Ethics and transparency
Policy and Strategy
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 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 are approved by the Board of Directors.
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 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. 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 four 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.
- *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.
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 2022, the Compliance Line received a total of 26 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 2022, including the dissemination of a message from the CCO, training for executives, and group training for executives and employees.
All executives and employees (including contract, temporary, and part-time employees) of the Group regularly 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. Plans are in place to launch e-learning programs with common global content in 2023.
Refer to the following for details of other major compliance training conducted during 2022.
Major Compliance Training Results in FY2022*3
You can see this table by scrolling horizontally.
|Category||Details||Scope||Number of Participants|
|Kyowa Kirin(Non-consolidated)||Group Companies|
|Overall training||Human rights and compliance training*4||○||○||4,777|
|Training by employee group||Compliance training for new employees||○||98|
|Training by specific field||Whistleblowing system*4||○||○||4,814|
- *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.
Compliance・Human Rights Awareness Survey
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.
Global Pharmacovigilance Organization
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:
- Become an agile organization that rapidly responds to changes in the internal and external environment, as we reach more patients across the world and manage a dynamic global regulatory landscape.
- Equip our colleagues with global leadership capabilities to carry the organization into the future.
- Implement innovative platforms to deliver better quality, more efficient and real-time safety analysis for proactive communication to our stakeholders.
Promoting Proper Use of Medication
Policy and Strategy
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 call center for fielding inquiries on drugs 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.
Medical Representatives (MRs)
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.
Call Center for Inquiries on Pharmaceuticals
We receive around 40,000 calls a year at our call center established exclusively for drug-related inquiries and consultations. These calls come primarily from pharmacists and other medical professionals. To share information with the broader public, we also offer information on our website in the form of answering frequently asked questions (FAQs). In addition, we provide our call center staff with training and opportunities to be assessed by external parties to improve their capacities to respond promptly and appropriately to inquiries.
Website: Kyowa kirin medical site®
Through our website "Kyowa kirin medical site®" exclusively tailored to medical professionals, we share detailed product information and disease-related academic meeting reports and publications on nephrology, cardiovascular disease, diabetes mellitus, oncology, blood, immunology/allergy, the central nervous system, and the gastrointestinal regions. Video contents are also offered to facilitate understanding.
Health/disease information websites for patients and the broader public
These websites provide information on the causes and symptoms of diseases, their therapies, and disease-related information useful in everyday life. We currently offer websites on chronic kidney disease, diabetes mellitus, pollen allergy, skin itchiness, nocturnal enuresis, Parkinson's disease, myelodysplastic syndromes (MDS), idiopathic thrombocytopenic purpura (ITP), and hematopoietic stem cell transplantation (HSCT). Ongoing efforts are made to make the websites more informative and easier to use and understand.
Policy and Strategy
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.
Efforts relating to clinical research
Kyowa Kirin Group Clinical Research Policy
Revised on April 1, 2020
Clinical research on humans is essential to verify the efficacy and safety. In order to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies, at Kyowa Kirin Group, we will conduct research based on the following principles:
- 1.Research significance
We will conduct or support clinical research that contributes to medical care on scientific basis.
- 2.Participants protection
We will respect the free will and privacy of the participants and their families in clinical research and protect the dignity and human rights of life. For this purpose, we will provide adequate explanation prior to participation in research activities and we will minimize potential risks and give due consideration to vulnerable populations, including children and the elderly.
We will comply with international norms such as the philosophy of the Declaration of Helsinki, applicable laws and regulations, guidelines, and industry codes in each country. Where applicable and appropriate, we will engage in third-party reviews and consider their advice.
- 4.Information management
We will strictly manage information of research contents and funds, and will disclose necessary information appropriately and accurately.
- 5.Implementation system
We will have appropriate knowledge on science and research ethics and we will conduct research with responsibility and commitment to our mission. We will construct and operate an appropriate organizational system, and compatible business processes. We will also collaborate with appropriate external research institutions to conduct appropriate ethical and scientific research.
