Call for expression of interest to join the Critical Medicines Alliance
The Critical Medicines Alliance is a consultative mechanism which brings together all relevant stakeholders, to identify priorities for action and propose solutions to strengthen the supply of critical medicines in the EU, to better prevent and combat their shortages.
Objectives
The key objective of the Alliance is to provide an inclusive and transparent consultative platform to the European Commission and other EU decision-makers. It focuses on identifying industrial challenges and determining the most suitable actions and tools to effectively address vulnerabilities in critical medicines supply chains.
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.
Governance
The Alliance will be set up for an initial period of five years. All its members have the right to participate in the Forum, which will be regularly consulted on key milestones of the Alliance activity. The Steering Board will provide strategic orientation to the work of the Alliance. It will be comprised of representatives from Member States (Ministries of Health and Industry), the industry, patients and healthcare professionals, the Medicine Shortages Steering Group (MSSG) and the EMA, as well as the chairs of the thematic Working Groups and representatives of the European Commission, acting as secretariat.
Working method
After the adoption of the rules of procedure during the first meeting of the Alliance Forum in Q2 2024, relevant Alliance members identified via the call for expression of interest will start their collaboration in thematic Working Groups. While the Working Groups are still to be determined, they are likely to include the strengthening of EU manufacturing capacities, strategic stockpiling, procurement, diversification of supply, and international partnerships and cooperation.
The recommendations of the Working Groups will form the basis of a Strategic Plan, a multi -annual set of actions with proposed milestones and corresponding deadlines drafted by the Steering Board and endorsed by the Forum. The Strategic Plan will guide the work of the Commission, Member States and other EU decision-makers if they decide to implement the proposed actions.
The Forum will evaluate the Strategic Plan every two years, to ensure it remains adapted to effectively support the strengthening of critical medicines supply chains and active pharmaceutical ingredients supply chains.
Additionally, the Commission may consult the Forum on other pertinent policies related to the outlined focus or the broader critical medicines sector.
Who can join and how
The alliance is open on a voluntary basis to all organisations active in the critical medicines ecosystem, for instance, in sourcing, production, transport, distribution, financial support, patient care, regulation and coordination, and patient and healthcare professionals representation. This includes companies and trade associations, Member States, EU institutions, bodies and agencies, local and regional authorities and their agencies, social partner organisations, NGOs and civil society groups.
The Alliance remains open to new members throughout its operation, the specific criteria for joining being set out in the Alliance Terms of reference. To become a member, an organisation must sign the Alliance Declaration, signifying alignment with the Alliance's vision and a commitment to actively contribute to its operational efforts.
The call for expression of interest opened on 16 January 2024, with a deadline for application one month later for the first stage of the call. The Alliance should commence its work in late April 2024, after the applications are reviewed. The Alliance remains open to new members at all stages of its operation. However, the first deadline for application is important as it will be used by the Commission to determine who will be able to participate in the first steps of the Alliance.
More information about the Critical Medicines Alliance and the Applications can be found here:
Timeline:
