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January 21, 2013

European CME Standards Evolving but Fragmented

European Meeting
Several recent articles have highlighted ongoing developments of the continuing medical education (CME) environment and industry in Europe. In particular, there has been a “rise in the expectation of the pharmaceutical industry to support CME,” however, “with a lack of guidance on what their role within CME should be, the appropriate level of support is unclear.”  Accordingly,pharmaphorum interviewed Eva Thalmann of Janssen, part of Johnson & Johnson, to find out how Janssen have been involved in CME activities and what she believes pharma’s role within CME should be.  Eva also explains how the CME environment in Europe is fragmented, and the challenges this presents.

Eva currently serves as Head of External Scientific Relations and Medical Education for Europe, Middle East and Africa.  She works with a team of Medical Education Scientific Relations Managers who cover the respective disease areas Janssen is focused on.  The team is responsible for interactions with the European Medical Societies as well as implementing educational activities, identified by external experts in our Therapeutic Area Steering Committees.

Over the past ten years, Thalmann recognized a “big change in the importance and visibility of CME programs.  While 10 years ago CME was mainly a topic in the US, we have now CME systems in nearly all disease areas driven by Medical Societies, countries as well as UEMS in Europe.”  Despite this growth, she recognized that “the CME environment in Europe is fragmented and, in addition, the importance of CME-endorsed programs differ among European countries.”  To address these issues, we previously noted that the Good CME Practice Group (composed of medical education companies in Europe) published its core principles to drive standards for CME in Europe.

Nevertheless, companies looking to support CME programs in Europe have to look for guidance through each specific medical society.  In addition, Thalmann noted that each company “has operating procedures on how to work with CME bodies or how to support CME programs through grant processes.”  She also recognized that “CME agencies have a broad range of how they define CME and support from pharma. There are also differences from disease area to disease area.”

Thalmann explained that “Janssen’s philosophy is to seek CME accreditation for all of our educational activities whenever possible.”  The company strongly believes that “educational programs need to fill educational gaps indentified by the medical community or their representatives,” and that these “programs should be driven by external experts and whenever possible should be reviewed and endorsed by independent CME bodies.”

Due to the fragmented nature and different accreditation systems, however, “CME accreditation is not always possible.”  As a result, she explained that Janssen follows “the input and guidance of our Steering Committees to ensure the scientific relevance and objectivity of educational programs.  Additionally, if scientific third parties, such as medical organizations, request grant support for educational projects that fall in disease areas of interest for Janssen, we have the possibility to support these after an internal review and approval process through educational grants.”

In discussing the challenges to pharma supporting CME activities in Europe, Thalmann noted the need for “a debate on how to cooperate between CME / accreditation bodies and industry.”  In observing the US, she noted “that not all CME programs are good,” and “not all non-accredited educational programs supported by industry in Europe are biased or promotional.”

Furthermore, “the question to be asked is who should be responsible to accredit programs?”  In Europe we have UEMS and the European Medical Societies who as a non-profit organizations are responsible for accreditation, and this ensures the relevance of accredited programs. In the US there are also Medical Communication Agencies, profit organizations, who could conduct CME programs in cooperation with individual academic institutions. 

Accordingly, she stated that “Discussion is needed as to which system would be best for Europe. Furthermore, is a uniform system in Europe possible? Just among the EU we have 27 countries with different codes of practice as well as health systems, so a completely different situation to the US.”

In concluding the interview, Thalmann noted that in Europe, there is a great need for “more cooperation and guidance on educational programs and topics from the Medical Societies,” particularly in reference to commercial support.  She added that Medical Societies should review more educational programs and could ask the industry to cover topics that are important.  There needs to be “new approaches between Medical Societies, accreditation bodies and the industry to ensure that all medical programs are meeting the highest possible standard.”

She also noted the need for more collaboration “between industry and CME bodies in the future to ensure that scientifically relevant programs will ensure the best care of patients. The role of CME bodies should be to supervise and ensure the clinical necessity of such programs, and the industry not only should support such programs financially but should act as a trusted scientific partner. How this collaboration should work still needs to be defined,” she concluded.

Unifying European Standards and Focusing on the Needs of the Physician

 In a second interview, pharmaphorum interviewed Professor Robin Stevenson, a retired respiratory physician who was president of the European Board for Accreditation in Pneumology and still serves on the EACCME taskforce for improving CME in Europe, about how the CME landscape has evolved over the years and how we can unify standards across Europe.

“There are two ways of thinking of standards,” Stevenson noted: “one is the standard actually delivered, and the other is the standard that has been decided should be aimed for.”  While the standard which should be aimed for has been upgraded over the recent years, both nationally and European wide … “what is actually delivered to the doctors probably hasn’t changed hugely,” he noted.

