Ethics and transparency

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 the framework necessary for compliance, including an organizational structure and basic policies to comply with all laws and regulations, internal and external guidelines and rules and social norms.

The Kyowa Kirin Group Code of Conduct sets forth the actions that should be taken by everyone working in the Kyowa Kirin Group. Translated into the local languages of each region, Kyowa Kirin is working to ensure that all employees of the Group around the world are familiar with and understand this Code of Conduct. All 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, basic policies related to individual business areas that must be observed have been established as the Kyowa Kirin Group Policies.
The Code of Conduct and the Group Policies have been established with the approval of the Board of Directors. The Code and Policies are continuously reviewed in light of changes in the external environment, including laws and regulations, as well as changes in the internal environment. Any revisions or repeals are approved by the Board of Directors.

The Kyowa Kirin Group Code of Conduct

Kyowa Kirin Group Policies

Under the supervision of the Chief Compliance Officer (CCO, Representative Director of the Board 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 (CSR) Management Department to assist the Head in their duties. The Global CSR Head and the CSR 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 three regions of Japan including APAC Cluster, North America and EMEA. The Kyowa Kirin Group has established regional CSR committees in the three regions to discuss compliance-related activities. These committees are held on a regular basis 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 three regions is held twice 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 of the board and Executive Vice President. Important matters discussed in these committees are reported to the Board of Directors^*2.

The Kyowa Kirin Group has put in place the Compliance Line, whistleblowing system, 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. On top of the strict adherence to confidentiality and a rule that those reporting an incident will not be subjected to any retaliation, steps have been taken to establish an internal and external point of contact for reporting that can be accessed by telephone, electronic and postal mail as well as online tools. Reports can also be filed anonymously. In this manner, every effort is being made to create a simple and easy reporting environment. 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 CSR Management Department, etc., of the Kyowa Kirin Group in accordance with predetermined rules to initiate an investigation and respond to the matter. We have also introduced a process under which reports concerning directors are passed directly to company auditors. 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. Moreover, 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. The point here is to ensure that employees gain a better understanding of the system through group training and e-learning and while maintaining a continuous awareness toward each point of contact for reporting. Details of the Compliance Line are readily available on the Company’s website and posters displayed throughout the workplace. In response to Japan’s revised Whistleblower Protection Act, we were confirming the design and operation of our system, revising internal rules, and making continuous improvements.
Overseas subsidiaries operate local whistleblowing systems in each region. We also established and operate a global line that enables overseas subsidiaries’ employees to report directly to the Group’s head office in Japan in their local language.
In 2023, the Compliance Line received a total of 34 reports in Japan and overseas.

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 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.

Each region of the Kyowa Kirin Group designates a compliance week or month each year to provide an opportunity to reaffirm the importance of compliance. In Japan, various e-learning and other programs were also held in 2023, including the dissemination of a message from the CCO, and group training for executives and employees.
All executives and employees (including contract, temporary, and part-time employees) of the Group annually attend training to ensure that the Code of Conduct is well understood. Training is conducted globally and held both in person and on an e-learning basis. In 2023, e-learning was conducted with common global content.
Refer to the following for details of other major compliance training conducted during 2023.

The Company participates in the annual Compliance・Human Rights Awareness Survey 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.

To protect public health by ensuring the safe and effective use of our innovative therapies across the world. We are dedicated to providing timely and accurate information to healthcare professionals, regulatory bodies and our patients.

We strive towards the ideal of patient safety by predicting and preventing adverse reactions through innovative pharmacovigilance practices.

As Kyowa Kirin's innovative therapies reach more patients across the world, the pharmacovigilance organization has evolved to ensure patient safety continues to be a priority across the product life cycle, from discovery through maturity in all our markets. As a result we have adopted a fully global operating model based on functional pillars (Medical Safety, Operations, Compliance, Planning), which underscores our ethos in working harmoniously across boundaries to serve our patients.

