Corporate Responsibility Report 2008

Animal research

Animal studies remain a small but vital part of our research.They are the only method that can demonstrate the effects of a potential new medicine in a living body before it is used in humans. In addition, research in animals can provide vital information about the causes of diseases and how diseases may develop.

Safety regulations require us to test all new medicines on animals before they are tested in clinical trials using humans. Most vaccines have to be tested on animals each time a new batch is produced.

Our non-medicinal Consumer Health products or ingredients, for example dietary supplements, are not tested on animals unless there is a specific demand from a regulatory authority or if we determine that a study is needed to support safe use. GSK does not conduct animal testing on our Nutritional Healthcare products or products classified as cosmetics, for example toothpastes marketed in the European Union.

When animals are necessary for our research, we are committed to acting ethically, providing for the animals’ health and wellbeing and practising good animal welfare.

Our approach

GSK has animal research laboratories in Europe, Asia and the US. Some animal research is conducted by external contractors on our behalf, representing around six per cent of our total animal use. We estimate that animal research accounts for around five per cent of all GSK research expenditure.

Almost all the animals used by GSK are rodents, mainly rats and mice. We also use rabbits, dogs, non-human primates, fish, ferrets, chickens, pigs, cats, sheep and goats. Together these account for just over one per cent and are listed in order of magnitude of use.

Ultimately GSK would like to see the important benefits of research being achieved and applied to humans without the need for animals in research. We do not believe this can be achieved in the foreseeable future. Our goal is to use animals only when scientifically necessary, use as few as scientifically feasible and to minimise pain and distress. Therefore GSK remains committed to the 3Rs.

The 3Rs

A key aspect of animal welfare is covered by what the biomedical community refers to as the three Rs (3Rs). These Rs are:

Replacing research using animals with non-animal alternatives or species of the lowest possible order (phylogenetically)
Reducing the number of animals used in experiments and still obtaining the same information as in a larger study
Refining techniques to minimise pain and distress and maximise the welfare of animals

Our scientists always try to devise experiments that do not require any animals. When that is not possible, the researchers will work with others to design an experiment so that we obtain the necessary information from the smallest number of animals possible, with the least effect on individual animals.

We implement the 3Rs by using advanced scientific methods, training, raising awareness, and sharing and encouraging best practice. For example, we use ultrasound for imaging heart disease in rats and we have a forum for discussion on global principles for animal housing. Read more on recent GSK advances in replacing, reducing and refining animal use

In addition we encourage a 3Rs culture at GSK through:

Regular training for staff involved in the care and use of animals
Review of study designs by an ethical panel which considers the 3Rs and whether alternatives to animal studies are possible prior to the approval of studies
Refining techniques to minimise pain and distress and maximise the welfare of animals
Our internal 3Rs website which champions advances in refinement, reduction and replacement of animal use in medicine discovery and development, and promotes their application across R&D
A news bulletin on advances in the 3Rs which is updated on a rolling basis and is easily accessible from the 3Rs website
Our internal Animal Welfare Awards for employees who have made outstanding advances in implementing the 3Rs

Non-human primates

Our policy requires that studies involving animals must use the lowest possible order (phylogenetically) of animal appropriate for the research study. Occasionally, non-human primates may be the only animals where the anatomy and/or physiology of a disease is similar to that in humans. Sometimes only human and non-human primates will be affected by or respond to a potential medicine or vaccine; for instance, a new medicine may be based on a molecule produced by primates, including humans, and would be destroyed by the immune systems of other species. We therefore use non-human primates, only if no species of lower neurophysiological sensitivity is appropriate. The two most common non-human primates species used in research are macaques and marmosets. Of the animal research that we carry out, less than 0.5 per cent involves non-human primates.

Transgenic (genetically modified) animals

Genetically modified animals, also known as transgenic animals, have been genetically adapted by scientists to create new characteristics. Most transgenic animals (over 95 per cent) used in biomedical research are mice. Transgenic strains of animals are developed to answer specific compound or disease-related questions as part of the medicine discovery process. For example, transgenic mice that model Alzheimer’s disease have been fundamental in biological research, new compound development and target validation. The use of such transgenic models in mice can sometimes replace the need for studies in higher order animals.

GSK worldwide standards

While recognising differences in country-specific regulations, GSK achieves worldwide standards by using core principles for the care of laboratory animals. These principles establish our basis for animal work conducted by or on-behalf of GSK. In addition, all GSK facilities and external laboratories conducting research on our behalf must follow all legal and regulatory requirements. In the UK these regulations are the responsibility of the Home Office. In Europe animal research comes under Directive 86/609/EEC and in the US is covered by the Animal Welfare Act 2006.

We also continue to seek voluntary accreditation from recognised agencies such as the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALACi).

Communicating our approach

Some people hold strong views on animal research and testing. We believe it is important to explain the need for animal research and testing and to be transparent about what we do.

Many of our laboratories host visits from schools, colleges, animal welfare organisations and others. We engage regularly with animal welfare organisations and our investors, as well as contributing to the debate in the media.

Protest

We accept the right of lawful protest against animal research as a part of a free society, but condemn the use of violence and intimidation by some who are opposed to animal use. We welcome the shift away from extremism to informed debate.