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Product Regulation & Liability

Italy: Medical device payback – The hearing before the Constitutional Court has been set for 22 May 2024

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In brief

The Constitutional Court has set the public hearing for 22 May 2024, to discuss the legitimacy of the payback regulation for medical devices.

Key takeaways

In particular, the Constitutional Court will discuss the merits of the multiple orders issued by the Regional Administrative Court of Lazio – Rome, with which questions of constitutional legitimacy, relating to Article 9 ter of Law Decree No. 78 of 2015, were raised, for violations of Articles 3, 23, 41 and 117 of the Constitution.

Hundreds of manufacturers of medical devices are awaiting the Constitutional Court’s decision, since, should the Court confirm the legitimacy of the legislation in question, they will be required to pay 1.1 billion euros on account of the expenditure overruns for the four-year period 2015-2018, in addition to the payback due for the following years.

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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.

Author

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

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