Italy’s Medicines Agency AIFA has issued a technical‑scientific determination that restores the 5% cut on retail prices for a wide set of medicines reimbursed by the National Health Service.
The determination DTS 1/2026 updates the public prices of products listed in Annex 2 to determination 80/2025, with effect from 1 January 2026, by reapplying in full the 5% reduction first introduced in 2006 and later suspended on an optional basis via pay‑back. It gives operational effect to article 1, paragraph 395 of Law 30 December 2025 n. 199 (Budget Law 2026), which from 1 January 2026 removes the legal possibility for companies to suspend the 5% reduction.
Under the previous regime, marketing authorisation holders could avoid lowering list prices by paying an equivalent amount back to the regions, turning the 5% into an ex‑post contribution rather than an ex‑ante price cut. With that option deleted, AIFA recalculates ex‑factory and retail prices for all affected medicines and formalises the updated tariffs in Annex A to determination 1/2026.
AIFA states that the reinstated reduction applies from 1 January 2026, even though the act appears later in the Official Journal, and requires wholesalers and pharmacies to adjust their price lists. The agency also indicates that the measure will stay in place until a new legislative provision changes the framework.
For companies, the end of the suspension option removes flexibility in managing the 5% cut through pay‑back and is likely to trigger broad list‑price reviews and renegotiation of commercial terms with the supply chain where margins are already tight.
Source: Agenzia italiana del farmaco, AIFA
Link: Determinazione DTS n. 1/2026. Ripristino della riduzione del 5% del prezzo al pubblico dei medicinali di cui all’Allegato 2 della determinazione n. 80/2025 (Determination DTS no. 1/2026. Reinstatement of the 5% reduction in the retail price of the medicines listed in Annex 2 to determination no. 80/2025)
Date: 9 January 2026
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