AETOX - Asociación Española de Toxicología

Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the use of Laboratory Animals (Refinement, Reduction or Replacement)+

Inventory: 6. A New Context in the use of Laboratory Animals

6.1.- European legislation

The social pressure and scientific advances produced have promoted important political and legislative changes. Among several important decisions for researchers are the following:

The most important was the European Directive 86/609/EEC, of 24 November 1986, concerning the protection of animals used for scientific purposes. In particular this Directive states, at Art. 23:

"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 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"

According to Article 7.1, experiments only will be carried out by authorized competent people or under their direct responsability.

The three Rs are included in Article 7, as follows:

7.2 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 practically available.

7.3 When an experiment has to be performed, the choice of species shall be carefully considered and, where necessary, explained to the authority. In a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected.

7.4 All experiments shall be designed to avoid distress and unnecessary pain and suffering to the experimental animals.

Similar words are used in the Council of Europe Convention for the protection of vertebrate animals used for experimental and other scientific purposes (EEC 1986b), urged to be signed and followed, particularly in relation to education and training, by the European Member countries by the Council Resolutions 86/C331/01 and 86/C331/02.

In 1993 the Member States of the European Union resolved that the number of vertebrate animals used for scientific purpuses should be reduced by 50 % to the year 2000 (COM (92) 23 final, DOCE C138, 1-98)

Moreover, art. 4 of Directive 76/768/EEC, as modified by the Sixth Amendment (Council Directive 93/35/EEC of 14 June 1993) established that after January 1, 1998, cosmetic ingredients or combinations of such ingredients tested on animals would not be allowed on the market. A recent directive established the postponement of the date mentioned for not less than two years (30 June 2000) until in vitro methods were validated (97/18/EEC).

There are movements against the in vivo production of monoclonal antibodies by the ascites method. The ECVAM Scientific Advisory Commitee have endorsed an statement about the availability of scientifically acceptable in vitro methods for all levels of monoclonal antibody production. The regulation of some countries (The Netherlands, UK, Germany, Switzerland...) prohibit the ascites method, and it is expected that many others will do so in the near future.

Adherence to regulations and guidelines not primarily designed to promote animal welfare, such as those associated with Good Laboratory Practice and international standards such as ISO 9001 or UNE 45001, might also lead to a reduction in the use of animals, because they ensure that procedures are carried out consistently, to predefined standards which are less likely to be erroneous or inappropriate (de Vrey, 1997).

Legislation and internal review procedures employing inspectors and/or ethics or animal experimentation committees have been developed, in part, as a response to the demand for the use of humane techniques. However, the law and requirements for review procedures vary between countries, and between institutes or companies within a country (Festing et al., 1998).

6.2.- Spanish legislation

The Real Decreto 223/1988 on the Protection of animals used for research and other scientific purposes, of 14 March 1988, published 18-12-88, incorporates the Council Directive 86/609/EEC into Spanish legislation. Some points can be outlined:

Article 11.1 states that experiments only could be carried out by competent people (researchers, project responsibles or specialists) or under their direct responsability. Authorization is not required, in contrast to the specifications of the European Directive 86/609/EEC.
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 practically available (Article 11.2).

According to article 4, the registration of public establishments correspond to the Ministry of Agriculture, Fishing and Food, while regional authorities are responsible for the rest, and for the communication to the Ministry of the animals used.

Requirements for registration of establishments and their obligations are referred in Article 6, including the notification of the number of animals used, and the prevision of use in 3 months time.

Thanks to a Ministerial Order of 13 October 1989 (E, 1989), that develop the Real Decreto 223/1988, the rules for the registration of producer, and animal user establisments and for the authorization for the employement of animals are established. The order is focussed on public and not in private establisments, as public centres are under the direct competence of the Ministry of Agriculture.

The Instrument of Ratification of European Convention for the protection of vertebrate animals used for experimental and other scientific purposes was signed and published in the 25-10-90 (E, 1990).

The Real Decreto 822/1993, of 28 May, established the Principles of Good Laboratory Practices and their application to non-clinical studies on substances and chemicals, have influence in toxicity testing studies.

6.3.- Regional legislations

As the Spanish organization is nearly federal in structure, many of the responsibilities in relation to animal experimentation are transferred to the regional governments. They are particularly responsible for the registration of non-public establishments, and for the communication to the Ministry Agriculture, Fishing and Food of the animals used within their regions. However, up to now, only two of the Spanish regions have established their own legislation:

1 Catalonia: The Law 5/95 of 21 June, published the 10-7-95 (DOGC), on the Protection of animals used for research and other scientific purposes, was completed with the Decreto 214/1997 of 30 July, and the Decreto 164/1998 of 8 July, that modify some aspects of the decreto 214/1997. Among the improvements introduced to the national legislation, ethical commitees are required for every centre, and a Commission on Animal Research was created.

2 Navarra has a Foral Order of 5 August 1991 to assure the fulfillment of the RD 223/1988, with no further specification.

3 Other regions (Galicia, Cantabria, Canarias, Madrid, Murcia, Baleares, Pais Vasco...) have prepared legislation more focused on domestic animals.

Fuente / Source: Guillermo Repetto, Ana del Peso, Manuel Salguero, Manuel Repetto (1999) Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the use of Laboratory Animals (Refinement, Reduction or Replacement) Revista de Toxicología 16: 50-127.