EU: Critical Medicines Act – new staff working document

 

The EU Commission has published a new staff working document regarding the draft Critical Medicines Act.

The working document summarizes evidence supporting the legislative proposal laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicines of common interest and amending Regulation (EU) 2024/795.

The Staff Working Document (SWD) presents the analysis and evidence underpinning the Commission’s legislative proposal for a Regulation establishing a framework to strengthen the availability and security of supply of critical medicinal products, as well as the availability and accessibility of other medicines of common interest. The proposal for the so-called Critical Medicines Act (CMA) was adopted on 11 March 2025.

Medicine shortages are an escalating threat to patients and public health. Healthcare systems across the EU face growing challenges in ensuring a reliable and resilient supply of essential medicines needed to maintain high standards of care. Recent global events, including the COVID-19 pandemic and Russia’s war against Ukraine, have highlighted vulnerabilities in pharmaceutical supply chains. Heavy reliance on non-EU suppliers and insufficient diversification further amplify the risk of shortages. Without decisive action, and in addition to the regulatory measures on shortage management and security of supply already introduced through the reform of pharmaceutical legislation, disruptions could seriously undermine patient care, leading to delayed treatments for life-threatening conditions.

The proposed Regulation delivers on the political commitment made by President von der Leyen (2) to introduce a Critical Medicines Act. Its objective is to address severe shortages, reduce dependency on external suppliers for critical medicines and ingredients, and secure access to affordable treatments. The Act is a key pillar of the European Health Union and complements:

1. the regulatory measures advanced under the ongoing revision of EU pharmaceutical legislation;
2. the strengthened mandate of the European Medicines Agency for crisis preparedness and medicines management;
3. actions to complete the European Health Union, ensuring that all Member States can jointly prepare for and respond to health crises while maintaining access to affordable, innovative medical supplies; and
4. recent industrial policy initiatives introduced in other critical sectors.

In addition, the Regulation seeks to enhance access to and availability of other medicines of common interest in cases of market failure, thereby reinforcing the measures proposed in the revision of pharmaceutical legislation.