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Product Regulation & Liability

Italy: Medical device payback – 22 May 2024 hearing before the Constitutional Court

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In brief

On 22 May 2024, the Italian Constitutional Court held a public hearing to discuss the issue of the legitimacy of medical device payback regulation, as raised by the Lazio Regional Administrative Court, for conflicting with Articles 3, 23, 41, and 117 of the Constitution.

Key takeaways

The medical device companies’ attorneys have joined the Constitutional proceedings, have supported the Regional Administrative Court’s constitutionality doubts, and have strongly affirmed the contrasting nature of the payback regulation with the canons of reasonableness and proportionality, as well as with the Constitutional principle of economic liberty.

The Constitutional Court will return its decision in the coming months.

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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.

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

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