CME Spotlight: education providers and pharma need guidance
pharmafile | April 27, 2011 | Feature | Medical Communications | CME, CME Spotlight
Transplanting the testes and pituitary gland of a social outcast into a dog is the theme of a new opera recently staged at the English National Opera in London.
‘A Dog’s Heart’ is based on a book written in 1925 by Mikhail Bulgakov. Unfortunately for Bulgakov, the censors deciphered the parallels he was making with the newly emerging repressive Soviet state; and this was to be the oeuvre that took him from being a minor celebrity.
But his criticial stance eventually saw him censored and ostracised. His legacy was only secured a quarter of a century after his death when ‘The Master and Margarita,’(one of my favourite books) was finally published.
It is an entertainingly terrifying story as the dog turns from a gentleman’s friend into a humanised but slovenly and violent creature.
There is a good twist, but I don’t want to completely spoil the ending for you here!
The book is now studied by Russian schoolchildren as an allegory of the Bolshevik Revolution and its misguided attempt to transform society and mankind.
European CME
The European CME environment is currently undergoing some major transformations of its own. In the past couple of years we have seen a new mandatory CPD system put into place in the UK, a new provider accreditation structure in Italy being implemented, the start of the merging of the multi-stranded Spanish system, and a regional German system operating within a national framework – which even with some teething problems, is progressing positively.
But we must be careful when it comes to defining which organisations play a part in the delivery of CME, as the most efficient way of catalysing the natural evolution of CME may not necessarily be achieved by identifying and transplanting a few key components into an organisation, or its practices, to make it somehow CME compliant.
It is clear that the academic providers would make the ideal CME providers in Europe, however, the universities and teaching hospitals rarely set their sights beyond post graduate education and the European medical societies are reluctant to venture beyond just having their own congresses accredited for CME.
But I would like to focus this article on who should be involved in CME when it comes to commercial organisations and non-academic partners, and how their activities dovetail into the existing structures that deliver ‘medical education’.
Immediately one is faced with the problem of defining ‘medical education’. An outsider may observe that this is ‘education’ that is ‘medical’ in nature, defining education as being something even-handed and unbiased, as one would expect at a school or university.
However, we know that this is not the case and find ourselves in a place where education is, at times, most certainly promotion.
Over the past couple of decades it has become standard practice to describe many promotional programmes as education, in most cases this can be justified, as we know from countless surveys that a lot of information from industry is considered to be of high educational value to the healthcare professional.
Considering the wide variety of educational activities some activities are more promotional than others.
Credibility, control and guidance issues
Issues of credibility and transparency are closely related to the separation of the supporting company from the messages.
All pharma marketers know that a higher credibility is achieved when a reputable third party delivers information rather than a company employee – which is why so much budget is spent on honoraria.
This would mean that on our education-promotion continuum there is a trend to try to push down and left – while maintaining as much control as possible. This is where problems start to manifest themselves for pharma.
They know that it is wrong to maintain control as they move into CME, but guidance just vanishes. Most CME bodies do not understand the problem so do not insist on strict enforcement of this important rule (except the ones who ask to see copies of contracts clarifying relationships) – and in light of the Foreign Corrupt Practices Act, US office colleagues hold their heads in despair as they watch European companies fall foul of basic anti-corruption laws.
Some go further and give rise to the bizarre situation of insisting that in the absence of clear European rules, that the European companies act within US rules. Some European CME bodies are discussing the potential for a ruling that programmes must be multiple supported; while introducing competition may help in self-policing in some industries, insisting on multiple support in European CME may lead to stagnation at best, and deeper abuse at worst.
The problem is that many companies interpret their role when supporting CME by the only set of rules clearly pertaining to them: the promotional code.
The expectation is that pharma does not relinquish control to a faculty and must control every word and deed of the programme development. The exact opposite of the expectations of CME! There needs to be a clear distinction between promotion and education in Europe with rules clarifying this.
