• 2025
  • 2024
  • 2023
  • 2022
  • 2021

Compliance

Compliance-Related Initiatives

As an R&D-oriented pharmaceutical company, Kissei Pharmaceutical strives to contribute to society through high-quality, innovative pharmaceutical products. Furthermore, as a company listed on the Prime Market segment of the Tokyo Stock Exchange, we are expected to be a role model for society.
Bearing this philosophy and these expectations in mind, we recognize that management in accordance with the law is the underlying premise and foundation of all our corporate activities.
Therefore, we have formulated the Kissei Code of Conduct, which serves as a code of conduct for corporate activities, as well as our Compliance Program Manual, and use both to operate in a way that promotes management in accordance with the law and a high ethical standard.

Compliance Promotion System

Kissei Pharmaceutical has established a Compliance Committee under the direct control of the Board of Directors to promote and maintain management in accordance with the law. The committee is chaired by the director of the Legal Department 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 finalized, these action plans are implemented thoroughly by each department head. Moreover, the Compliance Promotion Office of the Legal Department develops and implements education and training activities.
The Kissei Group also engages in Groupwide compliance practices led by compliance officers appointed by each Group company under an internal control agreement. The Kissei Group Compliance Officers’ Meeting is held regularly, during which these compliance officers share action plans, report results, and exchange related information. At these meetings, officers also receive education and training.

Whistleblowing and 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 such violations. Moreover, the hotline serves to heighten self-regulation among Group companies.
Officers, employees, and people who have left the company 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 (management in accordance with the law)

Continued education and training is crucial for employees to understand the importance of observing the laws and internal regulations, as well as the underpinning corporate ethics. This education and training also ensures that they can fulfill their respective roles and responsibilities under compliant management.
Efforts to encourage greater employee understanding and awareness regarding compliance include regular instructions and messages from top management about compliant management and the Company’s Compliance Program Manual, which is distributed to every employee and officer 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. This education matches the relevant stage in their careers. Furthermore, 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).
In fiscal 2024, we began providing education and training to ensure we meet all legal requirements as laws and regulations become increasingly diverse and complex.

Main Compliance Education and Training Implemented in Fiscal 2023

Main Items Implemented
Companywide training

• Reporting results of the Fiscal 2023 Compliance Status Questionnaire

• Month-long training dedicated to understanding the Code of Practice (held annually)

• Distribution of materials aimed at raising awareness of the Pharmaceutical and Medical Devices Act (Fifth Edition)

Rank-based training

• Training regarding the Guidelines for Sales Information Provision Activities for Ethical Drugs

• Training regarding proper promotion of labor management

• Training regarding a psychologically safe workplace

• Promoting new compliance that is stronger and more controlled

• Promoting management in accordance with the law in a new era

• Countermeasures against power harassment (an abuse of power by superiors) to improve psychological safety in the workplace

• New employee education (Management Philosophy, corporate code of conduct, etc.)

Departmental training

Conducted compliance-related training/education a total of 1,225 times in 152 departments, including training/education related to the Compliance Program Manual, promotional and drug information provision activities, Fair Competition Code case studies, etc.

Compliance Status Survey

Every year, we conduct a Compliance Status Questionnaire targeting all employees and workplaces. 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. Until fiscal 2023, the response rate to the questionnaire had increased every year following its introduction in fiscal 2005. However, at 93.1%, the rate remains high. 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.

Transparency Initiatives

Kissei Pharmaceutical established “Guidelines for Transparency in the Relationship between Corporate Activities and Medical Institutions” and “Guidelines for Transparency in the Relationship between Corporate Activities and Patient Groups” and discloses information on funding provided to medical institutions, patient groups, and other organizations.