France: the Ivermectin Dossier Before the Council of State

A new legal attempt to have ivermectin approved in France, through a Temporary Recommendation for Use, will be presented this Monday January 25 to the Council of State.

(see French version)

The move aims to force the French government, and more specifically the National Medicines Agency, to formally look at the ivermectin dossier – something it has avoided so far, despite two previous legal processes.

On November 6, Maître Jean-Charles Teissedre, criminal lawyer, representing the Association of COVID-19 Coronavirus Victims in France, pleaded in favor of Ivermectin before an administrative tribunal, with a view to seizing the competent authorities of the urgency to approve a Temporary Recommendation for Use. The request was rejected by the judge, although neither the ministry nor the drug agency were present at the hearing.

On December 28, a preliminary filing was forwarded to the Minister of Solidarity and Health, Olivier Véran, and to the National Medicines Agency, requesting a Temporary Recommendation for Use. As of January 15, the date of this new filing, Maître Teissedre had not received any response. The absence of a response from the authorities constitutes, according to Mr. Teissedre, proof of the authorities’ failure to deal with the emergency.

This third legal filing, which is addressed to the Council of State, is on a larger scale, with 18 doctors as plaintiffs, as well as two associations of doctors, – the Syndicat des Médecins d’Aix et Région and the International Association for Scientific, Independent and Benevolent Medicine – and the “Bon Sens” (good sense) association, which has among its members the highly mediatic Professor Christian Perronne, MD, also a defender of ivermectin.

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One item that may prove to be important is the recent decision, on January 14, of the influential National Institute of Health (NIH) in the United States, which has now taken a position to recommend neither for nor against ivermectin for the treatment of COVID-19. This neutral position succeeds to a previous recommendation against its use, except in clinical trials.

In France, the Temporary Recommendation for Use is the regulatory instrument which aims precisely to allow, on a temporary basis, the use of a medicinal product, here generic and repositioned drug, and to allow its effectiveness to be evaluated on the basis of its use.

This new filing is made to the Council of State, the highest administrative tribunal in the country, founded by none other than Napoleon Bonaparte.

Overview of the Legal Filing

Here are some excerpts from the filing translated in English. The filing can be viewed in its entirety, in French, at this link.

“The object of this request is to request, on the basis of article L.5121-12-1 V of the public health code, the Minister of Solidarity and Health, the National Security Agency Medicines and Health Products (ANSM) and the Haute Autorité de Santé (HAS) to take measures to treat patients suffering from Covid-19 with the ivermectin molecule, in particular by developing, as an emergency, ‘a Temporary Recommendation for Use (RTU) in favor of this molecule. ” …

“When the operators of the rights to a medicinal product do not request an RTU, the legislator has expressly provided that the minister in charge of health or social security can refer the matter to the ANSM for this purpose, in order to compensate for a possible failure of pharmaceutical companies, it being specified that the ANSM can also take action ex officio. ” …

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“It is clear that the ANSM was not seized in this regard and neither did it self-refer as it has the power to do.” …

“Since the authorities have chosen to interfere in unprecedented proportions in the doctor-patient relationship, they must in return mobilize the legal instruments suitable for securing the prescription of non-approved drugs.” …

“The freedom to prescribe, enshrined in law, is seriously questioned by the health authorities in the broad sense since a number of doctors have been, or are the subject of disciplinary proceedings which are regularly reported by the media.”

“The Temporary Recommendations for Use are specifically intended to secure the prescription and dissemination of information so that it can benefit the greatest number of patients in accordance with the requirements of the Hippocratic Oath.”

“All the applicants ask the competent authorities that the development of an RTU in favor of the ivermectin molecule be considered without further delay.” …

“The applicants are particularly concerned that certain treatments, which are presumed to be favorable, receive very little public attention while there are treatments which are inexpensive, available and safe.” …

“As this is a new disease that affects all countries in the world including France, it is indeed reasonable as much as it is imperative that the public authorities facilitate the prescription and repositioning of old molecules without the prescribing doctors having to fear to be prosecuted for seeking to obey their Hippocratic Oath. ” …

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“The urgency is established with regard to a relatively high case fatality rate observed around the world and especially in France.” …

“The right to health protection is also guaranteed by the constitution since the preamble to the 1958 constitution states that“ The Nation guarantees to all […] the protection of health ”. …

“Article L.1110-1 of the Public Health Code provides that:” The fundamental right to health protection must be implemented by all available means for the benefit of everyone. “

“In the present case, the applicants argue that the protection of health and the free prescription of the best care are hampered by the action of the public authorities as previously invoked.”

“The failure of the authorities is all the more established here as on December 28, 2020, a prior filing was sent to the Minister of Solidarity and Health and to the National Medicines Safety Agency, seeking the development of an RTU in favor of ivermectin. ”

“The benefit / risk ratio is very favorable for ivermectin, as evidenced by the scientific data published and appended to this request, whether these data relate to efficacy or harmlessness.” 

“It is further specified that the molecule is manufactured. and marketed on French soil by several pharmaceutical companies and that it is accessible in all pharmacies with a prescription.”

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