GovernanceSecurity Export Control

The Sawai Group strictly controls exports with the aim of preventing its goods and technologies from being used in the development of WMDs or terrorist activities, thereby helping to maintain international peace and security.
We will not only comply with applicable laws and regulations but also actively contribute to the maintenance of international peace and security.

About Security Export Control

Regulatory Framework: The Foreign Exchange and Foreign Trade Act

Export controls on goods and technologies related to WMDs and other weapons are governed by the Foreign Exchange and Foreign Trade Act (FEFTA). Any export of goods or transfer of technologies subject to the controls requires a license from the Minister of Economy, Trade and Industry (METI).

Basic Policy

The Sawai Group has established a basic policy on security export control as follows:

  • Prohibition of Illegal Transactions
    We will not export goods or transfer technologies controlled under the FEFTA or other relevant laws in violation of such laws.
  • Organizational Controls
    In order to ensure compliance with FEFTA and other laws and to implement appropriate export controls, we will designate a person responsible for security export control and develop and strengthen our export control systems.

Security Export Control Systems

Sawai Pharmaceutical Co., Ltd., our core operating company, has established export control systems in which multiple departments are involved to ensure the transparency and effectiveness of its security export control operations. These systems are structured as follows:
As the first line of defense, each organizational division has in place an export screening system.
At the second line of defense, cross-divisional monitoring is under the charge of the Security Export Control Committee, which is chaired by the Chief Compliance Officer and consists of officers responsible for the export screening from each organizational division and other members with specialized expertise in export control. This Committee receives, deliberates on, and approves reports and proposals on the status of export control activities and monitors critical issues related to security export control. In addition, the Security Export Control Secretariat, established within the Legal and Compliance Department, regularly monitors export control operations, coordinates related administrative tasks, and leads employee awareness-raising and educational initiatives.
Furthermore, as the third line of defense, the Internal Inspection Section maintains an internal audit system to ensure that all export control operations are conducted appropriately and in full compliance.

The diagram below illustrates the structure of our security export control systems.

The risk management system for security export control consists of three lines of defense. The First Line of Defense is Risk Management by Operational Divisions, which is managed by an officer responsible for the screening, a screening person in charge, and export staff assigned within each organizational division. The Second Line of Defense is Cross-Divisional Risk Management, which is managed by the Security Export Control Committee and the Security Export Control Secretariat. The ultimate responsibility for both the first and the second lines of defense lies with the Chief Compliance Officer. The Third Line of Defense is the Internal Audit System led by the Internal Inspection Section, which is responsible for the implementation and evaluation of internal audits for the first and the second lines of defense.

Screening

The Sawai Group has established a transaction screening system so that every transaction is subject to appropriate screening based on its specific nature.
For each export transaction, the staff member in charge of the export prepares a screening form whereby both classification determination and transaction screening are double-checked, and a screening staff member then reviews that form to confirm the legality and appropriateness of the transaction before the officer responsible for the screening makes the final decision through shipment control.
Transactions involving higher sensitivity or requiring a license from METI are subject to screening by the Chief Compliance Officer, whose approval is the mandatory requirement for such transactions to proceed. With this structure, we ensure the legal compliance of our export transactions.

Details of the screening procedure

  • Classification
    Determining whether goods or technologies are classified as controlled (listed) items
  • End-Use Verification
    Verifying that goods or technologies have no possibility of being used for military purposes
  • End-User Verification
    Verifying that transaction or transfer counterparts or the end-users of the goods or technologies are not parties of concern
  • Shipment Control
    Verifying that the actual state of outgoing exports or technologies correspond with the results of the classification and verification and that the necessary licenses have been obtained

Training and Education

The Sawai Group provides systematic training and education on security export control for its employees.
In the field of security export control, it is essential to respond promptly and appropriately to the changing international security situation, which requires a timely and accurate understanding of applicable laws and regulations. The Sawai Group works to promote an accurate understanding among all our employees to ensure proper security export control.

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