In response to persistent medicines shortages across the EU, several legislative initiatives were proposed and implemented in 2025 to strengthen supply security and enhance the resilience of the EU medicines market.

One of these initiatives was the full launch of the European Shortages Monitoring Platform (ESMP) in February 2025. The ESMP will serve as a centralized hub for data collection of shortages, enhancing the EU's ability to prevent, detect, and manage shortages adequately. Marketing authorization holders will be required to report shortages through the ESMP.

In March 2025, the European Commission published their proposal for the Critical Medicines Act (CMA), which aims to reduce the EU's dependency on external sources and diversify supply chains. It also seeks to improve access to medicines unavailable in certain Member States. To this end, the CMA introduces measures like the designation of strategic manufacturing projects for expedited regulatory procedures and improved access to funding, to boost EU-based production capacity. The CMA also introduces a framework for the public procurement of critical medicines, requiring Member States to prioritize resilience criteria over price. On 2 December 2025, the Council agreed its position on the CMA. On 20 January 2026, the European Parliament adopted its position on the CMA. One of the Parliament's proposals is to empower the Commission to mandate cross-border redistribution of medicinal products in the event of critical shortages. In 2026, the Parliament, Council and Commission will negotiate on the final text of the CMA.

The Pharma Law Package addresses shortages from a regulatory and operational perspective, as part of a broader revision of EU pharmaceutical legislation. Under the proposal, marketing authorization holders would face stricter obligations to notify authorities of foreseen supply disruptions. Marketing authorization holders would also be required to maintain shortage prevention plans for critical medicines and medicines listed as subject to critical shortages of EU concern. Additional obligations include the preparation of shortage mitigation plans and regular documented supply chain risk assessments. The proposal further enables wholesalers and suppliers to report shortages, and it allows Member States to impose transparency requirements on parallel traders to protect public health. On 11 December 2025, the Council of the European Parliament reached agreement on the Package, which is expected to apply from mid-2028.

The introduction of the ESMP and the proposals for the CMA and Pharma Law Package reflect a comprehensive EU strategy to tackle medicinal product shortages. For life sciences and health care companies, these initiatives signal a more interventionist and coordinated EU approach to supply security, creating both new obligations and strategic opportunities in 2026.