CORPORATE COMPLIANCE PROGRAM
To support all of our employees and maintain integrity within the organization, Eisai has established a comprehensive Compliance Program. It incorporates the elements of:
- U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers
- U.S. Department of Justice's Evaluation of Corporate Compliance Programs
- Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Practitioners
- PhRMA Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines
Our program is designed to help achieve our purpose and hhc mission by promoting integrity and accountability, as well as proactively identifying and responding to business conduct to ensure it is consistent with federal and state laws, as well as Eisai's values.
Our Corporate Compliance Program also complies with the requirements of Chapter 8, Section 11940 of the California Health and Safety Code. View our declaration of compliance here.
GLOBAL COMPLIANCE HANDBOOK
As a statement of our commitment to Integrity and compliance, Eisai has set forth the Global Compliance Handbook –similar to a code of conduct — that provides a uniform sense of guiding principles and expectation to all Eisai employees throughout the world. In addition, Eisai has established and distributes a Charter of Business Conduct for all affiliates throughout the world as a reminder that compliance is essential and is given top priority in all corporate activity.
COMPLIANCE STRUCTURE AND CULTURE
We work to cultivate a culture of compliance where our leaders and employees walk the walk and empower one another to speak up and seek clarity. Our Corporate Compliance Program is overseen by our Chief Compliance Officer (CCO), who is a member of the Executive Committee and regularly reports to that committee and the Global Compliance Committee regarding implementation of the Americas Compliance Program. These committees provide input and oversight of compliance initiatives and ongoing programs on a regular basis. In addition, the CCO reports independently and regularly to the U.S. Board of Directors.
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POLICIES AND PROCEDURES
Policies and procedures are a fundamental tool that Eisai utilizes to provide our employees with a roadmap of how to operate compliantly in a highly regulated industry. Eisai’s Compliance Handbook sets forth the foundational legal and ethical standards that guide all Eisai colleagues worldwide in their daily activities. Additionally, Eisai has adopted specific policies and procedures to address each region's legal and regulatory requirements. Eisai works to ensure that all employees are educated on and have access to the key policies and procedures necessary to conduct their jobs.
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EDUCATION AND TRAINING
Eisai’s learning program is designed to help our employees understand the Company values as well as the legal and ethical obligations and specific requirements that impact their daily job responsibilities. The goal with all company training is to empower confident and compliant decision making and execution. Eisai works to ensure that colleagues receive impactful and meaningful training that is easy to understand and that all employees receive and complete training in a timely manner.
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ENCOURAGE HEALTHY DIALOGUE
The channels of communication run both ways at Eisai and are always open. We keep our employees informed about policy changes, new compliance initiatives, and training programs through internal communications, Company intranet postings, and direct communications from senior management are cascaded throughout the organization.
Eisai also has a reporting line where anyone can ask a question or report an issue anonymously via the Eisai Integrity Line
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MONITOR BUSINESS ACTIVITIES
One way we work to help ensure that we walk the walk is to monitor our own business activities. We follow OIG Guidance in managing the way we assess our business activities in order to ensure our communications, trainings, and policies are resonating and working to help mitigate risk. We review our monitoring program each year and assess it regularly to ensure that it’s focused on meaningful business activities and risks.
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ENFORCEMENT OF STANDARDS
Our policies clearly state the consequences of violating law, regulations and Company policies, as well as failure to report instances of non-compliance to state and federal authorities, where required or appropriate. Although each situation is unique and considered on a case-by-case basis, we’re unwaveringly committed to taking appropriate disciplinary action to address misconduct and deter future violations.
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TAKE CORRECTIVE ACTION
Our responsibility as a human health care company is to act swiftly and decisively to address and deter misconduct. As a result, we’re committed to responding promptly to potential violations of law, regulations or Company policies, and to taking appropriate disciplinary and corrective actions, including changing or updating Company processes, whenever and wherever necessary.
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TRANSPARENCY
We’re committed to meeting disclosure obligations, including payments and other transfers of value provided by Eisai or our agents to healthcare professionals and organizations. W e comply with several global transparency laws, codes, regulations and disclosure requirements. Additionally, we’re advocates of clinical trial transparency, and publicly disclose information about our qualifying studies on the National Institutes of Health’s database of privately and publicly funded clinical studies conducted around the world.
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INTEGRITY AMBASSADOR AWARD PROGRAM
Eisai has implemented the Integrity Ambassador Award Program intended to recognize an employee each year who demonstrates an on-going commitment to integrity at Eisai.
Employees nominate their colleagues who exhibit outstanding ethical awareness and decision-making, who ask hard questions or raise issues through proper channels to gain clarity and alignment on Eisai processes, recognize gaps and drive meaningful improvements or innovation to close a gap, or who serve as a mentor for integrity that is noticeable and impactful to others.
Eisai expects our employees and our business associates to act with integrity at all times. We strive for consistent standards and accountability, and encourage open and honest dialogue on how we can build upon our company culture and better fulfill our corporate mission. In that spirit, Eisai has established the Eisai Integrity Line which is available 24/7 either online or toll free (1-800-467-1391) to anyone who has a question or would like to report a concern.