Italian Government Agency Declares Use of Hydroxychloroquine for Off-Label Against COVID-19 Legal: Revolt of the Doctors?

Italian Government Agency Declares Use of Hydroxychloroquine for Off-Label Against COVID-19 Legal: Revolt of the Doctors?

As TrialSite recently reported, the anti-malarial drug, originally a key focus in the response against COVID-19, but shortly after, when US POTUS marketed the drug publicly, was the center of political and scientific controversy. A number of studies led to the conclusion that the drug wouldn’t be effective, and there were even calls that some cardiovascular risks were apparent for at least some cohorts. The drug, already approved by the U.S. Food and Drug Administration (FDA), has a well-known profile. Interestingly, a good number of studies evidenced some positive findings, but critics quickly pointed out flaws in those studies. The pro-hydroxychloroquine camp always pointed out that the drug should be used as either A) early onset of COVID-19 cases (not in hospitalization stages as many studies had done) or even B) as PrEP (pre-exposure prophylaxis). Interestingly, the global research community recently opted to keep the drug at the center of investigational interest with the ANTICOV study in Sub-Saharan Africa, evidencing the continued interest in the drug as an early-stage treatment. That is, at least in the developing world. Now, the Italian Council of State reportedly issued a declaration that the drug can be used as a treatment for COVID-19. Interestingly, the government there in this Southern European nation will not reimburse. This move apparently came after physicians organized and issued a powerful petition. Does this represent the beginnings of additional actions in other European nations, or is this merely an isolated incident in what is known to be a politically dynamic and diverse Mediterranean nation?

In this recent action reported on by Peter D’Angelo writing for French media France Soir, the Italian Council of State does so as a “precautionary” measure and counters the Italian Medicine Agency recommendation issued on July 22, 2020, which previously prohibited even private physicians from prescribing the anti-malarial drug for purposes of treating COVID-19 off-label. This news was verified by multiple sources, including Huffington Post and La Repubblica

The order states: “The continuing uncertainty about the therapeutic efficacy of hydroxychloroquine, declared by AIFA to justify its continued evaluation, evaluation in randomized clinical trials—is not sufficient legal reason to justify the unreasonable suspension of its use on the Italian territory by treating physicians.”

At Physicians’ and Patient’s Discretion

As is the case with relevant off-label use in the United States the Council of State’s edict apparently has been influenced by the provider community when they declared:

“The choice of whether or not to use the drug, in a situation of doubt and opposition in the scientific community, on the basis of non-unequivocal clinical data, on its effectiveness at the initial state of the disease only, must therefore be handed over to the decision-making autonomy and responsibility of the individual physician in science and conscience and with the obvious informed consent of each patient, without prejudice to the constant and attentive supervision of the doctor who prescribe it.”

The Beginning of a Physician’s Revolt?

Apparently, providers in Italy started organizing, drafting and submitting a petition, following bans on off-label use of the generic drug for COVID-19.

What is the Italian Council of State?

Known as the Consiglio di Stato (Council of State), this legal-administrative consultative body exists to ensure that various public administrative laws and actions are legal in the nation of Italy. This council has jurisdiction on acts of all administrative authorities, except where such authorities lack discretionary power: in those cases they are matters of civil law. The council derives its authority and powers from several articles in the Constitution of Italy.