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National Research Council (US) Institute for Laboratory Animal Research. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington (DC): National Academies Press (US); 2004.
The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop.
Show detailsWim deLeeuw
Shortly after the end of World War II, several movements and activities were born that were dedicated to European unification. As an overall result, the Council of Europe was founded as an international political institution in 1949. It is designed only with international cooperation in mind. The general aims of the Council of Europe are to:
- Protect human rights, democracy, and the rule of law in all member states;
- Promote awareness and encourage Europe's cultural identity and diversity;
- Seek solutions to (social) problems facing European society;
- Consolidate democratic stability in Europe;
- Promote social cohesion and social rights; and
- Promote and develop a European cultural identity with emphasis on education.
The actual areas of concern are human rights, health, education, culture, youth, sport, the environment, local democracy, heritage, legal cooperation, bioethics, animal welfare, and regional planning. Today, the Council of Europe has 45 member states, including about 800 million people.
The Council of Europe must be distinguished from the European Union, which was set up in 1957 as the European Economic Community. First, it is not a supranational institution like the European Community. It does not have legislative power. Its member states are cooperating on a voluntary basis. The Council of Europe cannot impose any rule on its member states. Second, unlike the European Union, the Council of Europe is not an economic organization.
The geographical confines of the Council of Europe are larger than the membership of the EU. The EU has 15 member states: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. All of these countries are also member states of the Council of Europe. Next to these member states, however, the Council of Europe also includes 30 other European countries: Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Estonia, Georgia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, Moldova, Norway, Poland, Romania, the Russian Federation, San Marino, Serbia and Montenegro, Slovenia, Slovakia, Switzerland, the former Yugoslav Republic of Macedonia, Turkey, and Ukraine.
THE COUNCIL OF EUROPE: HOW DOES IT WORK?
The headquarters of the Council of Europe, Le Palais de l'Europe, is situated in Strasbourg, France. The Committee of Ministers is the decision-making body of the Council of Europe. It is composed of the Ministers of Foreign Affairs of the member states. This body officially adopts Conventions, Resolutions, Agreements, and Recommendations. The Committee of Ministers also ensures that the conventions and agreements are implemented. In addition, there are two other institutions: (1) The Parliamentary Assembly is the organization's deliberative body, the members of which are appointed by national parliaments. (2) The Congress of Local and Regional Authorities of Europe is a consultative body that represents local and regional authorities. Governments, national parliaments, and local and regional authorities are thus represented separately at the Council of Europe level.
The main tools of the Council of Europe to achieve its objectives are the following legal instruments:
- Recommendations—often referred to as “soft law.” There is no legal obligation to follow or implement these recommendations; and
- Conventions or treaties concluded between states. The member states are not legally obliged to sign a Convention, although they may be expected to do so since under the Council of Europe's Statute, they have undertaken to “collaborate sincerely and effectively in the realization of the aim of the Council.” Nonetheless, there are different ways a member can deal with a Convention. It may choose to ignore the Convention as being not relevant or not applicable to the national situation. By taking that position, a member is not obliged to comply with its provisions. A member can sign the Convention, thus recognizing the value and existence of the Convention. After having signed a Convention, a member is still not obliged to comply with the provisions of the Convention. However, once a state has signed and ratified (i.e., its Parliament has approved the instrument) and the Convention has become effective, the state will be morally and legally bound under international law to implement the Convention. Thus, the state has become a Party to that Convention and must ensure that the provisions will be respected on its territory. Most Council of Europe Conventions are not directly applicable within a member state; they are not “self-executing.” The most common way for a state to implement them is to enact appropriate national legislation or to adapt its existing domestic law to make it correspond to the rules in the Convention.
In contrast to the European Union, practically spoken, there is little legal enforcement of Conventions, which probably leads to variability in compliance. Some Conventions are also open for adoption by nonmember states. The Conventions and recommendations are drafted by governmental experts responsible to the Committee of Ministers, thereby providing for the interaction of political interests with technical considerations. They only have a legal status after they are adopted by the Committee of Ministers.
