The EC Directive Scope

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The provisions of the Directive apply to vertebrate animals used in experiments that are likely to cause pain, suffering, distress, or lasting harm. In several member states, the use of an invertebrate animal has been considered, too. For example, in the U.K., the use of Octopus vulgaris as an experimental animal is covered by the Animals (Scientific Procedures) Act. In the Netherlands, if, on the basis of scientific evidence, it is likely that an invertebrate species can experience discomfort, this species could be designated by an order to be covered by the Experiments on Animals Act. However, until now, no invertebrates have been so designated. The directive also covers the development of genetically modified animals likely to suffer pain and distress.

The killing or marking of an animal using the least-painful method is not considered an experiment. However, in France, Sweden, and the Netherlands, the definition of procedure is broader and includes the killing of an animal without any previous intervention.

The Directive is restricted in its application to experiments undertaken for the development and safety testing of drugs and other products, together with the protection of the natural environment. However, in 1987, the European Parliament passed a resolution stating that the provisions of Directive 86/609/EEC should also apply, through national legislation, to all animal experiments, including those undertaken for basic research and educational purposes.

In 2000, the European Commission became a party to the convention ETS 123. Therefore, a second amendment to Directive 86/609/EEC had to be prepared to bring the Directive in line with the convention. To that end, in 2001, the European Commission invited the National Competent Authorities to consider revising the scope of the Directive to include, for example, the use of animals for training purposes, forensic inquiries, and routine production; animals to be killed for tissue and organs; and the commercial breeding of animals destined for experiments (housing and care). Others issues to be dealt with were specific provisions concerning the use of nonhuman primates, dogs, and cats; specific conditions relating to the use of transgenics and cloning; authorization and inspection; statistical requirements; ethical review of protocols; and applications of the 3Rs. At this time, legislation on animal experimentation is under revision in several member states.

Most national laws are put into operation by a government-controlled "authority," as described by the directive. The control mechanism may rest with the authority itself, through a central licensing system, such as that operating in, for example, the United Kingdom, or may be (partially) deployed at an institutional level, such as through institutional (ethics) committees.

Accommodation and Animal Care

Article 5 of the Directive contains provisions to ensure that animals are treated humanely not only prior to, but also during and after, any experimental procedure. Detailed guidelines for the implementations of these provisions are set out in Annex II of the directive. These guidelines are based principally upon common laboratory practices. They can be amended as new scientific or other evidence emerges with improved methods for the housing and care of animals. In 1997, the parties to the Convention ETS 123 started a process of revising the guidelines for the housing and care of laboratory animals. It can be concluded that the revised parts will contribute to the well-being of these laboratory animals.

Competence

Article 5 states that a competent person must oversee the well-being and state of health of the animals. Article 19 stipulates that a veterinarian or other competent person should be charged with advisory duties in relation to the well-being of animals. The provisions on competence warrant special attention. Laws and regulations are poor tools if not based upon an understanding of what constitutes humane and responsible animal use. Therefore, additional education and training provide the opportunity for gaining this understanding and also for an evaluation of the ethical considerations.

Article 7 of the Directive states that animal experiments should be performed solely by a person considered to be competent or under the direct responsibility of such a person. This provision is amplified by Article 14, which states that persons undertaking experiments, taking part in procedures, or caring for experimental animals (including supervision) should have appropriate education and training. It is essential that the people involved in the design and conduct of experiments should have received an education in a scientific discipline relevant to the experimental work. They also need to be capable of handling and taking care of laboratory animals. Each member state must specify how the provision of competence is to be implemented within national legislation. The Federation of European Laboratory Animal Science Associations (FELASA)4 has prepared a proposal concerning educational and training requirements for scientists. Some countries have already introduced strict regulations regarding competence based upon these FELASA guidelines.

Alternatives to Animal Experiments

Article 7 of the Directive not only deals with competence, but also with alternatives to animal use. Performance of an experiment is not permissible if the result can be reasonably and practically obtained without the use of animals. If there is no alternative to animal use, then animals with the lowest degree of neurophysiological sensitivity (or the least capacity for suffering), compatible with the scientific objective, must be selected. Animals taken from the wild may not be used unless other animals would not fulfill the aims of the experiment. Furthermore, all experiments must be designed to minimize distress and suffering.

