Ethics & Compliance
Edwards Lifesciences’ work to manage Ethics and Compliance supports our Aspirations to Excel as a Trusted Partner and Global Leader Through the Quality of Our Work and Create Exceptional Shareholder Value.
At Edwards Lifesciences, our commitment to ethics shapes all that we do. We build our success from a foundation of integrity and have long been dedicated to doing the right thing. In our work to develop lifesaving therapies, our leaders and employees know every decision matters, no matter how small. We hold our team accountable to the highest ethical standards, strengthening Edwards’ reputation as a trusted partner.
Global Integrity Program
The purpose of Edwards’ Global Integrity Program is to detect and prevent behaviors that could harm our company and the people we serve. It includes written policies, communication channels, employee training, and audits and monitoring to achieve compliance.
Our Chief Responsibility Officer (CRO) oversees daily implementation and typically reports monthly to our Executive Leadership Team (ELT) and quarterly to the Board of Directors. Our goal is to conduct leadership training on making ethical decisions in 100 percent of Edwards Lifesciences Leadership Program courses. We believe a culture of integrity exists only when each employee makes ethical decisions in their daily interactions.
Our Corporate Compliance Committee provides support and guidance to the CRO. Comprised of executive team members, including business unit leads and functional heads, the Committee meets quarterly to discuss progress. In addition, our regional compliance officers chair regional committees that oversee compliance at a local level.
Global Business Practice Standards
Edwards strives to be transparent regarding our standards for ethics and compliance. We make our Global Business Practice Standards, also known as the “Titanium Book,” publicly available on our website.
The Standards outline ethical behaviors to which all employees and third-party contractors must adhere. These include interactions with health care professionals, quality control practices, intellectual property and patient privacy. We promptly investigate any reports of misconduct and take appropriate disciplinary action. Edwards’ Board of Directors receives a quarterly briefing of all reports and findings.
All new employees receive a copy of the Titanium Book and must certify they have read it and agree to abide by all applicable laws, industry codes and company policies relevant to their work. We mandate online training on the Titanium Book upon hire, and bi-annually thereafter. Through this online training, we aim to ensure 100 percent of our employees certify to understanding and agree to comply with these standards.
All professional employees must also complete an annual online certification, reinforcing their commitment to the Standards. We conduct this process in multiple languages, including Chinese, English, French, German, Japanese, Portuguese and Spanish. In conjunction with the certification, we survey professional employees on topics such as fear of retaliation and whether they have reported misconduct. Our goal is to achieve 100 percent certification from professional employees every year.
Edwards Integrity Helpline
Our goal is to create a culture of trust so all employees feel comfortable sharing their concerns. The Edwards Integrity Helpline is available 24/7 for both United States and international employees. The Integrity Helpline is hosted by a third party. Callers can self-identify when making a report or can report anonymously, where permitted by law. Our head of corporate investigations is immediately notified of all reports to the Helpline and opens an investigation based upon the concerns raised. Employees can also report concerns through other channels. We encourage employees to report issues to their managers, executive leadership members, and other functional groups such as legal or human resources. They can also report concerns directly to the Ethics and Compliance team by email or telephone. We treat all reports as confidential and share only with those participating in the investigation and, if appropriate, take corrective action.
We treat each concern seriously and with equal respect, care and consideration for all involved. We strictly prohibit retaliation against any individual who reports a concern in good faith or participates in the company’s investigation.
Compliance with Industry Codes
Edwards’ collaboration with physicians is essential for the continued innovation of our technologies and therapies. We align our internal standards for ethics with country-specific industry codes of conduct and require adherence by all our representatives. These organizations include:
- AdvaMed (U.S. and China)
- Canada’s Medical Technology Companies
- Amid (Mexico)
- Korea Medical Devices Industry Association
- Medical Technology Association of
- Taiwan Code (TAMTA)
- MedTech Europe (Europe)
- Abimed (Brazil)
- Asociacion Nacional de Empresarios
- The Japan Federation of Medical
- Medical Technology Association of Australia
- Thai Medical Device Technology Industry Association
- Medical Council of India
- Singapore Medical Technology Industry Group
Edwards continually strives to improve our culture to promote ethical business practices, trust and good decision-making. We require all professional employees to complete an annual online certification, reinforcing their commitment to our Global Business Practice Standards. In 2016, we surveyed and sought certification for nearly 5,000 professional employees, representing 45 percent of our total population. Our goal is to ensure 100 percent of applicable employees certify to understanding and agree to comply with Edwards’ code of conduct on an annual basis. For those certifying in 2016, we achieved a 97 percent participation rate. We did not require employees on leaves of absence to respond. Less than one percent of survey respondents globally indicated ‘no’ to the question of whether they could openly discuss ethical business practice concerns in the workplace without fear of retaliation. We followed up with 100 percent of these respondents. On our integrity helpline, only 25 percent of cases received at Edwards were anonymous, compared to 42 percent for the medical technology industry overall, as reported by our independent third-party case management system provider.
Also in 2016, we held our 4th annual Compliance Day in more than 20 sites worldwide and issued more than 4,500 raffle tickets to both corporate and manufacturing employees. Our annual Compliance Day engages employees across geographies, job descriptions and cultures to reinforce Edwards’ Credo and culture of integrity. This is one day around the world where we shine a spotlight on ethics and compliance, regardless of where employees are located, and reinforce the values we all share as Edwards’ employees.
Our theme was “We ALL Own Compliance.” Ethical activities included: Wheel of Fortune, Jeopardy and origami heart creation with ethical messages. In 2016, we added an Information Security awareness component to the event in select offices and plants, which were well attended with more than 3,500 raffle tickets issued.
Another goal in our ethics and compliance program is to conduct leadership training on making ethical decisions in 100 percent of Edwards Lifesciences Leadership Program (ELLP) courses. In 2016, we held two ELLP courses with over 40 leaders participating from around the world including New Zealand, Dominican Republic, France, Switzerland, Israel, Japan, Puerto Rico, Brazil, Singapore, U.S. and China. Living our Values and Making Ethical Decisions were significant aspects of the training provided in each of these multi-day courses.
Each year, the CRO conducts a self-assessment of our compliance program. The CRO updates the Board on the key elements of the program, including organizational structure and oversight, monitoring and auditing, training and communications, investigations and discipline, policies, and risk management. In December 2016, we responded for the first time to a robust third-party survey and assessment conducted by The Ethisphere® Institute. The Ethisphere survey reflects leading and current best practices, and offers companies a comprehensive look at their programs. We responded to more than 100 questions and provided supporting documentation on topics related to corporate governance, compliance and ethics, leadership and sustainability. As a first-time applicant, we were honored to be recognized as one of the World’s Most Ethical Companies.