• FDA
• ACRP
• AdvaMed
  • AdvaMed 2009 Conference
• PBMI
• EduQuest
• ISNetworld
• Seventh Generation
• Silliker
• The 8.45 Club

At the October 11-14 annual AdvaMed conference, Kaplan EduNeering organized and participated in a panel entitled Putting the Code into Effect.  The panel focused on AdvaMed’s revised Code of Ethics on Interactions with Health Care Professionals, which went into effect on July 1, 2009.  Leading the panel was Link Bonforte, a 30-year industry veteran who led the AdvaMed initiative to revise and restate its Code of Ethics.  Joining Link on the panel were Mark Bonaguro, Chief Compliance Counsel at Covidien, Donna Hill, General Counsel at Sarnova, and Joel Rogers, Vice President of ethics and compliance at Kaplan EduNeering.

The session was covered in an article published by Inside Washington Publishers following the conference. The article quoted Donna Hill, who described the typical company reaction to the revised Code, “The initial reaction is, ‘You’re going to change everything, we don’t want to do it.”  The reaction is understandable.  The AdvaMed Code of Ethics sets strict standards of behavior that allow companies to meet or exceed compliance requirements set by the FDA.  According to Hill, the goal of companies now is to integrate the Code into their business strategies.  Mark Bonaguro took the goal one step further, noting that training should emphasize the stringent enforcement environment – an environment he expects to grow in intensity.

Training on the Code is a subject Kaplan EduNeering takes seriously.  As the exclusive online learning partner to AdvaMed, we co-authored an online course on the topic.  The new AdvaMed Code course joins the more than 100 courses in our library used to achieve compliance with device regulations. 

So, even though we recognize the seriousness of the Code topic, we decided all of us could use something to liven up the discussion during the panel.  That “something else” was an interactive audience response segment – and it definitely stimulated robust discussion around the room.  It also produced some very interesting data that we’d like to share:

• While 75% of companies represented have implemented the AdvaMed Code, fewer companies have integrated it into their larger compliance and ethics programs.

• Training is a multi-prong process and the panelists recommend a mix of in-person training, role-playing, bringing in their law firm, and using online training.  But for sustaining the program and for onboarding, online training wins out.

• While almost 40% of participants provided training to their contractors, agents, distributors and other third-party manufacturers, their approaches and expectations varied widely.  More telling, some 60% have not yet tackled the issue of downstream training.

• Getting to the heart of the problem was our question on problems of introducing the new “rules” to the HCPs (largely doctors).  To quote one participant, “There is tremendous pushback from the doctors who continue to expect to be wined, dined, and golfed for our business.”

• Even thornier was the discussion about what the competition is doing and how their actions might impact a compliant company.  The panel was quick to caution that there were no gray areas – and even if your sales rep paid for a gift from his personal funds, it is still a violation of the Code and of company policy.

• Interesting responses on the question of the most challenging Code element.  Distinguishing between CME (continuing medical education) and HCP requirements caused confusion in some companies, particularly related to sponsorship of events.  Issues also continue to pop up about what is allowable in product demonstration and the definition of “modest meals.”

• Several scenarios were posed, with the one shared below focusing on proper behavior at an annual industry event.  Bottom line, the event needed to meet the “sniff test” for the CCOs in the room to accept it.

The panel discussion showed us that there were still questions about the Code, but it also showed that the majority of companies represented at the conference were moving forward in integrating the Code standards into the framework of their companies – and the behaviors of their employees.