Book II: Donation and use of human body parts and products

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…

An order by the ministers responsible for health and social security sets the prices for the sale of labile blood products, with the exception of plasmas for transfusion purposes covered by 1° of article L. 1221-8. For Guadeloupe, French Guyana, Martinique, Mayotte and La Réunion and for Saint-Barthélemy and Saint-Martin, an order from the ministers responsible for overseas departments and territories, health and social security may determine increases to the…

Labile blood products intended for direct therapeutic use are stored, with a view to their distribution and issue, at the Établissement Français du Sang and at the Armed Forces Blood Transfusion Centre. Health establishments and army hospitals authorised for this purpose by the administrative authority after receiving the opinion of the Établissement français du sang or, where applicable, the army blood transfusion centre, under conditions defined by decree, and the…

The Agence nationale de sécurité du médicament et des produits de santé may, after obtaining the opinion of the Etablissement français du sang and the armed forces blood transfusion centre, regulate the use of labile blood products. The Agency may impose special conditions, restrict, suspend or prohibit their use in the interests of public health.

Any violation in a health establishment, in an army hospital or in one of the structures mentioned in 1° to 3° of article L. 1221-10 and due to the latter, of the legislative and regulatory requirements relating to the storage of labile blood products with a view to their delivery, as well as the terms of the authorisation mentioned in the first paragraph of article L. 1221-10 , shall result…

Advertising for the substances mentioned in article L. 1221-2 is prohibited. Medical information and information intended to indicate the location of depots do not constitute advertising. By way of derogation from the first paragraph, promotional communication aimed at healthcare professionals relating to plasmas in the production of which no industrial process is involved, mentioned in 1° of article L. 1221-8, is authorised under the conditions defined in chapter III of…

The importation, by any organisation whatsoever, of a labile blood product or a plasma paste, for direct therapeutic use or intended for the preparation of health products, is subject to authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé under conditions defined by decree. The import or export of blood, its components or derived products for scientific purposes is subject to authorisation from the…

The purpose of haemovigilance is to monitor and evaluate all incidents and adverse reactions occurring in donors or recipients of labile blood products. It covers the entire transfusion chain, from the collection of labile blood products to the follow-up of recipients. Haemovigilance also includes epidemiological monitoring of donors. Health professionals, blood transfusion establishments and health establishments report and declare information relating to haemovigilance. A decree in the Conseil d’Etat shall…

Victims of injury resulting from contamination by the hepatitis B or C virus or the human T-lymphotropic virus caused by a transfusion of blood products or an injection of blood-derived medicinal products carried out in the territories to which this chapter applies shall be compensated on the basis of national solidarity by the Office mentioned in Article L. 1142-22 under the conditions laid down in the second sentence of the…