Corporate compliance
Because of our ethics, we obey all laws and regulations
Culture of integrity
Kyowa Kirin is committed to improving the lives of patients and their families. This common goal unites us and compels us to set high standards for ourselves, including always acting with the utmost honesty and integrity. There is never a situation when compromising our standards is either expected or acceptable.
Kyowa Kirin employees always seek to act with integrity and make ethical decisions in all aspects of the business based on Kyowa Kirin Group’s Core Values, Group Policies, and Code of Conduct. Kyowa Kirin refers to Kyowa Kirin USA Holdings, Inc., Kyowa Kirin, Inc., BioWa Inc., and Kyowa Kirin Canada, Inc.
As a global specialty pharmaceutical company operating in North America, our decisions are guided by established industry codes, including the Pharmaceutical Manufacturers Association (PhRMA) Code of Interactions with Healthcare Professionals, the Innovative Medicines Canada Code of Ethical Practices (IMC Code), and the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) Code of Practice.
In North America, our policies reflect the Company's strong commitment to integrity, a robust and effective compliance program, adherence with applicable laws, regulations, and internal guidance implemented to avoid corruption and other compliance risks that may arise in the conduct of the business.
Message from Tara D’Orsi, Executive Vice President, Chief Compliance Officer, and General Counsel
Building upon our ethical culture
Integrity and ethical conduct of our employees are the foundations of our company, and our unity in applying these principles is the key to our success. The reputation of our company is formed by each and every experience that people have with Kyowa Kirin – whether they are healthcare professionals, patients, customers, business partners, colleagues, or members of the communities in which we work. It is up to every employee to ensure that those experiences demonstrate our values and reflect the fact that integrity is our highest priority.
The officers and directors of this company are held to the same high standards and are bound by the same Code of Conduct and the Health Care Compliance Manual as any other employee. The principles and values contained in our Code of Conduct and the Health Care Compliance Manual guide our strategy and our decisions.
What is an ethical culture
- Every decision involves ethics.
- Every action must be completely honest and fair. We must observe our company’s policies and internal controls, knowing that they were put in place to ensure that we operate safely, honestly, and legally.
- Ethical action goes beyond compliance. To succeed, we must be able to trust one another, and earn the trust of our customers and the community at large. We never need to cut corners in any area, especially in ethics and compliance, to compete successfully.
- Ethical culture encourages dialogue at all levels. We encourage employees to speak up, contribute ideas, and help our company develop the right policies to conduct business.
- Learning must be continuous. It is important to be a student of our industry–and maintain your knowledge and awareness of laws and regulations.
Kyowa Kirin North America’s
Comprehensive Compliance
Program
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
Tara D’Orsi serves as the Company's Executive Vice President, Chief Compliance Officer, and General Counsel and heads the Compliance Committee. The Compliance Committee is made 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 in an effort 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, in particular, 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:
- Employee Integrity Hotline
1-877-295-7937 - Online report intake portal
http://kyowakirinusa.ethicspoint.com/ - Kyowa Kirin Group Global Compliance Line (Web based)
https://ml.helpline.jp/kyowakirin-complianceline/
The Company will not retaliate, or tolerate retaliation, against any Company employees 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.
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.
Code of conduct
You can read our code of conduct on Kyowa Kirin’s global website.
Transparency
Our collaboration with the healthcare community is an essential component of our core value to transform lives with passion and integrity. We comply with all applicable requirements for transparency and disclosure of transfers of value made in collaboration with the healthcare community.
California Declaration of Compliance
Statement regarding compliance with California Health & Safety Code § 119402
Based on a good faith understanding of the requirements of § 119402 of the California Health & Safety Code, Kyowa Kirin hereby declares that, to the best of its knowledge, its Comprehensive Compliance Program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and PhRMA Code and limits on gifts and incentives to health professionals. Subject to the above, Kyowa Kirin also hereby declares that it is in compliance with its Comprehensive Compliance Program as of September 1, 2024.
As part of the Compliance Program, Kyowa Kirin has established a specific annual aggregate dollar limit of $2,000 on gifts, items, or activities Kyowa Kirin may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis. This limit may be revised occasionally by Kyowa Kirin at its sole discretion, in which case the revised limit will be published in this section of the Kyowa Kirin website within a reasonable period following revision.
The annual limit does not include the following expenditures:
- Drug samples given to physicians and healthcare professionals
- Financial support for continuing medical education programs
- Financial support for health educational scholarships
- Payments for legitimate fair market value professional services, including but not limited to consulting fees, advisory board fees, and speaker fees, and any meals or expenses associated with the provision of such services
- Educational materials provided to physicians with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition.
Copies of the Declaration of Compliance may be obtained upon request by contacting Kyowa Kirin, Inc.
Expanded access
Kyowa Kirin’s Policy for Requests for Expanded Access to Unapproved Drugs describes the principles and procedures that the company will follow when considering requests by physicians for use of unapproved Kyowa Kirin drugs outside of clinical trials.
