Pharma Rules, Unwrapped

This month, the Pharmaceutical Research and Manufacturers of America's updated, voluntary Code on Interactions with Healthcare Professionals will go into effect, featuring stringent rules on gifts and giveaways that some say could chase away exhibitors at continuing medical education events -- a specialized niche in the meetings industry that combines presumably nonbiased instruction with the commercial imperatives of a trade show.

Other guidelines, on details ranging from when meals are allowed to third-party compliance, are laid out in the revised code as well. And the PhRMA update isn't the only set of regulations that planners have to mind. Depending on the type of meeting and who the exhibitors are, the American Medical Association, the Accreditation Council for Continuing Medical Education, the Advanced Medical Technology Association, the American Nurses Credentialing Center and other accrediting bodies offer their own ethics and compliance codes to follow.

With more states passing their own disclosure laws, not to mention the Physician Payments Sunshine Act, introduced in the House of Representatives earlier this year, the medical meetings industry is awash in myriad regulatory measures, some voluntary like the PhRMA code, that make it increasingly complicated to navigate. What follows is a summary of the latest major developments and what they mean to planners.

Gifts and giveaways
The new PhRMA code pulls no punches: "Noneducational items (such as pens, note pads, mugs and similar 'reminder' items with company or product logos) should not be offered to health-care professionals or members of their staff...even if they are of minimal value...or are accompanied by patient or physician educational materials. It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or health-care professionals if the items are not of substantial value ($100 or less) and do not have value to health-care professionals outside of his or her professional responsibilities."

This elimination of giveaways has some planners worried that meetings revenue will decline. "There will be a reduction in exhibitors and their giveaways," asserts Nancy Arendt, director of education and meeting services for the Atlanta-based Medical Association of Georgia. "I am concerned, but the new code hasn't had any direct effect yet on our current planning. I know some pharmaceutical company exhibitors have stated that their hands are tied."

Arendt, who plans about four symposia and one annual meeting a year for her organization's 5,300 physician members, says she thinks many doctors are split on the new no-freebie rule. "Some physicians said that it's about time and that it will help clean up the industry," she notes, "but I know some doctors who want to go home with a bag of goodies." Instead of giving out pens and mugs, Arendt says exhibitors should favor education materials such as anatomical models or CDs, which are allowed as long as their value falls under the recommended $100 ceiling. "I think it's going to take a bit of reinventing the wheel for the marketing folks," she adds.

"The key here is that show organizers and exhibitors should work together to make sure the meeting exhibition floor continues to provide a quality experience for health-care providers to learn about life-saving therapies," says Jennifer Palcher-Silliman, director of communications for the Atlanta-based Healthcare Convention & Exhibitors Association. She notes that having longer exhibit hours and decreasing or eliminating other activities while the exhibit floor is open can encourage more traffic.

"This [new code] gives us an opportunity to increase the perception that we're about educating health-care professionals first," adds Palcher-Silliman.

In addition to the prohibition of noneducational gifts, the revised PhRMA code also stipulates the following:

•  Company representatives only "occasionally" may provide meals that are "modest by local standards" to healthcare providers "so long as presentations during those meals provide scientific or educational value" and "are not part of a recreational event."

•  All pharmaceutical company representatives should "receive training about the applicable laws, regulations and industry codes of practice, including this code, that govern interactions with health-care professionals."

•  Companies that choose to abide by the code and complete an annual certification will be listed by PhRMA on a public website.

To read the entire code, go to phrma.org.

Laws from all over
A number of new state disclosure laws could give some medical meeting planners more cause for concern than the revised PhRMA code.

For example, last August Massachusetts approved a law that, as of Jan. 1, prohibits pharmaceutical and medical-device companies from giving physi­cians payments and gifts, including travel and honoraria, with a value of $50 or more. "I already have questions from exhibitors," says Randy Bauler, CEM, director of corporate relations and exhibits for the Aliso Viejo, Calif.-based American Association of Critical-Care Nurses, whose National Teaching Institute and Critical Care Exposition will be held in Boston in 2013.

Bauler adds that exhibitors aren't sure to whom and where the state laws apply. "We're going to have to find out what they can and cannot do. Some exhibitors are saying that they have to ask anyone who enters their booth what state they are from."

