Ethical Considerations in Accordance with Laws and Guidelines
Basic Policy
The Otsuka group’s multifaceted research and development— intended to discover highly innovative drugs for unmet medical needs—is guided by our corporate philosophy: “Otsuka-people creating new products for better health worldwide.” We also follow high ethical standards, including those covering bioethics.
Promotion System
The Otsuka group has established a promotion system for basic research and clinical trials based on compliance with all laws as well as a high level of ethics. For example, Otsuka Pharmaceutical has committees for research ethics, animal experimentation, genetic modification safety and biosafety under the guidance of the executive director in charge of research. The goal of our committees is to ensure the suitability of our research. We also held discussions on clinical trials from safety, medical and scientific perspectives under the executive director in charge of development to ensure that appropriate clinical trials are conducted.
Compliance in Basic Research
Research Involving Animals
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, and adopts experimental methodologies that respect animal life and are appropriate from the perspective of animal welfare. 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 principles, we conduct researcher education and internal inspections and evaluations of the implementation of experiments involving animals.
Research Involving Human-Derived Specimens
When conducting research using information or specimens collected from the human body, such as tissues or blood, the Otsuka group complies with all laws, ordinances, and guidelines and conducts scientifically and medically appropriate research that upholds ethical considerations. In addition, we establish 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 systems, research progress status, and research outcomes from the standpoints of ethical and scientific validity and of protection of personal information.
Research on Pathogenic Microorganisms (Pathogens)
In using pathogenic microorganisms (pathogens) or research samples that may contain these pathogens, the Otsuka group complies with all relevant laws and ordinances, including the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases (the “Infectious Diseases Control Act”). We have also established internal regulations regarding the safe management (handling and storage) of such pathogens and for environmental security, and work to prevent experiment-related accidents through employee education.
Research on Genetically Modified Organisms
In experiments involving genetically modified organisms, we comply with all laws and regulations, including the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (the “Cartagena Act”). We also have an internal review committee and to prevent environmental damage from the spread or leak of genetically modified organisms.
[Compliance in R&D by Otsuka Group Companies]
- Otsuka Pharmaceutical (Japanese)
- Otsuka Pharmaceutical Factory (Japanese)
- Taiho Pharmaceutical (Japanese)
Ethics in Clinical trials
When developing pharmaceuticals, we confirm the safety and effectiveness of candidate compounds by conducting clinical trials with the cooperation of healthy individuals and patients. To protect the human rights, safety, and welfare of clinical subjects, discussions are held within the Otsuka group on safety, as well as the medical/scientific aspects of clinical research. For multinational as well as domestic clinical trials, we conduct reviews from the ethical and scientific standpoints in addition to ensuring their compliance with ethical principles and standards, including ICH-GCP and JGCP (Good Clinical Practice), an international standard for clinical trials of pharmaceutical products. When conducting clinical trials, we follow internal regulations, standardized procedures, and so on. As well, free and informed consent must be obtained in writing from each person cooperating on the clinical trial. We handle personal information in the course of conducting clinical trials following our Basic Rules for the Protection of Personal Information and other related rules.
[Compliance in R&D by Otsuka Group Companies]
- Otsuka Pharmaceutical (Japanese)
- Otsuka Pharmaceutical Factory (Japanese)
- Taiho Pharmaceutical (Japanese)
Click here for details on post-sales safety measures
Management of Public Research Funds
The Otsuka group has formulated rules for management and control of public research funds and for prevention of research misconduct, based on the Guidelines for Managing and Auditing Public Research Funds at Research Institutions and the Guidelines for Responding to Misconduct in Research established by the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry.
[Management of Public Research Funds at Group Companies]
- Otsuka Pharmaceutical (Japanese)
- Otsuka Pharmaceutical Factory (Japanese)
- Taiho Pharmaceutical (Japanese)