Italian Medicines Agency Agenzia Italiana del Farmaco

Nisticò (AIFA): "In order to speed up access to medicines, it is essential to strengthen and qualify the Agency's personnel" - Nisticò (AIFA): "In order to speed up access to medicines, it is essential to strengthen and qualify the Agency's personnel"

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Nisticò (AIFA): "In order to speed up access to medicines, it is essential to strengthen and qualify the Agency's personnel"

Press release No 21/2024 - “The absence in the manoeuvre of measures for the strengthening and qualification of AIFA personnel risks to compromise the efficient functioning of the Agency, which regulates a market with a production value of EUR 50 billion through decisions on medicines’ prices and reimbursability’. This is how AIFA President Robert Nisticò expressed his regret for the deletion of provisions that, like others, did not find a place in the Budget Law 2025 printed text eventually, ‘despite the fact that the forthcoming application of the European regulation on HTA entails a greater commitment of our staff, but also more revenue”.

“Two measures - Nisticò continues- shall be considered indispensable for the proper functioning of the Agency and the speeding up of procedures: the one that provides for the reinforcement of the Agency’s personnel, in order to bring AIFA closer to the standards of other European regulatory agencies, whose employees almost double the current 600 workers of our Agency. The extension of the ‘single role’ to all AIFA's health officials which means both preventing the flight of health officials currently working at the Agency, as well as the possibility of finding new ones given that in view of absolute incompatibilities, at the moment they do not benefit from the exclusivity indemnity that, on the other hand, pertains to doctors employed by the NHS” Nisticò explains.

“In little more than six months, the post-reform new AIFA - he continues - has cleared more than 150 backlogged dossiers and speeded up approval times for new medicines. The current approval times are slightly better than the European average, but we are committed to reduce them even further in order to make innovative medicines available to citizens more quickly. This is an activity, that, as is perhaps little perceived externally, the Agency carries out in return for remuneration for each dossier completed, which produces an economic surplus that AIFA cannot, however, use to improve its own functionality. For this reason,” President Nisticò concludes, “the hope is that the provisions expunged from the manoeuvre may find a place in the parliamentary conversion”.


Published on: 31 October 2024

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