Our Compliance Program

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Commitment to Corporate Compliance
  • Mitsubishi Tanabe Pharma America, Inc. (MTPA) is committed to conducting its affairs in compliance with all applicable law and industry practices. MTPA’s comprehensive Compliance Program aims to ensure that MTPA operates at the highest ethical standard. To that end, MTPA has equipped its Compliance Program with the resources and authority necessary.

    MTPA’s Compliance Program has been designed in accordance with recommendations provided by the U.S. Department of Health and Human Services (HSS) Office of the Inspector General (OIG) and the Pharmaceutical Research and Manufacturers of America (PhRMA). The Compliance Program aims to prevent violations of law and company policy, and to detect and resolve potential violations. Regular monitoring, auditing and updating to the program help ensure that the Compliance Program remains viable and effective.

    Compliance is the culture of MTPA and is the responsibility of every person at MTPA. MTPA encourages open lines of communication, fosters an open-door environment, offers an anonymous compliance hotline (1-877-564-9624) and has a clear anti-retaliation policy.

Written Policies and Procedures:
  • MTPA’s Code of Conduct reflects the principles of corporate responsibility and integrity that all MTPA personnel must strive to embody. All MTPA personnel certify that she or he has read and agrees to abide by the Code and MTPA’s written policies and procedures.

    MTPA’s written policies and procedures cover its business activities across a wide array of legal, regulatory, business and governance perspectives. These policies and procedures are certified by MTPA personnel and applied to those who suppliers and service providers who contract with MTPA.

Compliance Personnel and Committee:
  • MTPA’s Compliance Officer chairs the Compliance Committee and is responsible for overseeing and administering MTPA’s Compliance Program. In that regard, the Compliance Officer owns the authority to exercise appropriate professional judgment regarding the Compliance Program. The Compliance Officer reports directly to the Chief Compliance Officer for the Americas region.

    The Compliance Committee meets at least quarterly and is composed of Officers and senior-level MTPA personnel charged with assisting the MTPA President and the Compliance Officer implement MTPA’s compliance program, including policies and procedures, training and education, open lines of communication, monitoring and auditing, and performing other duties as directed by the MTPA Board of Directors.

Effective Training and Education:
  • MTPA provides online and live training and compliance education to MTPA personnel. This includes comprehensive new-hire training, annual updated training, and online compliance training and targeted live training based on risk-assessments and the advice of the Compliance and Legal departments.
Effective Lines of Communication:
  • MTPA has an open door policy that encourages MTPA personnel to be forthright in discussing any concerns, problems, suggestions or other issues with supervisors, managers, human resources personnel, Officers of the corporation, Board Members of the corporation, the Legal Department members, the Compliance Department members or via the anonymous reporting hotline, under a policy prohibiting retaliation.

    MTPA personnel are encouraged to direct compliance-related questions or concerns to their supervisor, Human Resources, the Legal Department, Officers of the corporation, Board Members of the corporation or the Compliance Office. Moreover, MTPA offers an anonymous compliance hotline (1-877-564-9624) that allows anyone to raise concerns anonymously and in a confidential manner.

Internal Monitoring and Auditing:
  • Internal auditing and monitoring serve as fundamental components of MTPA’s Compliance Program. MTPA has enacted a Risk Assessment and Mitigation Plan (RAMP) to continually evaluate activities that, among other things, could have substantive involvement with or impact on Federal Healthcare Programs. MTPA’s RAMP provides MTPA with tools to prevent deviations and compliance issues before they start or detect deviations and compliance issues and facilitate the appropriate response. MTPA is committed to monitoring and auditing activities and reviews its RAMP periodically and routinely to continually evolve its Compliance Program.
Enforcement:
  • MTPA’s corporate policies and procedures, including MTPA’s Code of Conduct, make it clear that there are consequences for failure to adhere to MTPA’s compliance mission—including termination of employment. MTPA’s corporate policies and procedures are published and provided to all MTPA personnel.
Prompt Response & Corrective Actions:
  • MTPA’s Compliance Program is designed and staffed so that compliance deviations or issues will be reviewed and investigated in a timely and appropriate manner. If necessary after completion of an investigation, on the recommendation of the Compliance Officer and the advice of legal counsel, MTPA will take all appropriate corrective actions.
Interactions with Healthcare Professionals in California & Declaration of Compliance:
  • MTPA’s Compliance Program complies with California Health and Safety Code §§ 119400-119402. These laws mandate that MTPA not only adopt and implement an OIG-compliant Comprehensive Compliance Program and the provisions of the Code of Interactions with Healthcare Professionals created by the Pharmaceutical Research and Manufacturers of America (“PhRMA Code”), but also to set annual limits on aggregate expenditures for certain interactions with healthcare professionals (HCPs). MTPA has thus imposed an annual $2,000 per HCP limit on expenditures. This limit may be updated at MTPA’s discretion and does not necessarily represent a typical, average, usual or customary amount for HCPs. This limit takes into account restrictions on transfers of value to HCPs under federal, state and local laws and industry codes of conduct as well as the size, structure and organization of MTPA.

    To the best of its knowledge, as of July 13, 2020, MTPA is in substantial compliance, in all material respects, with its Comprehensive Compliance Program and its good faith understanding of the requirements of California’s Health and Safety Code §§ 119400-119402. This declaration is based on MTPA’s most recent evaluation, which includes consideration of the annual aggregate limit noted above. This declaration will be updated on an annual basis. A copy of this document can be obtained by calling 866-448-0446.