On March 11, 2025, the European Commission presented its long-awaited Critical Medicines Act (CMA), a key step towards strengthening the European Union’s (EU) pharmaceutical supply chain. The CMA seeks to address vulnerabilities, reduce reliance on single suppliers and third countries, and enhance the availability, supply and production of critical medicines within the EU. While the CMA is designed to enhance EU competitiveness, with a strong focus on the technical aspects of the pharmaceutical industry, such as manufacturing capacity and supply chains, it also aims to protect patients. Medicine shortages have increased over the past decade, putting citizens at risk. While the causes are complex, over 50% of reported shortages stem from manufacturing issues. By tackling key vulnerabilities in pharmaceutical production and supply chains, the CMA represents a crucial step towards reducing shortages and safeguarding people’s health.
IDF Europe welcomes this initiative to improve access to essential medicines, recognising that people living with diabetes (PwD) depend on life-saving treatments such as insulin, as well as other oral and injectable therapies like metformin to manage their condition and prevent complications. While the CMA is a step towards greater pharmaceutical supply chain resilience, it also raises critical questions for the diabetes community, particularly regarding the continued availability and accessibility of diabetes medicines.
Key provisions of the Critical Medicines Act (CMA)
The CMA ultimately aims to increase EU manufacturing capacity and diversify supply chains to ensure the security of medicines in the EU. The Act plans to do this through the following means:
- Facilitate investments that increase the manufacturing of critical medicines in the EU through strategic projects
- Incentivise supply chain diversification through public procurement
- Leverage the combined demand and buying power of Member States through collaborative procurement
- Support the diversification of supply chains by facilitating strategic partnerships
Through these means, the CMA has the potential to mitigate future supply crises and protect the health of citizens. For PwD, the implementation of the CMA could have both positive and challenging implications.
Considerations for the Diabetes Community
- Ensuring the availability of insulin: Europe has the highest prevalence of type 1 diabetes (T1D). Insulin is essential for people living with T1D to survive. The CMA primarily focuses on medicines included in the Union List of Critical Medicines, which currently comprises around 200 medicines, including three types of insulin. One way that the CMA aims to tackle shortages is by increasing the EU manufacturing capacity of critical medicines and their key ingredients by incentivising ‘Strategic Projects’. Projects receiving financial incentives would be obligated to comply with certain requirements, including prioritising EU supply. Increasing EU manufacturing capacity and safeguarding the supply of medicines to MS in the EU will help ensure the continued supply of essential medicines, like insulin, and prevent shortages. Shortages of insulin not only put lives at risk but also disrupts management by forcing people to change and adapt to new insulin regimens, causing distress and potential adverse health outcomes.
- Diabetes medications beyond insulin: Not all key diabetes treatments are included, despite their essential role in managing the condition and preventing life-threatening complications. While the CMA’s efforts to expand EU manufacturing capacity and diversify supply chains could have indirect benefits for medicines beyond those listed, it is currently unclear how the CMA will impact the supply and availability of other medications. The WHO also publishes a list of essential medicines which includes diabetes medicines beyond the three forms of insulin on the Union’s list. While both are likely to have slightly different methodologies and criteria for inclusion, the WHO list should be considered and inform the Union’s list to ensure that no essential medicines, including those for PwD, are overlooked.
- Re-localisation and supply chain resilience: While re-localising production may reduce external dependencies, the transition could bring about short-term challenges. Manufacturing and supply-chain shifts could impact the availability of medicines, including insulin, during the adjustment period. It is crucial to ensure that changes to manufacturing and supply chain do not disrupt patient care or threaten continuous access to essential medicines throughout the transition.
IDF Europe looks forward to engaging with key stakeholders in the development and implementation of the CMA
To ensure the CMA effectively supports PwD, collaboration between policymakers, healthcare professionals, and patient organisations is crucial. Clear communication about any changes in the availability of medicines is essential, along with ensuring that healthcare systems are equipped to manage potential disruptions. Ongoing dialogue with patient organisations will help to address concerns, gather real-time feedback, and ensure that PwD are not overlooked in the process.
The Critical Medicines Act presents a vital opportunity to enhance the EU’s pharmaceutical resilience and secure access to life-saving treatments. By prioritising the needs of citizens, ensuring transparency in the implementation process, and maintaining open communication with all stakeholders, we can help guarantee that no one living with diabetes faces uncertainty regarding their essential medicines.
