Kyowa Kirin is dedicated to complying with all applicable laws, regulations, guidance, and industry standards. Kyowa Kirin has developed a Comprehensive Compliance Program in accordance with the principles set forth in the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers dated May 5, 2003, published by the US Department of Health and Human Services Office of Inspector General and standards set by the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code) as well as other relevant industry guidance.
The Compliance Program is consistently assessed and evaluated to ensure alignment with updated laws and guidance. Further, Kyowa Kirin’s Compliance Program is designed to prevent, detect, and remediate violations of law, regulations, and Company policies, as well as to promote an ethical culture that guides interactions with healthcare professionals and healthcare entities.
In its efforts to engage the healthcare community in preventing and reducing fraud, as well as to promote voluntary compliance programs, the Office of Inspector General for the US Department of Health and Human Services (HHS) developed the OIG Compliance Program Guidance for Pharmaceutical Manufacturers. According to the OIG, it is essential for pharmaceutical manufacturers to establish and maintain effective compliance programs. The program should foster a culture of compliance that begins at the executive level and filters throughout the organization. The OIG's guidance provides 7 fundamental elements to an effective compliance program:
- Designated compliance officer and compliance committee
- Written standards
- Training and education
- Open lines of communication
- Internal monitoring and auditing
- Enforcement of standards through disciplinary guidelines
- Prompt response to detected problems through corrective actions
Designated compliance officer
Kyowa Kirin North America Vice President Lori Kagan serves as Chief Compliance Officer, U.S. She heads the Compliance Committee, which is up of senior leaders of all the major functions in the Company and meets regularly to oversee the Compliance Program.
Written standards
Kyowa Kirin’s written standards include our Code of Conduct and our Health Care Compliance Policy Manual.
Training and education
Training includes live training and online training on Kyowa Kirin policies as well as laws, regulations, and guidelines that govern pharmaceutical operations, marketing, and selling activities. Kyowa Kirin conducts new-hire, annual, and periodic training programs that support compliance education. Kyowa Kirin maintains online access to training materials and Company policies.
Internal auditing and monitoring
Kyowa Kirin conducts a variety of auditing and monitoring activities to detect and respond to potential noncompliance as well as training opportunities.
Open lines of communication
Kyowa Kirin is fully committed to fostering an environment where employees and others feel comfortable asking questions, raising concerns, or offering ideas. This includes the reporting of suspected improper practices.
Reports can be made in confidence and are hosted by a third-party hotline provider. We encourage reports to be submitted relating to potential non-compliance of law, regulation, or Company policy to:
The Company will not retaliate, or tolerate retaliation, against any Company employee for reporting in good faith any alleged compliance issue or other potential inappropriate activity involving laws or regulations, industry guidelines, the Company Health Care Compliance Policy Manual, or Company policies. The Company maintains confidentiality to the extent possible.
Enforcement of standards through well-publicized
disciplinary guidelines
In the event that Kyowa Kirin becomes aware of any suspected violations of law, regulation, policy, or procedure, we investigate the circumstances surrounding the suspected noncompliance to determine whether a violation has occurred. If a violation is found, Kyowa Kirin takes appropriate corrective action, which may include disciplinary action up to and including termination of employment.
Prompt response to detected problems through
corrective actions
Kyowa Kirin responds promptly to any potential compliance issues within the organization and conducts further review to determine appropriate corrective actions for activities that are deemed to be inconsistent with the policies and procedures of the Compliance Program or applicable laws.
