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92255

registered interest
date	26/09/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Smoking
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, how many adverse drug reaction reports have been received relating to the use of (a) nicotine replacement therapies, (b) varenicline and (c) e-cigarettes by school children.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	209711
answer	answer is ministerial correction date of answer 15/10/2014 answer text <p>Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects ADR reports from across the United Kingdom and includes all medicines, including those from prescriptions, those bought over-the-counter in pharmacies or general retail sales outlets. Reports are also received for herbal medicines and other unlicensed medicines.</p><p> </p><p> </p><p> </p><p>The table below shows the total number of UK spontaneous ‘suspected’ ADR reports in association with school children (ages 5-16), received by the MHRA up to 30 September 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline.</p><p> </p><p> </p><p> </p><table><tbody><tr><td><p> </p></td><td><p>Total Number of Reports</p></td></tr><tr><td><p>Varenicline</p></td><td><p>3</p></td></tr><tr><td><p>Nicotine Replacement therapy</p></td><td><p>8</p></td></tr><tr><td><p>E-Cigarettes</p></td><td><p>0</p></td></tr></tbody></table><p> </p><p> </p><p> </p><p>There is unknown and variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.</p><p> </p><p> </p><p> </p><p>The MHRA does not hold data on the number of fatalities associated with nicotine replacement therapies varenicline or e-cigarettes in other countries.</p><p> </p><p> </p><p> </p><p>The requirements for medicines labelling and patient information are set out in European and national legislation. Provisions already exist for a series of warning statements to appear on the packs of nicotine replacement therapy medicines. All medicines are also accompanied by a patient information leaflet which includes detailed information on the safe and effective use of the product and warnings about known adverse effects.</p><p> </p><p> </p><p> </p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 209710 209716 question first answered 15/10/2014 16:27:32 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies

92256

registered interest
date	26/09/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Smoking
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what information his Department holds on how many fatalities have been reported in other countries arising from the use of (a) nicotine replacement therapies, (b) varenicline and (c) e-cigarettes.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	209710
answer	answer is ministerial correction date of answer 15/10/2014 answer text <p>Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects ADR reports from across the United Kingdom and includes all medicines, including those from prescriptions, those bought over-the-counter in pharmacies or general retail sales outlets. Reports are also received for herbal medicines and other unlicensed medicines.</p><p> </p><p> </p><p> </p><p>The table below shows the total number of UK spontaneous ‘suspected’ ADR reports in association with school children (ages 5-16), received by the MHRA up to 30 September 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline.</p><p> </p><p> </p><p> </p><table><tbody><tr><td><p> </p></td><td><p>Total Number of Reports</p></td></tr><tr><td><p>Varenicline</p></td><td><p>3</p></td></tr><tr><td><p>Nicotine Replacement therapy</p></td><td><p>8</p></td></tr><tr><td><p>E-Cigarettes</p></td><td><p>0</p></td></tr></tbody></table><p> </p><p> </p><p> </p><p>There is unknown and variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.</p><p> </p><p> </p><p> </p><p>The MHRA does not hold data on the number of fatalities associated with nicotine replacement therapies varenicline or e-cigarettes in other countries.</p><p> </p><p> </p><p> </p><p>The requirements for medicines labelling and patient information are set out in European and national legislation. Provisions already exist for a series of warning statements to appear on the packs of nicotine replacement therapy medicines. All medicines are also accompanied by a patient information leaflet which includes detailed information on the safe and effective use of the product and warnings about known adverse effects.</p><p> </p><p> </p><p> </p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 209711 209716 question first answered 15/10/2014 16:27:32 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies

92259

registered interest
date	26/09/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Electronic Cigarettes
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what assessment he has made of progress by the British Standards Institute towards the creation of a publicly available specification for e-cigarettes.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	209746
answer	answer is ministerial correction date of answer 15/10/2014 answer text <p>The Department has not undertaken an assessment of work on developing best practice standards by the British Standards Institute.</p><p> </p><p> </p><p> </p><p>The revised Tobacco Products Directive (Directive 2014/40/EU), which will enter into force from May 2016, will ensure a high level of health protection for United Kingdom citizens. It will introduce a new system of regulation for e-cigarettes and the continued availability of products that meet the regulatory requirements. We will consult, in due course, on plans for implementation.</p><p> </p> answering member constituency Battersea answering member printed Jane Ellison question first answered 15/10/2014 14:26:04 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies

