On March 11, 2025, the EU formally proposed a regulation to not only fight drug shortages but also to maintain its status as a global leader in the production of pharmaceutical products. We have previously published a blog that identified the convergence of U.S. and EU efforts that can be found here. While the U.S. navigates the ongoing changes in its executive branch, the EU took a giant step forward to codify its efforts in order to protect public health by ensuring that patients can get the products they need.

The proposal was born out of the EU roadmap titled “Political Guidelines for the next European Commission,” which was published in July 2024. One of the key concepts identified and actioned in this roadmap is the global competition for resources, and the EU is proposing a Science, Technology, Engineering, and Math (STEM) Education Strategic Plan. This signals a clear intention for long-term investment to create and sustain a secure pipeline of talent in addition to the secure pipeline of product. Other key elements of the proposal include:

  • Assistance for companies that invest in the EU with:
    • Easier access to funding
    • Fast-tracked administrative, regulatory, and scientific support
  • Assistance for Member States with:
    • State aid guidance to support strategic projects for critical medicines
    • Procurement guidance to encourage local production and diversified supply chains
    • Support for possible joint or collaborative procurement of critical medicines and other medicines of common interest

The proposal is also in line with efforts made by the Duke-Margolis ReVamp Drug Supply Chain Consortium, which was the subject of a previous Lachman blog (here). The U.S. has also identified these issues as a priority as detailed in Executive Order 14017 on America’s Supply Chains | FDA and H.R.7085 – 118th Congress (2023-2024): BIOSECURE Act | Congress.gov | Library of Congress during a previous administration. However, the codification has yet to be completed. In addition, in a related matter, the FDA guidance Risk Management Plans to Mitigate the Potential for Drug Shortages has remained in draft status since 2022.

This topic was also discussed by yours truly, Lachman Consultants’ Pat Day, at the recent 49th International GMP Conference in a presentation that showed attendees how to utilize Quality Risk Management (QRM) to assess global risks with highly effective risk-assessment tools. With all of these efforts quickly converging, companies are well advised to start assessing their own supply chains. Lachman can help your organization focus on high-risk issues. Reach out to us at LCS@LachmanConsultants.com for your personalized review today, before drug shortages affect any additional patients.