French Public Health Code
In forceI.-For the duration of the performance study 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 the in vitro diagnostic medical devices which are the subject of the performance study free of charge.
II.-Non-commercial performance studies are performance studies whose results are not exploited for profit, which pursue a public health objective and whose promoter or investigators are independent of the companies which manufacture or market the devices which are the subject of the performance study.
III.-Sickness insurance funds cover the cost of in vitro diagnostic medical devices which are the subject of non-commercial performance studies under the following conditions:
1° In vitro diagnostic medical devices included on the list mentioned inarticle L. 165-1 of the Social Security Code or covered by the list of acts and services mentioned in article L. 162-1-7 of the same code or hospitalisation services mentioned in article L. 162-22-6 of this code, when they are used as part of a non-commercial performance study authorised under conditions giving entitlement to reimbursement;
2° By way of derogation, in vitro diagnostic medical devices which are the subject of a non-commercial performance study 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 relevance of their financial coverage. The decision on reimbursement 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 promoter of the performance study undertakes to make the results of its performance study public.
When a performance study which has been reimbursed no longer meets the definition of a non-commercial performance study, the promoter shall repay the sums incurred under the fifth paragraph for the performance studies concerned to the health insurance schemes in accordance with the rules set out inarticle 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 referred to 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 lodged against the decision fixing this repayment is an appeal of full jurisdiction.
If the promoter does not comply with the repayment obligation 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 terms and conditions for the application of this paragraph and the previous paragraph are laid down by decree.
IV.-When a performance study 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 homes or 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 previous paragraph 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 performance study, 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 performance study.
The conditions for the application of this article, in particular those to which the structures receiving the compensation mentioned in the previous paragraph must conform in their operation and in the use of the funds received, are specified by decree.
