It will be recalled that one of the main contributions of the Social Security Financing Act for 2021 (LFSS for 2021) is the total overhaul of two derogatory drug reimbursement regimes: temporary authorisations for use (ATU) and temporary recommendations for use (RTU).
Article 78 of the LFSS for 2021 abolishes the various ATUs and RTUs and replaces them with early access (AP) and compassionate access (CA) mechanisms. It should be noted in this respect that compassionate access covers compassionate access authorisations (CAA) – which broadly correspond to the former nominative ATUs – and compassionate access frameworks (CAF) – which correspond to the former RTUs.
The details necessary for the entry into force of the AP and CAA systems were provided by two decrees published on 1 July 2021 (see our article of 1st July 2021).
However, the decree that was to specify the CAF system had not been published, which blocked the system’s entry into force.
The CAF system finally came into force yesterday, following the publication in the Official Journal of Decree 2022-164 of 11 February 2022 on compassionate prescribing frameworks and amending the provisions of the Public Health Code relating to early access and compassionate authorisations.
As its title indicates, this text not only specifies the CAF scheme, but also provides a number of clarifications on the AP and CAA schemes.
Advertising on AP, CAA, and CAF
Decree No. 2022-164 provides in substance that information disseminated on pre-licensing AP (referred to in this case as AP1), CAA and CAF must not constitute advertising.
A contrario, it is possible to advertise on AP when the indication concerned has a marketing authorisation (in this case we speak of AP2, which corresponds to the former post-ATU).
Decree No. 2022-164 also imposes some sort of prior control on the dissemination of information on a AP1, CAA or CAF:
- the manufacturers must submit the draft communication to the ANSM (and, for AP1, to the HAS);
- the ANSM (and, for AP1, the HAS) then has 1 month to give an opinion on the draft.
In the absence of an opinion from the ANSM (or the HAS for AP1), the opinion is deemed to have been issued.
What if the ANSM or the HAS gives an unfavourable opinion? It should be remembered that this is a simple opinion and not an authorisation. Manufacturers will therefore be able to ignore unfavourable opinions, provided that they ensure that their communication does not constitute advertising.
Funding of data collection
It should be remembered that in the AP, CAA and CAF :
- prescribers and pharmacists are required to participate in the collection of information;
- however, it is the industry that finances the collection of data.
Decree No. 2020-869 of 30 June 2021 therefore stipulated that an agreement had to be concluded between the manufacturer and the health care institution to set out the terms and conditions of the latter’s compensation. The decree published on Saturday adds that this agreement will have to be brought into conformity with the model that will be set by ministerial decree, at the time of its renewal or by 31 December 2022 at the latest.
Some points of attention on the Compassionate Access Framework (CAF)
On the CAF system, which corresponds to the former RTU, it should be noted that :
- the initiative is necessarily taken by the administration (ANSM or Minister): the manufacturer cannot therefore request a CAF;
- the manufacturer can only “present observations”, but the administration can decide to set up a CAF without the manufacturer’s agreement;
- however, the industry must comply with a certain number of obligations, particularly in terms of data collection.
In other words, the industrialist may be imposed the obligations of the CAF even though he opposed the implementation of this derogation. In such a case, the industrialist may appeal against the administration’s decision.