The Italian government has implemented a significant procedural shift in pharmaceutical pricing by removing the option for manufacturers to suspend a mandatory 5% price reduction. This change was introduced under Articolo 1, comma 395 of the Legge di Bilancio 2026 (Budget Law 2026). The new legislation terminates the long-standing ability of companies to maintain higher public prices for reimbursed medicines in exchange for direct financial payments to regional authorities.
Previously, under the Legge 27 dicembre 2006, n. 296 (Law of 27 December 2006, no. 296), marketing authorisation holders could request the Agenzia Italiana del Farmaco (Italian Medicines Agency) to suspend a statutory 5% retail price cut. To avail of this, firms were required to pay the equivalent value – known as the 5% payback – into regional health accounts. This allowed companies to preserve list prices while fulfilling their financial obligations to the Servizio Sanitario Nazionale (National Health Service).
The resulting change, effective from 1 January 2026, replaces this voluntary payback system with an automatic and permanent 5% reduction across all pharmaceutical price lists. By abrogating the previous legal provisions, the government has structurally embedded a deflationary mechanism into the market. This shift marks a move from a flexible, negotiated cost-sharing model to a direct price-control doctrine.
Robert Nistico, the President of the Agenzia Italiana del Farmaco, oversaw the initial communication to the industry, confirming that the agency is now updating public price lists to reflect the mandatory cuts. The agency confirmed that pricing data are now being adjusted to ensure all reimbursed products comply with the updated legal thresholds. The measures are expected to streamline administrative processes by removing the need for annual payback applications and regional transaction monitoring.
The impact of this change will be felt through the immediate contraction of retail margins. Manufacturers can no longer use financial transfers to offset price erosion, potentially affecting long-term revenue projections and market access strategies. Furthermore, because these reduced prices are officially published in the Gazzetta Ufficiale (Official Gazette), they may trigger downward price revisions in other markets that use Italy as a benchmark for international reference pricing. Unlike the previous payback payments, which remained confidential and 'off-invoice', these transparent list-price cuts could have a cascading negative effect on global pharmaceutical revenues.
Source: Agenzia Italiana del Farmaco
Link: Budget Law 2026: the option to suspend the 5% legal reduction abolished
Date: 31 December 2025