Drug candidate testing in living animals is a requirement before they can be tested in humans and the authorities require efficacy, safety and toxicology data from both animal and human testing before approval of a new product. The use of experimental animals is, however, a source of concern for many people.
In Novo Nordisk we believe, that experiments on living animals should only be carried out when no other suitable alternative methods are available and the expected benefits to human should outweigh the costs to the animals.
We cannot replace all animal experiments in the foreseeable future, but we continuously refine the care and use of animals and develop procedures that reduce and/or replace animal experiments by eg applying computer simulation, tissue cultures and cell based methods.
Novo Nordisk has over the last decade reduced the number of experimental animals due to these improvements in screening methods.
Animal experiments are an integral part of our efforts to examine the efficacy, pharmacokinetics, metabolism and possible side-effects of new drug candidates before they are investigated in humans. Animals are also used in our research efforts to establish the causes of diseases. Some animal experiments are performed as part of the requirement by the authorities for the product control of selected products.
It is important for Novo Nordisk to act with due respect for the animals by establishing and ensuring high ethical and welfare standards. Novo Nordisk supports transparency and openness about animal experimentation and will continue to report on our use of experimental animals.
Novo Nordisk has for decades focused on a broad stakeholder engagement in relation to animal experimentation and will continue to engage in dialogue and partnerships with key stakeholders such as animal welfare organisations.
1) Reduce, Refine and Replace
Novo Nordisk supports the
principles of the Three Rs (Reduce, Refine and Replace) and is
integrating these principles in all our processes and procedure.
2) Internal ethical standards
Novo Nordisk supports high ethical standards in relation to animal experimentation and performs an internal ethical review of all new types of experiments on animals
3) External ethical standards
Novo Nordisk acknowledges its responsibilities in relation to
experiments on living animals carried out by external parties on
behalf of Novo Nordisk and supports high ethical and welfare standards
at our external partners, contract research organisations and
suppliers and monitors their performance
4) Use of non-human primates
Novo Nordisk acknowledges the specific concern about the use of
non-human primates and supports that all experiments on non-human
primates are thoroughly evaluated and special attention is paid to the
housing, training and socialisation as well as the source of non-human primates
5) High animal welfare standards
Novo Nordisk supports high animal welfare standards in relation
to the housing, care and use of experimental animals and will house
the animals according to their needs, provide appropriate training and
socialisation of the animals
6) Use of animal models
Novo Nordisk is aware of the specific concern about the use of animal models of human disease including the use of transgenic animals and the importance of considering and minimising the welfare impact on the animals
7) Experiments on living animals
Novo Nordisk supports the principle that experiments on living
animals are properly regulated, and that the ethical and welfare
aspects of the use of experimental animal are adequately addressed in
national and international legislation
The use of non-human primates in research is questioned by many people on ethical, welfare and conservation grounds. Non-human primates are used as a necessary animal model to evaluate certain drugs for efficacy and safety prior to the testing in humans and to model certain human disease states.
Novo Nordisk's position on non-human primates in research
1 Novo Nordisk supports the principle that the use of non-human primates must be clearly justified and that the number used should be kept to an absolute minimum
2 Novo Nordisk supports the principle that all experiments on non-human primates should be thoroughly evaluated, and that non-human primates only should be used if there are no acceptable alternative methods
3 Novo Nordisk acknowledges primates’ high level of development and social nature and supports the principle that special attention should be paid to the housing, training and socialisation of non-human primates requested by regulatory authorities
4 Novo Nordisk acknowledges the specific concern about the use of wild-caught primates and supports the proposition that their use is phased out and only purpose-bred non-human primates are used
5 Novo Nordisk supports a general ban on the use of Great apes such as chimpanzees and that these species are only used if specifically requested by regulatory authorities
To ensure uniform standards, a number of principles must be adhered to throughout Novo Nordisk and all our external collaborators including contract laboratories, research laboratories, partners and suppliers.
All activities involving animals must be conducted strictly in accordance with present legislation.
Alternatives to animal experiments must be used whenever possible.
Transgenic animals may be used for testing and experiments when this model is justified.
At Novo Nordisk records are kept updated on the type of experiment, animal species and number of animals used either in-house or by external contractors in accordance with the authorities’ and the requirements of Novo Nordisk. While we strive to keep the number of experimental animals to a minimum, the number of animals purchased each year by Novo Nordisk fluctuates due to different research activities in the R&D pipeline.
For full transparency, the number of purchased animals are documented below as well as published in the annual Novo Nordisk Report.
Download our brochure about animals in research and development.
Selected Novo Nordisk compounds are available for research purposes. When using these compounds for in-vivo purposes we believe that this use should meet the principles of the 3 Rs and for high animal welfare standards.
Please download the data sheet for NASH, or Non-Alcoholic Steatohepatitis which will give you relevant information to meet these requirements.
The company-signatories of this declaration share common values and believe that the welfare of animals used in the research and production of medicines and vaccines requires the greatest consideration. This work demands application of high and most consistent standards of animal welfare and laboratory animal science regardless of where it is performed.
In this document, the company-signatories state their expectations related to animal welfare practices to be used at their own sites in whatever country and by external partners worldwide when using living animals to conduct studies on their behalf. The company-signatories request that their external partners meet the following criteria or agree on a plan for implementation when using and caring for animals in connection with an existing business relationship.
1Depending on the local regulation, this may be an Institutional Animal Care and Use Committee, an Animal Ethics Committee, an Animal Welfare (and Ethical Review) Body or other comparable body.
2Beyond the 3 Rs to a More Comprehensive Framework of Principles for Animal Research Ethics. David DeGrazia and Tom L. Beauchamp. ILAR Journal, 2019, Vol. 00, No. 00, 1–10
Principles of Social Benefit
(1) The Principle of No Alternative Method
(2) The
Principle of Expected Net Benefit
(3) The Principle of
Sufficient Value to Justify Harm
Principles of Animal Welfare
(1) The Principle of No
Unnecessary Harm
(2) The Principle of Basic Needs
(3) The
Principle of Upper Limits to Harm
Signatory Companies
Novo Nordisk, Bagsvaerd, Denmark
Merck KGaA, Darmstadt,
Germany
Sanofi, Paris, France
Novartis AG, Basel,
Switzerland
LEO Pharma, Ballerup, Denmark
Lundbeck,
Copenhagen, Denmark
We have a centralised strategic department that contributes to internal awareness and education as well as ensure continued integration of the 3R considerations in our decision-making processes. Furthermore, the department engages in dialogues and partnerships with our key stakeholders.
When animals are necessary for research, their welfare is given high priority and attention in several ways. Not only when they are being tested, but also when they are housed.
Our state-of-the-art housing standards consider the physiological and ethological (behavioural) needs of the animals. We have successfully been able to implement the standards for all animals housed at our facilities.
The design of our renovated facilities was made in close collaboration with The Danish Animal Welfare Society and with valuable input from many internationally recognised experts within animal welfare, as well as input from the employees working every day with the animals, especially the animal caretakers.