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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 PHARMACEUTICAL has the Ono Pharmaceutical Code of Conduct to ensure that it acts in compliance with laws and regulations and that it meets high ethical standards. We thoroughly train all employees to ensure compliance and promote proper procurement activities in cooperation with suppliers.

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

ONO PHARMACEUTICAL’s Compliance System

Our compliance system consists of the Ono Pharmaceutical Code of Conduct as basic guidelines for corporate activities, the Compliance Program as a behavioral standard for its activities, and the Code of Practice based on pharmaceutical industry standards related to promotional activities. In practicing the compliance system, we are repeatedly informing our employees about ensuring transparency, preventing fraud and corruption, constantly being conscious of domestic and international social conditions. We will continue to recognize our ethical philosophy as a pharmaceutical company and will make every effort to further improve compliance in line with our compliance system.

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

Compliance Promotion Initiatives

Compliance Promotion System

To promote compliance, we have appointed a Corporate Compliance Officer and set up a Corporate Committee. The Corporate 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 internal and external contacts (refer to the chart below) including a 24-hour external contact service named the ONO Hot Line, which was set up in 2015 for compliance issues as well as a system to ensure that informants can directly report to or consult with top management-that is, the Representative Director, the Corporate Compliance Officer, and the Corporate Auditors. Under this system, compliance violations including harassment can be prevented, appropriate work environment can be ensured, and necessary measures can be taken to minimize any loss of credibility in the event of a compliance violation. We ensure that the matters including reporting person’s name, reported content, and his/her privacy are strictly kept confidential to other than those involved in the survey, and support anonymous reporting. In addition, we will never bring detriment to such a reporting person solely because of use of the system.
In particular, with regard to harassment, not only do we provide training courses for management staff, but we also include harassment and other issues in the sessions conducted by external lecturers, thereby enhancing awareness of compliance. We provide guidance to associated group companies in creating systems and rules to prevent the occurrence of noncompliance, and we strongly urge our affiliates and suppliers to do the same. We also continue enhancing the system to make the contacts available in the entire group so that employees can report or consult without hesitation.

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Ethical Considerations

ONO always gives consideration to ethical treatment in various stages of research and development.
We conduct research using human specimens (blood, tissue, cells, genes, etc.) after strict deliberations on ethical and scientific acceptability. To this end, we have established internal ethical codes based on the basic guidelines specified by the Japanese government and set up the Research Using Human Specimens Ethics Committee composed of internal and external members as an advisory board.
To ensure that the lives of the animals are respected and proper consideration is made to animal welfare in research using laboratory animals, we have established the Institutional Animal Care and Use Committee that reviews whether all animal experimental protocols are prepared based on the principles of the 3Rs―Replacement (active use of alternative methods of experiment), Reduction (reducing the number of test animals), and Refinement (alleviation of pain)―in advance. The committee also implements self-inspections and assessments of the animal experiment processes. In recognition of these initiatives, Ono has earned the Center for Accreditation of Laboratory Animal Care and Use (CALAC) in the Japan Health Sciences Foundation (JHSF) accreditation as an animal testing facility.
Clinical trials, which are essential for verifying the safety and efficacy of investigational compounds, must be performed with respect for the rights of trial subjects. Clinical trials are closely monitored for patients’ safety and are stringently conducted under high ethical standards. We are committed to evaluating the real merit of investigational compounds by steadily applying essential and complete testing procedures that comply with the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices of Japan (Pharmaceutical and Medical Device Act) and other related legislation, as well as the global standards based on the spirit of the Declaration of Helsinki.
In the past, inadequate safety monitoring performance for pharmaceuticals caused many chemical hazards. We periodically carry out education on chemical hazards for all employees so that we will not forget the patients' pain, the misery of chemical hazards, and the magnitude of corporate responsibility.

Fair and Transparent Business Activities

In order to conduct fair and transparent business activities, we repeatedly educate all employees every year so as to familiarize them with their duties to prevent fraud and corruption by providing e-learning opportunities and scheduling a special month-long period of intensive training during which we conduct training in each division.
We aim to contribute to healthcare all around the world and people’s health through continuous R&D activities and the stable supply of new drugs. To this end, we need to engage in collaborative activities-for example, providing support for patient organizations-and cooperate with research and medical institutions to help patients overcome disease and pain. To enhance the fairness and transparency of such collaborations and cooperation, 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 are formulated in line with the relevant guidelines of the Japan Pharmaceutical Manufacturers Association (JPMA).

Regarding tax compliance, Ono have established the ONO Pharmaceutical Global Tax Policy and, under the responsibility of a Corporate Compliance Officer, a Member of the Board of Directors, Executive Officer / Executive Director, Corporate Strategy & Planning, is making effort to implement it in a strict manner. For the details, refer to the ONO Pharmaceutical Global Tax Policy below.

While compliance with laws related to fraud and corruption is attracting increasing attention on a global scale, we always act in consideration of the social situation in Japan and overseas. To this end, we established ONO PHARMACEUTICAL Bribery Prevention Global Policy and the Regulations on Bribery Prevention in 2017 to clarify our bribery prevention system in a written form, and work to operate them in a strict manner. Furthermore, we support Transparency International's Business Principles for Countering Bribery, an international anti-bribery standard.
To ensure that publicly funded research is conducted in compliance with the relevant guidelines established by the Japanese government, we have formulated the Action Guidelines for Publicly Funded Research and the Regulations on Publicly Funded Research, and apply them for even more appropriate use and management of public research funds.

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 2018.

ONO PHARMACEUTICAL CO.,LTD., ONO PHARMACEUTICAL CO.,LTD., system
Governance :
Corporate Governance

リード文

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Governance :
Corporate Governance

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Corporate Governance Code

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We have laid out our operational system in compliance with the corporate go...

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Information Disclosure

As specified in our Codes of Conduct, we strive to establish transparent co...

Governance :
Compliance

リード文

ONO PHARMACEUTICAL’s Compliance System Compliance Promotion Initia...

Governance :
Compliance

ONO PHARMACEUTICAL’s Compliance System

Our compliance system consists of the Ono Pharmaceutical Code of Conduct as...

Governance :
Compliance

Compliance Promotion Initiatives

Compliance Promotion System To promote compliance, we have appointed a C...

Governance :
Risk Management

リード文

Risk Management System to ensure proper business operations of the...

Governance :
Risk Management

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Governance :
Responsible Promotion Activities

アンカーリンク用

Basic approach Promoting fair promotion activities Review syste...

Governance :
Responsible Promotion Activities

Basic approach

Our vision of our sales activities is to work as a team, think from the pat...

Governance :
Responsible Promotion Activities

Promoting fair promotion activities

ONO Pharmaceutical defines "promotion" as“provision to, collection from, an...

Governance :
Responsible Promotion Activities

Review system related to promotion

In promotion, the provision of accurate information is required to promote ...

Governance :
Responsible Promotion Activities

Training for thorough implementation of fair promotion activities

We provide training not only for the members of the department in charge of...

Governance :
Responsible Promotion Activities

Training for promoting proper use of pharmaceuticals and collecting safety information

In promotion activities, it is also important to quickly collect safety inf...