knowledge 15 May 2026 |

EU Critical Medicines Act: Political agreement reached – what life sciences companies need to know

This alert builds on our previous (pre-trilogues) update: EU Critical Medicines Act: What life sciences companies need to know (January 2026) – and highlights the key changes that life sciences companies need to know.

Recap

As outlined in our earlier update, the EU Critical Medicines Act (a regulation which will be directly applicable in EU Member States) complements the recently-agreed EU pharma reform package (which is due for publication in the Official Journal later this year – read our recent update for more information: EU Agrees Landmark Reform of Pharmaceutical Legislation).  While the EU pharma reform package focuses on the regulatory side, the EU Critical Medicines Act focuses on the industry side – in particular, diversifying supply chains, enhancing manufacturing capacity, investing in and supporting strategic projects, collaborative procurement, and international partnerships.

Key elements of the provisional deal

The headline features of the provisional agreement are:

• ‘Buy European’ procurement: contracting authorities will be required to apply resilience-related requirements in public procurement of critical medicines, supporting diversification of supply sources.
• ‘EU preference’ approach: for critical medicines that are highly dependent on third country suppliers, contracting authorities will be able to incentivise EU manufacturing through a range of flexible options, including rewarding suppliers in proportion to the share of the medicine and its active pharmaceutical ingredients manufactured in the EU.
• Strategic projects: the criteria for designating industrial “strategic projects” located in the EU (to create, modernise or increase manufacturing capacity for critical medicines and their active substances) have been confirmed.  Clear requirements will be set out for companies that benefit from national or EU financial support, including prioritising supply to the EU market.
• Lower threshold for collaborative procurement: as expected, the threshold number of Member States needed to submit a joint request to the Commission to procure critical medicines (or medicines of common interest) on their behalf has been reduced from 9 Member States to 5 Member States.  This is expected to make collaborative procurement materially easier to trigger.
• Orphan medicinal products: these have now been brought into scope for additional areas such as eligibility for strategic projects and collaborative procurement.  This is a positive development for companies operating in the rare conditions space (conditions affecting no more than 5 per 10,000 people in the EU).
• Safeguarding contingency stocks: while the European Parliament had looked for a mandatory EU coordination mechanism for national stockpiles, information-sharing will remain voluntary.  New measures have been agreed for sharing information on contingency stock requirements, and the existing voluntary solidarity mechanism will be used to share data on contingency stocks and reallocate critical medicines between Member States where needed.

Next steps

For life sciences companies, where (and how much of) a product is manufactured in the EU will increasingly affect competitive position in tenders, particularly for products with concentrated third country supply chains.  Once the agreed text is available, those considering investment in EU strategic projects will need to start reviewing, in detail, the requirements that will apply, and the wording of that agreed text will also be key to assessing the detail on procurement criteria and contingency stock arrangements.

With the European Commission welcoming the political agreement as key to the diversification of supply chains and to supporting EU-based pharmaceutical manufacturing, the European Medicines Agency also welcomed the agreement as a “significant milestone towards strengthening Europe’s capacity to improve the availability, supply and production of critical medicines”.  Through its Executive Steering Group on Shortages and Safety of Medicinal Products, the EMA is already assessing supply chain vulnerabilities in the first set of medicines included in the Union list of critical medicines.

The agreed text is subject to final endorsement by both the EU Council and European Parliament over the coming months and is likely to be published in the Official Journal towards the end of 2026 (with its application date to be confirmed). 

Keeping you up-to-date

Our market-leading Life Sciences Group will publish further analysis once the final text is available, including practical guidance on positioning for strategic project designation, navigating the new procurement rules, and alignment with the EU pharma reform package more broadly.