Reductions in Experimental Animal Numbers During the Past Decade in Europe The Situation in Germany

In 1989, EU Directive 86/609/EEC, for the first time, allowed government authorities in EU Member States to collect test animal numbers according to a standardized procedure [2]. Since that time, the annual numbers of experimental animals in Germany have decreased from 2.7 million in 1989 to 2 million in 2004. A closer analysis shows that the decrease was predominantly due to a reduction in animal numbers used for the development of drugs, which fell by more than 50% in the same 15-year period, from 1.4 million to 0.5 million. The decrease was even more impressive when taking into account earlier data provided by the German association of drug manufacturers, which showed that in 1977 a total of 4.4 million experimental animals was used for the development and safety testing of new drugs in Germany (Fig. 10.2) [3].

This dramatic fall in laboratory animal numbers has not been due to the high priority which EU Directive 86/609 gives to the development of in-vitro alternatives, but rather to general changes of methodology in the life sciences, from animal models to molecular biology and genetics, including cell and tissue culture models. In the field of drug development the new technology allows the high-throughput screening (HTS) of thousands ofnew drug candidates. This approach is, of course,

Fig. 10.2 Test animal numbers used by the German drug industry between 1977 and 2004. The data for 1977 were collected by the German Drug Manufacturers' Association (Bundesverband der Pharmazeutischen Industrie, BPI); the data for 1989 and 2004 were officially compiled by the German Federal Minister of Agriculture according to EU Directive 86/609/EEC.

Fig. 10.2 Test animal numbers used by the German drug industry between 1977 and 2004. The data for 1977 were collected by the German Drug Manufacturers' Association (Bundesverband der Pharmazeutischen Industrie, BPI); the data for 1989 and 2004 were officially compiled by the German Federal Minister of Agriculture according to EU Directive 86/609/EEC.

more predictive, faster and cheaper than animal models, which in the past have been used successfully for drug development. However, at the same time, it has proven extremely difficult to reduce animal numbers in regulatory safety testing by non-animal methods, as the established endpoints in toxicity tests in laboratory animals are usually organ-specific and cover endpoints that are quite similar to the situation in humans.

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