The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU/EEA, for which continuity of supply is a priority and shortages should be avoided. The European medicines regulatory network will prioritise critical medicines for EU-wide actions to strengthen their supply chain.
The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines. Inclusion in the list does not mean that the medicine is likely to experience a shortage in the near future. It means that the prevention of shortages is particularly important as a shortage could cause significant harm to patients and pose important challenges to health systems. A medicine is considered critical if it is used in serious diseases and cannot be easily replaced by other medicines, for example in case of a shortage. It is included in the Union list of critical medicines if it meets certain criteria, including being critical in more than one third of EU/EEA countries.
The list contains active substances covering a wide range of therapeutic areas, and includes vaccines and medicines for rare diseases. It reflects the outcome of the review of 600 active substances taken from six national lists of critical medicines . The Union list will be expanded in 2024 and will then be updated every year.
The review was carried out with all EU Member States, and criticality was assigned based on an agreed methodology developed in consultation with key stakeholder groups, including patients’ and healthcare professionals’ organisations and industry associations.
Medicines on the list can continue to be prescribed and used as usual by patients and healthcare professionals. Additional reporting requirements for marketing authorisation holders and national competent authorities will be established and become effective once the proposed pharmaceutical legislation becomes applicable.
The publication of the Union list will not impact existing or to-be-established national lists of critical medicines. However, it will support the network’s efforts in drawing up national lists where these do not yet exist. In addition, it will support and expedite the EC’s analysis of the supply chain of critical medicines to determine potential vulnerabilities, as announced in the EC’s communication of 24 October. The EC and EMA’s Medicines Shortages Steering Group (MSSG) may propose measures to address vulnerabilities in the supply of those medicines, to ultimately prevent and mitigate shortages.
More information on the list, including its composition, how it was established and how it will be used, is available in a question-and-answer document.
The Union list of critical medicines complements other measures adopted by the EMA / HMA taskforce on availability of authorised medicines and by the MSSG, such as Good practices for industry and for patients and healthcare professional organisations for the prevention of medicine shortages, the recently created MSSG solidarity mechanism, the MSSG toolkit, and the MSSG’s recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections.