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Product Regulation & Liability

Italy: Payback on medical devices – Extension of the payment deadline

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In brief

On 11 January 2023, Decree Law No. 4 (“Decree“) on “Urgent provisions regarding the procedures for the repayment of the medical device expenditure ceiling overrun” was published in the Italian Official Gazette.

Key takeaways

Article 1 of the Decree extends to 30 April 2023 the deadline by which companies that supplied medical devices to NHS during the years 2015-2018 must pay the required payback amounts.

In addition, it should be noted that on 17 January 2023 the first hearing concerning the interim requests filed within the payback appeals was held before the Lazio Regional Administrative Court’s Section III quater. The Court rejected the requests because of the time extension provided by the aforementioned decree, arguing that such an extension eliminated the existence of irreparable damage. It was also announced the scheduling of the first hearings to discuss the merits of the case in June 2023.

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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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