What is the Critical Medicines Act?
On Tuesday (11 March 2025) the European Commission presented the draft of its new Critical Medicines Act (CMA). The Science Media Centre España writes that the CMA’s objective is:
…to address the serious shortage of medicines and healthcare products, reduce external dependence on critical medicines and ingredients — especially from Asia — and guarantee the supply of affordable medicines in the European Union.
My colleague Antoine Miahle was quoted in Politico giving his thoughts on CMA:
Antoine Mialhe, senior managing director and head of health care and life sciences at FTI Consulting, said the Act is “an earthquake in the way drugs have been historically purchased in the EU.” “Building on the experience gained during the COVID-19 pandemic, the [European Commission] now wants to open widely the door to jointly procure a wide range of medicines, including innovative ones.”
As Mr. Mialhe mentioned, the need for CMA was driven initially by COVID-19 pandemic-related supply disruptions of life-saving, high-quality medicines. Additionally, ongoing geopolitical instability in recent years has lead to further threats to the global supply chains of essential medications and shortages in Europe
The European Commission characterizes CMA’s key features as follows:
Strategic Projects for critical medicines or their ingredients can be designated, so that they benefit from easier access to funding and fast-tracked procedures.Public procurement to incentivise the resilience of supply chains of critical medicines or to improve access to other medicines of common interest.Collaborative procurement among different member states will be supported by the Commission at the request of member states, to address availability and access disparities of critical medicines and other medicines of common interest.International partnerships with likeminded countries/regions will be explored, to broaden the supply chain and reduce dependencies on single suppliers.State aid guidelines to assist member states in financially supporting such strategic projects.
Ropes & Gray notes that The European Commission fast-tracked the CMA, which means they have opted not to conduct a dedicated impact assessment or public consultation. Of particular note is that CMA aims to make greater use of procurement requirements other than price (e.g., supply chain resiliency) which selecting suppliers.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) noted general support for more robust supply chains and insuring access to critical medicines, but also voiced some skepticism that collaborative procurement would be optimal. There was also some risk of increased administrative costs as well.
…while these options may be appropriate under very specific circumstances where they accelerate patient access to critical medicines, a systematic application could create more harm than offering a more permanent solution to access related issues. Therefore, clarity is required to identify those circumstances where collaborative procurement options would improve access beyond existing national pricing and reimbursement pathways…
EFPIA believes that the Act needs to go further and provide an effective response to fragmented national contingency stock requirements that disrupt the functionality of the single market.
With respect to obligations for market actors to provide information, we urge authorities to make use of existing data systems to avoid the duplication of reporting requirements. The information already stored in the European Medicines Verification System provides timely intelligence on the number of packs for all prescription products being supplied in the various Member States
A Politico article notes that while Belgium was one of the key drivers of implementing the CMA, some Belgian politicians are not happy with the final results.
“It lacks the urgency required to safeguard our health care and security,” Frank Vandenbroucke, who is also Belgium’s deputy prime minister, told POLITICO.
While he acknowledged the act is an “important step forward,” he added that the “proposed funding is insufficient, and there is no common strategy for stockpiling essential medicines.” Belgium has called for the act to be partly funded by Europe’s defense strategy.
The Politico article also has perspectives from a variety of perspectives on CMA.
What do patients think? The European Patients’ Forum (EPF) stated that it:
,,,welcomes the European Commission’s proposal for the Critical Medicines Act as an important step toward improving medicine security, availability as well as accessibility across the EU for ALL patients.
However, additional efforts and complementary political measures are strongly needed to ensure that the Act effectively meets its objectives of strengthening the security of supply, ensuring the availability of critical medicinal products for all EU patients, and upholding a high level of public health protection.
We are very concerned about how these initiatives will be financed in the short and longer term…
From our standpoint, there is insufficient focus on structured cooperation and involvement of civil society, particularly patient organisations, in the decision-making processes at the national and European level, for example on definition of public procurement criteria
Many commenters noted while CMA’s objectives for secure supply chain and reliable access to medicines are a laudable goal, sufficient funding and concrete actions are needed for CMA’s promise to become a reality.
