Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. Now, following the debut of a short-term plan to combat supply squeezes across the bloc this winter, European officials are taking a holistic look at the medicines most likely to run scarce.
Tuesday, the European Medicines Agency (EMA) laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA explained in a press release. Rather, the list spotlights therapies for which the prevention of shortages is “particularly important” given the risk of “serious harm to patients” should supply be interrupted.
The medicines on EMA’s list include basic antibiotics such as amoxicillin, plus painkillers like paracetamol and morphine, as well as vaccines for diseases like measles, rabies and the flu.
European officials whittled down the final roster from an initial review of some 600 solo and combination therapies. EMA says it plans to update and extend the catalog next year.
Europe will use the critical drugs master list to define medicines requiring “additional measures” to strengthen supply and prevent future shortages. Further, the European medicines regulatory network will monitor the drugs on the list and implement certain measures to minimize supply disruptions, the EMA added.
Specific supply security measures could take the form of recommendations for companies to diversify suppliers or boost production in the European Union, alongside investment incentives, additional regulatory obligations and procurement contracts, EMA explained.
For months now, Europe has been on a quest to blunt the impact of drug shortages in the bloc.
Back in October, the European Commission rolled out a short-term plan to help combat drug shortages, including plans to draft December’s critical medicines list. At the time, the Commission said the list would help guide decisions and mitigate the continent’s overdependence on generic medicines and drug ingredients from India and China, respectively.
Another short-term measure included in the Commission’s plan took the form of the Voluntary Solidarity Mechanism for medicines, under which countries will share their stocks of drugs as others in the bloc face shortages.
The European Commission is also setting up a Critical Medicines Alliance—due to come online in early 2024—that will enable national authorities to cooperate with industry and the EU to counter shortages and supply chain vulnerabilities. The goal of the alliance is to pave the way for potential legislation.