Frequently asked questions about the use of Animals in Scientific Procedures

 The use of animals in scientific procedures is regulated by the Animals (Scientific Procedures) Act 1986, which is widely viewed as the most rigorous piece of legislation of its type in the world. It puts into effect, and in some ways exceeds, European Union Directive 86/609/EEC (regarding the protection of animals used for experimental and other scientific purposes) and offers a high level of protection to animals whilst recognising the need to use animals in medical research, the development of new medicines and scientific testing. It also has sufficient flexibility to allow the latest ideas and technology to be taken into account when deciding whether the use of animals is justified.

Under the 1986 Act, both personal and project licences are required. These ensure that those doing the work are qualified and suitable; that alternatives to animals are used wherever possible; that the number of animals used is minimised; and that any suffering or other harmful effects experienced by the animals have been weighed against the potential benefits (to humans or animals). Special conditions control and minimise any pain or suffering. In addition, work can only be carried out at designated establishments which meet high standards and which have suitable veterinary and animal welfare personnel. See Licensing and training.

The Government is working to ensure that the highest possible standards of animal welfare are applied to animals used in scientific procedures and that they are used only where it is fully justified, where the benefits outweigh the costs and where there are no suitable alternatives. To this end we are promoting the fullest application of the 3Rs - the replacement of procedures with others which do not use animals, the reduction of the number of animals used and the refinement of procedures to minimise pain and suffering.

The Government's strategy is:

• To ensure licensed work is fully justified.
• To review policy continually as scientific and ethical considerations evolve, checking that the costs to animals are minimised and remain outweighed by the potential benefits of the work.
• To reinforce compliance and high standards through consistently applied inspection, training, guidance, and (if necessary) infringement procedures.
• To harness the advice of the Animals (Scientific Procedures) Inspectorate (ASPI), other welfare and scientific expertise, and the products of local ethical review processes in ensuring that the 3Rs are rigorously applied in every case and that highest standards of animal welfare are implemented.
• To encourage the development and use of alternatives and relevant databases through research funding and education, and through support for the European Centre for the Validation of Alternative Methods (ECVAM).
• To take a lead in formulating European policies, standards and targets which neither disadvantage the UK nor drive work abroad to countries where lower standards apply.
• To liaise actively with legitimate interest groups and to encourage the Animal Procedures Committee to take a more public role and offer broadly based and independent advice to Ministers.
• To make our administration under the 1986 Act as transparent as possible.

The House of Lords Select Committee on Animals in Scientific Procedures and the Animal Procedures Committee have endorsed the validity of animal experiments as did the Nuffield Report on Bioethics Report published in May 2005.  These are three bodies of substance and include personnel of varied backgrounds and opinions including some with non-scientific backgrounds.  They have all thoroughly considered the arguments for and against animal experimentation and concluded that there is a continued need for research and testing on animals as it provides information which can be of relevance to humans and does lead to medical benefits. In the light of these reports, the Government considers that there is no pressing need for a further review at the present time.

Section 24 of the Animals (Scientific Procedures) Act 1986 prevents the unauthorised disclosure of confidential information by Ministers and officials other than in the discharge of their functions under the 1986 Act. A review of Section 24 was completed in July 2004 and concluded that it should be retained for the time being.  It will be reviewed again shortly taking account of the implementation of public access rights under the Freedom of Information Act 2000 amongst other things.

In addition to our commitment to the fullest application of the 3Rs- replacing the use of animals with alternative methods; reducing the number of animals needed for a particular purpose and refining the procedures to minimise suffering - we have also:

