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Animal research

Animal research is essential to understand disease and to evaluate the safety and effectiveness of new medicines and vaccines before they are given to people.

Regulations require new medicines to be tested on animals before being tested on humans for safety reasons. Some vaccines have to be tested on animals each time a new batch is produced. We estimate that animal research accounts for around 5% of all GSK research expenditure.

GSK has 14 animal research laboratories in Europe, Japan, Singapore and the US. Some research (around 7% of our total animal research) is conducted by external contractors on our behalf. This percentage has remained relatively constant over the last three years.

Over 98% of the animals used by GSK are rodents (such as rats, mice, guinea pigs) and rabbits. The remaining 2% includes fish, ferrets, pigs, dogs, cats and primates.

Our goal is to use animals only when scientifically necessary, and then to use as few animals as possible and minimise their distress. Our animal research laboratories are subject to strict internal and legal controls. GSK is committed to the 3Rs - reduction, refinement and replacement - and to achieving the highest standards of animal welfare. We run award programmes to encourage implementation of the 3Rs, share best practice with others in our industry and communicate our approach to interested parties.

This approach is having an impact. Despite a significant increase in R&D activity since 1994 the number of animals used by GSK in our laboratories is broadly similar to that of eleven years ago.

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The three Rs
The 3Rs commit us to: reducing the number of animals used in each study; refining studies to minimise pain and maximise the information obtained from each animal; and replacing animal studies with alternative methods wherever possible.

Recent GSK advances in research techniques supporting the 3Rs and animal welfare:

1. Redesigning animal studies and refining testing methods so that more outputs (e.g biomarkers similar to those measured in blood tests in human clinical trials) can be obtained from the same animal, while it is alive. This reduces the total number of animals needed to obtain this data.
2. Use of radio-telemetry technology that enables continuous measurements to be made (e.g. for blood pressure, heart rate, and temperature), without disturbing or restraining the animal.
3. Observation of the night-time activity of marmoset monkeys which resulted in improvements to their nest boxes for resting and sleeping.

See research for more background information on implementation of the 3Rs at GSK.

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Training and awareness
We provide extensive training on the 3Rs to staff who are involved in the care and use of animals, and we have a number of initiatives to increase awareness of animal welfare. For example, we produce quarterly bulletins which review recently published journal and news items on these subjects. A UK-based 3Rs committee made up of GSK scientists, statisticians, senior managers, animal technicians and veterinarians encourages a 3Rs culture at GSK through seminars and production and promotion of ‘Recommended Practice’ guidelines for scientific procedures and animal welfare.

Our Animal Welfare Awards encourage employees to find alternatives to animal research. The awards, presented by GSK’s R&D Chairman, recognise employees who have made outstanding advances in implementing the 3Rs. In 2005 awards were made for further development in the use of advanced medical imaging systems to minimise animal use.

A GSK animal technician was awarded the 2004 Andrew Blake Tribute Award by Seriously Ill for Medical Research - the UK national patients’ group in support of humane animal research - for a paper on ‘Improvements in the housing, husbandry and welfare of ferrets at GSK’.

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Sharing best practice
GSK participated in a study by the UK Associate Parliamentary Group for Animal Welfare on ‘The use of animals in vaccine testing for humans’. Information on our work to develop new tests for vaccines, such as the replacement of primates with mice in testing for oral polio vaccines, is included in the final report published in March 2005, see The use of animals in vaccine testing for humans.

The annual GSK Laboratory Animal Welfare Prize recognises external researchers or laboratories developing the best new techniques for implementing the 3Rs. From 2006, we will increase the prize to £10,000 and it will be awarded through the new UK National Centre for the 3Rs.

Together with industry partners in the Association of the British Pharmaceutical Industry, we are funding a new three-year post at the National Centre for the 3Rs to encourage sharing of industry best practice.

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Regulation and internal controls
Our laboratories comply with strict national laws, guidelines and codes of conduct on animal welfare. Regulators carry out regular unannounced inspections of our sites to check standards of animal care.

To ensure appropriate use of animals, all proposed animal tests must be reviewed by our Ethical Review Committee. GSK laboratories, and any external laboratories conducting research on our behalf, must follow our Code of Practice on animal research which includes best practice standards for animal care and use. We reviewed and updated our Code of Practice and Policies in 2005.

'Best practice' is defined as a combination of what is currently known from the scientific literature, from published recommendations, and from the knowledge of experts within and outside GSK. Independent accreditation by the Association for the Accreditation and Assessment of Laboratory Animal Care (AAALAC) International is one way laboratories can demonstrate that they meet best practice.

Ten of our laboratories are accredited by AAALAC including all our animal laboratories in Belgium, Italy, Spain, the UK and US. At present the vast majority of the animals used by GSK are in AAALAC accredited facilities. We aim to achieve AAALAC accreditation for all our laboratories conducting animal research.

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Communicating our approach
Animal testing is clearly a very sensitive issue and some people hold strong views on it. We believe it is important to explain the need for animal research and to be open about what we do.

GSK took part in a two-year detailed ethical review by the Nuffield Council on Bioethics on ‘The ethics of research involving animals’, published in 2005. This concluded that animals can be useful models for studying specific aspects of human biology and disease and the likely effects of chemicals and medicines in humans. However, the usefulness of animal models has to be judged on a case-by-case basis for each type of research or testing.

The report recommended that more information be made available on the goals and welfare implications of animal research and alternative scientific methods to enable interested parties to judge whether specific types of research are justifiable. It emphasised the importance of using alternatives to animal research and the development of new alternative methods. It condemned the use of violence and intimidation by those opposed to animal research. GSK endorses the report’s findings.

Our laboratories host visits from schools, colleges, animal welfare organisations and others. In 2005, we also made over 25 visits to UK schools and about 10 visits to US schools and community groups to discuss issues around animal research. We engage regularly with animal welfare organisations, our investors and other interested parties, as well as contributing to the debate in the media.

In an article on animal research and the impact of animal rights extremism the Financial Times noted that “GlaxoSmithKline has led the UK pharmaceutical industry in a cautious move towards more openness about its use of animals” (20 October 2005).

We accept the legitimate right to lawfully protest against animal research as a part of a free society but condemn the use of violence and intimidation by those opposed to animal use.

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