Exploring Alternatives to Animal Testing: Scientific, Legal and Ethical Challenges in Developing Novel Alternative Methods with a Focus on Organoids as Potential NAMs

Abstract

Organoids are multicellular, three-dimensional structures derived from stem cells. They require an extracellular matrix and are capable of recapitulating cell types, organ structure, and organ function. Their characteristics indicate the potential for a wide range of applications. Moreover, they have the potential to promote and serve the 3R principle – i.e. the replacement, reduction and refinement of animal testing. To this end, however, organoids have to be accepted as so-called novel alternative methods or new approach methodologies (NAMs). NAM’s main objective is the promotion of the 3R using non-animal research methods. In this paper, we outline and analyze the legal and regulatory framework that governs the 3R-principle, the use of NAMs as well as the use of organoids using the example of Swiss law. In doing so, we identify concrete important limitations on the use of organoids as NAMs: their validation requires substantive financial and personal commitments and even a successful validation does not lead to their widespread adoption. Against this background, the paper makes first proposals to promote the adoption of organoids as NAMs.