To achieve our vision, we must:

Kyowa Kirin places a priority on providing information to promote the proper use of pharmaceutical products. We believe that it is imperative to promptly share accurate information with patients and medical professionals, who are flooded with miscellaneous information on drugs.

In addition to sales activities by medical representatives (MRs), we use multiple channels of communication, including a contact center for fielding inquiries on drugs, medical science liaisons (MSLs) and a website catering to medical professionals, in order to provide timely information in tune with the latest changes in the medical environment. The information collected is passed on to relevant divisions, and measures are taken to “foster” drugs by maximizing their product value while assuring their safety and quality.

Based on professional expertise, our MRs provide medical professionals with information highly useful for treating patients. They especially focus on providing information on the efficacies and safety of new drugs, for which medical professionals have both high hopes and doubts, as well as on the new value added to existing drugs due to their expanded indications and other factors.

In accordance with the policy advocated by the Japan Pharmaceutical Manufacturers Association, we provide appropriate use information regarding our pharmaceutical products. We are committed to addressing inquiries not only from healthcare professionals but also from patients and the general public who reach out to us by phone. However, please understand that we are unable to respond to inquiries pertaining to individual diseases, treatment methods, or health consultations that require a physician's diagnosis.
Additionally, 'Kyowa Kirin Medical Site_©' for healthcare professionals has a 'Product Q&A Chatbot' and 'Frequently Asked Pharmaceutical Product Q&A' available. We aim to provide comprehensive information to assist with the proper use of pharmaceutical products."

Medical Science Liaisons (MSLs) leverage their advanced expertise in their assigned therapeutic areas to engage in medical and scientific information exchange with healthcare professionals and provide information that addresses the needs of patients. They operate independently from the sales department (e.g., Medical Representatives) and work daily to promote the appropriate use of pharmaceutical products.

In each research, development, and production process, the Kyowa Kirin Group is making the following efforts to remain in compliance with domestic and international laws and regulations, internal and external rules and regulations as well as social norms, while fulfilling its legal responsibilities and the ethical responsibilities required by society.

In the drug discovery research and development process, the significance of research utilizing human-derived samples is rising, requiring increased focus on ethical considerations. In addition to complying with relevant laws and regulations including the Pharmaceutical and Medical Device Act, the Kyowa Kirin Group conducts education and training for its employees and creates opportunities to acquire third-party certifications and undergo third-party reviews in order to protect human rights and personal information and ensure the reliability of its research findings in line with the ethical principles of the Declaration of Helsinki.

For employees who are engaged in research, Kyowa Kirin Group conducts education and training on related laws and regulations, bioethics, etc.
When conducting research involving human subjects, we provide opportunities for review by a third-party organization such as a Research Ethics Review Committee or Institution Review Board.

The Kyowa Kirin Group has established its Animal Testing Regulation in view of laws, regulations and guidelines pertaining to animal testing. Based on this set of rules, we implement a range of initiatives to ensure that the breeding management of laboratory animals and animal testing are properly conducted in consideration of animal welfare and scientific rationality.

Approaches to Animal Experiments in Accordance with the Rule for Animal Experiments of Kyowa Kirin Co., Ltd. (in Japanese only)

Kyowa Kirin conducts proper animal testing and in-house inspection based on the Ministry of Health, Labour and Welfare’s guidelines and international guidelines. Furthermore, in November 2013, the Association for AAALAC International, a global third-party accreditation body, visited the Tokyo Research Park and Fuji Research Park to conduct surveys, and the two research sites obtained full certification in March 2014.

