The Chugai Group categorizes and promotes compliance in three areas: corporate compliance, healthcare compliance, and GxP^* compliance.

The aim of healthcare compliance is to ensure the proper and appropriate implementation of business activities, not only in compliance with laws and ordinances, industry standards, and internal regulations, but also based on socially accepted norms and values demanded of pharmaceutical companies. It applies mainly to the following themes.

1. Chugai-initiated clinical and preclinical research as well as joint preclinical research, excluding research used for drug application materials.
2. Support for investigator-initiated clinical and preclinical research
3. Collection of medical information
4. Creation and provision of information relating to Chugai’s pharmaceutical products (information on R&D, products, safety)

• * GxP: Good x Practice which means the standard practices and regulations for the range of operations such as development, manufacturing and marketing of the pharmaceuticals.
  e.g. GCP (Good Clinical Practice; the standard practice for conducting clinical studies)

Healthcare Compliance based on the Chugai Code of Practice

Chugai strictly punishes the pursuit of immediate benefits through unethical acts that abuse loopholes and also prohibits bribery, graft, and other corrupt acts in its code of conduct, the Chugai Group Code of Conduct (hereinafter the “CCC”).

Specifically, Chugai has established an Anti-Bribery Policy that prohibits bribing business partners, including public officials and medical professionals, either directly or indirectly through third parties, as well as compliance with applicable anti-bribery and anti-corruption laws and industry standards in all countries and regions where we operate. The policy also clearly stipulates that any act that would be suspected by society of being bribery is also prohibited.

Global Anti-Bribery Policy

When conducting transactions with designated suppliers, we conduct due diligence on the content of these transactions to evaluate the risk of bribery. For transactions that are deemed to have a high risk of bribery, a more detailed risk assessment is conducted using a checklist to determine whether the transaction is acceptable or not. For suppliers with whom transactions are acceptable, we execute anti-bribery memorandums with them which specifically define that the suppliers are obligated to prohibit and prevent their officers, employees, delegates, distributors, agents, consultants and other subcontractors from either directly or indirectly engaging in corrupt acts such as bribery, kickbacks, embezzlement, misappropriation, or any other illegal act intended to induce transactions.

As a member of the non-profit organization Transparency International Japan, the Chugai Group is working to gather information on risks of bribery and corruption worldwide, and periodically revise our bribery and corruption risk map accordingly.

We regularly conduct a compliance training called “CCC and Human Rights Training” for officers and all employees, as well as provide other study sessions. Additionally, I-learning materials have also been posted on the intranet, for officers and employees’ self-study as needed.

Chugai conducts annual training for all employees to further understand and comply with the CCC so that the code will take hold across the Chugai group.

In 2023, the theme for the training was “Creating a Harassment-Free Workplace.” We made this an opportunity for employees to learn about unconscious biases that can cause discrimination and harassment, and to conduct self-examination using a self-checklist and case studies.

The “CCC Hotline” and “Chugai Speak-Up Line” are available for our employees to provide consultations and reports regarding laws, internal rules and regulations, the CCC or related matters. Issues reported are investigated impartially and with strict confidentiality to find a solution while respecting the opinion of the person who made the report.

Our internal regulation explicitly prohibits retaliation or any other disadvantageous treatment of employees who seek consultation or make reports via the hotline. The goal of using the CCC Hotline to respond to problems or other matters that are difficult to discuss and resolve in the workplace is to create a reassuring work environment for all employees.

In-house area counselors and an external hotline have been set up to handle issues regarding harassment.

In addition, in accordance with the revised Whistleblower Protection Act that went into effect in June 2022, we have established “the Rules for the Protection of Whistleblowers”, establishing a contact point for inquiries from outside the company and a system to receive reports from those who have left the company within 1 year.

Status of consultations and reports by our employees in Fiscal Year 2023 was as follows.

• Number of consultations and reports: 99
• Details of consultations and reports: power harassment, discrimination, environment of workplace, internal policies and rules, others.

There were four external reports regarding compliance matters in Fiscal Year 2023.