Lundbeck’s core Belief of being Responsible provides a strong foundation for our compliant workplace. Lundbeck is committed to the highest standards of corporate conduct in all business dealings and conducting business and medical activities in an ethical and appropriate manner. At Lundbeck, the patient comes first. All Lundbeck employees work together to always do the right thing and work in a compliant way, be responsible stewards of the business and focus on what is important – helping patients.
In support of this commitment, Lundbeck has developed a Code of Conduct and Compliance Program in accordance with the April 2003 United States Department of Health and Human Services, Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Guidance”) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (“PhRMA Code”).
Lundbeck’s Compliance Program includes policies and procedures to ensure compliance with the OIG Guidance and PhRMA Code, as well as applicable laws, regulations and industry standards. The Compliance Program is structured to comply with the seven elements of an effective compliance program outlined in the OIG Guidance and includes:
- policies and procedures designed to detect, prevent, identify, and correct unlawful, non-compliant, and/or unethical behavior
- a designated compliance officer and committee
- effective training and education for applicable Lundbeck employees and third parties
- effective lines of communication
- internal monitoring, oversight, and auditing
- enforcing standards through well-publicized disciplinary guidelines
- responding promptly to detected and/or reported problems and taking corrective action
Lundbeck’s Compliance Program is a central component of how business is conducted and has oversight from the Board of Managers (the “Board”) and Compliance Committee. The fundamental elements of our Compliance Program are outlined below.
Chief Compliance Officer: Lundbeck has appointed a chief compliance officer to lead ethics and compliance activities for North America. The chief compliance officer is responsible for driving a compliant culture across Lundbeck and is responsible for the design, implementation, operation and monitoring of the Compliance Program. The chief compliance officer reports directly to Lundbeck’s executive vice president/head of North America and reports to the Board as to compliance matters.
Compliance Committee: Lundbeck has established a Compliance Committee consisting of senior leadership from all company business areas and support functions. The Committee is responsible for advising and supporting the chief compliance officer in the implementation and oversight of the Compliance Program and ensuring Lundbeck’s corporate commitment to abide by all applicable laws and regulations. The Committee is chaired by the chief compliance officer.
The chief compliance officer provides reports on the state of Lundbeck’s Compliance Program to the Compliance Committee and Board multiple times per year.
Written Standards, Education and Training
Lundbeck’s Code of Conduct is the statement of principles that guide the company’s operations and set clear expectations for operating in a way that is consistent with our core Belief of being Responsible. Our Code of Conduct contains standards of ethical conduct that apply to all Lundbeck employees, officers and applicable third-party agents acting on behalf of Lundbeck. It is based on our corporate policies governing all business areas and is supported by more detailed procedures and materials to guide our daily work.
Lundbeck requires ongoing training and education of its employees on the application of Lundbeck’s core Belief of being Responsible, and individual obligations in accordance with applicable legal requirements and company policies. Lundbeck trains all its employees on the Code of Conduct and provides targeted coaching and training in key risk areas, such as interactions with healthcare providers, external funding requests and patient assistance programs.
Asking Questions and Reporting Potential Violations
Lundbeck supervisors are expected to promote a compliant workplace and maintain an environment that fosters open communication. At Lundbeck, employees know they have multiple channels available to ask questions or report potential instances of fraud and abuse, or other potential violations of laws, regulations or company policies.
Officers, employees and contractors of Lundbeck who know of or suspect actual or potential violations of law, any Lundbeck policy or procedure or the Code of Conduct are required to report the matter immediately to their supervisor, or Lundbeck’s Compliance, Human Resources or Legal Departments. Lundbeck also has a Compliance Hotline which is available 24 hours a day, 7 days a week. To submit a report directly, anonymously or otherwise, please use Lundbeck's Compliance Hotline or dial (866) 913-7681.
Lundbeck takes a zero-tolerance approach to retaliation. No Lundbeck employee or contractor will suffer any adverse consequence or retaliation as a result of good-faith reporting of suspected fraud or other misconduct or a possible violation of law.
Auditing and Monitoring
Lundbeck’s Compliance Program includes ongoing efforts to assess, evaluate, monitor, and audit compliance with the company’s policies and procedures. The nature, extent and frequency of these activities depend on a variety of factors, including new regulatory requirements, changes in business practices and other considerations.
Lundbeck conducts annual auditing, monitoring and assessment activities and reports results to local management and corporate governance committees.
Responding to Potential Violations
Lundbeck’s Compliance Program includes disciplinary principles to identify consequences to individuals who violate the law, regulations or company policies. Although each reported violation is investigated fully and reviewed on a case-by-case basis, Lundbeck imposes discipline to address inappropriate conduct and to deter future violations.
In addition to imposing appropriate disciplinary action, the company also assesses whether a violation may present an opportunity to better mitigate risk with the implementation of corrective measures to enhance the Compliance Program and prevent further violations.