In brief

With order No. 7097 published on 11 December 2020, the Council of State upheld on a provisional basis the appeal filed by a group of general practitioners against the AIFA decision dated 22 July 2020 prohibiting the off-label use of the hydroxychloroquine in COVID-19 patients. In fact, the above-mentioned drug had initially been used in some experimental treatments against COVID-19 until the adoption of the AIFA decision, which had limited its use to those indicated in the relevant marketing authorization.


Pursuant to said order, the off-label use of the hydroxychloroquine has been reintroduced in the treatment of the initial phase of COVID-19, under the responsibility and strict control of the prescribing doctor. Until the definition of the trial, the AIFA decision to exclude the off-label use of hydroxychloroquine from the reimbursement regime continues to apply.