The Italian government has enacted Legge 30 dicembre 2025, n. 301 (Law of 30 December 2025, no. 301), more commonly known as the Legge di Bilancio 2026 (Budget Law 2026). This legislation implements several fundamental changes to the governance of pharmaceutical expenditure, moving away from temporary financial offsets towards permanent price controls.
A primary change involves the abolition of the voluntary suspension of the 5% price reduction for reimbursed medicines. Previously, under a 2006 framework, manufacturers could maintain higher list prices by paying an equivalent 5% payback to the Regions. The resulting change, effective from today, terminates this option and makes the 5% reduction automatic and permanent across all pharmaceutical price lists. This shift structurally embeds a deflationary mechanism that will be reflected in the Gazzetta Ufficiale (Official Gazette), potentially affecting international reference pricing.
The law also introduces a new competitive doctrine for biotechnological medicines approaching patent expiry. In the absence of available biosimilars, the Agenzia Italiana del Farmaco (Italian Medicines Agency) is now empowered to call in marketing authorisation holders to either renegotiate prices or apply an automatic 20% discount. Furthermore, for non-biological medicines where equivalents are present, the law mandates a new competitive bidding structure: the first-place winner in a public tender is allocated 55% of the market share, followed by 30% for the second and 15% for the third.
Other notable measures include a €140 million annual reduction to the Fondo per i farmaci innovativi (Fund for Innovative Medicines), which has been redetermined at €1.16 billion. Conversely, pharmaceutical expenditure ceilings have been slightly increased – by 0.20% for direct purchases and 0.05% for retail pharmacy spending – to help mitigate regional budget overruns.
These measures are intended to stabilise the national health budget by enforcing transparent price cuts and fostering competition. While the increase in expenditure ceilings provides some relief, the mandatory price reductions and the shrinking of the innovation fund will likely heighten fiscal pressure on the industry.
Source: Gazzetta Ufficiale della Repubblica Italiana
Link: Law of 30 December 2025, no. 301
Date: 30 December 2025