French Public Health Code
In forceFor the application of 2° of III of Article L. 1121-16-1, the sponsor may, provided that he has a favourable opinion from the Committee for the Protection of Individuals, ask the Ministers responsible for health and social security to waive the reimbursement by the health insurance funds of experimental medicinal products or authorised auxiliaries or products which are the subject of the research, when they are not used under conditions giving entitlement to reimbursement. An order of the ministers responsible for health and social security, issued after consultation with the Haute Autorité de santé and the Union nationale des caisses d'assurance maladie, specifies the data to be provided by the sponsor in support of its application for reimbursement.
The decision of the ministers responsible for health and social security concerning the reimbursement of authorised experimental or ancillary medicinal products or products which are the subject of the research is made with the approval of the Haute Autorité de santé and the director of the Union nationale des caisses d'assurance maladie. The ministers responsible for health and social security refer the matter to them as soon as the application is received.
They have two months from the date of referral to give their opinion.
If the ministers responsible for health and social security give a favourable decision, the medicines or products are then reimbursed under the conditions set out in articles R. 160-5 and R. 160-8 of the Social Security Code.
In the event of an unfavourable decision, the decision to refuse reimbursement is communicated to the sponsor within three months of receipt of the application by the ministers. This decision must state the reasons on which it is based and specify the appeal procedures and deadlines applicable to them.
