A new enabling act provides a "once-in-a-generation" opportunity to reform Italy's pharmaceutical legislation, with a focus on tackling regional access delays and preparing for high-cost gene therapies.
In a press release titled Nisticò, AIFA President: "The enabling act on pharmaceutical legislation is an opportunity to improve access and equity of care", issued on 19 September 2025, the President of the Italian Medicines Agency (AIFA), Professor Robert Nisticò, has welcomed a new law giving the agency powers to lead a major regulatory overhaul. He described it as a critical opportunity to modernise the legislative framework governing medicines in Italy.
Professor Nisticò highlighted specific reform priorities. A key goal is to harmonise the "regional formulary system" to reduce access delays for new medicines, which he noted can currently vary by up to 180 days between Italy’s different regions. The reforms will also focus on creating a new "national horizon scanning unit" within AIFA to better prepare the health system for the budget impact of high-cost cell and gene therapies expected in the coming years. This signals a move towards more proactive financial and logistical planning for innovation.
No specific timelines for the reforms were announced, but the statement indicates that AIFA will now begin the internal process of drafting new policies under the authority of the "legge delega" (enabling act). The next steps will likely involve forming working groups and stakeholder consultations in early 2026. This move heralds a period of substantial change that is poised to reshape Italy’s regulatory requirements, pricing systems, and market access pathways.
Source: Nisticò, Presidente AIFA: “La legge delega sulla legislazione farmaceutica occasione per migliorare accesso ed equità delle cure”
English: Nisticò, AIFA President: "The enabling act on pharmaceutical legislation is an opportunity to improve access and equity of care"
Date: 19 September 2025
