Changing Regulations: Compliance Effects Vary

When more stringent conflict of interest rules were adopted last fall for continuing medical education, some foresaw an end to the sharing of cutting-edge research sponsored by individual pharmaceutical companies at health care-related tradeshows.

But by the time the new rules went into effect last month, CME event providers had come up with strategies to avoid the potential conflicts the regulations were aimed at eliminating.

To comply with the Accreditation Council for Continuing Medical Education's "updated standards for commercial support," Advanstar Communications retooled its CME unit, separating the educational conferences from affiliated magazines that sold advertising.

And because Reed Exhibitions was just forming its Reed Medical Education unit, company officials were able to easily incorporate the new regulations, rather than make changes to existing programs.

"We'll be starting off already in adherence with the new regulations — with a completely unbiased third-party platform program," said Julie A. Brown, vice president of Reed Medical Education.

The regulations require accredited providers to not only disclose potential conflicts of interest, but also come up with ways to resolve them. ACCME defines a financial relationship as one in which an individual receives a salary, royalty or intellectual property rights. No dollar amount was set, but the financial relationships were only deemed relevant if they'd occurred during the past year.

According to ACCME, "circumstances create a conflict of interest when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship."

The accreditation group requires that providers obtain financial disclosures beforehand from speakers, planners and authors. Furthermore, individuals who refuse to disclose relevant financial relationships are disqualified from participating in the development or management of CME activities.

Providers can eliminate problems by removing speakers with conflicts from the agenda or suggesting that speakers limit presentation subject areas to avoid potential conflicts. They must document the ways in which conflicts are eliminated so they can be verified by ACCME.

Marissa Seligman, vice president of Pri-Med Institute, which handles compliance and accreditation for M|C Communications, said it helped that ACCME invited providers to come up with ways to resolve conflicts. M|C is taking a peer-review approach, since the company already had that process in place.

For the most part, she said, the transition has been easy, since ACCME also gave providers plenty of time to make the changes. But initially, said Seligman, some providers resisted the new rules.

The biggest challenge so far is educating faculty members and collaborators. "Faculty members are not as aware as providers are in terms of the mechanisms that need to be put in place," she said.

Brown, who has 15 years' experience working with CME, said speakers for Reed Medical Education's first event, Oncology World Congress, set for Nov. 17–19 at New York's Marriott Marquis, were all aware of the new regulations.

Brown added that one easy way providers can avoid conflicts is by holding multi-sponsored, rather than single-sponsor, events. "We will never do, as Reed Medical Education, single-sponsored events. In my personal opinion, that is where most of the issues lie. If it's a multi-sponsored event, it has to be fairly fair and balanced," she said.

In addition, the program is peer-reviewed. "It should be regulated. It should be watched. But in the final analysis, there's great research being conducted by pharmaceutical companies. They need to be heard from," Brown said.

Reed Medical Education was established as part of an innovation project with sister company Elsevier's office of continuing education. The medical education unit will handle events only, with separate units producing publications.