Virtually no other country regulates CME as heavily as the United States. While some countries have rules similar to those of the United States, others have little or no controls in place at all. And the attitude toward commercial supporters' influence on education varies as widely as the cultures of the world's many nations.
While the U.S. regulators and CME providers think they have a pretty good system, don't hold your breath waiting for European countries to adopt the United States' policies and procedures wholeheartedly. Efforts to formalize the CME process in some way are being hammered out in other countries, but to many providers and physicians across the pond, the idea of accepting the Uncle Sam plan is akin to agreeing to place themselves under Big Brother's thumb.
Euro Docs Resist Rules
“In Europe, there is an acceptance of the need to formalize the participation in continuing education,” says Leonard Harvey, MD, a Rugby, England-based gynecologist, past president and current liaison officer of the European Union of Medical Specialists (UEMS), which represents more than a million European medical specialists. But getting everyone to agree on CME rules makes the disputes about adopting the euro as the coin of the realm look mild.
“Whether it's a national healthcare system or an insurance-based system, the people who pay the money want more accountability for CME,” says Harvey. “But each country wants to do it their own way. Look at the Mediterranean countries and the Scandinavian countries. They're all very different — and proud of their cultural differences — and that all filters down to educational activities.” He adds, however, that one thing that is already uniform is the doctors' resistance to formalized CME rules. While Eastern European countries, which not long ago were under totalitarian rule, might be more accepting of U.S.-type “Big Brother” regulations, other countries, such as France, are likely to be much more resistant. Still, even in countries that do not have mandatory CME requirements, good CME is good for a physician's bottom line: Those with more credits often can qualify for higher pay.
One big difference is that in Europe, it's mainly the activities that are accredited, not the providers, as is the case in many of the U.S. accreditation programs. “I think there's a lot of people here who would like to be accredited as providers, but Europeans are suspicious of it because it can become a moneymaking empire if you're not very careful. We haven't seen many [medical education and communication companies] setting themselves up as CME providers in Europe yet — most activities come from specialty societies and colleges,” says Harvey.
The Accreditation Shuffle
“Many of the U.S. guidelines, like those foraccreditation, are slowly but surely being adopted on the country level or on a Pan-European level,” says Jan Heybroek, vice president of operations with Atlanta-based Imedex, which has offices worldwide and runs up to 25 European congresses annually. Adds Sue Potten, MediTech Media's director, conference services, in Princeton, N.J., “It'll be interesting to see who walks in and who walks out. I'm European so I can say this, but there are still countries digging in their heels about the euro. I can't imagine CME accreditation will be any different.”
The European Accreditation Council for CME, which connects existing and emerging accreditation systems in Europe and acts as a clearinghouse for CME accreditation and credits in Europe, has been operational only since 2000. Run under the auspices of UEMS's Management Council, its mission is to make inter-European credit exchange possible, though it does not supercede the authority of the regulators of individual European countries. While it does have strict guidelines on quality and funding, Sidonia Peto, CME manager, MediTech Media, says EACCME “still doesn't have teeth as an accrediting body for providers in individual countries.” But, it's made a lot of progress in just three years, and more is expected.
Stefan Terwindt, Imedex's executive vice president, explains that “in Europe, it just takes a longer time to get coordinated.” Heybroek adds, “But it is taking place. The EACCME is taking more leadership over CME activities.”
Despite all the international differences, says David Schlumper, a Rockland, Mass., senior program manager with Serono Symposia International, which has offices in Rome and Australia, “The U.S. and Canadian developments are held as a gold standard in the rest of the world.” One example is a program he did in Italy last year that didn't include the mention of a single product. “I was continually amazed at how many people came up to me afterwards and thanked me for holding an unbiased program. At first, I was a little stunned, but that's another way some of these CME regulations will catch on — not necessarily because the EACCME requires it, but because the physicians will demand it once they've been to an unbiased program. What we're seeing happen in North America may not be having a lot of impact yet, but if trends continue, I would guess that CME in the international arena will follow the path the United States and Canada are taking.”
According to Potten, pharma firms are already demanding tighter accreditation standards. “No matter where the meeting is held, our independent publishing company, International Medical Press, has noticed an emerging trend of commercial supporters who are only willing to provide support to meetings that are ACCME-accredited.”
The Buck Stops Here
Controls on commercial supporters may be nowhere near as prevalent in Europe as they are in the United States as of now, but with roughly three-quarters of European CME activities supported by the pharmaceutical industry, strictures similar to the PhRMA Code may be coming soon from government agencies or other regulating bodies.
There also are indications that pharma companies themselves may be looking to enforce PhRMA Code — like restrictions for overseas activities, even if the pharma company's overseas marketing division is kept completely separate from the U.S. division. Already, says Harvey, “Most [CME providers] have moved away from single-company — funded events. Instead, providers get a group of companies to support via an educational grant to make the activity nondirectional.”
Terwindt points out that a recent scandal about pharmaceutical company kickbacks in Italy “has changed the whole landscape in terms of pharmaceutical marketing.”
