The Consiglio dei Ministri (Council of Ministers) has approved the Schema di Disegno di Legge delega per la redazione del testo unico della legislazione farmaceutica (Draft Law for the Single Text of Pharmaceutical Legislation). This legislative mandate authorises the government to reorganise, harmonise, and simplify more than 700 individual norms and approximately 100 different laws that currently govern the sector.
The initiative marks a transition from a decades-old system of reactive, emergency-based amendments to a coherent national strategy. Under the current situation, the regulatory environment is hindered by bureaucratic complexity that often delays patient access to new therapies. The resulting change will consolidate these rules into a definitive ‘Single Text’ designed to provide legal stability and administrative efficiency.
Orazio Schillaci, the Ministro della Salute (Minister of Health), proposed the bill alongside Marcello Gemmato, the Sottosegretario di Stato al Ministero della Salute (Undersecretary of State at the Ministry of Health). Marcello Gemmato, who has championed the reform, noted that the data collected during the drafting process will allow for a total digitisation of drug monitoring, integrating prescription and stock information in real time.
The reform is a significant legislative doctrine rather than a periodic update. It requires the Ministero della Salute to work in coordination with the Ministero dell’Economia e delle Finanze (Ministry of Economy and Finance) and the Ministero delle Imprese e del Made in Italy (Ministry of Enterprises and Made in Italy). The government is mandated to adopt the necessary implementing decrees to complete the consolidation by 31 December 2026.
This restructuring is expected to significantly reduce administrative friction and create a more predictable environment for global research and manufacturing investments. By simplifying the path to market and modernising the governance of drug expenditure, the reform will likely enhance the country’s competitiveness within the European life sciences sector.
Source: Ministero della Salute, Ministry of Health
Link: Consolidated Act on Pharmaceutical Legislation
Date: 18 September 2025