2.1. The reduction, refinement and replacement of animal experimentation (the three "R"s)

The use of animals in experimentation, teaching and the evaluation of products has important ethical, social, political, scientific, industrial and legal implications.

 The concept of alternative methods. The origins of the search for new methods and procedures for a more reduced and adequate use of animals in basic and applied research were defined by the publication of the book "The Principles of Human Experimental Technique", by Rusell & Burch, in 1959. This volume was the result of a profound scientific and ethical analysis of trials conducted in animals, of their true utility and of the possible experimental alternatives. This work gave rise to the concept of Alternative Methods, which encompasses all those approaches that lead to the Refinement (Perfection) of animal experimentation methods, a Reduction in the number of animals used, and the Replacement of such practices by methods in which animals are not used.

 Ethical implications. Many ethical considerations apply to the use of living organisms for scientific purposes, based on the basic principle of respect for life - which moreover entails the avoidance of any type of suffering. In practice, this is often conditioned by the need or obligation to conduct certain trials. In any case, it is essential to previously establish a balance between the benefits expected and the damage that may be inflicted - in addition to sufficiently establishing the true validness and utility of the procedures employed for a specific purpose, and their possible alternatives. 

Scientific aspects. From the scientific perspective, animal models are not the most appropriate solution in all cases. It is almost always possible to improve such models and, in many cases, to replace them. Moreover, there have been important technical advances in models and bioindicators that should be applied by scientists. The alternative methods used in pharmacology, toxicology, biochemistry, etc, have experienced a spectacular growth in recent years - both from the scientific developmental aspect and in terms of their social impact. At present, it is possible to affirm that such alternative methodology constitutes a scientific activity in its own right, with a clearly defined setting and potential for application; furthermore, it has given rise to scientific societies, meetings and publications in journals that are firmly consolidated in the western world. This has been due on one hand to the existence of a receptive social context in favor of the reduction of animal utilization for experimentation purposes, and on the other to the pioneering and integrating efforts of many scientists who - by agglutinating efforts through scientific organizations, associations and societies - have managed to conform an obliged reference point for the social mediators.

 Logistic, economical and industrial implications. In real terms, consideration is also required of different economical and logistic criteria, for in many cases in vitro experimentation is less costly than in vivo studies and, in particular, may yield results in much less time. In vitro research thus has great appeal in the industrial setting.

 Social pressure. Since the fifties there has been a growing social movement, reflected in the consolidation of different groups concerned about animal experimentation. Examples include the Universities Federation for Animal Welfare (UFAW), the Fund for the Replacement of Animals in Medical Experiments (FRAME), and the International Council Laboratory for Animal Science (ICLAS). In 1976, several of these groups organized the Campaign of the Year for Animal Wellbeing in the United Kingdom, and managed to introduce changes in current legislation on experimentation. In 1980, 400 organizations from all over the world supported a Coalition to attempt to abolish the Draize eye irritation test. Posteriorly, the alliance between the British Veterinary Association, the Committee for the Reform of Animal Experimentation, and the FRAME, exerted a decisive influence upon the new British legislation of 1986. In Spain, social pressure groups contrary to animal experimentation have also developed - including the Association for the Defense of Animal Rights (ADAR)(Asociación para la Defensa de los Derechos de los Animales, ADDA), the Association for the Defense and Prevention of Cruelty to Animals (ADPCA)(Asociación para la Defensa y Prevención de la Crueldad con los Animales, ADPCA), and the National Association for the Defense of Animals (NADA)(Asociación Nacional para la Defensa de los Animales, ANDA).

 Legal implications. The great social pressure and scientific advances have had important political and legal repercussions that have in turn given rise to the adoption of a number of decisions of great relevance to researchers: 

q       The Directives of the Council 86/609/CEE on the Protection of Animals in Experimentation, promoted in Spain by Royal Decree 223/1988 of March 14, 1988, the basic points of which are reflected below:

-          Experiments with animals should not be conducted if some other scientifically satisfactory and reasonable procedure is available to obtain the desired information.

-          The choice of animal species should be made with care. Experiments should involve the fewest animals possible, with the lowest degree of neurophysiological sensitivity, and inflicting the least possible pain, suffering and stress to most likely yield satisfactory results.

q       In 1993, the Member States of the European Union agreed to adopt the necessary measures to reduce by 50% the number of vertebrates used for scientific purposes by the year 2000 (COM (92)23 final, DOCE C138, 1-98).

q       Directive 93/35/EEC prohibited the evaluation of cosmetics in animals since 1998, though its implementation has been postponed until the year 2000 - once scientifically validated in vitro methods become available.

q       There is increasing protest over the stressing and painful technique used to produce antibodies by inducing ascites in animals. To the activity of the antivivisection societies of the United States, a declaration was contributed in 1998 by the Advisory Scientific Committee of the European Center for the Validation of Alternative Methods (ECVAM), pointing out the existence of available alternative procedures. At present, it is already prohibited to use animals for producing antibodies by the so-called ascitic method in the Netherlands - a prohibition that will most probably soon extend to the rest of Europe.

 In order to coordinate this entire process, the European Union created the ECVAM, which has been found to represent a highly dynamistic force for the development, validation and acceptance of alternative methods to animal experimentation. 

In view of the mentioned ethical, social, political, scientific, industrial and legal implications, alternative methodologies presently center a great deal of attention.