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 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.

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ONO Pharmaceutical’s Compliance System

We recognize our responsibility, as a pharmaceutical company involved in the manufacture of pharmaceuticals that affect the people’s lives. As a part of our compliance system, we have established the "ONO Group Code of Conduct" to ensure that our actions are in compliance with laws and regulations and are based on a strong 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.
In addition, social demands for compliance have increased in recent years. In our company, we are increasing awareness of compliance, now more than ever. Our aim is to cultivate a company culture where every employee considers compliance as their own issue and to prevent compliance violations. As part of this effort, we included "fairness and honesty" as competencies into the performance evaluation criteria for all positions and levels to enhance employee awareness.

For details, please refer to the Corporate Philosophy / ONO Group Code of Conduct, Compliance Global Policy, and ONO Pharmaceutical Code of Practice below.

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Initiatives to Strengthen Compliance System

Compliance Promotion System

To strengthen our compliance system, we have appointed an Executive Officer as the Officer in Charge of Compliance and established the 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, we have implemented an operational structure aimed at enhancing compliance in October 2021. This includes appointing Compliance Promotion Lead 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 Risk&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 “Immediate response to serious compliance violations in FY2020.” We require our group companies to establish systems and regulations to prevent compliance violations.

Reporting and Consultation System

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 Representative Director, President & COO, 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 Risk&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 “Immediate response to serious compliance violations in FY2020.”

Management of Compliance Risks

The Risk&Compliance Management Department, which operates the PDCA cycle for compliance risk management, holds hearings twice 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 Promotion Lead 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 Risk&Compliance Management Department then discusses countermeasures with the Compliance Promotion Lead and the Risk Manager and monitors their progress after repeated examinations.

Compliance Education

To maintain and improve awareness of 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 from FY2021 to FY2023 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 “Immediate response to serious compliance violations in FY2020.”

Response to Violations and Corrective Actions

The Risk&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. Please refer to the ESG data for the number of violations.

Ethical Considerations in Research and Development

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.

Fair and Transparent Business Activities

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 officer in charge of accounting. 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.

We have also established the Anti-Bribery and Corruption Global Policy and the Anti-Bribery and Corruption Policy. 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 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 Anti-Bribery and Corruption Global Policy (hereinafter the "Global Policy") below.

For more information, see the web pages below:

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Immediate response to serious compliance violations in FY2020

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:

[1] Strengthening Our Compliance System

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.

  • As part of our efforts to strengthen internal systems, in October 2021, we established the Assessment Office within the Compliance Management Department (hereinafter referred to as the current name "Risk&Compliance Management Department"), which is in charge of compliance in the company. The Assessment Office serves as a new point of contact for employees with compliance-related questions and concerns, as well as for raising awareness within the company to prevent compliance violations.
  • In October 2021, 8 Members of the Board of Directors and Corporate Officers were appointed as Compliance Officers (hereinafter referred to as the current name "Compliance Promotion Lead") in each division. In addition, 85 Compliance Managers were appointed to each workplace as the primary point of contact for reporting and consultation in order to prevent compliance violations. Furthermore, the Sales and Marketing Department, which has a large number of personnel, has assigned 158 Compliance Assistants to each sales office/office to support the operations of Compliance Managers, so that more detailed reports and consultations can be provided.
  • The vertical reporting line is managed by the Compliance Promotion Lead, and horizontal management aimed at supporting the activities of Compliance Managers is conducted by the Risk&Compliance Management Department's Assessment Office. Based on these systems, the Compliance Manager at each workplace instigates efforts to always question how compliance-based business practices should ideally be, with the aim of encouraging employees to courageously speak up and whistle blow in order to prevent compliance violations.
  • The Compliance Manager is the primary point of contact within the business site for feedback from the frontline that is not or cannot be raised through the usual channels (via superiors).
  • Since the start of operations under the new system (October 2021), we have held a total of 417 workplace roundtable conferences mainly comprised of Compliance Managers to educate employees on the importance of initiatives that contribute to the prevention of compliance violations at the workplace level. We have also worked to ensure that employees who have courageously spoken up do not suffer any disadvantages in our operations, and have listened to feedback from our employees while disseminating this in our operations. As a result, over a period of about two and a half years up to March 2024, Compliance Managers consulted on 1009 matters (including simple questions). Of these, 98 were found to be consultation matters that could not be raised through the regular reporting line (i.e., those involving suspected harassment with superiors and those concerning the working environment). The Risk&Compliance Management Department’s Assessment Office also intervened, discussing and addressing response measures with Compliance Promotion Lead and Compliance Managers. As a result, we were able to eliminate words and actions that could have led to compliance violations before they developed into more serious situations, and we believe that initiatives that contribute to prevention have taken root and are beginning to function.
  • In October 2021, the company appointed a special compliance officer (Senior Partner) who is responsible for overseeing compliance training and overall management in the Sales and Marketing Department. This Senior Partner regularly participates in compliance-related meetings held within the Sales and Marketing Department and provides guidance and advice. The special compliance officer (Senior Partner) not only provides advice to the Executive Director of the Sales and Marketing Department, but also works with the Risk&Compliance Management Department as necessary to raise awareness and disseminate information on prevention among Sales and Marketing Department.
  • With compliance as an in-house goal, we continuously conduct training aimed at letting employees know the whole picture of the Misconduct that occurred in FY2020, without concealing it, so that the Misconduct will never be forgotten. Not only were we punished by industry organizations, but we were also prohibited from visiting certain medical institutions. In addition, we underwent assessments and sometimes received requests for audits from our partner companies. By having all employees understand the impact of actions that damage social trust, we are working to ensure that each employee sees compliance as his or her own responsibility.

