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The European Medicines Agency (EMA) has published its first list of “critical medicines”, which it says must be prioritised to strengthen their supply chain and help avoid potential shortages.
The list, which was co-published with the European Commission and the Heads of Medicines Agencies, contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the European Union and European Economic Area.
In a statement published on 12 December 2023, alongside the list, the EMA said that a medicine was deemed critical according to two main criteria: “the seriousness of the disease it targets and the availability of alternative medicines”.
Medicines on the list cover a wide range of therapeutic areas, as well as vaccines and treatments for rare diseases, reflecting the outcome of a review of 600 active substances taken from six national lists of critical medicines.
These include most major vaccines, antiepileptics, anaesthetics, immunosuppressants, insulin and antivirals.
The EMA said there was no action needed from healthcare professionals or patients as a result of the publication of the list, saying: “Medicines on the list can continue to be ordered, prescribed and used as usual, with no need to stockpile medicines [which] can put further strain on supplies and cause or worsen shortages.”
The EMA said that obligations for the supply chain, such as wholesalers and distributors, were “yet to be defined”, and the shortage list will be monitored, with vulnerabilities analysed by the European Commission.
The European Commission published proposed regulatory and industrial policy measures in October 2023 to address these vulnerabilities, including recommendations for companies to diversify suppliers or increase production within the EU, investment incentives, additional regulatory obligations for companies, and procurement with strong contractual obligations for delivery.
The EMA added that the list will be “expanded in 2024 and will then be updated every year”.
A voluntary ‘solidarity mechanism’ to tackle critical medicines shortages was also launched by the EMA in October 2023.
The scheme allows any member state facing a critical shortage of any medicines to report it to the EMA’s Medicines Shortages Steering Group (MSSG), which will then coordinate a pan-European request for assistance in obtaining medicine stocks.
In the UK, the Department of Health and Social Care (DHSC) was not involved in the creation of the EU list of critical medicines, but a spokesperson said the government was working with NHS England and other parties to develop a strategic approach to strengthening the long-term resilience of the UK medicines supply chain.
