Book I: Health establishments

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.