Embracing high ethical and moral standards in all our activities as a healthcare company
Corporate Ethics Take Priority over Profit
Chugai places paramount importance on respect for life, and pursues fair and transparent corporate activities based on high ethical standards, along with sincere scientific initiatives. This approach is essential for creating trusting relationships with stakeholders and contributing to the sustainable development of society.
When the new Chugai was created in October 2002, the president issued a message to all employees concerning the need to prioritize corporate ethics over profit.
The Company published a Mission Statement declaring its path to becoming a company that meets stakeholders'expectations and fulfills its social responsibilities, and also established the Chugai Business Conduct Guidelines (Chugai BCG) to accompany the statement.
To realize this mission, all employees of the Chugai Group place top priority on sharing these values, as well as on understanding and practicing the ethical standards necessary to execute their jobs. Chugai is committed to judging every action before taking it.
Commitment to Ethical Promotional Activities
Pharmaceutical companies have a responsibility to pursue quality, effectiveness and safety in all their operations, from product R&D to sales. They must also rapidly collect and disseminate accurate information on pharmaceuticals in an appropriate manner.
Japan's pharmaceutical industry has voluntarily established a promotion code for the independent marketing of pharmaceuticals. There is also a fair competition agreement that covers the manufacture and sale of pharmaceuticals, which serves to regulate the provision of free drug samples to medical institutions. The Chugai Group actively supports the efforts of the Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry and the Japan Pharmaceutical Manufacturers Association's Promotion Code Committee — the institutions administering the above-mentioned industry rules — and has also gone one step further by establishing and implementing its own code of conduct for pharmaceutical promotion. The Chugai Promotion Code Committee serves as the decision-making body for Chugai's code, and full-time monitors at the head office and branches ensure proper adherence to the fair competition agreement and the Chugai code. In these ways, we are taking decisive steps to ensure that all of our marketing activities are highly ethical.
Creating a Corporate Culture of Respect for Self and Others
The keyword can be translated into English as, "You cannot respect others if you cannot respect yourself."
A culture of respect for human rights is essential for building a dynamic, outstanding company that deserves the trust of society. Diversity management and respect for human rights are important parts of the Chugai Business Conduct Guidelines, which outline a code of conduct based on the Core Values shared by Chugai employees.
Chugai is committed to fostering a corporate culture where people respect themselves and others, where they can do rewarding work with creativity and enthusiasm. The key to this is creating a culture that encourages diversity and respect for others' values so that all employees can have strong self-esteem and live up to their full potential — that is, creating workplaces that are free from harassment and infringement of human rights.
A corporate culture that respects human rights inspires everyone, thus improving performance. Moreover, by raising awareness of human rights and promoting respect for diversity within Chugai, such a culture helps eliminate discrimination and infringement of human rights in broader society as the Company interacts with the public as a corporation, and through the everyday lives of its people.
Chugai's View of Animal Welfare
Research using laboratory animals to confirm the safety and efficacy of drugs is essential to the development of the pharmaceuticals that contribute dramatic improvements to human health. At the same time, this research must thoroughly comply with the 3Rs1 principles. In 1988, the Chugai Group established guidelines on how to treat laboratory animals in research, and has adhered to these ever since, conducting all animal testing in an ethical, scientifically sound manner.
Although these guidelines have been partially revised from time to time, Chugai has consistently practiced ethical animal testing in line with this basic philosophy: "We must consider both ethical and scientific issues when undertaking animal experiments, taking into account ethical issues including aspects of animal physiology, ecology, and behavior as they affect animal welfare, and rearing animals with compassion, respect for animal life, and measures to minimize pain." In 2005, Chugai reformed its Ethics Committee for the Treatment of Laboratory Animals, which was originally established with the advent of the guidelines, and renamed it the Institutional Animal Care and Use Committee. In addition to further clarifying the lines of responsibility within the Company, we added nonaffiliated voting committee members to ensure objective monitoring of animal testing from the perspective of the general public. At the same time, an institutional qualification program was adopted for researchers and animal handlers involved in animal testing to provide appropriate education and training designed to cultivate ethical animal testing. (In 2010, 159 participants took part in occasional training courses held 37 times, and 464 participants took part in annual training courses held four times.)
