Objective: Human cells procurement is the basis of biomedical research and, consequently, of the production of innovative therapies. In France, multiple procedures apply and overlap, which results in a complex regulatory landscape. The objective of this work is to provide a clear overview of the existing regulatory pathways for cell procurement, to assist stakeholders in navigating these various procedures and identifying easily the one most relevant to their respective cases.

Methods: First, we identified the relevant legal texts and their specific provisions that cover the procurement of human cells. Second, taking into account the identified relevant academic literature, we analysed them to determine the applicable legal frameworks as well as the areas of uncertainty that need clarification. Third, we used graphical representations to improve the accessibility of these applicable procedures.

Results: An array of procedures governs the use of human cells, depending on the source of the cells, the activities conducted with them, and the type of finished product. In certain contexts, multiple procedures may overlap. Although some existing resources explain each procedure individually, it remains challenging to identify all relevant frameworks applicable to specific activities. This issue is even more salient for (stem) cells researchers who must implement them to conduct their activities. While there are calls to simplify some of these frameworks by relying more on the accountability of actors, there has been no clear signal of legislative change in the near future.

Conclusion: While the French regulatory approach is complex, it is rooted in a strong ethical commitment, with particular attention paid to ethical issues in the bioethics law. However, this traditional stance has been increasingly challenged by international pressure to develop a more competitive research environment. As a result, the French legal framework for human cell procurement and biomedical use is shaped by this tension between ethical caution and the drive to increase competitiveness. Whether the ongoing calls for reform will translate into substantive changes remain a question of public and policy discussion.