Panels of experts were assembled to identify barriers to the acceptance of 3R pharmaceutical and chemical testing models in the E.U., and examine how to address the barriers, within the affected industries and in broader regulatory and cultural contexts. Chemical experts were more divided than pharmaceutical experts on the most significant barriers. The experts felt that better training and data on the new methods was needed, and called for subsidies. Regulatory changes are also needed to encompass the new procedures. The general public needs to feel sure that the new methods are safe, but less harmful to animals.

[Abstract excerpted from original source.]

“Pharmaceuticals and chemicals are subjected to regulatory safety testing accounting for approximately 25% of laboratory animal use in Europe. This testing meets various objections and has led to the development of a range of 3R models to Replace, Reduce or Refine the animal models. However, these models must overcome many barriers before being accepted for regulatory risk management purposes. This paper describes the barriers and drivers and options to optimize this acceptance process as identified by two expert panels, one on pharmaceuticals and one on chemicals. To untangle the complex acceptance process, the multilevel perspective on technology transitions is applied. This perspective defines influences at the micro-, meso- and macro level which need alignment to induce regulatory acceptance of a 3R model. This paper displays that there are many similar mechanisms within both sectors that prevent 3R models from becoming accepted for regulatory risk assessment and management. Shared barriers include the uncertainty about the value of the new 3R models (micro level), the lack of harmonization of regulatory requirements and acceptance criteria (meso level) and the high levels of risk aversion (macro level). In optimizing the process commitment, communication, cooperation and coordination are identified as critical drivers.”