Numerous appeals are still pending before the Regional Administrative Court for Lazio against the deed issued in December 2022 by the Regions, based on Article  9-ter of the Legislative Decree No. 78/2015 (as amended by the Legislative Decree No. 115/2022), ordering the suppliers of medical devices to public administrations to pay a contribution for the partial offset (so-called payback) to cover the regional governments’ public expenditure on medical devices in excess of a certain limit for FY’s years 2015, 2016, 2017 and 2018, as certified by the Ministerial Decree dated 6 July 2022.

The Court, in nearly all pending cases, has temporarily suspended the effects of the payment requests and, in order to adopt the final decision on the merits, formally requested to the Constitutional Court, on 24 October 2023, to verify the constitutional legitimacy of the rules regulating the payback system.

The Constitutional Court, with its final judgement No. 140 published on 22 July 2024, confirmed the constitutional legitimacy of the rules governing payback, essentially affirming that the law can limit private economic initiative in case of social needs, providing a solidarity contribution, provided that it responds to the principles of reasonableness and proportionality.

This solidarity contribution, according to the Constitutional Court, would be ‘reasonable’, as it is aimed at guaranteeing the protection of the public healthcare system and the rationalization of its costs, and ‘proportionate’, taking into account the reduction of the contribution for all suppliers of medical devices to an amount equal to 48% of the payments requested by the Regions.

In this latter respect, in fact, the Constitutional Court itself, with the judgement No. 139 published on the same date of 22 July 2024, declared the constitutional illegitimacy of the known Government provision (referred to in Article 8 of the Legislative Decree No. 34/2023) which provided for the said 48% reduction as reserved only for operators who decided to waive to the claims raised before the Regional Administrative Court, since such reduction should have been acknowledged to all the operators with no distinction.

Following the rulings of the Constitutional Court, which effectively represent a compromise between the various positions taken by the public and private entities involved in the dispute, it is now believed that there is no margin for obtaining a complete annulment or further reductions of the requests for contributions of payback.

Therefore, it is expected that the Regions will issue, within a period of time difficult to foresee, new deeds, redefining the amounts due (equal to 48% of the amounts originally requested for the FY’s 2015, 2016, 2017 and 2018) and the payment methods of the same. This may lead to a consequent conclusion of the pending appeals before the Court due to a supervening lack of interest.