In creating pharmaceuticals, the Kyowa Kirin Group advances its own research by means of advanced technologies and unique perspectives while developing and providing high-quality products. As a representative life science company of Japan with firm foundations in biotechnology, we will continue to contribute to the health and lives of people around the world.
To use biotechnology techniques that show consideration for environmental and safety aspects, we are complying with the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Cartagena Act) and, having put in place an internal committee, are managing the situation in an appropriate manner.
So that genetically recombined material is not released into the outside world, we are advancing measures designed to prevent environmental pollution by proper handling and being sure that such material has been inactivated prior to disposal.
To verify whether these initiatives are being implemented in an appropriate manner, we are performing regular monitoring activities at each business site. We are committed to ongoing risk minimization by sharing the results of these activities and any near-miss incidents that have occurred at business sites with the committee and applying them to countermeasures across business sites.

Kyowa Kirin Group has established regulations for dealing with misconduct in research activities, and is working to prevent misconduct in research activities.

Research and development (R&D) are the business foundation of the Kyowa Kirin Group, and therefore, intellectual property (IP) is an important business asset for us. For IP that is an essential part of our R&D and business strategies, we strive to maximize our product value through lifecycle management as well as acquire and maintain effective patent rights through strategic applications. At the same time, we endeavor to ensure freedom in our research and business activities while respecting the rights of other parties and promoting compliance so as not to infringe them, and we will respond promptly and appropriately to any IP dispute that may arise. We believe these activities contribute to maximizing the value of our global business activities, maximizing profits and minimizing risks, resulting in a stable supply of pharmaceuticals.

Intellectual Property Initiatives

The "Guiding Principles on Business and Human Rights" formulated by the United Nations emphasize "respect for human rights" as a value that companies should uphold. In the Kyowa Kirin Group, as we expand our business globally to achieve our 2030 vision, the number of our stakeholders has significantly increased, and the scope of 'business and human rights' has broadened. We have established a cross-organizational working team and, with advice from external experts, have formulated the "Kyowa Kirin Group Human Rights Policy" while deepening our understanding of the extensive human rights issues faced by global companies.
This policy applies not only to all executives and employees of our group but also to all individuals working in the value chain related to our group's business, products, and services, and we require compliance with this policy. Upholding one of our core values, "Integrity," and maintaining consistent honesty and ethics, we will continuously advance our human rights due diligence efforts based on this policy. We aim to create smiles for everyone working within our entire value chain.

The UN Guiding Principles on Business and Human Rights require companies to formulate a human rights response policy as their responsibility and to disseminate that policy not only to their employees but also to their various other stakeholders. Previously, the Kyowa Kirin Group had been promoting human rights initiatives in accordance with the Kirin Group Human Rights Policy. In December 2022, however, the Kyowa Kirin Group formulated its own Kyowa Kirin Group Human Rights Policy in light of changes in social conditions and demands from society. Positioned as the superordinate policy for all documents and norms concerning efforts to respect human rights in the Group’s business activities, this policy is applicable to all the Group’s officers and employees. Expecting all our business partners to give us their support in this matter, we will also strive to ensure that our suppliers remain in compliance with this policy.

Kyowa Kirin Group Human Rights Policy

Human Rights Policy Formulation Process

In receipt of cooperation in its formulation from external experts, the specified non-profit organization Caux Round Table Japan (CRT Japan), we subjected the Policy to repeated text brush-ups and multiple reviews, for example in human rights due diligence workshops, as well as by our parent Kirin Holdings Company, Limited, chief HR officers from overseas subsidiaries, and the Group CSR Committee.

In July 2017, we established the Kyowa Kirin Group Human Rights Enlightenment Promotion Committee. This committee formulates, promotes, and supports plans for human rights enlightenment. The committee also provides support for investigations and cooperation for the prompt resolution of human rights issues, if and when they arise. The Committee is chaired by the Director of the Human Resources Department of the Company and consists of Directors of the relevant divisions and heads of the organizations in charge of human resources at major subsidiaries. Kyowa Kirin's Human Resources Department serves as the secretariat.
In daily operations, Kyowa Kirin's Human Resources Department oversees general matters concerning human rights, but as human rights issues are wide-ranging, the department conducts its initiatives in cooperation with other departments and Group companies. The status of compliance with all laws and regulations, including those related to human rights, is reported at the CSR Committee (chaired by the Representative Director and Executive Vice President), which meets four times a year, to check the effectiveness of our measures, and the result is reported to the Board of Directors.

