On 10/11 July, MEPs of the ENVI committee will take an important step towards finalising the text of a new Tobacco Products Directive. If the preparation and voting goes well thousands of amendments and opinions will be honed into a single coherent legislative text to be presented to the European Parliament plenary in September. The process is a bewilderingly complex negotiation, but the successful MEPs will have a clear view of what they are trying to do and what matters. So I have written to set out 10 things they should really think about before they vote. Continue reading “MEPs – 10 things to think about before you vote”
When the UK Medicines Regulator (MHRA) consulted in 2010 on whether e-cigarettes should be regulated as medicines, it gave three options: I summarise the first two and quote the third: Option 1. Regulate as medicines and withdraw unlicensed products in 21 days Option 2. Regulate as medicines and withdraw unlicensed products in a year (June 2011) Option 3. “Do nothing and allow these unregulated products containing nicotine that have not been assessed for safety, quality and efficacy to remain on the market.” [emphasis mine]
See what they did there…? It’s either medicines regulation or ‘unregulated’. We call this framing bias – and they were rightly criticised for it. But the idea persists that e-cigs are unregulated, and it is the reason why some people think they should be regulated as medicines. In reality, there is very little in the European Union that is ‘unregulated’. Most products fall under general consumer protection legislation. Here is a selection of the key EU directives and regulations that already apply (or could be applied) to e-cigarettes and other non-medicinal nicotine containing products: Continue reading “E-cigarettes are unregulated, right?”
E-cigarettes represent an amazing market-based, user-driven public health insurgency. From nowhere to €500m in Europe, the market is growing rapidly and already almost equals the market for NRT, according to the European Commission’s consultants (see chart and Matrix report p21). Without anyone in the professional public health field doing anything and without spending any public money, smokers have been quitting, switching and cutting down using e-cigarettes. Enter the regulators… Continue reading “Medicines regulation for e-cigarettes – when caution can kill”
On 30 November, the draft EU Tobacco Products Directive was circulated for inter-service consultation (ie. sent round all other Directorates General in the European Commission). Its contents are not yet public, but it is widely thought to maintain the ban on snus and to impose strict restrictions or even bans on reduced risk non-combustible tobacco products, e-cigarettes and novel electronic nicotine devices. I cannot sufficiently stress how wrong and harmful that would be, given the role these products play as alternatives to smoking. I remain ever hopeful that good science, ethics and law (and common sense) will eventually prevail. To that end, I have written to the new Commissioner, Dr Tonio Borg, to suggest he makes five changes to the Commission’s approach. Here’s the letter: Continue reading “European Union making bad policy on nicotine – five ways to make it better”
Q. When does an ethnic conflict become a genocide?
A. In retrospect
Not an obvious subject for jokes, but the situation in the Darfur region of Sudan supports the case for cynicism. The elements of the current situation have been widely rehearsed (see BBC in depth coverage and The Guardian’s collection), but crisis point has been reached with the Government of Sudan demanding withdrawal of African Union peacekeepers while blocking the arrival of blue beret UN peacekeepers, which are not in any case forthcoming, while attacking civilians and arming the Janjawid Arab militia and using them as proxies in an orgy of killing, rape, abduction and atrocity (see 2006 conflict map). The destruction is systematic and ethnically targeted and has so far involved slaughter of at least 200,000 and ‘internal displacement’ of about 1.8-2 million, which the African Union are there to protect, with mixed results (see Brookings Institution). What is going on…? Continue reading “”