More than 350 nongovernmental organizations (NGOs) are granted a consultative status. Within the context of the Council of Europe, there are several consultation arrangements, which enable NGOs to participate in intergovernmental activities and encourage dialogue. These NGOs are a vital link to the public at large and to specific parts of society.
THE COUNCIL OF EUROPE AND ANIMAL WELFARE
The work of the Council of Europe on animal protection was started in the 1960s. Since then, the following five Conventions on the protection of animals have been drawn up:
- On animals during international transport (ETS 65, 1968), which establishes general conditions for the international transport of animals;
- On animals kept for farming purposes (ETS 87, 1976), which is a framework convention. More detailed recommendations on species are given in separate guidelines;
- On animals for slaughter (ETS 102, 1979);
- On vertebrate animals used for experimental and other scientific purposes (ETS 123, 1986); and
- On pet animals (ETS 125, 1987).
All of these Conventions are based on the principle that “for his own well-being, man may, and sometimes must, make use of animals, but that he has a moral obligation to ensure, within reasonable limits, that the animal's health and welfare [are] in each case not unnecessarily put at risk.”
These Conventions were the first international legal instruments to establish ethical principles for the use and handling of animals. They are the result of very lengthy research, discussions, and negotiations, undertaken by governmental experts, delegates from animal welfare organizations, scientific researchers, and representatives of professional associations directly concerned. They are therefore the results of compromises. The political and technical value of the legal instruments working method adopted in the framework of these activities is based on the close collaboration between representatives of all the governmental and nongovernmental organizations that are involved. They have been used as a basis for, and continue to influence, all of the national relevant legislation in Europe.
THE COUNCIL OF EUROPE AND THE PROTECTION OF LABORATORY ANIMALS
As early as 1971, the parliamentary assembly recognized that to protect animals against abusive and unnecessary experimentations certain norms should be established at an international level, to enable states to regulate such experiments in an harmonious way in their domestic law. A first draft of the Convention was elaborated by the Ad Hoc Committee of Experts on the Protection of Animals, the CAHPA. After lengthy discussions, the Convention was finally adopted in May 1985. The Convention is accompanied by an explanatory report, and attached to it are technical appendices. Appendix A presents guidelines for the accommodation and care of animals. Existing German and US guidelines were used as a basis. Unlike the provisions of the Convention itself, the guidelines in Appendix A are not mandatory; they are recommendations. These guidelines are based on knowledge of that time and good practice. Appendix A explains and supplements the principles on accommodation and care as adopted in article 5 of the Convention. Appendix B contains tables for the presentation of the statistical data on the use of animals for experimental and other scientific purposes. The object of the Appendix is thus to help authorities, institutions, and individuals in their pursuit of the aims of the Council of Europe in this matter.
The European Convention for the protection of vertebrate animals used for experimental and other scientific purposes (1986, ETS 123) includes provisions concerning the scope, care, and accommodation of the animals, conduct of experiments, humane killing, authorization procedures, acquisition of animals, control of breeding or supplying and user establishments, education and training, and statistical information. It is clearly visible from several provisions that the 3Rs of Russell and Burch are used as a basis for the Convention.
Currently, 15 countries have signed and ratified ETS 123 and thus are Parties to the Convention: Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, the Netherlands, Norway, Spain, Sweden, Switzerland, the United Kingdom, and the European Community. The Convention is signed by Bulgaria, Ireland, Portugal, Slovenia, and Turkey. The Convention provides for Multilateral Consultations of the Parties at least every 5 years, to examine the application of the Convention and the advisability of revising it or extending any of its provisions according to changes of circumstances and new scientific evidence. The Multilateral Consultations are prepared by a Working Party. For their work, the Parties have invited other member states of the Council of Europe and nonmember states and cooperate very closely with nongovernmental organizations that represent the fields concerned. In the preparatory meetings for the 4th Multilateral Consultation, the following observers participated:
Canadian Council on Animal Care (CCAC)
European Biomedical Research Association (EBRA)
European Federation of Animal Technologists (EFAT)
European Federation for Primatology (EFP)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Science Foundation (ESF)
Federation of European Laboratory Animal Breeders Associations (FELABA)
Federation of European Laboratory Animal Science Associations (FELASA)
Federation of Veterinarians of Europe (FVE)
International Council for Laboratory Animal Science (ICLAS)
Institute for Laboratory Animal Research (ILAR)
International Society for Applied Ethology (ISAE)
World Society for the Protection of Animals (WSPA)
Eurogroup for Animal Welfare (Eurogroup)
Member States: Austria, Croatia, Hungary
Nonmember State: United States of America
The participation of representatives of observer states and nongovernmental organizations is of great value. It implies a very broad exchange of information at technical as well as legal and political levels. Therefore, their involvement in this work has to be associated with the success of the Multilateral Consultations to ensure a common and satisfactory level of protection for animals used for scientific purposes, thus enabling the Council of Europe to maintain its position of initiator in Europe for the protection of these animals.
