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Understanding the New Rules for Speaker Programs

A mid-February virtual summit will address the PhRMA code changes that took effect on January 1, which have shifted how pharma and med-device companies can educate physicians through on-site events.

A Chinese proverb says, “May you live in interesting times.” Among those who plan speaker programs for life-sciences companies, the Covid pandemic was surely interesting enough that they’d prefer a smoother event landscape going forward.

However, January 1 brought yet another “interesting” wrinkle that these planners must address: Changes to the Code on Interactions with Health Care Professionals, known as the PhRMA code, for speaker programs involving HCPs.

The Latest Challenges—and a Forum for Addressing Them
The most recent changes to the PhRMA code are primarily focused on speaker programs, including the venue used, meals and drinks offered, and frequency of attendance by HCPs. According to a summary on the website of Hyatt, Phelps, & McNamara PC, a law firm that advises life-sciences companies on FDA regulations, “the substantive updates to the code are directly traceable to critiques of speaker programs” detailed in a November 16, 2020 Special Fraud Alert issued by the Office of Inspector General at the U.S. Department of Health and Human Services—even though there’s no reference to the OIG Special Fraud Alert in PhRMA’s announcement.

Specifically, OIG provided examples of practices “that are common in violative speaker programs conducted with the intent to induce healthcare professionals to prescribe or order products paid for by federal healthcare programs.” Violations include holding programs at non-conducive venues or events; providing meals that exceed being “modest by local standards”; repeat attendance by HCPs at substantially similar training sessions; and attendance by an HCP’s friends or family members.

More details about the code revisions—as well as reactions from planners and physicians—can be found in this MeetingsNet article.

Screen Shot 2022-01-19 at 1.39.50 PM.pngIn light of the changes that might be required across many speaker programs, show organizer Informa Connect (the parent company of MeetingsNet) is focusing its annual Speaker Programs Summit, set for February 15-17 as a virtual event, on “how industry has aligned its speaker programs’ policies and processes to the recent shifts in the PhRMA code and to the OIG Special Fraud Alert,” according to Tracey Kimball (pictured here), senior conference producer for Informa Connect who heads up the show.

A longstanding annual program for life-sciences marketing operations, marketing, compliance, and legal executives to discuss current challenges and best practices and to benchmark with peer companies, this year’s summit “examines all the PhRMA code updates, the possible interpretations of them, and the ways in which industry is responding,” Kimball says. As of now, “these PhRMA code updates are specific to speaker programs and not currently across all medical events.”

The Speaker Programs Summit was originally planned as a hybrid event to take place in Philadelphia on February 16 and 17. But in early January, “we made the decision to transition to fully virtual, to ensure the health and safety of attendees,” Kimball notes. “In turn, we chose to extend the agenda to three days and have fewer sessions each day, giving virtual attendees time to participate in the conference and still address their day-to-day work matters.

Even in the virtual environment, the event is designed to be “discussion-driven and very interactive,” says Kimball. There will be live polling, facilitated Q&A segments, networking sessions, and breakout discussion sessions so that attendees can connect with their peers and “gain a clear understanding of whether their approaches to addressing the PhRMA code changes align with the broader community that deals with speaker programs.”

More details and the registration page for the mid-February Speakers Programs Summit can be found here.

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