Adds Heybroek, “Italy is relatively stringent in its scrutiny of how marketing dollars are being spent and their potential for unduly influencing physicians. [Pharma firms'] marketing expenditures for physician invitations to meetings have to be cut by a certain margin each year.” France also is tightening up, he says. “Pharma companies have to discuss the level of their total marketing expenditures as part of the price negotiations that the companies have with the French government.”
And in some ways, pharma controls are stricter in Europe than in the United States, says Terwindt. “Sampling represents a significant commercial avenue for pharmaceutical companies in the U.S. That's something that has been regulated more strictly in many European countries.”
Again, it goes to the cultural difference. “In the U.S., reps have to squeeze in time to see docs, who are being pressured to see more patients so their hospitals can make more money,” says Heybroek. “In Europe, [pharma/physician interactions are] based more on personal relationships, so instead of samples, it's more accepted that reps take the doctors out for dinner.”
Another cultural difference is that in the United States, healthcare professionals are used to having to pay their own way to activities and to pay their own registration fees. Not so in Europe, where there's a long tradition of pharma companies paying for doctors — but that tradition is changing.
“It used to be that a company would invite a physician to a meeting and everything was paid for,” says Heybroek. “In the Netherlands, there's now a regulation that the company can pay only a fraction of the cost, with the balance being paid by the physician or the institution. That will affect the meeting business — physicians will become more discriminating about which meetings they'll go to.”
Perceptions of Pampering
“Industry in Europe is aware of the PhRMA Code restrictions here, but I don't see it having a huge impact on what they're doing,” says Elizabeth Wilson, senior director, business partnerships, with Bethesda, Md.-based American College of Cardiology.
While Terwindt hasn't noted any big movement toward downscaling medical meeting venues in Europe, “It's all about image and perception when it comes to pharmaceutical companies,” he says. Also, “some organizations have told us that it's difficult to get funding for meetings in Monte Carlo now — they all want to go there, but they can't get funding.”
But, says Heybroek, “Perception is reality. So we need to be mindful of what our clients, both physicians and corporate, want, and what ourchairs are interested in.”
Another sign that a change is anticipated, says Potten, is that she's gotten calls from people within the international venue community asking how she thinks the PhRMA Code could affect international attendees coming to their locations.
“That's a very proactive stance, for them to be contacting people in the industry in the U.S. to see how it may affect them,” she says. In the United States, it used to be a selling point for a hotel to have “resort and spa” in their titles, “but with a narrower definition of what is educationally appropriate, it'll be interesting to see if those types of properties market themselves differently to medical professionals, both within and without the U.S. In some ways, it's a shame, because you might be able to get a great deal there. But it's all about perception.”
So far, according to a spokeswoman for Ritz-Carlton, a chain renowned for luxury, the PhRMA Code hasn't had any impact on her company's non-U.S. properties. But that may change as the globalization of the pharmaceutical industry — most of whose major players are moving their headquarters to the United States — solidifies.
One of the large pharmaceutical companies already has put in placepolicies that could affect where it does its business and where it puts its commercial CME support dollars, says Heybroek. “On the other hand,” says Terwindt, “as long as we don't position meetings in Europe as being lavish, the real consideration when it comes to venues is that it is appropriate for a successful activity.”
Martin Cearnal, president and CEO of Thomson Physicians World, Secaucus, N.J., also thinks pharma globalization will have an impact on international commercial support. “With more of the decisions being made at U.S. headquarters for meetings held outside the United States, the mindset here is beginning to take hold for other countries' meetings allocations. I can envision that happening more in the future.”
Euro CME — Growing Competition
“The international area has to be where the growth will come from in the future,” says Elizabeth Wilson, senior director, business partnerships, with Bethesda, Md.-based American College of Cardiology. “Certainly the science is coming increasingly from the international arena — more than 50 percent of what we publish in our journal comes from outside the U.S.” The question is, will it stay outside the United States in the future?
With less restrictive policies, growing numbers of specialists outside the United States, and world circumstances that make travel to the United States more difficult — and the PhRMA Code restrictions making travel to U.S. meetings less attractive — some international meetings are picking up steam.
“The European Society of Cardiology is nipping at our heels,” says Wilson. “Last year, they had about 22,000 attending their meeting, and we had about 27,000 at our meeting here.” With pharma-funded symposia as part of the regular program and pharma companies having freer rein with European physicians at meetings, “I think it's becoming a real issue to get experts to give their most cutting-edge research at U.S.-based meetings,” she adds. “We still had a significant number of international attendees at our meeting this March, including a strong representation from France — our motto was that science rises above the political circumstance. But that doesn't mean that the societies over there aren't taking cold-hearted advantage of the fact to get more attendees to their meetings over there.”
David Schlumper, a Rockland, Mass., senior program manager with Serono Symposia International, has a slightly different take on the situation. “We used to have some South Americans who came to a lot of programs here, but now they're staying home because they can get quality education at home [due to the spread of U.S. CME standards across borders.] The quality of the education is going up outside the U.S.,” he says. “And that's good for everyone.”
CME Status Around the World
|Country||Mandatory CME||Voluntary CME Only|
|Source: Leonard Harvey's 2003 “Development and Structure of National CME/CPD”|
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