The law for mini-organ prototypes in a dish. Mapping the legal status options for organoids in Swiss law.

Abstract

Advances in generating human mini-organ prototypes will further improve fundamental research, disease modeling, drug screening and the development of personalized medicine. Currently, there is no legal definition, identified legal status, or existing regulatory framework for organoids. Ethical discussions regarding brain and embryo-like mini-organ models leave researchers uncertain about the extent to which work on any organoids is legally permissible. The legal protection of human embryos, many other separated human body parts as well as organoids is more complex than the application of the traditional rules of rights in rem or of the law of personality alone. The paper's focus is to examine whether the legal status of organoids or lack thereof, could influence their concrete regulatory framework, or whether a legal status in private law is necessary for their regulation. This paper deliberately chooses not to attempt a unifying theory of law but rather to argue for a possible regulation of organoids using the example of Swiss law. While, at present, there is no comprehensive research addressing either the status or the regulation of organoids, we believe that the argumentation presented could improve the overall understanding of how a potential organoid regulation could be set out within national legal frameworks.