In order to combat critical medicines shortages The European Medicines Agency (EMA) together with the European Commission and the Heads of Medicines Agencies (HMA) recently published the first version of the “Union list of critical medicines“. The list identifies medicines for human use for which continuity of supply in the EU is a priority and shortages should be avoided as they are critical for EU healthcare systems to function properly.
Released in December 2023, the list comprises over 200 active substances, selected from a pool of 600 substances drawn from existing national critical medicines lists of EU member states. The list, categorized by the ATC code, spans various therapeutic areas, and is anticipated to further expand in 2024.
The accompanying Q&A document provides further information on the list of active substances. It explains how the list should be used and understood, what obligations the list entails for marketing authorisation holders and what significance the list has for other stakeholders such as patients, suppliers, or doctors. Additional obligations for marketing authorisation holders and national competent authorities will be further defined in the upcoming proposed EU pharmaceutical legislation.
Critical medicine status was assigned based on a methodology developed by EU member states with input from key stakeholder groups. A critical medicine is identified by combining two criteria, the seriousness of the disease they target and the availability of alternative medicines. A medicine that meets the criteria for criticality is included in the list if it meets additional criteria being critical in at least one-third (33%) of EU/EEA Member States. Inclusion in the list, however, does not imply an imminent risk of shortage.
While the list itself may not immediately mitigate shortages, it serves as a crucial instrument for EMA and the European medicines regulatory network to proactively prevent future shortages and ensure a secure supply chain. Through vigilant monitoring and implementation of measures, the regulatory network aims to minimize supply disruptions, thereby guaranteeing continued access to critical medicines for patients and healthcare systems across the EU.
