French ANSM establishes accelerated procedures for Covid-19 treatments and issues FAQ for on-going clinical trials
27 March 2020
The French National Agency for Medicines and Health Products Safety (ANSM) recently announced the set-up of accelerated procedures for the assessment of Covid-19 treatments that are currently being developed. However, no further details regarding this accelerated procedure are publicly available.
In the context of the pandemic, clinical trials for other treatments taking place in French hospitals have been suspended to a large extent as healthcare professionals focus on taking care of patients suffering from Covid-19, and as a result of the implementation of new measures set up by the French government to prevent its further spread.
Hence, the ANSM has requested that clinical trial sponsors re-evaluate the necessity of initiating new trials or continuing on-going ones, and where relevant, adapt their planning accordingly. To that end, the ANSM has issued, in cooperation with the Health Directorate General (a department of the Ministry of Health), a guide (accessible in English here) on possible changes which can be implemented while conducting clinical trials, to take into account these new constraints and ensure patient safety.
The ANSM’s measures were followed by the publication of a new decree on 26 March 2020. The Decree n°2020-314 of 25 March 2020 (as modified by the Decree n°2020-337 of 26 March 2020) introduces new provisions relating to the making available of medicinal products to patients suffering from Covid-19 in an accelerated way:
- It introduces the possibility for physicians to prescribe (by collegiate decision only) and administer medicinal products containing hydrochloriquine (Plaquenil®) and lopinavir/ritonavir (Kaletra® and its generics) to hospitalised patients suffering from Covid-19 given that these active substances show potential as a treatment against such disease (despite not being authorised for such use);
- The prescription and administering of these medicines may be performed in a hospital or at home once the patient is discharged, though they will be delivered by hospital pharmacies (pharmacies à usage intérieur) only, except for patients which were given such products prior to the pandemic (for other illnesses). The ANSM will establish a protocol for therapeutic use and determine what information is to be given to patients;
- Exports of such medicinal products by wholesale distributors are banned.
Further to the publication of the Decree, the ANSM has called on pharmacists working outside hospitals not to deliver such medicines to patients suffering from Covid-19, in order to ensure sufficient supply to patients for whom the medicines are intended according to the marketing authorisation (i.e., patients suffering from chronic illnesses such as HIV or lupus).
This article was co-authored by Alexandra Lauré.