On 11 March 2025, the European Commission published the Proposal for a Critical Medicines Act 1, a new Regulation aimed at improving the availability of critical medicines in the European Union. The Proposal has however a wider scope and seeks to introduce collaborative procurement mechanisms and information sharing obligations not only for critical medicines but also medicines which are considered of common interest.
1. Securing Supply of Critical Medicines
According to European Health Ministers Europe now depends on Asia for 60 to 80 percent of its pharmaceutical supply including antibiotics. Such dependence is considered a public health and a security issue. In a world of geopolitical turmoil and trade wars there is a sense of urgency among European leaders to reshore production.
Proposed Measures
Facilitating investment in manufacturing capacity: The Regulation sets out a framework to facilitate investments in Strategic Projects that strengthen the manufacturing capacity of critical medicines, their active pharmaceutical ingredients (APIs), and other essential inputs within the EU. These projects, when designated as strategic, will benefit from fast track licensing processes, streamlined environmental assessments, administrative and scientific support and potentially also Member States’ and EU funding. To this end the Proposal includes an appropriation of €88.5 million from the Commission’s 2021-2027 budget, and gives countries more latitude to provide financial support for the manufacturing of critical medicines. In return for funding beneficiaries can be asked to provide necessary supplies of critical medicines to avoid shortages.
Public Procurement Award Criteria: To promote supply chain resilience and diversification the Proposal mandates Member States to apply procurement requirements other than price-only award criteria which may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery. For critical medicines with identified supply chain vulnerabilities and other medicines of common interest on justified grounds local manufacturing may be favoured.
Options for collaborative procurement: The Proposal foresees collaborative procurement in 2 forms for critical medicines (i) for which a supply chain vulnerability is identified or (ii) a common procurement procedure is recommended by the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products:
- European Commission procures in name and on behalf of Member States:
- At the request of at least 9 Member States
- The EC contracts in name and on behalf of Member States (based on practical modalities laid down in a mandate agreement)
- Joint procurement between Commission and Member States:
- At the request of at least 9 Member States or at the initiative of the European Commission
- the EC and Member States engage as contracting parties in their own name and on their own behalf in joint procurement procedures.
Establishment of Critical Medicines Coordination Group and International Cooperation: To facilitate the implementation of the Act a Critical Medicines Coordination Group would be established with Commission and Member States representatives and a secretariat provided by the European Commission. Within this group strategic orientation for financial support of strategic projects can be discussed.
Obligation to provide information: Marketing authorisation holders and other economic operators in the supply chain can be requested to provide information to the Commission and Member States which is necessary for the application of the Act. Such supply chain information is often of a strategic nature and therefore it will be quintessential that an appropriate framework for protection of commercially confidential information is put in place2.
International cooperation: Under the Proposal the Commission is tasked to explore the possibility of establishing strategic partnerships to diversify the sourcing of critical medicines, APIs, and key inputs, or by building on existing forms of cooperation.
2. Other Medicines of Common Interest
Despite its name, the proposed Act has a wider scope than critical medicines only. Measures on collaborative procurement and information sharing aim to improve availability and accessibility of medicines considered of common interest.
“Medicinal Products of Common Interest” (MPCIs) are those for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility of the products to patients.
For these medicines collaborative procurement will be possible using the above two mechanisms if a joint clinical assessment report has been published or voluntary clinical assessment under the HTA regulation has been conducted.
To further leverage aggregated demand of Member States there is even a third form of collaborative procurement for MPCIs which is referred to as ‘Commission facilitated Member States’ cross-border procurement’. Under this mechanism the Commission at the request of at least three Member States can act as a facilitator for cross-border procurement by interested Member States providing coordination support and providing advice on public procurement rules and regulatory matters.
Given that many novel medicines today are not available in three or more Member States, the scope for collaborative procurement for this category of products is vast.
Collaborative procurement has in recent months gained traction as a possible tool to improve access in certain (smaller) Member States. These proposals can therefore not be disconnected from the discussion on regulatory data protection (RDP) and the two years of conditional RDP for providing access in Member States. This is a highly controversial topic under the EU pharma package and has not been resolved yet as part of the Council negotiations.
3. Is it Enough?
According to Belgian’s Health Minister, Frank Vandenbroucke, the answer is an unequivocal no. Vandenbroucke whose country has been a driving force behind this legislative proposal points at the lack of sufficient financing of the initiatives in both the short and long term and the fact that the Act does not address sufficiently address aggressive stockpiling practices by certain Member States negatively impacting other ones. More budget and bolder action will be needed to fully achieve the objectives of the Act.
4. What’s Next
The Proposal will enter the legislative process and will be considered by both the Council and the Parliament which can each propose amendments. Despite the sense of urgency around the initiative overall timeframe remains hard to predict.
1Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795, 11 March 2025.
2This obligation also applies to M
