MDMA Introduces a Conduct Code of Its Own

CONFERENCE NEWS: MDMA ANNUAL MEETING

The Medical Device Manufacturers Association (MDMA) has unveiled its own code of conduct, despite AdvaMed having already crafted one for the device industry. The association has decided that its members, which tend to be smaller companies, need a code that's more flexible.

It was presumed that MDMA would have its members follow the AdvaMed code. The association had even offered presentations about the AdvaMed code at previous events.

But unexpectedly to nonmembers, MDMA unveiled its own code of conduct at its annual meeting in May. “We asked, ‘Do we adopt the AdvaMed code, or do we do something that's a little more dynamic?'” said Jason Hannon, senior vice president and general counsel for NuVasive Inc. (San Diego). Hannon presented the code at the meeting.

AdvaMed created its code of ethics in response to negative publicity about relationships between device companies and healthcare professionals that some considered too cozy. The AdvaMed code addresses issues such as what sort of consulting arrangements are proper and what kind of gifts to doctors are reasonable.

AdvaMed's code is a list of rules that all of its members must follow. But MDMA's code is a series of suggested best practices that member companies are recommended to follow. Companies can adopt the code as they see fit, in ways that make sense for their individual companies and business practices, Hannon said. “The code is dynamic, not static, and it is based on real-life applications, not just policies,” he said. “We want everyone to think, whenever an exchange [with a healthcare professional] is involved, ‘what should we be concerned about?' MDMA will list what it thinks are the best practices, but if that doesn't work for you, you can make it different.”

For those who wish to adopt the code, the first step should be to get buy-in from senior management, Hannon said. This step is key because its goal is “to create a culture of compliance, more than strict adherence to a bunch of rules.”

Firms should conduct training for all employees, particularly those who interact with customers. Training should be live and in-person, and interaction and discussion of specific real-life examples should be encouraged, Hannon said.

The code defines a customer as “any person or entity in a position to purchase, lease, recommend, use, or arrange for the purchase or lease of products.” It prohibits any payments, cash or otherwise, designed to induce or reward the purchase of goods.

Product training and education are encouraged, because they are critical to being able to get a technology adopted so it can benefit patients. But “meals and hospitality must be reasonable in value and subordinate in time and focus to the training,” Hannon said. Likewise, sales pitches and product demonstrations may include hospitality, but it should be “subordinate in time and focus to the bona fide business purpose of the meeting.”

“Expenses must be reasonable and not ostentatious,” he continued. “What that means exactly may depend on your customer and your company culture. You need some level of reasonableness, and you can get to it by having a good culture of compliance.”

NuVasive has developed a number of policies based on the code, Hannon said. In NuVasive's case, gifts of cash are prohibited, as are gifts intended to induce or reward the purchase of products. The only acceptable gifts are those that benefit patients, have a genuine educational function, or are branded promotional items that have minimal value, such as pens. Donations for charitable purposes are acceptable as long as they are documented and cleared by management and a compliance officer and support bona fide independent medical research. Consulting arrangements must be in writing and reflect fair market value. They may not be offered as an attempt to influence purchases, he noted, and “they must be dealt with at the highest level.”

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