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In brief

The European Medicines Agency’s Medicines Shortages Steering Group (MSSG) recently developed a list of recommendations in hopes of increasing the availability of critical medicines flagged for supply chain vulnerabilities or risks.


Established under EU Regulation 2022/123, the MSSG monitors medical shortages to ensure adequate responses, to prepare for and manage crises, and to coordinate urgent action as needed. MSSG’s new recommendations under EMA/44164/2024 include efforts to increase manufacturing capacity, diversify suppliers in supply chain, recommend action from MHAs, adjust EU joint procurement mechanisms, and incentivize investment among others.

The MSSG’s recommendations correlate directly with the EU’s list of critical medicines that affect healthcare operations across the Union. These recommendations outline what types of medication to stockpile before the shortages and supply chain issues hit the market.

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.