Brussels, 14 May 2026
The Plasma Protein Therapeutics Association (PPTA) notes the provisional agreement on the Critical Medicines Act (CMA) reached by the Council of the European Union and the European Parliament and calls for a flexible approach to its implementation that takes into account the distinctive characteristics of different medicine supply chains. PPTA also welcomes the provisions aimed at ensuring that Member States’ contingency stock requirements do not negatively impact patient access and the supply of critical medicines across the EU.
A differentiated and proportionate implementation of resilience measures will be important to ensure that the specific characteristics of different critical medicine supply chains and operational realities are adequately reflected in practice. Plasma-derived medicines rely on complex, highly specialised and globally interconnected supply chains, while their production depends on human plasma – a critical substance of human origin that cannot be substituted and depends entirely on donations.
“If we combine that almost all plasma-derived medicinal products are included in the Union List of Critical Medicines and that the starting material, human plasma, itself is recognised as a critical substance under the EU SoHO Regulation, we get a unique feature within the broader category of critical medicines. These medicines are produced through uniquely complex and time-dependent supply chains that differ significantly from other critical medicines. While the final CMA provisions remain under review, the implementation phase will be essential to ensure that these specificities are adequately reflected in practice in order to support long-term supply continuity and patient access across Europe,” said Marilena Vrana, Vice President, Public Affairs and EU Operations at PPTA.
The effectiveness of the CMA will ultimately depend on how it is implemented at the national level. Critical medicines are not produced, sourced or supplied under the same conditions, and these differences should be adequately reflected in interpretation and implementation measures to help support uninterrupted availability of therapies for patients.
The CMA introduces important tools such as resilience based public procurement, collaborative procurement mechanisms, and incentives to strengthen manufacturing capacity in Europe. In this context, PPTA highlights that all procurement frameworks should take into consideration distinctive characteristics of different medicine supply chains. All measures should be implemented in a way that complements global supply chains and encourages investment, rather than creating fragmentation or unintended barriers that could weaken supply security.
“PPTA welcomes safeguards ensuring that contingency stock requirements in one EU Member State do not unintentionally disrupt the availability of critical medicines in others. It is crucial to maintain and prioritise supply continuity for equitable patient access across the EU. As policymakers have increasingly recognised: patient access must come first,” added Marilena Vrana.
While targeted, proportionate and temporary contingency stocks may play a role in emergency preparedness, systemic and uncoordinated stockpiling of plasma-derived medicines can have unintended consequences. Because plasma-derived medicines rely on limited plasma availability and long manufacturing lead times, excessive or fragmented stockpiling risks diverting limited supply, increasing inequities between Member States, and ultimately weakening overall supply resilience and patient access across Europe.
“Ensuring equitable access to plasma derived therapies depends not on static stock levels, but on the continuous, prioritised flow of plasma through the supply chain. As policymakers have recognised throughout the CMA negotiations, patient access must remain the guiding principle,” Marilena Vrana concluded.
For more information, visit: www.pptaglobal.org.