Being aware of responsibilities as a pharmaceutical company dealing in pharmaceuticals upon which human lives depend, ONO has established the ONO Pharmaceutical Codes of Conduct to ensure all its members act in compliance not only with laws and regulations but also with high ethical standards. We also promote fair procurement activities by thoroughly training employees on compliance education and by closely cooperation of our suppliers.
We are aware of our responsibility as a pharmaceutical company involved in the manufacture of pharmaceuticals that affect the lives of people, and as a part of our compliance system, we have established the "ONO Pharmaceutical Codes of Conduct" to ensure our actions are in compliance with laws and regulations and are based on a high sense of ethics. Based on our corporate philosophy, we have established the "ONO Pharmaceutical Codes of Conduct" as a basic guideline for our corporate activities, and our "Compliance Program Policy" as a standard of conduct for our activities. We have also formulated "ONO Pharmaceutical Code of Practice," in line with the Japan Pharmaceutical Manufacturer's Association (JPMA) Code of Practice, which sets forth action standards for promotion activities, and we act in strict compliance with this code.
In putting the compliance system into practice, we adequately inform our employees to ensure transparency, prevent fraud and corruption, and to be constantly aware of domestic and international social conditions.
For details, please refer to the Corporate Philosophy /ONO Pharmaceutical Codes of Conduct, ONO Pharmaceutical Compliance Program Policy, and ONO Pharmaceutical Code of Practice below.
To promote compliance, we have appointed the Executive Director of Corporate Strategy & Planning (Member of the Board of Directors and Senior Executive Officer) as a Corporate Compliance Officer, and also set up a Compliance Committee. The committee examines and deliberates compliance-related issues, and plans and promotes training. In addition, in collaboration with the Internal Audit Unit, the committee confirms the status of efforts at each site. The committee also works with the Risk Management Committee to implement compliance risk management. In FY2021, we worked to strengthen the supervisory system of the Board of Directors, such as by taking measures to prevent recurrence based on the case of serious compliance violation that had occurred in the previous year, and regularly reporting the progress (such as the implementation status of company-wide training) to the Board of Directors and receiving advice from outside directors. Compliance Officer has been newly appointed to each department as the operational manager for strengthening compliance. The risk manager, who manages the overall risk of the organization, and the compliance managers, who have been newly assigned to all departments as a consultation desk in the workplace regarding compliance issues, work together to establish an operating system that promptly takes measures against issues that have been raised within the organization. Regarding consultation matters, we also share the information with the newly‐established Assessment Office in the Compliance Department and provide advice to the compliance managers. In addition, a specially appointed person in charge of overall compliance is assigned to the Sales and Marketing Division, and regularly participates in compliance promotion meetings within the Sales and Marketing Division, and strives to optimize operations and establish awareness of prevention by pointing out issues and giving advice. We instruct our group companies to establish systems and regulations to prevent any compliance violations. We also required suppliers etc. are request to do the same.
We have a whistleblowing system that includes several internal and external contact points (refer to the chart below), including a 24-hour external contact, the "ONO Hotline." Our whistleblowing system aims to prevent the occurrence or recurrence of harassment and other compliance violations, to create a healthy working environment, and to enable prompt action to be taken in the event of violation of compliance rules to minimize the damage or loss of our social credibility. We also have a system in place that enables whistleblowers to directly report to or consult with top management, including the President Representative Director, Corporate Compliance Officer, and Corporate Auditors. As for the use of the system, matters related to the privacy of whistleblowers, such as their names, and the reported content are kept strictly confidential and only disclosed to relevant persons involved in investigation. Anonymous reports are also accepted. We also ensure that employees who make whistleblowing reports are not subject to disadvantageous treatment for making such reports, and that they are legally protected. These policies are clearly stated in the internal whistleblowing regulations newly enacted based on the revised Whistleblower Protection Act that will come into effect in 2022, and are thoroughly known to employees. We are also expanding contact points for reporting and consultation across all Group companies to create a system in which employees can report and consult without hesitation.
To promote compliance, we recognize that it is important to continuously conduct employee training and awareness activities. We therefore provide compliance training to our officers and all employees every year. In FY2021, based on the lesson learned from the case of serious compliance violation that occurred in the previous year, we held training meetings with discussions to thoroughly prevent recurrence and conducted education and training on prevention of bribery. We also conduct annual training on harassment and continuously strengthen our efforts to create a comfortable working environment. As for the training related to the Guidelines on Activities to Provide Sales Information, the contents of the training are based on actual compliance issues. We provide not only regular training, but also training to prevent recurrence as soon as possible if any problem arises. We also promote risk-based training programs for other compliance themes.
