Issue: July 2009
July 01, 2009
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Updated AdvaMed code of ethics for medical device industry goes into effect

The code contains guidelines on royalty provisions and use of evaluation and demonstration products.

Issue: July 2009
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A revised code of ethics regarding conduct between the medical device industry and health care professionals issued by Advanced Medical Technology Association (AdvaMed) becomes effective this month.

The re-vamped Code of Ethics on Interactions with Health Care Professionals (see Orthopedics Today March 2009, page 20) covers a myriad of topics from payment of royalties to the giving of charitable donations. The code went into effect on July 1.

“Our code of ethics cut new ground and provided new guidance in areas where there was not a lot previously, either in our code, or [detailed] by other legal authorities,” Christopher L. White, JD, general counsel for AdvaMed, told Orthopedics Today.

AAOS

The voluntary code serves as a risk-management device that is mutually beneficial for medical device companies and health care providers working together.

“We must not fool ourselves,” White said during a recent presentation at the American Academy of Orthopaedic Surgeons annual meeting. “Although there are redeeming aspects of these relationships and although they are appropriately close, they are viewed with suspicion in some corners because they are so close. There are unique risks that come with a close relationship and our code of ethics seeks to address those risks.”

Royalties and products

The updated code establishes new guidelines regarding royalty provisions and evaluation and demonstration products.

“Royalties are entirely appropriate under our code of ethics,” White said. “They just need to be structured appropriately to ensure the integrity of the decision making and its independence in regard to product selection.”

He noted that the adopted approach is similar to that of the deferred prosecution agreements, but differ as it is constructed to apply to the whole industry.

The new guidelines regarding evaluation and demonstration products may manifest in the form of companies implementing stronger inventory control procedures or paying greater attention to device labeling, White said.

“We recognize that it is important for medical device companies to provide physicians demonstration products for evaluation purposes,” he said. “[But], we must be very careful to avoid the appearance that these are inducements.”

Limitations

Clear guidelines are also drawn in the code which prohibits companies from providing recreation or entertainment to health care professionals.

“The risks here are great and real,” White said. “Our industry concern is that the very credibility of our relationship is at stake because there are sometimes easily characterized premises on entertainment or recreation in the popular press.” Gift giving, including the distribution of branded promotional items, is also prohibited.

Since compliance is voluntary, some have said that the code lacks teeth. White acknowledged that there are limitations to the actions that AdvaMed can take and noted that the group is calling on companies to submit a signed, public document certifying their compliance each year.

“We received feedback from some groups that the code does not go far enough,” White told Orthopedics Today. “Some say that it goes too far. Some wonder why we have a code that differs from the pharmaceutical industry’s code. Ultimately, some of those questions are based on an under-appreciation for some of the unique attributes and interactions within the medical device industry.”

For more information:
  • Christopher L. White, JD, can be reached at AdvaMed, 701 Pennsylvania Ave., NW, Ste. 800, Washington DC 20004; 202 434-7233; e-mail: cwhite@advamed.org.
Reference:
  • White CL. Current: What’s happening in the orthopaedic industry? Advanced Medical Technology Association (AdvaMed) perspective. Symposium W: The evolving orthopaedic surgeon-industry relationship. Presented at the American Academy of Orthopaedic Surgeons 76th Annual Meeting. Feb. 25-28, 2009. Las Vegas.