Animal Welfare

Before any new treatment can be used in humans, it must first be tested in animals to determine its level of safety. The appropriate and responsible use of animal experiments is an indispensable part of biomedical research, as about 70% of serious side effects of new medicines can only be detected using these tests. Like all research-based healthcare companies, Roche conducts animal tests whenever they are essential for patient safety. The majority of these experiments are required by regulatory authorities.

We appreciate and take seriously public concern about the use of animals in science, and are committed to:

• Only use animal experiments where required to by law, or where no scientifically-acceptable alternative is available
• Ensure all tests on animals are carried out responsibly
• Invest in the development of alternatives to animal testing.
• We have strict rules in place to ensure the animal tests that are carried out:
• Are justified on scientific grounds
• Use the most appropriate animal species
• Use as few animals as possible to achieve reliable results
• Cause the least possible amount of pain and distress.

We provide special training and development to all employees who work with animals and monitor their activities. They are expected to follow the law at all times and to apply the highest standards of welfare. Contractors who carry out animal testing for Roche are also expected to apply the same ethical standards. We conduct inspections to ensure this is the case.

If the same test results can be achieved using scientifically-acceptable alternatives to animal testing, we will always use these. Thus, we have seen a significant reduction in animal experiments at Roche, despite a substantial increase in the number of research projects.

We also invest substantially in the development of non-animal testing methods. In Switzerland we support the 3R Research Foundation. This organisation provides funding to develop new or improved methods based on what is known as the 3R strategy:

• Replace – Use alternatives to animal testing whenever possible
• Reduce – Improve existing methods so that fewer laboratory animals are required in an experiment
• Refine – Improve existing methods so that animals experience as little discomfort and distress as possible.

Roche is also a member of the European Partnership for Alternative Approaches to Animal Testing (EPAA) – a joint initiative between the European Commission and number of companies and trade associations.

Roche complies with all applicable national and international requirements relating to animal testing, including the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines), the EU directive on animal experiments, OECD guidelines and local and national regulations. We also observe all applicable industry standards for animal experiments. Roche Group Research Centres are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).