Chairman and CEO
A message from Mike Mussallem, Chairman and CEO
Our reputation and integrity are central to Edwards Lifesciences' ability to be successful globally. Integrity is a key ingredient in building and maintaining our relationships as trusted partners, both internally and externally.
At Edwards, our people are committed to integrity, honesty, openness and fairness. Edwards' Global Business Practice Standards, what we call the Titanium Book, is a
practical guide to help us with business practice issues we face as a dynamic, growing corporation. It helps explain the universal principles governing our business, provides clarity about expectations and identifies resources that support these standards. We ask each of our employees to read this document carefully to be sure they understand its content and are willing to embrace its principles. We also depend on each employee to exercise intelligence, common sense and good judgment as they apply the principles in their work.
Our reputation must be guarded carefully and reinforced continuously through our actions. Our employees' performance and commitment to conducting Edwards' business in a manner consistent with our Global Business Practice Standards and Our Credo are essential to Edwards' continued success.
VP, Chief Responsibility Officer
A message from Diane Biagianti, Chief Responsibility Officer
Edwards Lifesciences has long been committed to doing the right thing. Compliance and ethics are a part of who we are and what we do. Our Board of Directors and senior leadership are committed to maintaining our ethical culture and give their unwavering support to our Global Integrity Program. As Edwards’ Chief Responsibility Officer, I oversee our compliance program. We strive to embed compliance in every aspect of our business. We challenge every employee worldwide to do the right thing and to lead by example. At Edwards, we recognize that success is built on integrity, and hold ourselves to the highest ethical standards. That is good business, and it is the right thing to do.
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
As part of Edwards Lifesciences Corporation’s ongoing efforts in the area of compliance, we have developed a comprehensive compliance program referred to as the Edwards Global Integrity Program, which is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of our products. Edwards holds its employees responsible for compliance, and expects each employee to comply with its Global Integrity Program. While Edwards cannot entirely eliminate the chance of individual employees engaging in conduct defined as non-compliant by Edwards policy, Edwards has made and continues to make a good faith effort to promote its Global Integrity Program, to prevent incidents of non-compliance and to address any inappropriate conduct.
To our knowledge as of the date of this declaration, Edwards Lifesciences is in compliance, in all material respects, with such comprehensive compliance program, as described here, and with California Health and Safety Code sections 119400-119402.
A copy of the Edwards Global Integrity Program and this annual declaration of compliance may be obtained by calling 800-424-3278 (request the Compliance Department) or by contacting email@example.com.
Dated: September 1, 2018
Edwards Lifesciences has established various methods and resources for raising ethics questions and concerns, and encourages employees to “Speak Up” if they have a question or concern. These resources are outlined in our Global Business Practice Standards. One such resource is the Edwards Integrity Helpline, a reporting resource that is available 24 hours a day, 7 days a week. It is hosted by a third party. Any matter reported through the Helpline is treated confidentially and shared only with those that need to know for purposes of an investigation and, if appropriate, corrective action. Reports can be made to the Edwards Integrity Helpline anonymously, as permitted by local law. In certain countries, anonymous reporting is prohibited and Edwards may be required to reveal a caller’s identity.
Edwards strictly prohibits retaliation against any individual who reports a concern in good faith or participates in the company’s investigation of such a concern.
The Edwards Integrity Helpline can be accessed by telephone in the U.S. by dialing 877.219.3178. Telephone numbers and instructions for employees based in other countries are published on the Edwards employee intranet. Reports to the Helpline may also be made via the internet:
Providing innovative solutions for people fighting cardiovascular disease requires collaboration with health care providers. Edwards Lifesciences is committed to ethical and socially responsible business practices, and respects the obligation of health care professionals to make independent decisions regarding medical technologies. In addition to our Credo and core values of integrity and service on behalf of customers and patients around the world, Edwards has adopted industry codes of conduct that govern our interactions with health care professionals. In the United States, we play an active role in the Advanced Medical Technology Association (AdvaMed), and have adopted the AdvaMed Code of Ethics on Interactions with Health Care Professionals. Outside the United States, we have adopted similar codes of conduct. To learn more about these medical technology associations and the codes we have adopted, you may visit the websites listed above.
Our sustainability commitment begins with our Credo which guides our values, spirit, and conscience in everything that we do, and forms the framework for our Aspirations, which are the goals that inspire us every day. As a leader in patient-focused innovation, we will engage in dialogue and transparency with our stakeholders to act as trusted partners and be accountable for our environmental, social and governance performance.
Based upon feedback from our stakeholders, we established several sustainability targets that cover product health and safety, ethics and compliance, access to healthcare, transparent communications, patient experience, product design and innovation and employee engagement. To learn more about our annual performance, visit our sustainability report.