MedTech Compliance Values

MedTech Compliance Values

By Nancy Travis, Vice President, International Compliance and Governance at AdvaMed

At the Global MedTech Compliance Conference that occurred in Paris this past May, I heard a lot of discussion around values-based compliance systems. This to me is emblematic of a shift away from rules-based, “check-the-box” compliance programs and toward something more comprehensive, and a change in culture within the health care system, the medtech space and individual companies themselves. By focusing on values, companies seem to recognize that ethical practices can and must permeate throughout the business.

At this conference, the Advanced Medical Technology Association (AdvaMed), announced the revision of its Code of Ethics on Interactions with U.S. Health Care Professionals, effective January 1, 2020. One of the most noteworthy improvements in the AdvaMed code is, in fact, the inclusion of a new section on values. Called “Cornerstone Values,” the code instructs medtech companies to review all interactions with health care professionals, considering these values and avoid anything that would circumvent them. The values are as follows:

Innovation: Advance the development and availability of safe and effective medical technology that health care professionals use to improve & save lives.

Education: Deliver high-quality training and education to help ensure that health care professionals safely and effectively use medical technology.

Integrity: Conduct business with integrity at all times and avoid real or perceived conflicts of interest with health care professionals.

Responsibility: Promote socially and ethically responsible business practices that protect patients, their rights and their safety.

Transparency: Conduct interactions with health care professionals fairly, openly and transparently.

I know from joining the revision discussions with the AdvaMed Code of Ethics Working Group – brilliantly described by my former colleague Matt Wetzel in this article, “ that AdvaMed members undertook a thoughtful process to align these values with those articulated in recent years through the code development processes in Asia-Pacific (Kuala Lumpur Principles, 2011), the Americas (Bogota Principles, 2017) and the global effort announced last year at this meeting, when the Global Medical Technology Alliance (GMTA) approved a Joint Statement on Global Harmonization”. Last month, the GMTA held the first meeting of the Global Compliance Network, where its member industry associations reaffirmed the values in that document and their pledge to work together to promote strong codes of ethics worldwide. 

To continue this discussion, I along with Jonathan Turner, Vice President of Ethics & Compliance at Smith & Nephew and Kristi Travers, Assistant General Counsel at Johnson & Johnson with Matt Wetzel, Senior Counsel at Akin Gump Strauss Hauer & Feld LLP moderating will speak at “AdvaMed’s New Code of Ethics: Is Your Company Prepared to Comply” session at The MedTech Conference in Boston this September. We will be discussing the Code of Ethics on Interactions with Health Care Professionals and how to get your company into compliance with only a few months left to prepare.

AdvaMed is looking forward to working with its medtech colleagues worldwide, as well as all health care industry stakeholders, to continue to advance these cornerstone values and build a firm ethical foundation for the medtech industry across the globe. We have a bright future ahead of us in medtech compliance. Together, we will facilitate a medical technology industry that sincerely serves the best interests of its patients, no matter where in the world they receive their care.