Medicine shortages

Medicine shortages can happen for many reasons, from supply disruptions to public health emergencies. They are a burden on healthcare systems and put patients at risk. Improving the availability of medicines is a priority for the EU medicines regulatory network. EMA plays an important role in this by monitoring the EU situation, coordinating the response to critical shortages and communicating with all relevant stakeholders, from industry to healthcare professionals and patients.

Monitoring EU shortages

Shortages are monitored by the Medicine Shortages Single Point of Contact (SPOC) working party. This group allows representatives from all Member States to regularly report shortages in their countries and exchange information on mitigation measures. To support the SPOC working party with the monitoring of shortages, in November 2024, EMA launched the European Shortages Monitoring Platform, a digital platform that will centralise and automate data collection from NCAs and marketing authorisation holders.

Preventing and managing critical shortages

The SPOC working party can escalate critical shortages or flag events that might lead to shortages to a group composed of heads of NCAs, patient and healthcare professional representatives, the European Commission and EMA. This is the Medicines Shortages Steering Group (MSSG). The group met 11 times in 2024. In this context, six oral explanations with marketing authorisations holders took place.

The main topics discussed were the ongoing shortages of Visudyne (verteporfin) and GLP-1 receptor agonists. For Visudyne, the MSSG supervised the allocation of available stock in the ongoing shortage. It worked with the marketing authorisation holder of the product to accelerate the implementation of a new supply chain in Europe and recommend additional mitigation mechanisms. For GLP-1 receptor agonists, recommendations to all stakeholders on managing the ongoing shortages were issued in July. A multi-stakeholder workshop was also then held to understand the needs of all relevant actors. In December, a real-world study characterising patients prescribed GLP-1 receptor agonists in five European countries was published to try and further understand how these medicines are used.

The MSSG also followed the supply situation for antibiotics used to treat respiratory infections throughout autumn/winter 2023-2024 and agreed on actions in preparation for autumn/winter 2024-2025. Additional supplies of antibiotics were identified and made available to Member States for the autumn/winter 2024-2025 season.

An analysis of vulnerabilities of the supply chain of insulins was initiated in 2024, with the aim of identifying prevention and mitigation measures to secure the availability of these important medicines.

Throughout the year, the MSSG continued to monitor events that could lead to public health emergencies, including the impact of the hurricane Helene on the availability of medicinal products in the EU/EEA.

New tool for coordinated EU response to shortages

At the end of 2023, the MSSG created the voluntary solidarity mechanism, to complement the existing tools included in the MSSG toolkit. This allows Member States to support each other in the face of a critical medicine shortage. The tool enables any Member State facing a critical shortage to request assistance from other Member States in obtaining stocks for a period of time.

This mechanism can only be used under limited conditions and was developed as a last resort for Member States after they have exhausted all other possibilities. In 2024, seven of these procedures were launched. All of these involved oncology medicines. In all cases at least one Member State was able to provide support.