Italian Medicines Agency

AIFA is the national public body that regulates medicines for human use in Italy. AIFA governs pharmaceutical expenditure and follows the life cycle of the medicine to ensure its effectiveness, safety and appropriateness as well as access to the national territory.

Specifically, AIFA manages the authorisation processes for clinical trials, the manufacturing of medicines and active substances as well as inspection and pharmacovigilance activities. AIFA is also responsible for defining the reimbursement and supply regime for all authorised medicines, by negotiating the price of drugs charged to the NHS, after negotiations with pharmaceutical companies.

AIFA operates independently, transparently and efficiently, under the guidance and supervision of the Ministry of Health and under the supervision of the Ministry of Economy and Finance, in conjunction with the Regions - in particular through the Permanent Conference between State, Autonomous Regions and Provinces (hereinafter “Conference”) - the Istituto Superiore di Sanità, Scientific Institutes for Research, Hospitalisation and Healthcare, Patient Associations, Practitioners, Scientific Societies, the production and distribution system.

The Agency operates in strict compliance with the following principles and operating methods:

• Effectiveness and efficiency. AIFA pursues its reference objectives by constantly improving both the operating procedures and the services offered. The adoption of KPIs in the 2021-2023 Program is due to the full awareness by the AIFA structures of having to comply with measurable objectives, thus being able to be verified in their work based on qualitative and quantitative assessments.
• Transparency and communication. These are cardinal principles of good administration towards citizens and all stakeholders with respect to public action: transparency and communication are implemented both through accessibility of data and documents - without prejudice to the due balancing of subjective (e.g. privacy) or industrial relevant interests - and through clearly presenting the institutional choices and decisions affecting drug accessibility. This is to protect the rights of citizens, promote the participation of interested parties in administrative activities and encourage widespread forms of control over objectives, actions and use of public resources.
• Sense of belonging and responsibility. The AIFA structures are aware of being part of a national government body financed by public resources and dedicated to the public service, aimed at pursuing the fundamental individual right to health and the protection of public health through the availability and efficient use of medicines. All this takes place in the integrated context of the National and Regional Health Systems, with a deep sense of common responsibility shared by all employees, experts, consultants and collaborators who work for the Agency in various capacities.
• Confidentiality. The sensitivity and relevance of many of the data and information that AIFA processes in fulfilling its duties are overseen by strict protection of their confidentiality. Upon entering the service, each employee and collaborator signs a specific public declaration of interests and commitment to confidentiality, being informed of the obligations under the Agency's code of conduct and current legislation. Special precautions are taken so that the information available for office reasons is not used for private purposes, and situations or behaviours are avoided which may hamper or be prejudicial, albeit only potentially, to the correct fulfilment of AIFA's tasks, as well as to the public interests that the Agency manages.