Global regs create new challenges for pharma exhibit pros
With pharmaceuticalregulations proliferating internationally, meeting and exhibit professionals face increasing compliance challenges. During a session on “Healthcare Exhibiting Around the Globe” at the Healthcare Convention and Exhibitors Association's 2008 Marketing Summit, January 24, in Hartford, Conn., participants discussed their experiences.
“We see [regulators] monitoring meetings internationally and we must abide by other countries' rules” when exhibiting overseas, said panelist Nancy Hoppe, CME, associate director, Wyeth Pharmaceuticals, Collegeville, Pa. “It is important that we share [regulatory] information with each other. Rules change daily and if you are not fluent in what is going on internationally, you could get yourself in a bind.”
Exhibit marketers also face risk management issues when bringing in exhibitors from other countries. Pharmaceutical companies “take a very different approach toward [industry] regulations overseas,” said panelist Joseph Agnese, senior manager, convention marketing, Novo Nordisk Inc., Princeton, N.J. “The U.S. has much stricter regulations regarding promotion than most other countries, so I find myself having to [assume the role of] a risk assessment manager for booth content developed overseas. In these situations, I feel like I work more for my regulatory and legal counterparts than marketing.”
Audience member Steve Hamburger, senior director of sales and marketing, Scherago International, West Orange, N.J., added, “We hold a conference for international exhibitors specifically to help them [understand] U.S. regulations, because many have no clue how to bring a product to the U.S.”
The Interpretation Issue
One area that can often trip up exhibitors and planners is preventing off-label discussions, especially at U.S. medical congresses with international healthcare professionals in attendance. “We have seen companies put out a flag to designate an international booth. Then staff will talk off-label in that area,” said Agnese.
Flags are not enough, said one attendee. “Off-label conversations in a flagged booth need to be in a language other than English,” she said.
Since regulations are not always clear-cut, different companies interpret them in different ways. Discrepancies can also come into play between a pharma company's marketing department and its regulatory team, said Jon Ellms, account director, AccessTCA, Whitinsville, Mass., particularly in the case of medical affairs booths. These are small areas, free from commercial flair, staffed by scientific personnel, where sales representatives can direct attendees with questions about off-label uses.
“We are increasingly being called upon by our clients' marketing leadership to enhance their exhibits' medical affairs areas by increasing the square footage and involving more vigorous messaging,” said Ellms. “Our clients' legal and regulatory groups push back on two levels: insisting on clear physical and visual segregation between commercial and medical information areas, and adopting a conservative view on what information can be highlighted.”
But given the chance to walk the exhibit floor, legal and regulatory execs may be more understanding of the marketing team's objectives, said Ellms. “At the 2007 American Society of Clinical Oncology meeting in Chicago [last June], I had a client lead colleagues from legal and regulatory on a tour of the show floor. He showed them how these medical affairs areas were being executed by their peers. It was my understanding that the team gained a greater perspective on the opportunities, which eased the planning effort for future meetings.”
Panelists also encounter obstacles dealing with country-by-country product labeling. Wyeth's Hoppe had recently struggled with this issue for an upcoming meeting in Italy. “Since we will not have product approval in time and we are not allowed to use branded promotional items, I had to explore other options for displaying the drug.” The result: Hoppe contacted her Italian regulatory department to figure out what was prohibited, and they worked to find a way to promote the drug that was in compliance. “Never say never,” she advised the group. “Keep questioning and exploring opportunities, and share this knowledge with your peers.”
• For info on international pharmaceutical marketing guidelines, visit Guidelines Go Global.