Animal testing, 3R models and regulatory acceptance: Technology transition in a risk-averse context

Abstract

Risk avoidance has resulted in a broad range of regulations to guarantee the safety of products such as pharmaceuticals and chemicals. Many of these regulations rely on animal tests. About 3 million laboratory animals are used annually in Europe to meet such regulatory requirements.Regulatory animal testing raises concerns for scientific, ethical and economic reasons. There are many 3R initiatives to replace, reduce, or refine laboratory animal use. A broad range of 3R models is available and their use is being instigated through Directive 2010/63/EU on the protection of animals used for scientific purposes (EU, 2010). However, the acceptance and use of 3R models in the regulatory domain lags behind. Regulatory acceptance is seen as one of the biggest hurdles 3R models face, but the rationale behind this process is still underexplored. This thesis analyzes the barriers and drivers influencing regulatory acceptance and use of 3R models in the regulatory domain and identifies ways to optimize this process.