European Parliament adopts its position – trilogue negotiations can begin

With the adoption of the Parliament’s position, the legislative procedure on the Regulation proposal for a Critical Medicines Act (CMA) enters its next phase. After the Council had already agreed its General Approach in December 2025, interinstitutional negotiations between Parliament and Council are now set to begin in the trilogue. The aim of the CMA is to stabilise the supply of critical medicines in Europe and to reduce dependencies on third countries.

Parliament vote with a broad majority

On 20 January, the European Parliament adopted the report of the Committee on Public Health (SANT), drafted by rapporteur Tomislav Sokol (EPP, Croatia), by a large majority (503 in favour, 57 against, 108 abstentions). Several amendments were still voted on in plenary. A proposal by the Renew group received a narrow majority and slightly broadens the scope of the Regulation. In the Parliament’s position, orphan medicines as well as contraceptive and abortive medicines are now automatically classified as Medicines of Common Interest (MPCI). This means that the Parliament’s position goes beyond the report adopted in the SANT Committee in certain respects.

Key elements of the Parliament’s position

Overall, the European Parliament places greater emphasis on European coordination and binding requirements than both the original Commission proposal and the Council’s position. The Parliament proposes, among other things, more detailed and expanded criteria for strategic projects aimed at creating, modernising and scaling up production capacities for critical medicines and their active substances. These should be accompanied by accelerated permitting procedures and supply obligations in cases of public funding. In addition, Parliament calls for the establishment of a dedicated Critical Medicines Security Fund under the next Multiannual Financial Framework from 2027 onwards. Regarding the scope, the Parliament distinguishes between medicines listed on the Union list of critical medicines, for which the CMA would fully apply, and medicines of common interest, for which only selected provisions – for example on public procurement or joint procurement – would apply.

Public procurement: Article 18 in focus

For statutory health insurance funds, as the main payers, security of supply is closely linked to the affordability of medicines and the financial stability of the solidarity-based healthcare system. The proposed rules on public procurement under Article 18 of the CMA are therefore particularly relevant, as European requirements would directly affect established national instruments such as rebate contracts.

The Parliament’s position envisages a reorientation of public procurement. Mandatory award criteria beyond price are foreseen, including resilience, supply chain security and diversification, as well as multi-winner tenders where medically and practically appropriate. In cases of identified dependencies, an EU preference should apply, linked to defined thresholds for the share of European production. Furthermore, voluntary joint procurement between Member States is strengthened. The threshold for such procedures is proposed to be lowered to five participating Member States, and the European Commission would assume a stronger coordinating role – including, as a last resort, with regard to emergency stockpiles in crisis situations.

DSV priorities for the trilogue

In its statement ahead of the trilogue, the German Social Insurance (DSV) calls for public authorities to retain sufficient flexibility to continue using national instruments such as rebate contracts and to respond effectively to specific supply situations. The DSV also advocates for the binding safeguarding of clearly defined exemption clauses, so that procurement obligations can be waived in cases of disproportionate costs, lack of competition or risks to affordability. From the DSV’s perspective, it is equally important to clearly limit the scope of the CMA to medicines included in the Union list of critical medicines, in order to preserve the focus of the Regulation.

Outlook

With both Council and Parliament positions now available, the two institutions will enter trilogue negotiations. An agreement before the summer recess in 2026 is considered likely.