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167070

	registered interest
	date	01/12/2014
	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, whether he plans to apply standardised packaging of tobacco to e-cigarettes.
	tabling member constituency	Monmouth
	tabling member printed	David T. C. Davies
	uin	216501
	answer	answer is ministerial correction date of answer 08/12/2014 answer text <p>The Government’s proposals for standardised packaging of tobacco products were set out in the consultation that was published on 26 June 2014. That consultation included draft regulations which specified requirements for the packaging of cigarettes and hand-rolling tobacco only.</p><p> </p><p> </p><p> </p><p>The consultation document entitled <em>Consultation on the introduction of regulations for standardised packaging of tobacco products,</em> has been attached.</p><p> </p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 216500 question first answered 08/12/2014 15:13:51 answering member 3918 label Biography information for Jane Ellison attachment 1 file name Consultation on the introduction of regulations for standardised packaging of tobacco products.pdf title Consultation on Regulations Standardised Packaging
	tabling member	1545 label Biography information for David T C Davies

167069

	registered interest
	date	01/12/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, whether he plans to apply standardised packaging of tobacco to legal high products.
	tabling member constituency	Monmouth
	tabling member printed	David T. C. Davies
	uin	216500
	answer	answer is ministerial correction date of answer 08/12/2014 answer text <p>The Government’s proposals for standardised packaging of tobacco products were set out in the consultation that was published on 26 June 2014. That consultation included draft regulations which specified requirements for the packaging of cigarettes and hand-rolling tobacco only.</p><p> </p><p> </p><p> </p><p>The consultation document entitled <em>Consultation on the introduction of regulations for standardised packaging of tobacco products,</em> has been attached.</p><p> </p> answering member constituency Battersea answering member printed Jane Ellison grouped question UIN 216501 question first answered 08/12/2014 15:13:51 answering member 3918 label Biography information for Jane Ellison attachment 1 file name Consultation on the introduction of regulations for standardised packaging of tobacco products.pdf title Consultation on Regulations Standardised Packaging
	tabling member	1545 label Biography information for David T C Davies

93017

	registered interest
	date	13/10/2014
	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 the implications are for his policy of the statement by the Chief Medical Officer that e-cigarettes represent one of the three major health threats to the UK.
	tabling member constituency	Monmouth
	tabling member printed	David T. C. Davies
	uin	210193
	answer	answer is ministerial correction date of answer 16/10/2014 answer text <p>The Government’s policy on e-cigarettes is to enable the availability of products which meet appropriate standards of safety, quality and efficacy to support smoking cessation and to reduce the harm of smoking to smokers and those around them.</p><p> </p><p> </p><p> </p><p>Beyond licenced medicinal products, the Government is working to transpose the provision of the Tobacco Products Directive (Directive 2014/40/EU) which will provide a framework for e-cigarettes which are not licensed as medicines. In addition to the safeguards the Tobacco Products Directive will introduce, the Government is committed to banning the sale of e-cigarettes to under 18s to protect children from the potential for nicotine addiction and the unknown risks of using e-cigarettes to developing lungs.</p><p> </p><p> </p><p> </p><p>The Government’s policy will remain evidence based and we will continue to closely monitor all emerging research.</p><p> </p><p><strong> </strong></p><p> </p> answering member constituency Battersea answering member printed Jane Ellison question first answered 16/10/2014 15:13:08 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

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

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