French Public Health Code
In forceAny organisation that has made a prior declaration to the Minister for Research may, for the purposes of its own research programmes, ensure the conservation and preparation for scientific purposes of tissues and cells from the human body as well as the preparation and conservation of organs, blood, its components and derived products. These activities include the creation and use of collections of human biological samples. Where the organisation is a health establishment, the declaration is made jointly to the Minister for Research and the Director General of the regional health agency with territorial jurisdiction.
The term "research programme" refers to a set of research activities organised with a view to facilitating and accelerating discoveries in a specific scientific field, as defined by an organisation carrying out or promoting research activities;
The term "collection of human biological samples" refers to the assembly, for scientific purposes, of biological samples taken from a group of people identified and selected on the basis of the clinical or biological characteristics of one or more members of the group, as well as the derivatives of these samples.
The Minister responsible for research and, where applicable, the Director General of the regional health agency with territorial jurisdiction may object, within a period set by regulation, to the performance of activities declared in this way if the scientific purpose of the activity is not established, if the conditions of supply, conservation and use of tissues and cells from the human body do not provide sufficient guarantees to ensure compliance with the provisions of Title I of this book, or with the rules in force concerning the safety of persons carrying out a professional activity on the site, or with the provisions applicable to environmental protection.
The Minister responsible for research and, in the case of organisations under his authority, the Director General of the Regional Health Agency may request information from the organisation at any time to enable them to ensure that the activities are being carried out in compliance with this article and with articles L. 1211-2 and L. 1130-5. They may also at any time suspend or prohibit activities that no longer meet these requirements.
The activities provided for in the first paragraph carried out in the context of research involving the human person are governed by the provisions specific to such research.
The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) is informed of activities involving the preservation or preparation for scientific purposes of tissues and cells from the human body carried out on the same site as activities of the same nature carried out for therapeutic purposes. In this case, the suspension or prohibition of the exercise of the declared activities is automatic when requested by the Agence nationale de sécurité du médicament et des produits de santé for health safety reasons.
