Management R&D Ethics
Ethical Considerations in Animal Experiments at the Research Stage
In new drug research, at the basic research stage prior to clinical trials, animal experiments are necessary to confirm efficacy and safety as pharmaceuticals. Mitsubishi Tanabe Pharma has formulated "Rules for Proper Conduct of Animal Experiments." The Company conducts animal experiments at the Yokohama Site certified by the Center for Accreditation of Laboratory Animal Care and Use of the Japan Health Sciences Foundation, a third-party assessment and accreditation organization, and also at the Shonan Site's animal testing facility since fiscal 2019, which was internationally certified by the AAALAC*1. The Institutional Animal Care and Use Committee has been established within the Company. In planning and implementing animal experiments, the committee evaluates experiment plans from the perspectives of the appropriateness and scientific rationale of the plans as well as whether those plans are in accordance with the 4Rs*2. In these ways, we are acting with consideration for animal welfare.
- *1AAALAC Int.: Association for the Assessment and Accreditation of Laboratory Animal Care International
- *2Refers to a program that adds the additional R of "responsibility" on the part of Company researchers to the 3R international standards for animal experiments ("replacement" with alternative testing methods, "reduction" of the number of animals used, and "refinement" of testing, centered on the relief of pain and distress)
Ethics Review Committee Initiatives
Discovery research using samples provided by patients, such as human tissue and cells, as well as information, such as treatment information, is increasingly important in the discovery of more-effective, safe drugs. In implementing this type of research, it is essential to pay careful attention to ethical issues, such as the receipt of appropriate informed consent, reduced burden on research subjects, and the protection of personal information. Mitsubishi Tanabe Pharma has established the Human Tissue Research Ethics Review Committee as an ethics review committee in conformance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology (MEXT); Ministry of Health, Labour and Welfare (MHLW)). This committee carefully reviews the ethical appropriateness and scientific rationality of research protocols. To promote objectivity and impartiality in these reviews, outside members are included to ensure that respect is given to a range of opinions and to facilitate appropriate reviews. To ensure full transparency, the Company posts the committee membership list, the rules governing the committee, and summaries of its proceedings on the research ethics committee reporting system established by MEXT and MHLW.
Human Rights and Bioethical Considerations in Clinical Trials
All Mitsubishi Tanabe Pharma clinical trials are subject to strict standards. The Company follows the guidelines set by the International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use/Good Clinical Practices (ICH-GCP), based on the Declaration of Helsinki. It also upholds the laws and regulations of the country in which the studies are conducted, as well as its own standards and clinical trial protocol. All volunteer trial subjects give their informed consent to do so. The Company's highest priority is to ensure the safety of its trial subjects, protect their human rights, and safeguard and improve their personal welfare.
Mitsubishi Tanabe Pharma's Clinical Trial Protocol Review Committee includes members from outside the Company and medical experts who are well-versed in clinical trial ethics. Before a trial is allowed to begin, the committee investigates the proposed study to confirm its ethical and scientific validity.
In addition, the Company's clinical trial management system is used to verify that studies are being properly administered, and we have established a system to ensure that the trial data is reliable.