• secured a voluntary ban on testing cosmetic finished products and ingredients on animals;
• the National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) was announced in May 2004 and acts as a focal point for research into the 3Rs. The centre is funded by Government through the Office of Science and Innovation and the Research Councils and also receives some funding from the Home Office, Wellcome Trust and Industry. NC3Rs
• banned the use of animals to test alcohol and tobacco products;
• announced an increase in the size of the Animals (Scientific Procedures) Inspectorate from 21 to 33 Inspectors by 2004;
• introduced and reviewed the implementation of a requirement that all establishments licensed under the 1986 Act have local ethical review processes as a complement to the existing controls under the Act;
• announced a cross-Whitehall data sharing concordat to enable Government Departments to avoid the duplication of tests on animals and set in hand a review of its effectiveness;
• announced our intention never to allow the use of Great Apes (gorillas, chimpanzees, pygmy chimpanzees and orang-utans);
• announced the phasing out of the use of ascitic animals in certain forms of monoclonal antibody production other than in exceptional circumstances;
• ended the licensing of the LD50 test and of tests for skin corrosivity and phototoxic potential where valid alternatives exist.
• the Government now publishes details of project licences granted under the Animals (Scientific Procedures) Act 1986 as a contribution to greater openess and public understanding about the use of animals in science.  These provide a useful insight into the range and purpose of the projects we licence. Abstracts

The justification for the testing of household products or their ingredients is the need for regulatory authorities to have sufficient information to assess the risks to which humans, animals, plants or the environment are exposed (and their efficacy if relevant), as required by National and International legislations, when these products or their ingredients are produced, transported or used.

The Secretary of State will only authorise animals tests when she is satisfied that the purpose of the test cannot be achieved by any other reasonably practicable method not entailing the use of protected animals.  A case by case approach is a requirement when animal tests are licensed.  Account will be taken of physio-chemical properties of the test substance, computer modelling and structure-activity relationships, and results of in vitro screening if appropriate which will inform the need and type of animal test needed.

The Home Office is aware that there is some public concern regarding the use of animals in testing certain types of household products. To address this concern we are considering whether additional steps might be appropriate to ensure that the costs and benefits of such testing have been fully weighed before it is authorised.

 

The Government strongly supports the development and use of non-animal alternatives where possible.  Indeed use of animals in scientific procedures will not be licensed if alternative non-animal techniques are available.  The National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) was announced in May 2004 and acts as a focal point for research into the 3Rs.

The NC3Rs is an independent scientific organisation which provides a UK focus for the advancement of the 3Rs. Working with stakeholders in academia, industry, Government, research funders, regulatory authorities, and animal welfare organisations the Centre aims to increase the development and implementation of the 3Rs in medical, biological and veterinary research and testing. The Centre is funded by Government and the Research Councils and also receives some funding from the Home Office, Welcome Trust and Industry.

We estimate that the total spent by the UK Government and funding bodies on alternatives research could be as high as £10 million each year. It is impossible to give an exact figure, as money spent on this is often part of wider budgets related to animal research

 

The United Kingdom Government continues to support ECVAM through contributions to the European Union. It is their task to monitor and co-ordinate research into alternatives and to develop the processes of validation- that is, the assessment of alternative methods to see whether they are reliable and whether they produce a level of information similar to the animal based tests they are to replace.

The wider scientific community recognises that whilst there are physiological or biochemical differences between species, there are greater similarities. Species differences are taken into account within the design of research projects and the results of testing a new drug, for example, on animals can often be used to predict the effect on humans. Animal procedures are, in any case, only one element of the tests carried out to assess the efficacy and safety of products. Before animals are used, they will also have been subjected to a variety of other screening processes including the use of computer models, cell cultures and other non-animal tests. Clinical trials in humans also play an important part. It is not justified, therefore, to single out animal experiments for criticism when unexpected results are seen in full-scale clinical use. The simple fact is that biological science is not exact. However, until other suitable alternatives are developed, animal tests will continue to play an important part in minimising the adverse effects to humans caused by unexpected reactions during clinical trials and use.

Examples of specific legislative requirements under which procedures on animals are carried out are provided in the Introductory Notes to the Annual Statistics of Scientific Procedures on Living Animals (Great Britain). These include:

• the Medicines Act 1968;
• the Health and Safety at Work Act 1974;
• Control of Substances Hazardous to Health (COSHH) Regulations;
• Control of Pesticides Regulations 1986;
• EU Pesticides Directives; and
• The Food Safety Act 1990.

Just over 3.2 million scientific procedures were started in 2007, a rise of about 189,500 (6%) on 2006.

The increased animal use was mainly due to increases in the use of mice, fish and domestic fowl, while the use of most other species was down when compared to 2006. 

