Animal welfare
Experiments on live animals are essential for the discovery, development and production of pharmaceutical and medical products, and they are required by regulatory authorities. However, it is also a source of concern for society and Novo Nordisk. As Novo Nordisk cannot replace all animal experiments in the foreseeable future, the company has to consider it is Novo Nordisk’s responsibility to refine the housing conditions, care and use of animals, to develop procedures that reduce and/or replace animal experiments, and to continuously challenge authorities on the appropriateness of using animals in drug release testing.
Novo Nordisk does everything that can be done to minimise the number of animal experiments. Between 1992 and 1999, Novo Nordisk succeeded in reducing the total number of animals used by Novo Nordisk by almost 70% and since then Novo Nordisk has been able to keep the numbers at approximately the same level while Novo Nordisk’s research activities are increasing every year.
Read more about Novo Nordisk and animal welfare at Novo Nordisk’s new Bioethics website.
Performance 2007
Despite a higher activity level in the discovery phase in 2007, there was a slight decrease of 3% in the number of purchased animals, from a total of 56,533 in 2006 to 54,675 in 2007 of which 95% were mice and rats.
Total number of experimental animals by species - 2007
Total numbers of animals purchased by Novo Nordisk and Contract Research Organisations (CRO)
Use of purchased animals 2000 to 2007
Removal of biological test types
During the last decade Novo Nordisk has succeeded in achieving regulatory approval for the total removal of all biological test types for product control in most countries. Only two test types remain to be removed to fully eliminate the use of laboratory animals for production control.
As it has not been possible to get the authorities of all countries to accept omission of viral testing in animals for production of NovoSeven®, Novo Nordisk has been forced to resume animal testing of NovoSeven® production to be able to deliver the product to customers. A strategy is being developed for the removal of this test type by 2010.
A novel in-vitro assay, to fully replace the present insulin bioidentity test in rabbits, is being developed and is planned to be validated and hopefully fully implemented in 2010.
Improved housing conditions
Novo Nordisk has established improved standards for experimental animal housing that comply with the spirit and values of the Council of Europe legislation on protection of experimental animals as well as Danish legislation. These standards take into consideration the physiological and ethological (behavioural) needs of animals. In 2007 the renovation of the Novo Nordisk pig facility was completed, and Novo Nordisk has now successfully been able to implement the new standards for all animals housed at Novo Nordisk. See videos of the experimental animal housing at Novo Nordisk and read more here.
Global Novo Nordisk housing standards
NN has a Standard Operating Procedure (SOP) on the housing of experimental animals at Novo Nordisk, which ensures that all experimental animals housed at Novo Nordisk (including affiliates) are housed, as a minimum, in a suitable environment for the species in accordance with Novo Nordisk standards and the revised Council of Europe EST123 (Protocol for the protection of vertebrate animals used for experimental or other scientific purposes).
Review of animal experiments
Novo Nordisk has an internal Ethical Review Committee (ERC). This is not a legal requirement, but it ensures that all experiments on live animals performed at or on behalf of Novo Nordisk are reviewed from an ethical perspective before initiation. All planned experiments on animals performed by Nov Nordisk or by external contractors on behalf of Novo Nordisk are included in the review process. A Guide to Ethical Review of Animal Studies performed by External Contractors has been developed as a tool for relevant internal stakeholders.
Pioneer in biosimulation
Novo Nordisk is a pioneer of a new discipline called biosimulation, which involves computer models that simulate human beings as closely as possible. As a partner in the EU Network of Excellence in Biosimulation (BioSim), Novo Nordisk has helped evaluate how biosimulation could contribute to future drug development and support the principle of The Three Rs (see description below). The Network has provided input to the European Partnership on ‘Alternative Approaches to Animal Testing’ and published a folder and a website on biosimulation. These activities have helped raise awareness of biosimulation as a new tool in drug development. In 2007 the Network evaluated the different approaches to modelling and simulation and their present and possible future contribution to drug development.
Novo Nordisk is a member of the European Partnership for Alternative Approaches to Animal Testing (EPAA), a joint initiative launched in November 2005 by the European Commission and a number of companies and trade federations to promote the development of The Three Rs. Novo Nordisk is also a co-founder and active participant of ‘Centre for Applied Laboratory Animal Research’ established in 1999, a research group working to improve the welfare for animals and humans in the modern laboratory animal facility. Through the Danish Association of the Pharmaceutical Industry (LiF), Novo Nordisk is also represented on the new Danish Consensus Platform for 3R Alternatives to Animal Experimentation (Dacopa) established in 2006.
Novo Nordisk’s approach
Novo Nordisk has a long history of engaging with stakeholders such as animal welfare organisations to find solutions for improving the welfare of experimental animals. Novo Nordisk recognises that not all animal experiments can be replaced in the foreseeable future, but Novo Nordisk will only use animals where no available and acceptable alternative exists. Novo Nordisk actively supports the principle of The Three Rs: to reduce, refine, and replace animal experiments, and have been setting new standards in this area. One example is Novo Nordisk’s state-of-the-art housing standards for dogs and rabbits.
See Novo Nordisk’s position on animal experimentation.
This page has been reviewed by PricewaterhouseCoopers as part of its assurance of Novo Nordisk’s non-financial reporting. Please refer to Audit and assurance for a full description of the conclusions and the nature of assurance offered.