Human Rights Due Diligence Working Team Activities

In accordance with the full-scale globalization of our business, the impact of our activities on rights-holders (those facing human rights issues) around the world is expanding. The co-creation of value with stakeholders is essential in the provision of life-changing value. In doing so, we believe that it is necessary to consider the human rights of not only our employees but also of those related to our business partners. Having launched a working team, consisting of Strategy Division, CSR Management Department, Procurement Department and Human Resources Department in 2022 to fulfill the corporate social responsibility that is respect for human rights, we are commencing initiatives with regard to human rights due diligence. Having obtained CRT Japan’s assistance, under the United Nations Guiding Principles on Business and Human Rights and based on the demands of society and the laws and regulations of each country, we are promoting the establishment of an internal system to fulfill our responsibility to respect human rights as a company. Having received multiple proposals from CRT Japan, we are progressing with them one by one. In 2022, we (1) formulated the Kyowa Kirin Group Human Rights Policy and (2) held study sessions on business and human rights and workshops to identify human rights issues (human rights due diligence workshops) for the relevant departments.

Holding of Human Rights Due Diligence Workshops/Kyowa Kirin Initiatives Designed to Identify Human Rights Issues

In August 2022, we held an online Human Rights Due Diligence Workshop for the purposes of: (1) Understanding the current situation and acquiring knowledge about business and human rights; (2) Identifying the human rights issues faced by Kyowa Kirin; and (3) Reviewing the above-mentioned Kyowa Kirin Group Human Rights Policy. (Participating departments: Strategy Division, Production Division, R&D Division, Pharmacovigilance Division, SCM Department, Corporate Communications Department, CSR Management Department, Procurement Department, Human Resources Department).
At the workshop, opinions were exchanged on, for example, current initiatives, potential human rights themes, rights-holders, developments in the value chain (to what stages in the value chain do human rights issues apply).
With regard to the human rights issues extracted at the workshop, we confirmed the status of awareness and efforts to address issues in all Kyowa Kirin departments while the working team prioritized the human rights issues that need to be addressed and promoted initiatives. We also identified high-priority issues not only by our own evaluation but also by factoring in the level of interest from society (evaluations by specialized institutions). In 2023, we conducted a survey on foreign technical interns for suppliers at the Takasaki Plant. We also directly interviewed the administrative departments and technical trainees of our suppliers (Shin Nippon Wex Co., Ltd., (Link)) who are actually accepting skilled trainees. As a result, the company confirms that human rights of skilled trainees are respected and that there were no particular concerns about human rights violations. The report is then fed back to the company.
We will continue to investigate and evaluate human rights issues in the supply chain.

Kyowa Kirin is endeavoring to ensure human rights throughout its pharmaceutical value chain.

Human rights considerations in research

Kyowa Kirin sets internal rules with the aim of assuring ethical and scientific validity in human genome analysis and research using human tissue as well as preventing the loss of dignity and protecting the human rights of tissue donors.

Safeguarding human rights in clinical trials

When conducting a clinical trial involving human subjects, Kyowa Kirin, pursuant to the Declaration of Helsinki, gives top priority to protecting the human rights and personal information of patients participating in the trial, securing their safety, and giving consideration to their welfare, and complies with the laws and regulations and Good Clinical Practices (GCP) guidelines of the applicable countries.

Ensuring human rights in purchasing activities

We have formulated the "Kyowa Kirin Group Procurement Policy" and the "Kyowa Kirin Group Supplier Code of Conduct" to help us ensure human rights throughout the supply chain in collaboration with our suppliers.

