Edwards Lifesciences Global Integrity Program
Edwards Lifesciences Corporation (“Edwards”) is committed to the highest standards of ethical conduct. To meet this commitment, Edwards has implemented this Global Integrity Program based upon recognized government standards for effective compliance programs, including guidance published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”).
The purpose of this Program is to detect and prevent behaviors, such as violations of law or company policy, which could harm Edwards and the people we serve. While the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated, it is Edwards’ expectation that employees will comply with Program requirements, including the Edwards Global Business Practice Standards (“Standards”) and the policies and procedures established in support of the Standards. In the event that Edwards becomes aware of violations of law or company policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
The fundamental elements of our Global Integrity Program are described below. In accordance with the HHS-OIG guidance, we have tailored our Program to fit the unique environment, organizational structure, resources, operations and size of our company.
Overview of Global Integrity Program
- Leadership. The Chief Responsibility Officer oversees the Program, and reports directly to the Audit Committee of the Edwards Board of Directors. The Chief Responsibility Officer is charged with developing, operating, and monitoring the Program. The Chief Responsibility Officer provides oversight to compliance staff responsible for day-to-day implementation of the Program, and has the ability to effectuate change within the organization as necessary and to exercise independent judgment. Edwards has established a Corporate Compliance Committee, composed of senior leaders, to advise the Chief Responsibility Officer and to assist in the implementation of the Program. Edwards seeks out leaders who operate legally and ethically, and we take steps to exclude from employment consideration anyone whose conduct does not meet our high standards.
- Written standards. Edwards’ commitment to ethics and compliance is set forth in the Standards, as well as in extensive policies and procedures intended to help Edwards comply with relevant laws and regulations, industry codes and best practices. The Edwards Standards set forth the ethical and compliance principles that guide our daily operations, reflecting the values identified in Our Credo. The Standards apply globally to all of Edwards’ businesses and subsidiaries, and to all employees, management, members of the Board of Directors, and agents of Edwards. We expect such persons to act in accordance with the law and applicable company policy. The HHS-OIG guidance has identified several potential risk areas for manufacturers, including data integrity pertaining to government reimbursement practices, and kickbacks and other illegal remuneration. These issues are addressed in the Edwards Standards and in Health Care (HC) Policies that Edwards has implemented. In the U.S., Edwards has voluntarily adopted the AdvaMed Code of Ethics on Interactions with Health Care Professionals, an industry code of conduct, as well as other industry codes of conduct promulgated in markets outside the United States. A specific annual dollar limit has been imposed on promotional materials, items or activities provided by an Edwards employee to covered recipients in California.
- Effective lines of communication. Edwards promotes an environment where employees can raise questions and concerns without fear of retaliation, and offers several resources for employees to report violations, which are promoted on the employee intranet, posters, wallet cards and other communications. One such resource is the confidential Edwards Integrity Helpline, which can be accessed by employees globally by telephone or a web portal. The toll-free number for the Helpline in the U.S. is 877.219.3178.
- Training. Edwards is committed to effectively communicating our Standards, policies and procedures to affected personnel, and provides appropriate education and training to employees and agents to help them meet their ethical and compliance obligations. Edwards regularly reviews and updates its training programs, and identifies additional areas of training on an “as needed” basis.
- Accountability. Edwards requires that all Edwards employees adhere to the Standards as a condition of their continued employment. Edwards supports ethical behavior, evaluating it as part of annual performance reviews, promptly investigating reports of misconduct and taking prompt disciplinary action against those who violate our Standards.
- Assessment. Edwards performs monitoring and auditing of the Program to evaluate its effectiveness, and conducts an annual employee Certification of Business Practices Compliance. The nature of our reviews as well as the extent of our compliance monitoring and auditing varies according to a number of factors, including regulatory requirements, changes in business practices, and other considerations.
- Remediation. Results of investigations, audits and monitoring are communicated to the Chief Responsibility Officer and business leaders. When an area for improvement is identified, Edwards takes appropriate corrective action.
Edwards recognizes that compliance is a dynamic concept, so we constantly review and update our Program to improve it and make it more effective.
Request a copy
To request a copy of this Global Integrity Program and Edwards’ annual declaration of compliance call 800-424-3278 (request the Compliance Department) or contact firstname.lastname@example.org.
Global business practice standards