EPF reaction to the adoption of the European Parliament position on the Critical Medicines Act (CMA)

The European Patients’ Forum welcomes the adoption of the European Parliament’s position on the CMA during today’s plenary session in Strasbourg.

The adopted report introduces a number of new recommendations that complement the European Commission’s proposal published in March 2025. We consider several of these elements as crucial to strengthen the overall framework and provide a solid basis for the upcoming negotiations. We want to reiterate the importance of allowing sufficient time for the trilogue negotiations to ensure that the legislation effectively reduces medicine shortages and improves access and availability of medicines for all patients. 

We particularly welcome the inclusion of patient representatives as permanent members of the new Critical Medicines Group. This reflects a long-standing demand from the patient community. The inclusion of patient voices supports the principles of patient-centred care and democratic health governance, while enhancing transparency, accountability, and inclusivity within the Critical Medicines Coordination Group. At the same time, we believe that patient representatives should be granted voting rights to make their contribution more meaningful.  

The European Parliament’s position also calls for increased consultation with patient representatives. This includes consultations of patient organisations by the Critical Medicines Group through joint meetings, as well as consultations in the establishment of national programmes supporting the security of supply of critical medicinal products in each Member State. Importantly, this also applies to public procurement procedures and the development of EU-level guidelines recommending the establishment of common standards. These provisions represent a step forward towards more transparent health decision-making that directly affects people facing medicine shortages and affordability challenges. 

Contrary to the Council position adopted last December, EPF welcomes the European Parliament’s strong support for EU joint procurement. This mechanism has the potential to improve patient access to vulnerable critical medicinal products and medicines of common interest. The proposed amendments of the EP clarify the joint procurement process, and we hope it may encourage the wider use of the mechanism, ultimately helping to improve access for patients across Europe. 

Regarding strategic projects (industrial projects which create, increase or modernise manufacturing capacity in the EU and that could benefit from easier access to funding and fast-tracked administrative, regulatory and scientific support), we acknowledge the European Parliament’s efforts to reintroduce safeguards and accountability mechanisms, including financial penalties in cases of non-compliance with specific criteria (prioritising appropriate and continued supply to the Union market / adopting measures that contribute to the availability and affordability / undertaking very best efforts to supply products in other Member State). However, in the absence of an impact assessment, it remains unclear whether these projects will effectively reduce shortages and dependencies without increasing patients’ out-of-pocket medicine costs to reflect potential higher production costs. 

EPF also welcomes the strengthened provisions related to national stockpiling and contingency stocks, notably through an enhanced role for the European Commission in monitoring, coordination, and ensuring greater transparency. The establishment and maintenance of a digital reporting system providing real-time information on national stock levels is a particularly positive development, as it can support more effective and equitable redistribution. We reiterate that strong, coordinated governance, along with accountable and sustainable management systems and logistics, are essential to ensure that national stockpiles do not result in waste or disrupt existing supply chains. 

EPF will remain actively engaged throughout the trilogue negotiations to ensure that patient safety, improved access to medicines, and transparency in health decision-making remain core objectives of this initiative.