Lyon, France, August 24th, 2023 – The Alliance Promotion Microbiote (APM), a prominent player dedicated to the development, production, and commercialization of therapeutic microbiome-based innovations, applauds a new legislative advancement with the publication of a decree[1] in the Official Journal on August 19, 2023. This decree establishes compensation terms for therapeutic stool donors and follows two implementing decrees[2][3] of Article 35 of Law No. 2021-1017 of August 2, 2021[4], related to bioethics, published in the Official Journal on July 28, 2023.
Since 2015 and building upon the initial stance taken by the French National Agency for Medicines and Health Products Safety (ANSM), France has emerged as a pioneering force in Europe for regulating microbiome-based therapies. The recent text clearly acknowledges the strict and specific constraints regarding stool donation and stipulates that “entities and organizations collecting stools for the preparation of fecal microbiota for therapeutic purposes can compensate donors for the endured constraint, up to a limit of 1,000 euros per month and 5,000 euros per year.” This progress effectively ensures the safety and sustainability of stool collection for medical and scientific applications within the microbiome field, particularly among stakeholders in France.
Sylvie Binda, Vice-President of Alliance Promotion Microbiote, states, “This significant achievement highlights France’s dedication to advancing medical progress in microbiome by establishing a clear legislative and regulatory framework for the entire industry. The APM takes pride in its instrumental role in this initiative and expresses satisfaction with the constructive interactions held with dedicated authorities, which played a pivotal role in shaping these diverse texts. Additionally, we extend our appreciation to the donors whose dedication drives forward microbiome research and facilitates access to patients of safe and effective treatments.”
About Alliance Promotion Microbiote
Created in 2022, the Alliance Promotion Microbiote is a nonprofit and independent entity that brings together over 20 key players from both the public and private sectors. Encompassing the full spectrum from laboratory research to patient care, APM covers the complete value chain of the microbiome industry. It aims to position France as a leader in Europe for developing, producing, and commercializing microbiome therapeutic innovations.
Members of APM include: Bioaster, Biocodex, Biofortis, Biose Industrie, Cynbiome, Eligo Bioscience, EverImmune, GMT Science, INRAE, INSERM, Lallemand Health Solutions, Lyonbiopôle, Luxia Scientific, MaaT Pharma, Medicen, Nexbiome, Novobiome, Seventure Partners, Skyepharma, and TargEDys.
Media contact
Alliance Promotion Microbiote I E-mail: contact@europeanmicrobiome.org
[1] French only – Arrêté du 1er août 2023 relatif à l’indemnisation des donneurs de selles destinées à une utilisation thérapeutique – Légifrance (legifrance.gouv.fr)
[2]French only – Décret n° 2023-672 du 27 juillet 2023 relatif à l’autorisation de l’activité de collecte de selles et de l’importation de selles ou de préparations de microbiote fécal – Légifrance (legifrance.gouv.fr)
[3] French only – Décret n° 2023-673 du 27 juillet 2023 relatif à l’encadrement de l’activité de collecte de selles et de l’importation de selles ou de préparations de microbiote fécal – Légifrance (legifrance.gouv.fr)
[4] French only – Article 35 de la loi n° 2021-1017 du 2 août 2021 relative à la bioéthique, (CSP, art. L. 513-11-1) – ajout d’une nouvelle catégorie de produits de santé en inscrivant le microbiote fécal en tant que médicament et définition d’un cadre juridique à la collecte des selles à des fins thérapeutiques.
