EUCOPE appointed to the new Critical Medicines Alliance

On 24 April 2024, EUCOPE was officially announced as a member of the Critical Medicines Alliance (“Alliance”). The Alliance is a consultative mechanism which brings together relevant stakeholders to identify priorities for action and propose solutions to better prevent and combat shortages of medicines, and to strengthen the supply of critical medicines in the European Union (EU).

Since the publication of the Commission’s Communication on Addressing medicines shortages in the EU, EUCOPE has firmly advocated for a nuanced and holistic approach to address shortages and strengthen supply of medicines in the EU. The Alliance represents a step in the right direction, to ensure that a similar approach is followed and to achieve optimal results in tackling such issues.

EUCOPE looks forward to actively participating in future discussions and to supporting initiatives that strengthen the role of the Alliance in addressing medicines shortages, in ways that are meaningful for both small and mid-sized companies and patients. It is crucial to ensure continuous patients’ access to medicines, while avoiding burdensome and unrealistic requirements for pharmaceutical companies, especially smaller, innovative developers.

As part of this effort, EUCOPE is proud to have been appointed as one of the industry representatives in the Steering Board of the Critical Medicines Alliance. As a member of the Steering Board, we are eager on providing strategic orientation to the work of the Alliance. We will work with representatives from Member States (Ministries of Health and Industry), patients’ organisations, healthcare professionals, industry, the Medicine Shortages Steering Group (MSSG) and the European Medicines Agency (EMA).

Background

One of the priorities of the European Health Union is the timely and equal access to medicines. While the Revision of the EU General Pharmaceutical Legislation addresses the related regulatory aspects, there is also an industrial and competitiveness dimension which requires the mobilisation of all stakeholders. On 16 January, the European Commission launched the Critical Medicines Alliance, with the aim to answer this need.

The key objective of the Alliance is to provide an inclusive and transparent consultative platform to the European Commission and other EU decision-makers. The work of the Alliance focuses on critical medicines that face the greatest vulnerabilities. The Commission is currently conducting vulnerability analysis for a first sub-set of substances listed on the Union list of critical medicines, first published by the European Medicines Agency (EMA) in December 2023.

The Alliance will work on that subset of substances, before tackling the rest of the EMA’s list, by pooling the expertise and resources of its members, to determine how vulnerabilities in the supply chains could be best addressed. It will then recommend priority actions for the near future and propose new tools to address the challenges it has identified. In particular, the recommendations will focus on mitigating structural risks, reinforcing supply by making demand more predictable, encouraging diversification, and boosting manufacturing. As such, the Alliance will play a key role in bolstering industrial competitiveness in the EU and strengthening its open strategic autonomy, in the best interest of EU citizens.

The launch and the first Forum of the Critical Medicines Alliance took place on 24-25 April 2024 in Brussels.