Section 6: Organ transplants and haematopoietic cell transplants

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…

The National Committee is chaired by the Director General of Healthcare or his/her representative. The Agence de la biomédecine provides the secretariat. The members of the National Committee are subject to the provisions of article L. 1451-1 and are bound by professional secrecy with regard to any information that may have come to their knowledge by virtue of their duties, under the conditions and subject to the penalties laid down…

The national committee rules on authorisation to carry out exceptional transplants and issues the opinion provided for in the first paragraph of I of article L. 162-30-5 of the Social Security Code. It issues an opinion for each graft on the amount of reimbursement and related hospitalisation costs, and the duration and conditions of reimbursement by the health insurance scheme of the lump sum referred to in II of the…

A visit to check compliance with the safety commitments and rules is carried out by the Regional Health Agency no later than two months after the implementation of the exceptional transplant activity. A representative of the Agence de la biomédecine will take part in this compliance visit.

Each year, the health care organisation which holds the authorisation sends an activity and assessment report to the regional health agency, the general directorate for healthcare provision and the biomedicine agency.

The health care organisation holding the authorisation submits its application for renewal of the authorisation fourteen months before the expiry date of the authorisation under the same conditions as those laid down for the application for authorisation.