The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem. The latest communication is titled, “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here). This is a deep dive into the status and accomplishments as outlined in the EU’s five-year strategy (here). Regardless of document titles, statistics, or economic impact, this EU update stays true to mitigation of the risk that “shortages put the health and well-being of citizens at risk.”

While the complexity of regulations in the EU is recognized among its twenty-seven member states, the activities in the global economy should be considered for similarities and contrasting traits. Some similarities with this document and the FDA publications are:

• Recognition that a disproportionate number of generic drug substances and components are sourced from non-EU- and non-U.S.-based suppliers (i.e., India, China);
• Regulatory flexibility can be key to mitigating drug shortages;
• Measures exist to predict or assess areas when a drug shortage “might” happen (i.e., ICH Q9 application of supply chain risk assessments); and
• Close government/industry partnerships are key to jointly identifying and mitigating shortages when they happen.

The EU publication identifies the intent to develop specific IT tools, referred to as a new “European Shortages Monitoring Platform,” to be operational in 2025. Artificial intelligence (AI) is intended to feature prominently in this platform as demonstrated by the quote in the communication: “Artificial intelligence will also be used to provide information about trends in demand and supply from existing data.” This declaration also includes identifying some significant risks that may hinder its delivery or sustainability. One of the more significant risks is the potential shortage of labor that is “well versed” in not only AI but also in the “regulatory framework, quality assurance and control.”

For more on cross-agency cooperation and additional insight on emerging AI regulatory publications, please see a recent blog found (here). With all the recent publications released in this fast-moving and evolving environment, companies are encouraged to assess the risk(s) they may experience and identify mitigation strategy as part of their 2024 objectives to ensure not only organizational focus but also the supply of critical medicines to patients. 

If you need any help assessing your firm’s risks or developing a strategy to mitigate them, Lachman can help! Please reach out to us at [email protected].

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Patrick Day, M.S. is a Principal Consultant in the Compliance Practice at Lachman Consultants and an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment as well as in leading the rollout of computer validation for vaccines, aseptic antibiotic, and cytotoxic operations. Mr. Day is well versed in FDA and MHRA regulations. He has trained FDA field inspectors for facility inspection techniques and has delivered talks on deployment of risk strategies and modern signal detection. His expertise includes in-house execution as well as outsourcing and governance of FM and laboratory services across US/UK and Asia-Pacific.