Council of Ministers n. 15 of 10 January 2023.
PAYBACK DECREE FOR MEDICAL DEVICES
Urgent provisions on shelf procedures for exceeding the expenditure limit for medical devices (decree-law).
The Council of Ministers, on the proposal of the President Giorgia Meloni, of the Minister of Economy and Finance Giancarlo Giorgetti and of the Minister of Health Orazio Schillaci, approved a decree-law which introduces urgent provisions on shelf procedures for overcoming the expenditure ceiling for medical devices.
By way of derogation from the regulations in force and limited to the years 2015, 2016, 2017 and 2018, the text postpones to 30 April 2023 the deadline within which medical device supplier companies are required to fulfill the obligation to compensate for exceeding the spending limit placed at their expense, making payments in favor of the individual regions and autonomous provinces.
A protest resulted in Piazza Santi Apostoli a thousand people, managers and representatives of companies in the sector, on the day the CDM approved the extension for a measure that prevents medical device companies from sleeping at night. Without the extension, the companies would have had to 'return' around 2.2 billion euros by January. Once again the request is that the mechanism be eliminated 
altogether.
Interviewed by AboutPharmaduring the event, Massimiliano Boggetti, president of Confindustria medical devices commented: “Extending by four months doesn't change anything. It's a time you need to sit down and understand. We have been asking for the establishment of this table for years, which is promised but then essentially rejected by the State Accounting Office. Profitable negotiation for us? It simply means that the payback must be cancelled. There is no reason why industry should bear the costs that the Regions have incurred in treating their own citizens. It is clear that the only way for us is for the payback to be cancelled, finding the resources to cover the 2.2 billion”.
The device payback system had been established under the Renzi government, together with a spending review, to contain the health expenditure borne by the Regions, but had been applied since 2008 only to the pharmaceutical sector, never to the biomedical sector, until the Draghi government.
