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Astellas US 2010
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 US, LLC (collectively "Astellas US" or the "Company"), wholly owned subsidiaries of Astellas Pharma Inc., are headquartered in Deerfield, Illinois.
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Astellas US has established, and is in compliance with, a Comprehensive Compliance Program ("CCP"), as required by California law. This program, which is 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 ("PhRMA") 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 our CCP. However, we train all employees on the various elements of our CCP and have established processes to identify potential violations, implement corrective measures, and discipline employees, if necessary. |
COMPREHENSIVE COMPLIANCE PROGRAM DESCRIPTION |
I. INTRODUCTION
Astellas is committed to conducting its global business in accordance with the highest ethical standards. In the United States, a key component of this commitment is our establishment and maintenance of a compliance program in accordance with the HHS OIG. A principal 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 eliminated entirely. Nonetheless, we expect all employees to comply with the laws, regulations and industry codes of conduct that govern our Company and business, as well as the Astellas US Ethics Policy, the Code of Conduct, the Astellas US Compliance Guide Policy, and all related company policies. Potential violations of law or Company policy are investigated, and corrective measures are implemented, as appropriate, to prevent future violations.
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Our program is scalable to address the size, organizational structure and resources of our Company, and it has evolved, and will continue to evolve, accordingly. We regularly assess and monitor our program in order to improve it. Described below are the fundamental elements of the Astellas Compliance Program. |
II. 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 Astellas Compliance Program and is advised regularly by the Compliance Committee (described below). This individual serves as the Company's Chief Compliance Officer and reports directly to the Company's CEO. The Compliance Officer reports annually on the Compliance Program to the Astellas US Board of Directors.
- Compliance Committee. Astellas US has established a Compliance Committee to advise the Compliance Officer and assist in the implementation of the Compliance Program. The Committee is comprised of senior members of 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 and Astellas Business Ethics Policy outline the Company's global commitment to compliance and corporate accountability. The Astellas US Ethics Policy and Code of Conduct define the principles that guide daily operations in the United States. The standards set forth in the Ethics Policy and Code of Conduct apply to all Company employees, and adherence to these policies is a condition of employment. The Company expects all officers and managers to review these and other Company policies with their employees and to ensure adherence both to them, and to all laws, regulations and industry codes of conduct governing our Company and business.
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- The Astellas US Compliance Guide Policy provides guidance and establishes limits on promotional materials and gifts to healthcare providers ("HCPs") that conform to both the letter and the spirit of the PhRMA Code.
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| Due to the nature of our business and products, Astellas US sales representatives call on a relatively limited number of HCPs in California. While these calls often involve little or no promotional spending, there are some instances when legitimate promotional spending occurs. We have established parameters on such spending, including an annual upper dollar limit on promotional spending directed toward individual California HCPs. We track and monitor this spending to the best of our ability and are prepared to modify our parameters if necessary. As of May 1, 2009, we have adopted an annual upper dollar limit of $1,200 on promotional spending directed toward individual California healthcare professionals. |
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| 3. Education and Training |
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| All employees receive general compliance training, both at new hire orientation and annually. In addition, more focused or specialized training is provided where a need for additional training has been identified. The Compliance Department addresses compliance issues at Company meetings and circulates regular communications to employees addressing compliance questions. Employees also are encouraged to report compliance concerns, either through internal channels or anonymously through the Company's third-party operated Compliance Hotline. |
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| 4. Internal Lines of Communication |
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| The Company employs a variety of tools to communicate with employees about compliance matters. The Compliance Department maintains an intranet website that is available to all employees, and the Company has an internal newsletter that features a regular column on compliance topics. As noted above, we also regularly circulate compliance communications to our employees addressing questions that have come to our attention or advising on compliance developments or interpretations. |
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| 5. Auditing and Monitoring |
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| The Astellas Compliance Program includes procedures for conducting compliance audits, and we regularly monitor our employees to insure adherence to our compliance standards. The nature, scope and frequency of our auditing and monitoring activities varies according to a number of factors, including new regulatory requirements, changes in business practices and other considerations. Results are reported to the CEO, the Compliance Committee and appropriate managers. |
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| 6. Responding to Potential Violations |
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| The Company responds promptly to potential violations of law, the PhRMA Code or Company policy. Potential violations are thoroughly investigated and evaluated on a case-by-case basis. When a determination is made that a violation has occurred, appropriate discipline is imposed, as set forth in the Company's policies. Employees can be, and have been, disciplined up to and including termination depending upon the severity of the violation. |
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| 7. Corrective Action Procedures |
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| As described above, after the Company completes its investigation of a potential compliance violation, it assesses whether disciplinary action is appropriate and determines the level of discipline to be imposed. In making this assessment, the Company addresses whether the potential violation is due, in whole or in part, to any gaps in our policies, practices, training or internal controls. If any such gap is identified, the Company takes commensurate action to correct the issue and prevent future violations. |
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To request a copy of the Astellas US Declaration and Comprehensive Compliance Program description, please call 1-866-605-1374. |
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