EU Commission releases "Assessment of the Supply Chain Vulnerabilities for the first Tranche of the Union List of critical Medicines"

On 10 July 2024, the European Commission's Health Emergency Preparedness and Response Authority (HERA) published a technical report evaluating vulnerabilities in the supply chain for medicines listed in the Union list of critical medicines. It is expected to provide valuable insights to the Critical Medicines Alliance (CMA), the EU Commission and EU Member States to better respond to potential supply shortages.

The technical report is part of the European Commission's ongoing efforts to tackle shortages of critical medicines. In December 2023, the first version of the Union list of critical medicines, which contains over 200 active substances that are classified as critical due to their therapeutic purposes and the accessibility of appropriate substitutes, has been published. Further information can be found in the news article regarding the Union list of critical medicines.

After the publication of the Union list, a pilot exercise was conducted to evaluate the supply chain weaknesses of an initial group of 11 critical medicines from the list.

The findings are as follows:

• Dependence on non-EU API Suppliers: The reliance on non-EU API suppliers leads to a significant risk of supply chain disruption in case of production issues. 
• Market Concentration Risks: The majority of supply originates from a single country or manufacturer thereby increasing the risk of a supply chain disruption from geopolitical problems, trade restrictions, or production issues.
• Variable Production Resilience: Diversification of production sites is essential to prevent risks of localized supply disruption and to ensure resilient supply chains.
• Uncertainty in Market Dynamics: The unpredictable demand for critical medicines leads to vulnerability to fast changes in demand. In order to adapt to rapid market changes, supply chain systems are required to be more flexible and adaptive.
• Economic Viability Challenges: Economic challenges threaten the long-term sustainability and profitability of the substances. Tackling these issues is key for maintaining strong supply chains.

These findings indicate that strategic measures are necessary to increase the resilience of the supply chain by diversifying sources of supply, increasing the flexibility of production capacity, and creating robust risk management measures to successfully manage economic and market fluctuations.

The main reason for shortages of essential medicinal products are manufacturing problems and unexpected surges in demand.