Recent legislative changes have introduced an important update to the regulatory framework governing animal research in Italy, with direct implications for xenotransplantation and substance abuse studies.
With the entry into force of Decreto-Legge n. 200 del 31 dicembre 2025 (Gazzetta Ufficiale, Serie Generale n. 302 del 31-12-2025), previous national restrictions affecting these research areas have been removed. The revised framework brings Italian legislation closer to the European standards set out in Direttiva 2010/63/UE, addressing a long-standing divergence from the regulatory approaches adopted in other EU countries.
The new provisions reopen the possibility to conduct experimental research that is essential for advancing knowledge in fields such as neuroscience, addiction, and transplantation medicine. These areas rely on well-regulated animal models to investigate disease mechanisms, evaluate therapeutic strategies, and support translational research aimed at improving clinical outcomes.
This regulatory update reflects years of engagement by the scientific and academic community and represents a meaningful step toward reinforcing Italy’s capacity to contribute to internationally competitive research. While the Decree-Law is currently undergoing parliamentary conversion and may still be subject to amendments, the present framework allows for continuity in research activities that are standard practice at the European level.
Our Society will continue to monitor the legislative process and will keep its members informed of any further developments.
For further details, the full text of the Decree-Law can be consulted on the Gazzetta Ufficiale della Repubblica Italiana website.
