Ethics of Research involving animals
International regulation
13.35 The basic principles that underlie the regulation of animal research are very similar in all countries in which animals have legal protection. Regulations specify the conditions under which animals may be used and seek to ensure that harms are minimised as far as possible. They are usually implemented through review of proposed research projects, applying the Three Rs where possible and assessment of the general standards of laboratory animal housing and husbandry.
13.36 However, countries differ in the complexity and detail of regulations, and the manner and strictness with which they are implemented and enforced. Some countries do not have national regulatory systems and use guidelines or policies developed by individual institutions. For example, Canada relies on a well-developed voluntary system of selfregulation based upon protocol review by institutional Animal Care Committees, which operate according to guidelines set out by the Canadian Council on Animal Care.34
13.37 The system of project review by an institutional committee is the most common method of self-regulation in most countries. Committees typically involve scientists with experience in the field and veterinary staff. In some cases, these committees have a broader membership which includes animal technicians, non-technical staff of the institution, external lay members or representatives with an interest in animal welfare.
13.38 In many countries, the detailed operation of these committees is controlled by agencies that fund research. The USA has an extensive system of Institutional Animal Care and Use Committees (IACUCs), created by the Animal Welfare Act and its regulations.35 The Act covers the use of warm-blooded animals in research, but excludes rats, mice and birds. The IACUCs operate according to the more detailed policies and guidance published by the National Institutes of Health.36 Australia uses a similar system of Animal Ethics Committees, created under state legislation, but operating in accordance with the code of practice produced by the National Health and Medical Research Council.37
13.39 Within Europe, there are two, almost identical, legal instruments. They are the Council of Europe Convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS 123, 1986), and the EU Directive EEC 86/609 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. The legal status of these instruments differs. Member States of the Council of Europe can decide whether or not to ratify the Convention by implementing it in their national legislation. By contrast, Member States of the EU are legally obliged to implement the goals set out in the Directive. All have transposed the Directive in their national or regional legislation, although the European Commission has referred several countries to the European Court of Justice to ensure that their legislation is fully in accordance with the Directive.
13.40 The main current provisions of the EU Directive are that:
- establishments conducting animal experiments must be registered with the authorities and maintain the housing and husbandry of the animals according to a standard set out in an annex to the Directive;
- experiments must only be conducted by, or under the direct responsibility of, a competent, authorised person, who should have appropriate education and training;
- animals cannot be used if another, scientifically satisfactory, method is available;
- experiments must be designed to use the minimum number of animals, the species with the lowest neurophysiological sensitivity and to cause the least pain, suffering, distress or lasting harm, compatible with the purpose of the experiment;
- wild-caught animals are not used unless necessary for the experiment;
- the experiments to be performed, or the details of the individuals who will perform them, must be notified in advance to the authorities;
- experiments that may cause severe pain that is likely to be prolonged must be justified in advance and authorised by the authorities;
- statistical information on the numbers and types of experiments conducted must be collected by the authorities; and
- breeding and supplying establishments must be registered and comply with the same standards as experimental establishments.
13.41 There is a significant variation in the national systems for regulating animal research introduced under the Directive. Member States are permitted to adopt stricter measures if they wish. Several countries have done so, including the UK. The UK system is widely considered to be the most comprehensive and detailed in the EU (and throughout the world). Nevertheless, there are some countries that regulate specific aspects of animal research that are not regulated in the UK. For example, training requirements are more detailed in The Netherlands, and provisions for freedom of information are more liberal in Sweden.
13.42 Most EU countries originally implemented the Directive with ‘external’ regulation, which means that authorisations for research projects are given by national or local government officials. Some countries opted for a system in which local or regional animal ethics committees authorise research involving animals. None of the EU countries have implemented systems of self-regulation.
