Healthcare: payback claims from businesses rise to 4 billion. The Government is considering countermeasures

From a despicable levy to a heavy surtax that has ended up presenting a hefty bill of around 4 billion to businesses in the healthcare sector that manufacture medicines and medical devices and work for the National Health Service. Here is the diabolical payback that forces companies to pay out of their own pockets half of the amount by which the spending caps – which are woefully underfunded and have therefore always been exceeded – are breached. But the figures are rising ever higher – the figure for medicines has more than doubled in the space of five years – so much so that the Constitutional Court may soon rule it unlawful, whilst the Government will attempt, in the next budget, to cushion the impact by raising the spending caps and promising to try to set a maximum ceiling for the payback as well, in order to ensure certainty. This is also because the excessive burden of the payback scheme risks adding fuel to the fire in the ‘war on medicines’ unleashed by US President Donald Trump with the new Most Favoured Nation clause, which aims to align the prices of American medicines with the lower prices in European countries, such as Italia.

The pharmaceutical payback figure, recently certified by the Medicines Agency for 2025 – the most recent year for which the accounts have been finalised – stood at 2.38 billion: five years earlier, in 2021, it stood at 1 billion and has since grown at a rate of 20–25 per cent annually, first to 1.26 in 2022, then to 1.6 billion in 2023 and finally to 2 billion in 2024, reaching 2.4 billion last year. The situation regarding the payback scheme for medical devices, introduced only in 2022, is more complex and convoluted: after charging companies 500 million for the three-year period 2015–2018, the colossal figure of 5 billion in payback for 2019–2024 remains outstanding, whilst for 2025 alone the ceiling has been exceeded by 2.89 billion, with an estimated payback to be borne by companies of 1.45 billion. This results in a total bill for all companies in the healthcare sector of nearly 4 billion just for last year. This is an unsustainable sum, and businesses are now awaiting a clear signal from the budget.

Pharmaceutical expenditure borne by the National Health Service (NHS) in 2025 reached almost 25 billion, growing by over 5 per cent and resulting in a breach of the spending cap on direct purchases (hospital medicines) of 4.76 billion, half of which – – 2.38 billion – was borne by pharmaceutical companies through the so-called ‘payback’ scheme. This is a record figure for this mechanism, which was introduced on an exceptional basis in 2013 to contain expenditure and has been stabilised since 2019; the Government now wishes to mitigate its impact. Having already raised the cap on direct purchases through last year’s budget, bringing it to 8.7 per cent of the National Health Fund (the total resources of the NHS), the aim now is to increase it by a further 0.20–0.25 per cent to reach practically 9 per cent, an increase which is, however, insufficient (by 2025, spending had reached 11.82 per cent of the health fund). The pharmaceutical sector should, however, also benefit from the overall increase in the Fund’s resources: Minister Schillaci has asked his counterpart at the Ministry of Economy and Finance (MEF), Giorgetti, for an additional 5 billion, a figure yet to be confirmed. However, measures are also being considered to spend all or nearly all of the resources from the 1 billion Fund for Innovative Medicines, which has over 500 million in unspent funds: the idea is to reduce these as much as possible, for example by increasing the amount allocated to antibiotics. The Government, together with the most ‘exposed’ ministries – Health, MIMIT and Foreign Affairs – is also working on a document setting out strategies to ‘curb’ Trump’s Most Favoured Nation (MFN) policy. Meetings have already taken place with the US Trade Representative and, as well as putting forward measures to ease the payback requirements, fast-track procedures for innovative therapies based on treatment outcomes are being considered, along with a commitment to standardise the often very lengthy authorisation times across the regions. These measures could be included in the consolidated pharmaceutical bill currently before Parliament. The underlying idea regarding the payback is also to set a maximum cap that cannot be exceeded: perhaps calculated on the basis of turnover (currently standing at 18 per cent), with Farmindustria having called at its last general meeting for it to be frozen at the 2023 level, when it reached 1.6 billion.

The situation for medical device companies remains far from clear: having paid 500 million in payback for 2015–2018, the companies have called for a definitive end to this mechanism, which risks stifling them. Whilst waiting to see what will happen regarding past liabilities – 5 billion in payback payments from 2019 to 2024 alone – the Department of Health is considering a further increase in the spending cap, following last year’s rise to 4.6 per cent of the National Health Fund: the idea is to raise it by a further 0.20 per cent. Also under consideration is the establishment – as with medicines – of a Fund for Innovative Medical Devices, starting with 330 million in 2027 and then rising to 500 million from 2028. These are all stopgap measures which, however, do not defuse the ‘payback’ time bomb, unless the Constitutional Court does so – to which the administrative judges have referred the question of the legality of this tax, which was originally introduced as a contribution ‘of an exceptional and solidarity-based nature’ and transformed ‘into a structural levy intended to finance healthcare expenditure on a regular basis’.