[2] Employee Education

Company-wide Compliance Training Held from January to March 2022 on the Subject of the Misconduct that Occurred in FY2020
Theme:
As for the full details on the incident and its ruling, the violation of industry rules, and the issue of compliance and corporate social responsibility, in order to learn from the Misconduct and to have all employees pledge that they will never make the same mistake again, compliance training was conducted based on the incident as follows:
Training Overview:
Executive Message VTR > Lecture by Lecturer > Discussion > Questionnaire
Implementation Status:
All employees have taken the course (3,260 employees: Including 12 make-up classes and excluding employees on leave for child care, injury or illness, and temporary employees)
Message from the President about the purpose of the training
[Training instructor] Senior Partner, Risk&Compliance Management Department
  1. Summary of the misconduct
  2. Impact the misconduct had on the company
  3. What we and the company are expected to do
  4. Challenges for Compliance of laws and regulations
[Discussion moderated by the head of the business site]
  1. Future initiatives (impressions/opinions, etc.)
A message from the Officer in Charge of Compliance at the end of the training
February-March 2022: E-learning Training on Anti-bribery Initiatives
Theme:
Anti-bribery
Training Overview:
Training via audio slides + confirmation test, pledge to comply with anti-bribery policies
Implementation Status:
Implemented by all employees, including officers, employees on secondment to an outside company (in Japan and overseas), and temporary employees (3,627 employees: Excluding those on long-term leave due to child care or injury/illness)
April-May 2022: E-learning Training on Company-wide Compliance Knowledge
Theme:
Acquiring compliance knowledge that should be acquired as a member of society
Training Overview:
E-learning in quiz format (100 questions)
Implementation Status:
All employees have taken the course (3,298 employees: Excluding employees on leave for child care, injury or illness, and temporary employees)
June 2022: Company-wide Training on the Subject of the Misconduct that Occurred in FY2020 (held in FY2021) Make-up Class
Theme:
About the full details on the incident and its ruling, industry rule violations, compliance and corporate social responsibility
Training Overview:
Lecture and training led by members of the Risk&Compliance Management Department
Implementation Status:
Persons who have returned from childcare leave or sick leave (10 persons)
June-July 2022: Company-wide Compliance Training in the First Half of FY2022
Theme:
To promote understanding of the Amended Whistleblower Protection Act, Whistleblowing Policy (enacted in April 2022), and workplace harassment
Training Overview:
Lecture and training led by members of the Risk&Compliance Management Department
Implementation Status:
All employees have taken the course (3,195 employees: Excluding employees on leave for child care, injury or illness, seconded employees on assignment in Japan and overseas, and temporary employees)
October-December 2022: Company-wide Compliance Training (Compliance Enhancement Month)
Theme:
Acquiring compliance knowledge that should be obtained as a member of society, and to continue learning from the lessons learned from the Misconduct in FY2020
Training Overview:
  1. Training held by members of the Risk&Compliance Management Department to prevent the Misconduct in FY2020 from being forgotten
  2. Discussion training for each department (selection of 2 out of the following 3 themes: Escalation, Power Harassment, and Corporate Social Responsibility)
  3. E-learning in quiz format (100 questions)
Implementation Status:
Implemented by all employees (approximately 3,215 employees: Excluding employees on long-term leave for child care, injury or illness, and temporary employees)

[3] Handling of Scholarship Donations, Etc.

Handling of Scholarship Donations
  • As for the contribution of scholarship donations (donations to general courses), the company has made an internal decision to first discontinue donations in FY2021 and not to continue donations after FY2022. This decision was announced when the financial results were released for the third quarter of the relevant fiscal year in January 2022. While considering the necessity of contributing to academia and the social significance of promoting research, we have continued to consider new ways of contributing that can ensure independence and impartiality. As a result, we have decided to establish the Ono Pharma Oncology, Immunology, Neurology Research Foundation and to provide research grants from FY2023.
  • As of October 2020, all new requests for donations to endowed courses have been rejected, and donations have been made only to those who had previously made a commitment or who had made a commitment under a multi-year contract. All donations have been completed during the FY2023. (Implemented in FY2021: 21, Implemented in FY2022: 8, Implemented in FY2023: 2)
Handling of Other Donations (General Donations, Donations to Academic Societies, Membership Fees for Supporting Members, Etc.)
  • In October 2021, we changed the system so that company-wide donations and requests for supporting membership fees are consolidated to the General Affairs Department of the Headquarters, and reviewed by the Donation Review Committee, which consists of the General Affairs Department, Legal Department, Compliance Management Department, and external experts (lawyers). The status of the activities of organizations eligible for donations and the appropriateness of amounts to be supported are examined, and the results are communicated directly to the applying facility by the General Affairs Department. Furthermore, since April 2022, we have adopted an open call system for accepting these donations online, eliminating direct involvement with medical professionals related to donations, such as employees (Medical Representatives those in charge at Clinical Development Departments and Medical Affairs Departments, etc.) receiving requests for donations or communicating the results of screenings.

[4] Development of Whistleblowing System

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 Risk&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.

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