EMA and EU Commission Strengthen Measures to Prevent and Mitigate Medicine Shortages

On June 18, 2024, the European Medicines Agency (EMA) released templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). These templates are aimed at marketing authorization holders (MAHs) in the EU/EEA to help minimize the risk of medicinal shortages. This initiative aligns with the European Medicines Agency Network’s strategy and the European Commission’s pharmaceutical strategy to mitigate medicine shortages, which already led to the revision of the pharmaceutical legislation in April 2023. The draft regulation mandates that MAHs establish these plans accordingly. As per Regulation 2022/123, the SPPs are already mandatory during public health emergencies or major events for drugs listed in the list of critical medicines.

Shortage Prevention Plans (SPPs) are designed to identify and manage potential supply chain risks. They should include details on the MAH, supply and manufacturing chain, stock data, sales, consumption, and an analysis of past supply issues. Each medicinal product marketed by the MAH must have a corresponding SPP. These plans should evaluate supply chain weaknesses, assess the risk of supply interruptions, and maintain a risk register for clinically significant products. MAHs are also required to determine corrective actions, maintain minimum stock levels, and regularly review prevention measures.

Shortage Mitigation Plans (SMPs) focus on eliminating potential or actual drug shortages and minimizing their impact on patients. They should outline procedures for dealing with shortages, including impact reduction, regulatory notifications, and follow-up actions. MAHs must define roles and responsibilities, establish escalation processes, and keep records of root causes and mitigation measures.

Both SPPs and SMPs should be developed with the highest level of management involvement, created in English, updated regularly, and submitted to the competent authorities upon request.

Additionally, on July 10, 2024, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) published a technical report assessing supply chain vulnerabilities for the first set of critical medicines. This report supports efforts to tackle shortages of critical medicines, which are listed due to their therapeutic importance and lack of substitutes. The pilot exercise, conducted to evaluate the supply chain weaknesses of an initial group of 11 critical medicines, revealed several vulnerabilities:

• Significant dependence on non-EU API suppliers, risking supply disruptions.

• Risk from market concentration: 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 needed to prevent localized supply disruptions.
• Market dynamics uncertainty: Unpredictable demand for critical medicines requires flexible and adaptive supply chain systems.
• Economic viability challenges threaten the sustainability of supply chains.

The report recommends strategic measures to enhance supply chain resilience, such as diversifying supply sources, increasing production flexibility, and implementing robust risk management. Addressing manufacturing issues and unexpected demand surges is crucial for preventing shortages.