Section 3: Insurance for research sponsors

Insurance contracts for the research referred to in 1° and 2° of Article L. 1121-1 guaranteeing, under the conditions provided for in Article L. 1121-10, the pecuniary consequences of the civil liability of the sponsor and that of any intervening party may not derogate from the provisions defined in this section, except in a way that is more favourable to the interests of the victims or their beneficiaries.

The contracts mentioned in article R. 1121-4 may only include clauses excluding cover for damage suffered by victims or their dependants in the following cases: 1° The research does not take place under the conditions set out in the second and third paragraphs of article L. 1121-3, as approved by the Committee for the Protection of Individuals pursuant to article L. 1123-7 and, where applicable, by the French National Agency…

The contracts referred to in article R. 1121-4 may not provide cover for less than : 1° 1,000,000 euros per victim ; 2° 6,000,000 euros per research protocol; 3° 10,000,000 euros for all claims made during one insurance year in respect of several research protocols.

The contracts mentioned in article R. 1121-4 may provide for an excess per victim.

The insurer may not invoke against the victim or his successors : 1° The fact that the research was carried out even though consent had not been given under the conditions provided for in articles L. 1122-1-1, L. 1122-1-3 or L. 1122-2 or had been withdrawn; 2° The excess provided for in article R. 1121-7 ; 3° The proportional reduction in compensation provided for in article L. 113-9 of the…

Subscription to the contracts mentioned in article R. 1121-4 is justified by the production of a certificate issued by the insurer, which constitutes a presumption of cover. This certificate includes the following information 1° References to the applicable legislative and regulatory provisions ; 2° The name of the insurance company; 3° The number of the insurance contract; 4° The name and address of the policyholder; 5° The precise name of…