Novo Nordisk position
Transgenic Animals
Novo Nordisk uses transgenic animals at its own facilities in Denmark and in the US and in collaboration with external partners. In all cases, Novo Nordisk obtains all the necessary approvals for this use.
Novo Nordisk believes that the use of transgenic animals offers new and better ways of understanding, preventing and treating human disease. Therefore, in the future, transgenic animals will become an integral part of Novo Nordisk´s biomedical research aimed at improving the quality of life of human beings by developing new and better pharmaceuticals.
Novo Nordisk believes that it is ethically acceptable to use transgenic animals when the objective is to develop safer, more effective pharmaceutical products.
The use of transgenic animals can also help to reduce the total number of animals used for experiments. In 2000, Novo Nordisk used approximately 2,085 transgenic mice for research in Denmark. The use of such animals has become an integral part of the development and testing of potential new pharmaceuticals, and of producing complex proteins in sufficient quantities for human medicine.
Novo Nordisk has invested in and established a collaboration with a Scottish research company, PPL Therapeutics PLC, a world leader in transgenic production technology. By using this technology, domestic animals such as sheep and cattle can be induced to produce specific human proteins in their milk.
What are Transgenic Animals?
Transgenic animals are animals whose hereditary properties have been permanently modified by the introduction of recombinant DNA into their germ cells. In the pharmaceutical industry, transgenic animals may be used for several purposes, such as:
Animal models for human diseases
The genetic setup of an animal may be modified in such a way that it develops a disease similar to an equivalent human disease. Typically, one particular gene has either been inactivated or inserted in such animals.
These animals greatly facilitate the search for important new drugs and reduce the number of laboratory animals used.
To test the identity and purity of human proteins used as drugs
A transgenic animal that makes a human protein (e g human insulin) will recognise this substance as its own and will therefore not produce an immune response against it. As a consequence, the identity and purity of the product can be tested more efficiently in such animals, thereby saving the use of many laboratory animals otherwise needed to obtain a statistically significant result.
To produce protein drugs
Complicated human proteins can often not be produced efficiently and in their correct form by microorganisms or mammalian cell cultures. Some human proteins, however, can be secreted in large amounts and in their correct form in the milk or blood of mammals such as cows, goats, sheep, rabbits or mice. In certain cases, transgenic animals represent the only means to produce important new human drugs.
Legislation and ethics
In Denmark, research involving transgenic animals needs approval by the Ministry of Justice (The Animal Experiment Inspectorate), the Ministry of Labour (The Directorate of National Labour Inspection) and the Ministry of the Environment and Energy (The Danish Environmental Protection Agency).
The Danish Ethical Council on Animals has accepted the use of transgenic animals in research if the purpose is essential and the animals do not suffer (Annual Report 1991). At a consensus conference in Copenhagen in 1992, the use of transgenic animals was considered permissible if the purpose in each case was considered to be reasonable and if the potential suffering of the animals had been considered in relation to the purpose of the research or use.
