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Animal research

Animal research is essential to understand disease and to evaluate the safety and effectiveness of new medicines 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 13 animal research laboratories in Europe, Japan and the US. Some research (around 7% of our total animal research) is conducted by external contractors on our behalf.

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

	%
Mouse	61.7
Rat	29.5
Guinea pig	6.1
Other rodent	0.6
Rabbit	0.7
Other	1.4

The three Rs
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.

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.

We provide extensive training on the 3Rs to all 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 twice a year by GSK’s R&D Chairman, recognise employees who have made outstanding advances in implementing the 3Rs. In 2004 awards were made for: refinement of an animal model to discover new treatments for brain damage caused by strokes; innovative use of imaging systems to minimise animal use while accelerating drug development; use of computer-generated prediction models and cell and tissue cultures to replace animal testing.

In Europe, we also give a GSK Laboratory Animal Welfare Prize each year to external researchers or laboratories for developing new techniques to implement the 3Rs. The prize this year was won for a project that promoted improvements in husbandry and housing for laboratory animals.

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

	1994	1995	1996	1997	1998
	(% change since 1994)
Animals used	100.0	85.9	83.1	86.5	95.5
R&D activity	100.0	120.4	128.8	135.2	140.7

	1999	2000	2001	2002	2003	2004
	(% change since 1994)
Animals used	92.5	92.8	92.4	103.3	105.0	103.9
R&D activity	154.0	168.6	176.2	191.8	195.8	203.0

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

1. Blood sampling techniques that reduce the number of animals used and the number of injections required per animal and increase the quality and efficiency of sample collection.
2. Refined methods for collecting DNA from transgenic mice, that reduce animal stress and increase productivity.
3. Development of better facilities and refined procedures for ferrets and guinea pigs. Exchange of this knowledge between GSK laboratories in different countries.

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.

GSK laboratories, and any external laboratories conducting research on our behalf, must also follow our Code of Practice on animal research. When GSK sponsors animal research at other companies or institutions, we require that such entities meet all legal requirements to conduct animal-based research and we establish to the best of our ability, that best practice standards for animal care and use are followed.

'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 from within and outside GSK. In addition, GSK expects these external collaborators to demonstrate application of best practice regarding animal research. Accreditation by the Association for the Accreditation and Assessment of Laboratory Animal Care (AAALAC) International is one example of how this can be demonstrated.

To ensure appropriate use of animals, all proposed animal tests must be reviewed by our Ethical Review Committee.

We also obtain independent evaluation from the AAALAC. Ten of our laboratories are accredited by AAALAC including all our animal laboratories in the UK and US. Our laboratories in Belgium, Italy and Spain achieved accreditation during 2004.

Communicating our approach

We believe it is important to explain the need for animal research and to be open about what we do.

Our laboratories host visits from schools, colleges, animal welfare organisations and others. In 2004, we also made over 45 visits to UK and US schools to discuss issues around animal research.

We are in regular discussions with animal welfare organisations, our investors and other interested parties. For example this year we have contributed to the work of the Nuffield Council on Bioethics and will be developing our relationship with the new UK national centre for the 3Rs (NC3Rs).

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