13.43 The system of regulation in most Member States uses either one or two licences. The main licence usually covers the research or testing activities of an institution and serves as the registration of the establishment and the licence for the research to be conducted. Other countries use separate licences for the institution and the projects, which may include details of the personnel who will carry out the research. For example, in France the personal licence is akin to the project licence in the UK; applicants submit an application that includes broad details of the intended project.38
13.44 To fulfil the requirement in the Directive for ‘verifying that the provisions of this Directive are properly carried out’, most Member States have established a system of inspection of establishments that conduct animal experiments. This function is usually added to the role of local veterinary inspectors, whose primary role is to inspect agricultural use of animals. Very few countries have statutory systems of inspection dedicated exclusively to animal research. In The Netherlands there are three inspectors for the 600,000 animals used annually (see paragraph 13.20). In the USA, only institutions that conduct research involving certain classes of animal covered by the Animal Welfare Act are subject to inspections from the US Department of Agriculture. Additional levels of inspection operate for institutions that receive federal funds. The non-governmental Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) also carries out inspections of accredited institutions. Accreditation is voluntary but includes most large companies and major universities as accreditation is an important factor for securing contracts and funding.39
13.45 Since the Directive was adopted in 1986, there has been a trend towards increased and more detailed regulation in many Member States.
- France, The Netherlands and some parts of Spain have added a system of local animal ethics committees to their previously existing systems of control.
- Austria, The Netherlands, Sweden and the UK have abandoned the use of great apes in scientific procedures, although they had not been used in the UK and Sweden for some years.40 With the voluntary retirement of a colony used in vaccine development in Austria, no great apes were used in the EU in 2002, the last year for which statistics are available.41
- The Netherlands and the UK have ceased using animals for testing cosmetics or cosmetic ingredients. Germany and Austria have introduced partial bans, permitted testing under some circumstances. More recently, a ban on the use of animals within the EU for the testing of cosmetics has been passed and is due to come into force in 2009 (and sales within the EU will not be allowed after 2013). However, there are certain exceptions for particular types of test and the EU Directive on cosmetics testing on animals is currently under legal challenge from the French Government.42
- The Netherlands and the UK have banned the acute oral LD50 test (see paragraph 9.14 and Box 11.2), with very limited exemptions.
13.46 Under the Council of Europe’s Convention ETS 123 there are periodic meetings of representatives of the Member States and relevant non-governmental organisations to ‘examine the application of this Convention, and the advisability of revising it or extending any of its provisions’. In 1997, the revision of Appendix A to the Convention, which gives guidelines for the accommodation and care of laboratory animals, was agreed. The revised Appendix A will include details about the husbandry and housing of all the principal laboratory animal species. It is expected that the Council of Europe will adopt the new Appendix in 2005. Since the EU ratified the Convention, Appendix A will be adopted as a revised Annex II to Directive EEC 86/609.
13.47 In 2001 the European Commission proposed that Directive EEC 86/609 should itself be revised. This process started in 2003 when the Commission formed four Technical Expert Working Groups (TEWGs) to offer advice on how the existing Directive could be improved. Discussions are currently in progress but it is likely that a revised Directive will not be adopted for several years. The provisions of the new Directive will be transposed into national legislation once the revisions have been agreed.
Footnotes34 See Canadian Council on Animal Care, available at http://www.ccac.ca/. Accessed on: 4 May 2005.
35 US Department of Agriculture Animal Welfare Act and Regulations, available at:
http://www.nal.usda.gov/awic/legislat/usdaleg1.htm. Accessed on: 4 Apr 2005.
36 See the Report of House of Lords Select Committee on Animals in Scientific Procedures (2002) Animals in Scientific Procedures (Norwich: TSO) for a description of the US system of regulating animal research. In the USA there is no legal obligation to report the numbers of mice and rats used in experiments. The system of regulation means that privately funded companies that use only rats, mice and birds are not subject to the same federal regulations or inspections as those that apply for researchers and institutions that receive federal funds.
37 National Health and Medical Research Council (2004) Australian code of practice for the care and use of animals for scientific purposes, 7th Edition, available at: http://www.nhmrc.gov.au/publications/pdf/ea16.pdf. Accessed on: 4 May 2005.
38 House of Lords Select Committee on Animals in Scientific Procedures (2002) Animals in Scientific Procedures (Norwich: TSO),
Chapter 1.
39 Ibid. Chapter 1.
40 Great apes have not been used for research in the UK since the passing of the A(SP)A in 1986. See House of Lords Select
Committee on Animals in Scientific Procedures (2002) Animals in Scientific Procedures (Norwich: TSO), Chapter 1.
41 European Commission (2005) Fourth Report on the Statistics on the number of animals used for experimental and other scientific purposes in the Member States of the European Union (Brussels: EC).
42 Directive EC 2003/15 amending Council Directive EEC 76/768 on the approximation of the laws of the Member States
relating to cosmetic products.