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 we cannot replace all animal experiments in the foreseeable future, we consider it our responsibility to continuously challenge authorities on the appropriateness of using animals in drug release testing, to refine the care and use of animals, and to develop procedures that reduce and/or replace animal experiments.
Performance 2006
Despite a higher activity level in the discovery phase in 2006, there was a slight decrease of 2.4% in the number of purchased animals, from a total of 57,905 in 2005 to 56,533 in 2006 of which 95.2% were mice and rats.
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.
In 2006 Novo Nordisk once again applied to the US authorities for acceptance of removal of the bioidentity test. This was declined, but the US authorities did accept a 75% reduction of the test frequency.
Novo Nordisk has now decided to develop an in vitro bioassay to replace the bioidentity test by 2010.
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®, we have 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.
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 new Danish legislation. These standards take into consideration the physiological and ethological (behavioural) needs of animals. Except for a small number of pigs, we have successfully been able to implement the new standards for all animals housed at Novo Nordisk. The pig facility is presently being renovated and will be completed at the beginning of 2007. The new, improved housing standards will then have been fully implemented for all animals housed at Novo Nordisk.
Global Novo Nordisk housing standards
In addition, a Standard Operating Procedure (SOP) on the housing of experimental animals at Novo Nordisk was approved in 2006. Its purpose is to ensure 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.
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. In 2006 all planned experiments on animals performed by external contractors on behalf of Novo Nordisk were 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). In 2006 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 2006 Novo Nordisk became 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. 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. We recognise that not all animal experiments can be replaced in the foreseeable future, but we will only use animals where no available and acceptable alternative exists. We actively support 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 our state-of-the-art housing standards for dogs and rabbits.
See Novo Nordisk’s position on animal experimentation.
This page has been assessed by PricewaterhouseCoopers as part of its assessment of Novo Nordisk’s statement that it reports ‘in accordance’ with GRI. Please refer to Audit and assurance for a full description of the nature of assurance offered.
