Commission publishes EU’s first list of critical medicines to tackle shortages

The European Commission today published the Union’s first list of critical medicines, in collaboration with the European Medicines Agency (EMA) and the heads of the medicines agencies (CAM). The publication follows the Commission’s commitment in its Communication ‘Tackling medicine shortages in the EU’ to accelerate work on this list, originally announced in the EU’s pharmaceutical reform proposal. the European Union (EU). This is an important part of the EU’s efforts under the European Health Union to ensure that patients have the medicines they need, by strengthening security of supply in critical medicines and to avoid shortages. The list is also part of the EU’s efforts to improve its resilience and strategic autonomy in the face of geopolitical challenges and unforeseen events.

A medicine is listed as critical when it is essential to ensure the provision and continuity of quality healthcare and a high level of public health protection in Europe. This first Union Critical Medicines List lists more than 200 active substances used in medicines for human use and considered essential within the EU/EEA.

The fact that a drug is on this list does not indicate that it is likely to be in shortage in the near future. Rather, it means that it is essential to avoid shortages of these specific medicines, as their unavailability could result in significant harm to patients and pose significant challenges to health systems.

The list was developed in collaboration with the EMA and all EU member states. It follows a strict method for assessing criticality – a method initially developed during the Commission’s structured dialogue on the security of the supply of medicines, launched as part of the pharmaceutical strategy which was carried out in 2021 on the basis of lessons learned from the COVID-19 pandemic. Key stakeholder groups, including patients, healthcare professional organizations and industry associations, were consulted.

Ensuring continuity of supply of critical medicines on the EU list is a top priority for the Commission. It will take all necessary measures to work hand in hand with Member States and relevant parties to avoid shortages, including implementing additional measures where necessary.

Next steps

The Union’s list of critical medicines will be updated annually. As announced in the Communication “Tackling medicine shortages in the EU”, the list of critical medicines will be used to facilitate and accelerate the Commission’s analysis of vulnerabilities in the supply chains of critical medicines that are listed on the list, following a step-by-step approach.

On this basis, the Commission and the EMA, in collaboration with Member States (through the Executive Steering Group on Medicines Shortages and Safety), will be able to recommend measures to address these vulnerabilities. This will be done, where appropriate, in consultation with the Medicines Alliance which is to be established in early 2024.

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