Being aware of responsibilities as a pharmaceutical company dealing in pharmaceuticals upon which human lives depend, ONO has established the ONO Group Code 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 Group Code of Conduct" to ensure our actions are in compliance with laws and regulations and are based on a high sense of ethics. Our compliance system is comprised of the ONO Group Code of Conduct which has been established as a basic guideline that should be followed in our corporate activities based on our corporate philosophy, and the Compliance Global Policy which has been established as the concept and management system for promoting our compliance system. 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 Group Code of Conduct, Compliance Global Policy, and ONO Pharmaceutical Code of Practice below.
In order to strengthen our compliance system, we have appointed a Member of the Board of Directors, and Senior Executive Officer as the Officer in Charge of Compliance and established the ONO Group Compliance Committee. The committee examines and deliberates on compliance-related issues, plans and promotes training and other programs, and takes up and discusses matters reported by subsidiaries. It also works with the Internal Audit Department to check the status of initiatives at each business site, and with the Risk Management Committee, which promotes enterprise risk management (ERM), to manage compliance risks. In response to serious compliance violations in FY2020, in October 2021, in order to strengthen compliance, we appointed Compliance Officers in each division who are in charge of operations for compliance, as well as Compliance Managers in all departments who act as the point of contact in the workplace for consultations regarding compliance matters. This system is designed to coordinate with the Risk Manager, who is in charge of managing the overall risks of the organization, and to promptly take measures in response to consultation matters that arise within the organization. Information on consultation matters is also shared with the Compliance Management Department, which provides advice to Compliance Managers. In addition, a special officer in charge of overall compliance has been separately assigned at the Sales and Marketing Department. In addition to regularly participating in the Compliance Management Committee within the Sales and Marketing Department and other meetings, this officer provides advice and suggestions in an effort to optimize operations and establish awareness of prevention. For more details on our compliance management system implemented from October 2021, please refer to "[1] Strengthening Our Compliance System" listed under the section titled “In response to serious compliance violations in FY2020.” We require our group companies to establish systems and regulations to prevent compliance violations.
We have established internal and external points of contact for reporting and consultation (see the chart below), including the ONO Hotline, which is open 24 hours a day. The aim of this is to prevent the occurrence and recurrence of compliance violations, including harassment, to secure an appropriate work environment, and to minimize loss and the erosion of public trust by taking swift action and measures in the event of a violation. We have also established a system that enables direct reporting and consultation with management, including the President, Representative Director and, CEO, the Officer in Charge of Compliance, and the Audit & Supervisory Board Member. All officers and employees (including contract employees, temporary employees, part-time employees, seconded employees, etc.) of the company (including its wholly owned group companies in Japan), as well as former employees who have retired within the past 12-month period (excluding officers) may use the points of contact for reporting and consultation. Reports and consultations received by the points of contact are immediately reported to the Compliance Management Department, which conducts an investigation to confirm the facts. As a result of the investigation, if the existence of misconduct, etc. is revealed, corrective actions, recurrence prevention measures and other necessary measures are promptly taken, and disciplinary action or other measures are strictly enforced. Efforts are made to notify the whistleblower of these developments as appropriate. When using the points of contact for reporting and consultation, the name of the whistleblower, the content they provide, and other privacy-related matters are strictly prohibited from being disclosed to parties other than those required for the investigation, and anonymous reports are also accepted. In addition, the whistleblower who uses these points of contact is protected by law and is not subject to any disadvantageous treatment on the grounds of whistleblowing. These matters are also clearly stated in the Whistleblowing Policy, which were newly established based on the Amended Whistleblower Protection Act that came into effect from FY2022. We also conduct training and other programs to ensure that our employees are aware of these reporting and consultation systems. We will continue to raise awareness on the significance and importance of reporting and consultation, as well as the protection of persons who report and consult, in order to establish a system that allows people to report and consult without hesitation.
For more details on the development of our whistleblowing system, please refer to "[4] Development of Whistleblowing System" listed under the section titled “In response to serious compliance violations in FY2020.”
The Compliance Management Department, which operates the PDCA cycle for compliance risk management, holds hearings four times a year with all of our divisions, supervisory departments, and other departments in order to visualize risks. In addition to the compliance risks identified by the Risk Manager and the Compliance Officers in charge of risk management in relevant departments, the results of these hearings are used to assess how frequently risks occur and the degree of their impact. The Compliance Management Department then discusses countermeasures with the Compliance Officers and the Risk Manager and monitors their progress after repeated examinations.
In order to promote compliance, it is important to continuously conduct training and awareness-raising activities for officers and all employees. We use e-learning to conduct a 100-question compliance test twice a year for officers and all employees. In addition, we have designated the three-month period from October to December of each year as our Compliance Promotion Enhancement Month, and we are strengthening our compliance initiatives, including holding division-specific discussions, for officers and all employees. In response to cases of serious compliance violations that occurred in FY2020, we conducted education and training in FY2021 and FY2022 on the prevention of bribery for officers and all employees in order to thoroughly prevent a recurrence. We also conduct annual training regarding harassment to strengthen our efforts to create a comfortable working environment. Training related to the Guidelines on Activities to Provide Sales Information is based on compliance issues that have actually been confirmed, and in addition to holding regular training sessions, if problems do arise, we promptly conduct training to prevent their recurrence. We also promote risk-based training programs on other compliance-related themes. For more details on our compliance training, please refer to "[2] Employee Education" listed under the section titled “In response to serious compliance violations in FY2020.”
The Compliance Management Department investigates any violations that occur. As a result, those who are found to have violated compliance are subject to disciplinary action, including termination of employment. We are also working to prevent recurrences by strengthening our compliance management system and thoroughly raising employee awareness through training, etc.
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.
For more information, see the web pages below:
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. For details, refer to the “ONO Pharmaceutical Global Tax Policy,” “Country-by-Country Report (Condensed),” “Business Description and Information on Subsidiaries and Associates,” and “Notes to Consolidated Financial Statements (Income taxes)” 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:
Since the misconduct that occurred in FY2020 (hereinafter referred to as the "Misconduct"), progress regarding the measures we have taken to strengthen compliance to prevent a recurrence is as follows:
Since September 2021, the Board of Directors has regularly taken up the following initiatives to strengthen our internal compliance system and reported on their progress in order to strengthen the supervisory system by Members of the Board of Directors, Outside directors.
| Message from the President about the purpose of the training |
[Training instructor] Senior Partner, Compliance Management Department
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[Discussion moderated by the head of the business site]
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| A message from the Officer in Charge of Compliance at the end of the training |
In anticipation of the enforcement of the Amended Whistleblower Protection Act, we reviewed our whistleblowing system and established it as an independent internal whistleblowing policy in April 2022 and made it known to employees. The key points are as follows:
| 1. In principle, reports shall be made under a public (real) name. (if there is a justifiable reason, an anonymous report is also possible) |
| 2. Investigations shall be led mainly by the Compliance Management Department |
| 3. Any person who makes a false statement or leaks information to a third party during an investigation may be subject to disciplinary action in accordance with the employment regulations, etc. |
| 4. Provide specific details about the content related to confidentiality |
| 5. Detailed description of content that prohibits searches on whistleblower |
After the above points were made known in the company, the number of whistleblowing consultation, as well as the ratio of anonymous reports have gradually been increasing.
The above is the status of responses regarding the handling of scholarship donations, efforts to strengthen our compliance system, employee education, and the establishment of a whistleblowing system. By promoting these initiatives, we will not only prevent recurrence, but also strive to prevent violations, and continue to work to restore the trust of patients, healthcare professionals, and related parties.