Lilly strives to maintain the highest standards of ethical behavior in all aspects of the company’s business, consistent with our brand. Because of this commitment, Lilly has established a dedicated and systematic program in bioethics to identify, evaluate, and communicate bioethics issues related to pharmaceutical research and development (R&D) activities.
Lilly was one of the first pharmaceutical companies to establish a standing bioethics committee. The Lilly Bioethics Committee (BEC), formed in 1999, includes senior leaders from various functional areas within and outside R&D, including medical, regulatory, patient safety, discovery research, legal, corporate affairs, international government affairs, and global brand development teams. In addition, two academic bioethicists serve on the committee.
To further support bioethics priorities and activities, Lilly has a full-time internal bioethics consultant who is formally trained in both science and bioethics. Additionally, a Bioethics Working Group (BEWG) comprised of Lilly employees with graduate training in bioethics supports the work of the BEC.
The BEC’s scope includes all aspects of global LRL R&D activities, with a primary emphasis on clinical research. The committee has several functions. It identifies and tracks developing bioethics issues, serves as an educational resource, consults on specific issues, develops company positions on specific bioethical issues, and informs global policies that are developed by the LRL policy committee.
The Lilly BEC has developed positions on several key bioethical issues including:
- Stem Cell Research
- Conduct of international clinical trials
- Circumstances under which a clinical trial can be discontinued
- When and how investigational medicines should continue to be made available to study participants at the conclusion of a trial
- Use of human tissues for research purposes
The positions developed by the BEC are incorporated into the policies, procedures, and practices of LRL. New employees receive training on these items at the time they are hired, and periodically as policies are updated.
Another important function of the BEC is providing consultation and advice to R&D teams on specific bioethical issues and questions that arise in the course of their research.
Lilly has developed a tiered consultative process designed to provide employees the support they need for reasoned decision-making. The process encourages researchers to raise issues of concern early so they can be resolved efficiently, and addressed thoughtfully. Depending on the complexity of the issue and the need for external input, it may be addressed by Lilly’s internal experts, by the Lilly members of the BEC or by the full committee, including external experts.
