The Activation of Payback on Medical Devices

Published

Oct 07 2022

Written By

Partner
Italy

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.

Jacopo Nardelli

Counsel
Italy

I am a counsel in our Regulatory & Administrative Group in Milan, where I work with clients across a wide spectrum of regulated industries.

Mauro Turrini

Counsel
Italy

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.

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