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In brief

On 25 May 2023, the Senate approved in final form the Law converting Law Decree 34/2023, which provides a 52% discount with respect to the payback amounts requested by the Regions and Autonomous Provinces to those medical device companies which have not started litigation on the matter or which waive any ongoing litigation.

Key takeaways

During the conversion process, some minor formal amendments were made by the parliamentary committees, including the clarification that the timely payment of the reduced payback amounts is ascertained by the Regions and Autonomous Provinces through the publication in their bulletins and institutional websites of specific provisions. Following their publication, the same provisions shall be communicated to the Administrative Court of the Lazio Region to determine the cessation of existence of the disputes and the compensation of legal costs.

With regard to the possibility for medical device companies to deduct the VAT from the payback amounts, the Law specifies that the determination of the VAT is to be made by the Regions and Autonomous Provinces by calculating the invoices issued by the companies to the National Healthcare System and taking into account the obligation to indicate separately the amount of the cost of the good and the cost of the service.


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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