Legal framework

The Agence de la biomédecine is responsible for monitoring and evaluating incidents and adverse events occurring during the collection, processing, storage and administration of breast milk for therapeutic use. Through this biovigilance system, the Agency contributes to identifying potential risks, improving the traceability of undesirable events and promoting the continuous improvement of healthcare professionals' practices in this field. It draws up recommendations and tools for healthcare establishments and lactariums to guarantee health safety throughout the process.

The legal framework for the Agence de la biomédecine's activities in this field is based on Article 173 of Law n°2016-41 of January 26, 2016 on the modernization of our healthcare system, which transfers breast milk biovigilance to the Agence. This legislative provision is supplemented by Decree n°2016-1622 of November 29, 2016, which specifies the definitions, the reporting procedures for incidents and adverse effects, and the responsibilities of the various players involved. The Agence de la biomédecine oversees the implementation of these texts, supports healthcare professionals and provides resources to ensure optimal compliance with regulations.