Association Urges Trilogues to Maintain Differentiation for Unique Plasma Products and Supply Chain
15 December 2025
The Plasma Protein Therapeutics Association (PPTA) welcomes the European Parliament’s Committee on Public Health (SANT) amendments to the scope of the Critical Medicines Act (CMA). By recognising the distinct characteristics of different pharmaceutical supply chains, the Committee has taken an important step toward a Regulation that can more effectively strengthen supply security and support patient access across Member States.
The PPTA notes that the Council’s general approach adapted the scope without adequately recognising this diversity. The Association therefore calls on the Council and the European Commission to align with the Parliament’s more differentiated approach in the upcoming trilogue negotiations.
For the CMA to be effective, it must acknowledge that not all critical medicines are manufactured in the same way or face the same constraints. Plasma-derived medicinal products (PDMPs) exemplify this reality. These unique, lifesaving therapies rely on human plasma, a starting material that cannot be synthetically produced or substituted – and require long, complex, and highly specialised manufacturing processes. Neither the Commission’s proposal, nor the Council’s general approach fully recognises these unique characteristics.
“All medicines listed on the Union List of Critical Medicines fall under the Act. But to address the manufacturing challenges across 276 different medicines, the Act needs flexibility,” said Marilena Vrana, VP of Public Affairs and EU Operations at PPTA. “Its scope must reflect the distinct characteristics of supply chains. Flexibility must be built into the Regulation so that measures aimed at boosting manufacturing, procurement, or stockpiling are tailored to unique production processes that help fulfil patient need.”
PPTA stresses that patient access and medicines’ availability must remain at the center of negotiations. Unilateral and uncoordinated national stockpiling can disrupt an already limited PDMP supply and inadvertently undermine patient access. PPTA therefore recommends avoiding national stockpiling and limiting EU-level stockpiling to clearly defined crisis situations.
For questions, please email media@pptaglobal.org. For more information, visit pptaglobal.org.