French Public Health Code
In forceI.-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 article L. 1243-6 of the present code or of the activity mentioned in 8° of article R. 6122-25 and which combines the transplantation of organs or parts of organs, tissues or vascularised tissues, from a living or deceased donor, and conservation techniques or specific immunological treatment related to the exceptional nature of the graft;
2° A graft meeting the conditions set out in 1° but which has not been the subject of prior research involving the human person, subject to the following cumulative conditions:
a) Absence of therapeutic alternative;
b) Situation involving the patient's vital prognosis or involving a risk of major disability;
c) Effectiveness and safety of the graft, presumed to be favourable in the light of current scientific knowledge.
When an authorisation for an exceptional transplant is granted under 2°, the authorised establishment must carry out research involving the human being as soon as possible, in order to validate the safety of the treatment in the indication in question.
II - The list of exceptional transplants is specified by an order of the Minister for Health.
