The proposal of a Critical Medicines Act regulation made by the European Commission on 11 March 2025 (COM(2025) 102 final) addresses the long-debated issue of the security of supply of critical medicines and improving the EU manufacturing capacity.
The text came after the structured dialogue on medicines supply of February 2021, the consultations on the review of the pharmaceutical legislation, and the Strategic Report published on 28 February by Critical Medicines Alliances, representing the industrial stakeholders, highlighting the key vulnerabilities of the European supply chains and the Alliance’s recommendations on how to address them.
The proposal of the Critical Medicines Act has now to undergo scrutiny by the European Parliament and Council, which will lead to the final text. Once implemented, it would undergo a first revision after five years and then every other five years. We resume the document’s main contents, complementing other actions against medicines shortages already put in place by the Commission and the European Medicines Agency (EMA) as part of the ongoing review of the pharmaceutical legislation .
Not only critical medicines
The Critical Medicines Act covers the supply and production of drugs listed in the EU List of critical medicinal products as well as other medicines of common interest subject to market issues in some European markets. It also covers the supply and domestic production of pharmaceutical active ingredients (APIs) for both critical and common-interest medicines.
According to the proposed text, the indicative overall budgetary impact of the Critical Medicines Act would be around €83.02 million for 2026-2027, to be covered under the current multiannual financial framework. The planned Strategic Projects may be funded under existing EU programmes, such as EU4Health, Horizon Europe, and Digital Europe, provided they fulfil the requirements of the calls. Priority for financial support would be given to strategic projects addressing supply chains vulnerabilities identified by a vulnerability evaluation and with reference to the orientations established by the Critical Medicines Coordination Group.
This Group, composed of representatives of the Commission and Member States, would facilitate the implementation of the regulation, focusing on strategy for financial support, national procurement policies, collaborative procurement initiatives, international partnerships, and advice on the order of priority for the vulnerability evaluation of critical medicines.
Medicinal products included in the Union List of critical medicines and receiving financial support for a strategic project should then prioritise supply to the EU market.
Priority to Strategic Projects
The planned Strategic Projects are industrial projects aimed to improve the EU manufacturing capacity for critical medicines and their ingredients based on the creation of new facilities or the modernisation of the existing ones.
To be considered strategic, a project in the EU would have to meet at least one of the criteria listed in article 5 of the Commission’s proposal. These also include the creation or increase in manufacturing capacity for key inputs necessary for the production of one or more critical medicines and the contribution to the implementation of new technologies playing a key role in enabling such manufacturing.
Selection and designation of projects meeting the criteria would be the responsibility of a designated authority to be named by each Member State. Assessment by the designated authority may be requested by both the promoter of the project or the Member State itself. Permits for processes related to strategic projects would be authorised on the base of accelerated procedures. Promoters may also apply for granting the status of projects of the highest national significance if the national laws allow so.
The development of these initiatives will be facilitated by an already issued State aid guidance to assist Member States in setting up the framework needed to financially support the Strategic Projects. Planned actions include easier access to funding and fast-track administrative, regulatory and scientific advice procedures. More specifically, Member States should provide regulatory support to strategic projects activated in their territory, including priority to GMP inspections needed to approve the new or modernised manufacturing sites. Promoters could request EMA to provide dedicated advice to develop projects on innovative manufacturing processes and to activate a coordinated or joint procedure for environmental assessment should this obligation refer simultaneously to two or more Council Directives.
Among the criteria identified in the Critical Medicines Act to support industrial ventures interested in developing Strategic Projects are a greater sustainability or increased efficiency of processes and the implementation of new key technologies in manufacturing. National, regional and local authorities would be responsible to develop the needed plans to ensure the realisation of strategic projects, including land use, spatial plans and infrastructures.
New criteria for public procurement
Access to critical medicines for all European citizens is a key goal of the Critical Medicines Act, which the Commission chose to pursue by diversification and resilience of the supply chains, with a special focus on overcoming the price-only criteria for tenders. Among the announced measures are the diversification of supply sources of input materials, stockpiling obligations, monitoring of supply chains, transparency to the contracting authority and inclusion of contract performance clauses on timely delivery.
The issuing of a guidance on the new criteria should support their application in procurement procedures. The Commission limited the possibility to favour made-in-EU criteria for public procurement only to justified cases of high dependency of supplies on a single or a limited number of countries. These criteria would support procurement from suppliers that manufacture in the EU a significant proportion of the interested critical medicine. The same would also apply to medicines of common interest, where justified to ensure access.
Member States may also request the Commission to activate collaborative procurement procedures to improve economies of scale. In this instance, the possibilities addressed in the Critical Medicines Act include cross-border procurement, the Commission’s acting on behalf of Member States, or voluntary joint procurement procedures. This type of action should respect the principles of subsidiarity and proportionality and address the existing disparities in accessing critical medicines and other medicinal products of common interest. The measure aims to prevent market failures typical of the smaller EU markets, namely in the field of medicines to treat rare diseases. On the other hand, the reduction of dependencies should also pass through strengthening existing bilateral cooperation and signing new international partnerships with like-minded countries/regions.
The Critical Medicines Act also indicates that Member States would have 6 months time from the entry into force of the new regulation to establish national programmes, including a public procurement procedure, to support the security of supply of critical medicines. These programmes should promote consistent use of requirements by contracting authorities, pricing and reimbursement measures, and multi-winner criteria for tenders. Building of national contingency stocks should be based on transparency and solidarity principles.
