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

The Etablissement Français du Sang is a public establishment under the supervision of the Minister for Health. It is responsible for meeting the need for labile blood products and for adapting transfusion activities to medical, scientific and technological developments, while respecting ethical principles. It organises blood collection, the biological qualification of blood donations, the preparation, distribution and supply of labile blood products and their quality control throughout France, within the…

I.-Subject to the provisions of article L. 5124-14, the Etablissement français du sang is responsible for developing all activities relating to blood transfusion, advice and monitoring transfusion procedures. As such, it may be authorised to manufacture, import and use blood-derived medicinal products as defined in b of 18° of article L. 5121-1. These activities are carried out under the responsibility of a responsible pharmacist participating in the general management of…

Compliance, at the Etablissement Français du Sang, with the legislative and regulatory provisions relating to the quality and safety of labile blood products is guaranteed by a responsible person appointed for this purpose by the President of the Etablissement Français du Sang under conditions laid down by decree in the Conseil d’Etat.

The Etablissement Français du Sang may only use labile blood products from collections made outside French territory with the authorisation of the Agence Nationale de Sécurité du Médicament et des Produits de Santé. This authorisation may only be granted if the needs of blood transfusion so require and on condition that the blood or derived products in question offer sufficient guarantees with regard to the safety of blood transfusion, in…

The Etablissement Français du Sang is subject to an administrative, budgetary, financial and accounting system and to State control adapted to the particular nature of its missions, defined by this chapter and specified by regulation.

The Etablissement Français du Sang is administered by a Board of Directors, half of whom are representatives of the State and half of whom are representatives of health insurance organisations, health system user associations approved under article L. 1114-1 and blood donor associations, health establishments, two representatives of the establishment’s staff and qualified personalities, in particular practitioners. The establishment’s Board of Directors also includes the Chairman of the Scientific Advisory…

Decisions relating to appointments, approvals and authorisations provided for in this code and to their withdrawal are taken, insofar as they fall within the remit of the Etablissement Français du Sang, by the President of the establishment, after obtaining the opinion of the Board of Directors, with the exception of those provided for in article L. 1222-3, for which the President of the Etablissement Français du Sang informs the Board…

The staff of the Etablissement Français du Sang include : 1° Employees governed by titles II, III or IV of the general statute of civil servants, employees mentioned in 1° and 2° of article L. 6152-1, or public employees governed by special statutes, on secondment or secondment; 2° Staff governed by the Labour Code. The conditions of employment of Etablissement Français du Sang staff mentioned in 2° above are determined…

The revenues of the Etablissement Français du Sang are made up of : 1° Income from activities relating to labile blood products ; 1° bis Income from activities relating to the supply of plasma for transfusion purposes covered by 1° of article L. 1221-8, the terms and conditions of which are laid down by decree in the Conseil d’Etat; 2° Income from ancillary activities; 3° Fees for services rendered established…

The Etablissement Français du Sang assumes responsibility, even without fault, for the risks incurred by donors as a result of blood collection operations. It must take out insurance to cover its liability for these risks.