnerable to shortages or even overnight interruption caused by a protectionist decision in the US or the emergence of a pathogen that would make US plasma unsafe.

Increasing plasma collection in Europe would also contribute to helping deliver on National and EU Climate Targets. There are significant transport-related greenhouse gas (GHG) emissions, primarily from shipping, associated with the reliance on plasma imports. The reduction in GHG emissions associated with a decreased reliance on US plasma will contribute towards meeting national and EU climate targets.

We note that some European countries who have committed to increasing plasma collection and allocated the necessary funding, have seen their levels of dependency on US plasma drop and expect to be strategically independent from plasma imports from outside Europe in the coming years. Such effort goes beyond increasing collections and implies a comprehensive mobilisation of national health care systems for a holistic approach to treating patients, from diagnosis to treatment and follow up.

In addition to providing enough plasma for the medicines its citizens need, these countries are also building strong and resilient public programmes which gives them better control over the raw material and the finished plasma products, with multiple advantages for the public health system .

Finally, increasing Europe’s public collection capacity will ease pressure on the global market for plasma products and thereby improve patient access to plasma products in other regions. Furthermore, these advances in public health in Europe can facilitate conversations on improved solutions for patients globally. Access to plasma products is a global concern and Europe must do its part.