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In brief

During the Council of Ministers of 28 March 2023 the Government adopted a Law Decree on “Urgent measures to support families and companies in the purchase of electricity and natural gas, as well as on health and tax compliance”, which has not yet been published in the Official Gazette, introducing new measures on the payback for medical devices.

Key takeaways

Rumors about possible Government’s decisions on this matter circulated in the preceding weeks, in relation to which the Chairman of Confindustria Dispositivi Medici (Italian Association of Medical Device Companies) expressed his concerns in an open letter to the ministers of Economy and Finance and Health.

Pursuant to the press release published on the Government’s website, the new Law Decree establishes a fund within the Ministry of Health to be distributed among the Regions and Autonomous Provinces in proportion to the payback amounts due to them for the years 2015, 2016, 2017 and 2018. In this respect, the Law Decree also provides for a reduction of payback amounts to be paid by medical device companies, on condition that the latter have not initiated any litigation, or have waived any pending litigation, challenging payback orders. In this case, the deadline for the payment of “discounted” amounts is 30 June 2023, while the 30 April deadline still applies to companies that proceed with their litigation proceedings pending before the Rome Administrative Court.

In addition, with reference to the above-mention payments, the Law Decree provides that VAT can be deducted from payback amounts paid to Regions and Autonomous Provinces.


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.


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

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