Background document on the Wellcome Trust policy on the use of animals in medical and veterinary research

Introduction

In this document we set out the background information explaining why animals need to be used in medical and veterinary research, how funding agencies such as the Wellcome Trust ensure their appropriate use within an ethical framework, and what is done to encourage the application of the principles of refinement, reduction and replacement, known as the 3Rs .

The document should be read in conjunction with the Wellcome Trust policy on the use of animals in medical and veterinary research and the ‘ Responsibility in the use of animals in biomedical research ’booklet.

Background – why animals are used in medical research

Research using animals has been an important part of medical and veterinary research.When animals are used in research, it is because there is no more effective way to:

develop drugs and therapies to treat disease
check the safety of the treatments for humans, animals and the environment
study the processes that can cause disease in animals and humans.

The use of animals in research has enabled major advances in the understanding of biology and led to the development of nearly every type of drug, treatment or surgical procedure in contemporary medical and veterinary practice. Some of the best-known examples include:

antibiotics such as penicillin and streptomycin
vaccines for polio, meningitis, distemper, foot and mouth
treatments for conditions such as cystic fibrosis and asthma
drugs to treat mental diseases like depression
organ transplants and blood transfusions
the use of insulin for diabetes
and contraception for use by people and in controlling animal breeding.

The Wellcome Trust is therefore convinced that the use of animals in research remains valid where the potential benefits to be gained by humans and other animals from such research outweighs the use of animals in that research.

Four pieces of research currently funded by the Trust have been presented as case studies to illustrate why the use of animals remains a necessity in order to understand the biology of disease, and from this develop novel treatments and potential cures. They are:

Some people argue that animals are misleading to use as models of human disease. However, as knowledge about genetics has increased, it has now been shown that humans and animals have a similar genetic makeup. For example, mice and humans share around 99 per cent of their genes, and 90 per cent of genes associated with disease are identical in humans and mice

Of course, no animal model is a perfect match – which is why all discoveries based on animal research, once they are at a well developed stage, are eventually tested on human volunteers before being used for treating patients. Animal research allows us to understand what happens in health and disease, therefore reducing the chance of developing unsuitable treatments and enabling research that would be considered unethical to be conducted on humans.

How many animals are used?

The majority of biomedical research in the UK does not involve the use of animals and this is also true for the research supported by the Wellcome Trust.In fact, less than one in five awards (18%) made in between 1 October 2011 and 31 September 2012 involved the use of animals.

Number of Wellcome Trust-funded projects(1 October 2011-31 September 2012) using animals listed under the Animals (Scientific Procedures) Act 1986

Animal research chart

In the UK, the Home Office regulates all research on living vertebrate animals – that is, mammals (mice, rats, dogs, etc.), birds, fish, reptiles and amphibians, and a special case is made to include work on the cephalopods (octopi and squid). UK law does not permit any experiments on the great apes or any vertebrate on the endangered species list unless special permission is given by the Secretary of State.

As part of this regulation the Home Office is responsible for licensing the use of animals for research, and publishes statistics annually (1).The number of scientific procedures started in 2011 was just over 3.79 million(2). A rise of about 68 000 (2%) on 2010. Mice, rats and other rodents were used in the majority of procedures - 79% of the total. Most of the remaining procedures used fish (15%) and birds (4%).

Research involving animals is licensed by the Home Office

The Animals (Scientific Procedures) Act 1986 (the Act) regulates the use of animals in research in the UK. EU directive 2010/63 was transposed into UK law on 1 January 2013 through amendments to the 1986 Act.

In order to undertake research falling under the Animals (Scientific Procedures) Act 1986, three types of licence must be applied for and granted by the Home Office:

Personal licence - each person who undertakes work under the Act must hold a personal licence, which lists the techniques and species they may use and the establishment(s) at which they may work.
Project licence - the programme of work must be authorised in a project licence, which specifies the species of animal used, the numbers used, and the procedures (which should minimise pain and suffering). The licence application must take into account the expected benefits from the work and the cost, in terms of the welfare of the animals involved. It must justify the use of animals, taking full consideration of the possibility of using other techniques, and must show how the applicant has considered the replacement, refinement and reduction (the 3Rs) in designing the experiment.
Establishment licence - the places where scientific procedures are carried out must be licensed. (Exceptions can be made for ecological fieldwork.) These establishments must provide appropriate standards of housing and care for the animals according to detailed guidelines produced by the Home Office. Certain types of animal must also be obtained from designated breeding or supplying establishments.

As part of the project license form, the Home Office expects applicants to produce an abstract of his/her proposed programme of work for publication on the Home Office website once a licence has been granted.

The licensing conditions in the UK are very stringent and, with Home Office control, this means that all research is accountable to Government and, therefore, to the electorate. The Act also applies to the statutory safety testing of medicines and other products on animals.

