Pending litigation in Italy

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 fundamental macro-arguments contained in such claims refer, inter alia, to:

1. the violation of the constitutional principle of reasonableness, proportionality as well as transparency;
2. the impossibility for the private companies to know and quantify, in terms of provisions and/or potential liabilities, the excess of the public expenditure;
3. lack of transparency about the list of suppliers, the uniformity of the products and the figures.

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, until the final decision in the merits.

In the meantime, the same Court has published a temporary decision, 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.

Therefore, the outcome of all the claims raised before the Court is still uncertain and will depend on the decision of the Constitutional Court which is expected by the end of 2024.

Not only. To date, the Companies manufacturing and distributing medical devices are going to face further difficulties in running their business.

A Ministerial Decree, published in the Official Journal on 9 February 2024, implementing EU Regulations No. 2015/745 and 746/2017 and European Delegation Law No. 53/2021, which established the “medical device government financing system” provides for the payment of an annual share of 0.75% of their turnover, net of VAT, deriving from sales of medical devices to the National Health Service.

Many of the arguments and complaints of constitutional illegitimacy made in the payback litigation could ground further claims against the said rules and regulations.

Consequently, further initiatives are expected from the Companies involved to protect their profit margins already seriously jeopardized by the payback system, with the additional risk that inevitable increases of bid prices would turn in a greater regional public spending for the purchase of medical devices and further difficulties to guarantee an efficient health service to the citizens.

Ermanno Vaglio
Pirola Pennuto Zei & Associati, Associate Partner
Working Group Healthcare & Life Science