The Italian Official Journal has published new legislation on 2nd November 2017 regarding the compassionate use program in Italy (Ministerial Decree September 7, 2017). In the EU, compassionate use programs can be used to gain early access to medicinal products. The regulations, which repeal the Decree 8 May 2003, will enter into force 30 days from the date of publication.
The new decree contains important updates to rules including:
- Expanded access programs intended to treat orphan drugs or rare cancers may now be requested using results from Phase I clinical trials under new and special conditions
- Expanded access can be requested for products that are either non-authorised or authorised for a different therapeutic purpose in Italy or abroad. In addition, expanded access can be requested for advanced therapy medicinal products (ATMPs)
- Pharmaceutical companies intending to activate an expanded access program in Italy must inform AIFA on the date of activation and termination specifying the medicinal product that they wish to make available free of charge
- The introduction of a new submission procedure with the request to be submitted by the physician(s) to the Ethics Committee (EC) only; then the opinion issued by the EC will be electronically forwarded to AIFA within 3 days as of the opinion date
- The inclusion of the Pharmacovigilance requirements provided in Ministerial Decree 30 April 2015