5 takeaways on the Critical Medicines Act

The European Commission unveiled this week one of its most significant health proposals, the Critical Medicines Act, which aims to enhance the security of supply and availability of essential medicines across the EU.

While ambitious in some areas, such as a proposed "Buy European" mechanism and new class of 'common interest' medicines, in other respects it was unspectacular, particularly in coordinating contingency stock. Funding, as so often on health matters, remains a key concern.

Euronews highlights the main open questions that still need to be addressed.

How risky is the protectionist ‘Buy European’ proposal?

One of the most talked-about aspects of the proposal is the ‘Buy European’ principle, which prioritises security of supply over cost in public procurement.

Under this new proposed rule, EU contracting authorities will apply procurement requirements favouring suppliers that manufacture a significant portion of critical medicines within the EU.

“This fits perfectly within the limits of what we have already in the EU. This is, after all, an overriding reason of public health because we have a problem with the security of supply,” said EU health Commissioner Olivér Várhelyi.

This new approach could expose the EU to international trade discontent. After all, it is not far from Beijing’s ‘Buy China’ policy on medical devices recently openly challenged by the EU as it restricts foreign suppliers, including those from the EU, from government contracts.

Earlier this year, the EU executive released a report providing evidence of China's unfair restrictions, arguing that market openness should be reciprocal.

If implemented, "Buy European" could put the EU in a similar position—risking retaliation from trade partners and reduced market access abroad.

Bringing production back to Europe (or closer)

To reduce dependence on non-EU countries, the proposal promotes increased European production of critical medicines as well as the new category of medicines of common interest.

But do these drugs need to be manufactured on European soil? According to the new proposal, not really. The Commission plans to strengthen bilateral cooperation and establish new strategic partnerships to ensure diverse sources of supply.

“I very much rely on the candidate countries and countries in our closest neighbourhood who should be in pole position to help us to bring back production in the EU or closer to the EU," said Várhelyi.

EU officials have also mentioned potential collaboration with other broader European third countries like the UK and Switzerland, given their strong trade links and proximity.

Show me the money – because so far, there’s not much

A major shortcoming of the proposal is its limited funding. The indicative budget of €83 million for 2026-2027, primarily from the EU4Health program, is relatively modest.

This funding will likely only cover the coordination efforts of the European Medicines Agency (EMA) and the European Commission, rather than supporting large-scale production shifts.

While strategic projects could receive additional funding from EU programs like Horizon Europe and the Digital Europe Programme, it's uncertain whether these resources will be enough.

Ahead of the proposal’s presentation, 11 EU health ministers called for expanding the scope of EU defence funding to include critical medicines. However, Várhelyi dismissed this idea, emphasising reliance on state aid instead.

To facilitate this, the Commission has loosened restrictions on state aid definitions in some new guidelines, encouraging member states to invest their national budgets in this initiative.

Joint procurement gets an upgrade

The proposal includes enhanced mechanisms for joint procurement, with the Commission taking on a stronger role.

Traditionally, joint procurement allows the Commission and at least nine Member States to negotiate as a single purchasing bloc, leveraging collective demand for better terms.

The new proposal formalises and expands this mechanism, enabling the Commission to act as a central buyer when requested by at least nine member states.

Additionally, a Commission-facilitated cross-border procurement model is introduced, where the EU executive provides logistical and administrative support to member states managing their own procurement.

This formalisation builds on past Commission-led procurement efforts, such as the purchasing of vaccines for mpox and influenza.

Isn’t something missing? The contingency stock question

One key recommendation from the Critical Medicine Alliance—a stakeholder body analysing supply chain vulnerabilities—was the establishment of a harmonised EU framework for contingency stockpiling.

However, this aspect was entirely omitted from the proposal. A European-wide stockpiling approach would ensure that member states do not compete against each other for supplies and could rely on EU solidarity during shortages.

Without coordination, stockpiling efforts risk being fragmented, leading to inefficiencies and potential inequities.

“It cannot happen again that larger states stockpile medicines without sharing them with smaller countries in need,” stressed Croatian MEP Tomislav Sokol from centre-right European People’s Party.

With the proposal now moving to the legislative process, MEPs are expected to introduce amendments pushing for coordinated stockpiling measures