HCEA Teleconference Probes into Effects of Revised AdvaMed Code

No more “business as usual” for medical device marketers was a predominant message during HCEA’s teleconference “Expert Insight:  The Inside Story on the Objectives of the Revised AdvaMed Code.”  The interactive educational teleconference, held February 17, 2009, provided valuable perspective on the objectives of the updated provisions and gave callers some pointers regarding compliance with the new code.

The presenters, Andy van Haute, Associate General Counsel, AdvaMed, and Kristine Rapp, Vice President, Global Ethics & Compliance, Hospira, Inc., were instrumental in the development of the new version of the “Code of Ethics on Interactions with Health Care Professionals.”  In addition, the teleconference, which was sponsored by Ascend Media, was moderated by Eric Allen, Executive Vice President, HCEA.

Van Haute and Rapp began the teleconference with background information on the general increased scrutiny targeting the medical device industry over the last few years.  For example, they provided information on various state and federal legislative initiatives governing device firms’ interactions with healthcare professionals, including the recently reintroduced Physician Payments Sunshine Act.  Then the presenters offered some specific history on the AdvaMed Code, which was originally introduced in 1991.  In 2003, AdvaMed released a revised version of the code (similar in many ways to the original PhRMA Code) that went into effect in 2004.  The most recently revised version (officially announced in December 2008) involved contributions from more than 80 people representing more than 60 device companies. 

Van Haute and Rapp explained that compliance with the code remains voluntary, but AdvaMed encourages all device companies – both AdvaMed members and non-members – to consider adopting its provisions.  The speakers also said that the code has two guiding points:  1) encouraging ethical business practices and responsible industry conduct, and 2) opposing unlawful inducements for selling healthcare products. 

The speakers next delved into the updated provisions, which go into effect July 1, 2009.  For instance, similar to the revised PhRMA Code, the new AdvaMed Code disallows branded giveaways such as pens, but it does allow educational gifts to physicians that provide benefits for patients.  The new code’s preamble makes a distinction between how device firms and pharma firms interact with healthcare professionals; for example, device companies often have more extensive interactions with doctors because they must train them how to use their products.  Also, the presenters described new details related to compliance with the code, including an annual certification process that companies may adopt to show they have implemented the code. 

Van Haute and Rapp stressed repeatedly that medical device manufacturers must always consult with their own attorneys to decide which compliance strategies work best for them.  They also made clear that the increased pressure from federal, state and industry groups is likely here to stay.  “Scrutiny is not going away,” explained van Haute. 

Further exploration of the updated AdvaMed Code will be featured at the 2009 HCEA Annual Meeting, to be held June 13-16 in Tampa.  Click here [link] to register and to get more details on the HCEA Annual Meeting.

In addition, HCEA will be providing other distance-learning opportunities in 2009, so stay tuned for information on these convenient new options for HCEA education.