Around two thousand claims raised in 2023 are still pending before the Italian Administrative Court of Rome against the Ministerial and Regional Decrees which, implementing the Legislative Decree 2015, No. 78, Article 9-ter, required the supplier of medical devices many years after – at the end of 2022 – to pay an amount corresponding to the percentage incidence of their sales to the Regional Healthcare Service (Servizio Sanitario Regionale), in order to contribute to the coverage of the regional governments’ public expenditure on medical devices in excess of a certain limit (as identified by Ministerial Decree 6 July 2022) for FYs 2015, 2016, 2017 and 2018.
The Administrative Court of Lazio, in the second half of 2023, issued a temporary decision in almost each pending claim which suspended all the deeds challenged, deciding to submit to the Constitutional Court the issue relating to the legitimacy of the payback system, provided by the said Legislative Decree No. 78/2015.
The Constitutional Court, with its final judgement No. 140/2024, confirmed the constitutional legitimacy of the rules governing payback, limited to 48% of the payments requested by the Regions, 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.
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, the final decision in the merit is now back to the Administrative Court.
On February 25th 2025, the final hearing in the merit of some of the pending claims was held with no anticipation of what the outcome of the claims will be. Certainly, should the Court reject the claims, it is expected that the Regions will issue new deeds, redefining the amounts due (equal to 48% of the amounts originally requested 2018) and the Company, on the other side, will appeal the decision of the Court, causing a further long period of uncertainty relating to the payback system.