By Orders Nos. 12114 and 12115 of 2 July 2026, the Regional Administrative Court (TAR) of Lazio referred to the Italian Constitutional Court the question of the constitutionality of the legislation governing the pharmaceutical expenditure payback mechanism (Article 1(145) of Law No. 145/2018 and Article 15(8) of Decree-Law No. 95/2012), questioning whether the financial burden imposed on pharmaceutical companies remains consistent with the principles of solidarity that originally justified its introduction.

Referring to the Constitutional Court's previous rulings on both the pharmaceutical payback scheme (Judgment No. 70/2017) and the medical devices payback mechanism (Judgment No. 140/2024), the TAR observed that the challenged legislation has, over time, resulted in the systematic and recurring imposition of a financial obligation whose annual amount is inherently unpredictable. According to the Court, the measure can no longer be regarded as addressing exceptional or contingent circumstances, nor is it limited to a predetermined period of time. It has therefore lost its original solidarity-based rationale and has evolved into an ordinary and structural instrument for financing the National Health Service. In the TAR's view, this may result in an unreasonable and disproportionate restriction on the freedom of economic initiative and an excessive interference with contractual autonomy.

These referrals depart from the most recent case law of the administrative courts, which had dismissed similar challenges concerning payback obligations for previous financial years.