Chapter VIII: Biomedicine

As part of the tasks conferred on it by Article L. 1418-1, the Agence de la biomédecine is in particular responsible for : 1° Managing the national list of patients waiting for organ and corneal transplants mentioned in Article L. 1251-1, the register of pairs of living donors and potential recipients who have consented to cross-organ donation mentioned in 7° of Article L. 1418-1 ; 2° The management and operation…

I.-The national register mentioned in 4° of Article R. 1418-1 comprises three files: 1° The file relating to voluntary donors of haematopoietic stem cells and peripheral blood mononuclear cells; 2° The file relating to placental blood units; 3° The file relating to patients awaiting a haematopoietic stem cell transplant in France or abroad. II – The Agency is responsible for 1° Managing the national register of voluntary donors of haematopoietic…

In order to monitor, evaluate and, where necessary, control the medical and biological activities provided for in 4° of Article L. 1418-1, the Agency shall carry out a quantitative and qualitative analysis of the information it has on these activities and on the techniques used, including therapeutic alternatives to transplantation, as well as an analysis of the results obtained.

In order to monitor the state of health of persons who have made an organ or oocyte donation as referred to in 6° of article L. 1418-1, the Agency uses directories concerning them, the creation, content and conditions of use of which are determined under the conditions defined by law no. 78-17 of 6 January 1978 relating to information technology, files and freedoms.

The Agency is informed by the regional health agencies of any failure to comply with the rules applicable to the medical and biological activities falling within its remit. It shall propose to the Minister for Health any measures required to remedy the situation. It informs the Agence nationale de sécurité du médicament et des produits de santé of any breaches of the rules of good practice referred to in articles…

At the request of the Minister for Health and under his authority, the Agency participates, in the fields within its remit, in the drafting of Community rules and international agreements, as well as representing France in all international bodies. In addition, as part of its international cooperation activities, it promotes the development abroad of activities falling within its remit.