Medicines: the budget bill provides for a reduction in payback, but only from 2028. Industry representatives: ‘Immediate action is needed’

There is a spending cap on pharmaceutical purchases made directly – the one that triggers the payback scheme – which rises to 9 per cent of the National Health Fund, committing an additional 292 million and thus providing some breathing space for businesses, albeit with the major drawback that the measure will only come into effect from 2028. There is also 160 million, again to reduce the payback, for all those companies investing in Italia, as well as a fast-track scheme for early access to treatments for serious illnesses for which there are no alternative therapies. In a nutshell, this is the package of measures for the pharmaceutical sector contained in the budget bill, on which businesses are reserving judgement for the time being, given that it does include a number of ‘important measures’ that continue ‘the positive path undertaken by the Government in recent years’. What is missing, however, is the ‘prospect of a structural solution to the reimbursement mechanism and a response to the extremely difficult scenario of the Most Favoured Nation. The resources are far from being sufficient to meet healthcare demand, and the 0.2 per cent increase in the spending ceiling will not come into effect until 2028. This limits the measure’s impact, particularly in the current international climate, which calls for strong and urgent measures to remain competitive’, emphasises Farmindustria President Marcello Cattani. He stresses that the resources in the budget are ‘insufficient to meet the challenges posed by the international context’. “As for the payback mechanism, we do not see a path that sets a limit and then allows for the structural increase needed to improve access and investment. It will, in effect, remain an unsustainable tax for the purposes of innovation,” adds the president of Farmindustria.

The payback figures – with companies bearing half the cost of exceeding the spending cap – speak for themselves: in 2021 it stood at just over 1 billion, before soaring to 2.384 billion in 2025, with an estimated bill of 2.5–2.6 billion this year. In practice, over the course of six years, the payback has risen by 130 per cent.

Farmindustria has, however, welcomed “the introduction of an early-access scheme that can make medicines for the treatment of serious and debilitating conditions available promptly. The measures envisaged to incentivise investment and reduce the payback period are also useful”. But for Cattani, it is essential “to bring forward to 2027 the 0.2 per cent increase in the direct procurement ceiling – currently scheduled only from 2028 – in order to have a greater impact on companies’ investments”. The ball is now in Parliament’s court.