Luca Li Bassi, Director General at the Italian Medicines Agency (AIFA), says it is a privileged perspective for regulators to better shape the decisional processes on medicines

Patients are the main stakeholders and beneficiaries of all drugs regulatory bodies, not only according to their institutional remit but primarily responding to ethical duty. Granting the broadest access to safe and effective medicinal products designed on patients’ health needs is the goal of the daily work of each competent authority, both at the centralised and local level. Thus, engaging patients in the regulatory processes concerning the approval and availability of treatments developed for them is fundamental.

On such basis, being part of the PARADIGM consortium is for the Italian Medicines Agency (AIFA) a unique opportunity to gain experience on the best approaches to involve patients in the whole drug lifecycle, whilst providing all the actors involved in the project with the regulatory perspective, so to better shape the recommendations and deliverables that will be developed at the end of these 30 challenging months of the initiative.

PARADIGM is an innovative platform of exchange, one that brings together cross-cutting competencies and the expert voice of patient representatives, which is critical to form and consolidate a patient-oriented culture.

The wide attendance at the September Patient Engagement Open Forum also witnessed how all the actors involved in the medicines lifecycle are increasing their commitment to take onboard patients and caregivers to benefit from their point of view. AIFA is among these actors and attended the PEOF representing the regulatory agencies together with the European Medicines Agency (EMA), providing insights and getting a useful overview of the status of implementation of the PE at the international level.

The Italian Medicines Agency is strongly committed to engaging in a productive dialogue with the patients; on a regular basis AIFA receives representatives from patient organizations in its periodical meetings held each month (called Open AIFA) dedicated to host delegates from the main stakeholder organisations, as well as individual representatives of the civil society, academia, HPCs, industry, etc. 

Moreover, according to the latest provisions of the pharmaceutical governance document issued by the Minister of Health in December 2018, the Italian Medicines Agency is now outlining a process to formally include patients in its decisional procedures.

With the same aim of being on the patients’ side in order to assure the widest and most sustainable access to medicines worldwide, Italy has been spending intensive efforts in the promotion of greater transparency in the medicines life cycle in order to make better policy decisions. AIFA took a leading role during the latest World Health Assembly held in May this year where the Resolution on Drugs Price Transparency was adopted from 192 out of 194 countries.

Patients are a value and can add value to the regulatory processes; they must be considered not simply as end-users but as main drivers of the medicine lifecycle.