DM 7 September 2017 contains a detailed list of experimental medicinal products and medical conditions that may justify a request for an expanded access program.
In particular, it is now made clear that the expanded access may be sought for non-authorised products, as well as for medicinal products that are authorised in Italy or abroad but for a different therapeutic use, or which has been authorised abroad but not in Italy. Expanded access may be requested also for advanced therapy medicinal products (ATMPs).
This is a clarification in the scope of the former regulation. Similar considerations apply as to the subjects who may submit an application for an expanded access (single or group of physicians) or could benefit from an expanded access program (either named patients or a specific category or population of patients).
Also, the procedure for seeking approval from the Ethics Committee and the Italian Medicines Agency (AIFA) does not appear to be materially different from the former regulation, even if some changes have been introduced. It remains to be seen whether these formal changes will actually result, in practice, in a more simple, fast and straightforward procedure.
It is further worth noting that DM 7 September 2017 does not affect or interfere with the applicability of the other means of early access and in particular with Law No. 648/96, which is particularly important since medicinal products under such regime are supplied by pharmaceutical companies at market price and usually for treating larger populations than expanded access.