Compliance

In order to put the 2030 Vision into practice under our philosophy, the Kyowa Kirin Group acts in accordance with its Core Values and with high ethical standards while aiming to become a corporate group trusted by society. Considering compliance as the foundation of all our corporate activities, we have established an organizational structure to comply with all laws and regulations, internal and external guidelines and rules and social norms.

Code of Conduct and Group Policies

The Kyowa Kirin Group Code of Conduct sets forth the actions that should be taken by all employees of the Kyowa Kirin Group. The Code of Conduct is translated into local languages and disseminated to all employees of the Group around the world. Executives and employees pledge to comply with the Code of Conduct, and their understanding and compliance is monitored through employee awareness surveys and other means. We also encourage all partners in our supply chain to comply with the Code of Conduct. In addition, action policies related to individual business areas have been established as the Group Policies.

The Code of Conduct and the Group Policies have been established with the approval of the Board of Directors. The code and the policies are continuously reviewed in light of changes in the external environment and laws and regulations, and any revisions must be approved by the Board of Directors.

Compliance Framework

Under the supervision of the Representative Director and Executive Vice President, the Kyowa Kirin Group has established a Global CSR Head, who is responsible for overall compliance throughout the Group, and a Corporate Social Responsibility Management Department to assist the Head in their duties. The Global CSR Head and the Corporate Social Responsibility Management Department take the leading role in compliance, formulating and implementing compliance measures on a global and regional basis in collaboration with the Regional CSR Heads,*1 who are responsible for compliance in the four regions of Japan, North America, EMEA, and Asia/Oceania.

The Kyowa Kirin Group has established regional CSR committees in the four regions to discuss compliance-related activities. They meet once a quarter to discuss the status of activities and issues that are global or specific to each region. In addition, a joint Group CSR Committee meeting encompassing the four regions is held once a year to deliberate on compliance strategies and actions plans for the entire Group, and to report on the progress of activities during the year. The Group CSR Committee is chaired by the Company’s Representative Director and Executive Vice President. Important matters discussed in these committees are reported to the Board of Directors.*2

  • *1:
    Currently, the Global CSR Head also serves as the Regional CSR Head for Japan.
  • *2:
    The regional CSR committee in Japan compiles reports from the regional CSR committees in other regions and presents them to the Board of Directors.

Whistleblower System

The Kyowa Kirin Group has put in place the Compliance Line, an internal reporting process, in order to prevent, detect at an early stage, and correct acts that are against the Kyowa Kirin Group Code of Conduct (bribery, improper profit sharing, illegal political contributions, other corrupt acts, harassment, and various human rights violations), as well as acts that seriously damage the brand value of the Kyowa Kirin Group. There are two points of contact—one internal and one external—for reporting. They can be accessed by telephone, electronic and postal mail as well as online tools. Anonymous reports are also accepted.
In the case of the internal contact point, the Human Resources Department receives reports. In the case of the external contact point, reports are forwarded from the outsourced external contact point to the Audit & Supervisory Board members and the Corporate Social Responsibility Management Department, etc., of the Kyowa Kirin Group in accordance with predetermined rules to initiate an investigation and respond to the matter. If the reported matter is found to be true by an investigation, corrective measures and recurrence prevention measures will be taken. In some cases, the matter may be referred to the Award and Disciplinary Committee, which will consider whether disciplinary action should be taken. The results of the company’s response to whistleblowing are reported to the Board of Directors and management on a regular basis. The regulations also stipulate that confidentiality will be strictly maintained and that no disadvantageous treatment will be given to anyone for reporting.
In addition, overseas subsidiaries operate local internal reporting systems in each region. Since 2016, we have been operating a global line that enables overseas subsidiaries to report directly to the Group’s head office in Japan in their local language.
In 2020, there was a total of 29 cases reported through the Compliance Line in Japan and overseas.

