The European Commission is under growing pressure to deliver the Critical Medicines Act quickly. EU Health Commissioner Olivér Várhelyi promised to present the proposal within his first 100 days in office. Yet, tight deadlines and bureaucratic hurdles raise doubts about meeting this ambitious timeline.
The legislation aims to tackle critical shortages of essential medicines, such as antibiotics, insulin, and painkillers. It focuses on addressing supply vulnerabilities caused by overreliance on limited manufacturers and fragile supply chains.
Regulatory Challenges: Balancing Urgency and Rules
Strict EU procedures add to the complexity. New legislative proposals require thorough impact assessments to evaluate their social, economic, and environmental effects. Skipping this essential step could delay approval within the Commission’s internal review process.
Several member states, including Poland, have questioned whether the act will be prioritized during their EU Council presidency, which runs until June 2025. To speed up progress, the Commission might apply an emergency process similar to the one used during the COVID-19 pandemic. In this case, the impact assessment would be completed after the proposal’s publication.
Stakeholders to Steer the Path Forward
The Critical Medicines Alliance, which includes 250 stakeholders, plays a vital role in the act’s development. Since April, the group has been analyzing weaknesses in Europe’s medicine supply systems. Their final recommendations, expected on February 12, could form the backbone of the new legislation.
Commission insiders suggest that combining the Alliance’s findings with a planned legislative gap study for 2025 might fulfill regulatory requirements. This strategy could allow the proposal to move forward faster without compromising EU standards.
Várhelyi remains steadfast: “This is a clear emergency. Europe must act now to secure its supply of critical medicines.” The European Commission continues to search for solutions that balance urgency with procedural integrity to protect Europe’s access to vital medicines.