The Regulation of Nicotine-Containing Products - Jeremy Mean - E-Cigarette Summit UK

The Regulation of Nicotine-Containing Products - Jeremy Mean - E-Cigarette Summit UK

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  The regulation ofNicotine-Containing Products (NCPs) 12 November 2013 Jeremy Mean
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  Outline • Regulation ofNicotine Containing Products (NCPs) • UK Government policy • EU Tobacco Products Directive 2
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  Regulation of NCPsin the UK • NRT, licensed medicine since the 1970s, • Expert Working Group in 2005 • Every strength/form available non-prescription • Flexible framework rather than fixed criteria • Objective to enable safe and effective products to meet public health aims 3
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  All of theseproducts contain nicotine 4
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  NCPs regulated by MHRA Theseproducts are NOT regulated by MHRA All of these products contain nicotine 5
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  Developing electronic cigarette market 6
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  Challenge for regulation •To enable safe and effective products • Not to ban potentially useful ones • To listen to stakeholders • To protect and promote public health 7
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  Public consultation • Growingconcerns about safety and quality of products on the UK market • Harm reduction approach to smoking “..to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them” 8
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  Outcome of consultation AgainstMHRA regulation For MHRA regulation Some importers ASH, Medical professional Users of NCPs bodies, NHS, Pharma, tobacco trading standards some importers 9
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  Working with stakeholders Publichealth bodies Across UK Government Researchers MHRA Pharmaceutical industry E-Cig industry 10
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  Research • Investigation ofthe levels of nicotine • The nature, quality and safety of unlicensed NCPs • The actual use of unlicensed NCPs in the marketplace • The efficacy of unlicensed NCPs in smoking cessation • The potential impact of bringing NCPs into medicines regulation on public health outcomes 11
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  Summary of mainfindings • Variable nicotine levels - labels and batches • Variable nicotine delivery • Unlicensed NCPs fail to meet standards of safety, quality and efficacy • Most NCP used to support stop smoking or harm reduction • Limited evidence of effectiveness • GPSD regulation does not serve public health objective 12
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  Medicines regulation • Proportionatelicensing regime • Labelling and product information • Sale and Supply • Advertising controls • Safety monitoring • Risk management tools 13
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  OTC medicines market– highly competitive, FMCG 14
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  OTC branded andown brand products even in small markets 15
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  OTC medicines market 16
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  Safety issues • Yellowcard Vs media reports • Relative risk:benefit - For smokers - For never smokers • Gateway? • Smoking maintenance? 17
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  European proposals onNCPs • Part of wider Tobacco Products Directive • Nicotine threshold approach • Medicines licence required for some products • Warnings for others 18
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  EP Position onNCPs • NCPs medicines by presentation • For others – Some controls like tobacco ones – Some controls like medicines ones • Conflicting provisions • Does not amount to a regime capable to protecting and promoting public health • Inflexible and unresponsive requirements • Fails to “future proof” 19
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  UK Government position •Medicines framework for NCPs serves public health objectives • MHRA stands ready to license NCPs now (by presentation) • Supporting true innovation, diversity, appeal • Support Europe wide certainty on legal position on NCPs as medicines 20
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  The regulation ofNicotine-Containing Products (NCPs) 12 November 2013 Jeremy Mean