At present, research using living animals is essential for all pharmaceutical companies in the discovery, development and production of new pharmaceutical and medical products. It is also a requirement from the authorities that drug candidates are tested in living animals before they can be tested in humans. Companies are required to provide appropriate data regarding efficacy, safety and toxicology from testing in both animals and humans before the authorities can approve a new product.
"For a long time to come we will need to use animals for scientific purposes. It is an important goal to ensure that the animals do not suffer unnecessarily, and that is why we have guidelines for how the animals are to be treated - also when they are not being tested, which is 99% of the lifetime of the animals."
Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer
We only use animals in research where no alternative exists. We recognise that not all research using animals can be replaced in the foreseeable future and consider it our responsibility to actively support the principles of the 3Rs (Reduce, Refine and Replace research using animals, Professor William Russell and Rex Burch, 1959) internally and externally. We have integrated these principles in all our processes and procedures and established a 3R Award to acknowledge and inspire employees who bring the 3Rs principles into action. We review animal models on a continuous basis for replacement with in vitro methods and use human cells and tissues instead of living animals wherever possible. We support the development of valid alternatives to animal experiments, e.g. through EPAA, CALAR, 3R-center and EFPIA.
Removal and replacement of tests
Novo Nordisk has challenged authorities on the appropriateness of using animals in drug release testing and as of November 2011 Novo Nordisk no longer tests the quality of batches of marketed products in living animals. These tests were required by health authorities, but after a decade of research and close collaboration with authorities around the world, incrementally Novo Nordisk was able to get authorities’ approval of the removal of redundant tests and the replacement of other tests with alternative testing methods.
In 2015 Novo Nordisk established a new, centralised strategic department '3R Strategy & Veterinary Services' driving 3R innovation. The department will contribute to internal awareness and education as well as ensure continued integration of the 3R considerations in R&D’s decision-making processes. Specific focus will be given to identification of new replacement initiatives. Furthermore, the department will engage in dialogues and partnerships with our key stakeholders.
When animals are used their welfare is given high priority and attention in several ways.
Novo Nordisk has initiated and developed new improved housing and care standards for all animal species used in-house, based on the natural behaviour and needs of these animals. We perform ethical reviews on all studies before they are initiated, and staffs are trained in animal welfare. We monitor conditions at external contractors as well as our suppliers, and they must follow Novo Nordisk global housing standards for animals. In addition, we support and encourage our employees and external contractors to share better practices.
We do everything we can to minimise the number of animal experiments. We cannot eliminate them completely, because the complicated interplay between a pharmaceutical product and a living organism will never be able to be replicated completely in a test tube. It is expected that our use of experimental animals needed to develop a drug within a given disease area will continue to decline over the next decades as new emerging technologies will make it possible to obtain even more important information without the use of living animals. However, the total number of animals purchased in a given year will depend on the specific disease areas and the level of investment in research.