HEALTHCARE
The Constitutional Court, in two anticipated decisions (Nos. 139 and 140 of 2024), has ruled on the legitimacy of the payback for medical devices. In the first decision (No. 139), rendered upon the appeal by the Region of Campania, the Court deemed legitimate the criteria for the allocation of the Fund established by Article 8 of Decree-Law 34/2023, which was created to alleviate the burden of payback imposed on companies. However, it declared the unconstitutionality of the provision insofar as it conditions the benefit of this reduction on the abandonment of litigation by the operators. In decision No. 140, the Court directly addressed Article 9-ter of Decree-Law 78/2015: while acknowledging the critical issues that characterize the regulatory framework, it judged the choice to have companies contribute to the payback of excess spending as overall reasonable, equating the payback to a "solidarity contribution" to ensure the supply of medical devices in a challenging economic context. According to the Constitutional Judges, the payback mechanism does not violate the legal reservation (Article 23 of the Constitution), as the Administration is only required to calculate the amount based on fully predetermined criteria, nor does it violate the principle of non-retroactivity, as the subsequent regulation (paragraph 9-bis of Article 9-ter) only governed procedural aspects without unconstitutionally affecting the private parties' reliance on maintaining the sale price of medical devices. However, the rejection of the constitutional challenges is expressly limited to the years (2015-2018) under litigation, for which the reasonable "sustainability" of the payback burdens on companies, made possible by the reduction of amounts due to the contribution under Article 8 of Decree-Law 34/2023, was deemed decisive. As a result of decision No. 139, this reduction is extended to all supplier companies regardless of their withdrawal from legal actions.