In an analysis published today on Formiche, our sister website, Stefano da Empoli and Thomas Osborn warn that the real risk is not to penalise companies, but to address the structural drivers behind rising expenditure.
Decoding the news: In a wide‑ranging interview with La Repubblica, AIFA President Robert Nisticò previewed the possible introduction of a new “safeguard clause” requiring automatic price renegotiations based on companies’ profit margins.
The authors on Formiche note that the debate resurfaces at a moment when:
- Pharmaceutical spending reached €37.2 billion in 2024.
- All regions exceeded their hospital spending caps, resulting in a total overshoot of €4 billion.
- Draft budget documents foresee only a marginal increase in spending ceilings from 2026.
By the numbers:
- +197%: growth of hospital pharmaceutical spending, 2008–2024.
- €10.2 billion: private pharmaceutical spending.
- 1 in 3: older adults taking 10 or more medications daily.
- 5%: share of the National Health Fund devoted to prevention.
- €2 billion: estimated payback burden on companies.
- €49 billion: pharmaceutical exports in 2023.
- Up to €4 billion: potential impact of new U.S. tariffs on Italian pharma exports.
What they’re saying:
- “Drug prices in Italy are the lowest in Europe — this is a structural fact that should guide the debate. If we continue to focus only on the price of individual medicines, we completely overlook the real picture: spending is rising because of demographic pressure, ageing, multiple chronic conditions and — above all — the frequent inappropriate use of treatments.”
- “That’s where the major costs arise, not from price lists that are already extremely low compared to other major European health systems.”
- “Italy’s population is ageing rapidly and is already among the oldest in the world. This makes the country one of Europe’s largest consumers of pharmaceuticals. It is no surprise that one in three older adults takes 10 or more medicines every day.”
- “The problem is that many of these therapies overlap, interact poorly or are not monitored consistently, creating new clinical risks and avoidable costs. This stems from a system oriented toward hospital care rather than territorial management, prevention, and assessing real patient needs.”
- “The lack of prioritisation of prevention is a collective failure. Today, Italy invests just over 5% of the National Health Fund in prevention — one of the lowest shares in the European Union. Yet every euro invested in primary prevention yields between 2 and 16 euros in overall savings.”
- “Ignoring this means locking the system into structurally higher expenditure and declining quality of care. Measures like the ‘safeguard clause’ risk addressing the issue from the wrong angle, penalising companies instead of fixing system failures — from payback pressures to regional fragmentation, from bureaucratic uncertainty to long timelines for market access.”
Between the lines: The authors highlight a paradox: Italians often forgo care due to long waiting lists, a lack of information, or the overall cost of treatments, but do not forgo purchasing medicines.
The big picture: Italy’s pharmaceutical sector is competitive and expanding, but new price controls, combined with regulatory uncertainty and international trade tensions, risk undermining its ability to grow.
- A comprehensive reform is needed, they argue — “a full overhaul of pharmaceutical governance that accounts for every factor. None excluded.”
