Monitoring external contractors

Interview with Jan Lund Ottesen, vice president at Novo Nordisk. Jan is responsible for monitoring the external contractors that perform research studies on living animals on behalf of Novo Nordisk.

 Why does Novo Nordisk have animal studies performed by external contractors?

We use external contractors to gain access to expert knowledge and research techniques that we do not have in-house, and when we do not have the necessary capacity to perform the animal studies that our scientists are asking for in-house. We only use professional contractors that live up to our global standards for animal welfare. This can be universities that hold knowledge within new fields or scientific research partners that are experts in handling specific animals or research models.

 How does Novo Nordisk ensure high standard of animal welfare at external contractors?

We inspect and evaluate the conditions at the contractors before we decide to have any study performed. All external contractors must live up to our global standards for animal welfare – no matter if we intend to perform just one study or several studies. A Novo Nordisk veterinarian will initially visit a new external contractor and monitor the conditions according to a specific list of criteria outlined in our global standard. We perform the monitoring in the same way at every external contractor. The veterinarian will for instance look at cage sizes, handling and care of animals, interaction with employees, training of employees and general animal welfare conditions at the contractor.

The outcome of the monitoring can result in one of three scenarios: fully approved, approved with reservations – i.e. the external contractor has to make corrections (e.g. larger cages or provide environmental enrichment) – and not approved. We will only perform studies at approved contractors and every fourth year we revisit the contractors to re-evaluate the conditions.

 Which criteria does Novo Nordisk have for animal studies performed by external contractors?

Novo Nordisk has for years used the guidelines for good animal welfare from the Council of Europe (Appendix A of ETS123) as our global standard. This guideline was implemented into Danish legislation in 2003. From 2010 it also became a part of the EU directive covering the area of experimental animals which was implemented in EU as of Jan 2013. 

We require that our external contractors both within the EU and outside the EU live up to our global standards – now part of the EU directive on animal welfare in studies.

 To what extent is Novo Nordisk willing to cooperate with external contractors who do not meet Novo Nordisk’s criteria?

If a monitoring at an external contractor shows that animal welfare conditions do not meet our standards the contractor will either be approved with reservations or not approved due to major deficiencies. 

In most cases we are willing to discuss ways of fulfilling our standards with contractor who are approved with reservations. This is typically a matter of changing cage sizes or providing the animals with environmental enrichment. We also look at the general conditions at the external contractor to ensure that animal conditions are fairly equal in the entire facility. We will not perform studies until the external contractor fulfills our standards.

We will not consider cooperating with non-approved contractors unless they improve to a level where they can be formally approved.

 Which developments have you experienced at external contractors regarding animal welfare?

I have experienced a continuous improvement in animal welfare at most external contractors during the past ten years and not seen any examples of conditions turning to the worse at contractors. I believe that there are many reasons for the improvements such as new legislation, media attention and customer demands. I have often experienced that the improved animal welfare standards that Novo Nordisk has imposed on a contractor are later on extended to the entire facility.