An update on transplants and foreign patients

In the field of organ removal and transplantation, the Agency is responsible for registering patients on a national list of people waiting for transplants, managing this list and establishing rules for the distribution and allocation of transplants. It also operates the automated national register of organ donation refusals.

The Agency also monitors and evaluates these activities, in particular through qualitative and quantitative analysis of the information available on the results obtained.

Lastly, it reports on these missions to the Government and Parliament in its annual activity report, and regularly draws up an inventory of any organ trafficking and the measures taken to combat such trafficking.

The conditions for registration on the national waiting list are set out in article L. 1251-1 of the French Public Health Code, which stipulates that "only those persons, regardless of their place of residence, who are registered on a national list, may benefit from a transplant of organs, corneas or other tissues, the list of which is set by decree, after consultation with the Agence de la biomédecine".

Under article L. 1418-1, 7°, of the French Public Health Code, the Agence de la biomédecine is responsible for "registering patients awaiting transplantation on [this] list". Inclusion on the national waiting list is first and foremost a strictly medical decision, taken by the hospital teams of establishments authorized to perform transplants.

The decree of November 24, 1994 on the management of the national waiting list stipulates that patients registered on the national list must submit a request for prior reimbursement to the health insurance organization to which they belong. Once this has been obtained, the establishment's director validates the patient's registration, which becomes definitive and gives rise to registration on the national list maintained by the Agence de la biomédecine.

With regard to foreign patients not resident in France, the decree of November 24, 1994 specifically stipulates that they must be in possession of a certificate from the Minister of Health in their country of origin, certifying that the transplant cannot be carried out in the country in question and stating the reasons for this impossibility. These patients must also provide the transplant establishment with a sworn statement that they are not registered on any other national waiting list. If they have met these requirements and the medical indication is accepted, they are placed on the national list after a favorable opinion has been given by the director of the health care establishment, who verifies in particular that the operation is financially covered by the patient's country of origin.

The decision to accept non-residents for transplant operations does not involve the Agence de la biomédecine at any stage. Only the OFII, and then the relevant prefect, are empowered to intervene in the preparation of residence permits issued for the purposes of removal or transplantation. The figures are therefore necessarily known to the OFII. These provisions apply whether patients are waiting for a transplant from a deceased donor or a living donor.

For patients in a super-emergency situation (i.e. whose vital prognosis is at risk in the very short term), there is a special procedure involving one or more independent experts. The patient's transplant team requests super-urgency registration, and the expert assesses whether or not to authorize it. The expert's decision is binding on the Agence de la biomédecine, which then places the patient on the waiting list as a national super-urgent.

Apart from rare and specific situations of super-emergency, living in a country without a high-performance healthcare system may constitute a contraindication to transplantation, which remains at the discretion of the medical team caring for the patient, since post-transplant follow-up requires close medical and surgical monitoring and long-term immunosuppressive treatment.

The legislative framework is clear and unambiguous: once registered on the national waiting list, considerations relating to non-resident status or nationality are inoperative.

Similarly, the nationality or place of residence of a person who dies in a hospital in France does not in principle prevent the removal of his or her organs for transplantation. Foreign patients residing in France are subject to French law, and foreign patients passing through France may also be harvested in France, in accordance with the rules governing consent under their national law.

Between 2015 and 2022, patients residing outside the European Union accounted for 0.8% of all transplant recipients, and those residing in the European Union (excluding France) for another 0.8%. This rate is stable. This is a very low rate compared with the number of transplants carried out in France.

The order of magnitude of patient registrations on the national waiting list is no different. Between 2015 and 2022, on a cumulative basis, patients residing outside the European Union represented 0.6% of the total number of people newly registered on the national waiting list, and residents of the European Union (excluding France) 0.67% of the same total. No upward trend has been noted in recent years.

In accordance with article L. 1418-1-1 of the French Public Health Code, the Agency draws up an annual report which includes an inventory of any organ trafficking and measures to combat such trafficking, for which it conducts an investigation.

The Agence de la biomédecine also cooperates with the Maghreb countries to help them develop their own organ procurement and transplantation capacities. Although the recent health crisis has limited the frequency of exchanges with our usual partners in North Africa, contacts have been resumed and have led to the organization of the France-Maghreb symposium in Paris in May 2022, aimed at strengthening procurement and transplantation capacities in these countries.

Bone marrow donation and transplantation are based on an essential principle of international solidarity. The 73 national registries of voluntary bone marrow donors worldwide, representing a database of 42 million donors, are all interdependent. In 2023, 1,174 patients in France benefited from a bone marrow transplant thanks to unmatched voluntary donors. Of these, 91% came from foreign donors.

To perform a bone marrow transplant, the donor and the patient suffering from a serious blood disease (such as leukemia) must be perfectly compatible, i.e. share the same "immunological identity card". Each person has their own genetic profile, determined by their origins and family genetic history. National donor recruitment targets therefore aim to ensure that each registry reflects the diversity of origins of the population living in the country.

Today, when a patient needs a transplant, the probability of finding a compatible donor in the registry is greater if the patient is Caucasian. Indeed, historically, voluntary bone marrow donor registries have tended to develop in the northern hemisphere, so the Caucasian population is very well represented there. There is therefore a major loss of opportunity for patients from countries with no national registers, or from mixed-race families, even within the same country.

This trend needs to be rebalanced, because the greater the diversity among donors, the greater the chances of finding people compatible with the maximum number of patients who need bone marrow transplants to recover.