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As known, with its two rulings No. 139/2024 and No. 140/2024 of 22 July, 2024, the Constitutional Court confirmed, on the one hand, the legitimacy of the Italian legislation on the payback for medical devices and, on the other hand, the right of all medical device companies, including those that did not waive their appeals before the Regional Administrative Court, to a 52% reduction on the payback amounts requested by Regions and Autonomous Provinces.
Notwithstanding several positions at the political-institutional level in favor of the abrogation of the payback system, so far no formal legislative initiative has been taken to this effect.
The Regional Administrative Court will now have to resume the pending proceedings for their decision on the merits, without prejudice to the possibility for the administrative judge to refer the matter to the Court of Justice of the EU, as requested by several appellants. In any case, medical device companies which obtained the suspension of the payment orders will not be required to pay the relevant amounts until the merits of the dispute are settled.
In the meantime, Regions and Autonomous Provinces will have to redetermine the payback amounts due on the basis of the aforementioned 52% reduction indicated by the Constitutional Court. The relevant measures may be challenged by the concerned medical device companies, possibly with additional grounds in the context of pending proceedings.
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