CME Spotlight: Raising standards
pharmafile | March 25, 2010 | Feature | Medical Communications |Â Â CME, CME Spotlight, Eugene PozniakÂ
In recent months, some in the UK have been questioning just how difficult is it to resist the normalisation of corruption in an open society.
Our bankers and politicians seem to be so ensnared in some kind of axis of sleaze that each comment to emerge contributes to its own satirical show: believing they deserve rewards for the stress of being at the helm as we ride from one financial crisis to the next.
The findings of a recent inquiry found that our politicians deliberately created a ‘culture of dishonesty’ rather than operating ‘within the rules’ – as has been the oft-repeated mantra from the succession of MPs called to account for their actions. While this clearly came as a shock to them, once things were brought into the open, the public quickly concluded that making up one’s own rules inevitably created the potential for dishonesty.
Clearly this brings to mind comparisons with our own sector, where both pharma and the medical profession have been allowed to operate with self-regulatory frameworks.
While there is little evidence of these kinds of misdemeanours in European CME, neither the healthcare profession nor the pharmaceutical industry escape criticism by any means. The quest to raise the bar on standards in CME is a long-standing topic for discussion and one where answers at times seem elusive.
Sweden and CME: relations perfected?
An idea that has been subject of much discussion recently is the shared funding of pharma-supported education and CME activities as practised in Sweden. But what are the main lessons that can be learnt from the ‘Swedish Model’? The aspect that seems to attract the most attention is the 50:50 shared funding approach where Swedish pharma companies are allowed to pay for the logistics of presenting the educational activity itself, but can only contribute up to 50% of the travel, food and accommodation for delegates. No fringe activities are allowed such as a dinner after a symposium, however frugal it may be. Added to this there is a catch-all phrase communicating that pharma is not allowed to offer anything that may count as a benefit declarable to the Swedish Inland Revenue.
However, looking beyond the financial regulations, we find that there is a requirement that the education delivered must be relevant and unbiased. Every educational activity must be approved by the proposed learners or their employers, who are required to assess whether anything might be considered detrimental to public confidence or to be seen to be unduly competitive. This includes evaluating the educational needs as identified by the organisers and the relevance of the proposed educational activity to the identified target audience. Also reviewed is the educational methodology to be employed: such as where case-based or problem-based learning structure illustrating the use of products and techniques are the expectation. If product specific messages are to be included then it must answer a specific learning need with the prior agreement of the invitees, and it should only be done whilst discussing all options in the disease setting, rather than as a standalone ‘detail’.
The formalities do not stop there, anything other than the smallest of meetings – which would be presented by, or at least in conjunction with, healthcare professionals – need to be submitted for review and approval by the national regulatory body.
As we can see, the Swedish Model is a little more involved than just a 50:50 split of funding. In fact, it exceeds may of the requirements of the various national and pan-European CME accreditation bodies! It is no surprise that Sweden does not have the kind of formal CME or CPD system as we see in Germany or the UK: what else could it possibly offer the learners? More protection from disguised promotion? Greater transparency? Less bias? Higher credibility? It is certainly not a system that needs any ‘fixing’.
There are changes afoot in the CME sphere. In the US under the revised CME requirements, involving things such as Performance Improvement CME, additional quality criteria are being introduced and by all accounts is being well received and is in the process of improving the CME environment. The bureaucracy now needs to flush out those organisations that do not want to adapt to the new systems, which will take a few years yet. The Rome CME-CPD Group, a think tank of members from a cross-section of international CME bodies, has been working on a Performance Improvement CME structure that can be adopted in Europe, and the EACCME is starting to put into practice the more demanding requirements that currently apply to e-learning – to live events in order increase levels of transparency and accountability.
Creating a culture of honesty in CME
Europe does not have a single body that can speak for all the stakeholder groups, which creates certain problems. CME bodies can unilaterally stipulate the requirements for their own accreditation – whether the programme is pharma-supported or not – and the promotional codes specify how pharma interacts with healthcare professionals. However, as pharma is not allowed to directly control CME activities, this then leaves pharma reliant on their own promotional codes for guidance on how they can behave in a CME setting! In addition to this, floating in an intellectual no man’s land between the two parties is the education provider, usually working with financial support from pharma, needing to be compliant with both sets of requirements.
In this kind of environment we are at risk of creating a situation where each group will continue cherry picking good ideas from various sources, but specifying ever tighter regulations, circling in a pattern of forever increasing ferocity of control: banning and forbidding things in a hyper-regulated environment. How will this progress the lot of the practicing physician wanting to improve the way they practise medicine and care for their patients?
Taking another look at the Swedish Model we find it is in fact a contractual agreement between the association that employs doctors and the pharma regulatory body. Throughout the contract the wording reflects a duty of care by all parties, describing transparent standards that can stand up to public scrutiny, and two way agreements which specify that where one party may not offer something, that the other may not demand or accept it.
Perhaps the main lesson we can learn from the Swedish Model is how to deliberately create a culture of honesty so that everyone can work confidently within the rules, ultimately serving the patient rather than a set of regulations.
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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