Regulatory animal testing : a survey of the factors influencing the use of animal testing to meet regulatory requirements

Abstract

Thirty percent of the animal tests conducted annually in Europe are performed to meet regulatory requirements pertaining to the authorization and release of a substance or product onto the European market. Regulatory animal testing is often repetitive in nature and more likely to cause severe suffering than other types of animal testing due to the procedures used. Because of these characteristics, regulatory animal testing is very interesting in terms of the 3R policy (Replace, Reduce and Refine). The Science Shop for Biology at Utrecht University asked the Utrecht School of Governance to conduct a survey into the actors and factors that affect regulatory animal testing. The project was commissioned by the ‘Regulatory Animal Testing’ Research Project Group, which consisted of representatives from industry, science and an animal welfare organisation. The study was conducted in the framework of the ZonMw 'Limits to Animal Testing' programme. This study surveys and describes the factors and actors that influence the use of animal testing to comply with regulatory requirements. Wherever possible, the research focussed on animal testing required by protocol for the authorization and release of pharmaceuticals. The research findings are based primarily on interviews with representatives of the main stakeholder groups (legislators, regulators, industry, science and NGOs). In other words, this study provides a survey of perceived influences. These findings are meant to help identify possible follow-up projects at the European level in order to reduce regulatory animal testing wherever possible. Regulatory animal testing is a persistent element in the assessment procedures for registering a substance or product for release onto the market. Even though the number of alternative test methods keeps increasing, these new methods are not automatically included in assessment procedures. In order to increase the use of alternative methods to comply with regulatory requirements, a number of obstacles must first be overcome. What follows below is a list of the most obvious factors influencing the implementation of the 3Rs in assessment protocols. These factors have been grouped into the following categories: technical, political/administrative and social. This survey identifies and describes the various opportunities and threats for the implementation of the 3Rs in regulatory animal testing. As mentioned before, this study is the basis for a follow-up project focusing on one or more of the factors identified. To this end, this report makes the following recommendations: - Invest in data sharing, retrospective analyses and strategic test approaches; - Use risk communication in order to influence the level of risk acceptance; - Make the costs of conducting animal tests transparent; - Widely publicize available alternatives; - Improve communication between stakeholders; - Strengthen the policy network; - Harmonize various laws and regulations.