French Public Health Code
In forceI.-For the duration of the research referred to in 1° of article L. 1121-1, the sponsor provides free of charge the investigational medicinal products and, where applicable, the ancillary medicinal products and medical devices used to administer them, as well as, for research involving products other than medicinal products, the products which are the subject of the research.
II - Non-commercial research is research whose results are not exploited for profit, which pursues a public health objective and whose sponsor or investigator(s) are independent of the companies that manufacture or market the products being researched.
III -Health insurance funds will cover the cost of non-commercial research products under the following conditions:
1° Experimental medicinal products or authorised auxiliaries, registered on the list mentioned in article L. 5123-2 or on one of the lists mentioned in the first paragraph or the second paragraph of article L. 162-17 of the Social Security Code, as well as products registered on the list mentioned in article L. 165-1 of the Social Security Code or reimbursed as part of the hospitalisation services mentioned in article L. 162-22-6 of the same code, when they are used in the context of non-commercial research authorised under conditions giving entitlement to reimbursement;
2° By way of derogation, authorised experimental or ancillary medicinal products, as well as products which are the subject of research mentioned in 1° or 2° of article L. 1121-1, for non-commercial purposes and which have received a favourable opinion from a committee for the protection of individuals and, where applicable, authorisation from the competent authority, in accordance with the procedures set out in articles L. 1123-7 and L. 1123-12, 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° of this article, with the exception of those involving national defence confidentiality, the research sponsor undertakes to make the results of its research public.
If the research that has been funded no longer meets the definition of non-commercial research, the sponsor will repay the sums incurred under the fifth paragraph for the research 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 penultimate paragraph of this article, 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 research mentioned in 1° and 2° of article L. 1121-1 with a commercial purpose 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 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 research, whether or not they relate to patient care. This agreement is sent to the Conseil national de l'ordre des médecins. It shall comply with the principles and guarantees set out in this Title. It shall be signed by the investigators participating in the research.
The conditions for the application of this article, in particular those to be complied with in their operation and in the use of the funds received, by the structures receiving the compensation mentioned in the second paragraph of IV, shall be specified by decree.