Quality assurance and a stable supply of products: Sustainable Procurement (Specific Initiatives)

Ensuring human rights in engaging with medical institutions and patient organizations

Pursuant to Kyowa Kirin Group Policy for the Promotion of Pharmaceuticals and Interactions with Healthcare Professionals, Healthcare Organizations and Patient Organizations, we act with high ethical standards and in the best interest of patients when we engage with medical institutions and patient organizations.

We have an internal reporting contact in place, to which employees can turn when they face human rights issues. When a report is filed, Human Resources Department and the CSR Management Department investigate the facts and take appropriate measures while protecting the informant and the confidentiality of the report. Furthermore, we have also established various contacts for other issues (including harassment, mental health, disabilities, and LGBTQ issues) to support those who face them.

The Group accepts human rights-related complaints and reports from all stakeholders in its supply chain through the engagement and remedy platform provided by the Japan Center for Engagement and Remedy on Business and Human Rights (JaCER), which is based on the United Nations Guiding Principles on Business and Human Rights.
We are committed to resolving essential human rights issues by accepting complaints through a third party, thereby ensuring equality and transparency in the handling of complaints, and responding appropriately to complaints and whistleblowing. With respect to whistleblower's reports we receive, we will investigate the facts of the report, engage in necessary dialogue regarding the report, and implement corrective measures (including prevention of recurrence and response to objections).In responding to the whistleblower's report, the Company shall ensure that the whistleblower will not be disadvantaged and shall protect his/her personal information. Unless there is a justifiable reason to do so, such as when required by law, we will not use the information related to the case for any other purpose.
For whistleblowing through JaCER, information will be disclosed anonymously on JaCER's website on a regular basis.

JaCER whistleblower report form

Internal Reporting System

Learn more about Kyowa Kirin's supplier hotline

Contact us

Kyowa Kirin offers a variety of training programs for its directors and employees with the aim of instilling its human rights policy based on the Kirin Group Human Rights Policy. In addition, we annually provide a human rights awareness program for all Kyowa Kirin Group employees in Japan—in 2022, we held training on corporate activities and human rights (human rights due diligence) for domestic employees as well as workshops and global crisis exercises on the theme of human rights due diligence for specific staff —and a human rights training program for new managerial staff as well as new employees under our rank-based training program.
We have taken various measures against the issue of harassment as one of the human rights issues, and are working to improve the environment and corporate culture to create a harassment-free environment.
Specifically, we send out a message by our CEO during the "Month for Eliminating Harassment," and conduct awareness-raising training for all employees. We continuously incorporate content related to harassment prevention in training based on rank such as new employee training and newly appointed managerial staff training, providing knowledge on how to prevent harassment according to job rank and position.
In addition, we are a member of the Business Ethics Research Center, and participate in the Harassment Study Group and the Diversity Management Study Group to acquire relevant knowledge and improve understanding. As a means of reviewing our measures, we conduct on an annual basis the Kirin Group Compliance/Human Rights Awareness Survey in conjunction with the entire Kirin Group. By analyzing the survey results, we identify changes in our employees' awareness and issues that need to be solved, which helps us implement effective initiatives within our Group.

Kyowa Kirin International plc, an overseas group company of Kyowa Kirin, discloses the status of its human rights initiatives related to modern slavery risks in its business activities and supply chain in accordance with the UK Modern Slavery Act.

Modern Slavery Act Transparency Statement

Kyowa Kirin International plc, an overseas group company of Kyowa Kirin, discloses the status of its human rights initiatives related to modern slavery risks in its business activities and supply chain in accordance with the UK Modern Slavery Act. Seeking to hire people who take pride in working to save lives as well as those with global competence, Kyowa Kirin pursues fair recruitment without discrimination on the basis of gender, nationality, disability or other traits.

DE&I Statement

Search job at Kyowa Kirin Worldwide

In addition, Kyowa Kirin supports the daily lives of its employees and their families through a variety of benefit programs. We also apply the programs to non-regular employees such as contract workers, including medical care such as health checkups, childcare leave, recreational support, use of benefit enhancement plans, and other benefits.

