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Governance :

Compliance

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Being aware of responsibilities as a pharmaceutical company dealing in pharmaceuticals upon which human lives depend, ONO has established the ONO Pharmaceutical 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.

ONO PHARMACEUTICAL CO.,LTD., ONO PHARMACEUTICAL CO.,LTD., system

ONO PHARMACEUTICAL’s Compliance System

Being aware of its responsibility as a pharmaceutical company dealing in pharmaceuticals upon which human lives depend, We have 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. Our compliance system consists of the ONO Pharmaceutical Codes of Conduct, which sets out basic guidelines for corporate activities; the Compliance Program Policy, which provides standards of conduct for corporate activities; and the Code of Practice, which is based on the pharmaceutical industry standards on promotion and other activities.

In practicing the compliance system into practice, we repeatedly informing our employees ensuring transparency, preventing fraud and corruption, constantly being conscious of domestic and international social conditions.

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For details, please refer to the ONO Pharmaceutical Codes of Conduct, ONO Pharmaceutical Compliance Program Policy, and ONO Pharmaceutical Code of Practice below.

ONO PHARMACEUTICAL CO.,LTD., ONO PHARMACEUTICAL CO.,LTD., system

Compliance Promotion Initiatives

Compliance Promotion System

To promote compliance, we have appointed the Executive Director, Corporate Strategy & Planning (Member of the Board of Directors, Executive Officer) as a Corporate Compliance Officer and set up a Compliance Committee. The Compliance Committee examines and deliberates on compliance-related issues, plans and promotes relevant training programs, and checks to what extent such compliant related matters are shared and understood within the company in cooperation with the internal auditing department.
We have a whistleblowing system with several internal and external contact points (refer to the chart below), including the 24-hour external contact “ONO Hotline,” set up in 2015. 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, Corporate Compliance Officer, and Corporate Auditors. From the perspective of protection of whistleblowers, matters related to the privacy of whistleblowers, such as their name, 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 only for the reason that they made such reports. We has acquired the Whistleblowing Compliance Management System(WCMS)(a system for self-declaration of conformity).
In particular, with regard to harassment, we incorporate harassment issues not only in annual training for management-level staff but also in training programs by external instructors, thereby enhancing employee awareness of compliance.
We instruct our group companies to establish systems and rules to prevent any compliance violations. We also strongly request our affiliated companies and suppliers to do the same. We have expanded our whistleblowing system to all group companies so that anyone working in our group can report or consult on compliance-related matters without hesitation.

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Ethical Considerations

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.
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 Center for Accreditation of Laboratory Animal Care and Use, Japan Health Sciences Foundation.
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.

Fair and Transparent Business Activities

In order to conduct fair and transparent business activities, we establish a training month for providing e-learning and training in each division every year to provide education thoroughly 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 R&D and a stable supply of our products, we need to cooperate with research and medical institutions and engage in collaborative activities (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 activities are undertaken under the responsibility of the director in charge of compliance, namely the Corporate 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 publicly funded research, 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.

No facilitation payment defined the Global Policy was exercised in FY 2019. For more information, see the web pages below:

ONO PHARMACEUTICAL CO.,LTD., ONO PHARMACEUTICAL CO.,LTD., system
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