The EU Critical Medicines Act introduces new resilience obligations for pharmaceutical procurement and a European preference, with significant implications for industry players and public purchasers.
On 12 May 2026, the European Parliament and the Council reached a provisional agreement on the Critical Medicines Act, based on Article 114 TFEU1 and complementary to the revision of EU pharmaceutical legislation.
What is the Critical Medicines Act?
The proposed legislation aims to secure the supply of critical medicines, such as antibiotics, insulin and painkillers, as well as medicines of common interest. It seeks to achieve this by diversifying supply chains, supporting the manufacturing of critical medicines and their active substances in the EU, and facilitating joint procurement.
What counts as a "critical medicine"?
A medicine is "critical" if it is on the EU's Union list of critical medicinal products, to be established under the companion EU pharmaceutical legislation. A product qualifies for that list where insufficient supply would cause, or risk causing, serious harm to patients, for example because no suitable alternative treatment exists. The list builds on prior work by the European Medicines Agency and national agencies, which identified 276 critical medicines in 20242, covering products such as antibiotics, insulin and painkillers.
Sitting on the list is only the first filter. Only some of the measures in the Critical Medicines Act, including the strongest procurement measures, apply additionally to products found "vulnerable": a separate, ongoing "vulnerability evaluation" assesses the medicine's supply chain by looking at all EU-authorised products sharing the same active substance, route of administration and formulation, to determine whether the EU is highly dependent on a single or limited number of third countries, or a limited number of manufacturing sites. A medicine flagged as vulnerable on that basis triggers the EU-preference procurement mechanisms described below3.
Article 18 requires contracting authorities to build "resilience requirements" into public tenders for critical medicines, and introduces a "European preference" favouring EU-based manufacturing, subject to limited exceptions including cost, absence of offers and urgency (Articles 18.2 and 18.5). The threshold of Member States needed to ask the Commission to procure on their behalf also drops from nine to five. Safeguards govern emergency stockpiles and a voluntary solidarity mechanism. Each of these points is unpacked below.
Resilience requirements, in practice
For every public tender covered by the EU procurement directive, contracting authorities must build in at least one "resilience requirement" aimed at keeping supply flowing: a selection criterion, a technical specification, an award criterion rewarding the best price-quality ratio, or a contract performance clause. In practice, this means tenders can reward bidders who diversify their suppliers of active substances, hold buffer stock, or commit to reliable delivery timelines, rather than awarding purely on price4.
Where a medicine has been flagged as "vulnerable" because of high dependency on a limited number of non-EU suppliers, the bar rises further: contracting authorities must actively favour EU-based manufacturing, either by reserving at least half of the tendered volume for suppliers manufacturing in the EU, or by scoring and weighting tenders so that a higher share of EU manufacturing earns more points. This preference applies for as long as the medicine stays on the critical list and is designated vulnerable, and for at least five years regardless, giving manufacturers a predictable investment horizon. Bidders must be ready to document where manufacturing actually takes place, since authorities can ask for evidence5.
The preference is not absolute. A contracting authority may depart from it where, for instance, only one supplier can realistically meet the need, where a prior similar tender drew no suitable bids, where compliance would mean paying a disproportionate price, or in narrowly defined emergency procurements. Any such departure must be justified and recorded in writing6.
Voluntary collaborative procurement: joining forces across borders
The Act also gives Member States two ways to combine their purchasing power. First, where three or more Member States ask, the Commission can act as a facilitator for a joint cross-border tender for medicines of common interest, providing logistical support and procurement advice without itself becoming a contracting party; participating states still procure, and pay, individually. Second, and more far-reaching, where five or more Member States (previously nine) jointly ask the Commission to run the procurement on their behalf, the Commission will generally do so for critical medicines already flagged as vulnerable, or for medicines of common interest that have been through an EU joint clinical assessment. Joining this route requires states to commit to binding minimum order quantities, and the same resilience and EU-preference requirements apply as in national tenders. Both routes are designed to let smaller markets achieve the scale needed to secure supply and negotiate effectively7.
Implications for pharmaceutical companies and public purchasers
Pharmaceutical companies and API manufacturers should prepare for resilience requirements in tenders launched 12 months after the date of application, and be ready to document storage, supplier diversification and supply-chain transparency measures.
Legal departments should track three milestones:
- monitor publication in the Official Journal of the European Union;
- track the establishment of national programmes within 12 months of entry into force; and
- follow the publication of the Commission's guidelines within six months.
On that basis, companies should assess whether to seek "strategic project" status for EU manufacturing investments, which can offer accelerated permits and financial support, and review their strategy for responding to hospital procurement tenders.
Read the press release from the Council of the EU here for more information.
1. Council of the European Union, document 11059/26, 30 June 2026, Interinstitutional File 2025/0102(COD).
2. Provisional agreement, recital 15.
3. Provisional agreement, Article 3(6)-(7) and recital 16.
4. Provisional agreement, Article 18(1).
5. Provisional agreement, Article 18(2) and 18(2a).
6. Provisional agreement, Article 18(5) and 18(5a).
7 Provisional agreement, Articles 21, 22 and 24; Council press release 351/26, 12 May 2026 (updated 30 June 2026).
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