The Use of Transgenic Animals in the European Union: The Report and Recommendations of ECVAM Workshop 28.

Transgenic animals present unique possibilities for medical, agricultural and fundamental research, and as a means of producing valuable pharmaceutical and nutrient products. Their use has increased dramatically in recent years and is set to increase further in the near future. It has been claimed that transgenic animals might allow reduction and refinement in animal use, via more-precise gene targeting in breeding programmes. However, these objectives are threatened by transgenic procedures which may promote greater animal use, more-varied applications, and the greater likelihood of animal suffering. Current legislation on animal experimentation, for example, Directive 86/609/EU, was passed and implemented before the full implications of transgenesis were recognised. For this reason, ECVAM organised a workshop which was held in Southwell, Nottinghamshire, UK, on 7-11 April 1997. The aim of this workshop was to reach a consensus on a set of guidelines designed to assist regulatory authorities in their decision-making process. The conclusions of the workshop are subdivided into general considerations, proposals to use transgenic animals, production and use of transgenic animals, specific considerations relating to animals used as basic research/disease models, animals used in testing for toxicity and carcinogenicity, and transgenic farm animals. 14 recommendations have been derived from these conclusions and should make an important contribution to ensuring that the interests and welfare of animals are given due respect. They demonstrate a willingness by scientists to respond to public concerns and they should facilitate a consistent, harmonised and equitable regulatory approach within the EU.