In brief

On 25 May 2023, the Senate approved in final form the Law converting Law Decree 34/2023, which provides a 52% discount with respect to the payback amounts requested by the Regions and Autonomous Provinces to those medical device companies which have not started litigation on the matter or which waive any ongoing litigation.

Key takeaways

During the conversion process, some minor formal amendments were made by the parliamentary committees, including the clarification that the timely payment of the reduced payback amounts is ascertained by the Regions and Autonomous Provinces through the publication in their bulletins and institutional websites of specific provisions. Following their publication, the same provisions shall be communicated to the Administrative Court of the Lazio Region to determine the cessation of existence of the disputes and the compensation of legal costs.

With regard to the possibility for medical device companies to deduct the VAT from the payback amounts, the Law specifies that the determination of the VAT is to be made by the Regions and Autonomous Provinces by calculating the invoices issued by the companies to the National Healthcare System and taking into account the obligation to indicate separately the amount of the cost of the good and the cost of the service.