EU reveals essential medicines list to combat drug shortages

The European Medicines Agency (EMA) has published its first version of the Union list of critical medicines, which contains over 200 medicines considered critical for healthcare systems across the EU. The list was announced on Tuesday by EMA, the Heads of Medicines Agencies (HMA) and the European Commission and was developed as part of the EU’s effort to address shortages of essential medicines.

EMA said inclusion on the list does not mean the medicine is likely to experience a shortage. Rather, it means that “prevention of shortages is particularly important as a shortage could cause significant harm to patients and pose important challenges to health systems” if a shortage were to occur.

A medicine is deemed critical if it is used to treat a serious disease that cannot be substituted with other medicines and is considered critical in more than a third of EU/EEA countries.

The list was put together by EU member states and culled from a review of 600 active substances taken from six national lists of critical medicines. EMA said the list will be expanded and updated every year.

The review of essential medicines will continue in 2024 for other authorized medicines not included in the first version, according to a questions and answer document.

Key stakeholders such as patients and healthcare professional organizations and industry associations, offered their input in the list.

The list covers a broad range of therapeutic areas and includes vaccines and treatments for rare diseases. It also includes IV solutions such as potassium chloride and magnesium sulfate; anesthetics such as fentanyl; opioids such as morphine; blood thinners such as warfarin and heparin; antidepressants such as esketamine; anxiolytics such as lorazepam; and human insulin.

EMA said in a Q&A that the publication of the list is not expected to reduce drug shortages, but rather “defines those medicines that require additional measures to strengthen their supply and avoid shortages in future. The introduction of these measures is expected to reduce the risk of shortages in the longer term.”

The Q&A also distinguishes between a critical medicine and critical shortage. A critical shortage is defined as “a shortage of any medicine that cannot be resolved by national measures only and requires coordinated action at EU level” whereas a critical medicine is “one for which no appropriate alternative is available and for which a shortage could result in serious harm or risk of harm to patients.”

EMA said the list complements an earlier plan announced in October to determine potential vulnerabilities in the supply chain. (RELATED: Euro Roundup: Commission proposes ‘regulatory flexibilities’ against drug shortages, Regulatory Focus 26 October 2023)

EMA, European Commission, Q&A