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.
Efforts relating to Animal Welfare
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.
Established on October 1, 2008
Revised on January 1, 2023
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.
Efforts relating to Biotechnology (Including Biohazards and Environmental Protection)
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.
Efforts to Prevent Research Misconduct
Kyowa Kirin Group has established regulations for dealing with misconduct in research activities, and is working to prevent misconduct in research activities.
Efforts relating to Intellectual Property
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.
Respect for Human Rights
Policy and Strategy
Message from Executive Officer in Charge of Human Resources
& General Affairs Department, Kyowa Kirin Co., Ltd.
Chief People Officer (CPO) & Global Human Resources Head
The Guiding Principles on Business and Human Rights formulated by the United Nations call for "respect for human rights" as a corporate responsibility. Moving ahead with its business to achieve its vision for 2030, the Kyowa Kirin Group must consider measures to prevent, mitigate, and remedy adverse impacts on human rights. Having formed a cross-organizational working team and received advice from outside experts while deepening our understanding of the wide range of human rights issues required of global companies, we formulated the Kyowa Kirin Group Human Rights Policy.
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. We will also request compliance with this policy from all business partners related to the business, products and services of the Group. In addition to continuing to implement human rights due diligence based on this policy to limit adverse impacts on human rights, we will contribute to ensuring people’s right to live a rich and healthy life and to live happily by engaging in the creation of positive human rights impacts.
As a Global Specialty Pharmaceutical Company (GSP), we are elevating our human rights initiatives to a global agenda while continuing to cherish consideration for those close to us whom we have always valued. We are working to create workplaces and a society free from discrimination and harassment by increasing opportunities for dialogue with each and every employee to make human rights issues their own.
By promoting such efforts, we will realize the creation of workplaces where not only our company but also our colleagues from outside the company can work in safe, secure, and healthy environments. Through Kyowa Kirin Group’s growth and the achievement of our vision, we will contribute to the health and well-being of people around the world.
Human Rights Policy
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.
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
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). Planning to advance initiatives starting with those issues on which we have placed the highest priority, in 2023 we are intending to conduct a survey on the "employment and working environments of technical intern trainees at our suppliers in Japan."
Human Rights Due Diligence
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 CSR Procurement Guidebook" to help us ensure human rights throughout the supply chain in collaboration with our suppliers.
Ensuring human rights in engaging with medical institutions and patient organizations
Pursuant to Kyowa Kirin Group Transparency Policy for the Relationships between Corporate Activities, 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.
Internal Reporting System and Contact for Inquiries
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. Inquiries from all external stakeholders are accepted through our website.
We accept inquiries from stakeholders outside the Company, including local communities and suppliers, through the contact points on this website.
Internal Reporting System
Training Programs and Awareness Activities
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.
Response to the UK Modern Slavery Act
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.
Recruitment and Benefits
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.
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.
Employee Health and Safety (Occupational Health and Safety)
Policy and Strategy
Kyowa Kirin Group Policy for Occupational Health and Safety
Established on November 22, 2018
We at the Kyowa Kirin Group (hereafter referred to as "Our Group") believe that ensuring the health and safety of all its employees is crucial in fulfilling its management philosophy of "striving to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies." Therefore we engage in ongoing activities to prevent occupational accidents and disasters. Our aim is to foster a deeply rooted culture that encourages each and every employee to think and act on their own accord so that the standards of Our Group's occupational health and safety can be enhanced.
- 1.By operating our management system for occupational health and safety, we promote ongoing improvements with the aim of enhancing Our Group's health and safety standards.
- 2.We strive to prevent occupational accidents and disasters by identifying and assessing sources of hazards in workplaces and taking measures to eliminate or reduce the identified risks.
- 3.We comply with laws and regulations concerning occupational health and safety in the countries and regions where Our Group conducts business activities, and make ongoing efforts to ensure the health and safety of our employees.
