Human Rights Human Rights Issues in the Value Chain
Ethical Considerations in Research
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 facilities certified by the Center for Accreditation of Laboratory Animal Care and Use, Japan Health Sciences Foundation, a third-party assessment and accreditation organization. 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 or not the plans are in accordance with the 4Rs. The term "4Rs" refers 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). In these ways, we are acting with consideration for animal welfare.
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 and the maintenance of the privacy of donors. 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 ethics review 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.
Ethical Considerations in Procurement
In accordance with the Mitsubishi Chemical Holdings (MCHC) Group Charter of Corporate Behavior, we are working to contribute to the realization of KAITEKI. In accordance with this concept, we have established the Procurement Policy for procurement activities, and we strive to conduct equitable, fair, and transparent transactions with suppliers. On that basis, we are advancing procurement activities with an emphasis on observing laws and regulations, and consideration for the environment, safety, and human rights.
Regarding human rights, we share MCHC's "Developing Cooperative Business Practices with Suppliers and Business Partners ‐ Guidebook [PDF: 454KB]" with business partners and ask them to respect human rights (respect the dignity and human rights of all people and to not unjustifiably discriminate based on race, gender, religion, or other characteristic regardless of the reason). On the other hand, because we cannot realize KAITEKI through our efforts alone, we also ask for the understanding and cooperation of our suppliers to realize KAITEKI.
Consideration for local communities in production
The Mitsubishi Tanabe Pharma Group implements environmentally friendly business activities. At the production stage, Group initiatives include energy conservation and recycling, as well as maintaining ISO 14001 certification, an international standard for environmental management, at major production sites.
To prevent the occurrence of environmental damage in the regions where its worksites are located, Mitsubishi Tanabe Pharma fully complies with all laws and regulations associated with its business activities, including Japan's Water Pollution Control Act, Soil Contamination Countermeasures Act, and Noise Regulation Law. In addition, each base is also in compliance with all special local regulations, such as the Act on Special Measures concerning Conservation of the Environment of the Seto Inland Sea, which are relevant to operations at the Onoda and Yoshitomi plants.
The Company acts with consideration for local communities. For example, when investing in new facilities that involve the construction of buildings or other structures, as a general rule the Company holds briefings for neighborhood residents before the project commences in an effort to help the local community better understand how they will be impacted.
Each Mitsubishi Tanabe Pharma plant carries out greening activities and local environmental cleanup campaigns, planting trees on factory grounds and collecting litter in the surrounding neighborhoods. The Yoshitomi Plant is involved in activities to promote interaction with local communities, including hosting events in which local residents are invited to participate.
Our overseas manufacturing bases also comply with the laws and regulations of each country and are engaged in a wide range of activities such as promoting energy reduction and recycling, volunteer activities such as clean ups, and support for disaster-stricken areas in case of natural disaster.
Human Rights Considerations in Marketing
As a pharmaceutical manufacturer, the Mitsubishi Tanabe Pharma aspiration is to realize the concept that "Everything we do is for the patients." To achieve this, the Company takes as its mission the provision of accurate information on its valuable pharmaceutical products to physicians, pharmacists, nurses, and other healthcare professionals in order to improve the welfare and medical care of the public and help people live healthy, quality lives.
Mitsubishi Tanabe Pharma medical representatives (MR) conduct themselves with the high ethical standards and common sense befitting employees of a global healthcare company, placing the highest priority on fairness and integrity in all of their activities. An MR's goal is to carry out promotional activities in a manner that respects the human rights of all patients.
Protecting Customer Privacy
Mitsubishi Tanabe Pharma is committed to protecting its customers' personal information. In keeping with its strong sense of responsibility regarding this subject, the Company has released its Policy on Protecting Personal Information to the public. Toward this end, the Company uses only fair and reasonable methods to collect customers' personal information and utilizes this information only to the extent necessary to achieve the permitted purpose. In addition to this fundamental approach, it has taken the following initiatives with regard to the handling of personal information.
- (1)Established defined regulations regarding the protection of personal information
- (2)Issued the Personal Information Leak Prevention Manual
- (3)Instituted a structure for the protection of personal information, headed by a chief privacy officer (CPO) and staffed by privacy protection division managers and privacy protection personnel
- (4)Educated and trained employees; Supervised and audited subcontractors
- (5)Implemented robust data encryption and security measures on company computers