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7 Elements of a Compliance Program; AdvaMed Code of Ethics

May 5, 2009

The newly revised AdvaMed www.AdvaMed.org for HCP was presented yesterday at AdvaMed’s 9th annual Emerging Growth Company Council meeting in Newport Beach, California. It was a compelling presentation, and any emerging growth life sciences company, or any company interfacing with HCP need to pay attention.  R. Michael Scarano, a Partner with the law firm Foley & Lardner presented a compelling story that included 7 elements of a compliance program.

The 7 elements include

1) Written polices and procedures

2) Compliance Officer and committee

3)  Effective training and education

4)  Effective lines of communication (including anonymous reporting function)

5) Internal monitoring and auditing

6) Disciplinary enforcement

7) Mechanisms for resonding to detected problems

Conflict needs to be managed in several areas.  The example used in the presentation included a sales representative that offered to take his HCP client to lunch, with golf, hotel, airfare, and a tour of a company in the medical device business.  Putting it in plain terms, the day of the branded pen and paper, or logo golf balls, are over.  Lunch is acceptable as long as it is subordinate to the conversation, and it has to be reasonable.  Golf is definitely out, unless the HCP pays his way.

It would be wise to take a tour through the code, available for members on the AdvaMed website, and adopt it as part of your company if you are interfacing with health care professionals.

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