Ethical considerations concerning appropriate R&D
The use of experimental animals to verify efficacy and safety in R&D is at times necessary. The Otsuka group complies with all related laws, ordinances, and guidelines while striving to uphold scientifically valid methodologies and ethical considerations from the viewpoints of animal protection and welfare, including the lives of the animals; preservation of the environment; and the safety of experimenters.
As an in-house management system, we have developed and implemented rules on experiments that involve animals, have established an Animal Experiment Committee, and properly carry out animal experiments and breeding. The Animal Experiment Committee evaluates whether each proposed animal experiment plan is appropriate based on the 3Rs principles. These are Replacement/avoidance or replacement of animal use, Reduction/minimization in the number of animals used, and Refinement/minimization of animal suffering. Based on these, we conduct researcher education and internal inspections and evaluations of the implementation of experiments involving animals.
Ethical considerations in research using human-derived specimens
When conducting research using information or specimen collected from the human body, such as tissues and blood, the Otsuka group complies with all laws and guidelines and conducts scientifically and medically appropriate research with consideration of ethics. Each group company establishes committees that include outside members to ensure the appropriateness and credibility of research. The committees do so by examining research plans, the significance and goals of research, personal information management system, research progress status, and research outcomes from the standpoints of ethical and scientific validity and of protection of personal information.
Considerations in research using pathogenic microorganisms/genetically modified organisms
In experiments using genetically modified organisms, and in the use of pathogenic microorganisms or research samples that may contain these, the Otsuka group complies with laws and ordinances, and works toward the prevention of experiment-related accidents and toward consideration of the environment. We do so through the setting of internal rules and through examination by safety committees and screening committees.
Ethics in development
In the development of pharmaceuticals, we confirm the safety and effectiveness of candidate compounds by conducting clinical trials with the cooperation of healthy individuals and patients. Recognizing the importance of ethical considerations toward human rights and personal information, the Otsuka group implements clinical trials in compliance with ethical principles and standards, including ICH-GCP, an international standard for the implementation of clinical trials for pharmaceutical products.