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In brief

Several Regions and Autonomous Provinces published the measures requiring medical device companies to pay, within 30 days, payback amounts aimed at covering the overrun of the expenditure ceiling for the purchase of medical devices for the years 2015, 2016, 2017 and 2018.


Key takeaways 

In light of the various judicial appeals pending before the Administrative Court of the Lazio Region on the matter of payback for medical devices, the Health Department of the Sardinia Region, with Resolution of 12 December 2022 resolved to suspend, until the ruling of the Regional Administrative Court, the effectiveness of the previous Resolution of 28 November 2022 identifying payback amounts for the years 2015, 2016, 2017 and 2018. This suspension applies to all medical device companies identified in Annex A to the above-mentioned Resolution.

More in general, the matter of payback for medical devices will be discussed by the Italian Parliament, following the amendment proposed in the context of the approval of the Budget Law for 2023, which aims to suspend the payback for small and medium enterprises.

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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