Until now, three Multilateral Consultations have been held. At the 1st Multilateral Consultation held in 1992, the Parties adopted a resolution in which the scope of the Convention was made more precise in respect for genetically modified animals, and certain tables for statistical data were remodeled.
At the 2nd Multilateral Consultation that was held in 1993, a resolution on education and training of persons working with laboratory animals was adopted. This resolution contained guidelines for the education and training of persons taking care of animals (Cat. A), persons carrying out procedures (Cat. B), and persons responsible for directing or designing procedures and animal science specialists (Cat. D). The guidelines included in the resolution were mainly based on a report that had been issued by FELASA.
At the 3rd Multilateral Consultation that was held in 1997, a resolution on the acquisition and transport of animals was adopted. This resolution contained guidelines that complemented the guidelines on this topic included in Appendix A.
Concerning the care and accommodation of animals, the Parties recognized that Appendix A had proven to be of great value and was widely used as a reference. At the same time, however, it was realized that the Appendix had been drafted more than 10 years ago. The Parties agreed that new scientific evidence and new experience since then made it necessary to revise the Appendix and to define the areas where further research is needed. They therefore agreed that this revision of Appendix A should be on the agenda of the 4th Multilateral Consultation. Pending this revision, a resolution was drafted presenting guidelines for the improvement of the accommodation and care of laboratory animals, which would complement the guidelines in Appendix A. The guidelines in the resolution were mainly based on the conclusions and recommendations of the International Expert Workshop on laboratory animal welfare that was held in 1993 in Berlin. It was concluded that the most important areas appeared to be the enrichment of the environment of the individual species according to their needs for the following:
- Social interaction. Group or pair housing was considered to be preferable to individual housing for all gregarious species, as long as the groups are stable and harmonious;
- Activity-related use. Cages should be structured to enable an activity-related use of the space available; and
- Appropriate stimuli and materials. It was recognized that guidelines could never replace close and regular observations of the animals involved to ensure that the enrichment initiatives do not have adverse effects for groups or individuals.
Taking into account the evolution of scientific knowledge and changing circumstances, the Parties realized that the technical Appendices might need to be adapted more frequently than its main provisions. However, because these Appendices are an integral part of the Convention, such adaptations could result in complicated amendment procedures. Therefore, a Protocol of Amendment (ETS 170) providing for a simplified procedure for the amendment of the technical Appendices to the Convention was drafted and opened for signature in June 1998. Thus, the Parties are able to amend the technical Appendices, without formal adoption by the Committee of Ministers.
The finalized documents must be formally adopted at the 4th Multilateral Consultation. Thereafter they will be submitted to the Committee of Ministers. The text of the Convention and the related documents, such as resolutions adopted by the Committee of Ministers, as well as the draft proposals for the revision of the Appendix on which the discussion is finalized and the finalized background documents, are available on the website of the Council of Europe (www.coe.int/animalwelfare/) .
The work that has been done at the Council of Europe in the area of laboratory animal welfare was based on a very fruitful cooperation between member states and observers of various organizations. To be more effective, it will be very important that the cooperation between the European Union and the Council of Europe is intensified and that cooperation with other international umbrella organizations is developed further.
- The Council of Europe: What Is It? - The Development of Science-based Guidelines...The Council of Europe: What Is It? - The Development of Science-based Guidelines for Laboratory Animal Care
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