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by Michael J. Shapiro | February 01, 2011

Planners in the medical and pharmaceutical fields have faced their fair share of challenges in the past few years. As the meetings industry continues its economic recovery, what are the major concerns still facing these specialists? M&C spoke with a number of leading voices in this niche market to get their views. Here's what med/pharma planners are up against.

1. Keeping abreast of the rules.  One of the greatest ongoing challenges for planners of medical and pharmaceutical meetings is fully understanding the influence of regulatory codes, restrictions and legislation, notes Pat Schaumann, CMP, CSEP, DMCP, president of St. Louis-based Meeting I.Q. and U.S. director of its affiliate, China Connect. "It's just mounds of information, and trying to decipher the codes, and to understand the ramifications of the Sunshine Act and health-care reform, is a serious challenge," says Schaumann, who also is founder of the Inter­national Medical Meeting Professionals Association.

Self-regulatory industry codes of ethics, as well as both federal and state legislation, deal primarily with interactions with health-care professionals -- and how to avoid undue influence, or the perception thereof, over the prescription and medical-device decisions doctors make. The PhRMA Code on Interactions with Healthcare Professionals, specifically for the pharmaceutical industry, was updated in January 2009, while the latest iteration of the AdvaMed Code of Ethics on Interactions with Health Care Professionals (advamed.org/MemberPortal/About/code), for medical-device manufacturers, took effect the following July.

Both codes offer guidelines for companies within the respective industries; it's up to the companies to develop and enforce internal policies. As such, in an effort to ensure compliance -- or to avoid the public perception that undue spending or influence is occurring -- company policies could change more often than the codes themselves.

Last year's passage of U.S. federal health-care legislation, which included provisions of the long-debated Physician Payments Sunshine Act, requires companies to disclose payments made to health-care professionals -- essentially giving the codes more teeth, as well as adding federal government oversight to the equation. Adding to that complexity is legislation passed in many states over the past several years, much of which specifies payment limits.

In other words, if the code changes caused planners' heads to spin, government oversight should intimidate them into thinking straight. "What's become very clear to companies over the past year," says Schaumann, "is that audits can take place, and you have to be able to account for every penny."

Bringing international health-care professionals to an event further complicates matters, since pharma and ethical guidelines also vary by country.

"The last event we handled was for physicians from 10 different countries," says pharmaceutical-industry planner Christine Kelly, managing director of Cheshire, U.K.-based Gemini International. "And each country had different regulations in terms of the level of hospitality allowed, so we had to find a balance that was suitable for everyone. Particularly in the U.K., that's becoming more and more of an issue." Regulations are different even among countries within the European Union, Kelly adds.

While the pharmaceutical and device companies ultimately bear the responsibility of compliance, notes Schaumann, it is incumbent upon third-party planners, such as her company, to understand the requirements and aid in the process. "If you're planning a health-care meeting or working with health-care companies, you need to stay in the game," she insists. "There's too much on the table, and I think it's up to planners to stay on top of trends and changes." That's a big reason Schaumann founded IMMPA last year. "We're trying to help as much as we can to educate planners about the latest that's happening in the industry," she says.

Of course, understanding the regulations is only part of the challenge. The end result of all the legislation and industry regulation is that companies are being held accountable for their spending, and tracking those dollars is crucial. "On top of needing to keep up with the regulations and what you can and can't do," says Teresa Bria, SMMC, president of Oakland, Calif.-based Bria Events, "there's just the sheer volume, the sheer workload, that's being added to the responsibilities of the meeting planner. My staff probably spends two-thirds of their time dealing with paperwork, and one-third actually planning the meeting."