Chapter I: Levy and collection.

The removal of tissues or cells or the collection of human body products from a living person with a view to donation may only be carried out for therapeutic or scientific purposes or for the production or testing of in vitro diagnostic medical devices and their accessories or for quality control of medical biology examinations or as part of the expert assessments and technical controls carried out on tissues or cells or on human body products by the Agence nationale de sécurité du médicament et des produits de santé pursuant to 1° of Article L. 5311-2. Only tissues on a list provided for this purpose may be removed for donation for therapeutic purposes, with the exception of tissues removed as part of research covered by Title II of Book I of this Part.

The removal of tissues or cells other than haematopoietic cells, or the collection of products of the human body with a view to donation for therapeutic purposes or with a view to producing or checking in vitro diagnostic medical devices and their accessories or with a view to quality control of medical biology examinations or within the framework of expert assessments and technical checks carried out on tissues or cells or on products of the human body by the Agence nationale de sécurité du médicament et des produits de santé pursuant to 1° of Article L. 5311-2 may only take place on condition that the donor, having been duly informed of the purpose of the removal or collection and the consequences and risks associated therewith, has given his consent in writing. This consent may be revoked without formality and at any time. However, the conditions for expressing consent and obtaining authorisation set out in article L. 1231-1 shall apply where this is justified by the nature of the removal and its consequences for the donor.

The removal, with a view to donation for therapeutic purposes, of haematopoietic cells collected from bone marrow or peripheral blood may only take place on condition that the donor, having been informed in advance of the risks involved and the possible consequences of the removal, has expressed his consent before the president of the judicial court or the magistrate designated by him, who shall first ensure that the consent is free and informed. In the event of a life-threatening emergency, consent is obtained by any means by the public prosecutor. Consent may be revoked without formality at any time.

The removal of haematopoietic cells from cord blood and placental blood as well as cord and placental cells may only be carried out for scientific or therapeutic purposes, with a view to anonymous and free donation, and on condition that the woman, during her pregnancy, has given her written consent to the removal and use of these cells, after having received information on the purposes of this use. This consent may be revoked without formality at any time before the cells are removed. By way of derogation, the donation may be dedicated to the child born or to the child's brothers or sisters in the event of a proven therapeutic need that is duly justified at the time of collection.