To assess the potential safety, toxicity, and efficacy of compounds for human use, Lilly researchers conduct tests in laboratory animals. Animals are used when other reasonable alternatives do not exist. Safety studies are mandated by law and are conducted to understand the effects of new medicines. We recognize we have an ethical and scientific obligation to ensure the appropriate and humane treatment of animals used in research, and we have systems in place to fulfill this obligation. Lilly requires its R&D staff to comply with all applicable country and local laws, regulations, and standards regarding the care and use of animals. We require the same of all individuals and organizations that supply animals to be used in Lilly research, and with which Lilly contracts for animal research services.
Moreover, we require application of the Lilly Animal Care and Use Principles by Lilly researchers and contractors, even if these principles are more stringent than applicable local laws. Lilly also encourages animal-research and animal-supply companies globally to obtain and maintain accreditation from the AAALAC. Through active engagement, we are helping to raise the standards of animal care and use.
Accreditation, Regulations, and Inspections
Lilly maintains the highest standards of animal care and demonstrates best practice globally. All Lilly facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). All animal facilities are subject to external review and inspection. As appropriate, in the United States, our facilities are subject to unannounced site inspections by the U.S. Department of Agriculture. In Europe, local and national authorities regularly inspect all animal facilities. AAALAC also provides an independent review and confirmation of appropriate animal care and use.
In the United States, Lilly’s animal care and use committee (which includes an independent, third-party member) approves and oversees animal research activities and care programs. Similarly, Lilly’s U.K. ethical committee reviews all animal usage in that country and ensures that people using animals are appropriately qualified.
Lilly Animal Care and Use Principles
Lilly’s Animal Care and Use principles state that animals shall be treated humanely, with pain and stress minimized. Animal research should be performed after consideration of the 3 Rs: replace animals whenever alternatives are scientifically valid and acceptable to regulators; reduce the numbers of animals used; and refine procedures to minimize distress. Specifically:
- Living conditions for research animals must be appropriate for their species and contribute to their health and well-being.
- Personnel who care for animals or who conduct animal studies must be appropriately qualified regarding the proper care and use of animals in research.
- Studies involving animals must be designed and conducted in accordance with applicable country and local regulatory guidance and the following widely recognized principles of animal care and use:
- with due consideration of the relevance of the study to human or animal health and the advancement of scientific knowledge,
- selecting only animals appropriate for that study,
- using the minimum number of animals required to obtain valid results,
- using alternative methods instead of live animals where appropriate, and
- avoiding or minimizing discomfort and distress to the animals.