EPF releases statement on the European Commission's proposal for the critical medicines act

The European Patients’ Forum (EPF) 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. The Act includes several strong elements that align with patient needs but also leaves serious gaps that must be addressed to ensure its effectiveness.

From everyday medicines and antibiotics to highly specialised products, patients across Member States experience difficulties in accessing the medicines and treatments they need. Shortages and availability issues are major public health problems that can seriously harm patients’ health and safety, quality of care, professionals’ ability to deliver care, and health system functioning.  

The proposal rightly emphasises the need to secure the supply of critical medicines and reduce geopolitical dependencies, ensuring that patients are not left vulnerable due to external supply chain disruptions. The focus on ensuring security of supply, availability and accessibility of critical medicines and medicinal product of common interest (such as for rare diseases and antibiotics) within the EU is a necessary and welcome step. The inclusion of public procurement based on criteria other than price such as the security of supply and a number of diversified suppliers, as well as EU joint procurement mechanisms, for which EPF has advocated for a longtime, can strengthen medicine availability and facilitate collaborative purchasing among Member States. The commitment to evaluating the Act’s impact five years after implementation provides a structured mechanism to assess progress and make necessary improvements 

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. We understand that the costs of the proposal for 2026-2027 will be covered through “redeployments within existing financial envelopes of the current multiannual financial framework, including the EU4Health Programme and Horizon Europe”. This clearly means that initiatives that should have been funded under the current programmes will be deprioritised, with no clarity on which ones and with what impacts. The EU4Health Programme was already cut by 20% last year following a decision of the Council of the EU and the 2025 EU4Health Work Programme still has not been published, which poses significant challenges to civil society organisations and others that depend on EU funding for their research and public health activities. In addition, this issue must be addressed in the forthcoming discussions on the Multiannual Financial Framework (MFF) in order to guarantee a robust health budget: while the focus is currently on defence and competitiveness, strong and resilient healthcare systems should be an integral part of a comprehensive security strategy.  

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. It is also important that complementary measures in the pharmaceutical legislation are reinforced, such as enabling patients to report shortages and to be fully involved in the development of the Critical Medicines List.  

In addition, any public contribution and financial incentives should be backed up by transparency provisions, strong requirements, such as an obligation to supply and ensure equitable access, monitoring measures, and sanctions if the conditions are not met. At the moment, these aspects are largely absent from the text.  

Ensuring strong solidarity and cooperation between EU member states is essential to guarantee that all EU patients have access to critical medicines in times of shortages. In particular, we call for a strong EU coordination mechanism for stockpiling to avoid duplication, ensure consistency, and facilitate reallocation of stocks between EU member states.  

Therefore, while the proposal is a positive step, it requires further strengthening to ensure an effective, patient-centred approach. For the Act to succeed, it must move beyond broad ambitions and commit to tangible actions.  

EPF is ready to support efforts to put in place a comprehensive, patient-centred system to prevent shortages, mitigate the impacts on patient communities and ensure equitable access to medicines for all patients in the EU. We look forward to working with the EU institutions and continuing to convey the voice of the patient community in this critical debate, while conveying best practices for patients and patient organisations in the event of shortages and providing community support services.