BACKGROUNDER
Purpose of the Policy
GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Millions of people across the world owe their lives to our success in discovering and developing safe and effective vaccines, antibiotics, antiviral and anti-asthma drugs. Others have the quality of their lives improved significantly by GlaxoSmithKline medicines which treat peptic ulcers or alleviate the symptoms of conditions such as arthritis or depression. None of the medicines which benefit society today would have been developed without the appropriate use of laboratory animals.
GlaxoSmithKline acknowledges that use of animals for research purposes is a subject of enormous sensitivity that rightly commands a high level of public interest. It also acknowledges that it has a moral responsibility to ensure best practice in the humane treatment of laboratory animals.
This policy defines GlaxoSmithKline’s principles and standards for the care and use of animals by the company or on behalf of the company.
1. Animal research is vital to the discovery of new life-saving medicines
Many serious diseases such as AIDS, cancer, malaria, TB and stroke are still both poorly understood and treated, and cause immense suffering and death. New and better therapies are desperately needed. GlaxoSmithKline’s aim is to discover and develop vaccines and medicines that will help alleviate the suffering caused by these and other diseases. This goal is unattainable if animals could not be used to understand disease mechanisms, discover novel ways to rectify them and evaluate the efficacy and safety of potential new medicines before they are given to humans.
Regulatory authorities world-wide require that all new prescription medicines and vaccines must be subjected to extensive and prolonged safety testing in animals and in human clinical studies before they are approved for use by doctors. These requirements were developed to protect people from potentially dangerous products.
Much research work can be done using non-animal methods, such as computer modelling and isolated cells and tissues, and GlaxoSmithKline uses them wherever possible. However, these methods simply cannot reproduce the complexity of changing the course of a disease in a living creature. They cannot, for instance tell the scientist if the candidate medicine will get to the right part of the body in the right concentration for the right amount of time to produce the desired effect, or if it will do so safely. Such questions can only be answered by carrying out well-designed tests in live animals. That is why national regulatory authorities require animal testing to fulfil the legal requirement for safe and efficacious medicines. It is not possible to obtain regulatory approval for new medicines without using animals.
GlaxoSmithKline also markets and manufactures over-the-counter medicines that people can buy for self-treatment without a prescription. Information about the safety and efficacy of the ingredients used in these medicines is generally already available before they are offered for sale to consumers. Consequently our policy is not to test them on animals unless required to do so by regulatory authorities to substantiate safety. Even then, animal tests would only be undertaken following a comprehensive internal review procedure to ascertain that the product had proven therapeutic benefits and there were no alternatives to animal tests.
GlaxoSmithKline’s Nutritional Healthcare products, which include Lucozade, Horlicks and Ribena, are not tested on animals. Non-medicinal Consumer Healthcare products, like toothpastes or their ingredients, which are classed as cosmetics in some countries, are never tested on animals unless there is a specific demand for this from individual national governments.
2. Code of Practice observed by GlaxoSmithKline
GlaxoSmithKline is committed to maintaining high standards for the humane care and treatment of all laboratory animals, and it is the policy of GSK that all due measures are taken to prevent or minimise pain and distress before, during and after experimental procedures.
GlaxoSmithKline’s animal facilities and R&D programmes comply with all national laws, guidelines and codes of conduct and the company regards these standards as a minimum. Inspectors from many regulatory agencies, including the UK Home Office, the UK Department of Health, the US Department of Agriculture and the US Food and Drug Administration, pay unannounced visits to check that the projects and the animal care and use programmes meet all statutory requirements.
In addition, the Company also has its own ethical Code of Practice that imposes higher standards and more stringent constraints on its scientific staff than the laws of individual countries governing animal research. Peer-review and Animal Care and Use Committees, comprising veterinarians, scientific staff, senior managers and technicians, meet regularly to review animal practices and animal-based research is allowed to begin only after approval of scientific proposals or protocols by these groups (and any external authorities where required). We involve people not affiliated with GlaxoSmithKline in these activities and voluntarily undergo independent accreditation of animal care, for example by the Association for the Assessment and Accreditation for Laboratory Animal Care.
Ultimately the welfare of our animals depends on the individuals who handle them on a day-to-day basis. These people - veterinarians, scientists, technicians - care about the well-being of animals just as other people do. Many of them have chosen their work precisely because they love animals. Our policy on animal care and use states that failure to meet Company standards, maltreatment of animals or non-compliance with the laws governing animal studies is treated as grounds for immediate dismissal.
All staff involved in animal research are trained to standards which are approved by recognised professional bodies and which adhere to national guidelines. Animals are transported, housed and cared for by dedicated staff. All due measures are taken to prevent or minimise pain and distress during and after experimental procedures. The company supervises all staff appropriately and provides suitable facilities so that staff can carry out their duties responsibly and humanely. Qualified veterinarians are available at all times for advice and help in the care of animals and in the conduct of the research.
