Organoids – “mini organs” derived from stem cells – represent a promising alternative to animal testing. They could ultimately be used in a wide range of settings and have an impact on the 3Rs, by refining, reducing and, to an extent, replacing animal testing.

Organoids could bridge the gap between preclinical and clinical research (human trials); for example, as part of drug testing procedures. However, there are several legal issues relating to their development, status and use that must be clarified before their potential can be fully exploited.

“The legal status of organoids is currently relatively unclear in Switzerland,” explains Alfred Früh, Professor of Private Law at the University of Basel. For example, where does the law stand on organoids grown from human stem cells? Does it make a difference legally whether the organoids are derived from heart, brain or embryonic tissues?

The project will investigate how Swiss law approaches organoids and ask whether the current legal framework supports the 3R principles. In particular, it will seek to ascertain whether the law needs to be adapted and if so, what the changes might look like. “Our findings will provide legal clarity for researchers, as well as for legal experts in hospitals, at universities and in technology transfer. A solid legal foundation is urgently needed for practical applications if this technology is to be used in future.”