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10.2. SR 09-08-2015
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10.2. SR 09-08-2015
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16 <br />Regulatory idea Likely unintended consequence <br />Ban sales to minors There is near universal support for this. However it is worth noting that NRT is made available <br />to people over 12 years in some jurisdictions – because young smokers also need to quit. It <br />should not be assumed that ‘harm reduction’ should start at 18. <br />Prohibit health claims <br />unless regulatory <br />approval <br />This denies smokers real world truthful information about relative risk and may cause more <br />smoking. It is uncontroversial that e-cigarettes are safer than smoking – the debate is over <br />where in the range 95-100% less risky. This erects high and unnecessary regulatory barrier to <br />truthful communication, and claim-making should be tested in the same way any consumer <br />claim must be truthful and proportionate – not to the standard required for medicines. <br />Regulate as a medicine E-cigarettes are not medicines – in common sense or in law. Using ill-fitting or excessive <br />regulation designed for a different purpose would simply limit the development of competitive <br />alternatives to cigarettes. The costs, burdens and restrictions of medicines regulation are <br />excessive and serve little useful purpose (for example, ‘consistent dosing’ is important for <br />medicines, but not for products where the user controls the dose). <br />Regulate as a tobacco <br />product <br />Most tobacco regulation is designed to prevent, supress and control tobacco use. With e- <br />cigarettes the public health imperative is best served by these products growing and innovating <br />to capture market share from cigarettes – many of the tools of tobacco control applied to e- <br />cigarettes are therefore harm-inducing and protective of cigarette sales. <br /> <br />4.2.1 The risk of user countermeasures to overcome poor regulation <br />Regulators do not have a free hand. If regulation is excessive, or removes products from the market <br />that users want, then users will revolt and legitimately subvert regulation that they perceive to be <br />harmful to their health or welfare. It is better to avoid the development of unregulated black or <br />grey markets and home producing by having proportionate regulation. <br />4.3 The current approach of key regulators is arbitrary and disproportionate <br />It is not possible to review all regulatory developments, especially in relation to marketing, age <br />restrictions and banning vaping in public places. This section comments on the main initiatives with <br />respect to regulating the product itself. <br />4.3.1 UK approach <br />The UK’s preferred approach was originally to regulate vapour products as medicines.54 This onerous <br />regime applies costs, burdens and restrictions that would dramatically contract the range of <br />products and number of suppliers, whilst acting as a barrier to innovation 55 and unlawfully forcing a <br />non-medical consumer product into a medical definition and regulatory regime 56. After this <br />approach was rejected in the European Union, the UK has adopted the EU ‘twin track’ approach (see <br />below). The UK government generally has a positive outlook towards tobacco harm reduction, but <br />as long ago as 2009, its policy-makers incorrectly assumed such developments would come through <br />pharmaceutical innovation. It has taken several years to adjust to a different reality – a process that <br />is not yet complete. The separate jurisdictions on England, Scotland and Wales have adopted <br />different stances on vaping in public and other policies. <br />4.3.2 European Union approach <br />The EU’s favoured approach is “twin track”: to regulate using measures designed for tobacco <br /> <br />54 MHRA, Press Release: 13 June 2013, UK moves towards safe and effective electronic cigarettes and other nicotine- <br />containing products [link]. See overview page: Nicotine Containing Products [link]. <br />55 Bates C, Stimson S, Costs and consequences of regulating e-cigarettes as medicines, 20 September 2013 [link] <br />56 Bates C, Are e-cigarettes medicines? Counterfactual March 2013. [link]
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