EU Critical Medicines Act: new rules for procurement and supply

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 TFEU 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.

It requires contracting authorities to include "resilience requirements" in tender procedures (Article 18.1), introduces a "European preference" subject to exceptions, including cost, absence of offers and urgency (Articles 18.2 and 18.5), and lowers from nine to five the threshold of Member States required to ask the Commission to procure on their behalf. Safeguards govern emergency stockpiles and a voluntary solidarity mechanism.

Implications for pharmaceutical companies and public purchasers

Pharmaceutical companies and manufacturers of active pharmaceutical ingredients (APIs) should prepare for resilience requirements to be incorporated into tender specifications launched 12 months after the date of application, and document their ability to meet them. These requirements may include storage, supplier diversification and supply-chain transparency.

Legal departments should:

• 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 this basis, they should then assess whether to seek "strategic project" status, which may offer accelerated permits and financial support. A review of strategies for responding to hospital public procurement tenders is recommended.

Read the press release from the Council of the EU here for more information.