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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.

  • *Act on Welfare and Management of Animals, Basic Guidelines for the Conduct of Animal Experiments in Implementing Agencies under the Jurisdiction of the Ministry of Health, Labour and Welfare, Guidelines for the Proper Conduct of Animal Experiments, Standards Relating to the Care and Management of Laboratory Animals and Relief of Pain

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 guidelines, laws, and ordinances such as the Ethical Guidelines for Medical and Health Research Involving Human Subjects and conducts scientific and medical research that follows these ethical standards. 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]

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.
For example, at Otsuka Pharmaceutical we have established an internal planning review committee for clinical trials to protect the human rights, safety, and welfare of clinical subjects. This committee discusses safety from medical and scientific perspectives prior to clinical trials. We also conduct risk assessments for potential issues before the start of clinical trials and continue to evaluate these risks during the trials. This approach allows us to maintain and improve the quality of clinical trials while taking actions to mitigate risk.

For international and domestic clinical trials, Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, and Taiho Pharmaceutical adhere to ethical principles (Helsinki Declaration) as well as the implementation standards for clinical trials of pharmaceutical products (ICH-GCP, Japan GCP). For instance, Otsuka Pharmaceutical has established and closely follows global standard operating procedures (SOPs) to ensure compliance with the standards of regulatory authorities worldwide. At the same time, every company requires informed consent through the voluntary decision of the subjects to protect their rights. Personal information obtained during clinical trials is handled following each company's basic regulations for personal information protection and other related guidelines.

For compassionate use* among clinical trial participants, Otsuka Pharmaceutical permits access to the drugs being investigated after the trial ends, provided the request is made through the trial's physician and that this process is internally reviewed. At the same time, when participants in clinical trials submit inquiries through our customer service center, the individual overseeing the trial handles these requests.

  • *Compassionate use refers to special exemptions from regulations that would normally prohibit the manufacture, importation, and sale of restricted, unapproved drugs for severely ill patients with no alternative treatment options.

[Compliance in R&D by Otsuka Group Companies]

Click here for details on post-sales safety measures

Managing clinical trial programs

At Otsuka Pharmaceutical, the ethical oversight of clinical trials occurs at two levels. For each trial, the person in charge of the trial bears responsibility for ethical conduct. Further, across all clinical trials, the Director of the Clinical Development Division has the overall responsibility.
For approving, making changes to, or terminating clinical trials, an independent review is conducted at all clinical trial facilities in line with good clinical practices (GCPs). For certain trials, we establish independent data monitoring committees to gather the opinions of external experts.
In the case of outsourced clinical trials, our in-house personnel assess whether the external service providers are being effective throughout the duration of the trial based on procedures for overseeing and managing these providers. Further, depending on the level of risk, Otsuka’s representatives accompany the clinical research associates (CRAs)*1 from the contract research organization (CRO)*2 to ensure the quality of monitoring by each CRA.

Notes:

  • 1.CRO: An organization that takes responsibility for outsourced drug development
  • 2.CRAs: Professionals responsible for monitoring clinical development

Training for Employees Involved in Clinical Trials

At Otsuka Pharmaceutical, we provide training for employees working in clinical trials and studies, including conducting GCP training for newly hired employees and delivering ongoing education to all CRAs. Otsuka Pharmaceutical’s representatives also verify the implementation of training for CRAs from the CRO.
On top of that, we conduct monthly training sessions for all employees to keep them updated on the latest industry information, regulations related to clinical trials, and internal policies. We also systematically organize position-based training sessions on business skills, such as logical thinking, enabling others, and coaching.

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]

Patient-Centricity for Drug Development Based on the Patient’s Voice

Patient-centricity means that the medical institutions, regulatory authorities, and pharmaceutical companies surrounding patients always put the patient at the center of their actions, focusing on the patient, and ultimately respecting the patient’s own judgment to the greatest extent possible. Otsuka Pharmaceutical’s Headquarters of Clinical Development formed a task force in 2020, and it is working on a daily basis.

Atsuko Hara
Manager Department of Clinical Development
Coordination,
Talent Development (Training)
Otsuka Pharmaceutical Headquarters
of Clinical Development

Formed a Task Force to Promote Patient-Centricity Activities

The Headquarters of Clinical Development conducts patient-centricity activities with the aim of developing drugs based on the opinions of patients. Through activities to obtain opinions on the content of the clinical trial consent document from general patients, and through interaction with employees who work at Heartful Kawauchi, a special subsidiary of Otsuka Pharmaceutical, who suffer from mental illness, and the employees who support them, we have been able to improve mutual understanding and expand the capability of our development work. We will continue to promote this activity in the hope that it will contribute to patientcentric drug development.

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