The European Commission faces mounting pressure to deliver the Critical Medicines Act swiftly. EU Health Commissioner Olivér Várhelyi has pledged to present the initiative within his first 100 days in office. However, tight deadlines and bureaucratic hurdles threaten to delay this vital proposal.
The legislation aims to address critical shortages of essential medicines, such as antibiotics, insulin, and painkillers. It focuses on drugs that are particularly difficult to source or whose production relies on a limited number of manufacturers and suppliers.
Bureaucratic Challenges: Balancing Speed and Procedure
One major obstacle is the EU’s strict requirements for impact assessments. These assessments ensure new legislation is thoroughly evaluated for social, economic, and environmental effects. Skipping this step could risk internal delays within the Commission.
Some member states, including Poland, have expressed concerns about prioritizing the act during their EU Council presidency, which ends in June 2025. A faster process, similar to what was used during the COVID-19 pandemic, could bypass initial assessments. In that case, the impact analysis would follow the law’s publication.
A Path Forward: Support from the Critical Medicines Alliance
The Critical Medicines Alliance, a group of 250 stakeholders, could play a decisive role in moving the act forward. Since April, the Alliance has been analyzing weaknesses in Europe’s medicine supply chains. Their findings, expected on February 12, could provide the evidence needed to accelerate the proposal.
Reports suggest the European Commission is exploring whether the Alliance’s recommendations, combined with a separate study planned for 2025, could fulfill regulatory requirements. This approach could speed up the legislative process without bypassing formal guidelines.
Despite these challenges, Várhelyi remains determined: “The time to act is now. The current shortages are a clear emergency.” The European Commission is working urgently to secure long-term solutions for Europe’s medicine supply.