- 4.We implement education, training and awareness activities on occupational health and safety in a rigorous and systematic manner with the aim of raising employee awareness.
- 5.We actively encourage communication between the employer and each employee indispensable for ensuring employee health and safety, and implement health and safety activities engaging all employees.
Indicators and Targets
Accident frequency rate*1
- *1Up to and including 2018, the plants and research laboratories in Japan of Kyowa Kirin, Kyowa Medex, Kyowa Hakko Bio and Kyowa Pharma Chemical were covered, and in 2019 and 2020, all Kyowa Kirin locations were covered. All Kyowa Kirin Group business sites in Japan and overseas production and research sites have been covered from 2021 onward.
- *2Accident frequency rate: The number of fatal and lost time accidents per million working hours
- *3Accident severity rate: The number of lost days per 1,000 working hours
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.
Promotion of Safe Driving
Kyowa Kirin has a fleet of around 1,200 vehicles driven by sales representatives. To prevent accidents, we strive to promote safe driving using diverse approaches, including implementing measures to prevent risks and allocating effective resources for safe driving, in addition to raising safety awareness among drivers.
Having in 2008 introduced a Traffic Safety Training Program, which is mainly aimed at new employees who are inexperienced drivers, we are working to improve their skill levels and safe driving awareness based on a unique five-scale assessment. We are lending driving recorders to employees who are inexperienced in driving vehicles. In addition, all vehicles are equipped with a rear-end collision prevention and mitigation device (pre-crash safety system), which is continuing to demonstrate effectiveness in reducing traffic accidents.
Anti-Bribery and Anti-Corruption
Policy and Strategy
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. They are also posted on the intranet so that they can be viewed by all employees in Japan and overseas.
Kyowa Kirin Group Anti-Bribery and Anti-Corruption Policy
Established on December 13, 2013
Revised on June 9, 2022
The Kyowa Kirin Group (the "Group") aims to be a corporate group that society can trust, while operating in line with its Management Philosophy, Core Values and Vision and through its strict adherence to high ethical standards. As part of this effort, with full recognition of the fact that bribery and corruption are major obstacles to sustainable development of society, we maintain business relationships with stakeholders in compliance with laws and regulations and also in accordance with high ethical standards, and at the same time, engage in fair, transparent and free competition and appropriate transactions. The Group’s position on anti-bribery and anti-corruption is described in the Kyowa Kirin Group Code of Conduct, and we hereby specify our anti-bribery and anti-corruption guiding principles.
This Group Policy applies to everyone working in the Group, regardless of country or region, position or title, such as officer, employee, fixed-term employee or temporary staff, or full time or part time (the "Employees of the Group"). We will also require all of our business partners or agents to act in accordance with the underlying principles set forth in this Group Policy.
- 1."Bribery and Corruption" means (i) offering, promising, providing, authorizing, accepting or requesting anything of value, including improper payments, goods, entertainment, or other improper financial advantages that exceed what is considered appropriate under the applicable laws, regulations, guidelines or relevant industry codes in the country or region where the Group company operates and (ii) making Facilitation Payments (as defined hereinafter).
- 2.."Facilitation Payments" means small payments made to a government official, etc. to expedite or secure a routine governmental action.
- Ⅳ.GUIDING PRINCIPLES
We will abide by the following anti-Bribery and anti-Corruption guiding principles:
- 1.We will fully understand the underlying principles of and comply with applicable anti-Bribery and anti-Corruption laws, regulations, guidelines or relevant industry codes in the countries where we operate and do business.
- 2.We maintain a zero tolerance policy against all forms of Bribery and Corruption.
- 3.We strictly prohibit any form of Bribery and Corruption against any party. All Facilitation Payments, even if permitted under the applicable laws, regulations, guidelines or relevant industry codes in the country where the Group company operates, are prohibited under this group policy.
