For the past decade, it seems that medical meeting planners have watched their focus shift from planning an event to planning for an audit. A recent survey of medical event planning professionals said that they spend over 50% of their time compiling data and records to comply with federal reporting requirements. Between the self-imposed guidelines of AdvaMED and PhRMA—not to mention the Sunshine Act--it's no wonder planners are drowning in paperwork. Paperwork aside, however, these new guidelines have a real impact on the planning process for life science meetings.
In spirit, the AdvaMED and PhRMA compliance guidelines are essentially the same: Both seek to avoid the perception of influence through financial incentives and drive increased transparency for patients. However, the AdvaMED guidelines recognize the more intimate role HCPs have in the development and testing of medical devices and the more involved training requirements for HCPs.
Devices versus Pharma
Meeting planners should be aware of the differences in the device and pharmaceutical industries that explain the variance between the AdvaMED and PhRMA code of ethics. The main differences in the codes fall under the Company-Conducted Product Training and Education section. Device manufacturers are legally obligated to provide HCP training as a part of the FDA approval process. In addition, with large or fixed equipment, or implantable devices where training occurs on a cadaver, centralized training is more efficient. The AdvaMED code is more specific and "forgiving" of travel and meal expenses related to training activities.
Common Medical Meeting Formats
In a recent webinar on Meetings.net, James Vachon, CMM, Millennium: The Takeda Oncology Group, and Gavin Houston, EVP of Universal WorldEvents, identified several meeting types unique to life sciences that are affected by the guidelines:
- Advisory Board Meetings
- Investigator Meetings
- Speaker Training Meetings
- Promotional Speaker/Dinner Meetings
What do meeting planners need to know about AdvaMED and PhRMA compliance guidelines in planning these types of events?
Advisory Board Meetings
These are strategy meetings involving key opinion leaders (KOLs) and typically involve fewer than 25 attendees; they are usually full-day meetings. In addition to KOLs, internal staff and communications professionals attend. These are high-level meetings and typical include honoraria to each advisor, as well as incidental expense reimbursement. How do the guidelines differ?
PhRMA allows reasonable and fair market value for consultant arrangements including travel expenses. Not allowed are entertainment or recreation expenses, or expenses related to an HCP not in a formal consulting arrangement.
AdvaMED allows similar reimbursements under much stricter guidelines:
- There must be a written, comprehensive consultant agreement.
- Only actual, reasonable documented expenses can be reimbursed.
- The meeting must be in an appropriate venue.
- Meals must be modest and subordinate to the meeting's focus.
These are HCP-attended meetings designed to train investigators participating in clinical trials or other developmental processes; they usually take place at a hospital or clinic over a period of 2-3 days. HCPs are typically covered under consulting or advisor agreements and payments are treated in a similar fashion to advisor meetings.
Speaker Training/Promotional Speaker Meetings
For meeting planning purposes, these two meetings are treated virtually identically under industry guidelines. Reasonable expenses are allowed for HCPs whether they are training for peer-to-peer speaker's bureaus or giving a promotional speech at a dinner meeting. Here's what the guidelines say:
PhRMA allows reasonable compensation and expenses for speakers, provided the venue is "appropriate" and "conducive" to training. It also stipulates that the speaker disclose corporate sponsorship, and that all materials reflect sponsorship, as well.
AdvaMED does not specifically address speaker's bureaus; however, consultant agreements would apply.
In planning medical meetings that won't offend the sensibilities of either governing body, location is key. Event planners should avoid locations associated with lavish vacations—Temperate island destinations and popular ski towns are taboo. Look for cities with major airport hubs like Dallas, San Francisco and Chicago. Pass on five-star hotels like Four Seasons and Ritz-Carlton; four-star hotels are fine as long as the words spa, resort, beach or golf don't appear in their name. Airport hotels are often an ideal venue choice, satisfying the "reasonable and modest" requirements, as well as saving on ground transportation expenses and transit time.
With Sunshine Act reporting requirements in effect, disclosure goes a long way towards building good relationships with HCPs. Include an estimate of reportable TOVs with any meeting invitation materials.
Planning medical meetings that comply with the alphabet soup of regulatory bodies is a challenge, but successful planners keep three keywords in mind: Reasonable, appropriate and modest. Payments and arrangements that pass the keyword test will ensure you don't run afoul of compliance guidelinesand endear you to your HCP attendees.
Want to learn more about how AdvaMED & PhRMA codes are impacing medical meeting planning? Join us at "Compliance Coaching- An Introduction to Pharmaceuticals, Medical Device & Biotechnology Meetings for Planners & Suppliers" session March 23-26, 2014 in Orlando, FL at PHARMA FORUM 2014.
(Image courtesy of Falk Lademann via Flickr)