ROME. "We're...lucky: the bill is so enormous that no one can pretend not to see the problem anymore." This is the warning sounded by Gennaro Broya de Lucia, president of Conflavoro PMI Sanità, the Italian medtech association, at the Conference of Regions and Autonomous Provinces on the medical device payback mechanism. According to estimates for the period 2019-2024, excluding 2020 (the year of Covid), the overruns of regional caps would exceed €10 billion, with a potential burden of over €5 billion on supplier companies. This is a particularly severe impact for a sector made up of over 4.000 companies, the vast majority of which are micro, small, and medium-sized enterprises.
"We're not talking about an accounting adjustment, but a threat to the survival of companies," Broya de Lucia emphasizes. "Companies have been supplying supplies regularly ordered by healthcare facilities, without setting spending caps or managing regional budgets. Yet they're being asked to cover the overruns."
Payback, Conflavoro PMI Sanità further recalls, requires suppliers to contribute to the repayment of regional overruns in proportion to the value of supplies made, regardless of profits earned and in addition to taxes already paid.
"Having provided a hospital cannot mean having to finance it out of one's own pocket," the president blurts out. "If the Regions want to avoid the bankruptcy of hundreds of businesses, they must find funding through general taxation and ask the government for adequate resources to meet the real need for medical devices."
Conflavoro PMI Sanità is therefore calling for effective protection for SMEs and the elimination of the payback period. "We are not willing to negotiate how much businesses can still lose before closing. The mechanism is flawed: the more the Regions exceed their budget, the greater the burden is passed on to suppliers. This is not spending control, but shifting the consequences onto those who cannot protect themselves."
Broya de Lucia finally recalls Constitutional Court ruling no. 140 of 2024, covering the period 2015-2018: "The Court emphasized the temporary nature of the levy and the significant reduction in the amounts requested. That ruling is anything but a license to perpetuate the mechanism."
"Regions must choose whether to protect the business fabric of their territories or sacrifice it to cover the overruns. Public healthcare cannot be saved by bankrupting the businesses that supply it every day," he concludes.



