List and transposition mechanism of critical medicines categories

Subject: List and transposition mechanism of critical medicines categories

On 12 December 2023, the Commission, together with the European Medicines Agency (EMA), published the first Union list of critical medicines. The list contains more than 200 active substances for human use that have been identified as critical for the functioning of healthcare systems and for which continuity of supply must be an absolute priority in order to prevent shortages in the EU/EEA. According to the methodology used to establish this list (EMA/432940/2023), two key criteria have been taken into account: the therapeutic indication and the availability of appropriate alternatives.

Given that a potential shortage of a critical medicine may be due to either a lack of a finished active substance or a disruption in the supply chain process, what specific mechanism has been proposed for the flexible transfer of labels of a list of critical medicines (‘critical medicine’, ‘high-risk medicine’, ‘medicine for which an alternative exists’) that would accurately reflect the emergence of potential gaps in product supply chains that would result in a particular medicine being transferred to another critical category?

Submitted:26.12.2023

Answer given by Ms Kyriakides on behalf of the European Commission (29 February 2024)

The Commission, together with the European Medicines Agency (EMA) and the Member States’ Heads of Medicines Agencies published a first Union list of critical medicines on 12 December 2023 (1).

The Union list will undergo regular updates, starting in 2024 and continuing annually, to ensure up to date coverage of all relevant critical medicines.

While the categorisation as critical medicine itself is not related to an actual critical shortage, it signifies the critical importance of preventing future shortages through additional measures to strengthen the supply of these specific medicines.

In a second phase, the Commission, together with Member States, and based on information from other stakeholders, will analyse the supply chains of the critical medicines on the Union list, to assess potential vulnerabilities.

As announced in the communication from the Commission addressing medicines shortages in the EU of 24 October 2023 (2), this analysis is already ongoing for a first tranche of these critical medicines.

This phased methodology will enable the Medicines Shortages Steering Group of the European Medicines Agency to provide specific recommendations to address the identified vulnerabilities.

The identified vulnerabilities will also enable the soon to be set up Critical Medicines Allianc e (3) to recommend possible industrial policy measures.

The aim of these two work streams is to support the prevention and mitigation of critical shortages and to contribute to ensuring that there is appropriate and continued supply of critical medicines for patients and health systems across the EU.

1 ∙ ⸱ https://ec.europa.eu/commission/presscorner/detail/en/ip_23_6377

2 ∙ ⸱ COM(2023) 672 final (https://commission.europa.eu/system/files/2023-10/Communication_medicines_shortages_EN_0.pdf).

3 ∙ ⸱ https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/overview/european-critical-medicines-alliance_en