Chapter I: Collection, preparation and storage of blood, blood components and labile blood products.

Blood transfusion is carried out in the interest of the recipient and is governed by the ethical principles of voluntary and anonymous donation, and the absence of profit, under the conditions defined by this book.

Human blood or its components may only be collected for therapeutic use by the Etablissement Français du Sang mentioned in Chapter II of this Title and by the Armed Forces Blood Transfusion Centre, approved under the conditions set out in Chapter II of this Title.

The sample may only be taken with the donor’s consent by a doctor or under his direction and responsibility. By way of derogation from the first paragraph, a decree of the Conseil d’Etat lays down the conditions under which medical students who have completed the second year of the second cycle of medical studies may take such a sample. No remuneration may be paid to the donor, without prejudice to…

Blood, its components and their derivatives may not be distributed, issued or used without biological examinations and screening tests for transmissible diseases having been carried out. Blood, its components and their derivatives may be distributed and used for research purposes, for the control of medical biology examinations or for the control of in vitro diagnostic medical devices and their accessories, excluding any administration to humans, before the results of the…

No blood or its components may be collected for therapeutic use by a third party from a minor or from an adult who is the subject of a legal protection measure with representation relating to the person. However, in the case of minors, a sample may be taken in exceptional circumstances, when this is required for reasons of therapeutic urgency or when no immunologically compatible donor of legal age has…

The characteristics of the blood may only be modified prior to collection for therapeutic use by a third party by a doctor within the Etablissement Français du Sang or the Armed Forces Blood Transfusion Centre. This modification may only be carried out with the written consent of the donor, who has been warned in advance in writing of the risks involved and the possible consequences of the donation. It may…

The recipient cannot know the identity of the donor, nor can the donor know the identity of the recipient. No information that could identify both the donor and the recipient may be divulged. This principle of anonymity may only be waived in cases of therapeutic necessity.

The following may be prepared from blood or its components: 1° Labile blood products, including in particular whole blood, plasma, the production of which does not involve an industrial process, whatever its purpose, and blood cells of human origin. With the exception of labile blood products intended for research involving the human person, only labile blood products whose list and characteristics are set by decision of the Agence nationale de…

Blood and blood components may be used for research purposes, whether or not they have been collected by the Etablissement Français du Sang. In this case, the research is carried out using samples taken either for medical purposes or as part of research involving the human body. In all cases, the principles mentioned in Articles L. 1221-3, L. 1221-4 and L. 1221-6 are applicable, without prejudice to the provisions of…

Labile blood products proposed for inclusion on the list referred to in 1° of article L. 1221-8 are assessed by the Agence nationale de sécurité du médicament et des produits de santé, on the basis of a dossier, the content of which is set by decision of the Agency and which may be supplied by the Etablissement français du sang, the Armed Forces Blood Transfusion Centre, any blood transfusion establishment…