A Home Office inspector can visit the research establishment without prior warning and can take action on any breach of the regulations.

Good standards are not only necessary to protect animal welfare; they are also necessary to ensure that the experimental results obtained are valid.

The Home Secretary takes advice on the working of the Act from the Animals in Science Committee. Membership of the committee includes experts in medical and veterinary practice, the law, ethics and animal welfare.

Research must be approved as ethical

Any proposed research requiring a licence has to obtain ethical approval from a local ethical review committee based at the host institute, called an Animal Welfare and Ethical Review Body (AWERB). These replaced the Ethical Review Process from 1 January 2013. The committee includes non-scientists and members who are independent of the institute. The committee provides independent ethical advice to help ensure that:

all use of animals regulated under the Act is carefully considered and justified
proper account is taken of all possibilities for reduction, refinement and replacement (the 3Rs)
high standards of accommodation and welfare are achieved.

Wellcome Trust-funded research involving animals

All research funded by the Wellcome Trust must be fully compliant with the law. Scientists and facilities that the Wellcome Trust funds must be covered by current Home Office licences at the time the research commences. The Wellcome Trust is an international funder of research and, while it cannot enforce the UK regulations overseas, it does expect that the proposed research is carried out in the spirit of the UK legislation, as well as being compliant with all local legislation and ethical review procedures. In certain cases steps are taken to ensure this through site visits to overseas facilities. The Wellcome Trust has turned down applications for funding research involving animals in other countries which it believes would not obtain a licence in the UK.

As well as complying with the legislation, all Wellcome Trust grants are assessed by independent experts from the scientific community, a process known as peer review. These experts are asked to ensure that the use of animals in the research is necessary and relevant.

In all research using animals supported by the Wellcome Trust, the principles of the 3Rs apply. The Wellcome Trust is also committed to improving best practice through its support of the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). Any application for Wellcome Trust funding which involved the use of non-human primates, cats, dogs or horses undergoes independent review by the NC3Rs as part of the application process.

The 3Rs – replacement, reduction and refinement

Replacement means the replacement of animals with methods that do not require animal use, for example the use of tissue cultures and the use of computer modelling. Where possible, experiments on animals should be replaced by experiments not requiring animals. The whole animal, however, reacts differently in comparison to isolated cells, and some work on whole animals remains necessary.

Refinement means the improvement of experimental techniques to minimise pain, distress or other adverse effects and/or the enhancement of the animals' well-being.

Reduction means using as few animals as possible. Improvements in statistical techniques, more sensitive recording and better management of animals bred for research means that the number of animals bred and used for research can be minimised. It is important, however, not to use too few animals in an experiment as this may invalidate the results, thus making the experiment meaningless.

Alternatives to animals in medical research

The development of alternatives to animals continues on many fronts. However there are currently no methods which can satisfactorily replace animals in all cases, therefore the use of animals in research will need to continue in order to make advances in human and animal health. The development of new techniques - such as cell lines, tissue cultures or imaging and computer modelling - will reduce the need for use of animals in research in some areas.

In October 2012 the Wellcome Trust signed a Declaration of Openness on animal research along with other research funders and charities, universities and pharmaceutical companies. The Declaration commits the organisations to work together to develop principles of openness, practical steps and measurable objectives that will underpin a more transparent approach to animal research.

Other sources of information

There are many organisations with views on the use of animals in research. By listing these sources of information the Wellcome Trust makes no endorsement of their content. Some examples are:

ABPI – Association of the British Pharmaceutical industry
AMRC (Association of Medical Research Charities)
ECVAM -the European Centre for the Validation of Alternative Methods
ESF -European Science Foundation
FELASA -Federation of European Laboratory Animal Science Associations
FRAME - Fund for the Replacement of Animals in Experiments
LASA -Laboratory Animal Science Association
MRC -Medical Research Council
RSPSCA – The Royal Society for the Prevention of Cruelty to Animals
NC3Rs - the National Centre for the Replacement, Refinement and Reduction of Animals in Research provides a UK focus for the promotion, development and implementation of the 3Rs in animal research and testing
The Boyd Group – UK based forum for open exchange of view on issues of concern related to the use of animals in science
The Home Office
UAR - Understanding Animal Research
UFAW -Universities Federation for Animal Welfare.
World Congress on Alternatives and Animal use in the Life Sciences.

(1) Statistics of scientific procedures on living animals, Great Britain 2011. (2012). The Stationery Office.

(2) Some animals have more than one procedure applied to them, so the number of procedures is slightly higher than the number of animals used. For example, in 2011, there were 3.79 million procedures compared to 3.71 million animals used. In addition, breeding to maintain a genetic strain of mice is counted as a procedure so not all procedures are a measure of the number of experiments carried out.