Since 2005, the committee has been conducting self assessments twice a year to ensure that researchers are following the guidelines, and implements improvements in animal testing to reflect changes in the social environment and scientific advances.
These initiatives have been evaluated by AAALAC International,2 a global independent evaluation organization. In 2007 Chugai obtained full accreditation, which was renewed in 2010. Inspection by AAALAC International is repeated every three years, and we will continue our tireless effort to ensure animal welfare.
1. The principles of replacement, reduction and refinement, which are applied in order to ensure animal welfare during research
2. Association for Assessment and Accreditation of Laboratory Animal Care International, a private non-profit organization that promotes the humane treatment of animals in scientific research through voluntary inspection and accreditation programs. More than 790 facilities in 32 countries have been accredited.
Bioethics Initiatives in R&D
Chugai has established Ethical Guidelines for Research that Uses Human-derived Test Material. Chugai has also formed a Research Ethics Committee to ensure that research using human-derived test material is carried out appropriately, with human dignity, respect for human rights and the understanding and cooperation of society. Half of the members of this committee are from outside Chugai. Of the outside members, more than half are people from the humanities and social sciences, including ethics and law, as well as people with a more general background. The composition and operation of the committee helps to ensure that it is responsive to changes in social conditions while carrying out fair, objective evaluations from an interdisciplinary and pluralistic frame of reference.
In response to the enactment of sweeping revisions to the Japanese government's Ethical Guidelines for Clinical Studies in April 2009, Chugai carries out researcher training each year on the knowledge required when conducting research, including ethics for research using human-derived test material. Chugai will continue it as a regular training program to ensure that research is conducted with the highest priority on ethics.
Conduct of Clinical Trials
Clinical trials are essential for verifying the safety and efficacy of investigational products, and they must be performed with respect for the rights of trial subjects. Clinical trials are closely monitored for patient safety, following stringent scientific methodology based on the highest ethical standards. The Chugai Group is committed to evaluating the real merit of investigational products using well-established, reputable testing procedures that comply with Japan's Pharmaceutical Affairs Law and other related legislation, as well as the Declaration of Helsinki3 and ICH-GCP4, which are global standards.
Protocol Review Committee
Before the start of a proposed clinical trial, the Protocol Review Committee checks the protocol to ensure that it is ethically and scientifically sound. The protocol is then checked by a governmental regulatory agency, before being carefully examined by an Institutional Review Board, which is composed of medical professionals and non-medical members at medical institutions. This board makes a decision on whether or not Chugai may proceed with a given trial.
Standard Operating Procedures
Clinical trials are undertaken in compliance with specific Standard Operating Procedures (SOPs) prepared and updated by Chugai. Chugai's SOPs comply with all applicable pharmaceutical laws and regulations.
Safety Evaluation Committee
Whenever obtaining important information on safety of investigational products from clinical trials, Chugai promptly gathers the needed information, and then analyzes and deliberates on it in a Safety Evaluation Committee composed of medical and scientific experts including physicians. This ensures that patient welfare always remains the highest priority through the meticulous process of sharing information with regulatory authorities and the medical institutions involved.
3. Officially titled "Ethical Principles for Medical Research Involving Human Subjects," the Declaration of Helsinki is a code of ethics that medical researchers proposed and adopted at the World Medical Association in 1964 to regulate themselves. Recognizing that experimentation on human subjects is necessary for medical progress, it establishes the principle that the well-being of human subjects should take precedence over all other interests. (Source: World Medical Association)
4. Good Clinical Practice (GCP) guidelines adopted by the International Conference on Harmonisation (ICH) for conducting pharmaceutical clinical trials in Europe, the United States and Japan