Benefits

In 2023, there was one lost time accident at all Kyowa Kirin Group business sites. The accident frequency rate^*2 was 0.09 and the accident severity rate^*3 was 0.0026.

In the event that an explosion or fire or a natural disaster such as an earthquake causes damage to one or more of our business sites, the Kyowa Kirin Group's rule is to establish a crisis management division or a large-scale disaster management division led by top management to engage in rescue operations and support the site's restoration activities. Each business site has its own disaster response scheme and holds regular disaster drills to minimize the damage caused by a disaster.

Kyowa Kirin's corporate structure is that the head office provides materials that analyzed the status of accidents and violations while reflecting feedback from the sales offices, and traffic safety promotion committee members appointed at each sales office assist the safe driving manager in raising awareness of traffic safety.
Meanwhile, all leased vehicles have already been switched to "vehicles equipped with a collision damage mitigation braking system," and in addition, we are also progressing with the switch to "vehicles equipped with an all-surrounding-area monitor" to prevent accidents in parking lots and other locations. Furthermore, all drivers conduct alcohol level test with an alcohol detector device before and at the end of the working day to keep employees safe and ensure compliance.

Acts of corruption hinder the sustainable development of society. The United Nations and the Organisation for Economic Co-operation and Development (OECD) as well as national governments around the world have urged global companies to strengthen their measures to prevent such conduct. Acts of corruption are not tolerated under any circumstances at the Kyowa Kirin Group.

To clarify its strong determination to prevent bribery and corruption, the Kyowa Kirin Group explicitly states in the Kyowa Kirin Group Code of Conduct, which serves as the guiding principles for all who work for the Group, that it prohibits bribery, unjust provision of benefits, illegal political donations, and other acts of corruption. In addition, the Kyowa Kirin Group Anti-Bribery and Anti-Corruption Policy has been put in place to complement the Code of Conduct, along with internal regulations that set forth concrete operational procedures. Meanwhile, Facilitation Payments are prohibited under the Group Policy, even if permitted under the applicable laws, regulations, guidelines or relevant industry codes in the country where the Group company operates.

The Code of Conduct has been translated into languages of the regions in which the Group conducts business and is disseminated across the entire Group together with the Group Policy. The Code of Conduct and the Group Policy are posted on internal and external websites so that they can be viewed by all employees in Japan and overseas.

Kyowa Kirin Group Code of Conduct

Kyowa Kirin’s Chief Compliance Officer (CCO; Representative Director of the Board and Executive Vice President) supervises the Group’s initiatives to prevent bribery and corruption. Under the CCO’s leadership, the Group CSR Committee and its secretariat, the CSR Management Department, play a central role in executing the initiatives with managers assigned to the task at each Group company. In addition, the audit unit, which is independent from the business execution lines, audits the activities undertaken to mitigate the risks associated with bribery and corruption. The results of these audits are reported to the Audit & Supervisory Board members and the Board of Directors. The Board of Directors oversees the status of implementation of the Code of Conduct and Global Policy including the prevention of bribery and corruption, and their revision is subject to approval of the Board of Directors.

The Group implements a series of ongoing risk management activities, which comprise identifying, analyzing, and evaluating risks, taking measures against risks, checking how risks are addressed, and improving the measures. We recognize that bribery and corruption poses risks that could impact our business management. As far as transferring value to healthcare professionals and others is concerned, we have established a pre-screening and approval process to ensure that an honorarium is set at fair market value and the provision of such benefits as food and beverages is in accordance with industry rules. In addition, we conduct regular risk assessments, and for subsidiaries and departments with a high risk of bribery and corruption, we put in place specific measures in our business plan and monitor progress of initiatives. The CSR Management Department reports updates on risk management at periodic CSR Committee meetings, checks its effectiveness, and reports the result to the Board of Directors.

