All animal experiments carried out at Novo Nordisk, or on our behalf by external contractors, require review and approval by our internal Ethics Review Council (ERC). The council has reviewed animal applications for internal studies since 2002 and all protocols for external studies since 2006.
Novo Nordisk performs approximately 80% of our animal studies at our own research facilities, the majority in Denmark. Before any of these studies are undertaken in Denmark, an application for the specific animal studies must be sent to the Ministry of Environment and Food of Denmark for legal and ethical approval. In addition, our internal Ethics Review Council (ERC) reviews and approves these applications before they are sent to the authorities.
At other sites the approval process is according to national laws and to ensure Novo Nordisk global standards the local ERCs align with the ERC in Denmark for final approval.
Novo Nordisk has established an assessment and monitoring procedure to ensure global animal welfare standards for all animals used in-house and by external contractors. Animal studies that are to be performed by contractors are described in study protocols. These must all be reviewed and approved by our ERC before the studies can be initiated.
The ERC carefully reviews animal studies performed by or on behalf of Novo Nordisk from an ethical perspective and ensures integration of the principles of the 3Rs (Reduce, Refine and Replace). The impact of the ethical review has been very visible; information on ethical concerns is distributed widely within Novo Nordisk, and the ERC and the scientists have very close dialogue. ERC was established as our way of making sure that any animal study performed by or on behalf of Novo Nordisk is carefully reviewed from an ethical perspective and integrated with the principles of the 3Rs (Reduce, Refine and Replace).
The ERC has the means to challenge and change or even reject study protocols or applications whenever ethical concerns about the animals' welfare and use arise.
"At Novo Nordisk we set the aspirations high. We do our utmost to assure that animal welfare is focus for everyone working with animal experimentation. The ethical considerations permeate the organisation and we have a strong dialogue between the ERC, the scientists and our collaborators leading to constant improvements and knowledge sharing."
Stine Øvlisen, Chair, Ethical review council, Novo Nordisk
The ethics review process focuses on the following issues: 1) Adherence to Danish and European legislation, presently setting the highest ethical standards globally, 2) Adherence to Novo Nordisk’s Bioethics Policy, 3) The principles of the 3Rs, and 4) Harm/benefit analyses of the experiment in question as well as assessments of humane end points and pain and distress to the animals. This includes justification of the choice of animal model, the number of animals required to test the given hypothesis, and the study design.
The council meets monthly and the members of the council include both academic and technical experts as well as lay people, to ensure that the animals' welfare is taken into broad consideration.
Conclusions from the globally standardised animal welfare monitoring of external contractors and decision points from the ERC do sometimes increase costs to Novo Nordisk. We believe that this economic downside is more than outweighed by the value of exchange of experience and better practices, more reliable scientific results, broader public acceptance and always, of paramount importance, improved animal welfare.