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Governance :

Compliance

リード文

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.

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ONO Pharmaceutical’s Compliance System

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 comply 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 also act in compliance with the "ONO Pharmaceutical Code of Practice," which is in line with the Japan Pharmaceutical Manufacturers Association(JPMA) Code of Practice related to promotion 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.

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.

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Compliance Promotion Initiatives

Compliance Promotion System

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 Compliance Committee deliberates and determines compliance-related issues, and plans and promotes training. In addition, in collaboration with the Internal Audit Unit, we confirm how much information has been disseminated. It also works with the Risk Management Committee to implement risk management. 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.

Reporting and Consultation System

We have a whistleblowing system that includes several internal and external contact points (refer to the chart below), including a 24-hour external contact "ONO Hotline," which was 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 Representative Director, 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 for making such reports. We have acquired the Whistleblowing Compliance Management System (WCMS) Certification, which is a system for self-declaration of conformity.
We are also expanding the internal and external contact points for reporting and consultation across all Group companies to create a system in which employees can report and consult without hesitation.

Compliance Education

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 FY2020, based on the results of the employee awareness survey conducted in FY2019, a discussion-style training program was held for leaders to improve the working environment in order to further strengthen the corporate culture for reporting and consultation related to compliance within the organization. In response to a mandatory requirement for employers to take measures to prevent power harassment, we work to raise awareness of compliance by incorporating these principles into a training program conducted by external lecturers in addition to annual training for management. 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. (As an example, we ensure that information on the efficacy and safety of drugs is provided without bias.) We also promote risk-based training programs for other compliance themes.

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 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.

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 creation 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 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:

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