The evolution of dialogue and relations between AIFA, clinicians, scientific societies, patient associations, and civic activism organizations

Introduction: This document aims to provide an overview of the interactions between the Italian MedicinesAgency (AIFA) and various stakeholders, placing them in the context of the European and national regulatoryframework, with particular reference to Regulation 536/2014 and HTA Regulation 2021/2282.Methods: Through the efforts of a multidisciplinary working group, areas for action and improvement, operationalcriteria, and tools aimed at optimizing the decision-making process, ensuring greater transparency, andpromoting more effective collaboration between the parties involved, have been identified.Results: The recommendations included in the document comprise the adoption of thematic round tables anddigital platforms for dialogue, the appropriate management of conflicts of interest, and the need for continuousmonitoring of interactions. Furthermore, the document emphasizes the importance of a systemic approachthat considers the needs of all stakeholders involved, while promoting the centrality of the patient as the mainbeneficiary of healthcare policies. The concrete application of these measures represents a fundamental steptowards a more equitable, transparent, and sustainable healthcare system in the long term. Finally, the paperhighlights the opportunity to promote constructive and ongoing dialogue between institutions and stakeholdersthrough innovative technological tools and inclusive participatory processes, in order to consolidate a high-levelhealthcare governance model.