The Employment, Social Policy, Health and Consumer Affairs Council witnessed a significant clash between delegations over the ambition and scope of the Critical Medicines Act. On one side, Germany, backed by the Netherlands, Slovenia, Estonia, Ireland, Finland and others, supported a compromise text they considered balanced and workable. On the opposing side, Belgium, Czechia, Malta, Latvia, and France argued the text lacked sufficient ambition, especially criticizing the weakening of EU manufacturing preference rules and the deletion of key enforcement provisions such as joint procurement by the European Commission. This division revealed broader cleavages on the size and nature of EU intervention, balancing national sovereignty and EU-level coordination.
The debate took place at the Council meeting on 2 December 2025 under the Danish Presidency, focusing on a legislative proposal initiated by the European Commission in March 2025 aiming to strengthen EU security of supply for critical medicines and key active substances.
Concrete proposals came from various member states and the Commission itself. The Danish Presidency presented a compromise general approach text to be adopted, with Olivér Várhelyi of the Commission emphasizing maintaining and reinforcing core principles of the original proposal with strategic public procurement tools, preferential treatment for EU manufacturing where dependencies exist, and diversification through strategic partnerships. Several countries proposed strengthening the EU manufacturing focus with clear resilience criteria and EU preference—for instance, Spain, Greece, France, Czechia, Portugal, Romania, and Poland. They sought predictable conditions for strategic projects to enhance resilience and availability. Others, like Belgium and Malta, criticized the deletion of article 4, which imposed stronger obligations on industry, and highlighted the need for a reinforced joint procurement mechanism, particularly to aid smaller markets' bargaining power and ensure a fairer playing field across member states.
A major policy cleavage concerned joint procurement and collaborative purchasing mechanisms: Lithuania, Slovenia, Estonia, Malta, and others urged reintroducing or strengthening the role of the European Commission as a contracting authority to consolidate bargaining power and coherence. Germany and Bulgaria opposed this, preferring voluntary arrangements and rejecting compulsory joint procurement to preserve national autonomy.
On national versus EU competences, the debate revealed tension between calls for stronger EU-level intervention to ensure supply resilience and respect for national health system prerogatives. Countries like Finland, Italy, and Bulgaria stressed preserving national competence in preparedness, stockpiling, and price-setting, wary of overreach. Meanwhile, Spain and Luxembourg supported stronger EU coordination to harmonize efforts and prevent market distortion.
In terms of financing, nations including Spain, Portugal, Poland, Romania, Latvia, and Austria advocated for greater EU-level funding instruments to support strategic projects and level the playing field. Several others, such as the Netherlands and Ireland, did not raise this, implying acceptance or neutrality on funding levels.
The proposed governance structure included the establishment of a Critical Medicines Coordination Group; however, Italy warned of potential overlaps with existing EMA shortage groups, seeking clearer functional distinctions.
The impact of differing approaches is significant for several key stakeholders: European producers in the pharmaceutical sector may face varying compliance demands depending on the strength of EU manufacturing preference and strategic project conditions, which could increase operational costs but also enhance market predictability. National authorities could see a shift in control over stockpiling and pricing, impacting their autonomy and budget allocations. EU consumers stand to benefit from enhanced security of supply and availability, though adjustments in procurement rules may affect medicine prices or diversity. European taxpayers might experience shifts in the allocation of public resources, especially if increased EU funding mechanisms materialize.
Looking ahead, the agreement to adopt a general approach opens the door to trilogue negotiations with the European Parliament and Commission, where contentious issues such as procurement powers, strategic project conditions, and funding levels will likely be further contested. The incoming Cyprus Presidency committed to defending the Council’s position in forthcoming talks, emphasizing continuity and pragmatic progress.
how to balance enhanced integration and coordination to secure critical medical supplies while respecting diverse national health systems and fiscal realities. This balancing act will continue to shape the evolution of the Critical Medicines Act and related health security frameworks.