Medical devices: the budget confirms the payback scheme, with a bill of 12.5 billion for businesses

“To date, with the Budget Bill, the Government is not only leaving the payback mechanism intact, but is also making sums that are unsustainable for businesses payable within a very short timeframe: this is unacceptable and we will not remain silent.” The president of Confindustria Dispositivi Medici, Fabio Faltoni, strongly criticised the budget measures presented by the Government during the public assembly “MedTech for Italia’s health and economy” held in Rome, repeatedly referring to “disbelief and bitterness” because the cost to businesses is truly exorbitant: 12.5 billion euros from 2019 to 2029, “which jeopardises investment, employment, production capacity and, in many cases, the very survival of companies”.

According to Confindustria DM, the problem is structural: between 2019 and 2025, no region managed to stay within the spending cap for medical devices, and in 2025 as many as 14 regions exceeded it by more than 50 per cent. Meanwhile, as Faltoni pointed out, “more than one in two businesses has increased its debt: it is no longer sustainable to ask businesses to bear the cost of these overspends retrospectively; we expect the Government to set out a concrete plan to phase out this mechanism”.

In a statement, the Minister for Enterprise and Made in Italy, Adolfo Urso, points out, however, that “a first step” has been taken in the Budget Bill: the ceiling for the purchase of medical devices has been raised from 4.6 per cent to 4.7 per cent, providing an additional 146 million per year, and provision has been made for the State to contribute towards covering part of the costs borne by companies, with 350 million per year from 2028 to 2031, totalling 1.4 billion. But the president of Confindustria DM is quick to clarify: “Presenting the state’s 1.4 billion contribution as a subsidy to companies is misleading: this sum is intended to shore up regional finances and covers less than a third of the 4 billion in payback for the 2019–2023 period alone. Failing to address the mechanism means accepting that the regions will exceed their budgets, which businesses will then have to repay.”

On average, the payback bill amounts to 1.5 billion euros each year and, as if that were not enough, Faltoni adds, “the first instalment, relating to 2019, must be paid by 30 July 2027: this is unacceptable”. “We will not remain silent,” continues the president of Confindustria Dispositivi Medici, “we are calling on Parliament to make fundamental changes to the budget and to scrap the measures that affect businesses. We appeal to the Government to find a structural solution by 31 December 2026 that definitively overcomes the payback mechanism. There is still time to correct the course and provide the sector with a sustainable and certain framework, in the interests of businesses and the stability of the National Health Service”. Overcoming the payback mechanism, setting spending caps consistent with actual needs, incentivising and protecting innovation, and developing an industrial policy for medtech: these are the four priorities that Confindustria Dispositivi Medici has placed at the centre of the General Assembly and brought to the attention of the institutions.

This view is also shared by the vice-president of Confindustria responsible for the Research Centre, Lucia Aleotti, who was present at the Assembly’s proceedings. According to her, “the time has come to sit down at the table and consider whether it is right to continue asking for emergency measures for sectors that are the driving force behind the Italian economy, or whether it might also be ethically correct to consider moving beyond this”. For Aleotti, “we must not look solely at what the ‘payback’ brings into regional coffers: this is the wrong way to think”. Instead, it is right “to regard the life sciences as a key sector that can contribute far more to our economies than what is currently generated by the payback, an inappropriate tax on businesses”. The vice-president of Confindustria therefore highlights the need for an industrial policy capable of supporting competitiveness, particularly in light of the strategies implemented by the United States and China. “We have a Europe which, by constantly talking about itself as a single market, has become nothing but a market,” observes Aleotti, “whilst it is urgent to place the competitiveness of businesses at the heart of European policies.” Finally, an appeal to the manufacturing sector: “We must not cut back on investment; we must not miss the boat when it comes to new technologies, artificial intelligence and digitalisation. We cannot afford to fall behind, and we do not want to fall behind.”