Compendium of European legislation on animal

5.5.1 The Council of Europe

The Council of Europe is a political organization, founded in 1949, which groups together 45 nations, including 21 countries from Central and Eastern Europe and it is distinct from the 25-nation European Union.

Among other aims, the Council was set to defend human rights and to develop wide agreements to standardize member countries´ social and legal practice. Since 1989, its main job has become a political anchor assisting the countries of Central and Eastern Europe in carrying out and consolidating political, legal and constitutional reform in parallel with economic reform.

The first European document covering laboratory animals is the

“European Convention for the Protection of Vertebrate Animals Used for Experimentation and other Scientific Purposes, No. 123 of 18 March 1986”⁷, promulgated by the Council of Europe. The provisions of the Convention are designed to help the signatory states to guarantee that

7 European Convention for the Protection of Vertebrate Animals Used for Experimentation and other Scientific Purposes, No. 123 of 18 March 1986, http://conventions.coe.int/Treaty/en/Reports/Html/123.htm

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animals are treated properly and humanely and that where procedures causing pain, suffering, distress or lasting harm to an animal are kept to a minimum. While accepting the need to use animals for experimental and other scientific purposes, the Convention recognises “that man has a moral obligation to respect all animals and to due consideration for their capacity for suffering and memory”. Everything possible shall be done to limit such use with the ultimate aim of replacing such experiments by alternative methods. In this vein, the document follows the Three Rs principles (reduction, refinement and replacement) of humane experimental research (Russel & Burch, 1959). The Convention applies to any live non-human vertebrate animal, including free-living and larval forms (excluding foetal or embryonic forms) used or intended for use in any experimental or other scientific procedures causing pain or lasting harm (Wilkins, 1997). Such Convention defines:

1. Legitimate purposes for which laboratory animals may be used, that is:

a) Diagnosis, treatment, avoidance or prevention of disease, ill-health or other abnormality, or their effects, in man, vertebrate or invertebrate animals or plants, including the production and the quality, efficacy and safety testing of drugs, substances or products;

b) Detection, assessment, regulation or modification of physiological conditions in man, vertebrate and invertebrate animals or plants;

c) Protection of the environment;

d) Scientific research;

e) Education and training;

f) Forensic inquiries.

2. General care and accommodation guidelines; any animal used or intended for use in a procedure shall be provided with accommodation, an environment, at least a minimum degree of freedom of movement, food, water and care, appropriate to its health and well-being. Also, the Declaration sets detailed

European Legislation 63 guidelines for accommodation and care of animals in Appendix A.

3. Conduct of procedure regarding restrictions to animal experimentation. A procedure shall not be carried out if there are other ways and means to obtain the same results. The decision whether a procedure is indispensable shall be based in particular on the applicable state of scientific knowledge. It lays emphasis on the reduction of the number of animals used and of animal pain to a minimum. Also, it excludes procedures without an anaesthetic, except in cases where the administration of such an anaesthetic would be more painful than the procedure itself, or would be "incompatible with the aim of the procedure". In the latter case, appropriate legislative or administrative measures must be taken to prevent such procedures from being carried out unnecessarily.

Those measures, including compulsory declaration to, and specific authorisation by the responsible authority must be taken to prevent unnecessary experiments which cause severe pain to an animal.

4. Authorisation matters, that is the Convention states that the procedures may be carried out by persons authorised, or under the direct responsibility of a person authorised. The scientific competence of the persons concerned is the condition for granting such authorisation.

5. Breeding or supplying establishments; the Convention lays down special rules for dogs and cats. Such provisions are necessary because of the great number of animals used. Also, it requires that in user establishments the administrative responsibilities be clearly defined, that sufficient trained staff be employed, that, when needed, veterinary advice and treatment be at hand and, finally, that a competent person to supervise the well-being of the animals.

6. User establishments; the Convention recognises the need to use animals of known origin in order to avoid illegal

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acquisitions and to preserve rare and endangered species. It is also the surest way of obtaining domesticated animals, already adapted to laboratory life.

7. Education and training; the Convention allows procedures to be carried out in education and training programmes, directed to preparing for professional activities involving the performance of procedures or the treatment or care of animals.

8. Statistical information; the Convention obliges each party to collect statistical information on the use of animals in procedures and to make such information available to the public. Information shall be collected in respect of:

a) the numbers and kinds of animals used in procedures;

b) the numbers of animals used in procedures directly concerned with medicine and in education and training;

c) the numbers of animals used in procedures for the protection of man and the environment;

d) the numbers of animals used in procedures required by law.

Briefly, the document aims:

1. to define legitimate purpose for which laboratory animals may be used;

2. to exert control over permissible levels of pain and other distress;

3. to provide for inspection of facilities and of procedures;

4. to ensure humane standards of animal husbandry and care;

5. to ensure public accountability of scientific results.

The Convention was opened for signature on 18 March 1986. Once the conventions have been signed and ratified, they should be transposed into national law and be enforced into practice. Notwithstanding, the

European Legislation 65 Council of Europe obligation is a moral one, rather than a legal one.

Finland has signed the convention since 1991 and it entered into force on July 3^rd , 1992 while Italy has never signed the convention.