French Public Health Code
In forceI.-For the duration of the clinical investigation involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which are not minimal, the sponsor provides free of charge the medical devices which are the subject of the clinical investigation.
II - Non-commercial clinical investigations are clinical investigations whose results are not exploited for profit, which pursue a public health objective and whose promoter or investigator(s) are independent of the companies which manufacture or market the medical devices which are the subject of the clinical investigation.
III.The health insurance funds cover the cost of medical devices which are the subject of non-commercial clinical investigations under the following conditions:
1° Medical devices included on the list mentioned in article L. 165-1 of the Social Security Code or covered by the hospitalisation benefits mentioned in article L. 162-22-6 of the same code, when they are used as part of a non-commercial clinical investigation authorised under conditions giving entitlement to reimbursement;
2° By way of derogation, medical devices which are the subject of a non-commercial clinical investigation and which have received a favourable opinion from a committee for the protection of individuals and, where applicable, authorisation from the competent authority, when they are not used under conditions giving entitlement to reimbursement, subject to the appropriateness of their financial coverage. The decision to reimburse is taken by order of the ministers responsible for health and social security.
In the cases mentioned in 1° and 2°, with the exception of those involving national defence confidentiality, the sponsor of the clinical investigation undertakes to make the results of its clinical investigation public.
When the clinical investigation which has been reimbursed no longer meets the definition of a non-commercial clinical investigation, the sponsor pays the sums incurred under the fifth paragraph for the clinical investigations concerned to the health insurance schemes in accordance with the rules set out in article L. 162-37 of the Social Security Code. The repayment due is set by decision of the ministers responsible for health and social security after the sponsor concerned has been given the opportunity to present its observations. The proceeds of the repayment are collected by the bodies mentioned in article L. 213-1 of the same code, designated by the Director of the Agence Centrale des Organismes de Sécurité Sociale (Central Agency for Social Security Bodies). Any appeal against the decision fixing this repayment is an appeal of full jurisdiction.
If the promoter does not comply with the obligation to repay referred to in the previous paragraph, a penalty of no more than 10% of the promoter's turnover for the previous year will be applied. The procedures for applying this paragraph and the previous paragraph are laid down by decree.
IV - When a clinical investigation for commercial purposes, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products used in the usual way, is carried out in health establishments, in army hospitals or other elements of the army health service, at the Institution nationale des invalides, or in health centres, the sponsor will cover the additional costs relating to any supplies or examinations specifically required by the protocol.
The assumption of additional costs is the subject of an agreement between the sponsor, the legal representative of each of the organisations mentioned in the first paragraph of this IV and, where applicable, the legal representative of the structures receiving the compensation paid by the sponsor. The agreement, which conforms to a standard agreement defined by order of the Minister for Health, includes the conditions for the reimbursement of all costs associated with the clinical investigation, whether or not they relate to patient care. This agreement is sent to the Conseil national de l'ordre des médecins. It complies with the principles and guarantees set out in this Title. It shall be signed by the investigators participating in the clinical investigation.
The conditions for the application of this article, in particular those with which the organisations receiving the compensation mentioned in the second paragraph of this IV must comply in their operations and in the use of the funds received, shall be specified by decree.
