Around two thousands of claims were raised 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 total amount due is about two billion euros, a prohibitive sum for pharmaceutical companies.

The Administrative Court issued temporary decisions in each pending claim which suspended all the deeds challenged, and requested to the Constitutional Court to verify the compliance of these regulations with constitutional principles of reasonableness, proportionality and transparency.

The decision No. 140/2024 of the Constitutional Court stated that the payback contribution would be ‘reasonable’, as it is aimed at guaranteeing the protection of the public healthcare system and the rationalization of its costs, and ‘proportionate’ also taking into account that, in the meantime, the Government decided to reduce the contribution for all suppliers of medical devices to an amount equal to 48% of the payments requested by the Regions.

This outcome led the Administrative Court, in May 2025, to issue its first final judgment, expected to be replicated with reference to all the other pending claims, which rejects a petition against the payback system.

Throughout this long period of uncertainty, pressures of trade associations on the Government never stopped, with the aim of having the payback system finally repealed or the relevant contribution further reduced.

Hence, the Decree dated 30 June 2025, No. 95, published on the same date (which shall be converted into Law, with possible amendments in the subsequent 60 days) provides that the obligations of paying payback contributions for the years 2015-2018 are considered fulfilled with the payment of the 25% of the amounts initially requested by the Regions.

According to the Decree, the payment – to be made within thirty days from the date of entry into force of the Law converting this Decree- will be communicated to the Administrative Court, with reference to the pending claims, implying their extinction; otherwise, the same claims will remain pending in the merit, with the very high risk of rejection and the consequent obligation to pay the full amount of the contribution due.

The intervention of the Government is certainly welcome, but unfortunately it does neither fully repeal the payback system as expected, nor clarify what is going to happen for the years after 2015-2018, leaving, once again, the operators in the uncertainty for the future of their activity.