In brief
Following the public hearing held on 22 May 2024, on 22 July 2024, the Italian Constitutional Court issued two judgments (judgment No. 139/2024 and judgment No. 140/2024) to decide the various appeals concerning the legitimacy of medical device payback regulation, i.e., the system under which medical device companies are required to contribute to the coverage of the NHS deficit in the years 2015-2018.
In depth
In a nutshell the Constitutional Court issued a Solomonic decision whereby it declares the payback system itself legitimate, as aimed at covering the NHS deficit for public health and social purposes and, on the other hand, it grants a 52% reduction on the amount to be paid by all medical device companies, including those who have pending litigation against such a system. Below is a brief summary of the relevant points of the decisions.
By the first judgment (judgment No. 139/2024), the Constitutional Court, upon explicit requests and arguments raised by the Campania region, stated that the provisions of the Law Decree 34/2023, granting the 52% reduction of the payback system only to companies waiving their claims before the Rome Administrative Court are illegitimate and in contrast with the Italian Constitution, since these provisions discriminate companies that decided to challenge in court the payments orders to protect their rights and interests. In this respect, the Constitutional Court expressly pointed out that “The payback mechanism does not appear disproportionate in light of the significant reduction to 48% of the amount originally charged on companies, a reduction now unconditionally recognized for all companies ” (see judgment No. 139/2024). As a consequence, the 52% reduction for the payback related to the years 2015 – 2018 shall be granted to all medical device companies, including those which still have pending proceedings before the Rome Administrative Court.
By the second judgment (judgment No. 139/2024), the Constitutional Court, stated that the payback system is compliant with the Italian constitutional framework. In particular, the Constitutional Court ruled out that “The payback itself presents several critical issues, but it is not unreasonable with reference to Article 41 of the Italian Constitution, as far as the period 2015- 2018 is concerned. It, in fact, places on companies for that time frame a solidarity contribution, correlated to reasons of social utility, in order to ensure the supply of medical devices necessary for the protection of health in an economic and financial situation of serious difficulty”.
It is worth noting that, according to the Constitutional Court, the payback system is legitimate also because it does not trigger retroactivity of rules of law. Indeed, according to the Constitutional Court, paragraph 9-bis of Article 9-ter of law decree no. 78/2015, introduced in 2022, merely made operative and effective a prior obligation – binding the medical device companies – to pay-back a portion of the profit from the sale of medical devices. The Constitutional Court clarified that such obligation does not unlawfully / unconstitutionally affect the private parties’ reliance on maintaining the sale price of medical devices.
The administrative legal proceedings before the Administrative Court will proceed with the discussion of the merits of the relevant cases and, therefore, with the Court’s analysis of the claimants’ arguments (e.g., wrong calculation, illegitimate inclusion of services in the payment orders, etc.). For the time being no payment is due by those companies benefiting of the suspension orders issued by the Administrative Court.
