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.

Novo Nordisk's position on animal experimentation

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.

  • Animals bred specifically for experimental purposes must be used unless special conditions are in evidence
  • Housing, husbandry and transportation of animals must as a minimum comply with internationally approved standards
  • Housing conditions must take into consideration the special needs for the animals species in question
  • Housing, husbandry and care of animals must be undertaken by personnel having received adequate and relevant education. The level of education must be documented
  • Health control should be supervised by a veterinary officer experienced in regard to laboratory animals
  • Transportation of animals must be as lenient as possible, taking into consideration the special needs for the animal species in question
  • All precautions must be taken to reduce suffering and distress
  • Procedures for monitoring and evaluation of the well-being of the animals as well as treatment must be implemented

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.

Number of animals purchased from 2000 to 2021

Number and kind of animals purchased from 2018 to 2021

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.

  • Culture of Care: The company commitment and dedication to and engagement of individual employees towards animal welfare is promoted via support of a strong and clearly defined and documented Culture of Care program. Such program is a key asset for a continuously evolving high quality animal care and use program.
  • Oversight Bodies: Institutional independent multidisciplinary expert governance or oversight bodies1 approve all animal use by ensuring the scientific merit and regulatory requirements of in vivo protocols are met. The considerations of the 6 Principles of Animal Research Ethics2 are applied to ensure that the value and quality of life is considered for each individual animal and the 3Rs and that the quality of the animal care and use program is assessed.
  • Continuous Education & Training: A holistic program of professional education and continuous professional development exists for all staff working with animals and conducting animal studies. The training program should be adjusted to the relevant needs of each employee and performed in respect with current best practices. This training program shall define training requirements for all roles that use animals directly or are responsible for animals via management of work or staff.
  • Veterinary Care: Appropriate veterinary care to manage animals both at an individual and a colony-wide level. Presence of a competent veterinarian with sufficient authority for rapid intervention and veterinary advice. Institutional commitment to veterinary care is clearly in place and consistent with current best practice in veterinary medicine.
  • Housing & Husbandry: Housing and husbandry conditions shall ensure that the basic needs of animals are fulfilled unless required by the objective of an experiment that is unavoidable and can technically and scientifically not be achieved in any other way. The basic needs of animals are species specific and entail at least: species adapted temperature, humidity, and noise; nutritious food and clean water; safe shelter; adequate and species specific stimulation; species specific environmental conditions that allow setting-up functional units (meals, sleep, play/explore, defecation, urination); social species socialization in groups according to species specific needs; provision of veterinary care; sufficient rest to maintain physical and mental health; freedom from harm, pain and fear; freedom from disease, injury and disability; freedom of movement with adequate space to execute physiological movement sequences and behavioral patterns.
  • Environmental Conditions: Controlled species-specific environmental conditions ensuring at a minimum that animal discomfort is prevented and that provisions for animal behavioral and physiologic needs are in place.
  • Caging and enrichment program: Caging systems must be designed to meet the fundamental behavioral characteristics of each species, and the environmental enrichment program should be designed around the specific social, behavioral, and nutritional needs of every animal.
  • Species: With special attention to the specific needs of dogs, pigs and non-human primates, all signatories are committed to applying and promoting the care and accommodation standards that are consistent with those required by the European Union and United Kingdom. If external partners do not meet these welfare and care expectations, they should provide a specific plan indicating how they will implement their intent to meet this goal. These species should be purpose-bred and NHPs should have a pedigree with individual animal history data provided and should preferably be from self-sustaining colonies.
  • Post Approval Monitoring: A formal Post Approval Monitoring program of the site-specific animal care program, including regular program review and vivarium walkthroughs is in place and documented to ensure compliance and appropriate animal use. Relevant performance standards are used to advise the staff about the function of the animal care and use program. A qualified person is appointed who regularly oversees performance of animal activities.
  • Risk Management: A program of disaster planning and risk management that covers all risks that may impact the welfare of animals or quality of results is implemented and regularly reviewed.
  • Incident Reporting: A formal incident reporting process with a clear program for the development and implementation of corrective and preventative actions and parties responsible for implementation of actions is implemented and successes are documented. All incidents with the potential to impact animal welfare, quality of results, or company reputation must immediately be reported to the sponsor.

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
Merck KGaA, Darmstadt, Germany
Sanofi, Paris, France
Novartis AG, Basel, Switzerland
Novo Nordisk, Bagsvaerd, 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.