[Early access to innovative drugs, ethical impacts]

EARLY ACCESS TO INNOVATIVE DRUGS, ETHICAL IMPACTS In France, the average time between marketing authorisation and patient access to drugs is 530 days, this period takes into account the period of price negotiation and reimbursement specific to countries that provide medical coverage to the entire population. Regarding innovation, since 1994, the introduction of the ATU system has made it possible to reduce this delay. The new system set up in July 2021 includes the ANSM and HAS with the objective of linking the access decision and the reimbursement decision of the innovation. Nevertheless, therapeutic innovation can give rise to ethical problems: the performance of repeated biopsies in a patient with limited survival, a non-existent benefit in terms of quality of life or survival of certain innovations, the interest of opinion leaders and industrials which is not always that of the patient, opposition in the analysis of a benefit depending on whether one is a methodologist, a physician, a public decision- maker or a patient, and lastly, a price which is not related to the efficacy of the health products but rather to the acceptability or the sustainability of our health care system.