In the US anything that is not CME is, by definition, promotion.
It is clear where responsibilities lie; for a CME activity pharma is not allowed to be involved in any way, even if it is a completely unbiased piece of education, it is called promotional medical education and pharma must follow the promotional code.
Guidance needed, and not just for pharma
Activities of the European CME Forum have shown that there is a need for guidance, not just for pharma but also the education providers. The Good CME Practice group is now in the consultation phase of their work and will soon publish their guidance for European education providers, setting out the standards and conditions that should be met when working on CME programmes.
This will also guide pharma how to engage appropriately and demonstrate to CME accreditation bodies what kind of relationships can be structured between commercial supporters, in order to appropriately satisfy their objectives of appropriate separation and transparency to avoid potential conflicts and problems.
This separation must be clarified and implemented in order for the fourth area in the bottom figure (right) to be appropriately populated with knowledgeable people, and clearly defined organisations working in CME in Europe. When it comes to having the appropriate organisations working in CME, we need the right animal for the job, transplanting bits and pieces from one being into another can only lead to unacceptable behaviour and devastation on an operatic scale.
THE EDUCATION-PROMOTION CONTINUUM
The first diagram*, graphically represents the broad selection of ‘educational’ activities that companies working in medical education deliver, and I call this the education-promotion continuum.
At one end ‘pure promotion’ with the ultimate promotional vehicle – the press advertisement, and at the other, ‘pure CME/CPD’, an activity that a financial supporter such as a drug company is absolutely forbidden from having any involvement in or control. I have then placed the other activities along the continuum where they seem best suited in relation to each other. There are some activities where there may be multiple iterations depending on how they are executed: an advisory board for example may address general topics to do with disease management or be convened to review product specific messages to help with marketing strategy.
I have also circled four key areas which broadly represent the various agency-types responsible.
The top sector controlled by the advertising agency, the next, the PR agency, and the bulk in this representation by the medical comms agency.
All fine, but looking at my last sentence you will notice that each company type has the word ‘agency’ – the single fact in the business relationships these companies have is that they are paid by pharma to act as their agents. Any activity that they produce must be controlled, de facto, by the pharmaceutical company.
How can any of these organisations be involved in CME if the main tenet of involvement is that the supporting company must not have any involvement in CME?
EDUCATIONAL ACTIVITIES AND CME
My second diagram* shows which kinds of educational activities are being accredited for CME.
I have put in three lines representing nominal lines of demarcation between activities that can be perceived as education and accreditable for CME, and what is considered promotion and unacceptable for CME.
The first line ‘A’ shows an ideal scenario. It is the situation as it stands in the US under this definition.
The companies involved in promotion cannot work in CME because CME is delivered only by accredited CME Providers under strict conditions.
Line ‘B’ shows the situation we find ourselves in Europe. There are few activities that fall into the ‘pure CME/CPD’ category, however, many CME authorities find it acceptable to accredit satellite symposia, stand-alone meetings, and advisory board meetings traditionally controlled by pharma, as long as the faculty can declare they have had a free reign in the programme development.
This highlights an immediate problem where we have the issue of transplanting CME-compliant organs into new beings: the ‘agencies’ that have traditionally managed these activities under total pharma control, now need to change their master and be an ‘agent’ of the faculty.
The third line ‘C’ is a special case which we find in the UK. It is quite possible under the new revalidation structure for a whole host of activity to be acceptable for CPD. The line may be a little lower in the case of programmes prospectively approved for CPD (as CME accreditation is called in the UK), but all doctors, especially GPs, can self-accredit the education they receive, accredited or not; if they deem that an educational activity has the potential to have an impact on their clinical practice, even if it is promotional and product specific, then it can be recorded as a CPD activity.
*The diagrams for this article can be viewed online here.
Eugene Pozniak is managing director of Siyemi Learning and programme director of European CME Forum. Email: epozniak@siyemi.org Information about the Good CME Practice Group can be found at www.gCMEp.eu
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