In a document posted on the Internet site of the IHU Méditerranée infection by Pr Didier Raoult, we discover a letter signed by the President of Sanofi and addressed to the Minister of Health Olivier Veran.
In this letter, the pharmaceutical company details the regulatory reasons for which it has decided not to honor orders for Plaquenil from the AP-HM.
By unveiling this letter, Professor Raoult hopes to obtain a clarification of the position of the Ministry of Health on the treatments it delivers to its patients suffering from Covid-19.
In this letter, Olivier Bogillot, the president of Sanofi explains that he receives “numerous and recurring requests from the AP-HM and more particularly from the department of Professor Didier Raoult to provide this product. This specialty marketed under the name Plaquenil® 200 mg is widely prescribed by doctors from the IHU of infectious diseases in Marseille in the context of the Covid-19 epidemic. ”
Plaquenil & COVID-19, neither Marketing Authorization, nor exemption for a prescription outside Marketing Authorization, according to SANOFI
Olivier Bogillot explains that despite the lack of MA for Plaquenil in the treatment of COVID-19 and after the end of the derogatory measures granted to hydroxychloroquine in this indication on May 27, the French laboratory received Large orders of Plaquenil in September 2020 from pharmacists at AP-HM. He informs the Minister of Health that the laboratory has decided not to honor these orders for these reasons and in the absence of a new Temporary Recommendation for Use [RTU], or the implementation of a clinical study within the meaning of l ‘Article L. 1121-1 of the CSP
“ We reminded the AP-HM, by letter of August 26, 2020, of our obligations in terms of proper use and compliance with the terms of the MA for this treatment, and that it does not benefit to date from any Marketing Authorization whether in France or elsewhere in the world, for an indication relating to the treatment of COVID-19. ”
The freedom to prescribe outside the Marketing Authorization is understood on a case-by-case basis for SANOFI
For the French laboratory, the freedom of prescription outside Marketing Authorization as defined in article R.4127-8 of the Public Health Code, cannot apply in the case of the IHU Mediterranean Infection because the services of Professor Raoult organizes this prescription on a large scale while this freedom of prescription is provided only on a case-by-case basis in the interest of the patient.
“ The prescription of an off-label drug by a doctor is in fact understood on a case-by-case basis , must be in the patient’s interest, and justified by the data acquired from science. These conditions are no longer met insofar as the AP-HM organizes this prescription on a large scale even though the data acquired from science and the interest for patients have not been demonstrated (ANSM decision relating to RTU ). “
Sanofi relies on the wisdom of Olivier Veran
“Thus, apart from any official recommendation that could, if applicable, emanate from your Ministry regarding the off-label use of our specialty Plaquenil® in the context of the management of Covid-19, I wanted you to inform us that it is impossible for us to follow up on orders for the AP-HM in still large quantities […] today I wish to rely on the wisdom of the Government and more specifically that of your Ministry, alone legitimate to decide this delicate question. “
After the ANSM, Pr Raoult engages in a standoff with Oliver Veran
In a video titled “Sanofi or Ministry: who is blocking the sale of hydroxychloroquine?” and posted on the Internet, Professor Raoult explains that he disclosed this letter so that the Ministry of Health could clarify its position on the subject.
For the infectious disease specialist, one of two things, namely SANOFI “ lies ” and “ it is refusal to sell ” because “ SANOFI does not have to know for what we use the drugs that we receive in the hospital ”, or it is the ministry which “ tries to go through a biased relationship with SANOFI ” to prevent the delivery of a “ drug which is unquestionably considered effective in ¾ of the countries of the world ”.“
I hope that the Minister will answer this question so that we will see who… is lying in this story ” Pr RAOULT
Finally, Professor Raoult explains the reasons which led him to bring the director of the ANSM before the courts . “ The answer given to us by the director of the ANSM is absolutely unreasonable in terms of scientific reasoning… They did not consult me… to my knowledge they did not consult Sanofi. It is not a reasoned decision, but a personal decision… I consider that it plays a dangerous role for the health of the French ”.