Book II: Donation and use of human body parts and products

To be authorised to carry out organ removal for therapeutic purposes on a deceased person, health establishments must: 1° Have the staff and equipment necessary to establish the fact of death, under the conditions defined in Chapter II of this Title; 2° Demonstrate that their organisation and operating conditions allow for the satisfactory performance of removal operations; 3° Appoint a coordinating doctor for the removal activity, after consultation with the…

To be authorised to carry out organ removal from a living person, health establishments must : 1° Demonstrate that their organisation and operating conditions allow for the satisfactory performance of organ retrieval operations; 2° Have an intensive care unit on site; 3° Have the medical staff and other personnel required to carry out the sampling activity; 4° It must have the premises, and at least one operating theatre, equipped with…

Health establishments authorised to carry out organ removal take the necessary steps to ensure, for a period of thirty years after the donation, that all documents relating to the removal mentioned in the rules of good organ removal practice approved by order of the Minister for Health are kept. In the case of international exchanges of organs, the Agence de la biomédecine is also responsible for keeping these documents.

Each year, health establishments authorised to carry out organ removal for therapeutic purposes send the Director General of the Regional Health Agency and the Director General of the Biomedicine Agency the information required to evaluate their activity, in accordance with the procedures specified by order of the Minister for Health issued after consultation with the Director General of the Biomedicine Agency. These establishments shall also send the Director General of…