With Law Decree no. 115/2022 (Aiuti Bis Decree), the Italian Government reactivated the so-called “payback” system for medical devices. With the goal of rationalizing public spending, this requires companies that have supplied medical devices on the Italian market to pay "back" any sum exceeding the allocated budget for purchases of medical devices by the Italian Regions. This time the system will hit companies that have supplied devices in Italy between 2015 are 2018. Indeed, on 15 September 2022 the Italian Ministry of Health issued a Ministerial Decree certifying such expenditures in excess of statutory budgets at both the national and regional levels for the years 2015, 2016, 2017 and 2018. According to forecasts, companies operating in the sector will find themselves forced to repay millions of euros in a few months from today, facing significant financial exposure and repercussions.

Any affected company can challenge the Ministerial Decree before the competent Regional Administrative Court (TAR) within 60 days of publication in the Italian Official Journal, on grounds which may include the violation of the principle of legitimate expectations (legittimo affidamento), the unlawful retroactive application of the rule and the violation of the right of freedom of enterprise. Following this initial deadline, companies will be entitled to challenge any subsequent measure that will be adopted by the various entities involved.

The payback system has existed in Italy for medicinal products for several years, having generated high volumes of litigation where companies are very often successful in challenging unlawful decisions by the Italian regulatory authorities. With the extension of a comparable model to medical devices through Law Decree 115/2022, we anticipate that similar developments will follow in this sector as well in the immediate future.