Compliance / Risk Management

Compliance

Basic Principles

We have established a department to promote and support compliance within each Group company and developed the necessary internal systems, and rules and regulations. The structure we have created facilitates the prompt handling of cases, the formulation of measures to prevent violations, and other measures. This means that officers and employees can engage in corporate activities with peace of mind. To increase awareness of compliance of employees of the Group, we are conducting compliance education for each job level while working to grasp the level of employee awareness through questionnaire surveys and identify points for improvement.
In FY2021, we conducted interviews with each department of the Group based on the results of the compliance awareness survey and worked for more thorough compliance by gaining a greater understanding of the current situation, identifying problems, and conducting training and problem solving based on actual conditions. The Group Compliance Promotion Committee has been established to supervise the Group’s efforts toward recognizing and responding to risks that could have a significant impact on Group management and promoting a compliance system that thoroughly complies with laws and corporate ethics.

Group Compliance Promotion Structure

The Group Compliance Promotion Committee has been established to supervise the Group’s efforts toward recognizing and responding to risks that could have a significant impact on Group management and promoting a compliance system that thoroughly complies with laws and corporate ethics.

The Group Compliance Supervisor and the Group Compliance Promotion Supervisor are appointed from among the representative directors, executive directors, and directors (executive officers), respectively, who are appointed within each company and notified to the Supervisor.

Charter of Corporate Behavior/Compliance Code of Conduct

>All officer[s and employees of the Group strive to comply with the Compliance Program, which includes the Charter of Corporate Behavior, the Compliance Code of Conduct, and the Whistleblower System.

Charter of Corporate Behavior

Sustainability / Ethics and Compliance

Compliance Education and Training (Awareness survey)

We have established a department to promote and support compliance within each Group company and developed the necessary internal systems, rules, and regulations. The structure we have created facilitates the prompt handling of cases, the formulation of measures to prevent violations, and other measures. This means that Board Members and employees can engage in corporate activities with peace of mind. To increase awareness of compliance of employees of the Group, we are conducting compliance education for each job level while working to grasp the level of employee awareness through questionnaire surveys and to identify points for improvement. In FY2022, we worked to further ensure compliance by conducting training and problem solving based on actual situations upon our understanding of the current situation and by identifying problems from the results of the compliance awareness survey. The Group Compliance Promotion Committee has been established to supervise the Group's efforts toward recognizing and responding to risks that could have a significant impact on Group management and promoting a compliance system that thoroughly complies with laws and corporate ethics.


FY 2022 2023 2024
Number of compliance training held 15 31 35
Event duration (hour) 0.4 0.7 0.9
Total number of participants 223 6,928 8,951

Whistle-blower System

External Consulting Desk

The Company has established a contact point for external whistleblowers. We maintain a contact point for inquiries in the event of any perceived violation of laws, regulations, or ethics in our dealings with the Company.

Consultation and Inquiries about Compliance and Human Rights

Internal Consulting Desk

To ensure that employees’ voices are reflected in compliance practices, the Group has established the ASKA Pharmaceutical Holdings Compliance Consultation Hotline as an internal whistleblowing channel and promotes awareness of the hotline through training and educational programs.
In addition to internal reporting channels and an external reporting channel operated by legal counsel, the Group has established the Audit & Supervisory Committee Hotline, operated by a Full-time Audit & Supervisory Committee Member, as a dedicated channel through which compliance-related matters involving Group officers may be reported or discussed. Reports may also be submitted anonymously.
The Audit & Supervisory Committee Hotline is intended to lower the psychological barriers to consultation and reporting by officers and employees of the Group regarding compliance-related matters involving senior management, through the provision of a reporting channel that is independent of management. This helps ensure that investigations and corrective actions are conducted in a timely and appropriate manner.
In accordance with the spirit of Japan’s Whistleblower Protection Act, the Group operates this system not only to protect whistleblowers, but also to ensure the timely and appropriate collection, investigation, and remediation of compliance-related matters.

