Amid Push-Back, Direct Industry Sponsorship of Physicians on Its Way Out in Europe

Next week, MedTech Europe, an alliance of medical technology industry associations, is moving ahead with plans to phase out direct sponsorship of healthcare professionals attending conferences and other continuing medical education (CME) activities. The group will also tighten regulation of indirect support through educational grants, moving closer to how these relationships are managed in the United States.

If approved in a December 2 vote by MedTech Europe’s members—the European Medical Technology Industry Association (Eucomed) and the European Diagnostic Manufacturers Association (EDMA)—the updated codes of ethical business practice, which address industry support for education along with various other topics, will call to end direct sponsorship by January 1, 2018.

A group of leading interventional cardiologists has called for a postponement, however, citing a host of concerns and unresolved issues. The changes “may significantly impact the future of CME, create major restrictions for smaller meetings, and have a severe impact on larger conferences,” according to an editorial commentary in EuroIntervention authored by the journal’s Editor-in-Chief Patrick Serruys, MD, PhD, of Imperial College London; William Wijns, MD, PhD, of Cardiovascular Center Aalst (Aalst, Belgium); and Stephan Windecker, MD, of Bern University Hospital (Bern, Switzerland).

They predict that attendance at educational events could be reduced by as much as 30% to 50% if the proposed regulations—which have not been released to the public in detail—are adopted.

Lack of Physician Input

The editorialists, who focus specifically on Eucomed, take issue with the lack of outreach to the physician community since the proposed recommendations were released in September 2014, stating that a meeting on October 21, 2015, was the first open dialogue between cardiologists and Eucomed.

Although he would not address the editorial commentary directly, Serge Bernasconi, CEO of MedTech Europe, Eucomed, and EDMA, told TCTMD in an interview that professional societies and hospital management associations—but not individual physicians—have been consulted throughout the process of developing the code. Talks have been constructive with some organizations, he said, whereas other groups have been resistant to the proposed changes. There will be further discussions both at the European level and at the national level within each country to transition to the new way of doing things, Bernasconi added.

Nevertheless, Serruys and colleagues say, “whilst both parties agree that direct sponsorship can be perceived by the public as an issue in creating inappropriate interactions” the proposed changes need a rethink. ”We believe that the code is a one-sided document, which cannot lead to an optimal solution,” they add.

Falling Conference Attendance?

The new code, the editorialists argue, will have a dramatic impact on attendance at conferences and other CME activities. “For example, attendance at conferences and meetings will become more complicated: individual attendance will become more difficult with new finance models emerging through third parties such as teaching hospitals, scientific societies, congress organizers, and other institutions,” they write. “Costs for projects will be questioned in greater depth, with the need to prove fair market value for all services from catering through to speaker fees.”

Pointing to the importance of attending educational meetings, which serve as “a forum of exchange between physicians in order to properly implement and evaluate pharmaceutical and device therapies in clinical practice,” they assert that “the risks and potential harm associated with an anticipated gap in [CME] and training will have a direct impact on patient access to care, increased risk of inappropriate use of devices, lower safety of procedures, and worse outcomes.”

Hardest hit in terms of the ability to attend conferences would be the more “vulnerable” healthcare professionals, including younger physicians, nurses, and technicians, they contend.

When asked about the potential impact of the proposed changes on conference attendance, Bernasconi responded with “hopefully none.” He said that if there is a major decline in attendance it will raise questions about why physicians were attending the meetings in the first place, adding that if the scientific content of a program is strong enough, physicians will go even without direct sponsorship.

“I’m not as pessimistic as what’s been said, because I do believe and I want to believe that physicians are going to these interesting congresses for good scientific reasons [and] good medical education reasons, and consequently they will not drop off the meetings,” he commented.

Move to Educational Grants

Bernasconi said that the elimination of direct sponsorship would likely be accompanied by an increase in indirect support through educational grants provided to hospitals, scientific societies, and other healthcare organizations, who would have to seek funding for specific programs. That process will be covered by a set of strict guidelines in the proposed code of ethics.

“We think that educational needs are best evaluated by scientific societies, hospitals, or any officially registered medical or clinical organization,” he said.

