Animal studies remain a vital component of the discovery and development of innovative medicines for both humans and animals. Regulations that govern the approval of our products for human and animal use dictate that we use animals for testing when alternatives do not meet regulatory standards. At Lilly, we believe we have a moral, ethical, and scientific responsibility to ensure the welfare of animals used for any purpose by our company. Our policy and standards regarding the use of animals are based upon the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.
All Lilly-owned animal testing facilities are accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC). AAALAC provides independent review and confirmation of appropriate animal care and use. Lilly also uses the services of third party facilities located at various sites around the world. These third parties include contract research organizations or third party operations that conduct research on behalf of Lilly, supply animals to Lilly, or supply feedstuffs to animals at Lilly. More than 95 percent of the animals used in pharmaceutical research for Lilly—including at third party facilities—are rats and mice.
To monitor practices on animal research and welfare, Lilly maintains a global oversight program of all animal testing facilities with which we do business, including visits by trained specialists to conduct welfare evaluations. Lilly requires all employees and all third parties involved in our research to adhere to all applicable country and local laws, regulations, and standards regarding the care and use of animals. Moreover, we require adherence to 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.
Lilly Animal Care and Use Principles
When other acceptable alternatives do not exist, Lilly researchers conduct in vivo studies to assess the potential efficacy and safety of compounds for human use. When conducting such live animal assessments, all personnel must comply with our global policy on animal care and use. They must also adhere to the following principles:
- Studies must be designed and conducted with due consideration for the relevance of the study to human or animal health, and to the advancement of scientific knowledge.
- Animals must be provided with living conditions that are appropriate for the species and that will contribute to their health and well-being.
- Personnel who care for animals or who design or conduct animal studies must be appropriately qualified and trained
- Animals must be treated humanely to eliminate or minimize pain and distress.
- Lilly has adopted "3Rs" replacement of animals whenever scientifically valid and acceptable alternatives exist, reduction of the number of animals used, and refinement of procedures to minimize distress to the animals. The 3Rs will be applied prior to the start of any study involving animal testing.
- Studies involving animals must be designed and conducted in accordance with applicable local regulatory guidance.
The Lilly 3Rs Initiative
As part of our ongoing commitment to ethical research, in 2012, senior leadership created the Lilly 3Rs Initiative, a more formal articulation of the animal care and use strategy and practice at Lilly. The Initiative benchmarked similar activities among global pharmaceutical companies and set goals for Lilly, including increased awareness of the 3Rs by encouraging the communication of strategies for reduction, refinement, and replacement of animal use within the company; enhanced employee training on the 3Rs; and the dissemination of 3Rs information through a new global database and increased internal networking.
In 2013, senior management at Lilly also established and directed a new 3Rs Steering Committee to accomplish several objectives:
- The creation of an internal 3Rs Award to recognize accomplishments with existing techniques or with new research approaches, such as use of tissue-based models, analytic and computational models, study refinements, or environmental enhancements.
- The support of 3Rs research at external organizations in collaboration with the National Centre for the 3Rs based out of the United Kingdom.
- The establishment of company guidelines for the use of nonhuman primates. Lilly has not used chimpanzees in research since the late 1980s. Careful consideration is given when other nonhuman primate species are used in research, and these new guidelines will address the use of those species.