ok from the Council of State

Published on: 11/12/2020 11:37 AM

The Council of State says yes to the use of hydroxychloroquine as therapy for Covid-19, provided it is prescribed by a physician and confirms the drug agency’s decision to exclude the drug from reimbursement Ssn. With ordinance number 7097/2020, published today, Section III of the Council of State has accepted, as a precautionary measure, the appeal of a group of general practitioners and suspended the AIFA note of July 22, 2020 that prohibited the unauthorized prescription (that is, for a use not provided for in the package insert) of hydroxychloroquine for the fight against Covid 19.

“The persistent uncertainty about therapeutic efficacy hydroxychloroquine, admitted by Aifa itself to justify further evaluation in randomized clinical trials – read full-body ordinance – not reason enough at the legal level to justify the unreasonable suspension of its use in the national territory attending to doctors “.

And again: “The choice to use or not the drug, in a situation of doubt and contrast in the scientific community, on the basis of non-univocal clinical data, on its efficacy only in the initial stage of the disease, should therefore beAutonomy in decision-making and responsibility of the individual doctor in science and conscience.“and with the evident informed consent of the individual patient, without prejudice to the constant and careful monitoring of the doctor who prescribed it.

The order specifies that AIFA’s decision to exclude the unauthorized prescription of hydroxychloroquine from the reimbursement regime is not subject to suspension (or prior to litigation).