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The regulation of Nicotine-Containing Products (NCPs) 12 November 2013 Jeremy Mean

The regulation of Nicotine-Containing Products (NCPs) 12 November 2013 Jeremy Mean. Outline . Regulation of Nicotine Containing Products ( NCPs ) UK Government policy EU Tobacco Products Directive . Regulation of NCPs in the UK. NRT , licensed medicine since the 1970s ,

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The regulation of Nicotine-Containing Products (NCPs) 12 November 2013 Jeremy Mean

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  1. The regulation of Nicotine-Containing Products (NCPs)12 November 2013 Jeremy Mean

  2. Outline • Regulation of Nicotine Containing Products (NCPs) • UK Government policy • EU Tobacco Products Directive

  3. Regulation of NCPs in 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

  4. All of these products contain nicotine

  5. NCPs regulated by MHRA These products are NOT regulated by MHRA All of these products contain nicotine

  6. Developing electronic cigarette market

  7. 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

  8. Public consultation • Growing concerns 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”

  9. Outcome of consultation AgainstMHRA regulationFor MHRA regulation Some importers ASH, Medical professional Users of NCPs bodies, NHS, Pharma, tobacco trading standards some importers

  10. Working with stakeholders

  11. Research • Investigation of the 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

  12. Summary of main findings • 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

  13. Medicines regulation • Proportionate licensing regime • Labelling and product information • Sale and Supply • Advertising controls • Safety monitoring • Risk management tools

  14. OTC medicines market – highly competitive, FMCG

  15. OTC branded and own brand products even in small markets

  16. OTC medicines market

  17. Safety issues • Yellow card Vs media reports • Relative risk:benefit - For smokers - For never smokers • Gateway? • Smoking maintenance?

  18. European proposals on NCPs • Part of wider Tobacco Products Directive • Nicotine threshold approach • Medicines licence required for some products • Warnings for others

  19. EP Position on NCPs • 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”

  20. 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

  21. The regulation of Nicotine-Containing Products (NCPs)12 November 2013 Jeremy Mean

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