- 4.We require our business partners or agents not to engage in any Bribery and Corruption.
- 5.We will refuse to continue doing business with any business partner or agent if we become aware of any Bribery and Corruption committed by such business partner or agent in connection with the Group’s business.
- 6.The Employees of the Group are required to report immediately any known violations of this Group Policy, including those of applicable laws, regulations, guidelines or relevant industry codes.
- 7.The President and CEO of Kyowa Kirin Co., Ltd. is responsible for the Group's anti-Bribery and anti-Corruption program, and will appoint anti-Bribery and anti-Corruption officers at each Group company for the execution of necessary anti-Bribery and anti-Corruption measures.
- 8.We will keep accurate records of all payments made to and business transactions with the parties concerned.
Responsible Department: CSR Management Department
Established on December 13, 2013
Revised on October 1, 2018
Revised on March 14, 2019
Revised on June 9, 2022
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.
Indicators and Targets
In 2022, 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. The program contains the president’s message, and elaborates on the Global Policy and internal regulations as well as covering social trends including the latest exemplary cases and updates on laws and regulations. In FY2022, 6,608 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.
- *2:Duty of care and effort that companies are required to exercise as a matter of course. In this case, due diligence indicates investigating suppliers’ risk of becoming involved in bribery or corruption.
Policy and Strategy
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 Promotion Policy 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 Group Promotion Policy
Established on August 31, 2018
Revised on June 1, 2020
We at the Kyowa Kirin Group (hereafter, referred to as "Our Group") consider promotion to be an important activity from the standpoint of letting the people of the world know the value of the Group's products and giving them the opportunity to experience the value. Promotion must never be performed by inappropriate methods or to obtain undue profit.
As a group of corporations involved in a business that is deeply invested in people's lives and health, the Group engages in ethical promotion with healthcare professionals to provide timely and truthful information that is scientifically and clinically significant when marketing our products.
"promotion" means any activity undertaken, organized or sponsored by a member company which is directed at HCPs to promote the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through all channels of communication.
- 1.Communication with healthcare professionals
We will communicate with healthcare professionals aiming to benefit patients and enhance the practice of medicine, by focusing on providing valid scientific and educational information.
- 2.Independence of healthcare professionals
We will not provide and offer gifts, financial gain and/or benefits (e.g. scholarships, grants, consultant contracts, travel and accommodation upgrade, etc.) to healthcare professionals in exchange for the prescription, recommendation, purchase, administration of our medicinal products or the promise to continue these practices or as a reward for these practices in the past. We will not provide or offer any information in a manner or under conditions that may improperly affect the prescribing practices of healthcare professionals.
- 3.Proper use of drugs
We will promote the proper use of pharmaceuticals in an accurate, fair and balanced manner by presenting the characteristics of pharmaceuticals objectively and without exaggeration.
- 4.National regulations of each country
We will abide by any applicable laws to laws, guidelines and industry rules on promotion in the countries and regions where our group operates. We will follow the IFPMA codes when conducting activities in countries or regions that do not have proper laws and regulations or industry codes.
We will establish and operate appropriate organizational structures and business processes that comply with laws and regulations and industry codes in countries and regions where we operate.
System for the Appropriate Provision of Information
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 code, additional training is promptly conducted to prevent recurrence.
You can see this table by scrolling horizontally.
|Training organizer||Target||Frequency||Scope of training|
|CSR Management Department||Personnel in charge of creating materials||12 times a year||Knowledge required to create materials in compliance with laws and regulations|
|Sales office manager||Sales & Marketing Division||12 times a year||Guidelines, fair competition rules|
|CSR Management Department||Medical Information Department,
Sales & Marketing Division
|4 times a year||JPMA Code of Practice,
guidelines, fair competition rules
|CSR Management Department||All employees of Kyowa Kirin Group (in Japan)||Once a year||JPMA Code of Practice|
Policy and Strategy
Kyowa Kirin Group Tax Policy
Established on September 1, 2021
The Kyowa Kirin Group (hereinafter, the "Group") strives to carry out corporate activities in a manner trusted by society, based on our philosophy, vision and core values.
