Donation, procurement and transplantation of organs and tissueUpdated on 22.10.14
The procurement of organs and tissue intended for therapeutic use can only be carried out in health institutions authorised by the administrative authority (regional health authority), on the recommendation of the Agence de la biomédecine. The same conditions apply to the authorisation of organ transplants.
PROCUREMENT FROM LIVING DONORS
Since 1976, the therapeutic purpose of organ procurement from a living person has been incorporated into French legislation. Any removal for other purposes is against the law.
The legislation distinguishes between the removal of organs from an adult with legal capacity and a person without legal capacity (i.e. a minor or a protected adult). It prohibits the removal of organs from any living minor or from any living adult benefiting from legal protection (penalty: 7 years’ imprisonment and a fine of €100,000).
The donors: French legislation has progressively extended the circle of living organ donors, although it still requires a direct link between donor and recipient. The donor must be the father of mother of the recipient. Notwithstanding this stipulation, by derogation, the following may be authorised to volunteer to donate organs for the direct therapeutic benefit of the recipient: spouse, brothers and sisters, sons and daughters, grandparents, uncles and aunts, first cousins, father’s or mother’s spouse and any person able to prove cohabitation with the recipient for at least two years.
Reflecting the French parliament’s desire to meet the expectations of patients and their families and to encourage transplants of this type, the law of bioethics of 7 July 2011 further broadens the circle of donors, previously restricted to close relatives, to any person with a strong and stable emotional relationship with the recipient that has lasted at least two years (“links of friendship”).
The donor’s consent is formally obtained by a High Court judge. A committee of experts is also involved in the procedure in order to provide the donor with information on the medical, social and financial consequences of the organ removal and to decide whether to authorise or refuse the organ removal. This is binding on the donor and the transplantation team.
As in the rest of the European Union, the principle of the financial neutrality of organ donations is maintained, with the compensation of expenses incurred by the donor. The 2011 law prohibits any discrimination against organ donors with regard to loans on the part of insurance companies (which have sometimes refused to guarantee the risk incurred or applied significantly higher premiums because of the surgery carried out on the donor).
The 2011 law also introduces the paired kidney donation between living people. In the event of immunological incompatibility between donor and recipient, it is possible to make used of a cross over donation when another donor-recipient pairing is in the same situation and compatibility can be achieved by “crossing” the two pairs. The ethical principles of prior consent, revocable at any time, of the gratuity of donation, of anonymity between pairs and of implementation of a system of health surveillance apply. Specific information must be provided by the committee of experts.
PROCUREMENT FROM DECEASED DONORS
Organs may only be retrieved for therapeutic or scientific purposes from a person whose death has been duly certified. For organs to be removed from a body, it is compulsory by law for the death to be certified by two doctors.
With regard to organ removal, French legislation applies the principle of presumed consent but allows each individual the right to express refusal by any means, but chiefly by registering on the national refusals register. Refusal can concern the removal of organs or tissue for therapeutic purposes (in view of a transplant), removal for diagnostic purposes (non-forensic medical autopsy to determine the cause of death), or removal for scientific purposes (research). Any doctor who does not have direct knowledge of the deceased’s wishes must endeavour to recover the position of the deceased with regards to donation from the deceased’s relatives.
If the deceased was a minor or an adult under legal protection, the organ may only be removed if all those possessing parental authority or exercising guardianship have given written consent.
Organ donation after circulatory death (and not in a state of brain death) began in France in 2006 for kidneys and in 2010 for livers. Volunteer transplant centres must sign an agreement committing them to respecting protocols approved by the Agence de la biomédecine, particularly in terms of material and human resources, respect for medical and surgical procedures shared by all centres, and the transmission of monitoring data for purposes of evaluation.
It also reinforces information on organ donation, which in particular must be circulated in high schools, higher education institutions and during the annual citizenship and defence day for young people. After having provided the information, a doctor must indicate on the young patient’s social security card and medical record that he or she has been provided with information on organ donation.