In the coming decade, more European patients will need access to plasma-derived medicines. A European Commission survey shows that, contrary to a declining need for blood components for transfusion, clinical need for plasma derivatives increases every year.
Plasma-derived medicinal products (PDMPs), derived from human plasma from healthy donors, are essential for around 300,000 European patients who rely on these therapies to treat a variety of rare, chronic and potentially life-threatening conditions, which are often genetic in origin. Without these treatments, many patients might not survive or would have a substantially diminished quality of life.
There is a growing clinical need for PDMPs, mainly immunoglobulins which drive the need to collect more plasma. Improved diagnostic techniques identify patients earlier, allowing them to access appropriate medicines earlier in life. As those children grow, however, their dosage volumes increase. With more people diagnosed, and at earlier ages than previously possible, more people are living longer, healthier lives, which ultimately leads to increased use of immunoglobulin products. Further, expanded treatment of secondary infections has helped cancer patients, but also requires more immunoglobulin.
The foundations of ensuring safe access to PDMPs is a regular healthy plasma donor population. However, plasma collections globally declined significantly due, in part, to the impacts of social-distancing measures and other mobility restrictions caused by the COVID-19 pandemic., Considering the complex manufacturing of plasma-derived therapies can take between seven and 12 months, any decline in plasma donations could impact patients’ ability to access their lifesaving therapies.,
Europe needs to collect more plasma
Today, the EU relies on plasma from the U.S. for about 30 percent (or 3.8 million liters) of its need. This dependency is now negatively impacting patient access to PDMPs. The revision of the EU Blood Directive and the European Commission’s goal of an Open Strategic Autonomy within the EU’s pharma and trade strategies, however, offer an opportunity for a change in policy and to reduce the dependency of starting materials for PDMPs from the U.S.
Plasma can be obtained from whole blood donations (resulting in ‘recovered’ plasma) or collected directly through a process called plasmapheresis (resulting in ‘source’ plasma). Plasma donation requires commitment from the donor, as the plasma donation process generally takes about 1.5 hours, and plasma can be donated more often than whole blood. The European Commission highlights that plasma donation by plasmapheresis is more efficient, compared to recovering plasma from whole blood donations.
Countries that have a combined public-private collection model (Austria, Czech Republic, Germany, and Hungary) contribute the most to plasma collections in the EU. In these four countries, four times more plasma per resident is collected, compared to other countries. These countries allow plasma collection centers to compensate plasma donors, using a fixed-rate allowance of which the conditions are defined by the regulators, for their expenses and inconveniences related to the donation.
Most EU countries provide some form of compensation for plasma donors. It covers expenses incurred and recognizes the inconvenience related to donating, following the principle of Voluntary Unpaid Donation (VUD). Some apply fixed-rate allowances, others reimburse specific expenses or compensate with time off from work, tax reductions, vouchers or by other means. All these forms of compensation are altruistic-focused inspirations for those already motivated to donate, and in reality, all these ways of compensating donors have a monetary value. Yet compensation as a direct allowance, to compensate for expenses and inconvenience, seems to be the most efficient approach to encourage more plasma donations.
Increase the role of the private sector in plasma collection
The EU’s public sector has shown little growth in plasma collection over the past decade. Most growth in plasma collection was offset by declining collections of recovered plasma (whole blood). In contrast, over the same period, private plasma donation centers have delivered most of the EU’s increased plasma donations that are required to meet the growing clinical need for PDMPs. Yet, to collect more plasma and to reduce the reliance on U.S. plasma properly, more EU countries should adapt the plasma collection model in which private sector works hand-in-hand with the public sector to broaden the plasma collection ecosystem.
For more information, visit www.euneedsmoreplasma.org.
 European Commission report on the implementation of the Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components, , 2016. https://ec.europa.eu/health/sites/default/files/blood_tissues_organs/docs/com_2016_224_en.pdf
 Cherney, Mike. “Coronavirus Pandemic Slashes Donations of Lifesaving Plasma.” Wall Street Journal, August 19, 2020.
 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. (2020, April). Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry. https://www.fda.gov/media/136603/download
 Hartmann J, Klein HG, “Supply and demand for plasma-derived medicinal products – A critical reassessment amid the COVID-19 pandemic.” Transfusion. 2020 Aug 28:10.1111/trf.16078. doi: 10.1111/trf.16078.
 Prevot J, Jolles S, “Global immunoglobulin supply: steaming toward the iceberg?” Curr Opin Allergy Clin Immunol. 2020, 20:000–000 DOI:10.1097/ACI.0000000000000696
 Statement from the European Commission: Coronavirus: European Commission strengthens support for treatment through convalescent plasma. https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1435 (accessed September 2021)
 Marketing Research Bureau (2019)
 Commission staff working document on the implementation of the principle of voluntary and unpaid donation for human blood and blood components as foreseen in Directive 2002/98/EC on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:52016SC0130
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