The European Medicines Agency (EMA) has revealed a new mechanism to combat critical medicine shortages across the European Union. Developed by the EMA Medicines Shortages Steering Group (MSSG), the solidarity mechanism’s goal is to foster collaboration among EU Member States in times of dire need.
The mechanism, which builds on an informal setup implemented during the COVID-19 pandemic, enables a Member State facing a severe medicine shortage, developed in the MSSG for European coordination, to request assistance from other Member States in obtaining crucial medicine stocks. This option is a last resort, to be used only when all other alternatives have been exhausted.
The solidarity mechanism complements various actions outlined in the MSSG Toolkit, such as supply and demand monitoring, negotiations with marketing authorization holders and manufacturers, and the implementation of regulatory flexibilities. These measures intend to address critical medicine shortages effectively, ensuring that patients receive the necessary treatments.
The MSSG, established under Regulation (EU) 2022/123, further solidifies the EMA’s role in crisis preparedness and management for medicines and medical devices. This regulation, which was created in response to lessons learned during the COVID-19 pandemic, aims to monitor and respond to shortages swiftly and efficiently.
The voluntary solidarity mechanism reflects the EU’s commitment to ensuring the uninterrupted supply of essential medicines, offering a safety net for Member States when conventional solutions are exhausted. While the mechanism is voluntary, all Member States are encouraged to respond to requests for assistance, with a clear focus on timely and effective support during emergencies. The EMA plans to publish information on the mechanism while protecting the privacy of participating Member States.