From fundraising challenges to changing joint drug procurement: Here’s what you need to know about the new regulations aimed at ensuring European access to critical drugs:
This week, the European Commission announced one of its most important health proposals: the Critical Medicines Act. It aims to increase the safety of the supply and availability of essential medicines throughout the EU.
It is ambitious in some areas, such as the proposed “European” mechanism and a new class of “common interest” drugs, but in other respects it has not been overlooked, particularly in emergency inventory adjustments. Frequent funding for health issues remains an important concern.
EuroNews highlights the main open questions that still need to be addressed.
How dangerous is the protectionist’s suggestion to “buy Europe”?
One of the most talked about aspects of the proposal is the “European Purchase” principle, which prioritizes supply security over the costs of public procurement.
Under this new proposed rule, the EU contracting authority will apply procurement requirements in favor of suppliers who manufacture a significant portion of key drugs within the EU.
“This fits perfectly within the limits of what we already have in the EU. EU Health Commissioner Olivel Valier said:
This new approach could expose the EU to international trade dissatisfaction. After all, it’s not too far from Beijing’s “purchasing China” policy on medical devices recently openly challenged by the EU to limit foreign suppliers, including the EU, from government contracts.
Earlier this year, EU officials released a report providing evidence of China’s unfair restrictions, arguing that market openness should be mutual.
If implemented, the EU can be placed in a similar position by “buying Europe.”
Returning production to Europe (or closer)
To reduce dependence on non-EU countries, this proposal will promote an increase in European production of important drugs and an increase in new categories of medicines of common interest.
But should these drugs be manufactured in European soils? According to the new proposal, it is not. The committee plans to establish new strategic partnerships to strengthen bilateral cooperation and ensure diverse sources of supply.
“I rely very much on the nearest neighbor candidate countries and countries that should be in pole position to either get back in production in the EU or get closer to the EU,” Várhelyi said.
EU officials also mention potential cooperation with other broader third countries, such as the UK and Switzerland, taking into account the strong trade link and proximity.
Show me the money – so far, there aren’t many
The main drawback of the proposal is its limited funding. The 2026-2027 83 million euros indicator budget is relatively modest, mainly from the EU4Health programme.
This funding could only cover coordination efforts by the European Medicines Agency (EMA) and the European Commission, rather than supporting a large-scale production shift.
advertisementStrategic projects can receive additional funding from EU programs such as Horizon Europe and the Digital Europe program, but it is unclear whether these resources will be sufficient.
Prior to the presentation of the proposal, 11 EU health ministers called for the expansion of the scope of EU defence funds to include important medicines. However, Várhelyi dismissed this idea and instead emphasized his reliance on state aid.
To promote this, the committee has loosened restrictions on the definition of state aid in several new guidelines and encouraged member states to invest their national budgets in the initiative.
Joint procurement gets an upgrade
The proposal includes an enhanced mechanism for joint procurement, and the committee plays a stronger role.
advertisementTraditionally, joint procurement allows the Commission and at least nine member states to negotiate as a single purchase block, taking advantage of the collective demand for better terms.
The new proposal formalizes and extends this mechanism, allowing the Commission to act as a central buyer when requested by at least nine member states.
Additionally, it introduces a cross-border procurement model promoted by the Commission, which provides logistical and administrative support to member states where EU executives control their own procurement.
This formalization is based on past committee-led procurement efforts, including purchasing MPOX and flu vaccines.
advertisementAre you missing something? Emergency Stock Questions
One important recommendation from the Critical Health Union – stakeholder associations analyzing supply chain vulnerabilities – was the establishment of a harmonious EU framework for contingent stockpiling.
However, this aspect was omitted entirely from the proposal. The European-wide stockpile approach ensures that member states do not compete with each other for supplies and rely on EU solidarity during shortages.
Without adjustment, stockpile efforts are at risk of fragmentation, leading to inefficiency and potential inequality.
“It cannot happen again for a large state to stockpile drugs without sharing with a small country in need,” emphasized Croatian MEP Tomislav Sokol, of the European People’s Party on the centre right.
advertisementWith this proposal moving into the legislative process, MEPS is expected to introduce amendments that drive coordinated stockpile measures.
