Advice: Framework for Prioritising Animal Experiments for Replacement

It is currently not yet feasible to replace animals in safety and toxicity tests and fundamental and translational research, with animal-free alternatives or New Approach Methodologies (NAMs), on a large scale. Nevertheless, there is increasing attention for the development of these NAMs.

In 2021, we decided to investigate whether it was possible to prioritise which animal experiments should be replaced with NAMs first. We asked Corné Rademaker, who is an ethicist and member of several animal ethics committees, to write a report on prioritising animal experiments for replacement. The report prepared by Rademaker amounts to a comprehensive review of criteria by which animal models could be prioritised for replacement by animal-free alternatives.

Rademaker recommends to prioritise to the replacement of animal models that:

1. Have a low degree of translatability, and/or;
2. Serve peripheral goals, and/or;
3. Cause severe suffering, and/or;
4. Seriously violate the integrity (species-specific ability) of animals

We responded to Rademaker’s report in the form of an advisory report. This advisory report reflects on the criteria described by Rademaker. We also discuss the implications of Rademaker’s report for harms-benefit analyses and how the report can steer the prioritisation of the development and validation of NAMs.