Testing drug candidates in living animals is a prerequisite before they can be tested in humans. The authorities require data on efficacy, safety, and toxicology from both animal and human trials before approving a new product.
At Novo Nordisk, we believe that experiments on living animals should only be conducted when no other suitable alternative methods are available, and the anticipated benefits to humans must balance the harm to the animals.
While we cannot foresee replacing all animal experiments in the near future, we continuously refine the housing, care, and use of animals. We also develop new methods and technologies that don't involve animals, such as computer simulations, tissue cultures, and cell-based methods.
Over the last decade, Novo Nordisk has reduced the number of experimental animals used per individual project due to improvements.
The total number of animals used at Novo Nordisk depends on the number of projects in our overall research and development pipeline, including projects related to companies which we have acquired. Several factors determine how many animals Novo Nordisk requires in a given year, such as the number, nature, and development phases of new pharmaceuticals, regulatory requirements, and the development of validated new methods that can reduce or replace the use of animals.
Novo Nordisk continually strives to reduce the number of animals used. However, due to the company's significant growth and increased research activities, the total number of animals needed is likely to increase.
Animal experiments play a crucial role in our efforts to investigate the effects of a new drug candidate in the body, as well as identifying potential side effects. These are health authority requirements before the drug can be administered to humans.
We also use animals to gain a better understanding of the causes and
effects of diseases, and how we can find new treatment methods or even
a cure.
At Novo Nordisk, it's important for us to act with due respect for the animals by establishing and ensuring high ethical and welfare standards. We support transparency and openness about animal experimentation and will continue to report on our use of experimental animals.
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 a concern for many people due to ethical, welfare, and conservation reasons. At Novo Nordisk, we approach the use of non-human primates with great care and consideration. Non-human primates are only used when absolutely necessary, where other animal species cannot be used to evaluate certain drugs for efficacy and safety prior to testing in humans. For instance, this may occur when testing potential new therapies where homology to the human genome is essential.
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, several principles must be adhered to throughout Novo Nordisk and by 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.
We maintain updated records of the number and species of animals used, both in-house and by external contractors. We do this in accordance with the requirements of the authorities as well as our internal commitment to transparency.
Several factors determine the number of animals Novo Nordisk requires each year, such as the number, nature, and development phases of new pharmaceuticals, regulatory requirements, and the development of validated new methods that can reduce or replace the use of animals. Over the last decade, Novo Nordisk has reduced the number of experimental animals used for each individual project. However, the total number of animals may increase if the number of research activities increases, for instance, due to new acquisitions of companies using animals.
The number of animals purchased for research includes all animals purchased for research conducted by Novo Nordisk, either in-house or by external contractors. The number of animals purchased is based on internal registration of purchased animals and annual reports from external contractors.
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
At Novo Nordisk, the Laboratory Animal Science unit is responsible for general animal welfare. Our approach is focused on the practical aspects of housing and caring for our animals, while also ensuring the continuous integration of the 3R principles in our decision-making processes. Additionally, we engage in dialogues and partnerships with our key stakeholders.
Novo Nordisk is in the process of establishing a dedicated unit
aimed at accelerating the development and implementation of methods
that do not involve animals. This will not only speed up the process
and enhance translation but also reduce animal use. Ultimately, this
will lead to swifter implementation of these methods, which either use
fewer animals or none at all.
When animals are necessary for research, their welfare is
prioritized and given considerable attention in several ways. This
applies throughout the entire duration of their time under our care -
before, during, and after the studies.
Our state-of-the-art housing standards take into account the
physiological and ethological (behavioral) needs of the animals. We
have successfully implemented these standards for all animals housed
at our facilities globally.
When Novo Nordisk acquires a new company with an animal facility,
that company has naturally complied with all applicable national laws
and regulations. These laws and regulations may differ from the Novo
Nordisk global standards, and aligning any necessary changes requires
adequate time for full implementation.
In the past, we have collaborated closely with several local and
international animal welfare societies when renovating our facilities.
We also sought valuable input from many internationally recognized
experts in animal welfare, as well as feedback from the employees who
interact with the animals daily, especially the animal
caretakers.