The 3Rs
Animal testing is indispensable for the development of innovative medicines. All over the world, regulatory authorities require that medicines in an early R&D stage are first tested on animals before clinical trials can be conducted. Novartis only does testing on animals when it is unavoidable from a scientific point of view and when no other tests are possible. Experiments are conducted solely when they can be scientifically and ethically justified and only after they have been accepted by Institutional Animal Care and Use Committees and/or local authorities.
We acknowledge the importance of animal welfare and, as part of that commitment, support the development of alternative research methods according to the 3R concept - namely, Reduction, Refinement and Replacement of animal experimentation - wherever possible. In addition, we ensure that the animal welfare skills of our researchers remain state-of-the-art, we offer a broad set of training programs, including anesthesia, analgesia and surgical techniques, as well as ethical training.
Reduction
Novartis is committed to reducing the number of animals and to improving animal welfare where reduction/elimination is not possible. In addition, in areas where animal testing is essential, Novartis is committed to adopting a transparent and open approach to address public concerns.
There has been an extraordinary decline in the number of animals used in the pharmaceutical industry since the 1980s due to better testing methodologies, technological innovations and the use of alternative approaches.
Novartis Animal Health (NAH), for example, decreased the number of cattle and sheep used for strain maintenance of gastrointestinal nematodes through the introduction of cryopreservation technology. To ensure efficacy testing of new anthelminthics for cattle and sheep, NAH requires a regular supply of nematodes at their different larval stages. Previously, this stock of nematodes and larvae had to be maintained in live animals. NAH developed a cryopreservation protocol which allows certain nematode strains to be kept deep-frozen for several months. Strain maintenance in host animals is still required for other strains and to guarantee viability of preserved strains at regular intervals, but the cryopreservation protocol allows the reduction of host animals required for parasite passaging.
Similarly, the introduction of combination testing for cattle vaccine batch releases has reduced the number of animals required to test for potency and safety. By law, each new batch of vaccines must be tested for potency and safety. In the UK these tests were routinely carried out separately. By combining the protocols, however, we have been able to address regulatory demands while at the same time reducing the number of animals by a factor of two. The revised protocol has been accepted by the regulatory authorities and should enter into effect during 2007.
Code, policies and guidelines
Find here our Code of Conduct, citizenship-related policies and guidelines