Limited to the emergency period, in order to improve the ability to coordinate and analyse the available scientific evidence, the Italian Medicines Agency (AIFA) has the possibility to have access to all the data of the experimental studies and compassionate uses of medicinal products for patients with COVID-19. Furthermore, it is provided that, limited to the emergency period:
(i) the study protocols are subject to a preliminary assessment by AIFA’s Technical Scientific Commission (CTS), which also communicates the results to the Technical Scientific Committee of the Crisis Unit of the Department of Civil Defence;
(ii) the National Institute of Infectious Diseases Lazzaro Spallanzani’s Ethics Committee in Rome is the only national ethics committee for the evaluation of clinical trials of medicinal products for human use and medical devices for patients with COVID-19 and expresses the national opinion, also based on the evaluation of AIFA’s CTS;
(iii) the Spallanzani Ethics Committee acquires from the promoters all the protocols of the experimental studies on medicines of phase II, III and IV for the treatment of patients with COVID-19, as well as any amendments and requests from doctors for compassionate uses;
(iv) the Spallanzani Ethics Committee communicates its opinion to AIFA’s CTS, which publishes the same through its institutional website.
It is expressly provided that, after having heard the opinion of the Spallanzani’s Ethics Committee, AIFA must – within 10 days from the entry into force of the decree (i.e. 27 March 2020) – publish instructions indicating the simplified procedures for the aforementioned data acquisition as well as the procedure in order to join the studies,.
In closing, the article also provides that no new or additional expenditure by way of public finance is necessary for the purposes of its application.