Seminar with Inesa Fausch

Mini-organ prototypes in the legal spotlight: Analysis of Organoids Status, Ownership and Regulatory Challenges

Abstract

Advances in the generation of human mini-organ prototypes, or organoids, will further improve basic research, disease modelling, drug screening, the development of personalised medicine, and the perception that organoids could become potential alternatives to animals used in research. However, despite their potential, organoids pose significant challenges, particularly in terms of their status, property rights and regulation. Therefore, the presentation will be thematically divided into three parts. The first part will deal with the legal status of organoids. Notwithstanding the absence of a delineated legal status, organoids may not be perceived as persons (legal subjects).Nevertheless, it should be noted that not all types of organoids could be regarded as things (legal objects) either. Consequently, researchers may be uncertain as to the extent to which work on an organoid is legally permissible. Therefore, the status of organoids will be analysed, in particular to see whether it might differ according to the type of organoid or even according to how the organoid is used. The second part will focus on the ownership of different types of organoids, and specifically the potential commercialisation of embryonic and brain-like organoids. The final part will address whether the status of organoids could influence their concrete regulatory framework and how organoids could potentially be treated from a public law perspective.
The research on this work is funded by Swiss National Science Foundation, project Nr. 79.

Registration 

Please register no later than the 3 March 2025 at 09:00 CET using this registration form.

Bio

Dr. Inesa Fausch is a PostDoc, legal researcher and attorney-at-law with over 10 years of professional experience in health law. She is currently a researcher at Basel University within the National Research Programme "The Use of Organoids to Promote 3Rs under Swiss Law", project No. 79. In 2019, she received her PhD from the University of Basel, Faculty of Law, with the thesis "Personalized medicine as a challenge for patent law". She has held positions in state institutions and academia (University of Basel, Swiss Institute of Comparative Law), industry (Novartis AG), non-governmental organisations (AO Foundation, EUCOPE) and law firm (Ellex). Ms Fausch is the author of numerous publications in the field of health law, including "The law for mini-organ prototypes in a dish. Mapping the legal status options for organoids in Swiss law (Journal of Law and the Biosciences, Oxford University Press, December 2024), and the entry on ATMPs (with Aurelie Mahalatchimy) in the Online Encyclopaedia of EU Health Law (Oxford University Press, 2025).

In addition, Ms Fausch is the host of the interdisciplinary podcast Law in Science.