Conference Organizers, Physicians Wary as Direct Industry Sponsorship Winds Down in Europe

January 1, 2018, will no doubt be a day of rosy predictions for the year to come—made in the haze of the previous night’s celebrations—but for European physicians and other healthcare professionals across medical specialties, the day also ushers in a dawning uncertainty.

New Year’s Day marks the implementation date for a new policy from MedTech Europe, a trade association representing medical technology companies, that ends direct industry sponsorship of individual healthcare professionals attending conferences and other continuing medical education (CME) activities. The old system will be replaced by one involving educational grants provided by industry to medical societies, professional congress organizers (PCOs), and hospitals, who will then take responsibility for doling out the money, much like the way industry funding of CME is handled in the United States.

Because it’s still business as usual until the end of the year, it’s unclear what impact the policy change will have, but speaking with TCTMD, medical society leaders and conference organizers involved in cardiology meetings in both Europe and the United States expressed concerns about a potential drop-off in attendance, particularly during the first half of 2018 as the new system takes effect.

“This is probably the hottest topic for all of us who are organizing these kinds of conferences,” said Michael Haude, MD, PhD (Städtische Kliniken Neuss, Germany), who is president of the European Association of Percutaneous Cardiovascular Interventions and is involved with congresses under the PCR and European Society of Cardiology (ESC) umbrellas. “I hope it will not be too sharp, but we have to prepare ourselves that the number of attendees will probably drop,” he said, adding that meetings of small-to-intermediate size could be hardest hit.

The Code

MedTech Europe’s members voted in December 2015 to adopt a new Code of Ethical Business Practice, which regulates interactions between industry and healthcare professionals and organizations. Most of the code—including stricter rules regarding indirect sponsorship through educational grants—took effect at the beginning of 2017, but there was a 1-year delay allowed for the elimination of direct sponsorship of individuals to attend third-party-organized educational events. Direct support will still be allowed for individuals attending third-party-organized procedure-training meetings or company-sponsored satellite symposia (as long as there is a consulting agreement).

To ease adoption of the new rules, MedTech Europe launched the Ethical MedTech website. The site serves as the home base for a revamped Conference Vetting System used to make sure third-party conferences are eligible to receive educational grants from industry, the Transparent MedTech portal through which industry discloses all payments made toward independent medical education, and related resources.

Additionally, an independent compliance panel has been installed as a mechanism to make sure all of MedTech Europe’s industry members play by the rules. “Our expectation is that through such a mechanism . . . industry will self-regulate,” Aline Lautenberg, the trade association’s director of legal affairs & compliance, told TCTMD, adding that complaints can be made by anyone.

Lautenberg said the level of detail requested by member companies, medical societies, and PCOs about how to implement the policy was unexpected, but that MedTech Europe has been working to provide the needed information.

She pointed out that the organization will not change the start date for the ban on direct sponsorship, despite a formal request for a delay that came from the ESC. Discussions revolving around eliminating direct sponsorship started almost 10 years ago, she said, noting that numerous other medical societies did not have an issue with the established timeline.

Culture Changes Take Time

Isabel Bardinet, chief executive officer of the ESC, advocated for additional time to implement the new sponsorship policy, describing the new rules as more than just a simple change in the way CME is funded. “It’s not only the change of a process, it’s a change of culture,” she told TCTMD. And that kind of change takes time, particularly when dealing with dozens of countries and different systems, she said. “One of the concerns that we have is that we feel that between the decision and the implementation there’s not been enough time for the physicians and the associations of the physicians to find other solutions.”

What has become apparent in recent months, she said, is that even though there is one rule from MedTech Europe, implementation of the policy and how it will be handled internally has not been consistent across member companies as the deadline for elimination of direct sponsorship looms.

It’s not only the change of a process, it’s a change of culture. Isabel Bardinet

“The system’s not in place, and it’s not smooth and it’s not harmonized,” Bardinet said. “So our concern is that in 2018, and particularly for the congresses in the first half of 2018, this system is not actually going to be operational.”

The potential impact of that remains uncertain, she said. “We know what we would like, which is that we continue to be able to deliver as much unbiased education as possible. Is that going to happen? Well, unfortunately, we’re not quite sure.”

Lautenberg, questioned on this point, responded by email saying that “the MedTech Europe Board adheres to its commitment to continue their support [of] independent medical education. Companies have [had] grant systems for many years. It is just that going forward the grant system is the unique system to funnel funds.”

Could Attendance Drop 30% to 50%?

When the new code was being discussed in 2015, a group of prominent European cardiologists predicted that it could have dramatic effects on medical education, including as much as a 30% to 50% drop in attendance at educational events after axing direct sponsorship.

