Healthcare Compliance in the Chugai Group
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.
- Chugai-initiated clinical and preclinical research as well as joint preclinical research, excluding research used for drug application materials.
- Support for investigator-initiated clinical and preclinical research
- Collection of medical information
- 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)
Efforts to prevent corruption
In order to eliminate unlawful acts in pursuit of immediate benefits and unethical acts that abuse loopholes, Chugai prohibits bribery, graft, and other corrupt acts in the Chugai Group Code of Conduct.
Specifically, it has established an Anti-Bribery Policy, and prohibits bribery and facilitation payments (small payments made to domestic or foreign public officials for the purpose of expediting general administrative or clerical services) to business partners, including public officials and healthcare professionals, either directly or indirectly through third parties.
Regarding entertainment, gifts, and invitations, employees are required to comply with the laws and regulations of each country, regardless of whether they are spending their own money, and they are prohibited from providing cash, cash vouchers, prepaid cards, gift cards or other cash equivalents.
When conducting transactions with all suppliers, including agents and other intermediaries, we conduct risk assessments on the content of these transactions to prevent corruption. For high-risk transactions, memorandums are signed with the officers, employees, delegates, distributors, agents, consultants and other subcontractors of the client prohibiting them from either directly or indirectly engaging in corrupt acts such as bribery, buy-offs, embezzlement, misappropriation, or any other illegal act intended to induce transactions. In addition, among suppliers that are important to our business activities, we send check lists to and conduct in-depth risk assessments on those that are located in regions where the risk of corrupt acts is relatively high.
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 makes revisions to its bribery and corruption risk map.
Education and training are provided annually in CCC and Human Rights Training, a compliance training program held twice a year for officers and all employees. E-learning materials have also been posted on the intranet, allowing officers and employees to study them when needed.
The CCC Hotline and Chugai Speak-Up Line have been established as points of contact to provide consultation for and receive reports from officers and employees regarding anti-corruption. Issues reported are investigated impartially and with strict confidentiality to find a solution while respecting the opinion of the person who made the consultation. Company rules prohibit retaliation or any other disadvantageous treatment of employees who seek consultation or make reports.
In FY 2022, no one was subject to disciplinary dismissal for violating anti-corruption policies.
CCC and Human Rights Training
Chugai conducts annual training for all employees to further understand and comply with the Chugai code of conduct so that the code will take hold across the Chugai group. In the first half of 2022, the training program focused on business and human rights. It was an opportunity to raise awareness about human rights in the supply chain and the workplace for employees, and to think about the stakeholders involved in our business activities and how we address human rights issues throughout the supply chain.
In the second half of 2022, the training focused on the theme “No harassment, no tolerance”. We learned about social trends, the current status of harassment and its prevention measures, and consultation desks, and enlightened the importance of creating a better work environment in which all employees respect each other.
CCC Hotline and Chugai Speak-Up Line
The CCC Hotline and Chugai Speak-Up Line is available to provide consultation for and receive reports from the Chugai Group employees and other individuals regarding laws, Company rules, 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.
Company rules prohibit 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 handling in Japan in FY 2022 was as follows.
- Number of consultations and reports: 82
- Details of consultations and reports: power harassment, discrimination, environment of work place, internal policies and rules, others