Serruys and colleagues, however, question how congresses and other CME activities will be deemed worthy of support by educational grants, pointing out the shortcomings of a vetting system mentioned by Eucomed during the October meeting.

“Whatever the rules are, the ones that should be on the top of the list pertain to the quality of the event,” Wijns told TCTMD in an interview. “Is there added value in the eyes of the attending physician for their practice? Quality of the education should be on top of the list.”

There is also concern, the editorialists say, that the new regulations could lead to a decline in industry providing financial support for medical education, but Bernasconi strongly denied that would be the case.

“Industry is not in this to reduce its investment in medical education. That’s not the objective,” he said. “But it is time that we try to work differently for our industry. We have to make sure that everything we do, we do it with the highest standards and with the highest level of ethical business conduct. We will continue to support medical education.”

Getting in Line With US Regulations

The elimination of direct sponsorship of healthcare professionals is consistent with the code established by AdvaMed, MedTech Europe’s US counterpart. In the United States, support is given through educational grants to specialty societies and direct sponsorship is considered taboo.

“The reason why we have a code of ethics that addresses that point is because we don’t want to fuel inaccurate perceptions around industry relationships with physicians,” Christopher White, AdvaMed’s senior executive vice president and general counsel, told TCTMD in an interview. “These are grants to support the education of these clinicians. They’re not intended for any improper purpose.”

The use of educational grants, he added, “creates independence and respects the roles of the specialty societies and others in that important clinical content.”

Prediman K. Shah, MD, of Cedars-Sinai Medical Center (Los Angeles, CA), who served as co-chair of the American College of Cardiology (ACC) Scientific Sessions in 2014, told TCTMD that direct sponsorship of physicians has not been seen in the United States for at least 20 years. He noted that direct sponsorship allows many healthcare professionals to travel to meetings they otherwise would not attend and that getting rid of the practice could potentially lead to a drop in conference attendance.

A 30% to 50% drop in attendance, as predicted by Serruys and colleagues, would not be out of the question, Shah said. “I think that’s probably quite reasonable to assume because industry sponsorship of individuals is a big part of meeting attendance,” he said. Shah pointed out that ACC’s annual meeting has attracted about 2,000 Europeans annually in recent years, asserting that the proposed European code would cause that to fall, even with a shift to more support from educational grants.

Also playing into declining conference attendance are the increase in meeting content that is now available the Internet, a reluctance to leave practices and lose money, and a siphoning of participants from larger meetings to those of subspecialty societies, he said.

Industry Support for Education Vital

Shah cautioned against moving too far in removing ties between physicians and industry, saying that large annual meetings would not be possible without industry support.

“To completely keep [industry] out of it is not a good idea,” he said. “If industry sponsorship of symposia is stopped there would be very little continuing medical education because institutions—academic institutions—don’t have the budgets to cover educational meetings and symposia. It’s better to have a good relationship with industry, of course with limits, than to completely cut it off.”

That link between industry and physicians is particularly important for interventional cardiology because without industry support, “there would be very little education and very few training opportunities for individuals in new and emerging devices and technology,” Shah said.

Wijns agreed. “[The device field] is different, in a way, from pharma because of the need for physicians to learn about new devices, how to use them properly, and then at the level of clinical evidence, to be able to exchange experiences, discuss the appropriate indications, etc.”

Bernasconi pointed out that the updated codes would unify the patchwork regulations already in place across European nations.

“I think there is a desire for industry to have one approach to this, which is an approach that will hopefully make sure that we build trust in our industry, the way we work,” and remove perceptions that industry is injecting biases into physicians’ clinical decisions, he said.

Referring to the close relationship between physicians and the medical technology industry in bringing new devices to the market, Bernasconi said “that’s our development model, and we need to do everything possible to protect that model. And that’s the reason why we’re making the decision to really tighten up the way we work and interface with physicians. We don’t want any doubt in terms of that relationship.”

Serruys and colleagues have asked that the phase-out of direct sponsorship be postponed until 2019.

Source: 
Serruys P, Wijns W, Windecker S. A vote taking place on 2 December 2015 (EUCOMED) that will definitely influence our profession and continuing medical education. EuroIntervention. 2015;Epub ahead of print.

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