Legal framework

The Agence de la biomédecine is involved in drawing up and applying regulations governing medical genetics, prenatal diagnosis and preimplantation diagnosis. It issues approvals for practitioners, and issues opinions on the authorization of medical biology establishments and laboratories authorized to carry out genetic tests. The Agency issues authorizations to operate multidisciplinary prenatal diagnosis centers and five preimplantation diagnosis centers. It monitors, evaluates and controls these activities through inspection and vigilance missions, guaranteeing compliance with ethical and regulatory requirements.

Each year, the Agency collects and analyzes data from centers and laboratories to assess activity in this field. It also supports healthcare professionals by organizing working groups and drawing up best practice rules and professional recommendations. The Agency supports research via a dedicated annual call for tenders, and regularly informs Parliament and the Government of advances in genetics. Finally, it provides the public with information on medical genetics.

The missions and legal framework of medical genetics activities are set out in Articles L.1131-1 et seq. of the French Public Health Code. These provisions are set out in detail in decrees, orders and circulars. The Agence de la biomédecine oversees the implementation of these texts, supports healthcare professionals and provides resources to ensure optimal compliance with regulations.