• 2024
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  • 2022
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  • 2020

Compliance

Compliance-Related Initiatives

Kissei Pharmaceutical developed the Kissei Code of Conduct for its corporate activities. In order to adhere to this code of conduct, ensure compliance with laws and regulations, maintain a high sense of ethics, and warrant the trust of society, we conduct corporate activities centered on compliance, with guidance from the Compliance Program Manual and the Kissei Pharmaceutical Code of Practice (Principles of Kissei Pharmaceutical’s Corporate Activities for Medical Institutions and Healthcare Professionals). Kissei is a company that supports people’s health and is involved in the research and development of pharmaceutical products. We will work in this role to build relationships of trust with all our stakeholders through ethics, transparency, and fairness and by being accountable for our corporate activities.

Compliance Promotion System

Kissei established the Compliance Committee to optimize compliance promotion, promote the Compliance Program, and serve as an advisory body to the Board of Directors. The committee is chaired by the Director of the Legal and is composed of managers from each division. It discusses and determines a specific implementation plan for the Compliance Program for each fiscal year. Once this plan has been determined, the Legal Compliance Office, the division managers (who are in charge of compliance promotion and are also members of the Compliance Committee), and the Compliance Promotion Supervisor develop and conduct specific activities for compliance education and understanding.
In addition, the Kissei Group engages in Groupwide compliance practices led by compliance officers appointed by each Group company. The Kissei Group Compliance Officers’ Meeting is held regularly, during which these compliance officers share plans for activities, report results, and exchange related information. At these meetings, officers also receive education and training.
As a member of a life-related industry, the high ethical standards demanded of the Group are a given. However, if we can commit to not only complying with the law but also maintaining these high ethical standards, upholding social norms, and fulfilling our social responsibilities, we stand to gain a greater degree of trust from society, which is true for Group companies as well. Therefore, we are working to practice compliance on a daily basis with this goal in mind.

Whistleblowing and the Consultation System “Kissei Hotline”

In response to amendments to the Whistleblower Protection Act (Act No. 51 of 2020), the Kissei Group has established the Kissei Hotline, its whistleblowing and consultation system. The goal of the Kissei Hotline is to protect whistleblowers, while preventing the violation of laws and regulations within the Group, as well as any damage or losses that could result from these violations. Moreover, the hotline serves to heighten self-regulation among Group companies. Officers, employees, and retirees can file a report or consult with an external contact independent of the Company regarding legal violations or harassment within the Group. The external contact can be reached by phone, email, post, or via a dedicated website. Furthermore, users of the hotline can opt to remain anonymous, in which case the Company will not know who is filing the report.

Compliance Promotion Activities

Continued compliance education and training is essential to firmly entrench the importance of observing the law and internal regulations as well as corporate ethics, and to ensure that all officers and employees fulfill their responsibility toward proper compliance.
Efforts to encourage greater employee understanding and awareness regarding compliance include regular messages from top management and the Company’s Compliance Program Manual, which is distributed to every employee and contains policies for ensuring proper compliance during daily activities and conduct. In addition, the Company provides rank-based education to officers, division and department managers, newly appointed managers and supervisors, and new employees that matches the stage in their careers. In addition, employees receive education and training for work directly related to their duties, covering the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the Pharmaceuticals and Medical Devices Act). Additional focus has been placed on the topic of harassment, an important issue for companies with the growing awareness of different forms of harassment in recent years.

Main Compliance Education and Training Implemented in Fiscal 2022

Main Items Implemented
Companywide training

• Fiscal 2022 Compliance Status Questionnaire

• Training over the course of one month dedicated to understanding of the Code of Practice (held annually)

• Training regarding the establishment of a legal compliance system as required by the Pharmaceuticals and Medical Devices Act

• Training regarding in-Company whistleblowing system

Rank-based training

• Training regarding the revised Act on the Protection of Personal Information

• Training regarding the establishment of a legal compliance system in line with the revised Pharmaceuticals and Medical Devices Act

• Training regarding proper promotion of labor management

• Anger management training

• Psychological safety in the workplace training

• New employee education (Management Philosophy, Kissei Code of Conduct, etc.)

Departmental training

• Conducted compliance-related training/education a total of 1,214 times in 170 departments, including training/education related to the Compliance Program Manual, promotional and drug information provision activities, Fair Competition Code case studies, etc.

Compliance Status Questionnaire

Every year, we conduct the Compliance Status Questionnaire targeting all employees. This questionnaire allows employees to check their level of understanding, while allowing the Company to confirm whether proper compliance is being carried out and work toward even more thorough compliance practices. The response rate to the questionnaire has been high since it was introduced in 2005, increasing with each year. In fiscal 2022, the response rate remained high at 95.6%.
The results of the questionnaire are collected and analyzed and then each division and department is provided with feedback, which the division manager (in charge of compliance promotion), the compliance promotion supervisor, and other persons in charge use to deliver appropriate compliance education to employees.
Going forward, we will continue to utilize these questionnaire results and enhance our workplace environment, while striving to improve compliance awareness.