Haematopoietic stem cell treatment can only be carried out in cell therapy institutions authorised for this purpose by the National Agency for the Safety of Medicines and Health Products (ANSM), on the recommendation of the Agence de la biomédecine.
The law of bioethics of July 7, 2011 harmonised the legal framework applicable to haematopoietic stem cells, whether they are collected from bone marrow, peripheral blood, or cord blood.
Collection intended for a donation of haematopoietic cells collected from bone marrow or peripheral blood for therapeutic purposes can only occur after the donor, informed of the risks he or she is incurring and the foreseeable consequences of the procedure, has expressed his or her consent. This is formally obtained by a High Court Judge (or the court prosecutor in an emergency).
No cells intended for donation may be collected from a minor or from any adult benefiting from legal protection. However, on an exceptional basis and in the absence of any other therapeutic solution, haematopoietic cells may be collected from the bone marrow or peripheral blood of a minor or an adult benefiting from legal protection, but only for the benefit of his or her brother or sister.
A committee of experts is also involved in the procedure in order to provide donors who are minors or protected adults with information on the medical, social and financial consequences of donation.
- If the donor is a minor or an adult under one of the less stringent forms of legal protection, the committee issues an authorisation or a refusal for donation, which is binding on the donor and the transplantation team. It ensures in advance of the absence of risk to the minor given his or her age and development, and that every effort has been made to find an adult donor who is sufficiently compatible.
- If the donor is a major under guardianship (the highest level of legal protection), the committee of experts issues a recommendation on the donation envisaged, and the donation must be authorised by the judge supervising the guardianship.
- In all cases, the person’s consent must be sought. Any refusal precludes donation.
The 2011 law strengthens the ethical framework of provisions relative to cord blood cells, placenta blood cells and cord and placenta cells. It establishes the principle of the allogeneic use of umbilical cord blood, as well as cord and placenta cells. It specifically mentions the anonymous, free and non-directed donation of haematopoietic stem cells from cord blood.
However, notwithstanding this stipulation, the donation may be specifically directed to the newborn child or his or her brothers or sisters in the event of a therapeutic need that is clear and duly justified at the time of collection.
The mother is informed in advance about the purpose of donation (scientific or therapeutic), and her consent to the donation and use of cells is obtained in writing during the pregnancy. This is revocable at any time as long as the sample has not been taken.
As in the rest of the European Union, the principle of the financial neutrality of donation is maintained, with the compensation of expenses incurred by the donor (cost of examinations, accommodation and transport, loss of earnings, etc.).