Barriers and drivers of regulatory acceptance and use of 3R methods

Commitment, coordination, cooperation and communication

The past three years INT has collaborated with several partners within a project called SLiM. The SLiM project aimed to accelerate the regulatory acceptance for promising 3R methods, i.e. methods suitable to reduce, refine or replace animal testing. The SLiM project aimed specifically for test methods that could reduce or replace the number of animals used in hazard and risk assessment for toxic properties of substances in humans. These methods must overcome many barriers before being accepted for regulatory risk management purposes.

On January 16th, a concluding symposium was organized with which the project was officially concluded. During the past three years however multiple workshops organized by the project team that lead up to this concluding symposium. Many representatives from industry, regulatory bodies and research organizations participated in the workshops. Marie-Jean Schiffelers, PhD candidate at the Utrecht University School of Governance (USBO) distilled the most important drivers and barriers that act upon regulatory acceptance of 3R methods. The most important conclusions of the discussions during the different workshops as well as drawn from interviews with representatives of the stakeholders have been summarized in a workshop report, published as an article in Regulatory Toxicology and Pharmacology.

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.

Read the full article here:
Schiffelers MJ, Blaauboer BJ, Bakker WE, Beken S, Hendriksen CF, Koeter H, Krul C.
Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals:
Expert opinions on the state of affairs and the way forward.
Regul Toxicol Pharmacol. 2014 Feb 15. pii: S0273-2300(14)00031-2.