Pending litigation in Italy

Around two thousands of claims were raised in 2023 before the Italian Administrative Court of Rome against the so called ‘payback system’ according to which the supplier of medical devices were requested 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 issue was submitted by the Administrative Court of Lazio to the Constitutional Court that, with its final judgement No. 140/2024, confirmed the constitutional legitimacy of the rules governing payback, in the limit of 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.

Subsequently, after continuous pressure of Associations of operators, the Government further reduced to 25% the payments requested by the Regions, which led the majority of the operators to pay the amounts requested, waiving the pending litigations.

A similar situation is currently evolving against a contribution of 0.75% of companies’ annual turnover introduced to finance a fund for the governance of medical devices provided for by Legislative Decree No. 137/2022.

Numerous operators have filed appeals also against the introduction of this contribution before the administrative Court, all of which were rejected.

However, recent news is that, in appealing these rulings, the Supreme Administrative Court has decided once again to involve the Constitutional Court to ascertain the constitutional legitimacy of the relevant rules and regulations.

Particularly, the Supreme Court issued the decision No. 1588/2026 highlighting a possible violation of the constitutional principles of reasonableness, equality, and proportionality, considering that such contribution (in addition to the payback) creates a sort of undue taxation exclusively on a limited group of operators who sell medical devices to the public health service, without a precise assessment of the balance between public needs and entrepreneurial freedom guaranteed by the constitution.

Pending the Constitutional Court’s ruling and the subsequent final judgement of the Supreme Administrative Court, the contribution of 0,75% of revenues continues to be due, causing again an inevitable, prejudicial uncertainty regarding the outcome of this legal proceeding and the possibility of obtaining full or partial reimbursement of the amounts paid.