The transfer of Data of non-profit clinical trials to pharmaceutical companies is now allowed in Italy
Published on 5th Apr 2022
Previous restrictions on data transfer are lifted, enabling more investment - some clarification on practical issues is awaited
In the framework of the Italian reform on clinical trials, a new decree of the Ministry of Health came into force on 3 March 2022 in order "to facilitate and support the implementation of non-profit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of non-profit trials for registration purposes" (decree dated 30 November 2021, published on the Official Gazette on 19 February 2022).
This is a very important step taken by Italy: it will now be possible for pharmaceutical companies to use the data and the results of clinical trials carried out by non-profit organisations for registration purposes. The previous provision (decree no. 17/2004) had prevented the transfer of the above data and resulted in considerable limitation in investments by pharmaceutical companies in Italy.
The new law
The new law provides, among other things, that:
- non-profit clinical trials (falling under the definition of art. 2, paragraph, 2, n. 2 of Regulation (EU) 536/214), shall also meet some specific requirements such as: (i) not being aimed at the industrial or commercial development of medicinal products; (ii) the promoter must be a research or public health organisation, a non-profit entity or other as indicated in details in the decree; (iii) the promoter must not be the marketing authorisation (MA) holder of the medicinal product under trial and have economic interests with the MA holder; (iv) the promoter must be the exclusive owner of the data and results of the trial;
- non-profit observational studies (falling under the definition of art. 2, paragraph, 2, n. 4 of Regulation (EU) 536/214) shall also meet the four requirements mentioned above for non-profit clinical trials; within 30 days from the entrance in force of the decree, AIFA shall issue the new guidelines for the classification and conduct of the studies on approved medicinal products;
- if the data/results of non-profit clinical trials to be transferred are to be used for the registration of one or more medicinal products, in Italy or in another state, the sponsor or the transferee of the data is obliged to bear and reimburse all direct and indirect costs related to the trial together with AIFA's fees and those of the competent ethics committees;
- the value of the data/results to be transferred is to be established, in view of their expected commercial exploitation, by a patent expert (registered in the register of consultants in industrial property or with the Bar Association) appointed jointly by the transferor and transferee;
- the transfer of the data/results is governed by a specific agreement between the sponsor and the transferee, which must be sent to AIFA and the competent ethics committees; and (iii) as a result of the transfer, the transferee takes over all the responsibilities for the processing of data carried by it, as new data controller, after the transfer (on this point, in particular, it is hoped that indications will be given to clarify the many doubts the provision raises from a privacy perspective).
Osborne Clarke comment
How the new law will be applied in practice will require some clarification: there is some doubt as to the construction of some of its provisions. In addition, guidance by the Italian Medicines Agency, AIFA, on certain points is awaited.
If you would like to discuss any of these issues further, please do not hesitate to contact the authors or your usual Osborne Clarke contact.