Ref. Ares(2024)512545 - 23/01/2024
EUROPEAN COMMISSION
HEALTH EMERGENCY PREPAREDNESS AND RESPONSE AUTHORITY
The Director-General (acting)
Brussels
HERA.3/LJ/sk(2024)565687
Your excellency,
On 16 January 2024, the Commission published an open call for expression of interest to
join the Critical Medicines Alliance. The set up of the Alliance is one of the key actions to
prevent and address shortages of critical medicines in the EU announced by the
Commission in its Communication of 24 October 2023 (1).
The Alliance will bring together all relevant stakeholders, and work to strengthen
cooperation between the Commission, national governments, industry, and civil society. It
will identify the industrial challenges, priorities for action, and possible policy solutions to
the issue of shortages of critical medicines in the EU. The Alliance is a consultative
mechanism that will also act as a network to accelerate the delivery of EU action in this
field.
The objective is for the Critical Medicines Alliance to become the industrial arm of a strong
European Health Union. It will develop recommendations and provide advice to the
Commission, Member States and other EU decision makers on how to address long-
standing medicines shortages. Building on the Union list of critical medicines published
by the European Medicines Agency in December 2023, it will focus on medicines with the
highest risk of shortages and the highest impact on healthcare systems and patients.
The Alliance will help unlock manufacturing, contractual or financing solutions to allow
better strategic autonomy for critical medicines, in the interest of European citizens. It will
build on the experience from other EU alliances that address major industrial challenges
(such as the Batteries and Critical Raw Materials Alliances) and will be able to rely on a
varied toolbox of policy measures.
Following the selection of its members, the inauguration of the Critical Medicines Alliance
Forum is expected to take place in April 2024. Alliance members will then start to work
together in thematic working groups to elaborate recommendations around priority topics
(which could include strengthening manufacturing capacities in the EU, strategic
stockpiling, procurements and other tools, diversification of supply, international
partnerships, and cooperation, as well as data sharing and transparency).
In this context, we would very much welcome the participation of your Member State to
the Critical Medicines Alliance, both from experts active in the health policy and in the
industrial policy field, as the two aspects will be closely intertwined for such purposes.
We would welcome the names of the colleagues you have identified for such purpose by
16 February 2024.
(1) COM(2023)672
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111
Further information about the Alliance can be found on the dedicated website Critical
Medicines Alliance - European Commission (europa.eu) or by contacting the functional
mailbox
[email protected].
Please note that we have also informed your representatives at the HERA Board of this
letter.
We thank you in anticipation for your support in this important initiative.
Yours faithfully,
Laurent MUSCHEL
2
Electronically signed on 23/01/2024 17:14 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121
Saatja: HERA 03 <
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Teema: Letter from HERA to the Permanent Representations - Ares(2024)512545
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