The directive clearly states that the EC and member states should encourage research into the development and validation of alternatives. In 1991, the European Centre for the Validation of Alternative Methods (ECVAM) was established. In several member states, a national institute has been established for the development and application of alternative methods. These institutes are working closely together, with ECVAM as the coordinating body.

Anesthesia

All experiments must be carried out under general or local anesthesia (Article 8), unless anesthesia is judged to be more traumatic than the experiment itself, or is incompatible with the aims of the experiment. If anesthesia is not possible, then pain, distress, or suffering must be limited, and analgesics or other appropriate methods should be used. No animal should be subjected to severe pain, distress, or suffering.

Euthanasia

At the end of the experiment, a veterinarian or other competent person must decide whether the animal should be kept alive or be humanely killed. No animal is to be kept alive if it is likely to remain in permanent pain or distress, or if its well-being is otherwise jeopardized (Article 9). It is not permissible to use animals more than once in experiments entailing severe pain, distress, or equivalent suffering.

Registration

There is an obligation to notify the (governmental) authority in advance about the proposed use of animals in experiments and who will be conducting them. If an animal is expected to experience severe pain that is likely to be prolonged, the experiment must specifically be declared and justified to, or specifically authorized by, the authority. Such an experiment is permitted only if it is of sufficient importance in meeting the essential needs of man or animal.

Statistics

The authority must collect information on the total number of animals used and statistics detailing the number used for specific purposes. As far as possible, this must be made available to the public in the form of published statistics. In addition, the information has to be sent to the European Commission.

In 1997, after several years of negotiation, the EC and the member states reached agreement on the (scientific) purposes for which data on animal use should be collected. Specific EU tables have been designed and distributed for the collection of such data. From 1999 on, data on animals used for scientific purposes is collected in all member states. Every two years, the EC sends a report on animals used for scientific purposes in Europe to the European Parliament.

Supply of Animals

Only establishments approved by the authority in each member state are allowed to breed or supply animals for research. Such establishments must keep records of the number and species of animals sold or supplied, and the names and addresses of the recipients. Dogs, cats, and nonhuman primates must be supplied with an individual identification mark.

Animal Facilities

Establishments for animal use must be registered with or approved by the authority. Each user establishment must have sufficient numbers of trained staff and provision for adequate veterinary support. Only animals bred within the animal facility or from authorized breeding or supplying establishments may be used. The use of stray animals is not allowed. Records must be kept of all animals used.

Inspectorate

In most countries, the authority for supervising compliance with the regulations is a governmental inspectorate. The inspectors are mainly veterinarians or biologists with experience in research and training in laboratory-animal science. For purposes of public accountability, some member states report to Parliament each year on the animals used for the life sciences.

Ethics Committees

There is no specific provision in the Directive requiring the establishment of such committees. However, during the last decade, as a result of animal welfare concerns of the general public, the ethical review of proposed animal experiments has been considered as the next step in improving animal welfare. An assessment of likely benefit and potential for animal suffering is an essential part of the review process. In Belgium, Sweden, and the Netherlands, the ethical review process has a legal basis. In Denmark, the inspectorate has the right to reject an application for a project if the suggested activity is judged not to be of "essential value or benefits." In France, the United Kingdom, and Finland, institutional committees are specifically dedicated to review the ethical aspects of animal experimentation prior to the commencement of the animal experiment.

In Europe, several scientific organizations have prepared guidelines for the ethical use of animals in research. The European Science Foundation (ESF), an association of 67 member organizations devoted to scientific research in 24 European countries, has stipulated that member organizations will adopt guidelines for the ethical use of animals in research. According to a survey done by the ESF, there is already an ethical review committee in most member states. The competence of the committee members, the committee composition, and the committee members' responsibilities vary considerably. It can be expected that the ethical review process will be adopted by the European Commission and, therefore, will be mandatory for all member states in the near future.

Because the provisions of the directive are considered minimum standards, member states are free to regulate specific issues more strictly. As a consequence, considerable differences among legislative procedures can occur. Furthermore, in some member states (e.g., Finland, Germany, and Portugal), the Minister of Agriculture is responsible for the protection of laboratory animals. In other member states, the responsible minister can be the Home Office (U.K.), the Minister of Justice (Denmark), the Minister of Science and Education (France), or the Minister of Public Health (The Netherlands).

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