Rules defined for transparent dialogue with associations. The AIFA Incontra project has also been redesigned for other stakeholders.

The Board of Directors has adopted the AIFA Ascolta Regulation (AIFA Listens), a dialogue space with the Agency reserved for patient associations, networks, and federations. This initiative forms part of a broader strategy to promote active stakeholder engagement and listening, to leverage their contributions to improve pharmaceutical care. It complements the already established ‘AIFA Incontra’ project, which focuses on other external stakeholders.     
Both regulations have been sent to the Ministries of Health and Economy and Finance for final approval.

“AIFA Ascolta is a project we deeply value,” said President Robert Nisticò, “as it marks the beginning of a structured and transparent relationship with patient associations. This will enable a meaningful exchange of knowledge and best practices, while catalysing faster and more effective action by the Agency on complex or critical issues brought to our attention. We wanted to create an exclusive channel to underscore AIFA’s commitment to being closer to patients’ needs. At the same time, through the parallel initiative ‘AIFA Incontra,’ we strengthen dialogue with all other stakeholders, fostering open and transparent collaboration on global issues that significantly impact public health and healthcare systems-such as driving innovation, ensuring fair and timely access to care, and addressing medicine shortages.”

AIFA Ascolta will consist of a series of meetings, preferably held at the Agency’s headquarters, designed solely for information purposes and not for decision-making. It aims to raise the Agency’s awareness of issues and challenges of particular concern to patients. Through this dedicated listening platform, patient organisations that submit a request and meet the requirements set out in the Regulation will have the opportunity to engage directly with AIFA’s President and relevant AIFA representatives, involved on a case-by-case basis depending on the topics discussed, to share questions, experiences, and concrete problems.

Meetings will generally be scheduled every four months, where possible grouping stakeholders by topic similarity. Requests considered most significant, at the initiative of the President, may subsequently be submitted to the Board of Directors or the Scientific and Economic Committee, which will evaluate whether to invite the proposing parties to a formal hearing.

A ‘Transparency Register,’ published on the Agency’s portal in the section dedicated to the initiative, will include the meeting calendar, topics and objectives, participants, the final report, and all related documentation. Transparency will also be reinforced by allowing other associations to attend as observers, provided they submit a prior request and demonstrate a direct and tangible interest.

While AIFA Ascolta is the Agency’s preferred channel for engaging with patient associations, the AIFA Incontra project is dedicated to scientific societies, pharmaceutical companies, research institutes, and industrial and consumer associations. AIFA Incontra has already been active since 2023, but has recently been revised to define its new scope.