Other states that have passed similar laws include California, Maine, Minnesota, Vermont and West Virginia, as well as Washington, D.C. And, according to the National Conference of State Legislatures, at least 27 other states have similar legislation in the works. 

Under most of the proposals, pharmaceutical and medical-device companies will be required to keep a list of all health-care providers who receive gifts exceeding the set limits in that state, and said list possibly will be made public. Policing and actual penalties vary from state to state.
 
"With the exception of West Virginia, all of the states that have laws on the books have penalties for noncompliance," notes Kathy Melley, director of communications for The Prescription Project, a Boston-based nonprofit organization that promotes the elimination of conflicts of interest between physicians and the pharmaceutical and medical-device industries, among other issues. Melley says that some states, like Minnesota, don't have the resources to police the law, but Vermont has sent out letters of noncompliance to companies that have failed to disclose their gifts. However, "we're unaware of any prosecutions," Melley adds.

"I certainly understand why states are passing these laws, but hopefully over time there will be a national consensus," says Bauler. In the meantime, on a federal level, the Physician Payments Sunshine Act was introduced in the House of Representatives in early 2008 and remains in deliberation. The measure would require all pharmaceutical and medical-device companies to submit the names and contact information of all health-care providers who receive gifts valued at more than $25, which would be available for public viewing. Companies that fail to comply with the law can be fined up to $100,000.

"Between the PhRMA Code and the state laws, it's a lot for our members to take in," acknowledges Palcher-Silliman.

Chicago-based independent planner Jackie Trimble, CMMM (certified medical meeting manager), says she keeps track of various state disclosure laws through the Accreditation Council for Continuing Medical Education. "The bottom line here is to use a tool that any good meeting planner uses: databases," advises Trimble, who has been planning medical meetings for 15 years. "Whether it's historic attendance figures, historic room rates or pick-up rates, those databases have to be maintained and revered," she adds. "Find a way to incorporate these state-specific laws into your working databases."

Pfizer vs. MECCs
Perhaps the segment of the industry experiencing the most volatility is medical education and communication companies (MECCs). Some in the industry say that MECCs are hired by pharmaceutical and medical-device companies for the express purpose of influencing doctors' prescriptions.

In the wake of aggressive legislation, pharmaceutical giant Pfizer announced last July it would stop all direct funding of conferences and meetings put on by such entities. (According to a report from the Wall Street Journal, Pfizer spent nearly $40 million on MECC-sponsored medical education last year.)

"We believe this change will significantly address the ongoing criticisms of conflicts of interest in industry-supported CME/CE, which persist despite increasingly high firewalls to protect against conflicts," Pfizer said in a statement. "We will still support CME programs at many of the world's leading academic medical centers and teaching hospitals, as well as programs sponsored by associations, medical societies and community hospitals."
 
The North American Association of Medical Education and Communication Companies issued a three-page response stating that the organization is "profoundly disappointed" with Pfizer's decision, and believes it might prompt other pharmaceutical and medical-device companies to conclude that MECCs do not merit support, resulting in many of the companies "effectively [going] out of business."

Meanwhile, according to data the ACCME reported in 2006, MECCs led in compliance in accordance with the council's standards for commercial support in its rankings of all accredited providers, including academic medical centers, professional medical societies and hospitals.

Some think Pfizer's move is less about ethics and more about giving its public image a positive boost. In a July blog posting on the Wall Street Journal's website, someone remarked that the move was "another ploy for Pfizer to cut costs and spin as positive PR," and many others posted similar comments. Last October, Pfizer finished paying out $60 million in penalties resulting from lawsuits charging the company illegally promoted its drugs, Bextra and Celebrex, for purposes other than their intended uses, according to the Associated Press. Another separate lawsuit filed by an ex-Pfizer employee alleges the company used CME to encourage doctors to prescribe the cholesterol-lowering drug Lipitor to patients who didn't need the medication.

"I think Pfizer made an excellent argument as to why they discontinued support of MECCs," says Trimble, who has planned medical meetings for both associations and corporations. "I think it's an inevitable step, and Pfizer will forevermore have its name associated with it."