CME Spotlight: De-coding the letter of the law
pharmafile | April 29, 2010 | Feature | Medical Communications | CME, CME Spotlight
Legal systems can raise interesting philosophical points sometimes.
At the time of writing, the UK is in the throws of a panic about new ‘street drug’ mephedrone – or ‘miaow miaow’ as it is playfully known. Several teenagers have died as a result of taking the amphetamine-like stimulant, and there are demands for legislation to be swiftly passed to make it illegal.
I am still mystified as to how someone discovered this product’s effects in the first place. An image comes to mind of a poor misguided teenager scouring the shelves of B&Q, licking their finger against fertiliser bottles and weedkiller packets in a desperate search for a cheap buzz. But times are clearly changing: in earlier times it was the solvents in the paint section which would have been the attraction. As plant food is not derived from anything that has a blanket ban, such as an opioid base, there is a loophole to be exploited: our constitutional principle that says “everything which is not forbidden is allowed”, thus rendering it not illegal.
I once asked someone at a CME accreditation body what they thought accounted for the differences between the US and European accreditation systems. They explained that the root cause of many things is that in the US, “what is not allowed is forbidden”, and for Europe, “what is forbidden it is not allowed”.
These statements also help to offer explanation as to why we find huge swathes of explanatory text in the US that defines all the things that are allowed in CME in order for them not be forbidden, and why in Europe by comparison there seems to be so little written guidance. But is the approach more relaxed in Europe?
Following the spirit of the law in CME
There are so few things that are actually forbidden by some organisations, sometimes it looks like anything can be allowed. Professor Nigel Sparrow (director of CME at the Royal College of General Practice) described at a recent PM Society meeting how the new CPD system for UK GPs operates.
It seems that GPs can count absolutely anything against their CPD requirement, even a promotional mailing from a drug company, as long as the doctor has learnt something. He also described the parameters that the College welcomed input to CPD from the commercial organisations.
At first this sounds like an ‘anything goes’ scenario, but in reality there are a lot of guidelines, and here is the rub – there are a lot of implied rules and regulations. For instance, certain standards, even if not explicitly stated, have to be observed in the ‘spirit’, which is also dictated by ‘common sense’.
Reading promotional literature may be an interesting and valuable information channel, but a promotional activity would have to be rather special if it is to be declared as a CPD activity. These are things that do not necessarily exist in the US rules, and due to the highly implicit nature of the knowledge, it is sometimes hard to explain fully to a non-European.
I have to admit that I used Google to check these phrases for this article as they can be rather mind-boggling at times. While doing so I also came across what was described as ‘jocular’ variations: the French version says that “if something is forbidden it is still allowed”. Sarkozy jibes aside, we can see a link with the CME system, one that makes us Brits roll our eyes: CME in France was in fact made a legal requirement in 1988.
The French parliament passed the legislation and it was written into law. However, it was not until 2006 that the first office of CME was actually opened. We find that there is a two stage process in French law, whereby just because something has been made a legal requirement, it does not necessarily mean people are obliged to comply, or indeed indicate that there are ‘punishments’ for non-compliance. This comes later as the law is ratified and then put into practice.
In the latest round of changes, the French CME community has been waiting for a further ratification process to be completed: the expected completion date of last January has long-since been passed and people still do not know how this legal obligation will eventually be put into practice.
But this maxim, silly as it may sound, applies very nicely to many scientific observations.Betraying my own roots in chemistry, I remember two semesters of transitional metal chemistry that really would have been incredibly dull with odourless, inert, white solids and colourless solutions, were it not for the ‘forbidden transitions’ as electrons behave ‘illegally’ giving rise to a beautiful spectrum of colours of metal salts: copper sulphate solution is not allowed to be blue – it is forbidden.
‘Ignorance of the law is no defence’
While CME in Europe does not have a large library of documentation, it means that many people engaging in CME activities, especially for the first time, find that relevant practical guidance is not necessarily available. Especially if the education provider may have extensive experience acting as an ‘agency’ for a ‘client’ doing their bidding, how do they behave in an environment where independence from sources of funding is a pre-requisite?
I have described in previous articles the activities of the Good CME Practice group, and I notice that guidance is now becoming easier to find and follow on the European CME accreditation bodies’ own websites. EACCME has also recognised with their more stringent e-learning requirements that providers may need some additional guidance, which is now factored into the approval process where a couple of weeks can be granted to work out potentially problematic issues as soon as they are identified. So more guidance is being generated, it just needs to be found and followed. As higher rates of non-accreditation start to emerge, a situation will soon emerge here of “ignorance of the rules is no defence”.
Whichever way the CME rules evolve in Europe, it should be remembered that legislation can easily be added, banning any misguided behaviour very quickly. So it is worth examining just how to engage in this activity before throwing oneself headlong into developing education that may be perceived as biased or of low quality.
There also exists the Soviet-era version of the phrase which can be applied to errant programmes where comrades explained that “everything is forbidden, even that which is expressly allowed”.
Eugene Pozniak is managing director of Siyemi Learning and Programme and 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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