For the first time in nearly a decade, the Advanced Medical Technology Association (AdvaMed) has updated its Code of Ethics on Interactions with Heath Care Professionals (HCPs) in the United States (the Code or the AdvaMed Code). On January 9, 2019, AdvaMed announced that its Board of Directors has approved an updated Code, which will take effect on January 1, 2020, and replace the current version of the Code in effect since July 1, 2009. As described by AdvaMed President and CEO Scott Whitaker, “[t]he updates reflect evolving legal standards, care delivery models and best practices over the last decade . . . and are designed to ensure the Code’s continued effectiveness as a premier foundational document for ethics and compliance across the medtech industry.”
The AdvaMed Code is a set of recommended ethical guidelines for medical device manufacturers to observe when collaborating with HCPs. Leaders in the medical device industry drafted it to help ensure compliance with certain state and federal laws and regulations, such as the federal Anti-Kickback Statute. Although not law, the AdvaMed Code carries some weight with federal enforcement authorities, who generally view the Code as setting the standard for ethical interactions between medical device manufacturers and HCPs. Many states have also enacted laws that either reference or mandate compliance with industry codes.
The updated AdvaMed Code contains several new sections to address the additional types of HCP interactions that have surfaced in recent years. The new topics include: education and marketing programs conducted jointly by device manufacturers and HCPs, manufacturer communications about the safety and effectiveness of their products, manufacturer representatives providing support in the clinical setting, placement of consignment products at an HCP’s patient care setting, the applicability of the Code to interactions outside of the U.S., and catch-all cornerstone values to regulate activities not expressly addressed in the Code.
In addition to the new sections, the updated Code adds guidance to supplement certain topics addressed in the current version of the Code. The updated Code clarifies, for example, when device manufacturers are deemed to have a “legitimate need” to enter into consulting arrangements with HCPs. In addition, the update establishes several new sections to better organize and consolidate the guidelines governing when device manufacturers can cover HCPs’ meals and lodging expenses, and when they can provide grants, sponsorships, and donations to third-party programs.
