European Commission Proposes New Act to Secure Critical Medicines Supply and Enhance Access to Other Medicinal Products Through Collaborative Procurement Framework
**European Commission Proposes New Act to Secure Critical Medicines Supply and Enhance Access to Other Medicinal Products Through Collaborative Procurement Framework**
*Brussels, [Date]* — In a significant move to bolster the resilience of the European Union’s healthcare systems, the European Commission has unveiled a new legislative proposal aimed at securing the supply of critical medicines and improving access to other essential medicinal products across Member States. The proposed “Critical Medicines Act” is designed to address long-standing vulnerabilities in the pharmaceutical supply chain, particularly those exposed during the COVID-19 pandemic and recent geopolitical disruptions.
### Background and Rationale
The European Union has faced increasing challenges in ensuring consistent access to vital medicines, including shortages of antibiotics, oncology drugs, and other life-saving treatments. These shortages have been attributed to a combination of factors, such as over-reliance on third-country suppliers, limited manufacturing capacities within the EU, and fragmented procurement strategies among Member States.
The COVID-19 crisis highlighted the urgent need for a more coordinated and strategic approach to pharmaceutical procurement and supply chain management. In response, the European Commission has prioritized health security and pharmaceutical resilience as key pillars of the European Health Union initiative.
### Key Objectives of the Proposed Act
The Critical Medicines Act aims to:
1. **Strengthen EU Manufacturing Capacity**: The Act proposes targeted investments and incentives to boost domestic production of critical medicines and active pharmaceutical ingredients (APIs). This includes support for innovation, modernization of manufacturing facilities, and the establishment of strategic reserves.
2. **Enhance Supply Chain Transparency and Monitoring**: The legislation will introduce mandatory reporting obligations for pharmaceutical companies regarding production capacities, supply disruptions, and stock levels. A centralized EU monitoring system will be established to provide real-time data and early warning signals.
3. **Establish a List of Critical Medicines**: In collaboration with the European Medicines Agency (EMA) and national authorities, the Commission will maintain a dynamic list of critical medicines that are essential for public health and vulnerable to supply disruptions.
4. **Create a Collaborative Procurement Framework**: Building on the successful joint procurement mechanisms used during the pandemic, the Act proposes a permanent framework for voluntary joint purchasing of medicines. This will allow Member States to pool resources, negotiate better prices, and ensure equitable access to essential treatments.
5. **Promote Strategic Partnerships and Diversification**: The Act encourages partnerships with trusted international suppliers and promotes diversification of sourcing to reduce dependency on single countries or regions.
6. **Support Research and Development**: The proposal includes measures to support R&D for new and improved formulations of critical medicines, particularly in areas where market incentives are lacking.
### Implementation and Governance
The European Commission will work closely with the Health Emergency Preparedness and Response Authority (HERA), the European Medicines Agency (EMA), and national health authorities to implement the provisions of the Act. A new Critical Medicines Board will be established to oversee strategic planning, coordinate procurement efforts, and ensure alignment with Member States’ healthcare priorities.
### Reactions and Next Steps
Health Commissioner Stella Kyriakides welcomed the proposal, stating: “This Act is a cornerstone of our efforts to build a stronger European Health Union. By securing the supply of critical medicines and fostering greater solidarity among Member States, we are taking a decisive step toward safeguarding the health of our citizens.”
Industry stakeholders have generally expressed support for the initiative, though some have called for further clarity on regulatory requirements and the scope of the critical medicines list.
The proposal will now be submitted to the European Parliament and the Council for consideration. If adopted, the Critical Medicines Act is expected to come into force in 2025, with phased implementation of its key components.
### Conclusion
The European Commission’s proposal marks a proactive and strategic shift in the EU’s approach to pharmaceutical security. By addressing systemic weaknesses and promoting collaborative procurement, the Critical Medicines Act aims to ensure that all Europeans have timely and equitable access to the medicines they need—regardless of market dynamics or global disruptions.