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.