EFPIA acknowledges today’s vote in the European Parliament plenary on the Critical Medicines Act (CMA). The Act is an opportunity to improve Europe’s approach to medicines supply resilience, provided the final design remains proportionate, targeted and evidence-based.

The Parliament’s position includes welcome steps toward greater alignment of contingency stock requirements across Member States. A more coherent, risk-based approach can help reduce fragmentation and increase predictability for supply chain operators, as long as obligations are focused on medicines where shortages are demonstrably likely.

EFPIA remains concerned that elements of the adopted text risk diluting the CMA’s original intent. In particular, the extremely broad framing of ‘medicinal products of common interest’, the scope and thresholds for joint and collaborative procurement, and the introduction of local-content considerations without sufficient impact assessment raise questions about proportionality and effectiveness.

Measures that favour procurement based on manufacturing location risk weakening global supply diversification, reducing flexibility in supply chains and undermining Europe’s position as an export-oriented base for innovative medicines.

EFPIA is also concerned by the inclusion of compounding activities within the scope of measures aimed at increasing manufacturing capacity for strategic projects. Compounded medicines are prepared on an ad-hoc basis for specific patient needs. Their inclusion risks enabling stockpiling or broader use of unlicensed products, raising patient safety concerns and undermining public trust.

Nathalie Moll, Director General, EFPIA, said:

“In order to successfully achieve its aim, the Critical Medicines Act needs to focus on real supply risks and practical solutions. A one-size-fits-all approach will not deliver resilience.

With Parliament and Council positions now on the table, the trilogue negotiations should ensure the Act is focused on targeted, evidence-driven measures that strengthen supply security while preserving Europe’s attractiveness for manufacturing, investment and innovation.”