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Italy: The new decree on the assignment of results of non-profit studies for registration purposes

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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.

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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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