Non-profit clinical studies have a new source of regulation: the Ministry of Health November 30, 2021 decree (“Non-Profit Decree”), repealing the December 17, 2004 decree.
The Non-Profit Decree applies to:
- low-intervention clinical trials;
- observational trials;
- non-profit clinical trials provided that the following conditions apply:
- The trial is not aimed at industrial or commercial developments of drugs;
- The sponsor is a non-profit entity (if non-profit and profit sponsors coexist, then the trial falls outside the scope of the Non-Profit Decree);
- The sponsor does not have title to the marketing authorization of the trial drug, nor has any economic relationships (cointeressenze) with the marketing authorization holder;
- Data and results of the trial, as well as decisions over their publication, are exclusively of the sponsor.
The main novelty of the Non-Profit Decree is the possibility that sponsors of non-profit trials transfer the relating data and results, both in the trial phase and once the trial is completed, for registration purposes. Such transfer must be governed by a contract between the promoter and the transferee, the consideration of which is identified by a patent consultant jointly identified by the parties.
In the event of a transfer:
- The transferee becomes the data controller of the trial data;
- Costs associated with the trial, as well as fees due to AIFA and the competent ethics committees, which were waived in light of the non-profit status of the trial, must be paid; and
- The proceeds of the transfer are allocated in favor of the sponsor (50%), a non-profit trial fund (25%) and a an AIFA fund (25%).
The transfer must be notified by the promoter to AIFA, the competent Ethics Committee and the trial centers involved.
The Non-Profit Decree also sets forth that observational studies require prior approval by the competent ethics committee and that AIFA will adopt new guidelines for the classification and conduct of observational studies on drugs.
In case of any non-profit trial on a study drug, the pharmaceutical company having title to the drug must share with the sponsor an updated copy of the drug dossier and any safety data on the trial drug must be shared between the pharmaceutical company and the sponsor.
The Non-Profit Decree opens new opportunities for non-profit sponsors: it remains to be seen if there will be an appetite to purchase data by private entities and if a price set forth by an independent expert will be an effective mechanism.