Medicines on the list can still be prescribed but will be under tight monitoring by a regulatory network, which can implement measures to prevent shortages and ensure supply chain continuity.
Pictured: The Berlaymont building, which houses the headquarters of the European Commission/iStock, olrat
The European Commission, the Heads of Medicines Agencies and the European Medicines Agency released a first list of more than 200 medicines on Tuesday considered critical for healthcare systems across Europe.
Critical medicines are those that are used to treat serious diseases, and for which there are no easy and equivalent replacements in case of a shortage. According to a Q&A document, the European medicines regulatory network will closely monitor these medicines and take steps to minimize the risk of shortages and supply disruptions.
Medicines on the agencies’ list will also come with “additional reporting requirements” for national authorities and holders of marketing authorizations, as defined by the proposed revisions for the European Union’s pharmaceutical legislation. The list will also support European Commission (EC) efforts to analyze the supply chains of these critical medicines to spot potential weaknesses.
The agencies will expand the list in 2024 and will update it annually thereafter, according to Tuesday’s announcement.
“Inclusion in the list does not mean that the medicine is likely to experience a shortage in the near future,” the agencies noted. “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.”
Some of the drugs on the agencies’ list include the antithrombotic agents warfarin and heparin, the systemic corticosteroids prednisolone and hydrocortisone and the cancer drugs cisplatin, carboplatin, oxaliplatin and tretinoin. Several anti-infectives are also on the list, including doxycycline, cefixime, emtricitabine and various bacterial and viral vaccines.
Products on the list can still be prescribed and used by healthcare professionals and patients, according to the agencies. The list will also not affect any existing or upcoming national lists of critical medicines, though it may serve as a guide for countries that do not yet have such lists.
Tuesday’s initial list comes shortly after the EC announced in October 2023 additional steps to “prevent and mitigate” drug shortages. The Commission launched the European Voluntary Solidarity Mechanism for medicines, which identifies shortages in one member state and connects it with another member state with available stock.
The EC has likewise allowed regulatory flexibilities which would enable member states to extend shelf lives of medicine products and accelerate the approval of alternatives.
By early 2024, the EC will also institute the Critical Medicines Alliance, which will act as an industrial policy pillar to the European Health Union. The effort is aimed at helping to prevent shortages by coordinating procurement practices across the EU, improving Europe’s capacity to produce and innovate in the field of critical medicines, while fostering strategic partnerships to improve supply chains.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