We always give consideration to ethical treatment in various stages of research and development.
For research using human-derived samples (blood, tissue, cells, genes, etc.), we have established internal ethical rules based on the basic guidelines issued by the Japanese government. We have also established the Ethics Committee for Medical and Health Research Involving Human Subjects, as an advisory body comprising members from inside and outside the company, to ensure that such research is conducted only after the Committee conducts strict assessment of its ethical and scientific validity. We also recognize that the use of human embryonic stem cells (ES cells) for research purposes raises bioethical concerns because human ES cells are derived by destroying human embryos, which are the emerging potential of human life, and they have the potential to differentiate into any type of human cell. We believe that we should carefully consider the use of human ES cells for research purposes at the internal Ethics Committee based on relevant laws and regulations and guidelines.
For research using laboratory animals, we have established the Institutional Animal Care and Use Committee. The Committee reviews submitted animal experimentation plans in advance to determine whether they have been prepared based on the principles of the 3Rs-Replacement (use of alternative methods), Reduction (reducing the number of test animals) and Refinement (alleviation of pain)-to ensure that animal experiments are carried out appropriately, with respect for the lives of animals and taking into consideration animal welfare. In addition, we conduct self-inspections and assessments of the implementation status of animal experiments. In recognition of these initiatives, we have acquired third-party certification from the Japan Pharmaceutical Information Center.
We ensure that clinical trials, which are essential for verifying the safety and efficacy of pharmaceuticals under development, are carried out in a highly ethical manner, with particular attention to the rights, safety and welfare of study subjects. Clinical trials are a long process. We ascertain the true value of a new drug step-by-step by taking all necessary and appropriate procedures that comply with Japan’s "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices（Pharmaceutical and Medical Device Act）" and other related legislation, as well as the global standards specified based on the spirit of the Declaration of Helsinki. In the past, many drug-induced injury cases occurred due to inadequate safety monitoring of pharmaceutical products. We regularly provide education on drug-induced injuries to all employees so that they will never forget patients’ pain, the drug-induced toxicity, and the grave responsibility of a pharmaceutical company.
In order to ensure our business activities are conducted fairly and transparently, we provide e-learning and establish a training month in each division every year to provide thorough education to all employees concerning the prevention of fraud and corruption. To contribute to healthcare and people’s health around the world through continuous new drug creation and provision of a stable supply of our products, we need to cooperate with research and medical institutions and engage in collaborative activities such as support for patient organizations to help patients overcome disease and pain. To enhance the fairness and transparency of these cooperation and collaborative activities, it is important to ensure transparent relationships with our partners. We therefore disclose information on the costs of our assistance to medical institutions and patient organizations in accordance with our transparency guidelines, which were developed in line with the relevant guidelines of the Japan Pharmaceutical Manufacturers Association (JPMA).
Regarding tax compliance, we have established the ONO Pharmaceutical Global Tax Policy, in strict accordance with which all tax-related management are undertaken under the responsibility of the director in charge of compliance, namely the Corporate Senior Executive Officer/Executive Director of the Corporate Strategy & Planning Division. For details, refer to the ONO Pharmaceutical Global Tax Policy below.
Amid a globally mounting interest in compliance with laws governing unfair and corrupt practices, we established the ONO Pharmaceutical Global Anti-Bribery and Corruption Policy and the Regulations on Bribery Prevention in 2017 to clearly define and state our company’s stance and system in preventing bribery and corruption. We endeavor to ensure strict implementation of the policy and regulations. Furthermore, we support Transparency International’s Business Principles for Countering Bribery, an international anti-bribery standard.
As for research receiving public fund as research funding, we have formulated the Action Guidelines for Publicly Funded Research and the Regulations on Publicly Funded Research, in compliance with the relevant guidelines established by the Japanese government, to ensure further appropriate implementation and management of research projects.
For the details of our system for preventing bribery and corruption, refer to the ONO Pharmaceutical Global Anti-Bribery and Corruption Policy (hereinafter the "Global Policy") below.
For more information, see the web pages below: