Chapter III: Conditions for setting up certain healthcare activities and heavy equipment

I.-For the purposes of article L. 162-30-5 of the French Social Security Code, the following are considered to be exceptional: 1° A graft with rare medical indications which, in the indication in question, has been the subject of research involving the human being validating its safety, which concerns an organ or tissues or a composite graft of vascularised tissues, not usually grafted within the scope of article L. 1234-2 or…

Only health establishments authorised to perform organ transplants in application of article L. 1234-2 may be authorised to perform exceptional organ or tissue transplants or exceptional composite vascularised tissue transplants.

The authorisation shall specify: 1° The organs or tissues or vascularised tissues for which it is granted; 2° The indication or situation concerned; 3° Whether the activity concerns children, adults and children or adults only; 4° The site on which the activity is carried out. It may be subject to special conditions in the interests of public health or patient safety.

The health care establishment authorised to carry out the activity of exceptional organ or tissue transplantation or composite vascularised tissue transplantation must be able to ensure its implementation at all times. The authorised health establishment provides medical care before and after the graft operation. Where the establishment does not itself provide full patient follow-up, it will enter into an agreement with one or more health establishments as part of an…

Exceptional organ or tissue transplants or exceptional composite transplants of vascularised tissues may not be carried out as part of the self-employed activities of statutory full-time practitioners as provided for in article L. 6154-1.

When the situation warrants it, the Minister for Health will issue a decree laying down specific quality and safety rules for an exceptional type of transplant.

The application for authorisation is sent to the Director General of the Regional Health Agency, by any means which provides a date certain of its receipt, by the health establishment seeking authorisation. The composition of the application is defined by an order of the Ministers responsible for health and social security. The Regional Health Agency sends the application, within a maximum of one month of its receipt, by electronic means,…

The national committee provided for in article L. 162-30-5 of the Social Security Code comprises: 1° The Director General of Healthcare or his representative; 2° The Director General of Health or his representative; 3° The Director of Social Security or his representative; 4° The President of the Haute Autorité de Santé or his representative; 5° The Director General of the Agence de la biomédecine or his representative; 6° The Director…