In France, community pharmacies are the standard point of dispensing for outpatients when medicines are not restricted to hospital use.
“Retrocession” refers to the dispensing of medicines to outpatients by hospital pharmacies (PUI – pharmacies à usage intérieur), as an exception to or in addition to the community pharmacy supply chain. It is justified by public health or safety reasons listed in the French Public Health Code.
According to Articles L5126-6 and R5126-58 of the French Public Health Code, and the dedicated page on the ANSM website, medicines must meet the following criteria to be eligible for rétrocession:
- not be restricted to hospital use (RH status),
- present specific dispensing or administration constraints,
- have particular requirements related to supply security,
- require monitoring of the prescription or dispensing.
Medicines are included on this list for public health reasons, in the interest of patients.
The retrocession list, initially established in 2004 and managed by the Ministry of Health until 2021, was originally built on the basis of practice and needs.
Its management was then transferred to the ANSM at the end of 2021 (Decree No. 2021-1531 of 26 November 2021). It is now supplemented by generic medicines corresponding to reference products already listed, or by certain new medicines considered by the ANSM to have added value when dispensed through hospital pharmacies due to safety-of-use or supply considerations. These medicines hold a Marketing Authorisation (MA) or an Import Authorisation (AI). The ANSM has expressed its intention to streamline this list, keeping only medicines that legitimately require access through this distribution channel.
Decisions to include medicines on the retrocession list are published on the ANSM website approximately every 15 days, depending on the flow of newly granted MAs. A consolidated and updated retrocession list is also available (including antibiotics/antifungals, anticancer agents/immunosuppressants, antivirals, plasma-derived medicinal products, etc.).
Other medicines may be dispensed through retrocession without being explicitly listed. These include the following categories: magistral or hospital preparations, medicines granted early access or compassionate use.
The purpose of the retrocession system is to ensure that patients can access certain treatments despite specific distribution, dispensing, or administration constraints, or when particular monitoring of the prescription or dispensing is required, without the need for hospitalisation.
When medicines have been marketed for several years and sufficient experience has been gathered, their switch to community pharmacy dispensing logically leads to their removal from the retrocession list.
Atessia supports pharmaceutical companies in defining or modifying the prescribing and dispensing conditions of their medicinal products.
This article was written by Estelle ICARD, Regulatory & Pharmaceutical Affairs Consultant.