The regulation of Nicotine-Containing Products (NCPs)

UK National Smoking Cessation Conference

28 June 2013

Jeremy Mean

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Outline

• MHRA and the regulation of Nicotine-Containing Products (NCPs)

• Main features of medicines regulation

• European proposals for regulating NCPs

• UK Government action

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Role of the MHRA

• The Medicines and Healthcare products Regulatory Agency (MHRA) is the Government Agency responsible for ensuring medicines and devices work and are acceptably safe – a statutory role

• The Agency is part of the Department of Health and supports the Government’s wider public health policies

• This includes reducing the impact of smoking on public health and how NCPs are regulated

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All of these products contain nicotine

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All of these products contain nicotine

NCPsregulated by MHRA These products are

NOT regulated by MHRA

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Public consultation

• Growing concerns about safety and quality of products on the UK market

• Growing acceptance of 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”

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Outcome of consultation

Against MHRA regulation For MHRA regulationSome importers Medical professional

bodies,Users of NCPs NHS, pharmaceutical

industry tobacco industry trading

standards some importers

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Working with stakeholders

Researchers-UKCTCSProf Hajek

Pharma ECITA

NICE, DH, BIS,

No. 10

Public Health Sector

MHRA

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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 these products into medicines regulation on public health outcomes

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Summary of main findings

• Nicotine levels vary from the labelled content and from batch to batch

• Variable content and 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

• Current regulation does not serve public health

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Main features of medicines regulation

• Proportionate licensing regime

• Labelling and product information

• Sale and Supply

• Advertising controls

• Safety monitoring

• Risk management tools

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European proposals on NCPs

• Part of wider Tobacco Products Directive

• Nicotine threshold approach

• Medicines licence required for some products

• Warnings for others

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UK Government action

• Regulation of NCPs as medicines serves the public health

• MHRA stands ready to license NCPs now

• UK Government will press for EU law to create a Europe wide legal position on NCPs as medicines

• This will mean all NCPs will require a medicines licence

The regulation of Nicotine-Containing Products (NCPs)

UK National Smoking Cessation Conference

28 June 2013

Jeremy Mean