The Agenzia Italiana del Farmaco (Italian Medicines Agency) has formally opened the collection phase for the retail pharmacy payback covering the first half of 2025. The announcement, Avvio del procedimento di Pay-Back convenzionata 1,83% e della procedura di retrocessione – 1° semestre 2025 (Start of the procedure for retail pharmacy payback 1.83% and the rebate procedure – 1st half of 2025), confirms that companies must now simultaneously manage the statutory 1.83% levy and a newly introduced rebate procedure.
The previous situation involved a straightforward calculation based on the retail price of medicines reimbursed by the Servizio Sanitario Nazionale (National Health Service). However, the resulting change requires firms to account for the ‘procedura di retrocessione’ (rebate procedure). This addition stems from recent legislative shifts, notably Legge 213/2023 (Law 213/2023), which reclassified several high-cost medicines from hospital-led direct distribution to the retail pharmacy channel.
As these drugs carry confidential discounts negotiated during the reimbursement process, the agency has bundled the collection of these rebates with the standard 1.83% payback. Consequently, the calculation is no longer a uniform flat rate but a variable figure that factors in product-specific price-volume agreements.
Robert Nisticò, the Presidente (President) of the Agenzia Italiana del Farmaco, oversaw the activation of the Spending-Pha platform for this cycle. The data used for these calculations must reflect all pharmaceutical movements recorded between 1 January and 30 June 2025.
The measures are subject to a strict implementation timeline. Marketing authorisation holders must verify their final balances and complete payments to individual Regions by 31 December 2025. Evidence of these transactions must then be uploaded to the agency's portal no later than 12 January 2026.
This evolution in the payback doctrine is expected to increase the administrative burden on corporate finance departments. By centralising these different financial flows, the regulator aims to ensure that the cost savings achieved through confidential negotiations are effectively recovered now that these medicines are dispensed through the retail network.
Source: Agenzia Italiana del Farmaco, AIFA
Link: Start of the procedure for retail pharmacy payback 1.83% and the rebate procedure – 1st half of 2025
Date: 16 December 2025