The publication of today’s Critical Medicines Alliance’s Strategic Report is a major milestone in securing access to critical medicines for European citizens. 

EFPIA supports the European Commission’s goal of strengthening pharmaceutical supply chains and boosting EU competitiveness. We have actively engaged in the Alliance, participating in the Forum, supporting our members in the working groups, and as a Steering Board member. 

The Strategic Report aligns with many of EFPIA’s policy recommendations for a Critical Medicines Act, however, some concerns remain regarding its implementation:  

• The use of a binary EU/ex-EU industrial presence indicator for assessing supply chain vulnerability does not fully capture the complexity of global supply chains. A product manufactured outside the EU is not necessarily more vulnerable than one produced within the EU. EFPIA encourages an approach that reflects different levels of risk from a global perspective that should consider trade agreements, geographical proximity, and country stability indicators, among others. 

• Procurement rules established under the Critical Medicines Act must remain in line with the EU’s commitments under the WTO Agreement on Government Procurement (GPA) and relevant Free Trade Agreements (FTAs). On joint procurement, EFPIA takes note of the recommendation and considers that such a mechanism may be appropriate in very specific circumstances where it accelerates patient access to critical medicines and is structured in a balanced way that delivers demand predictability, simplifies market entry requirements, and avoids spillover effects that may negatively impact supply-side sustainability and competition. A systematic application of joint procurement would create more harm to the sustainability of supply than offering a long-standing solution. 

• National stockpiling requirements, if not coordinated, risk causing supply imbalances and unintended shortages across Member States. If required, contingency stocks should be managed at the EU level to prevent duplication and inefficiencies.  

• The European Medicines Verification System already provides substantial data on supply and demand, making additional IT systems or data collection requirements unnecessary and duplicative. Existing resources should be fully leveraged to streamline monitoring processes. 
  
  
• The proposed timeline for developing a preliminary list of vulnerable medicines by mid-2025 is too short. As highlighted in the lessons learned from the Technical Report on the Q1 2024 exercise, “all the involved stakeholders expressed concerns about the time and the resources required to participate in these exercises; especially if expanded to include the full EU critical medicines list. Streamlined data submission process and legal framework are pivotal to scale this exercise to the full Union critical medicines list.”  Therefore, a single EU list of Critical Vulnerable Medicines should be reviewed no more than once per year. 

Further call to action: 

• Continued and regular engagement with authorities is essential to ensure the smooth implementation of supply chain policies and increased transparency on the demand and supply of critical medicines. The Critical Medicines Alliance serves as a valuable platform for dialogue among a diverse set of stakeholders. Given its importance, the engagement through the Alliance should continue to support effective policymaking. 

• EFPIA believes an evidence-based impact assessment of the key provisions included in the Act would be valuable to monitor their effectiveness in the short, medium, and long term. 

EFPIA members remain committed to actively engaging in the necessary discussions to ensure that this Act effectively supports patients across Europe and the rest of the world. 

Nathalie Moll, Director General, EFPIA, said:  

“EFPIA and our members are fully behind the Critical Medicines Act and its ambition to ensure Europeans always have access to the right medicines, wherever they live. 

We recognize the urgency behind the development of a Critical Medicines Act and the Commission’s efforts in this regard and believe that continued collaboration between the institutions and industry will be essential to ensure its successful implementation. We would also urge that the Act is subject to ongoing monitoring and assessment so that policies are coherent, workable and effectively support our ability to get essential medicines to patients in Europe.” 

Read the full report here.