Europe has a plasma problem. The continent is over-reliant on the US for plasma – donated, purified human blood liquid – which is a key component in several lifesaving drugs for immunity, bleeding, critical care, and rare disorders.
The Donor Dilemma
One explanation for these shortages is the lack of financial incentives for plasma donors in Europe, where – for both ethical and safety reasons – donors are often not compensated for plasma donation.
In countries like France, Italy, Spain, the Nordics, Belgium, and the Netherlands, only direct expenses such as travel and meals are reimbursed for plasma donors. However, in Germany, Austria, the Czech Republic, Hungary and Slovakia, donors are offered some financial compensation, meaning that those countries consequently have higher donation levels.
On the ethical front, plasma and blood are generally seen as gifts in Europe rather than commodities. Paying donors also increases the potential exploitation of vulnerable groups such as students and those on low incomes.
Meanwhile, in terms of safety concerns, paying donors increases the risk of individuals not disclosing underlying health conditions (although modern screening technology removes some of this risk).
On the other side of the Atlantic, a different philosophy prevails. Americans are paid between USD 30 and 70 per donation, with frequent donors potentially earning up to USD 1,000 per month, according to GoodRx.
This – along with the sheer scale of the plasma collection network in the country – has led to the US accounting for more than 60 percent of global plasma supply. Moreover, around 70 percent of all plasma-derived medicines sold worldwide are derived from US-collected plasma.
Beyond the ethical contradictions of this setup for Europe – which champions the principle of voluntary, unpaid donations yet buys huge volumes of therapies made from paid US plasma – there are serious supply security concerns at play.
Reliance on imports means Europe is paying billions to US-based collection and manufacturing networks instead of building its own capacity; undermining the continent’s industrial sovereignty goals.
Additionally, as the COVID-19 pandemic experience – where US donations fell sharply – showed, Europe’s plasma supply is particularly vulnerable to health crises in the US, to say nothing of the country’s increasingly unreliable trade policies.
Surging Demand
This reliance is especially problematic given that European demand for PDMPs is surging. According to analysis from the Spanish firm Grifols, which runs around 400 plasma donation sites in the US, this is due to earlier and more accurate diagnosis of pathologies treatable with plasma-based products, meaning that patients live longer and with better health; the identification of new applications for available proteins; and continued industry R&D investment to identify new proteins.
Meeting the demand for plasma-derived medicinal products (PDMPs) is going to prove increasingly challenging in the coming years. Lutz Bonacker, head of European commercial operations for CSL Behring, the global industry leader in PDMPs, explains that “Hundreds of donations are needed to produce the plasma therapy to treat every patient, ranging from 130 donations per year to treat one primary immunodeficiency patient, to 1,000 donations to treat a person with hereditary angioedema over the same period.”
He continues, “Despite plasma being collected across Europe, this only meets approximately 70 percent of the overall need in the EU, and the majority of it is collected in the four EU member countries that allow collection centers operated by industry. The gap is filled by additional plasma collected by industry outside the EU, the largest source being the US.”
Bonacker adds that bolstering European collection of plasma and production PDMPs is no mean feat and requires significant levels of investment and coordination, stressing that PDMPs are uniquely complex, requiring long-term investment in donor networks, advanced technology, and safety oversight.
Towards Self-Sufficiency
Yet while demand climbs, Europe’s collection model and industrial base remain patchy, leaving policymakers scrambling for solutions. In these uncertain socioeconomic and geopolitical times, the European Commission is attempting to reduce Europe’s reliance on foreign nations for critical medicines and ingredients.
On the plasma collection front, the 2024 EU SoHO (Substances of Human Origin) Regulation (set to be enforced from 2027) includes a refreshed approach to donor compensation in Europe. This aims to boost collection levels on the continent, as Jacques Brom, CEO of the French state-owned plasma-derived products manufacturer LFB, told PharmaBoardroom in a recent interview.
“This framework sets unified safety and quality standards across the EU while preserving the founding principle of voluntary, unpaid donation,” said Brom. “Importantly, it also recognises that certain forms of compensation, as permitted by national legislation, can be compatible with ethical donation practices. This gives Member States the flexibility to design systems that reflect both their regulatory philosophies and operational realities.”
However, Brom – whose company recently announced a EUR 700 million commitment to modernising and expanding plasma fractionation capabilities at its Arras site in northern France – warns that without a more comprehensive shakeup of Europe’s approach to donor compensation, shortages may prevail.
“With demand for plasma-derived medicines growing at around seven percent annually, even substantial increases in donations (such as France’s Ambition Plasma initiative, which aims to raise national collection from 800,000 to 1.4 million litres by 2028) may not be enough,” he states. “At some point, we will need to reassess whether the current model can deliver at scale and ensure our decisions are guided by measurable outcomes rather than assumptions.”
CSL’s Bonacker adds that greater levels of collection alone will not be enough to secure European “open strategic autonomy” in plasma and PDMPs. He proposes coordinated efforts on four fronts: boosting plasma supply by expanding donation networks, deploying advanced collection technologies, and building international partnerships; reinforcing the manufacturing base; modernising supply chains with more predictable procurement, harmonised regulation, and coordinated stockpiles; and aligning pricing and reimbursement with the unique economics of PDMPs, thereby ensuring greater patient access.
The wheels are in motion on a number of these fronts, but whether Europe can truly achieve plasma sovereignty remains to be seen.
