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CME faces change

The rules on funding doctors' continuing medical education and the interests doctors have to declare are getting increasingly more stringent, as European accreditation bodies adopt the tough standards seen in the US

Change written on a blackboard - CME It seems that every other month there is a new story about European continuing medical education (CME); it is coming of age and developing into something that many companies can no longer avoid. Additionally, the changes in the US are now being felt in Europe, not just a sharing of ideas or practices, but also the legal imperatives that must now be followed.

As the CME community gathers in November for the fourth annual meeting of the European CME Forum, what key developments have taken place among the three main stakeholder groups: the CME accreditation bodies, education providers and the pharma supporter?
CME accreditation bodies
The European Accreditation Council for Continuing Medical Education (EACCME) – run by the European Union of Medical Specialists (UEMS) – was the initial driving force. Since 1999, it has been setting standards and creating the value proposition to the physician members of many medical societies. However, as it stands, the system struggles to assess and accredit thousands of meetings per year. While it is true that review times have improved considerably in recent months, it is still difficult to see how the process will cope with the required tens of thousands of programmes as European CME develops.

One potential solution is to implement a provider accreditation system, as in the US, where carefully overseen accredited educational providers are responsible for managing the accreditation of programmes. While it may alleviate the pressures of accrediting each individual meeting, an argument against provider accreditation is that it is inherently flawed to have an organisation accrediting its own work, however many checks and balances are in place. This is a reason why the European Board for Accreditation in Cardiology (EBAC) decided to move out of the offices of the European Society of Cardiology last year, and to run as a completely separate independent organisation. It remains to be seen if this provides the solution and whether others will follow, even in the US.

Revised standards
UEMS-EACCME is expected to announce its revised standards for the accreditation of live events this month – they were being discussed at a council meeting as this article was being written. Some insiders say that the standards are potentially too strict on pharma, making demands on huge degrees of separation from the funding, so much so that they may not be able to specify which areas of medicine are being addressed, or even to suggest potential faculty members. An added twist to the tale is that, during the same meeting, the results of the election for the UEMS board had completely changed the profile of the decision makers. The only certainty at this time is that there will be significant change. 

Education providers
The main education providers in Europe are still the medical societies, with their education committees working to address the needs of their society members and looking to expand their educational offerings beyond the main output of their annual congresses. The commercial organisations that are involved in European CME are becoming increasingly busy and many of the traditional 'agencies', communications or other, are being asked by their pharma 'clients' how they can support CME activities.

As a largely invisible breed, comms agencies occasionally struggle to serve the emerging new masters that CME demands. However, they are already seeing that the days of carrying out exactly what was demanded of them by their pharma clients are slipping away and the old safety net of the pharma company's internal regulatory approval rounds no longer offers the guidance or protection it once did. They now have legal and regulatory responsibilities of their own. Whether following the good publication practice for publishing company-sponsored medical research (GPP2), complying with corporate integrity agreements or considering whether they have fallen foul of the UK's Bribery Act, comms agencies need to demonstrate that they themselves are able to work within a transparent and ethical framework. Some are making the additional step and taking on the role, where they are allowed, of CME education providers, assuming full responsibility for the educational activities developed. The debate continues as to what is 'education' and what is 'promotion', and who governs what. But it is important to have crystal clear transparency, especially in an environment of mistrust of disguised promotion by pharma.

As part of the drive to help guide this new emerging sector, the Good CME Practice group, a collection of 14 European providers that engage in CME and education at arm's length from industry, has been deriving standards and definitions for education providers in CME. The members have spent the past year working in consultation with CME accreditation bodies, medical societies and pharma then validating their findings. They are presenting more information at the European CME Forum meeting and aim to have the guidelines published before the end of the year.

Pharma supporters
The overwhelming majority of support for European CME still comes from the pharmaceutical industry. Theoretically, anyone can be a supporter; but, as with any sponsorship however 'hands-off', it is the company which has the most to gain that will be supporting CME. An insistence that pharma companies support education in areas not of interest to them (and ignoring the fact that it is forbidden to do so in Germany anyway) will receive no backing.

Less often discussed is the desire for the doctors to pay for their own CME. It is now an accepted norm that doctors are the only professionals to have their continuing professional development paid for by the industry that serves them, and heads still nod in agreement when explanations are offered that they, or their employers, are simply too poor to pay for it.

In an increasingly critical atmosphere, pharma companies in Europe are adopting unilateral interpretations of the new legal and regulatory environment in Europe. For example, AstraZeneca recently announced that it would cease to pay for delegate travel and congress registrations. Transparency is also driving new companies to fund CME. Two notable global top-ten pharma companies that have not supported CME in Europe to date are now looking to engage in it as a demonstration of their arm's-length relationship with the faculty. They are also making the financial relationships less direct so that the individual physicians will no longer need to declare the financial relationships, as this is now removed from their personal responsibility.

What is the future?
While the checks and balances that CME accreditation offered may have led the way in 1999, without the much needed revisions over the years, they no longer accommodate the ever-increasing requirements of pharma and providers. Requirements for financial disclosures are only a small first step and many involved are unaware of the seismic changes that are taking place in the commercial sector.

US experts are increasingly reticent to fly to Europe for pharma-run meetings, as the resulting financial declarations could jeopardise career-enhancing moves, such as advising government bodies. Up to now, this may have sounded a little strange to us in Europe, but we are now seeing evidence of this. For example, the European Society of Cardiology recently announced that it would be expecting members of its guidelines committees to have no financial relationships to disclose with pharma. And, as of October this year, the European Medicines Agency, following direct intervention by the European Parliament, is making all its experts' declarations publicly available on its website and excluding anyone with a 'competing interest'. The Rubicon has been crossed.

Thus, CME accreditation bodies are no longer alone in the driving seat when it comes to controlling pharma relationships. Medical societies, education providers and regulatory bodies are also navigating the new rules. All stakeholders want to drive up standards; all need to be acting transparently and seen to be behaving ethically. It is critical that all groups communicate with each other and address one another's concerns and aspirations. If not, we may find ourselves in the following weird default position by dint of our inaction: that the US government – as a major initiator of demands on transparency and pharma behaviour – will be the single most powerful voice affecting CME development in Europe!

Eugene Pozniak is managing director of Siyemi Learning, which he founded in 2006. He delivers CME accredited education with collaborative education providers and as a consultant to education providers, agencies on pharma-supported projects, medical societies and regulatory bodies.

He is also programme director and guarantor of European CME Forum, a not-for-profit organisation. He is a chemistry graduate and spent the first 12 years of his career working for pharma and in the agency sector, delivering his first CME programme in 1996. In 2000 he left the promotional sector and has worked in CME ever since. He developed the first pan-European CME accredited e-learning for the European Society of Cardiology.

28th November 2011


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