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Rules & Regs

Planners of pharmaceutical and medical meetings know the regulations that govern these gatherings are extraordinary, even by the standards of a profession where attention to detail can literally mean life or death. But what’s less well known is how those regs affect their negotiations with conference venues, hotels and vendors.

Lisa Keilty, CMP, HCC, vice president of planner-strategy firm PMC2, specializes in helping planners determine how the regulatory system affects everything from negotiating with venues to ensuring planners can adjust to last-minute changes in drug or device approvals. The first thing she does is help the client determine whether it’s an opportune moment to hold a particular meeting at all, given that pharma and medical meetings mix the three most unpredictable elements—science, people and government—that a planner can face.

“I don’t have checklists per se, but I work with clients to produce decision trees to decide whether they’re truly ready for this meeting or not,” Keilty says. “I help design proactive documents and processes so they don’t book a hotel that they don’t use and then lose, or pay a penalty. ... [I] make sure they are driving the process and not the process driving them.”

Keilty calls this process “aggressively tiptoeing,” a way of quietly helping the client double-check what they want, and most importantly need, from a meeting—and that they want it now.

If the answer is yes, a planner must then ask whether a healthcare professional (HCP) will be present. The client should be able to state whether they’re defining an HCP broadly—physicians, pharmacists, dentists, nurse practitioners, nurses, chiropractors—or narrowly, such as only those who write prescriptions.

That client definition then serves as the basis for much of what planners should discuss during subsequent negotiations.

“Anyone managing and interacting with the host needs to understand what their definition is, as ABC Pharma or ABC Device is allowed to apply that definition” based on their understanding of the law, Keilty says.

Beyond legal regimes, planners of pharmaceutical and medical meetings must be aware of the type of meeting—corporate board, advisory board, sales meeting, clinical research, clinical trials, continuing medical education (CME) for physicians—and that their clients are in a highly competitive business. The sheer unpredictability of the regulatory environment is well-known—“Hey, FDA may approve our new medication tomorrow! Oops, no they won’t!”—but details such as cancelation penalties or the potential for sudden dips or rises in the number of attendees to seat, house and feed must be captured in contract documents, as well as in backup documents concerning accommodations, and food-and-beverage folios.

“Companies will ask for certain clauses to be in the hotel contracts that normally wouldn’t be requested,” Keilty says. “Here’s an example: non-compete clauses. So if there’s another pharma [company] in house, a pharma won’t or can’t have their meeting in there.”

Then there’s food and beverage, which is governed not just by how much the host can spend on a doctor’s lunch versus a salesperson, but by how things might look in any future media coverage.

“There are HCP-specific menus and food requirements, [but also] the perception issue,” Keilty says. “So the sales guys get foie gras and lobster, and the physicians get the ham sandwich.”

The list of variables goes on, ranging from signage to security to considerations that simply wouldn’t come up in planning a non-medical meeting, says Pat Schaumann, CMP, CSEP, DMCP, founder of the International Medical Meeting Planners Association (IMMPA) and president of Meeting IQ and Present China. “It could be things we bring into venues that are pretty scary. [For example,] explaining to the venue that we’re going to bring in blood and how we’re going to dispose of it.”

Here’s where large hotel chains may have an edge over smaller or independent properties, Keilty contends, because they can typically dedicate a salesperson to the pharmaceutical/medical market who then becomes well-versed in the planner’s and client’s needs.

“An independent boutique hotel may not know, but a Hyatt or Starwood, they have to know—not necessarily what is an HCP and what to put in the contract, but the triggers and deliverables of the life-sciences industry.”

Pat Schaumann notes that IMMPA and the Convention Industry Council are co-developing a healthcare-focused CMP subcertification program aimed at both planners and hoteliers, which she says is designed to allow them to share a body of knowledge and speak a common language.

“What’s most important is ... the supplier, the planner and the client having enough knowledge to understand what is going to be the primary business of the meeting so [they] have some commonality of understanding about the complexity of the regulations.”

Things get more complex when a meeting is at a non-U.S. venue, or when international attendees are present, Schaumann says. She has just published a reference book on pharma and medical meetings titled Breaking the Code to Healthcare Compliance. The tome covers not just the ins and outs of compliance with the Sunshine Act, the Pharma Code and other U.S.-centered rules, but features a global section on 196 other countries’ HCP-related regulations as well.

“We think it’s hard in the U.S., but plan meetings abroad and it becomes even more complicated,” Schaumann concludes. “Meeting professionals sometimes [need to] know more than physicians; we’re kind of the executors of compliance, and we’re on site and have to make sure things are done in a certain way.”

 

Paul Kretkowski is an Iowa City, Iowa- based writer who finally learned how to surf.

 

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About the author
Paul D. Kretkowski