The Critical Medicines Alliance (CMA), set up in January 2024, is a consultative mechanism bringing together relevant stakeholders from EU Member States, key industries, the civil society, and the scientific community. The Alliance aims to identify key areas and priorities for action, proposing solutions to strengthen the supply of critical medicines in the EU, ultimately enhancing efforts to prevent and address shortages effectively.
Objectives
- Providing an inclusive and transparent consultative platform to the European Commission and other EU decision-makers.
- Focusing on critical medicines that face the greatest vulnerabilities, on the basis of the Commission supply chain vulnerability assessment for a sub-set of substances listed on the Union list of critical medicines, first published by the European Medicines Agency (EMA) in December 2023.
- Identifying vulnerabilities in critical medicines supply chains.
- Pooling the expertise and resources of its members, to determine how vulnerabilities in the supply chains could be best addressed.
- Recommending priority actions and proposing new tools to address the identified challenges. In particular, the recommendations focus on mitigating structural risks and reinforcing supply by:
- encouraging diversification;
- 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 and working methods
The Alliance is set up for an initial period of five years. All Alliance members have the right to participate in the Forum, which is regularly consulted on key milestones of the Alliance activity.
The Steering Board provides strategic orientation to the work of the Alliance. It is comprised of representatives from Member States (Ministries of Health and Industry), relevant industries, patient and healthcare professionals’ organisations, 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.
- Current composition of the Steering Board
- Rules of procedure for the Critical Medicines Alliance Steering Board
- Meetings
The Alliance members collaborate in two thematic Working Groups:
Working Group 1: Strengthening EU manufacturing capacities for critical medicines and their active pharmaceutical ingredients;
- Rules of procedure for the Critical Medicines Alliance Working Group on Strengthening manufacturing capacity in the EU
- Membership
Working Group 2: Diversifying international partnerships and cooperation.
- Rules of procedure for the Critical Medicines Alliance Working Group on the Diversification of supply chains, international partnerships and cooperation
- Membership
The recommendations of the Working Groups will form the basis of the Strategic Plan, a multi -annual set of actions with proposed milestones and corresponding deadlines drafted by the Steering Board and endorsed by the Forum, to be adopted by the end of 2024. The Strategic Plan guides the work of the Commission, Member States and other EU decision-makers, should they decide to implement the proposed actions.
The Strategic Plan is evaluated every two years by the Forum, to ensure its adaptability in effectively bolstering the supply chains of critical medicines and active pharmaceutical ingredients. 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 brings together EU institutions, Member States, specialised bodies and agencies, local and regional authorities, companies and trade associations, social partner organisations, non-governmental organisations (NGOs) and civil society groups.
The Alliance is open on a voluntary basis to all organisations active in the critical medicines’ ecosystem, such as, for example, in sourcing, production, transport, distribution, financial support, patient care, regulation and coordination, and patients and healthcare professionals representation.
The Alliance is open to new members at all stages of its operation. The specific membership criteria are 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.
Background
One of the priorities of the European Health Union is the timely and equal access to medicines for all European patients. While the proposed revision of the EU pharmaceutical legislation addresses the related regulatory aspects, there is also an industrial and competitiveness dimension which requires the mobilisation of all stakeholders. The Critical Medicines Alliance answers this need, building on successful precedents such as the European Battery Alliance or the European Raw Materials Alliance.
Timeline
Contact
The Health Emergency Preparedness and Response Authority (HERA) provides the secretariat for the Critical Medicines Alliance.
Contact: HERA-CRITICAL-MEDICINES-ALLIANCE
ec [dot] europa [dot] eu (HERA-CRITICAL-MEDICINES-ALLIANCE[at]ec[dot]europa[dot]eu)
Documents
- Frequently asked questions (FAQs)
- Critical Medicines Alliance Declaration
- Critical Medicines Alliance Terms of reference
- Guidelines for competition law compliance within the Alliance
- Privacy statement
- Factsheet
- Assessment of the supply chain vulnerabilities for the first tranche of the Union list of critical medicines: Technical report
Related links
- Communication from the Commission – Addressing medicines shortages in the EU
- Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency
- First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