With regards to tax operations, the Group strives to maintain and improve our tax compliance, and tax risk management, through enhancing our global tax governance systems.
The Group has established this tax policy and it is applicable to our entire Group. It will ensure tax transparency and appropriate tax payments.
1. Global Tax Governance
The Executive Officer in charge of the Finance Department is the person ultimately responsible for the Group’s tax governance and tax risk management. The Director of the Finance Department shall supervise the execution of the Group’s tax governance and tax risk management activities. In addition, the Director of the Finance Department shall report on the progress of these activities to the Executive Officer in charge of the Finance Department and report matters of significance to the Board of Directors via the Executive Officer in charge of the Finance Department.
The Group shall endeavor to enhance the Group’s corporate value sustainably through establishing this tax policy by resolution at the Board of Directors, by building and maintaining an effective global tax governance structure aligned with our "One Kyowa Kirin" business management structure, and by providing the global oversight of tax initiatives.
2. Tax Planning
The Group shall conduct reasonable tax planning where it is aligned with our business objectives and strategies. Since the Group’s corporate value may be undermined in the event that full consideration from multiple tax viewpoints is not given to any global business plan, the group shall consult with external advisors and ensure that sufficient research and consideration is undertaken in respect of our activities. The Group shall only carry out tax planning activities compliant with the relevant tax laws and regulations in the jurisdictions in which we operate.
The Group shall not conduct excessive tax planning that is deemed to be an act of tax avoidance in light of socially accepted practices, or an act of tax avoidance that is without business substance including use of tax havens.
3. Tax Transparency
The Group shall comply with both the tax laws and regulations of each relevant jurisdiction and the OECD Transfer Pricing Guidelines. The Group shall strive to ensure tax transparency by disclosing appropriate tax information in a timely manner.
4. Tax Compliance
The Group shall keep up-to-date with developments in the tax laws and regulations in each relevant jurisdiction and shall make appropriate tax payments in compliance with them.
5. Transfer Pricing
The Group shall comply with the OECD Transfer Pricing Guidelines and set transfer prices for intercompany transactions in accordance with the arm’s length principle. We shall analyze the functions, assets and risks of each Group company in light of the substance of their business activities, and periodically evaluate whether the profit allocation is appropriate in line with the contribution. The Group shall pay appropriate amounts of tax in each jurisdiction based on the value created by our business activities.
The Group shall prepare transfer pricing documentation in accordance with the relevant transfer pricing regulations in each jurisdiction.
6. Tax Incentives
The Group shall endeavor to improve tax efficiency and enhance our corporate value by appropriately utilizing applicable tax incentives, available in each relevant jurisdiction, based on a proper understanding of the intent behind them.
7. Attitudes toward Tax Risk
In the event that the Group is in an uncertain tax position, such as a transaction having multiple possible tax treatments or differences in opinion with the tax authorities of any jurisdictions concerning a tax treatment that the Group has judged appropriate, the Group shall make investigations into such matters by consulting with external advisors and considering the outputs. Also, in order to ensure certainty, the Group strives to reduce the tax risks associated with uncertainty by proactively seeking rulings by tax authorities where they are available.
8. Relations with tax authorities
The Group shall endeavor to establish cooperative relationships with tax authorities by providing appropriate information in a timely manner and by engaging in constructive discussions, in response to inquiries by the tax authorities.
9. Prevention and elimination of double taxation
The Group shall strive to prevent double taxation levied by multiple jurisdictions on the same economic benefits through conducting tax operations in accordance with this policy. If double taxation occurs, the Group shall strive to eliminate it by taking advantage of tax treaties or mutual agreement procedures available in the relevant jurisdictions.