The decree of 30 November 2021 of the Italian Ministry of Health concerning “Measures intended to facilitate and support the conduct of non-profit clinical trials of medicines and observational studies and to govern the sale of non-profit trial data and results for registration purposes, pursuant to art. 1.1.c), of legislative decree no. 52 of 14 May 2019”, which abrogates the ministerial decree of 17 December 2004 and will come into force on 6 March, has been published in Italy’s Official Journal no. 42 of 19 February 2022.

The decree applies, pursuant to article 1, to non-profit clinical trials, to low-intervention clinical trials and to observational studies. It recalls the article 2.2 of Regulation (EU) no. 536/2014 which came into force on 31 January 2022, for the relative definitions, and also sets out the requirements relating to non-profit clinical trials.

The decree envisages the sale of non-profit trial data and results, both during and after completion of trials, for registration purposes, specifying that, after the sale, the specific provisions and special terms envisaged for the non-profit trials will no longer be applicable.

Sales shall be regulated by a contract between the sponsor and the assignee that establishes the agreed amount for the purchase of the data and the results, which is to be set with the assistance of a registered patent attorney.

In the event of a sale, the sponsor of the trial or the assignee is required to (i) cover and reimburse all direct and indirect expenses associated with the trial, (ii) pay the fees due to AIFA (the Italian medicines agency) and the relevant ethics committees, and (iii) allocate a fair valuation of the sale that has taken place to support the non-profit trials.

Furthermore, the sponsor shall transmit to AIFA, to the relevant ethics committee and to the trial centres involved an official notice informing them that the sale of the data and/or results of the non-profit trials has taken place.

Art. 3 also establishes that in case a non-profit trial is requalified as a for-profit trial by its sponsor, the sponsor is required to cover and reimburse all direct and indirect expenses associated with the trial, to pay the fees due to AIFA and the relevant ethics committees and to reimburse funding received for the trial until that time.

Finally, the decree sets out additional provisions envisaging special terms for non-profit clinical trials (art. 2), the application of the provisions as per art. 72 Reg. (EU) 536/2014 regarding co-sponsorship also for non-profit trials and low-intervention clinical trials (art. 4) and the adoption by AIFA of the new guidelines for the classification and conduct of observational studies on pharmaceuticals (art. 6).