Commission opens participation to Critical Medicines Alliance

The European Commission's Health Emergency Preparedness and Response Authority (HERA) launched today 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 announced by the Commission in October 2023.

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 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.

A new industrial dimension to the European health Union

The Critical Medicines Alliance will 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, such as:

• Exploring how to diversify global supply chains through strategic international partnerships;
• Boosting Europe's capacity to produce and innovate in the manufacturing of critical medicines and their ingredients, in coordinated way;
• Developing a common strategic approach to medicines stockpiling in the EU;
• Helping to leverage and align EU and national funding to implement solutions to medicines shortages.

Open to all 

The Critical Medicines Alliance is open to all companies and organisations, Member States, local and regional authorities and their agencies, social partners, civil society, health professionals, patients, consumers as well as other stakeholder groups, EU bodies and agencies.

Those who are interested should complete the interest form available on the website of the Alliance.

Next steps 

The Alliance will last for 5 years. It is expected to start its work this coming Spring and publish its first recommendations on actions to take to improve the supply of critical medicines by this Autumn. 

Background

The Commission adopted on 24 October 2023 a Communication presenting actions to better prevent and mitigate critical medicine shortages in the EU for this winter and beyond. Recent critical shortages, including of certain antibiotics, show that continued coordinated action is needed to make Europe's medicine supply chains more resilient in the long run.

The Communication puts a particular focus on the most critical medicines, for which security of supply in the EU must be ensured at all times.

The Communication builds on the work under the European Health Union, notably the reinforced mandate of the European Medicines Agency and the recently published pharmaceutical reform. It follows a strong call by Member States at the 2023 June European Council, confirmed in Granada in October 2023, and from the European Parliament.

For more information

Alliance website

HERA website

Communication on addressing medicines shortages in the EU

European Medicines Agency list of critical medicines

Quote(s)

Today’s launch of the work on a Critical Medicines Alliance is another chapter for our European Health Union. It marks the beginning of a concerted push to bolster and modernise the production of critical medicines in the EU and diversify international supply chains. As a new industrial pillar of our strong European Health Union, the Alliance will help to change the way we produce and procure medicines and ultimately reinforce our security of supply. With this initiative, we will ensure that governments, industry, health professionals and civil society work closer together than ever before to identify solutions to ensure patients are better protected and always have access to the medicines they need.

Stella Kyriakides, Commissioner for Health and Food Safety