Novo Nordisk Inc. (“Novo Nordisk” or the “Company”) has a long-standing commitment to compliance with the laws and regulations that govern pharmaceutical and biotechnology marketing and selling activities in theUnited States. Novo Nordisk's Compliance Program also is consistent with the voluntary guidelines set forth in the "OIG Compliance Program Guidance for Pharmaceutical Manufacturers" published by the Office of the Inspector General, U.S. Department of Health and Human Services (“OIG Guidance”) and the provisions of the PhRMA Code on Interactions with Healthcare Professionals ("PhRMA Code").
The goal of Novo Nordisk's Compliance Program is to maintain a culture that promotes the prevention, detection and resolution of potential violations of law or Company policy.
The Comprehensive Compliance Program Mission
Novo Nordisk is committed to upholding the highest standards of business conduct and ethics. In all of its activities, Novo Nordisk seeks to promote the core principles of good citizenship and integrity. The Compliance Program has been tailored to fit Novo Nordisk’s unique environment. The goal of Novo Nordisk’s Compliance Program is to:
Exemplify Novo Nordisk’s commitment to good corporate citizenship.
Develop a process that encourages employees to report potential problems.
Monitor adherence to applicable statutes, regulations, and program requirements.
Investigate acts of alleged misconduct and initiate corrective action where appropriate.
Emphasize the dedication of the Company and the Company’s employees to honesty, integrity, ethics.
Although the OIG Guidance explicitly recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer, Novo Nordisk has implemented disciplinary and corrective procedures in the event Novo Nordisk becomes aware of violations of law, regulations, or Company policies.
Novo Nordisk continuously reviews and enhances its Compliance Program to meet changing needs and demands.
In compliance with the California Health & Safety Code § 119402, Novo Nordisk has established annual spending limits for promotional activities directed toward healthcare professionals in accordance with the OIG Guidance and PhRMA Code. A $2000 spending limit forCaliforniahealthcare professionals is monitored and enforced. This limit is a maximum expenditure and does not represent a spending “goal” or an average.
II. Leadership and Oversight
The Corporate Compliance Officer
Novo Nordisk has appointed a Chief Compliance Officer as the focal point of compliance activities. The Chief Compliance Officer oversees the administration and implementation of the Compliance Program and reports directly to the Vice President and General Counsel. The Chief Compliance Officer may exercise independent judgment and has the authority to lead change in the organization regarding compliance activities.
The Corporate Compliance Team
Novo Nordisk has established a compliance team to aid the Chief Compliance Officer in the implementation of the Compliance Program. A Compliance Committee comprised of the Novo Nordisk executive team supports the development, operation, and monitoring of the Compliance Program.
III. Education and Training
The continual training and educating of Novo Nordisk employees concerning their ethical and legal obligations of compliance with policies, procedures, and applicable laws and regulations is a critical component of the Compliance Program. We are committed to taking all necessary steps of communicating and implementing the standards, policies and procedures to all affected personnel. We routinely review and modify the training programs as needed and enhance the training to incorporate additional areas of training necessitated by the changing business environment.
IV. Internal Communication
We seek to foster open discourse between management and employees. Any employee who has concerns or questions regarding policies, procedures, or particular activity that the employee feels may violate policies or the law is required to report such concerns.
Employees are encouraged to ask questions about compliance issues and urged to make reports of potentially problematic situations and conduct to their managers or the Compliance Department. Employees may contact the internal Hotline toll free 24 hours a day/7 days a week. The Hotline is administered by a non-affiliated contractor and provides for confidential and, if requested, anonymous reporting. Hotline administrators are trained to handle such calls and encourage anyone with concerns to call at anytime. Employees can also anonymously report an incident via a website link from the intranet or through an email communication.
Company policy prohibits retaliation by any employee against another employee for good faith reports of potential or suspected violations of law, regulations, or company policies.
V. Auditing and Monitoring
The Compliance Program incorporates efforts to monitor, assess, audit and evaluate compliance with Novo Nordisk’s policies and procedures. In accordance with the OIG Guidance, the nature, extent, and frequency of Novo Nordisk’s monitoring, assessing and auditing correlates with a variety of factors including new regulatory requirements and adaptations of business practices as well as other considerations.
Novo Nordisk may use a combination of internal and external auditing resources. The Chief Compliance Officer works with management and internal and/or outside experts to evaluate audit results and implement any training or corrective action deemed necessary resulting from audits and routine monitoring activities.
VI. Enforcement and Discipline
The Compliance Program’s goal is to prevent violations. However, as the OIG Guidelines recognize, even an effective compliance program may not safeguard against improper conduct. In the event noncompliant conduct does arise, Novo Nordisk’s Compliance Program sets forth clear disciplinary action to address violations of the law, regulations or company policies. Although each situation is considered on a case-by-case basis, Novo Nordisk consistently evaluates and implements the appropriate disciplinary action to address inappropriate conduct and deter future violations. Disciplinary action may include termination or other adequate discipline of the individual involved, as well as discipline of the supervisor.
VII. Corrective Action Procedure
The Compliance Program requires the company to respond promptly to potential violations of law, regulations, or company policies. Novo Nordisk will take the appropriate disciplinary actions as discussed above. Furthermore, Novo Nordisk will take action to prevent future violations from occurring, such as increasing auditing and monitoring procedures, and/or revision of the guidelines, policies and procedures.
Novo Nordisk’s Compliance Program is indicative of the Company’s dedication to and commitment to our Company’s Triple Bottom Line. We strive for the utmost degree of honesty and integrity. The policies and procedures discussed above represent a responsive program to compliance concerns within the industry, and are representative of our commitment to uphold the highest standards of business conduct and ethics in our relationships with customers, employees, stakeholders, the business community, and state and federal governments.
Headquartered in Denmark, Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy, and hormone replacement therapy.
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