EARLY ACCESS PROGRAM
Compassionate and early access
Certain pharmaceuticals products that are not authorised may exceptionally benefit from the ANSM an early access program, if they are intended to treat rare or severe diseases that do not have appropriate treatment and when the treatment cannot be deferred.
There are two types of schemes:
Early access :
these authorisations are requested by the pharmaceutical company and granted to medicines for which the results of clinical trials conducted in order to obtain a marketing authorisation (MA) strongly suggest that they are efficient and safe. The MA request must have been already filed or the relevant company must undertake to file it within a given timeframe.
Compassionate Use :
These authorisations are requested by the prescribing physician for a specific patient and who cannot participate in a biomedical research. They are granted if the efficiency and safety of the medicines can be assumed in light of the current state of scientific knowledge.
These authorizations are granted for a defined period of time that cannot exceed a year and can be renewed.
Medicines that have been authorised through an EAP are only available in the health care facilities in which they are either directly administered to hospitalised patients or, under certain conditions, delivered to patients by duly authorised hospital pharmacies (retrocession).
In France, from July 1st, 2021, the provisions governing early access will change with a total recast of the two dual process in place:
ATU will be replaced by Early Access and Compassionate Access
Early Access requests will be evaluated and granted by the HAS instead of the ANSM
Eligibility criteria will change and the innovation is the key of it
The system linked to taxes and rebates is updated
Objectives are to simplify and accelerate the procedure and thus, facilitate access to these medicines.