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In brief

On 7 February the decrees of the Ministry of Health aimed at aligning the Italian legislation with Regulation EU 536/2014 on clinical trials were published in the Official Gazette.

Key takeaways

The decrees identify 40 Territorial Ethics Committees (TECs) and, more generally, regulate the functions and composition of Ethics Committees and establish the criteria for the allocation of responsibilities between TECs and National Ethics Committees (NECs). Provided that the functions of TECs and NECs are identical, the above decrees specify that the TECs may also perform, upon request from the relevant clinical sites, functions falling with the competence of NECs’, except for the evaluation of clinical trials and investigations. The decrees also regulate the transitional phase concerning assessment activities of and interactions among the National Coordination Center of Ethics Committees, TECs, NECs, and the Italian Medicine Agency as regards applications for substantial amendments to clinical trials carried out pursuant to Directive 2001/20/EC. Lastly, in order to simplify administrative procedures, the decrees also establish a single fee for clinical trials, which applies throughout the Italian territory.


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.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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