Compliance

In keeping with the Whistleblower Protection Act, the Kissei Group has established the Kissei Hotline, its whistleblowing and consultation system. The goals of the Kissei Hotline are to protect whistleblowers, prevent the violation of laws and regulations within the Group, help prevent and mitigate damage or losses that could result from such violations, and 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.

Kissei Pharmaceutical recognizes its important mission (challenge) as an R&D-oriented pharmaceutical company to support people's health, and undertakes necessary efforts daily. Specifically, by engaging in the research and development of safe and effective pharmaceuticals, manufacturing high-quality products and ensuring their stable supply, promoting sales activities in compliance with regulations, and providing appropriate information required in medical settings, we aim to address the challenges in the manufacturing and sales of pharmaceuticals and contribute to society through high-quality, innovative pharmaceutical products.
As part of this effort, we have established the "Kissei Code of Practice" and the "Kissei Code of Practice for the Promotion of Ethical Drugs" as our own codes, in accordance with the JPMA Code of Practice set by the JPMA based on international industry standards, and we adhere to these codes as norms for interactions between all our officers and employees and healthcare professionals, medical institutions, and patient organizations.
Furthermore, to provide healthcare professionals with the necessary information about pharmaceuticals, we comply with the relevant regulations such as the "Guidelines for Sales Information Provision Activities for Ethical Drugs" and strive to provide scientifically based and timely, and appropriate information. Additionally, to ensure fair and honest sales information provision activities for pharmaceuticals, we conduct material reviews and monitoring of sales information provision activities.

Continued education and training is crucial for officers and 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 compliance management.
Efforts to encourage greater employee understanding and awareness regarding compliance include regular instructions and messages from upper management about compliance 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. Additionally, in conjunction with the Japan Pharmaceutical Manufacturers Association’s annual Code Awareness Promotion Month, we conduct regular training on the Kissei Pharmaceutical Code of Practice for all officers and employees. As needed, we also provide education on the guidelines for providing sales information on pharmaceutical products. These efforts aim for the responsible development, manufacture, supply, sales promotion, and provision of drug information. In addition, the Company provides rank-based education to officers, executive 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 2024

Every year, we conduct a Compliance Status Questionnaire targeting all employees at each workplace. 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 results of the questionnaire are collected and analyzed, then each division and department is provided with feedback, which the head of compliance promotion (the responsible party), the compliance promotion supervisor, and other persons in charge use to deliver appropriate compliance education to employees. The results are also used as a reference for the Legal Department’s educational and awareness raising activities.
Going forward, we will continue to utilize these questionnaire results and enhance our workplace environment, while striving to improve compliance awareness.

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.