Legal Framework in Europe for Developing Alternatives to Experimental Animals

According to Article 7.2 of EU Directive 86/609/EEC (EU Commission, 1986) on the use of experimental animals "... an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available". Moreover, in the same Directive it is proposed in article 23 that "... the Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals, but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. The commission and Member States shall monitor trends in experimental methods". The German animal welfare legislation (Tierschutzgesetz) is taking into account the principles of EU Directive 86/609/EEC as far as the protection of laboratory animals is concerned.

To promote the implementation of the EU Directive 86/609/EEC on the use of experimental animals, the European Commission and several Member States have established centers for the validation of alternative methods. For example, in 1989 ZEBET, the German Centre for the Documentation and Evaluation of Alternative Methods, was established at the Federal Health Institute BGA in Berlin, and in 1993 ECVAM was established at the JRC in Ispra, Italy. In the UK, FRAME had already been established before EU Directive 86/609/EEC had been adopted, and in the Netherlands, the National Centre for Alternatives (NCA) was established in 1992 in the National Institute of Health (RIVM) in Bilthoven. However, since ECVAM was established in 1993, none of the other EU Member States has established a national center for the promotion of alternatives to testing in animals; while more recently, in 2001, in Poland the NCA "Vitryna" started its activity at the Nofer Institute for Occupational Health in Lodz.

In the USA, several institutions serving the development of alternative methods have been established during the past two decades. These included, in 1981, the Johns Hopkins University alternatives center CAAT (Centre for Alternatives to Animal Testing), in Baltimore; in 1997, the Institute for In Vitro Sciences in Gaithersburg (MD); and in 1998, the validation center of the federal government ICCVAM (Interagency Co-ordinating Centre for the Validation of Alternative Methods) in Washington DC. Finally, in 2005, the government Japanese Validation Centre JaCVAM was established at the NIH in Tokyo.

To provide an example of the duties assigned to validation centers, the national German center ZEBET has served the following mission:

• to establish a database and information service on alternatives at the national and international level;

• to develop alternatives according to the 3Rs principle of Russell and Burch;

• to fund research on alternatives;

• to co-ordinate validation studies;

• to co-operate with national and international funding agencies and validation centers; and

• to provide a forum for information on alternatives to animal testing.

At the Federal Institute for Risk Assessment BfR, ZEBET's main activity is the reduction of animal tests conducted for regulatory purposes. The EU validation center ECVAM is also focusing its activity on reducing regulatory safety testing in animals, and the US validation agency ICCVAM is serving a similar mission. ECVAM and ZEBET have funds to support the development and validation of alternative methods, while ICCVAM has so far limited its activity to evaluating the results of validation studies conducted elsewhere.

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