On 12 December 2023, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) published the first version of the Union list of critical medicines (the list). Along with the list, the EMA published a Questions & Answers document (Q&A).
The list identifies medicines that are critical and for which the prevention of shortages is particularly important as “a shortage could cause significant harm to patients and pose important challenges to health systems” across the EU/European Economic Area (EEA). A medicine is considered critical when used “in serious diseases and cannot be easily replaced by other medicines”. To be included in the list, the medicine should meet an additional criterion, which is to be critical in at least one-third of the EU/EEA Member States (MS).
The list is intended to serve as an indicator for the MS authorities of the medicines whose security of supply needs to be monitored with particular attention and, when required, for the MS to take appropriate action.
The list includes innovative and generic medicines covering a wide range of therapeutic areas.
Methodology behind the list
In June 2023, the European authorities published the Methodology to identify critical medicines, referring to two criteria to identify a medicine as critical:
- the importance of the therapeutic indication of the authorized medicine; and
- the availability of appropriate alternatives. An alternative is considered appropriate when it is authorised and available on the market for the same indication in the MS concerned, and when it provides the same level quality of care and does not have a negative impact on the patient.
Each criterion is assigned a risk level (low, medium or high), which allows classifying the medicine as (i) “critical”, (ii) “at risk”; or (iii) “other”.
- For the first criterion, the level of risk is assigned according to whether it meets the conditions set for high risk cases (e.g., irreversible progressive condition) or those set for medium risk cases (e.g., medicines to treat children).
- For the second criterion, a quantitative and qualitative risk classification of the available alternatives is carried out. A medicine will be classified as critical when both criteria are high risk, and when one of them is high risk and the other is medium risk.
Note that where medicines are classified as “at risk”, their supply chains will be assessed by the Commission and, when vulnerabilities are identified, their classification may be changed to “critical”.
The publication of the list and the inclusion of medicinal products therein do not, in themselves, trigger additional regulatory or reporting obligations for marketing authorisation holders or other stakeholders (i.e., wholesalers or distributors) concerned by the listed medicines. Such requirements are expected to be introduced by the new EU pharmaceutical legislation, currently under discussion in the European Parliament and the Council, and will only become mandatory when the legislation enters into force.
The European Commission may, however, take further actions, as required even before the new EU pharmaceutical legislation is adopted. These may include:
- monitoring requirements for the competent authorities;
- incentives to diversify and attract manufacturing investments in the EU;
- procurement strategies to better support security of supply;
- seeking feedback on specific points through public consultations.
The current list has been drawn up on the basis of six existing national lists of critical medicines in the EU and will be extended in 2024 to other medicines not yet listed. Note that the list will not:
- automatically include the medicines listed by the World Health Organization (WHO) as essential medicines; or
- influence existing or to-be-established national lists of critical medicines and will not necessarily include the same medicines as those on the national lists.
Once finalised, the list will be updated to take into account the outcome of the Commission’s ongoing supply chain vulnerability assessment, as mentioned in a previous blog.
In addition, the Union list will be updated every year to add or remove medicines as necessary.