The European Commission has identified up to €83 million to support the Critical Medicines Act (CMA) during the final two years of the current EU budget cycle. The funding, as Health-Director General Sandra Gallina confirmed, is to come from existing programmes.
Speaking before the European Parliament’s SANT Committee, Ms Gallina called the figure a realistic starting point for strategic manufacturing investments. She stressed, however, that any long-term financing would depend on negotiations for the next Multi-Annual Financial Framework (MFF). “We have, within the existing programmes, identified the possibilities of financing,” she said, estimating “some €80–83 million for 2026–2027, roughly €40 million per year. Mathematics are not an opinion.”
Some MEPs questioned the policy. They wondered whether the limited short-term envelope could deliver on the ambition of securing Europe’s supply of critical medicines.
MEP Tomislav Sokol (EPP/CRO), rapporteur for the CMA called for stronger commitments: “We believe that for strategic projects, for major projects, European funding should also be used. (In) the next EU budget, the next Multiannual Financial Framework, we should have a strong budget also for the implementation of the CMA. This is why it is very important to have a separate EU health programme in the next budget. I am counting on you and DG SANTE to fight for that—because for us, this is a major priority.”
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Beyond price
Ms Gallina said the Commission will publish updated EU procurement guidelines to help national authorities apply resilience-based criteria under the CMA. These criteria allow procurers to consider factors such as backup production capacity, buffer stocks, and geographic diversification, alongside price.
(In) the next EU budget, the next Multiannual Financial Framework, we should have a strong budget also for the implementation of the CMA. This is why it is very important to have a separate EU health programme in the next budget. I am counting on you and DG SANTE to fight for that—because for us, this is a major priority. – MEP Tomislav Sokol
“The way to procure was to look, first of all, to the price. Now, we are saying, you can also look at other criteria,” the Health-Director General said. A forthcoming “modern toolbox” will help implement this approach across member states.
Ms Gallina acknowledged the importance of predictability for industry, but reaffirmed that procurement and health financing remain national responsibilities.
Several MEPs, including Romana Jerković (S&D/CRO), asked how the CMA aligns with the EU’s procurement directive revision. Ms Gallina assured them that both initiatives “try to pursue similar ideas” and are in lockstep with DG GROW.
Contingency stocks
In response to concerns about national stockpiles, Ms Gallina said the Commission will issue guidance on EU-wide contingency stocks. “It’s very important that we keep an EU-wide contingency stock,” she said, warning that national hoarding can lead to “negative spillover” and waste.
Ms Gallina noted that contingency stocks are more cost-effective and strategic than traditional stockpiles. She acknowledged the political sensitivity around stockpiling, but called for “predictability, transparency, and cooperation” to ensure member states do not unintentionally drain supplies from each other.
Mr Sokol strongly backed a coordinated EU mechanism: “It is very important to have a common European system, to unite all the systems into one (…) so that a medicine sitting in member state A can be sent to member state B as soon as possible.”
It’s very important that we keep an EU-wide contingency stock. – Sandra Gallina, Director-General for Health, European Commission
Joint procurement: thresholds and voluntary logic
Ms Gallina disclosed that a minimum of nine participating member states is needed to make joint procurement attractive for industry. “Nine member states was really the bare minimum to get a quantity that was interesting,” she said, referring to failed pandemic-era framework contracts due to low volumes and non-binding commitments.
She stressed that all procurement mechanisms under the CMA remain voluntary. She reiterated, “We want to create a balance in the act, respecting competencies and offering a different path.”
Her comments came in response to several members who urged the Commission to take a more active coordination role. MEP Bartosz Arłukowicz (EPP/PL) insisted, “It cannot be that the Commission announces that maybe we can buy joint respirators,” he said. “The Ministry of Health gathers, determines where there are shortages (…) and makes a decision whether we buy or not.”
Rare diseases included
Ms Gallina clarified that the CMA’s scope is intentionally broad and allows member states to define “medicines of common interest” based on national needs. This means the Commission does not exclude orphan drugs and new antimicrobials from support. “Rare diseases, yes, they will be covered,” she confirmed.
She also described the CMA as a complement to the broader pharmaceutical reform and the upcoming Biotech Act, and noted that future legislative files will likely include additional innovation-related incentives, particularly for SMEs and vulnerable regions. “The Critical Medicines Act is to complement the pharma reform,” she said. “We are working hand-in-hand with our colleagues in digital and research.”
The European Parliament will now begin drafting its report, with a first discussion of the rapporteur’s text due in September. While the Commission’s message was one of flexibility and subsidiarity, MEPs signalled they would seek stronger financial commitments, governance safeguards, and more precise tools for operational delivery. How far the Parliament can go in strengthening the text, while maintaining member state buy-in, will be decisive in shaping Europe’s future approach to medicine security.
