AdvaMed wants to encourage member and nonmember adoption of the ethics code, says Christopher White.
In December, 2008, AdvaMed released a new version of its Code of Conduct. Changes in the code emphasize increased restrictions on promotional items and gifts. They also include clarified guidelines for conduct for entering into royalty arrangements and introduce parameters for providing products for educative purposes.
The organization updated the ethics code to better reflect the increasing expectations of patients, doctors, and news media. “In light of the focus on transparency…, the aftermath of the [accusations faced by] orthopedic companies in 2007, and increased scrutiny from the press, we felt it was time to reexamine the code,” says Christopher White, who serves as general council for the association.
AdvaMed's board of directors unanimously approved an overhaul of the code of ethics. The amended code clarifies appropriate and inappropriate activity between AdvaMed members and doctors and other healthcare professionals (HCPs).
Significant adjustments to the code include the following:
- Prohibition of gifts of any type, including all noneducational branded promotional items such as pens, notepads, coffee mugs, and raffles at trade shows, regardless of value.
- Explicit guidelines that allow for companies to enter into royalty arrangements with HCPs in exchange for substantial contributions that improve medical technologies.
- More-explicit prohibition on providing entertainment or recreation to HCPs. (Entertainment was previously allowed if modest in value.)
- A new section addressing evaluation and demonstration of products, which sets forth appropriate parameters under which companies may provide products intended to educate both doctors and patients about newer or improved medical technologies.
Doug Mowen says that increased transparency protects OEMs' relationships with physicians.
Doug Mowen, of PricewaterhouseCoopers, sees the changes to the code as a positive step, rather than an increased burden for device firms. PricewaterhouseCoopers LLP (a partner to AdvaMed) has praised the new code as a driver of innovation, helping OEMs and physicians collaborate without appearing biased.
“The code addresses the relationships with innovating physicians, particularly through its emphasis on royalties,” Mowen says. Increased transparency, he says, will protect those relationships. “The government doesn't care that these relationships exist. It just wants to ensure that payments are for services rendered.”
However, Mowen also says that the code only works if compliance is incorporated into the process. “The processes most device companies have are fundamentally sound, but it's about getting the right controls in, too.”
A working group comprising AdvaMed members created the updated code, White says. However, the association hopes that both members and nonmembers will adopt the standard.
Adopting the ethics code may soon be a necessity for device makers. Both state and federal governments are turning their attention to ethics violations, and increased scrutiny could affect medical device businesses. Massachusetts has just enacted a law that requires device firms to use AdvaMed's code of ethics to market device products in the state. Mowen says that state-by-state adoption would work, but a federal law for ethics is more effective. “It would be difficult to comply with inconsistent reporting systems across states.”