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In brief

On 22 October 2020, the Italian Medicine Agency (AIFA) published the standard template for clinical investigations on medical devices, as developed by the National Coordination Center of Territorial Ethics Committees.


In depth

Although the standard template precedes the application of Regulation EU 2017/745 (scheduled for 26 May 2021), the AIFA pointed out that the adoption of said instrument is still necessary to promote uniformity and quality of agreements between sponsors and clinical sites. In this respect, the standard template sets forth the minimum contents that all agreements must comply with, including those relating to fees, relationships between the sponsor and the investigator, the confidentiality of information during the investigation, the ownership and use of results, and the protection of personal data.

The AIFA also specified that the identification of minimum contents does not prevent the possibility of supplementing the relevant agreement if this is necessary to address specific needs or justified by the peculiarities of a clinical investigation. Lastly, the AIFA clarified that, in any case, the adoption of the standard template does not affect ongoing agreements, for which no changes will be required to ensure compliance with its provisions.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

Author

Irene Carlet is a Law Clerk/Intern in Baker McKenzie's Rome office.