Whether a reduction of that magnitude will occur is unknown, but industry will have to start focusing on getting their customers to events that represent solid educational value and a good return on investment, according to Romain Despax, director of PCR activities for Europa Group, a PCO based in Paris, France. “What we foresee is that some of the medical meetings may indeed suffer in terms of attendance, because the code can redirect some of the investment made to smaller [and] less educational meetings toward leading medical platforms in the field of cardiology.”

Haude predicted that there could be a shift toward more company-organized events, some of which are not subject to the limitations on direct sponsorship. Those events, which are shorter than the larger congresses and include several hundred attendees, involve programs that are mainly guided by the industry sponsor.

I’m still belonging to a generation where I feel that we need to have congresses where we also have the capability to have personal meetings and personally exchange face-to-face and not sitting in front of a monitor.” Michael Haude

There could also be a growing reliance on online conferences because they ease access and avoid the costs associated with in-person meetings, Haude said. “Nevertheless, I’m still belonging to a generation where I feel that we need to have congresses where we also have the capability to have personal meetings and personally exchange face-to-face and not sitting in front of a monitor.”

‘Arms-Length’ Funding for Medical Education

In a pamphlet designed for healthcare professionals, MedTech Europe says: “The new code is a clear message from the medical technology industry that we want to safeguard and protect our relationship with healthcare professionals by adopting a clear and strict self-regulation. Our industry is still fully committed to support independent medical education. We will now do this at arms’ length through independent third parties. The independent third party will decide which [healthcare professionals] receive the funding.”

Barbara Mintzes, PhD (University of Sydney, Australia), whose research has focused on pharmaceutical policy, called the new code of ethics “a real advance for the European medical device industry.”

It will not, however, completely block industry’s influence on clinical practice, she said, pointing to several “loopholes” that still allow companies to pay individual physicians. Industry can still make direct payments for attendance at events where practical training will be provided, for contracted speakers at satellite events, for attendance at company-sponsored events, and for service on advisory boards.

“Is this restriction on sponsoring of individuals going to solve the problem of undue commercial influence? No, it won’t, but I’d say that it’s a step in the right direction, because it is breaking the link between the individual health professional being funded by a company to attend an event versus a situation where the company has no say in who it is who would be funded,” she told TCTMD.

Whether the new ethics policy will effectively establish a fire wall between industry and individual physicians depends on cooperation of the involved stakeholders, according to Patrick Jolly, director of PCR strategic & market development at Europa Group.

“I’m born to be optimistic, so I believe this will achieve this if everyone really plays the game according to the established rules,” he told TCTMD. “And I have no reason to believe that the major players are not going to play according to the rules until proven otherwise.”

I have no reason to believe that the major players are not going to play according to the rules until proven otherwise. Patrick Jolly

Despax added that how things go in 2018 will be critical in determining the long-term impact of the ethics policy. If industry continues to support third-party educational conferences and other events rather than redirecting funds to company-sponsored events or decreasing investment in education, then the policy should have positive effects in the long run, he said. If some companies decide to go their own way, however, that’ll make it difficult for the system to work.

“We need to rely on the commitment by the MedTech members that their support to continuous medical education through independent societies and bodies or physicians remains intact,” Jolly said. “This commitment I think is crucial, because if they divest those independent meetings and reinvest everything in company-originating trainings and educational forums then the whole community is going to be losing a lot.”

Haude, too, underscored the importance of independent medical education. “Unbiased medical education is important—it has to be continued, it has to be part of our overall cardiology medical training, and it cannot be done by industry partners,” he said. The large congresses are major sources of unbiased education, he said, because even though they receive industry sponsorship, the money comes from multiple sources, creating a balance. If industry takes over responsibility of medical education, “it will no longer be unbiased, and then education is hurt,” Haude said.

Dependence on Industry Funding

Regardless of how industry money gets to healthcare professionals—either directly or indirectly—both sides seem to agree that the relationship between the two parties helps maintain quality in the practice of medicine.

MedTech Europe’s Lautenberg stressed that industry remains committed to funding independent medical education.

“Our leadership has made it very clear from the very beginning that the decision to adopt this new code, and this phaseout which is part of the new code, is done for compliance reasons and not for budget reasons,” she said. She added that she doesn’t expect the overall amount of industry funds dedicated to medical education to change substantially, although differences in strategy across individual companies might change how those funds are allocated.

But the careful phrasing adopted by physicians and conference planners who spoke with TCTMD hints at some jitters over the possibility of dwindling dollars, despite assurances from industry.

Jeroen Bax, MD, PhD (Leiden University Medical Center, the Netherlands), president of the ESC, underscored the importance of having a balanced relationship between industry and healthcare professionals to maintain high-quality CME programs. Damaging that relationship, he said, could harm medical education and, ultimately, patient care.

“Industry is helping to bring physicians to these meetings and that has a direct effect, a positive effect, on patient care and the way medical practice is being delivered,” he told TCTMD.

