CME/H Challenges: Working with Medical Associations (A CEU-accredited Article)

Much of the education that exists for exhibit management professionals is geared toward working within general markets at a variety of shows that include industries across all SIC (Standard Industry Classification) codes. And while this general education is a good background for a job as a healthcare exhibit professional, there are some unique challenges for pharmaceutical or medical equipment exhibit managers that are not found in broader, less regulated industries. The goal of the CME-H program is to introduce those involved in healthcare exhibiting to the unique issues which they will face in their careers.

Often those not directly involved in healthcare exhibiting are skeptical about the assertion that the field is 'different.' Outside of the regulatory environment, which is clearly a defining factor, there are certainly many transferable skills from the larger universe of exhibit marketing to healthcare exhibiting.

Healthcare exhibiting tends to attract attention from all segments of the exhibit industry because the revenues at stake for both exhibitors and for those who produce and manage their shows are significant. The fact that healthcare usually shows up in annual surveys as leading the exhibiting universe in overall growth makes it a desirable field both for suppliers and for trained exhibit professionals who are looking for a job that is both challenging and rewarding.

One important differentiating factor for those involved in implementing a healthcare exhibit program is the prevalence of medical associations which provide the context for medical exhibiting. For most exhibitors, the show floor is the province of either for profit companies or non-profit associations. Healthcare exhibitors, with very few exceptions, work primarily with non-profit associations. The exhibiting opportunities are generally offered as part of association-sponsored medical meetings; exhibits give association members, who are healthcare providers, a chance to learn more about what is available in their fields within an environment that allows them to focus without day-to-day interruptions..

As mentioned above, healthcare exhibiting is highly regulated. That fact alone causes much confusion to those outside this segment of exhibiting, so perhaps this is the appropriate point to explain the regulatory environment in which exhibit professionals in the healthcare field operate.

There are three major entities issuing directives involving regulatory issues.

1. Government bodies:
   
   The Food and Drug Administration (FDA), among its other duties, governs the delivery of promotional messages. An exhibit staffed by sales people is considered a promotional vehicle. In the exhibit, only FDA approved messages can be communicated to healthcare professionals. These approved messages are exactly as stated by the FDA when it approves a product, whether pharmaceutical or device. Anything other than that approved use (or "indication" in the language of pharmaceutical marketers) is considered 'off label' and cannot be discussed in the promotional booth. Often pharmaceutical companies will have a medical affairs area attached to their promotional exhibits, physically separate from the promotional area and staffed by non-sales personnel. Doctors can approach the medical affairs staff with unsolicited off-label questions. The FDA offers no directives on how an exhibit should be built or how it should look; it simply requires adherence within that promotional space to approved messages.
   
   Within FDA, there is a group that oversees the promotional activities and marketing efforts of healthcare marketers. Until recently, that group was the Division of Drug Marketing, Advertising and Communication, or DDMAC. During the second half of 2011, this group was upgraded from a division to an office and is now the Office of Prescription Drug Promotion (OPDP). As both the new and old names suggest, this body regulates the appropriateness of drug advertising, marketing, and yes, what is said and displayed within promotional exhibits.
   
   However, the FDA is not the only government body issuing directives. Different states have specific laws governing exhibit behavior, and the exhibit professional needs to be familiar with these laws. These laws can cover exhibit activities within the state itself or the conduct of state-based doctors at exhibits.
   
   
2. Industry Governance Associations:
   
   Both pharmaceutical and medical device manufacturers have their own manufacturing associations. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading pharmaceutical research and biotechnology companies while the Advanced Medical Technology Association (AdvaMed) plays a similar role in medical technology. Both of these organizations have voluntary codes for their members which attempt to define consistency for promotional activities and avoid the appearance of conflict of interest. In many ways these codes are pre-emptive, and as self –governing bodies, both PhRMA and AdvaMed strive to manage the perceptions of their member companies by healthcare professionals, the market, and their associations.
   
   
3. Internal regulatory and compliance departments:
   
   In any given healthcare company, regulatory and compliance departments interpret the above guidances. Although eventually the OPDP needs to approve promotional material, internal departments minimize the risk of having materials and activities rejected and are an important part of the entire convention process.

These are basic descriptions of the regulatory environment in which healthcare exhibitors work. It is important to note that nowhere is there a strict list of what is permitted and what is not. The closest thing to such caveats are the voluntary codes from the industry manufacturing associations and a few of the more restrictive state laws. (Note: recently state laws have been challenged and at first glance, it is not clear whether or not they will hold up when reviewed by the courts.)

With an ever-expanding awareness of the regulatory environment in mind, the exhibiting process begins when healthcare marketers decide that the exhibition at a medical association meeting is the perfect place to showcase their products, whether those are drugs, medical devices or equipment.

