Key elements to the political agreement
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SubscribeOn 12 May 2026, the European Parliament and the Council of the EU reached a provisional political agreement on the Critical Medicines Act (CMA). This is a significant milestone in the European Union's efforts to prevent shortages of essential medicines, reduce the dependence of supply chains on third countries and strengthen the competitiveness of the European pharmaceutical sector.
The CMA will complement European pharmaceutical reform —see more on our Post | European pharmaceutical reform—.
Key elements of the political agreement
- Public procurement and European preference: Contracting authorities should refrain from relying on a “lowest price” criterion in public procurement. The CMA will require the application of supply chain resilience requirements in the public procurement of critical medicines, favoring non-economic criteria such as those related to stock obligations, diversification of supply sources, or supply chain monitoring.
For medicines with a high dependence on suppliers from third countries, the CMA goes further and provides for the obligation to favor manufacturing within the EU (EU preference) through the attribution of incentives to contractors who centralize their manufacture and supply in the EU. - Strategic projects: The agreement sets out the criteria for the Commission’s designation of "strategic" industrial projects located in the EU, aimed at boosting the manufacture of critical medicines and their active ingredients within the EU.
These projects will benefit from faster access to funding (both national and Union) and accelerated administrative support. In addition, projects aimed at the manufacture of orphan drugs will also be able to benefit from faster administrative processing. - Collaborative procurement: The CMA supports collaborative procurement between Member States, making it easier for Member States to procure critical medicines and medicines of common interest together, thereby increasing their negotiating capacity. In particular, the threshold of Member States necessary to activate a joint public procurement request before the European Commission is reduced: from nine to five Member States.
- Orphan drugs: The agreement expands the scope of the CMA to include orphan drugs in additional areas, such as strategic project eligibility and collaborative procurement.
- Contingency reserves and solidarity mechanism: The exchange of information on contingency reserves will remain voluntary, but the objective of making national reserve requirements transparent has been reinforced and new measures have been agreed to share information on reserve requirements, to avoid disparities between Member States and disproportionate burdens that have a negative impact on access to medicines. In addition, the existing voluntary solidarity mechanism will be used to share data on existing stocks and redistribute critical medicines in stock between Member States if necessary, with the objective of reducing waste and improving access.
- International strategic alliances: The CMA envisages exploring strategic alliances with like-minded international partners with whom the EU has close trade, economic and regulatory relations (such as the UK or Switzerland) to expand the supply chain and reduce dependencies on single or limited suppliers.
Next steps
The provisional political agreement will need to be formally ratified by both the Council and the European Parliament in the coming months. The final text is expected to be published in the Official Journal of the European Union (OJEU) towards the end of 2026, at which time its date of application will be confirmed.
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