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Italy: Medical devices – The National Health Technology Assessment Program gets underway

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In brief

On 15 November, the Minister of Health, together with the National Agency for Regional Health Services (Agenas) and the Conference of Regions and Autonomous Provinces, presented the Italian National Health Technology Assessment (HTA) Program for Medical Devices covering the years 2023-2025, that was published in the Italian Official Gazette on 15 September 2023.

Key takeaways

HTA is a multidisciplinary process that intends to determine the value of a healthcare technology at different life-cycle stages and the related National Program represents a planning tool aimed at the critical assessment and introduction of health technologies in the context of the NHS. The aim of the Program is to ensure that available resources are allocated effectively and efficiently, promoting equitable access to health technologies and improving the quality of care provided to patients.

The implementation of the New Program will have the cooperation of the Minister of Health, Agenas and the Regions. With this Program, Italy aligns with the provisions of the EU Regulation 2021/2282 on healthcare technology assessment, which entered into force on 11 January 2022 and will apply from 12 January 2025.

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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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Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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