CHAPTER 2
THE REGULATION OF EXPERIMENTS ON CATS AND DOGS
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Animal experiments conducted in member states of the European Union (EU) are regulated according to European Directive 86/609/EEC (25). The Directive provides a minimum legal framework: member states may control animal experiments more stringently if they wish, as long as they fulfil their obligations under the Directive. Member states were obliged to implement the Directive by 24 November 1989.

Directive 86/609/EEC
The Directive controls the purposes for which animal experiments may be done; provides measures to ensure basic standards of housing and care; requires that the amount of harm done to animals shall be minimised; and has provisions relating to the sources of laboratory animals, the notification in advance of proposed experiments, the education and training of persons who conduct experiments and the registration of laboratories which perform experiments.

Pain, suffering and the Three Rs Principles
Regarding anaesthetics and analgesics, the Directive states that anaesthetics must be used unless their administration causes more suffering than if they were not used; or unless anaesthetics are incompatible with the purpose of the experiment. Analgesics must be used to ensure, as far as possible, that pain and suffering do not occur, or are limited to the absolute minimum; and certainly to ensure that no animal suffers severely.
It is important to realise that some pain and suffering are relatively common features of animal experiments, as a substantial proportion of experiments, including those on cats and dogs, are conducted without anaesthetics. Equally, analgesics are not always used if they might interfere with the experiment, for example in the case of toxicity tests, which can severely harm and kill animals. Dogs are frequently used in toxicity tests (see Chapter 4).

The Directive requires that animals are provided with housing and some freedom of movement appropriate to their health and well-being. Any restriction on the extent to which animals can satisfy their physiological and behavioural needs should be “limited to the absolute minimum” (Article 5). Confining animals on their own, or in cages (as opposed to pens), even for a short time can cause distress – especially if they are used to living in social groups and with more available space. In some of the Case Studies in this Report (Chapter 6), animals were confined singly and/or in cages prior to or during the experiment, without justification being made in the published paper. The Three Rs Principles are enshrined in the Directive (Articles 7[2], [3] and [4] and 23[1]). Accepted worldwide (26), the principles require those responsible for conducting and regulating animal experiments to implement valid Replacement methods (which do not use living animals); to Refine experimental protocols in order to minimise animal suffering; and to Reduce the numbers of animals used in experiments. The Commission as well as each EU member state have an obligation under Article 23[1] to “…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…”.
Of particular relevance to cats and dogs are the following Articles from Directive 86/609:
* Article 7, which requires that experiments shall not be conducted on animals if a satisfactory non-animal method is reasonably and practicably available.
* Article 15, which requires that animal breeding and supplying establishments shall be approved by and registered with the appropriate national authority.
* Article 17, which requires that proper records shall be kept by these establishments of animals bred and/or supplied.
* Article 18, which requires that cats, dogs and primates shall be individually identified before weaning with a permanent mark, and records of their identity and origin kept.
* Article 19, part 4, which requires laboratories only to use animals from breeding or supplying establishments unless a special or general exemption has been obtained. Purpose-bred animals are to be used whenever possible, and stray cats and dogs shall never be used in experiments.
* Article 21 and Annex I, which require that cats and dogs (and certain other species) shall be purpose bred unless the national authority gives a special or general exemption (see Chapter 3).

National legislation and regulation
In France, the national legislation that transposes the European Directive is Decree No. 87-848 of 19 October 1987 (27) , implemented by three interministerial orders of 19 April 1988. The Decree has subsequently been amended by Decree No. 2001-464 of 29 May 2001 and by a Decision of 20 June 2001 (28).

The French Ministry of Agriculture is responsible for the legislation which is enforced by the Veterinary Service. Unfortunately, there are too few veterinary inspectors to ensure that the best standards of animal care and welfare are practised. The national commission of animal experiments is an advisory body to the Ministry, commenting on aspects of the legislation as well as the training of those who handle and use laboratory animals.

A laboratory must apply for an institutional licence if it wants to conduct animal experiments, detailing the broad categories of experiments to be carried out and the type and number of animals to be used. The premises are inspected, and the licence lasts for up to five years. Individual scientists apply for personal authority to carry out animal experiments. This involves completing an application form, but applicants are not generally interviewed or visited by the Veterinary Service. The application describes the broad outline of the proposed animal experiments, but does not include the details of experimental protocols which will be used by the researcher. This lack of information limits the ability of veterinary inspectors to judge whether or not researchers have adequately considered and implemented the principles of Replacement, Reduction and Refinement.
Recently, voluntary ethics committees have started being introduced in France. Some countries, such as Sweden, have had ethical committees for many years and in 1999 they were introduced at the institutional level in the UK. Institutional ethics committees should be mandatory in France. In addition to having scientific and veterinary members, the committees should include external and lay members as well as experts in ethics, the Three Rs and animal welfare. At least one member external to the institution can provide an essential independent viewpoint. The committees’ duties should include assessing applications for personal licences, to ensure that the Three Rs are being implemented, as well as monitoring the animal experiments at their institution, as they proceed.

Failure to implement fully the EU Directive
On 24 April 1998, the European Commission gave formal notice to the government that it intended to take action regarding France’s failure to properly implement six of the measures in the EU Directive.

The Commission claimed that France had:
* Failed to prohibit experiments on animals of endangered species as set out in the Directive (Article 4);
* Failed to implement adequate provisions to ensure that the correct choice of species is made and that, in a choice between methods, to ensure that the method using the fewest animals, animals with the lowest degree of neurophysiological sensitivity and causing the least harm, while providing satisfactory results, shall be chosen (Article 7 in the Directive);
* Failed to implement measures, as described in the Directive, permitting an animal to be set free after an experiment under certain conditions (Article 11);
* Failed to introduce regulations to ensure that an experiment which may cause an animal “severe pain which is likely to be prolonged” shall be specifically declared and justified to, or authorised by, the national authority (Article 12);
* Failed to implement fully requirements that dogs and cats (and non-human primates) are given an individual identification mark before being weaned; or if this is not practicable before animals are transferred from one establishment to another, that the receiving establishment shall maintain a full documentary record until the animals are so marked (Article 18).
* Failed to implement requirements to avoid unnecessary duplication of animal experiments by recognising the validity of data generated by experiments in other countries (Article 22).
The Opinion of Advocate General Geelhoed, delivered in February 2002, stated that the Commission’s claims were upheld. He declared that alterations to implementing the Directive introduced by the government in Decree No. 2001-464 and the Decision of 20 June 2001 were not relevant to the situation which existed in 1999, by which date the Directive should have been fully implemented. The Advocate General recommended that the Court of Justice should declare that France had failed to fulfil its obligations under Directive 86/809/EEC and should order France to pay the costs.
These failings are very serious, and may have had a significant impact on the suffering of laboratory animals and the regulation of the supply of dogs and cats for experimental use.

(25) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, Official Journal of the European Communities L358, 1-29
(26) Anon. [2000] The Three Rs Declaration of Bologna and Background to the Three Rs Declaration of Bologna, as adopted by the Third World Congress on Alternatives and Animal Use in the Life Sciences, Bologna, Italy, on 31 August 1999, in: Developments in Animal and Veterinary Sciences, 31A, 15-22
(27) Décret pris pour l’application de l’article 454 du code pénal et du troisième alinéa de l’article 276 du code rural et relatif aux éxperiences pratiquées sur les animaux
(28) Arrêté du 20 juin 2001 relatif aux bonnes pratiques de laboratoire pour les médicaments vétérinaires.