Animal care and use
Since our founding in 1876, Lilly has worked tirelessly to discover medicines that make life better.
Prior to the clinical trial phase, a critical and legally required part of the drug development process is known as “in vivo” studies conducted in animals. In these studies, potential new medicines are tested in animals to evaluate how the medicine functions in a living organism, as well as its safety profile. In biomedical research, animals have contributed to life-saving treatments in the areas of cancer, diabetes, vaccines, high blood pressure, and neurological disorders, just to name a few.
Research advances in human medicines have made life better for a countless numbers of people worldwide. However, at Lilly, we also recognize that we have a moral and ethical responsibility for the welfare of animals used in research, which is why we have strong policies and principles in place to ensure that all animal research conducted either by our employees or by third parties on our behalf is in line with our values.
Our commitment to responsible animal research
At Lilly, we know we have both an ethical and a scientific responsibility toward animals used in research. That’s why we have adopted the “3 Rs” when it comes to our principles of animal care and use. The 3Rs are applied prior to the start of any study involving animal testing:
Replacement: The replacement of animals with alternative non-animal methods including the application of in vitro (test tube) systems or in silico (computer based) systems. We also utilize Microphsiological systems (MPS), such as organ-on-chip technology and orgorganoids.
Reduction: The reduction in the number of animals used by the application of good experimental design and the proper statistical methods
Refinement: The modification of experimental technique to eliminate or minimize pain or distress and enhancements in animal husbandry to improve overall well-being in their colony environment (e.g. environmental enrichment)
Our 3Rs Global Committee is charged with ensuring implementation of the 3Rs and providing 3Rs Awareness Training to all Lilly employees who are associated with animal research. Sharing of 3Rs information across all sites is highly encouraged.
Our principles for the ethical treatment of animals
We recognize we have ethical and scientific obligations to ensure the appropriate and humane treatment of animals used in research, and we have systems in place to fulfill this obligation. Lilly has developed a global Animal Care and Use Standard on Animal Care and Use that defines our principles by which we conduct in vivo research. This standard mandates the humane care and use of all animals used in research. Any animal research conducted at Lilly
should be performed only after consideration of the 3Rs as described above. Once the 3Rs have been implemented, Lilly’s Animal Care and Use principles state that animals used in research shall be treated humanely, with pain or distress eliminated or minimized.
Specifically, our Principles state:
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Living conditions for research animals must be appropriate for their species and contribute to their health and well-being.
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Personnel who care for animals or who conduct animal studies must be appropriately qualified for 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 study relevance to human 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.
- with due consideration of the study relevance to human health and the advancement of scientific knowledge,
Implementing these principles has resulted in increased awareness of the importance of quality animal care and use globally. The global procedure and principles have been supplemented by further standards specific to in vivo research.
Lilly animal care and use ethical committees
Our compliance with global animal research regulations and standards
Consistent with our commitment to the responsible and ethical treatment of animals, we maintain the highest standards of animal care and we strive to demonstrate best practices in animal research. Lilly requires its R&D staff to comply with all applicable country and local laws, regulations, codes of conduct 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.
Our policy and standards regarding the use of animals are based upon the Animal Welfare Act for all USDA regulated species and the Guide for the Care and Use of Laboratory Animals.
Inspections and Accreditation
We self-inspect our animal research programs and facilities regularly, including annual program reviews and semi-annual facility reviews. In situations where we have recently acquired another company, we work closely with that group to ensure that animal welfare standards align with our policy and principle sand work towards AAALAC accreditation if not already accredited. We also maintain a global oversight program of all animal research and supply companies with which we do business – including visits by trained specialists to conduct welfare evaluations – and encourage these companies to obtain and maintain accreditation from AAALAC International.