The Activation of Payback on Medical Devices

The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in Italy, at national and regional level. Companies that have marketed medical devices in Italy at a cost to the national health service (NHS-SSN) during the years 2015, 2016, 2017 and 2018, may soon be required to pay a total amount of approximately 2.08 billion euros. This is unless they manage to effectively challenge (in or out of court) the so-called payback mechanism and the payment demands that will be made by the competent authorities. This is in view of the rules on ‘payback relating to medical devices’ that have been in force for several years but have so far never been applied in practice.

Read the full alert here.

Written by
Simone Cadeddu
Simone Cadeddu
I am a partner and Head of our Italian Regulatory and Administrative (Public Law) department. Working across several industry sectors being changed by the digital world, I provide expert advice on complex regulatory, antitrust and public procurement issues.
Mauro Turrini
Mauro Turrini
As Counsel in our Milan and Rome offices and a member of our International Life Sciences and Intellectual Property groups, I have a longstanding reputation as an expert in both the regulatory and IP aspects of life sciences.
Nadia Feola
Nadia Feola
I am a lawyer in the Intellectual Property department with experience in the life sciences and healthcare sector. I assist international companies in dealing with regulatory and compliance issues concerning medicinal products, medical devices, food supplements and other health-related regulated products.

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