Draft report on the CMA – DSV sees need for improvement.

After the European Commission presented its proposal for a Critical Medicines Act on 11 March this year, the European Parliament has also taken up the dossier. On 1 September, Tomislav Sokol (EPP, Croatia), rapporteur of the European Parliament, presented his draft report on the Critical Medicines Act in the Committee on Public Health (SANT). The aim of the CMA is to strengthen production in Europe and to ensure the long-term supply of critical medicines (see News 07/2025).

Extension of scope – risk of dilution

In his draft report, Tomislav Sokol proposes to extend the scope of the CMA to “medicinal products of common interest.” The German Social Insurance (DSV) takes a critical view of this. If – as proposed in the report – orphan drugs or novel antimicrobial products are included in strategic projects and public funding schemes, there is a risk of resource misallocation and a dilution of the CMA’s objectives. The focus of the regulation should therefore remain on a narrowly defined set of medicinal products with immediate and critical supply relevance.

Award criteria – preserving flexibility for health insurers

Another key proposal of the draft report is the mandatory introduction of award criteria beyond price. While additional criteria such as resilience or EU-based production can, in principle, contribute to security of supply, EU procurement law already provides sufficient flexibility to include such requirements. This flexibility is already used in practice, for example in Germany, where health insurers are legally obliged to take account of certain medicines manufactured in Europe when concluding rebate contracts.

The DSV sees a need for adjustment here: mandatory application of additional criteria would restrict the flexibility of contracting authorities – in particular health insurers – and, in combination with mandatory multiple sourcing, would lead to significant cost increases without actually improving security of supply. The DSV therefore calls for such criteria to remain optional.

Sanctions – public funds only in return for commitments

The DSV welcomes the proposed sanctions in the draft report. Companies that fail to meet their supply obligations despite receiving public support should in future be held accountable. This sends an important signal: public funds must always be linked to enforceable commitments and clear returns.

Outlook

Until 19 September, the members of the SANT Committee were able to submit amendments to Sokol’s draft report. Following this, cross-party negotiations are now taking place to work out compromises in order to build majorities. The final vote on Sokol’s report is scheduled for 2 December in the SANT Committee. The opinions of the associated committees, Industry, Research and Energy (ITRE), Internal Market and Consumer Protection (IMCO) and Environment, Public Health and Food Safety (ENVI), have meanwhile also been issued and will feed into the discussions.

For the DSV, it is essential that the CMA remains focused on truly critical medicines, strengthens security of supply and at the same time safeguards the financial sustainability of solidarity-based health systems. The DSV will continue to closely monitor and assess the legislative process with this focus.

The DSV statement on Tomislav Sokol’s draft report can be found here. The comprehensive DSV opinion on the European Commission’s proposal for the CMA can be found here.