Critical Medicines Alliance Publishes Report on Shortages of Critical Medicines

• 03/03/2025
• News

On 28 February 2025, the Critical Medicines Alliance (CMA) published its Strategic Report on shortages of critical medicines (see, attachment – the Report). The CMA was established in April 2024 as a broad-based coalition of governmental authorities, businesses, industry associations, and non-governmental organisations (see, Van Bael & Belis Life Sciences News and Insights of 25 April 2024). It currently has 279 members and 7 observers.
 
The Report tackles the industrial challenges behind shortages of critical medicines, a list of which was created in December 2023 and updated in December 2024, and offers possible remedies at EU level. It does so by focusing on the supply chain of critical medicines and on an EU industrial policy to support and develop that supply chain. The Report’s remedies fall into 6 general categories: 

• Establishing a list of Critical Vulnerable Medicines based on a Vulnerability Assessment – The CMA developed a methodology, outlined in the Report, to carry out a Vulnerability Assessment of critical medicines which will help to identify the critical medicines whose availability is uncertain from a manufacturing and supply perspective. According to the Report, such an assessment should be conducted regularly. 
• Strengthening European manufacturing of critical medicines – The Report calls for the development of a strategic project framework for funding from both public and private sources. Public funding should comprise both EU and national instruments and should initially focus on active pharmaceutical ingredients and intermediate products.   
• Creating security of supply – This category contains two sub-categories   

1. Work on contingency stocks – The scope of this work has 2 aspects: (i) compulsory supplier contingency stocks; and (ii) contingency stocks created, operated, and controlled by national governments or by the EU. The Report calls for an EU-wide “comprehensive, harmonised, and balanced framework” governing both types of contingency stocks to avoid a misallocation of products and a resulting worsening of specific shortages. The Report points out that this seemingly obvious objective requires careful consideration of several factors, including collection, use and sharing of such data between Member States (the Report advocates for a dedicated database); waste prevention; regulatory reallocation flexibility in matters such as packaging and labelling, product information, use of unauthorised medicines, and solidarity mechanisms between Member States; assessment of the financial impact of stocking requirements; unfinished products; and the prioritisation of EU contingency stocks over national stocks for low consumption medicines. 
2. Work on public procurement – The Report calls for the promotion of what it refers to as “virtuous” public procurement practices by causing tendering bodies to rely on essential qualitative procurement criteria such as supply security, resilience, and environmental impact in addition to price. Separately, the Report recommends relying more frequently on the Joint Procurement instrument between Member States.   

• Establishing a level playing field for critical medicines production – This part of the Report lists the requirements for ensuring a level playing field for producing Critical Medicines and their inputs between the EU and the rest of the world. It discusses environmental quality; regulatory standards; and the use of trade defence instruments.  
• Enhancing the resilience of the pharmaceutical supply chain – The Report wants the EU both to leverage existing international partnerships and develop new relationships based on a new and detailed methodological framework.   
• Increasing international solidarity cooperation – The Report recommends the Executive Steering Group of the European Medicines Agency on Shortages and Safety of Medicinal Products (MSSG) to “expand, intensify and complement [its] ongoing work on international solidarity cooperation” (see also, Van Bael & Belis Life Sciences News and Insights of 2 November 2023). 

The Report is expected to inform the proposed Critical Medicines Act which the European Commission is scheduled to table on 11 March 2025. While the Report and the associated Critical Medicinal Act create promising avenues for a guaranteed access to must-have medicines, they will also give rise to further layers of regulation. The resulting burden for business and occasional lack of efficiency will at some point have to be assessed as well, and critical rules will have to be distinguished from redundant measures. That exercise, combined with a review of the institutional architecture which has also grown in complexity, will prove necessary, given the various levels of regulation (EU, member state, and in some cases further layers of government), the expanding number of institutions, and the myriad sources of new rules. Just in the coming weeks and months, new rules will not only result from the proposed Critical Medicines Act, but also from the draft EU Biotech Act (see, Van Bael & Belis Life Sciences News and Insights of 31 January 2025), and the pending EU pharmaceutical package of new regulations (see, Van Bael & Belis Life Sciences News and Insights of 3 May 2023).