“It has changed in that there has been more of a shift away from didactic lectures on to more interactive small group teaching, and that’s been a good thing.  However, there are still a great many didactic lectures delivered without any terrific benefit.”

“The main way in which standards have changed for the better has nothing to do with CME, accreditation, or CME planning, but it’s simply the accessibility of the internet.  Now when doctors want to learn more in a particular area, they just Google it or they go into one of the medical software platforms like Up To Date. That’s been a revolution because 10 years ago that didn’t happen at all, and so to that extent doctors are much better educated, or are educating themselves much better than they ever did before.”

Then Stevenson went on to explain the current CME/CPD environment in Europe.  He noted how European scientific societies are the main providers of CME in Europe, and they all operate quite independently. They apply for accreditation to the national authorities of the country where they are operating, and also to UEMS, the European Union of Medical Specialists via their European Accreditation Council for CME – EACCME.

“The process of accreditation in relation to these organisations has very little effect on the quality of CME that they deliver, because almost everything that they apply for is granted.  The only time it’s not granted is if it’s thought to be obviously influenced by commercial bias,” he noted.

In the European environment though, “much more important is the fact that the doctors are undertaking their own CME either by themselves, or locally within their own hospitals at multidisciplinary team meetings. These provide very good educational value, but are quite below the radar of all the big players such as EACCME and the Federation of the Royal Colleges.”

To ensure that CME activities across Europe are of a more unified standard, accreditation bodies need to be “more potent,” Stevenson said.  Presently, he said that accreditation in Europe is merely a “formality”; aprovider simply applies to the appropriate accreditation body for accreditation and “they almost always are given accreditation and they go ahead with it without having to change anything in their programme.”  He noted that the “difficulty is that the event has to be accredited before it takes place.”

“The accrediting agency has no idea how the event will actually play out, all they can do is look at the programme, see who are holding it, and try to come to a decision about whether it’s worthy of accreditation or not. They almost always say it is, not because they believe it to be so, but because they have no justification in saying that it won’t be any good.”

Accordingly, Stevenson said that Europe needs a Provider Accreditation, system similar to USA and Canada, “where it’s not the individual events that are accredited, but it’s the providers themselves.”  The providers apply for accreditation for a period of years. The accreditation agency—the ACCME—requires the provider to show what they’ve been doing in the recent years in detail and this process may take days.  The CME provider has to produce all the documentation they have for the events that they have put on, the evidence in relation to the needs assessment, the aims of the meetings, the methods of delivery of the CME, and the ways in which the effectiveness of the CME is evaluated. The agency spends a lot of time looking at all this information, and then they decide whether the provider is worthy of accreditation and for how long.

Although this is “an expensive system … it means that the providers are being held to account much more rigorously than in Europe,” and “until Europe adopts provider accreditation it won’t have much chance of unifying standards for CME,” Stevenson explained.

With respect to the focus of CME programs, he noted that there is investment in CME by pharmaceutical companies for diseases that involve drug therapy.  However, he explained that “it’s the specialties which use a great many drugs or devices that have more CME, and cardiology is the classic example.  There’s much more CME in cardiology than say in respiratory medicine, because respiratory doctors don’t use so many expensive drugs, or expensive devices.”

To ensure that CME activities are more focused on the needs of the physician, Stevenson said that “CME should be predicated on an initial needs assessment.”  Thus, “the people who are providing CME should go to the trouble of identifying gaps in practice, gaps between what is and what should be.  He maintained that the needs assessment should be “an important part of the planning of any CME, and without it the CME probably should not be accredited so easily.”

Stevenson also said decisions should be made about the way CME is delivered, noting that when CME is “delivered in an interactive way, such that the doctor participates in the learning, it’s more likely that his practice will be affected,” rather than in a didactic lecture that is unlikely to change clinical practice.  The difficult part, however, is that “European medicine is quite conservative and is reluctant to change,” and such a big change “involves setting up a considerable infrastructure.”

In changing the European system, Stevenson noted that industry should not have a big role, and that accreditation agencies that will be involved should be totally independent of pharma, similar to the ACCME.  “Pharma would continue to be able to sponsor education, but it would have to be done at arm’s length,” and “there’s no reason why sponsorship by a drug company should not continue.”

Stevenson clarified, however, that while drug companies “can decide what topic it wants to sponsor education in, it should have no part in how the programme should be developed, who the speakers should be etc. These aspects of the education should be done by a faculty or an organising committee, which should operate independently of the drug company.”

 

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“It has changed in that there has been more of a shift away from didactic lectures on to more interactive small group teaching, and that’s been a good thing. However, there are still a great many didactic lectures delivered without any terrific benefit.”

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