Italy has formalised two AIFA dialogue routes that convert stakeholder engagement into scheduled, transparent procedures. The change is a governance measure rather than a pricing or reimbursement reform, but it creates a clearer channel for raising access-to-medicines and pharmaceutical-assistance issues with the national agency.
The Italian Medicines Agency (Agenzia italiana del farmaco, AIFA) announced on 8 April 2026 that the regulations for AIFA Listens (AIFA Ascolta) and AIFA Meets (AIFA Incontra) had been definitively approved and published in the Official Gazette (Gazzetta Ufficiale).
AIFA Ascolta is designed for patient associations, networks and federations. AIFA says the route will allow these groups to raise complex issues, share experience and contribute to improving pharmaceutical assistance, including on access to medicines and protection of the right to health.
AIFA Incontra is the parallel mechanism for institutional, scientific, industrial and civic stakeholders working in the pharmaceutical and health sectors. It allows AIFA to collect qualified information and gives stakeholders a formal setting to present observations and proposals.
Meetings under both routes will normally take place every four months. AIFA states that the meetings will be for information-gathering only and will not have decision-making status. That limit keeps the procedures outside formal assessment or negotiation pathways, while still giving stakeholders a recognised route into agency-level discussion.
The regulations also establish a transparency register for both initiatives. AIFA will publish key information on its website, including the subject and purpose of meetings, participants, the final report and related documentation.
The new procedures place patient and stakeholder dialogue on a more formal footing at a time when AIFA is also adjusting its internal governance through the unified Scientific and Economic Commission. The main effect is likely to be earlier and more visible escalation of policy, access and service-delivery concerns, rather than a direct change to individual access decisions.
Source: Italian Medicines Agency, AIFA
Link: Approvati i Regolamenti di AIFA Incontra e AIFA Ascolta (Regulations for AIFA Meets and AIFA Listens approved)
Date: 8 April 2026
