BY MARIA BURKE | 17 JANUARY 2024
The European Commission has published its first ever list of critical medicines. It includes both innovative and generic medicines for human use, covering a wide range of therapeutic areas such as painkillers and vaccines.
Medicines are assessed on the seriousness of the disease they treat and the availability of alternatives. Additional criteria include being critical in at least one-third of EU/European Economic Area countries.
The list contains over 200 active substances, selected after 600 were reviewed. It includes medicines to prevent blood clots such as warfarin, as well as antibiotics such as amoxicillin, salbutamol used in asthma inhalers, and insulin for diabetes treatment. This is only the first draft; the Commission will continue to review medicines throughout 2024.
The Commission stresses that being on the list doesn’t mean that a medicine is likely to experience a shortage. Instead, it highlights the critical importance of averting shortages for these specific medicines. Last winter the EU faced shortages of some critical medicines due, to a rise in demand, low production capacity and shortages of raw materials.
The Commission will use the list to aid analysis of supply chains to determine potential vulnerabilities. New proposals for reforming pharmaceutical legislation, currently under discussion, aim to tackle supply chain issues by requiring pharma companies to have shortage prevention plans, and to be quicker to notify authorities about potential shortages.
Supply problems have many different causes, including manufacturing issues and lack of capacity associated with long investment lead times as well as stronger and unexpected demand due to public health emergencies or poor forecasting, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).
This was the case for the antibiotic amoxicillin at the end of 2023, when the authorities didn’t spot demand increases in time. EPFIA says its members are willing to help design and implement supply chain solutions. But if they are going to adapt production, they require better information on infection rates and demand from the European Centre for Disease Control Prevention and and national authorities ahead of time.