The vast majority of animals (over 97%) used by GlaxoSmithKline are rats and mice. Very few studies use dogs, cats, rabbits or non-human primates. All the animals used in Research and Development are specifically-bred for research and could never have been someone’s pet. Minimising the number of surplus animals we breed for research purposes is a priority.
The only exception to this policy is that a number of wild-caught monkeys are used to make and test oral polio vaccine. These animals are sourced from Barbados where they are categorised as agricultural pests and are being culled. Cells from each monkey enable production of 5 million doses of polio vaccine. GlaxoSmithKline is actively developing alternative ways to produce and test the vaccine, and will stop using monkeys when the alternatives are validated and approved by regulatory authorities. We are playing a major role in this validation process. In the meanwhile, vaccine production must be maintained to achieve the World Health Organisation’s goal of eradicating polio by 2005. Ceasing use of these animals prematurely will delay the accomplishment of this important global objective without saving the life of a single monkey, as the animals would be culled as pests in any case.
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. The Company only works with licensed Contract Research Organisations that comply with government requirements and implements robust auditing processes to ensure that it is aware of all indirect use of animals in research which it sponsors via contractors and academic partners.
3. Reduction, Replacement and Refinement
GlaxoSmithKline is committed to implementing the three Rs - Reducing the number of animals used for research, Replacement by non-animals methods whenever possible and Refinement of the techniques used to eliminate or reduce suffering and improve animal welfare. In addition, GSK has added a fourth R - Respect to ensure that appropriate care is taken in the conduct of all our animal studies. The 3Rs approach is not only ethical, it also makes good financial sense because animal testing is not a cheap option.
Much preliminary research undertaken by GlaxoSmithKline scientists on new prescription medicines is carried out on isolated tissues and cell cultures rather than animals. Not only is this more humane, it is also a more cost effective way to conduct research. Scientists try to devise tests that do not require any animals at all, and if that is not possible, they try to obtain the information they need from the smallest number of animals, with the least effect on individual animals.
GlaxoSmithKline is actively engaged in research to develop and validate experimental methods that can provide more and better alternatives to the use of animals in research. To this end GlaxoSmithKline has instituted an Animal Welfare Award to encourage and recognise individual efforts to develop alternative test methods and other practices to ensure we use only the optimal number of animals. The company shares "best practice" with other scientists and pursues the acceptance of validated alternatives with regulatory authorities.
The Company is also actively involved with external organisations that aim to reduce the need for animals: FRAME (The Fund for the Replacement of Animals in Medical Experiments) in the UK , the Prince Laurent Foundation (an organisation concerned with animal welfare, including the development of alternative testing methods) in Belgium, ECVAM (European Centre for the Validation of Alternative Methods) and the European Cosmetics Companies’ Trade Association’s "Alternatives to Animal Testing" programme in Europe, and CAAT (Center for Alternatives to Animal Testing) at Johns Hopkins University in the US.
4. Engaging in public debate/communication
Animals could not be used in the discovery and development of new medicines without public acceptance that it is necessary, done humanely and benefits society. GlaxoSmithKline therefore welcomes and encourages responsible dialogue about the need for animal research and the care and welfare of the animals used. Sharing their concerns about the welfare of laboratory animals, GlaxoSmithKline engages with law-abiding organisations such as the Royal Society for the Prevention of Cruelty to Animals, the Universities Federation for Animal Welfare, the Prince Laurent Foundation and the Scientists Center for Animal Welfare.
GlaxoSmithKline publishes the results of its research in scientific journals that have world-wide readership and in a way that ensures the work is made available to other researchers. It supports publications that emphasise the 3Rs approach. The company also provides data to the Centre for Medicine Research, which has established a database for sharing information from pharmaceutical companies around the world.
A comprehensive schools programme is in place to enable students and teachers to visit GlaxoSmithKline’s facilities to learn more about medicines research and to see the animals under our care. Our animal facilities are also open to all employees as well as other small groups of visitors by arrangement.
5. Safeguarding employees and premises
GlaxoSmithKline believes that companies and scientists should be able to pursue legitimate research goals in accordance with the law without fear of harassment, intimidation or violence. This includes pharmaceutical companies conducting animal research to discover and develop new life-saving medicines.
For many years pharmaceutical and research industries have been the focus of protests by various animal protection groups. Animal research is a subject of enormous sensitivity which, understandably, provokes strong emotions. However, we believe there is a substantive difference between lawful protest against the company and aggressive, abusive and hostile demonstrations at private residences and the sending of vicious hate mail and hoax bombs to family homes to cause disruption and alarm. The company condemns organisations and extremists that terrorise people, destroy property and commit other acts of aggression under the banner of animal rights to prevent individuals and organisations from going about their legitimate business.
GlaxoSmithKline works closely with law enforcement agencies, government and the scientific community to ensure the safety of its personnel and increase security at our facilities. The company has implemented various initiatives to help employees reduce the risks to themselves and their families, and to provide support to those who are victimised by extremists.
