Legal framework

The French Bioethics Act defines the fundamental principles governing research on the human embryo and human embryonic stem cells. It also provides a framework for research using human induced pluripotent stem cells. Research is authorized if :

• the scientific relevance of the research is established ;
• the research has a medical purpose or aims to improve knowledge of human biology;
• the project and the conditions under which it is carried out respect the fundamental and ethical principles enshrined in law.

Certain practices are strictly prohibited by law:

• the creation of embryos for research purposes ;
• the introduction of cells from another species into a human embryo;
• the culture of a human embryo beyond 14 days.

All embryo research projects must be registered with the Agence de la biomédecine. After examination and approval by its Steering Committee, the Agency issues :

• authorizations for research protocols involving the human embryo and human embryonic stem cells ;
• authorizations to import and export human embryonic stem cells for research purposes;
• Research using human induced pluripotent stem cells is also subject to prior declaration.

The Agency monitors, evaluates and controls authorized research projects. It may oppose the implementation of a research protocol, or suspend or withdraw an authorization in the event of a breach of regulatory obligations.

The missions and legal framework of embryo research are set out in articles L. 2151-5 to L.2151-9 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.