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In brief

In a press release dated 3 April 2023, Confindustria Dispositivi Medici (the Italian Association of Medical Device Companies) announced the submission to the European Commission of a complaint to initiate infringement proceedings against Italy for the breach of the EU legislation on the matter of competition, market access and public procurement resulting from the Italian law governing the payback for medical devices.

Key takeaways

With the same press release, Confindustria Dispositivi Medici also expressed its disappointment at the measures recently introduced by Law Decree No. 34/2023 which, by establishing a fund to cover a share of the deficit resulting from the overrun of the expenditure ceiling for the purchase of medical devices and providing, in relation to the remaining share, a 52% discount on the payback amounts requested by Regions and Autonomous Provinces, has restricted the possibility of benefitting from such a discount to those medical device companies which have not undertaken legal proceedings against the payback or waive them. In this respect, Confindustria Dispositivi Medici suggested medical device companies to reject the offered discount and continue with the legal proceedings.


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.


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


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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