In 2023, no fines, penalties, or settlements were imposed on the Group for the violation of anti-bribery or anti-corruption laws, and no disciplinary dismissal resulted from the violation of such laws.

All executive and employees, including contract, part-time, and temporary employees, annually undertake a mandatory anti-bribery and anti-corruption e-learning program, which is available in 10 languages. In addition to the president's message and the contents of the Global Policy and internal regulations, the program includes social trends such as the latest case studies, legal and regulatory developments, and after completing the program, participants commit to comply with the rules. In FY2023, 6,552 executives and employees participated in the program.

The Group offers multiple consultation hotlines to enable any executive or employee to voice any doubts or concerns regarding bribery or corruption with a sense of security. One of them is the Compliance Line, which serves as a contact point for discussing or reporting compliance matters in general including bribery and corruption. Executives and employees can remain anonymous when contacting the Line, their reporting will be kept confidential, and whistleblowers will not suffer any disadvantages as a result of their action.

The Group sets forth the Supplier Code of Conduct, which stipulates the actions and behavior that suppliers (including intermediaries) are expected to adhere to, including those concerning bribery and corruption. We hold briefing sessions for suppliers^*1 as an opportunity to regularly explain this "Supplier Code of Conduct" and other guidelines as a part of efforts to promote communication. We conduct questionnaire surveys of new suppliers, as well as of existing suppliers, before entering into transactions with them to assess their adherence to the Supplier Code of Conduct. In view of the survey results, we perform due diligence^*2 and strive to reduce the risks related to bribery and corruption.

As a corporate group undertaking business that is deeply connected to people’s lives and health, the Kyowa Kirin Group must strive to engage in promotional activities by consistently upholding a high standard of ethics.

To articulate its commitment to ethical promotional activities, the Group has established the Kyowa Kirin Group Policy for the Promotion of Pharmaceuticals and Interactions with Healthcare Professionals, Healthcare Organizations and Patient Organizations in line with relevant laws and regulations of each country in which it conducts business, codes of conduct and guidance set by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and regional industry associations.

Kyowa Kirin provides information materials, including those pertaining to its pharmaceuticals and products in related fields, advertisements and materials for patients, only after ascertaining their full compliance with relevant laws and regulations of applicable countries and standards set by industry associations.

In Japan, such information materials are reviewed by multiple relevant divisions independent of the sales division as well as by the Information Materials Review Committee, whose members include third parties. Information materials are reviewed from the viewpoints of their scientific validity and whether they comply with the JPMA Code of Practice, fair competition rules and other external standards. The sales division that uses the applicable information materials is not involved in the review process. All divisions are prohibited from using information materials that have not been reviewed and approved.

In our efforts to comply with the Guidelines for Provision of Sales Information on Prescription Drugs set forth by the Ministry of Health, Labour and Welfare (hereinafter, "Guidelines")^*1, we have also established a system for checking that sales information is provided in an appropriate manner.

Specifically, we have a division that supervises our activities for providing sales information by way of monitoring and providing guidance to ensure that they are conducted appropriately. Moreover, when providing information on off-label uses of the Group’s pharmaceuticals or unapproved drugs under development by the Group, we ensure compliance with relevant laws and regulations.

Furthermore, we have in place a committee for supervising our sales information provision activities, whose members include third parties, to oversee and guide such activities. The supervisory department for information material review periodically reports to the committee and seeks advice.

Employee training is a key factor in ensuring ethical promotional activities.
Training is offered periodically to employees who create information materials and those who engage in promotional activities. Programs include in-person classes given by sales office managers and members of the CSR Management Department, as well as online-based and e-learning courses.

An annual Compliance Promotion Month has been established, with all employees required to undergo a training program to learn about and better understand the code of practice. In the event of any violation of the rules, additional training is promptly conducted to prevent recurrence.

Information on tax payments by country, etc. (summary of Country-by-Country Reporting)