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 act of fraud or corrupt practices acts of fraud or corruption, harassment 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, in handling reports of legal violations, corrupt or dishonest acts, harassment, etc., in accordance with the Whistleblower Protection Act, the Company ensures the confidentiality of information related to whistleblowers and prohibits the identification of whistleblowers or any prejudicial treatment of whistleblowers by the Group companies.

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.

It is important and indispensable for officers and employees to recognize the importance of compliance with laws and company regulations as a matter of course, as well as with corporate ethics that support such compliance, and to ensure that they fulfill their respective roles and responsibilities in law-abiding management through ongoing education and training.
In addition to periodic instructions from top management regarding law-abiding management, the "Compliance Program Manual" is distributed to all officers and employees as a guideline that indicates what employees should be and what actions they should take in their daily activities, to promote understanding and awareness of compliance. And internal audits are conducted periodically to confirm the effectiveness of the compliance system.
In conjunction with the Pharmaceutical Manufacturers Association of Japan's Code Awareness Month each year, we conduct regular training on the Kissei Code of Practice for all officers and employees, and strive to maintain responsible development, manufacturing, supply, and sales promotion activities for pharmaceutical products in accordance with international standards. In addition, we ensure that our sales promotion and drug information provision activities are appropriate and in compliance with laws and regulations by providing education on guidelines for sales information provision activities for ethical drugs as needed and by supervising the provision of information in accordance with the guidelines.
Furthermore, we provide education and training by rank according to career stage for officers, corporate officers, department heads, newly appointed managers and supervisors, and new employees, as well as education and training on relevant laws and regulations in line with business operations, such as the "Act on Quality, Efficacy and Safety Assurance, etc. of Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act)". In particular, to respond to increasingly diverse and complex laws and regulations, we have started to develop education and training programs intended to meet the required standards set forth by laws and regulations since fiscal 2024.

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.

Kissei Pharmaceutical stipulates in “Kissei Code of Conduct”, which serves as the behavioral standard for all officers and employees, that all business activities must be conducted with fairness, transparency, and free competition, while prohibiting corrupt practices such as bribery and other forms of misconduct.
In addition, we have established a "Basic Policy on Prohibition of Corrupt Activities" to prohibit such anti-social activities and to ensure compliance with the applicable anti-corruption laws and regulations in the countries and regions where the Kissei Group operates, including those related to bribery and other corrupt practices, as well as laws and regulations to eliminate acts that subsidize anti-social forces and criminal organizations, including money laundering. The Company is committed to compliance with the laws and regulations related to anti-corruption such as bribery.
This policy is available to all officers and employees via a company-issued computer, and we regularly conduct anti-corruption training for officers and employees to ensure that they understand this policy. After the training, employees are given a confirmation test to deepen their understanding of corrupt practices in general and to deter corrupt practices.
The establishment of the system under the Policy is made by and under the supervision of the Board of Directors in accordance with the Companies Act. Amendments to the Policy and Regulations must also be approved by the Board of Directors. As part of the anti-bribery measures, the scheme also requires the approval of the Board of Directors for donations over a certain amount.
In accordance with its Basic Policy on Prohibition of Corrupt Activities, Kissei Pharmaceutical has established Anti-Corrupt Practices Regulations and is committed to preventing corrupt practices by its business partners, both internally and in its contracts with them. Before negotiating important contracts, we confirm matters related to the prevention of corrupt practices as part of our legal due diligence. In other words, we have clauses in our contract negotiations with our business partners that prohibit corrupt practices or state and guarantee that they will not engage in corrupt practices. If a supplier does not accept this clause, we consider it as a factor in deciding whether or not to enter into a business relationship with them. In addition, any violation of the anti-corruption clause or the warranty and representation clause in the contract is grounds for termination of the contract due to a material breach.
In practice, we take measures such as discontinuing transactions with suppliers who have fraudulently received government subsidy grants.