Union list of critical medicines published
The EU's list will have a far-reaching impact over the next few years.
UM – 12/2023
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.