In order to ensure that employees gain a better understanding of the Compliance Line, messages from the CEO on such topics as the importance of the Compliance Line, confidentiality, and non-retaliation are sent out on a continuous basis. In addition, we ensure that employees maintain a continuous awareness toward each point of contact for reporting through e-learning and group training. The details of the Compliance Line are readily available on the top page of the Company’s website and on posters displayed throughout the workplace.

For opinions from external stakeholders, including local residents and suppliers, several contact points are available on the Company’s website to respond to various inquiries.

Internal Audits

At the Kyowa Kirin Group, the internal audit unit conducts risk-based audits from an independent standpoint at approximately 100 locations, including subsidiaries in Japan and overseas. Internal audits verify and evaluate the status of compliance framework establishment and implementation at each site. In addition to pointing out issues and proposing recommendations for improvement, internal audits also help monitor conduct to ensure that appropriate corrective measures are taken. The results of internal audits are presented to the Representative Director and President, Executive Vice President and the Board of Directors. At the same time, efforts are directed toward strengthening collaboration and improving governance to enhance the effectiveness of audits within the Group by sharing details of the information discussed at regular meetings with company auditors as well as accounting auditors.

Compliance Training

The Kyowa Kirin Group provides a variety of training programs, including group training and e-learning, on topics such as codes of conduct, anti-bribery and anti-corruption, personal information protection, compliance standards specific to the pharmaceutical industry, human rights, and anti-harassment. These courses are mandatory for all directors and employees, or assigned according to rank or duties.

Each region of the Kyowa Kirin Group designates a compliance promotion period each year to provide an opportunity to reaffirm the importance of compliance. In Japan, various programs were held in 2020, including the dissemination of a message from the Representative Director and Executive Vice President, training for executives, and group training for executives and employees.

All executives and employees of the Group regularly attend training to ensure that the Code of Conduct is well understood. The target audience for this training program includes contract employees and temporary employees. When the Code of Conduct was revised in 2020, training was provided to executives and employees. In Japan, e-learning was conducted, and 4,638 people took the course. Training is also conducted for overseas subsidiaries outside Japan to familiarize them with the Code of Conduct in the same manner according to local conditions. Also, global e-learning was conducted in the areas of anti-bribery and anti-corruption. The details of the training are designed to provide participants with a variety of knowledge about corruption, including bribery and commercial bribery. As of the end of 2020, 6,154 executives and employees in Japan and overseas took the course. Refer to the following for other major compliance trainings conducted during 2020.

Major Compliance Training Results in FY2020*3

You can see this table by scrolling horizontally.

Category Details Scope Number of Participants
Kyowa Kirin(Non-consolidated) Group Companies
Japan Overseas
Overall training Human rights and compliance training 4,633
Training by employee group Corporate ethics lecture meeting for executives 28
Compliance training for newly appointed evaluators 83
Compliance training for new employees 71
Training by specific field The Kyowa Kirin Group Code of Conduct*4 4,638*5
Anti-bribery and corruption prevention*4 6,154
Whistleblower system*4 4,683
Japan Pharmaceutical Manufacturers Association (JPMA) Code of Compliance “Promotion of Understanding the Code Month”*4 4,608
Personal information protection*4 4,584
Research ethics 424
Sales data provision activities compliance training 6,413*6
Interaction with various parties including healthcare professionals in Europe and the US 53
  • *3:
    Training was conducted by the head office in Japan. Region-specific training was conducted via respective region.
  • *4:
    Participants include temporary employees, contract employees, and part-time employees.
  • *5:
    Overseas Group companies’ data was not tabulated and is therefore excluded from the number of participants.
  • *6:
    Conducted four times each year for the Sales & Marketing Division. The total number of participants for each training is recorded.

Survey of Human Rights and Compliance

The Company participates in the annual Awareness Survey of Human Rights and Compliance implemented by the Kirin Group. The results of the survey help to identify changes in employee awareness and issues that need to be addressed, and are utilized in formulating the Group’s initiatives.