Number of Cases Reported Through the Internal Whistleblowing Hotline

FY 2020 2021 2022 2023 2024 2025
Number of Cases 14 11 10 6 5 5

Anti-Bribery and Corruption Policy

ASKA Pharmaceutical Holdings Group (the "Group") is committed to preventing bribery and corruption in accordance with the Charter of Corporate Behavior and the Code of Conduct for Compliance.
This policy applies to all officers and employees of the Group. We request the same understanding from all domestic and overseas stakeholders, including those in our supply chain, who are involved in our business activities.

Prohibition of Bribery

In all of its business activities, whether in Japan or overseas, the Group shall engage in fair, transparent, and free competition, and shall maintain sound and normal relationships with medical professionals, related business partners, government agencies, political organizations (individuals), and others. We prohibit the giving or receiving of illegal money or other forms of payment.

Prohibition of Bribery by Business Partners, Agents, etc.

We request that all domestic and overseas stakeholders, including those in our supply chain, involved in our business activities understand the prohibition of bribery.

Anti-Bribery Due Diligence

The Group conducts due diligence on companies with which it intends to enter into new transactions or with which it already does business in order to mitigate risks related to bribery and corrupt practices.

Prohibition of Illegal Political Contributions

The Group prohibits illegal political contributions and other corrupt practices.

Entertainment and Gifts in Compliance with Laws and Internal Standards

When providing or receiving entertainment or gifts with business partners, our Group conducts corporate activities in compliance with applicable laws and internal standards. In cases of uncertainty, employees are required to consult with the responsible department in advance.

Prohibition of Anti-Competitive Practices

Our Group is committed to ensuring fair market competition and eliminating unfair trade practices. We strictly prohibit anti-competitive behavior in accordance with relevant laws and social norms.

Laws
  • Antimonopoly Act
  • Unfair Competition Prevention Act
  • Act against Unjustifiable Premiums and Misleading Representations
  • Subcontract Act, etc.
Social Norms
  • Fair Competition Code
  • JPMA Charter of Corporate Behavior
  • JPMA Compliance Program Guidelines
  • JPMA Code of Practice
  • Transparency Guidelines for the Relation between Corporate Activities and Medical Institutions, etc.
  • Code of Practice for Prescription Drug Promotion
  • Guidelines on Collaboration with Patient Organizations, etc.

ASKA Pharmaceutical Code of Conduct

As a responsible life sciences company engaged in the development and provision of pharmaceuticals, ASKA Pharmaceutical Co., Ltd. recognizes the importance of maintaining the highest standards of ethics and transparency in its business activities. To this end, the Company has established the “ASKA Pharmaceutical Code,” a code of conduct governing interactions among all officers and employees, as well as with researchers, healthcare professionals, patient organizations, and other stakeholders. By ensuring that the Code is thoroughly communicated and adhered to by all officers and employees, the Company promotes business activities that earn the trust and understanding of society.

Role of Top Management and Enforcement of this Policy

The top executives and other officers shall take the initiative in taking action to prevent bribery and corruption in accordance with the Charter of Corporate Behavior and the Code of Conduct for Compliance, and shall ensure that all employees are fully aware of these standards.
In addition, we will understand internal and external opinions, build effective governance, and ensure that corporate ethics are thoroughly upheld. In the event of a violation of this policy, top management will take responsibility for resolving the problem, investigating the cause, preventing recurrence, and promptly and accurately disclosing information to the public. In addition, the top management will fulfill its responsibility as a corporation, restore trust in the Company, and take strict disciplinary action, including that of the Board of Directors and officers.

Protection of Intellectual property

Intellectual property rights include patent rights, utility model rights, design rights, and trademark rights, which protect creations through intellectual creative activities. We respect the rights of third parties and cooperate with relevant departments to formalize and protect intellectual property rights throughout the Company. In addition to protecting rights related to newly developed products, we maximize value by utilizing intellectual property rights to extend the life cycle of existing products, including new dosage formulations. Moreover, we are promoting the globalization of our intellectual property activities and have established a system that enables us to collect and utilize intellectual property information overseas. We are working to strengthen cooperation with our partner companies in terms of intellectual property. With the growing importance of intellectual property, we will further contribute to our business growth through these efforts.

