Our Compliance Program

Commitment to Corporate Compliance:

Mitsubishi Tanabe Pharma America, Inc. (MTPA) is committed to conducting its affairs in compliance with all applicable laws and regulations. MTPA’s Compliance Program aims to ensure that all aspects of MTPA’s business operate at the highest ethical standards. To that end, MTPA has equipped its Compliance Program with the resources and authority necessary to discharge MTPA’s duties and responsibilities.

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 as necessary, to detect and resolve such potential violations. Regular monitoring, auditing and updating help ensure that the Compliance Program continues to operate at the highest ethical standards as business activities and endeavors change.

All MTPA personnel are expected to contribute to compliance and receive training on an ongoing basis. Thus, MTPA encourages an open-door environment, offers a confidential compliance hotline (1-877-564-9624) and remains dedicated to anti-retaliation protections for all MTPA personnel.

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. As such, all MTPA personnel must certify that she or he has read and agrees to abide by those principles as they are further enumerated in MTPA’s written policies and procedures.

MTPA’s written policies and procedures cover its business activities across a wide array of legal, regulatory and policy perspectives. These policies and procedures are provided to MTPA personnel and those who contract with MTPA, including third-parties.

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.

The Compliance Committee meets at least quarterly and is composed of senior-level MTPA personnel charged with assisting the Compliance Officer in his duties, including knowledge maintenance, training and education, and monitoring and auditing of MTPA’s Compliance Program.

Effective Training and Education:

MTPA believes in a culture of compliance, so in that spirit, MTPA provides regular training and compliance education to MTPA personnel. This includes comprehensive new-hire training, yearly update training as required and online access to compliance training and corporate policies.

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 or the Compliance Office without fear of retaliation and with the assurance that maintaining the confidentiality of information relating to an investigation will be given high priority.

MTPA personnel are encouraged to direct compliance-related questions or concerns to their supervisor, Human Resources, the Legal Department or the Compliance Office. Moreover, MTPA offers a confidential compliance hotline (1-877-564-9624) that allows anyone—regardless of whether employed by MTPA or not—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. These processes provide 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 each year.

Enforcement:

MTPA’s corporate policies and procedures, including MTPA’s Code of Conduct, make it clear that there will be consequences for failure to adhere to MTPA’s compliance mission—including potential termination of employment. MTPA’s corporate policies and procedures are published and made available for all MTPA personnel.

Prompt Response & Corrective Actions:

MTPA’s Compliance Program ensures that compliance deviations or issues will be reviewed and investigated in a timely and complete manner. If necessary after completion of an investigation, MTPA will take the appropriate corrective action, which may include in some instances termination of employment as well as reporting to the relevant governmental authority.

Interactions with Healthcare Professionals in California:

MTPA’s Compliance Program is in compliance with California Health and Safety Code sections 119400-119402. These laws mandate that MTPA not only adopt and implement an OIG-compliant Comprehensive Compliance Program, as discussed here, 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.