The primary focus of a medical association is furthering excellence in patient care through education, research and advocacy. The medical association's charter is to provide these benefits to its members by means of multiple offerings, including meetings which feature an exhibition. Many medical associations have an intermediary role between the physician member and industry partners, and while the association as a whole understands industry concerns and issues regarding government oversight and regulations, these issues and concerns may not resonate with or be a primary concern to the individual physician member. Within the last few years, physicians are under increasing pressure to distance themselves from interactions with industry that may have the appearance of potential conflict of interest. Medical associations and healthcare companies have the opportunity to work in partnership to assist physicians in understanding the vital role the exhibition plays in product education and furthering excellence in patient care.

Working with medical associations requires the knowledge of all of the internal and external forces at play if the exhibit program is going to be successful and meet corporate goals and objectives.

In other words, working with the associations means that the exhibit professional

1. understands industry concerns and challenges
2. reflects an understanding of the individual physician's concerns for education, research,and advocacy.

Let's go back to the exhibit professional mentioned at the beginning of this article, the one who has general training in managing an exhibit program. That person now has additional education and an understanding of the regulatory and compliance challenges facing the industry as well as an overview of the mission of the medical association. How does this person now make the leap from knowledge to implementation, to establishing an actual a working relationship with a medical association?

Here is some guidance for developing a collaborative partnership with medical associations:

1. Often the association staff is charged with a variety of tasks, which means that in addition to handling exhibits, their time may be split among several different responsibilities. If you understand this, you will be more proactive when working with your contacts. Take time to review and understand the exhibition policies and respect these. They are designed to insure that the exhibition is a professional and productive environment for all exhibitors. If you have concerns, don't be afraid to ask for what you need.
2. Don't assume that the staff is up to speed on the ever expanding universe of new regulations. For example, the Federal Healthcare Reform Law mandates an accounting of aggregate spend by industry on individual physicians. Commonly referred to as "The Sunshine Act, " companies will be required to begin recording any physician payments that are worth more than $10 and to report them. In order to do this, the implementation involves capturing National Provider Identifiers (NPI).*
   
   Collecting the NPI numbers is currently perceived as a joint responsibility of the healthcare exhibitor and the association. The association is in a position to start capturing these numbers, ideally, in the registration. However, this will require modification to existing practices as well as input from exhibitors. Working together to stay current on the rules for tracking aggregate spending will ensure that exhibitors are compliant and that associations facilitate this compliance.
   
   
3. Help associations understand the pharmaceutical and device business processes related to marketing. For example, the pharma product lifecycle from pre-launch to patent expiration means that pharmaceutical companies promote their products differently along this continuum. When a drug is first launched, the exhibit will be used as part of the introduction process; often this entails a large footprint. As the patent expiration date approaches, the space will most likely shrink, if the company chooses to exhibit at all. By sharing this information, exhibitors and associations can work together to find ways for healthcare companies to support the association and communicate with members through other means, such as sponsorships.
   
   
4. Find out how to become a member of the Exhibit Advisory Council (EAC) for the association's meeting. Contribute! and if the association does not currently have an EAC, lobby for one.
5. Bring your own ideas to the staff. One area where this is important is sponsorships. For many years, associations have offered traditional sponsorships which may no longer be considered compliant by the exhibiting companies' internal regulatory departments. These decisions are usually based on interpretations of the various guidelines mentioned earlier. If you as an exhibit manager have a sponsorship idea that not only has the blessings of your compliance department but will help promote your brand, by all means suggest it to your counterparts at the association.
   
   
6. Build relationships with the associations. Invite representatives to your offices to meet with the sales and marketing departments and with the brand teams. Build bridges and don't hesitate to invite the association to include all relevant members of the team in the visit. For instance, having association executive present can be very positive for both sides. And of course, the people who can handle questions about the details of various association offerings and programs should be included as well.
7. Be careful not to use personal and business relationships with physician leadership or faculty to attempt to influence the association. Many associations have strict disclosure policies of conflict of interest. A physician can be put in an extremely uncomfortable position when he or she is asked to intervene on behalf of a company.
8. As an exhibit manager, you attend many meetings while the medical association meeting planners may focus only on their own meetings. Share ideas that you find helpful from other meetings. Best practices are always welcome.

* The NPI (National Provider Identifier) is a unique identification number for covered healthcare
providers. Covered healthcare providers and all health plans and healthcare clearinghouses
must use the NPIs in the administrative and financial transactions adopted under HIPAA. The
NPI is a ten-position, intelligence-free numeric identifier . This means that the numbers do not
carry other information about healthcare providers, such as the state in which they live or their
medical specialty.

To earn a .1 CEU, review the guidelines in the TSEA/UNLV-Accredited Trade Show Study Program and take the applicable exam in the Article and Research Archives (Members Only)

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About the Authors

Pat Friedlander, owner of Word-Up! a consultancy that specializes in but isn't limited to healthcare convention marketing, is an accomplished marketer, writer, speaker, and trainer in the meeting and convention industries.

Sara Peterson, is Senior Manager Exhibits, American Academy of Dermatology