Intellectual Property Strategy

Risk Management

Basic Policy on Risk Management

In order to deal with risks that may affect the business activities of the Group, we have established the Group Business Risk Management Rules and are implementing a risk management system with classifications based on characteristics and risks. Each department prepares and operates procedure manuals and systematically works to resolve issues through annual risk assessments and the formulation, implementation, and evaluation of countermeasures based on the results of those assessments.

Risk Management System

Every organization within the Group has formulated and implemented a business risk management manual in a bid to avoid risks and minimize damage. If crises actually occur, the Task Force takes action as necessary.

Business Continuity Plan(BCP)

In order to ensure a stable supply of pharmaceuticals and other products, we have formulated three types of BCP: one for natural disasters such as large-scale earthquakes and tsunamis, one for the spread of infectious diseases such as the novel influenza, and one for security incidents. We are working to establish a system that will enable us to quickly restore our business activities. Going forward, we will continue to enhance our preparedness for anticipated risks, conduct employee awareness activities, and further improve our crisis management system.

Information Security Policy

ASKA Pharmaceutical Holdings Group (hereinafter referred to as "the Group") recognizes that the appropriate management of information assets is an important management issue and has implemented the following measures to ensure safe and secure management.

  1. Establishment of information security management system
    The Group has established an information security management system to protect information assets held by the Group and to maintain and improve information security.
  2. Establishment of internal rules for information security
    The Group has established internal rules for information security in order to appropriately manage information assets.
  3. Education on information security
    All officers and employees of the Group are informed of the importance of information security and the proper use of information assets held by the Group.
  4. Implementation of Information Security Measures
    The Group takes appropriate measures to prevent and correct unauthorized access to, loss, leakage, falsification, and destruction of information assets.
  5. Compliance with laws and regulations
    The Group shall comply with laws, regulations, and other relevant norms related to information security.
  6. Maintenance of audit system
    The Group shall strive to ensure information security by establishing an internal audit system to check and evaluate the status of compliance with laws, regulations, and internal rules.

Cyber Security Initiatives

Cyber Security Compliance

ASKA Pharmaceutical Holdings Group shall prevent and take measures against risks such as unauthorized access, loss, leakage, falsification, and destruction, and shall take prompt and appropriate corrective measures if any damage should occur.
In addition, we have a thorough process for verifying the reliability of computer network communications to ensure the safety of communications. Furthermore, in response to ransomware attacks and new cyber attacks using generative AI, we have installed the latest security tools and monitor them 24 hours a day, 7 days a week.

OT (Operational Technology) Security Compliance

As manufacturing sites become increasingly digitalized, the ASKA Pharmaceutical Holdings Group is strengthening OT security for manufacturing facilities and IoT devices to minimize the risk of external attacks by isolating networks and implementing multi-layered defenses to ensure safety.
We also comply with the regulations and standards of the pharmaceutical industry and implement advanced security measures based on these standards, thereby contributing to the maintenance and stable supply of high quality products.

Cyber Security Education (Awareness survey)

The ASKA Pharmaceutical Holdings Group thoroughly educates all Board members and employees on cyber security threats and the importance of taking countermeasures.
Specific efforts include training to increase resistance to phishing attacks, learning how to deal with malware infection, and sharing information on cyber attack trends and recent security incidents in order to raise security awareness.

FY 2022 2023 2024
Number of compliance training held 4 2 1
Event duration (hour) 0.4 0.4 0.5
Total number of participants 907 840 846

Assurance of Product Quality, Safety Control and Stable Supply

As a total healthcare company that operates in the entire healthcare market of "prevention, testing/diagnosis, treatment, and prognosis," the Group is responsible for ensuring compliance with the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other laws and ministerial ordinances, ensuring the quality and safety of our pharmaceutical products, and supporting a stable supply. All employees of our group are committed to thorough compliance governance and fostering a corporate culture that emphasizes product reliability as its first priority.

Please see the page link below to refer to ASKA Pharmaceutical's efforts to ensure the quality and safety of the products, and maintain a stable supply system.

Customer Health and Safety - Production / Quality & Safety Assurance