The Italian Medicines Agency started a new dialogue with stakeholders, inspired by the recent regulatory trends aimed at open government and at establishing a public agenda of meetings based on the combination of “right to speech/duty to listen”.
The Chairman of the Board of Directors Giorgio Palù and the Interim DG Anna Rosa Marra presented the initiative at the AIFA headquarters.

“AIFA Incontra is an open forum to foster dialogue between AIFA and its interlocutors within the scope of the Agency’s mission and in the perspective of its upcoming reform – said Giorgio Palù - In the biomedical-pharmaceutical field, crucial for the National Health Service and for the international scientific competition, able to promote the economic and technological development of the country, the commitment of the Agency will be increasingly aimed at guaranteeing universal access to care, reducing bureaucratic time that hinders the early clinical use of advanced molecular therapies, and giving greater support to research and innovation. For this reason, AIFA considers it essential to engage constructively with the various stakeholders: Universities, research organisations, scientific societies, pharmaceutical companies, industrial associations and consumer and patient associations”.

“It is a simplified channel to improve the communication process and virtuous collaboration between AIFA and its stakeholders, while respecting the roles and autonomy and independence of the Agency. – said Anna Rossa Marra - The recognition of the various stakeholders and their increasingly active involvement on issues concerning medicines and health are principles that AIFA intends to promote, in line with what is happening at the European level. In the recent legislation on Health Technology Assessment, for example, there is a Network of Stakeholders, and the role of patients and healthcare professionals is well highlighted in the proposal for a new regulation in the context of the revision of the current European pharmaceutical legislation”.  

As an expression of the Agency’s autonomy and independence, the regulation of “AIFA INCONTRA”, which will be published on the Agency’s portal, sets out principles such as the obligation of compatibility of activities with AIFA’s operating rules and with the regulation on conflict of interests; the inadmissibility of requests related to procedures under evaluation of medicines both at national and European level; the non-binding nature of informal hearings, which will be devoid of a verbatim report; the obligation for applicants to declare interests.

The meeting agenda will be published in a dedicated section of the AIFA website, along with the contributions (reports-presentations) by the stakeholders, if the request for a hearing is positively assessed, in compliance with the principle of transparency.