Europe publishes first list of critical medicines
Posted: 13 December 2023 | Caroline Peachey (European Pharmaceutical Review) | No comments yet
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first Union list of critical medicines.
The list contains more than 200 active substances that are considered “critical for healthcare systems” across the EU/EEA. Continuity of supply is seen as a priority for these substances and shortages should be avoided.
The active substances on the list cover a wide range of therapeutic areas, including treatments for rare diseases.
The Union list was put together following a review of 600 active substances taken from six national lists of critical medicines. The list will be expanded further in 2024 and updated annually.
More than 80 anti-infectives are included on the list, including antibiotics, antifungals, antiviral drugs and vaccines.
Last winter, many Member States experienced critical shortages of certain antibiotics, endangering patient health and risking the development of antimicrobial resistance. This prompted EC/HMA/EMA to publish recommendations for avoiding antibiotic shortages in 2023-2024 season.
Helping to avoid shortages of critical medicines
“A medicine is considered critical if it is used to treat serious diseases and cannot be easily replaced by other medicines”
The list is an important tool in the EU’s efforts to ensure supply security and prevent shortages of critical medicines.
Inclusion in the list does not mean that the medicine is likely to experience a shortage. Instead, it underscores the importance of preventing shortages as these could “cause significant harm to patients and pose important challenges to health systems.”
A medicine is considered critical if it is used to treat serious diseases and cannot be easily replaced by other medicines. Medicines in the list must also meet certain criteria, including being critical in more than one third of EU/EEA countries.
Medicines on the list can continue to be prescribed and used as usual. However, additional reporting requirements for marketing authorisation holders and national authorities will become effective once the proposed pharmaceutical legislation becomes applicable.
