#2026-263Decree No. 2026-263 of April 8, 2026, on the Modification of Conditions for Organ and Hematopoietic Cell Graft Activities
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The law updates the requirements for medical facilities involved in organ and hematopoietic cell transplants in France. It mandates that these facilities must have access to or agreements with intensive care units for emergency care. Additionally, it allows adult hospitals to treat children in exceptional cases when no timely alternative is available, under the supervision of the Biomedicine Agency.
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Key Changes
- Facilities must have access to intensive care units
- Adult hospitals can treat children in exceptional cases
- Involvement of the Biomedicine Agency for children's emergencies
Obligations
What this law requires
Medical facilities authorized for hematopoietic cell transplants must have an intensive care hematology unit (unité de soins intensifs d'hématologie) as an authorized activity.
Medical facilities performing organ and hematopoietic cell transplants must have access to a reanimation (intensive care) unit either on-site or through a formal agreement (convention) to provide emergency care within timeframes compatible with patient safety requirements.
Adult-only authorized hospitals seeking to treat a pediatric patient must verify with the Biomedicine Agency (Agence de la biomédecine) that no therapeutic alternative exists within a timeframe compatible with the child's health status before enrolling the child on the transplant waiting list.
The Biomedicine Agency must verify the exceptional conditions (absence of timely therapeutic alternatives) before authorizing enrollment of a pediatric patient on the transplant waiting list in an adult-only facility.