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Astellas U.S. declaration and comprehensive compliance program |
DECLARATION
On April 1, 2005, Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. merged to form Astellas Pharma Inc., headquartered in Tokyo, Japan. In the United States, Astellas Pharma US, Inc. and Astellas U.S., LLC (collectively "Astellas U.S."), wholly owned subsidiaries of Astellas Pharma Inc. are headquartered in Deerfield, Illinois.
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Astellas U.S. has established and is in compliance with a Comprehensive Compliance Program (CCP), as required by California law. This program, described in further detail below, contains policies, procedures and processes to address risk areas identified in the "Compliance Program Guidance for Pharmaceutical Manufacturers" published by the Office of the Inspector General, U.S. Department of Health and Human Services ("HHS-OIG Guidance") and the Pharmaceutical Research and Manufacturers of America voluntary Code on Interactions with Healthcare Professionals (the "PhRMA Code"). We cannot completely eliminate the possibility that an employee, through inadvertence or otherwise, will fail to comply with some aspect of the CCP. However, we train all employees on the various elements of our CCP and have established processes for identifying potential violations and disciplining employees, if necessary. |
COMPREHENSIVE COMPLIANCE PROGRAM DESCRIPTION |
INTRODUCTION
Astellas is committed to conducting its global business based on the highest ethical standards. In the United States, a key component of this commitment is the establishment and maintenance of a compliance program in accordance with the HHS-OIG. The purpose of our CCP is to prevent and detect violations of law or company policy. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is our expectation that employees will comply with the Astellas Charter of Corporate Conduct and with the Astellas U.S. Code of Ethics, as well as with company policies established to support the Charter and the Code. In the event that Astellas U.S. becomes aware of violations of law or company policy, we will investigate the matter and, where appropriate, implement corrective measures to prevent future violations.
Our program is scalable to address the size, organizational structure, and resources of our company and will continue to evolve accordingly. We regularly monitor and reassess the program in order to improve it. Described below are the fundamental elements of the Astellas U.S. Comprehensive Compliance Program.
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COMPLIANCE PROGRAM OVERVIEW |
| 1. Leadership and Structure |
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Compliance Officer. The Vice President, Compliance, is charged with developing, operating and monitoring the Compliance Program, and is advised regularly by the Compliance Committee. This individual serves as the company's Chief Compliance Officer with direct access to the CEO, Board of Directors, and senior management. The individual provides a report on the Compliance Program to the Astellas U.S. Board of Directors both annually and on an as-needed basis.
Compliance Committee. Astellas U.S. has established a Compliance Committee to advise the Compliance Officer and assist in the implementation of the Compliance Program. The Committee is comprised of members from functional units across the company. It meets on a monthly basis to monitor company activities and compliance developments. |
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| 2. Written standards |
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| The Astellas Charter of Corporate Conduct outlines the company's global commitment to compliance and corporate accountability. The Astellas U.S. Code of Ethics defines the principles that guide daily operations in the United States. The standards set forth in the Code apply to all Astellas employees, and adherence to the Code is a condition of employment. The company expects all officers and managers to review the Code with their employees and to ensure adherence to the Code and to all other applicable policies, procedures, laws, guidance and regulations. |
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| Our CCP limits on gifts and promotional materials conform to the PhRMA Code in that (1) medically relevant gifts (valued at $100 or less) primarily benefiting patients are acceptable, but only if provided on an occasional basis; (2) reminder items of only nominal value (pens, notepads, etc., with product name) may be provided; and (3) modest meals may be provided on an occasional basis to healthcare providers if accompanied by an informational presentation. |
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| Astellas U.S. sales representatives call on a relatively limited number of healthcare professionals in California. While these calls often involve little or no promotional spending, there are instances when legitimate promotional spending occurs. As a result, we have established spending parameters which include an annual upper dollar limit on promotional spending directed toward individual California healthcare professionals. We track and monitor these spending parameters to the best of our ability, using available resources, and will modify them if necessary. As of May 1, 2008, the annual upper dollar limit on promotional spending directed toward individual California healthcare professionals is $1200. |
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| 3. Education and Training |
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| All employees, at new hire orientation and annually, receive general compliance training which includes training on the Astellas U.S. Code of Ethics and internal compliance resources. Specialized training occurs in specific departments where a need for additional training has been identified. In addition, members of the Corporate Compliance Department periodically address compliance issues at regional and national company meetings. Employees are trained on how to report compliance concerns through internal channels, including anonymously through the Compliance Hotline. |
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| 4. Internal Lines of Communication |
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| A variety of internal communications tools exist for communicating compliance issues and concerns, including an intranet site and an internal company newsletter which contains a regular monthly column on compliance. We have communicated to all Astellas U.S. employees that the company maintains a toll-free hotline for reporting compliance concerns and that they may use the hotline anonymously if they wish. |
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| 5. Auditing and Monitoring |
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| The Astellas U.S. compliance auditing and monitoring plan includes various monitoring activities that occur routinely. The nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations. Results are reported to the Compliance Committee and to appropriate managers. |
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| 6. Responding to Potential Violations |
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| Enforcement action for compliance program violations is addressed in the Astellas U.S. Code of Ethics as well as various other company policies. We have a progressive disciplinary process, up to and including termination, depending upon the severity of the violation. |
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| 7. Corrective Action Procedures |
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| Our CCP requires that the company respond promptly to potential violations of law or company policy. After investigation of a reported or detected issue, the company will assess whether disciplinary action is appropriate, and whether a violation is in part due to gaps in our policies, practices, training, or internal controls, and take action to prevent future violations. |
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To request a copy of the Astellas U.S. Declaration or Comprehensive Compliance Program description, please call 1 (800) 395-3660. |
