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Stop demonising a potentially useful product for smokers


@Richard Schmidt 12 Sep To take these points one at a time: 1. Closed doors? It is a matter of record that the terms of Article 20 of the Tobacco Products Directive were negotiated behind closed doors: firstly, as a hastily contrived amendment hammered out in closed political group meetings in the week before before the 8 Oct 2013 plenary. Secondly in a closed 'trilogue' process that ran from October to December 2013, with most of the agreement on e-cigarette happening late in December, with all relevant documents classified Limité. The proposals that now make up Article 20 of the directive have not been subject to rigorous justification, options appraisal or consultation - and the normal processes of national parliament scrutiny were bypassed. 2. Scientific basis? A group of Europe's most credible experts in these subjects wrote to the Commission to protest that the science based used was completely flawed. Their letter: Scientific errors in the Tobacco Products Directive is well worth a read, and has never received an adequate response (17 January 2014) 3. Legal basis. In EU law the science and law are linked. The directive is supposed to be justified as enabling free movement of goods, subject to high levels of health protection. So a justification is required to show that any impediment of free movement of good is justified with reference to health protection. At the same time the measures have to be 'proportionate', 'non-discriminatory' and have adequate legal base. In addition the EU legislature is required to consult etc on new legislation - something it didn't do. Many of the measures in the TPD fail these tests. However, no definitive judgement can be made on that until the ECJ hears a judicial review. This is likely - one company has mounted challenge and it is likely that the high court will refer the case to the ECJ on 6 October. If you want an idea of where the legal vulnerabilities lie, please look here: Flawed science, irregular procedure, unlawful measures - 4. It is not that everything in the TPD is wrong - and it is quite right to insist on pharmaceutical grade nicotine, excipients and purity standards. It is fine to classify them as medicines when they are sold with a medical therapeutic claim, though this hardly ever happens. 5. Most products are not bought or sold as medicines and manufacturers generally don't make claims about treating or preventing disease that would bring these products into the classification of 'medicines by presentation'. 6. Much PR effort goes into demonising nicotine - but although it is the addictive agent in e-cigarettes its risks are quite low at the concentrations and exposures typical of e-cigarette use. There is an extensive literature on this, and of course nicotine is sold in licensed NRT products, with relative light warnings and contraindications. It will always be better to use nicotine from an e-cigarette than to smoke. 7. It would be better not to classify and regulate these products as either tobacco or medical. They are neither. Consumer protection legislation (some of which is mentioned in the comment) would provide most safeguards necessary - and specific standards could be applied to require, inter alia, pharma grade ingredients, child resistant containers, purity standards etc. Marketing restrictions similar to those applied to alcohol would be more appropriate than the total ban applied to tobacco. The reality is that the EU has, through a wholly inadequate process, contrived regulation that it arbitrary, counter-productive, and discriminatory. Some how they have made it easier to put cigarettes on the market. Through unjustified restrictions that provide no health benefits they weakened a competitor to smoking, even though all informed opinion is considers the risk 95-100% lower than smoking.

Posted date

15 SEP 2014

Posted time



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