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MedTech companies’ hopes betrayed: Italian Constitutional Court confirms medical device payback

Expectations of MedTech companies on a possible repeal of the payback mechanism for medical devices have been disappointed by two recent rulings of the Italian Constitutional Court (no. 139/2024 and 140/2024), which confirmed...more

Clinical Trial Regulation: Italy approves the new decrees on ethics committees

On 7 February 2023, four long-awaited decrees of the Ministry of Health on the reorganisation of ethics committees were published in the Official Journal. They contribute to the full implementation of the Clinical Trials...more

Payback and Health Technology Assessment in Italy: a new governance for medical devices?

While waiting for a new governance to make the process of selecting and purchasing medical devices more efficient, thus incentivizing investment in innovative technologies, the activation of the payback mechanism may...more

Italian Sunshine Act and transparency in the health sector

From June 26th, 2022, the “Italian Sunshine Act” entered into force. This is a piece of legislation aimed at preventing corruption and fostering transparency in the health sector by imposing disclosure obligations on...more

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