In brief

On 16 February 2022, the Decree of the Ministry of Health dated 30 November 2021 governing the assignment for registration and commercial purposes of data relating to nonprofit clinical studies (“Decree”) was published in the Official Gazette. Said Decree repeals the previous Ministerial Decree dated 17 December 2004.

Key takeaways

In particular, the Decree, which applies to nonprofit clinical trials, low-intervention clinical trials and observational studies, provides that: (i) data can be assigned either during the trial or after its conclusion; (ii) to use data for registration purposes, the sponsor or the assignee must bear or reimburse all the direct and indirect costs connected with the trial and is required to pay the relevant fees to the Italian Medicines Agency (AIFA) or the competent Ethics Committee; (iii) the assignment of the data must be governed by a contract between the sponsor and the assignee; and (iv) the sponsor must notify the AIFA, the relevant Ethics Committee and each trial site of the assignment.