Changing compliance codes in Europe regulating medical-device companies are expected to have a major effect on U.S.-based medical conferences — and to continue to do so for years to come. Specifically, any conference with a European delegation sponsored by a medical-device company will be affected by the new EthicalMedTech regulations coming into play in 2018, according to Patricia Andrade, vice president of marketing and communications at ABTS Convention Service
“Medical conferences should brace themselves for an impact,” Andrade said. “They will need to plan for a loss in revenue from any international delegation sponsored by medical-device companies in Europe.” No longer will a conference merely be vetted as in the past — an entire procedural change must take place, she added. ABTS is laying the groundwork to prepare associations, so they don’t encounter massive losses to meetings with high numbers of international medical-technology sponsorships.
“From our clients, we expect about 30 percent of their delegations to be at risk for 2018,” Andrade said. “We are currently working on a process to manage sponsors, who may want to use allowed educational grants. Direct sponsorship of health-care professionals is no longer going to happen, regardless of whether the meeting is pre-vetted or not.”
The effects of the adopted changes from MedTech Europe and Mecomed — the de facto authorities for European medical-technology health-care companies — will be implemented beginning in January 2018. It’s expected that they will not only affect the number of international delegates attending medical meetings, but also have a ripple effect on exhibit halls, Andrade said. When a medical-technology company buys floor space in the exhibit hall, it targets specific attendees. If the health-care practitioners targeted are no longer attending the meeting, those companies will no longer buy that exhibit space — and with less demand for exhibit space, there is less revenue for the association on both the exhibit and registration sides.
‘Navigating the Labyrinth of Regulatory Guidelines’
Fortunately, according to Andrade, European delegations sponsored by pharmaceutical companies will not necessarily be affected by the regulations, because they are written specifically for medical-technology companies and don’t fall under the regulatory authority of EthicalMedTech. Previously, Europe, through the EFPIA Disclosure Code, tightened disclosure requirements on sponsorships of health-care professionals by pharmaceutical companies. The U.S. medical-meetings industry braced for a loss of revenue that didn’t materialize. Andrade says this won’t be the case for 2018.
“The EFPIA Disclosure Code did not go as far as ‘banning’ pharmaceutical companies from sponsoring delegations — it only required that all information be disclosed openly,” she said. “But the EthicalMedTech is prohibiting any member medical-device company from sponsoring delegations of health-care professionals attending educational medical conferences unless it is done in educational grant form.”
The disclosure ruling, named “MedTech Europe Code of Ethical Business Practice,” is spelled out in a 68-page guide for disclosing relationships between health-care providers and health-care organizations, and specifically addresses international travel.
ABTS Convention Services has long specialized in facilitating large medical association meetings, primarily for U.S.-based medical meetings with large quantities of international attendees, Andrade said. It partners with 27 medical associations around the globe, and is experienced in navigating the labyrinth of regulatory guidelines.
Staying nimble and providing alternatives so clients don’t lose international delegations sponsored by medical-technology companies is a big focus for the company at the moment, Andrade said. If nothing is done, she added, there will be a significant drop in attendance at meetings for medical specialties that are heavily focused on medical devices, among other things. ABTS clients, including the U.S.-based Heart Rhythm Society (HRS), are already being proactive, researching solutions to prepare for when the new codes are implemented.
“The HRS Scientific Sessions offers the latest science, cutting-edge technology, and unique networking opportunities, and it would be a disservice to our European attendees to not work toward finding solutions to these new regulations so that they can participate,” said Kristin K. Mirabal, HRS’s vice president of meetings. “Over the next several months, our focus will be to set up processes to allow EthicalMedTech members a pathway to continue supporting medical education. Knowledge and early action are key.”
‘Not Much Clarity’
As of 2018, EthicalMedTech will still require all meetings to be vetted through its syste and only these meetings will be eligible to receive funds from Eucomed and EthicalMedTech member companies — and only through educational grants. There is an exception noted for third-party procedural trainings, and EthicalMedTech has hinted that procedural trainings, with their own separate registration processes, could be performed adjacent to an educational conference and still receive sponsorships. However, Andrade pointed out, this exception is full of questions, and so far there isn’t much clarity on the nature of the required “separation” between procedural training and educational conference to maintain the former category and not the latter when both activities are held in close proximity to each other.
The largest change coming from the new educational grant system is that the burden of choosing the health-care professionals attending the meeting will now fall onto the shoulders of the medical association. Sponsoring companies can no longer have any input or influence on health-care professionals being chosen to attend the medical meeting, creating more work for the medical associations and adding a disincentive to the sponsors. With 22 years of experience managing international delegations and unique ongoing relationships with international sponsors, ABTS is focusing efforts on creating a seamless process that will allow effortless grant requests for the association.
“Medical education is important for every health-care professional and every patient they treat. Making sure international health-care professionals are educated in the latest medical knowledge is important,” said Davide Veglia, president of ABTS. “ABTS has an obligation to our medical-association partners, to our international attendees, and to our medical-device sponsors to make this process work.”
For more information on ABTS Convention Services, visit abtscs.com.