INTERVIEW : Can doctors prescribe Plaquenil ? Me Krikorian responds.

INTERVIEW: After the press release of May 27 from the Ministry of Health, several of our readers asked us the following question: how to interpret this press release? Can doctors prescribe Plaquenil or not and if so in what context? We asked the questions to Me Philippe Krikorian who answers us:

"In the current state of things, there is, from my point of view, in accordance with the order of the summary judge of the Council of State of April 22, 2020, no legal obstacle which would prevent the doctors from prescribing this drug. "

This sheds light on the details:

FS: Me Krikorian, what does the law say to date?

PK: the legislator (article L. 5121-12-1, I of the Public Health Code) says:

“I.-… In the absence of a temporary recommendation for use in the indication or the conditions of use considered, a pharmaceutical specialty cannot be the subject of a prescription that does not comply with its marketing authorization. that in the absence of an appropriate drug alternative having a marketing authorization or a temporary authorization for use and provided that the prescriber deems essential, in the light of the data acquired from science, the use to this specialty to improve or stabilize the clinical condition of his patient. "  

In the order of April 22, 2020, the judge in summary proceedings begins by recalling the text of the applicable law referring to article L. 5121-12-1, I of the Code of Public Health (CSP):

“…Furthermore, these recommendations do not in any way prevent, as the High Council recommends, the inclusion of patients in existing or future clinical trials, necessary to have the data allowing, if necessary, much prescription broader, on the basis of article L. 512112-1 of the public health code, of hydroxychloroquine to patients with covid-19 "

And resumes in paragraph 7 the law: “… Its administration, if it can be done by city doctors, thus supposes not only the respect of particular precautions, but also a specific follow-up of the patients, in particular on the cardiac level. Finally, given the hopes aroused by the first results made public by a team from the hospital-university institute Méditerranée infection, a sharp increase in sales of Plaquenil in pharmacies was recorded, revealing tensions in supply of certain pharmacies and the difficulties in obtaining it for patients needing this specialty in the indications for its marketing authorization. "

So on April 22 with retroactive effect from March 25, 2020, doctors can prescribe freely as the right has been conferred on them by the legislator within the framework of their mission of doctor.

FS: what did the Minister of Health write on May 27, 2020?

PK: the press release of the Minister of Health of May 27, 2020 publishes the following elements: “… The decree published on May 27 draws once again the conclusions of the opinion of the HCSP and modifies the derogatory conditions of prescription of hydroxychloroquine: whether in town or in hospital, this molecule should not be prescribed for patients with Covid-19… "

FS: is this a ban or a recommendation supported?

PK: the words used by the Minister of Health are: "whether in the city or in the hospital, this molecule should not be prescribed for patients with Covid-19". The "must not be" has been interpreted by the media and therefore by doctors and the French as a "prohibition to prescribe".

In reality, this is not as clear as that:

•  The Minister of Health does not have the power of prohibition, which alone is conferred on the legislator (article L. 5121-12-1, I CSP).

• However, by the effect of the jurisprudence of the Council of State relating to flexible law (CE Ass. March 21, 2016, Société Fairvesta; Société Numéricâble), the Minister has latitude to "issue opinions, recommendations, "warnings or positions" which are not decisions as can be a decree and / or an order.

• The Minister of Health in making use of the syntactic formula "must not be" therefore exceeds the prerogatives which he derives from this flexible right as soon as a reasonable person would interpret this formulation as a firm ban.

•  In practice, the doctors, in order to avoid disciplinary proceedings and despite the right to prescribe that the legislator has conferred on them, have for the most part stopped prescribing this drug to treat covid-19.

•  This therefore results in a de facto prohibition to prescribe and prevents doctors from fulfilling their priestly mission to care.

Since it is a de facto prohibition, it contradicts the terms of the law and must not remain in the legal order, a circumstance justifying an action for annulment for excess of power which I intend to bring soon before the Council of State.

FS: what is your conclusion?

PK: in the current state of things, there is, from my point of view, in agreement with the order of the judge of summary procedures of the Council of State of April 22, 2020, no legal obstacle which would prevent the doctors from prescribing this medicine.

Me Philippe Krikorian is a lawyer at the Marseille bar whose administrative law is one of the dominant subjects of his law firm for having attacked the decree of March 23 modified on March 25 and 26 which prohibited dispensing in pharmacies of Plaquenil and indirectly the prescription of this drug by city doctors.

Translated by @Smackenziekerr & @PaulGreeff