Strategic ambition requires operational realism: plasma-derived medicines and Europe’s health future

Increasing pressure on healthcare systems

Europe’s healthcare systems are operating under constantly increasing pressure. Global geopolitical instability, workforce shortages, financial constraints, demographic change and chronic diseases are reshaping policy landscapes. In response, Europe is rightly placing greater emphasis on regional strategic autonomy, resilience, innovation and supply security across the healthcare sector.

Legislative initiatives such as the Critical Medicines Act and the European Biotech Act reflect an important strategic shift in the EU’s approach to healthcare. The Critical Medicines Act aims to strengthen the availability, supply, and production of critical medicines within the EU, while the Biotech Act seeks to boost Europe’s health biotechnology ecosystem by supporting innovation, manufacturing capacity, digitalisation and investment. Together, these initiatives signal growing recognition that healthcare, biotechnology and industrial policies are interconnected.

One size does not fit all – flexibility is essential

Such political evolution is welcome. But Europe’s healthcare ambitions cannot be approached through a one-size-fits-all approach. Different critical medicines rely on fundamentally different manufacturing models, supply chains and operational realities. Plasma-derived medicinal products (PDMPs) are perhaps one of the clearest examples of why implementation realism matters for sustainable patient access.

For many people living with rare, chronic and often debilitating conditions, plasma-derived medicines are not optional therapies. They are lifesaving and life-sustaining treatments that support survival, functional independence and quality of life. Immunoglobulins, for example, are essential for many patients living with primary and secondary immunodeficiencies, neurological conditions and many others for whom treatment continuity is critical. Patient organisations have repeatedly stressed the importance of securing uninterrupted access to the most appropriate therapy for individual patients and avoiding non-clinical disruptions to treatment.

Demand for plasma-derived medicines continues to rise, driven by better diagnosis, improved survival and discovery of new therapeutic uses. At the same time, a fundamental characteristic of these therapies remains unchanged: plasma is a finite, critical human substance and starting material that cannot be synthetically produced, but only voluntarily donated by healthy donors.

This unique starting point fundamentally shapes the entire value chain. Unlike other medicinal products, plasma-derived medicines depend on healthy donors and specialised collection infrastructure – namely plasmapheresis for source plasma collection. The production system is highly regulated and resource-intensive, relying on highly specialised manufacturing processes and long production cycles.

The pathway from donation to finished medicine can take up to a year. Expanding capacity therefore requires sustained long-term investment, operational predictability, broader awareness and understanding of plasmapheresis, donor recruitment, donor monitoring and long-term donor retention.

Reduce the reliance!

Europe faces structural constraints in plasma collection itself. While demand for plasma-derived medicines continues to grow, the use of plasmapheresis remains uneven across Europe and is not yet scaled across all member states. In recent years, public plasmapheresis programmes have evolved in some countries, which is a positive development. In addition, only four EU member states have operated mature plasma collection ecosystems based on coexistence models where public, private and non-profit actors have worked alongside one another for decades.

Europe today remains significantly dependent on plasma collected outside the EU, specifically from the United States, which supplies a substantial share of source plasma globally. Europe also faces an internal structural imbalance: the four member states with coexistence collection systems account for half of the plasma collected in the EU for manufacturing critical PDMPs. These dependencies represent a challenge that deserve serious attention.

Policies rooted in reality

Real change is possible. With sustained investment, deeper European collaboration and policies grounded in operational realities, Europe can strengthen both its strategic autonomy and its ability to deliver equitable access to critical plasma-derived medicines for all patients across the region.

Strategic autonomy in healthcare is a shared responsibility. It should not be understood as eliminating interdependence altogether, which cannot happen overnight. Instead, it should mean gradually reducing external dependency through stronger European cooperation, increased plasma collection, and better use of Europe’s strong plasma and PDMP industry to build more resilient supply systems over time.

Building greater European capacity and reducing structural vulnerabilities will require realism about what these political ambitions entail in practice. Resilience is not cost-neutral. Strengthening Europe’s plasma and PDMP ecosystem requires tailored policies and regulatory predictability, as well as aligned legislative frameworks that support long-term planning, operational stability and continued innovation. It also requires sustained investment in donor awareness, donor safety and monitoring systems, collection infrastructure, manufacturing capacity, alongside digitalisation and supply chain redundancies.

Innovation should be recognised across entire value chains

Innovation plays a central role in this discussion. In Europe, innovation policy is primarily associated with the discovery of novel therapies. Though new discoveries are essential, innovation in the plasma-derived medicines sector is much broader.

Alongside research into new proteins, therapeutic uses and indications, significant innovation is taking place across the entire value chain: donor detection and monitoring systems; manufacturing processes including protein yield optimisation and purification technologies; digital transformation tools such as data analytics and artificial intelligence applications; as well as operational efficiency and supply chain management.

These advances are critical not only for European competitiveness, but also for long-term manufacturing resilience, donor and patient safety and well-being.

Increasing the resilience needs financial effort

Despite innovations, challenges remain. Policymakers must acknowledge growing tensions within European healthcare systems. Demand for critical therapies continues to increase, while financial pressures on healthcare budgets also intensify. Cost-containment measures frameworks focused predominantly on short-term cost considerations are increasingly used to manage expenditure.

Economic sustainability remains essential for healthcare systems. However, policies focused primarily on short-term cost optimisation may unintentionally discourage long-term investment in innovation, manufacturing capacity and supply chain robustness, if they fail to reflect the specific characteristics of different critical medicine ecosystems.

Ad hoc reactions or strategic approach?

Europe now stands at an important crossroad. It has both the opportunity and the capability to strengthen the resilience of its healthcare systems while reinforcing its biotech and life sciences ambitions. Europe already hosts a significant plasma-derived medicines industrial ecosystem, including world-class manufacturing facilities, advanced scientific capabilities and tens of thousands of highly skilled jobs across the value chain. The challenge is not whether Europe can build stronger and more sustainable plasma and PDMPs ecosystems – it can. The challenge is whether political ambition will be matched by long-term alignment across policy, investment, innovation and collaboration between member states and stakeholders. Europe’s current dependence on imported plasma did not emerge overnight, and reducing vulnerabilities will also take time. But the groundwork for change is now being laid. If approached with realism, cooperation and strategic consistency, Europe has the capacity to strengthen supply security to deliver equitably critical medicines for all patients.

The debate around plasma collection for PDMPs manufacturing is often framed too narrowly as a discussion about institutional models or ideological preferences. In reality, public, private and non-profit actors are already deeply interconnected within the plasma ecosystem. The central question, therefore, is not who participates in the system, but whether the system as a whole can sustainably meet growing patient needs. All actors ultimately share the same objective: ensuring that patients receive the therapies they depend on, no matter where they live.

The views expressed in this #CriticalThinking article reflect those of the author(s) and not of Friends of Europe.