The EU's list will have a far-reaching impact over the next few years.

The European Commission (EC), the heads of the national medicines agencies (HMA) and the European Medicines Agency (EMA) published their initial version of the EU's critical medicines list on 12 December 2023. It is a building block in the EU's battle against supply shortages, and the European Commission also announced it in their communiqué about tackling medicine shortages in the EU issued on 24 October 2023.

Political importance

The importance of this Union list lies in the fact that it forms the reference point for further political steps at EU level. The Commission plans to form an Alliance for Critical Medicines by the beginning of 2024 to promote cooperation between national authorities, industry, civil society and the EU agencies. The focus will be on strategic objectives such as diversifying supply chains or promoting and modernising the production of critical pharmaceuticals.

Practical importance

The list also includes voluntary measures, such as the solidarity mechanism that was recently created for the EMA's Medicines Shortage and Safety Steering Group (MSSG). If there is a risk of critical medicines being sold out at short notice, this mechanism will enable member states to request support when procuring stocks. However, the EU's list will also trigger legal obligations such as the reporting obligations for the holders of the marketing authorisations for critical medicinal products. They are provided for in the pharmaceutical reform, which is currently being discussed politically.

Critical here are …

The Union medicines list contains active ingredients that cover a wide range of therapeutic areas, and it also includes vaccines and medicines for rare diseases. It reflects the result of the review of 600 active ingredients taken from six national critical medicines lists, which included Germany's list. A medicine is considered critical if it is used for serious illnesses and cannot be easily replaced by other medicines. It is included in the EU's critical medicines list if specific criteria are met, and it must also be critical in more than one third of EU and EEA (European Economic Area) countries.

... there are currently around 200 active ingredients

The EU's list will be expanded in 2024 and updated annually thereafter. The current initial version lists just over 200 active medicinal ingredients for human use that are considered particularly important for healthcare in the EU or the EEA. The list should not have an effect on existing national lists. However, according to the EC's expectations, it should also be seen as a contribution to stimulating the development of suitable national overviews in those countries that do not have their own lists.