92262

registered interest
date	26/09/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Smoking
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, pursuant to the Answer of 4 September 2014 to Question 206979, with reference to the finding that the number of serious suspected adverse drug reaction reports arising from use of nicotine replacement therapies and varenicline is significantly higher than that arising from the use of e-cigarettes, if his Department will require more prominent health warnings to be displayed for those drugs than for e-cigarettes.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	209716
answer	answer is ministerial correction date of answer 15/10/2014 answer text <p>Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects ADR reports from across the United Kingdom and includes all medicines, including those from prescriptions, those bought over-the-counter in pharmacies or general retail sales outlets. Reports are also received for herbal medicines and other unlicensed medicines.</p><p> </p><p> </p><p> </p><p>The table below shows the total number of UK spontaneous ‘suspected’ ADR reports in association with school children (ages 5-16), received by the MHRA up to 30 September 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline.</p><p> </p><p> </p><p> </p><table><tbody><tr><td><p> </p></td><td><p>Total Number of Reports</p></td></tr><tr><td><p>Varenicline</p></td><td><p>3</p></td></tr><tr><td><p>Nicotine Replacement therapy</p></td><td><p>8</p></td></tr><tr><td><p>E-Cigarettes</p></td><td><p>0</p></td></tr></tbody></table><p> </p><p> </p><p> </p><p>There is unknown and variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.</p><p> </p><p> </p><p> </p><p>The MHRA does not hold data on the number of fatalities associated with nicotine replacement therapies varenicline or e-cigarettes in other countries.</p><p> </p><p> </p><p> </p><p>The requirements for medicines labelling and patient information are set out in European and national legislation. Provisions already exist for a series of warning statements to appear on the packs of nicotine replacement therapy medicines. All medicines are also accompanied by a patient information leaflet which includes detailed information on the safe and effective use of the product and warnings about known adverse effects.</p><p> </p><p> </p><p> </p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 209710 209711 question first answered 15/10/2014 16:27:32 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies

90489

registered interest
date	03/09/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Electronic Cigarettes
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what research his Department has assessed or commissioned on whether e-cigarette vapour carries health risks to bystanders.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	208087
answer	answer is ministerial correction date of answer 08/09/2014 answer text <p> </p><p>The Department has not to date directly commissioned any research on this topic but is keeping the research that has been done under review.</p><p> </p><p> </p><p> </p><p>The studies that have been conducted to date indicate that the risk of passive exposure to electronic cigarette vapour is small relative to tobacco cigarettes.</p><p> </p> answering member constituency Battersea answering member printed Jane Ellison question first answered 08/09/2014 15:39:08 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies

90491

registered interest
date	03/09/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Electronic Cigarettes
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, if he will estimate potential savings to the NHS from more widespread use of e-cigarettes.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	208086
answer	answer is ministerial correction date of answer 08/09/2014 answer text <p> </p><p>There is not yet enough evidence on the impact of e-cigarettes on tobacco smoking to make an estimate of their impact on National Health Service costs. Some research suggests they have the potential to reduce the harms of smoking by supporting attempts to quit, and while e-cigarettes are not risk free, they carry a lower risk to health than tobacco smoking.</p><p> </p> answering member constituency Battersea answering member printed Jane Ellison question first answered 08/09/2014 16:02:50 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies

89426

registered interest
date	29/08/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Electronic Cigarettes
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, when he expects to announce the implementation of industry standards for those e-cigarettes regulated as consumer products.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	207465
answer	answer is ministerial correction date of answer 03/09/2014 answer text <p>I refer the hon. Member to the Written Answer I gave him on 1 September 2014, <em>Official Report</em>, columns 185-86W.</p><p> </p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 207463 question first answered 03/09/2014 14:51:22 answering member 3918 label Biography information for Jane Ellison attachment 1 file name Hansard extract - PQ206977_78.docx title Hansard extract - e-cigarettes
tabling member	1545 label Biography information for David T C Davies

89428

registered interest
date	29/08/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Electronic Cigarettes: Imports
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what steps he is taking to implement stronger checks to ensure no rogue batches of e-cigarettes and liquid are reaching the UK.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	207463
answer	answer is ministerial correction date of answer 03/09/2014 answer text <p>I refer the hon. Member to the Written Answer I gave him on 1 September 2014, <em>Official Report</em>, columns 185-86W.</p><p> </p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 207465 question first answered 03/09/2014 14:51:23 answering member 3918 label Biography information for Jane Ellison attachment 1 file name Hansard extract - PQ206977_78.docx title Hansard extract - e-cigarettes
tabling member	1545 label Biography information for David T C Davies

89686

registered interest
date	29/08/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Electronic Cigarettes
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what his policy is on the definition of e-cigarettes as tobacco products under the terms of the Framework Convention on Tobacco Control.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	207464
answer	answer is ministerial correction date of answer 03/09/2014 answer text <p>Electronic cigarettes are not defined as tobacco products under the World Health Organisation (WHO) Framework Convention on Tobacco Control. The regulation of e-cigarettes, is however, scheduled for discussion at the sixth session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control on 13–18 October 2014.</p><p> </p><p><strong> </strong></p><p> </p> answering member constituency Battersea answering member printed Jane Ellison question first answered 03/09/2014 14:34:29 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies

79284

registered interest
date	22/07/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Electronic Cigarettes
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what steps he is taking to ensure that no rogue batches of e-cigarettes and liquid reach the UK market.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	206977
answer	answer is ministerial correction date of answer 01/09/2014 answer text <p>The revised European Tobacco Products Directive (2014/40/EU), which has a transposition deadline of May 2016, establishes new rules for the safety, quality, ingredients and presentation of consumer electronic cigarettes, as well as refill mechanisms. The new regulations will require six month prior notification of a range of information before either e-cigarettes or refills are placed on the market.</p><p> </p><p> </p><p>In the meantime, e-cigarettes are subject to general product safety regulatory requirements, which include powers for local trading standard officers to withdraw unsafe products from the market.</p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 206978 question first answered 01/09/2014 11:52:27 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies