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79285

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, when he plans 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	206978
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 206977 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

79388

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	Smoking
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, how many serious health events have been recorded per thousand (a) e-cigarette users, (b) users of nicotine replacement therapies and (c) users of the Champix form of varenicline in the last year.
tabling member constituency	Monmouth
tabling member printed	David T. C. Davies
uin	206979
answer	answer is ministerial correction date of answer 04/09/2014 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 whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines.</p><p>There is unknown and a variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence, as such we cannot provide the number of serious health events per thousand. 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>The following table shows the total number of serious UK spontaneous ‘suspected’ ADR reports received by the MHRA between 23 July 2013 and 22 July 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline:</p><p> </p><table><tbody><tr><td> </td><td><p>Total Serious Reports</p></td></tr><tr><td><p>Varenicline</p></td><td><p>297</p></td></tr><tr><td><p>Nicotine Replacement therapy</p></td><td><p>75</p></td></tr><tr><td><p>E-Cigarettes</p></td><td><p>5</p></td></tr></tbody></table><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p> answering member constituency Battersea answering member printed Jane Ellison question first answered 04/09/2014 13:15:22 answering member 3918 label Biography information for Jane Ellison
tabling member	1545 label Biography information for David T C Davies