AAC is an authorization granted by the French Medicines Agency (ANSM) to allow a patient suffering from severe or life-threatening disease access to a new therapeutic product that has not yet been authorized for marketing in France. The AAC procedure applies to products that have already been approved in another country, and for which there is no equivalent authorized product available in France.
The AAC procedure is an exceptional measure, reserved for patients who have exhausted all other therapeutic options and for whom there is a reasonable expectation that the new product will improve their condition. AACs are granted on a case-by-case basis, taking into account the patient’s individual circumstances.
AACs are granted by the ANSM following a positive opinion from the Haute Autorité de Santé (HAS), France’s national health technology assessment body. AACs are valid for one year and can be renewed on a yearly basis.
Patients who have been granted an AAC must be treated in a hospital setting and monitored closely by a medical team experienced in using the new product.