By Nancy Travis, Vice President, Global Compliance and Governance at AdvaMed
Note: This article was originally published on LinkedIn
As many of you know, I work for AdvaMed, a trade association that represents medical technology companies – companies that have been on the front line of responding to the COVID-19 pandemic, manufacturing more of the vital equipment that health care workers need, developing new technologies and diagnostic tests, transforming existing manufacturing lines to new needs – the list goes on and on.
From this birds-eye view, I have been struck by two things: 1) people in our industry are driven to do the best they can, as quickly as they can; and 2) they want to do it the right way. The main focus of my job at AdvaMed is to oversee the implementation of our Code of Ethics on Interactions with Health Care Professionals. Almost as soon as the coronavirus crisis emerged, I began to receive urgent questions from our members: “I have a training scheduled over lunch and now it’s virtual, can I still send lunch?” “I have boxes of surgical masks in my warehouse, can I send them to the hospital down the street?” “My technicians are not needed for elective surgeries and want to volunteer at the hospital, can they go?”
Everybody wants to support the COVID response effort, but how you do it matters. The guidance in the AdvaMed Code of Ethics is derived from various U.S. statutes and guidance, including the False Claims Act and Anti-Kickback Statute, which both very much still apply even during a state of emergency. Therefore, we quickly convened a group of senior compliance leaders to talk through the new emerging issues and created a COVID Compliance Working Group to develop guidance. This was published earlier this month and is available here. We decided that the fundamental principle of the AdvaMed Code of Ethics still applies: arrangements anticipated and described by the members who had raised important questions can go ahead as long as they do not constitute an incentive to sell more products – or reward past purchases.
Looking at the example of the box of masks, if the hospital that is asking for those masks happens to be your best customer, and there’s another hospital down the road with the same need but a less robust purchase history, you may feel pressure to reward that good customer, which would not be appropriate under the Code of Ethics. Our guidance recommends putting in place a single approval point that ideally is governed by a panel that includes representatives from several different business areas, one of whom should be a Compliance Officer. In addition, it recommends documenting that decision-making process so that the company can demonstrate that the donation decision was based on need, not greed.
AdvaMed has been working with its association partners around the world to share challenges, best practices and work together on a consistent response. In all my interactions, I have been struck by how theCOVID-19 pandemic has only sharpened the industry’s commitment to business ethics. Now is precisely the right time to reinforce our efforts together.
As the medtech industry continues to grapple with its response to the challenges of COVID-19, I can recommend three best practices that have emerged from these global discussions:
First, each medical technology company and association should continue to place ethics and compliance as a top priority during and after the crisis. This means involving your compliance leadership in the COVID-19 response team and as appropriate in business decisions, broadening compliance linkages and awareness across the entire business. As an example, ethics and compliance leaders are sometimes the first line of defense with a company’s business team in identifying inappropriate circumstances in the marketplace that could drive an uneven playing field. Alerting such circumstances to trade associations or government agencies can help ensure a “race-to-the-top,” and an ethical business environment can be maintained.
Second, all should continue to embed best practices. While uncertainties abound during a crisis, the medical technology industry’s established guidance and best practices remain clear. The AdvaMed Code of Ethics focuses on guidance for collaborations with physicians and other healthcare practitioners to bring the most effective and innovative care to patients around the world. AdvaMed updated the code in January 2020 to include a number of new tools that can benefit the industry as they reinforce business integrity during and after the crisis.
An important issue to underscore is the continued importance of ethical third party intermediary relationships. There are more medical device distributor associations partnering with medical device company associations in this effort than ever before. The APEC Guidance for Third Party Intermediary Relationships in the Medical Device Sector and Bogota Principles bring forth key implementation tools such as communication, policy, and legal references. Leveraging these best practices and resources will help continue to embed business integrity with industry stakeholders and third parties.
Third, each company should work to enhance collaboration among diverse stakeholders through leading international platforms. Examples of these platforms include the Business Ethics for APEC SMEs Initiative in the Asia-Pacific, and the Inter-American Coalition for Business Ethics in the Medical Technology Sector across the Western Hemisphere. Such platforms can facilitate coordination on unified strategy, communication, and identification of emerging ethical challenges as a result of COVID-19. Robust platforms that include broad health care stakeholder groups – including medtech industry participants, health care professionals, providers, governments, and patients – can help reinforce our goals to uphold and promote integrity while fostering a level playing field for the benefit of patients.
The medical technology industry remains devoted to leaning into trusted collaborations established with many health care stakeholders as we address the COVID-19 pandemic. The source of this motivation comes from our unwavering commitment to save lives and improve patient health before, during, and well after the crisis. I invite you to join us.