The use of mice increased for fundamental research and breeding.  There was increased use of fish in applied studies for human medicine and protection of man, animals and the environment.  The use of domestic fowl increased for applied veterinary studies.

Mice, rats and other rodents were used in the majority of procedures: 83% of the total. 

Most of the remaining procedures used fish (10%), and birds (4%). Dogs, cats, horses and non-human primates, afforded special protection by the act, were collectively used in less than 1% of all procedures.

 

For reliable results, most experiments depend on animals being free of infection or disease, which can best be achieved if they come from a known source with fully documented breeding histories. Cats and dogs and all mice, rats, hamsters, guinea pigs, rabbits, quail, primates, ferrets, gerbils and genetically modified pigs and sheep must be obtained from designated (licensed) breeding establishments. Exemptions from this rule are rarely granted. Stray pets are never used.

As regulator, the Home Office is demand-led and we have no control over the number of project licence applications we receive. Whilst we seek to minimise the number of animals used in particular programmes of work, we cannot influence the overall amount of animal research which takes place. That is determined by many other factors, including the economic climate and global trends in scientific endeavour.

It is very difficult to project the number of animals likely to be used in future years. Numbers depend on the type of project licence applications that will be made and progress on current project licences, as well as global trends in scientific endeavour.

New molecular biology techniques are opening up new areas of research which will lead to an increase in the use of genetically modified (GM) animals. In addition, new regulatory proposals set out in the EU Chemicals Strategy White Paper will, if agreed and implemented, also lead to increased use of animals for human health and safety purposes.

Genetically altered animals were used in 1.15m regulated procedures, representing 36% of all procedures for 2007, compared with 34% in 2006, and 8% in 1995.  The vast majority (99%) of these procedures used mice and fish.

Genetic alteration allows the quality of science in many areas of research and testing to be improved. It also allows a gene or sequence to be deleted or inserted so as to produce animals in which a more precise study can be made of a physiological process, a natural defence system or a disease mechanism.  Animals can be genetically altered to become models for human diseases, aiding research into therapies or to be resistant to disease or other adverse conditions which might affect the animal.  GA animals provide the potential for investigating, and hopefully finding treatments for, diseases such as cancer, cystic fibrosis and multiple sclerosis.

Only one in three procedures involving the use of GA animals is for a purpose other than the maintenance of breeding colonies. The use of GA animals provides the potential for investigating, and hopefully finding treatments for, diseases such as cancer, cystic fibrosis and multiple sclerosis. Animals can be genetically modified to produce human proteins (in their milk) to help treat human disease, to allow their organs to be used for transplant to humans (xenotransplantation), to become models for human diseases, aiding research into therapies or to be resistant to disease or other adverse conditions which might affect the animal.

No. We have already announced that no more animals will be used in this country for the testing of cosmetics ingredients or finished products.

No. The Government announced a ban on the use of animals in the testing of alcohol and tobacco products in November 1997.

Cats, dogs, non-human primates and some other species are given special protection by the Animals (Scientific Procedures) Act 1986 and may only be used where no other species is suitable. Collectively they were used in less than 1% of the procedures carried out in 2007. The use of Great Apes (gorillas, orang utans and chimpanzees) is not allowed.

In addition to regulatory testing to help ensure the safety of medicines, non-human primates are also used for other important areas of fundamental research. Research using non-human primates is a tiny, but currently vital, part of work to protect and improve human lives.  For instance, the UK uses small numbers of non-human primates for the development and testing of vaccines against some the world’s largest killers such as malaria, HIV/AIDS and TB, and the potential future treatment of degenerative diseases such as Parkinson’s and Alzheimer’s.  (HIV/AIDS and TB are numbers 1 and 3 respectively in the top 8 leading causes of death and disease burden.)

They are primarily used in pharmaceutical research and development, or in pharmaceutical safety and efficacy evaluations. They are also used, when no other species is suitable, in the evaluation of cardiovascular and cardiorespiratory problems in humans. Such work contributes to advances in human healthcare. Dogs are also used in the development of veterinary medicines and techniques.

Cats are primarily used in the development of veterinary medicines and techniques, and in neurological research. Much of the veterinary research is for the benefit of cats.