More coop­er­a­tion for greater supply reli­a­bility.

On 11 March, the European Commission published its Proposal for a Regulation on critical medicines, the so-called Critical Medicines Act (CMA). With the proposed regulations, it aims to strengthen supply reliability and availability of critical medicines within the European Union (EU) and to improve the accessibility of medicinal products of common interest. The proposal contains industrial policy measures, regulations on public and joint procurement and on strengthening international partnerships.

In the run-up to the draft, the German Social Insurance (DSV) already pointed out the "fine line between industrial and healthcare policy" (see News 02/2025) – a tightrope walk that the draft now reflects in specific terms.

Promo­tion of the industry

The draft provides for a series of industrial policy measures, including the designation of strategic projects aimed at establishing, expanding or modernising production capacities for critical medicines in the EU. For example, a manufacturer expanding its European Union-based production of critical medicines can benefit from certain incentives and facilitations as a strategic project, such as accelerated administrative, regulatory and scientific support. Strategic projects that address supply chain vulnerabilities can also gain easier access to EU funding (including through the Strategic Technologies for Europe Platform (STEP)). Under certain conditions, the Member States should be able to prioritise financial support for these strategic projects.

Public procure­ment, joint procure­ment

The draft also proposes measures in the area of public procurement to help diversify and strengthen the resilience of supply chains. In addition to the development of guidelines on procurement crtieria, the Commission proposes that procurement criteria that favour production in the EU, also known as "Buy European". should be applied in individual or a small number of countries where there is a high dependency on critical medicines. In Germany, the German Act to Combat and Improve the Supply of Medicines (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz - ALBVVG) already contains a regulation that favours European manufacturers. Health insurance funds are to favour antibiotics manufacturers with European active ingredient production in the award procedure for medicinal product discount contracts.

The Commission also wants to regulate the joint procurement of medicinal products. The degree of autonomy and responsibility of the European Commission varies depending on how much the Member States delegate this to the Commission. It can act as a supporter, agent or representative in the joint procurement of critical medicines or medicinal products of common interest.

More coor­di­na­tion of national regu­la­tions

At first glance, the draft makes it politically (path-dependent) clear that the safety of care and the availability of critical medicines for patients are strategic goals of the Union. Cooperation between the Member States and the Commission is emphasised in order to achieve these goals. The potential of the single market is to be "fully utilised"; however, the extent to which this is actually achieved in the draft remains a matter of opinion.

It is particularly striking that the regulation appears to be more focussed on coordination rather than the EU taking its own measures at its own level. There is no intervention in stockpiling, no build-up of EU reserves, and the EU's financial support is cautiously expressed.

The draft and its objectives basically have the character of an industrial promotion law. It sends a signal to the industry and at the same time puts political pressure on the negotiators of the EU pharmaceutical reform to achieve swift adoption of the legislation. However, when reading through the draft, it is noticeable that many aspects are still open, pending clarification in the political consultations. One of the biggest unresolved issues concerns the regulatory framework and funding: Where will the necessary financial resources for promotion of production in Europe come from? And how many critical medicines and medicinal products of common interest will there actually be in the end?

The draft regulation is now being discussed in the Council and the European Parliament. Both institutions work out their respective positions in the ordinary legislative procedure, which are then harmonised in the trialogue. The legislative process is expected to take years. Based on their Feedback, the DSV will now review the draft and prepare a detailed statement.