There is thus a shared responsibility between industry and healthcare professionals to find ways to maintain funding for medical education at the current level, especially considering the need to keep the community up to date on rapid developments in pharmacology and technology, he said. “If a lot is happening . . . then there is also this increasing need to parallel these developments with education.”

The level of funding is a key issue, Haude pointed out, because medical societies and PCOs will be required to expend more resources handling educational grants to get attendees to events, a process previously managed by individual companies. He noted that the proportion of attendees with industry support is about 50% for the annual ESC Congress—which attracts roughly 30,000 registrants—and 80% to 85% for interventional cardiology meetings.

That means there will be a lot of new work for medical societies and PCOs to do. And even if industry maintains its current level of support, there will be a net decrease in funding for medical education because of the overhead costs—which could eat up 15% to 25% of the total sum—related to managing the new system, Haude said. That issue will become less of a problem over time after processes are established and efficiency is increased, but there will probably be a substantial negative impact over the next few years, he said. “This is a challenge, honestly speaking.”

Despax said that at Europa Group, which plans PCR meetings around the world, there is a new service being built to manage the educational grants and other financial support received from industry. That has involved hiring extra people, who have been working on pilot programs—including one around PCR London Valves—involving a few hundred physicians to evaluate how the new system will work in 2018 and beyond. The team will need to grow in size after the implementation date, Despax said.

Lautenberg, however, said MedTech Europe is not concerned about a potential net decrease in funding for medical education, “given the prices that we see PCOs are trying to charge companies as overhead for handling such grants.”

The US Perspective

The phaseout of direct sponsorship will not only affect European congresses, but also those in the United States and elsewhere.

The American Heart Association, asked about the potential impact of the new code on its annual meeting, responded with an emailed statement saying that it “agree[s] that transparency is very important so patients and the public are aware of funding support. We also acknowledge that industry partners are an essential part of the equation in not only discovery but in bringing and disseminating that discovery to the professionals, patients, and the public.”

The American College of Cardiology (ACC) directed TCTMD to Jeffrey Kuvin, MD (Dartmouth-Hitchcock Medical Center, Lebanon, NH), chair of the ACC’s 2017 and 2018 Scientific Sessions. Kuvin said it’s unclear what the impact of the new code on attendance at US meetings will be, but he predicted the opportunities available at in-person meetings will continue to be a draw.

“Our hope is that people recognize the value of networking and listening to presentations live and having important conversation and interactivity with speakers and colleagues at meetings such as annual sessions and I really hope that regardless of funding circumstances that these meetings continue to have an important place in our academic world,” he said. “I do think that the new regulations are going to come into play, but I think that if we continue to maintain the highest quality that it won’t have a significant impact.”

But other US conference organizers have niggling doubts. One of the course directors for TCT, Gregg W. Stone, MD (NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY), said the elimination of direct sponsorship could have a major impact on meeting attendance in the future.

“While we don’t know with any level of certainty the percentage of physicians that come to TCT and other [Cardiovascular Research Foundation] meetings from Europe that are supported by industry, the general belief is that it is a high percentage, and the extent to which this will inhibit travel and therefore inhibit medical education is potentially substantial,” he told TCTMD.

It is in everybody’s best interests, and ultimately in the patient’s best interests in terms of their health outcomes, for a very high level of medical education at the best conferences to continue or even increase. Gregg Stone

He said that TCT leaders have been working with multiple companies on a demonstration project to determine how the new grant process will work after the ban on direct sponsorship is fully implemented. “There is an additional responsibility and substantial extra time commitment required to do that, such that the organization has to gear up for that,” Stone commented.

Once the new rule comes into effect, all stakeholders will have to remain vigilant to make sure that industry continues funding physician travel to major meetings at current or even higher levels, Stone said, adding that companies themselves might not have a firm grasp of how much they’re spending on medical education because the money often comes from different divisions.

“[Companies] want physicians to use their devices and drugs appropriately and optimally, and they know that without medical education that’s not going to happen,” he said. “So it is in everybody’s best interests, and ultimately in the patient’s best interests in terms of their health outcomes, for a very high level of medical education at the best conferences to continue or even increase.”

It won’t take long before the cardiology community finds out whether the new rules around funding medical education will pan out: the first ESC meeting of 2018—the Acute Cardiovascular Care Congress in Milan, Italy—is now just four and a half months away.

ESC’s Bardinet remains concerned that there will not be enough time for the new system to start running smoothly right away, leaving physicians unable to access CME activities and tap into the communal knowledge they need to stay up to date. “We wouldn’t want to see that collective intelligence, that growing body of knowledge that is then used across the world to look after patients . . . being put in jeopardy by something that’s implemented a little bit fast,” she emphasized.