Business and Regulatory Impact Assessment (BRIA) for the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill
The Business and Regulatory Impact Assessment (BRIA) for the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill.
Footnotes
1. References to NVPs throughout this document refer to non-medicinal NVPs, e-liquids and other substances intended to be used in NVPs (including items containing such substances).
2. http://www.gov.scot/Publications/2013/03/3766
3. http://www.scotpho.org.uk/publications/reports-and-papers/868-smoking-ready-reckoner
4. http://www.gov.scot/Publications/2014/08/7973
5. http://www.scotpho.org.uk/publications/reports-and-papers/868-smoking-ready-reckoner
6. http://eur-lex.europa.eu/legal-content/EN/NOT/?uri=OJ:JOL_2014_127_R_0001
7. Article 2 of the EU Tobacco Products Directive 2014/40/EU (the TPD) defines an "electronic cigarette" as: "a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges."
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2014_127_R_0001
8. ASH (2014) ASH briefing: E-cigarettes; this includes an accessible description of the main types of device on the market. Available at: http://www.ash.org.uk/files/documents/ASH_715.pdf
9. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2014_127_R_0001 The Trading Standards Institute and ASH have produced a summary of the TPD provisions: http://www.ash.org.uk/files/documents/ASH_937.pdf
10. These are described in the PAS produced by the British Standards Institute: http://shop.bsigroup.com/ProductDetail/?pid=000000000030303130
11. http://www.scottish.parliament.uk/parliamentarybusiness/Bills/89934.aspx
12. ASH (Action on Smoking and Health). 2014 Use of electronic cigarettes in Great Britain. http://www.ash.org.uk/files/documents/ASH_891.pdf
13. Dockrell M, Morrison R, Bauld L, McNeill A. (2013) 'E-cigarettes: prevalence and attitudes in Great Britain', Nicotine and Tobacco Research 15(10):1737-44
(http://www.ncbi.nlm.nih.gov/pubmed/23703732).
14. Preliminary figures from the Office of National Statistics, based on data collected January-March 2014, showed that, in the UK, 12% of current smokers, 5% of ex-smokers and 0% of non-smokers used NVPs:
15. Prior to 2009 NVP use was negligible but thereafter increased rapidly across Europe and the USA. (Hajek P, Etter JF, Benowitz N, Eissenberg T, McRobbie H. (2014) 'Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit', Addiction, 109: 11: 1801-1810 (http://www.ncbi.nlm.nih.gov/pubmed/25078252)
16. ASH Scotland (May 2014) Briefing paper on 'Electronic cigarettes/E-cigarettes': http://www.ashscotland.org.uk/media/6093/E-cigarettesbriefing.pdf
Data tables available at:
17. http://www.smokinginengland.info//: The Smoking Toolkit's Smoking in England Survey collects data from a representative sample of households every month.
18. The website includes a quarterly update on "Electronic cigarettes in England - latest trends" - http://www.smokinginengland.info/latest-statistics/ In the first quarter of 2015, 35.1% of reported quit attempts by survey respondents had involved an NVP.
19. This was undertaken by ASH with a representative sample of the population: ASH (Action on Smoking and Health). 2014 Use of electronic cigarettes in Great Britain. http://www.ash.org.uk/files/documents/ASH_891.pdf.
20. Scottish Schools Adolescent Lifestyle and Substance Use Survey (SALSUS), Smoking Among 13 and 15 year olds in Scotland 2013. http://www.isdscotland.org/Health-Topics/Public-Health/SALSUS/Latest-Report/
21. SALSUS figures are broadly comparable with data that ASH gathered from 11-18 year olds in 2014: see ASH (Action on Smoking and Health). 2014 Use of electronic cigarettes in Great Britain. http://www.ash.org.uk/files/documents/ASH_891.pdf
22. http://www.scottish.parliament.uk/parliamentarybusiness/Bills/89934.aspx
23. Internationally, there are a number of trials of NVP effectiveness but it will be some time before there is a sufficient evidence for solid judgements to be made about their benefits versus risks.
24. Cochrane Reviews are systematic reviews of primary research in health care and health policy, and internationally recognised as the highest standard in evidence-based health care. They are published in The Cochrane Library.
25. McRobbie H, Bullen C, Hartmann-Boyce J, Hajek P (2014) Can electronic cigarettes help people stop smoking or reduce the amount they smoke, and are they safe to use for this purpose? http://www.cochrane.org/CD010216/TOBACCO_can-electronic-cigarettes-help-people-stop-smoking-or-reduce-the-amount-they-smoke-and-are-they-safe-to-use-for-this-purpose
26. Quelch, J and Rodriguez, M. (2014) E-cigarettes: Marketing versus Public Health, Harvard Business Review, 16 September 2014.
27. http://www.who.int/fctc/text_download/en/ - Article 5.3 enshrines a principle for public health departments and agencies in countries which are parties to the FCTC: "In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law."
28. http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf
29. http://www.scottish.parliament.uk/parliamentarybusiness/Bills/89934.aspx
30. http://ec.europa.eu/health/tobacco/docs/ev_20120703_mi_en.pdf
31. MacGregor, J (2014) Youth Access to E cigarettes and associated products, Commissioned by Public Health England for the Trading Standards Institute
32. http://www.legislation.gov.uk/ukdsi/2015/9780111130568
33. http://www.northernireland.gov.uk/news-dhssps-030914-proposals-underway-to
34. http://www.legislation.gov.uk/asp/2010/3/contents
35. http://www.scottish.parliament.uk/parliamentarybusiness/Bills/16857.aspx
36. http://www.legislation.gov.uk/ukpga/2002/36/contents
37. See specifically Recitals 43 and 48, EU Tobacco Products Directive 2014/40/EU:
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2014_127_R_0001
38. The Scottish Government will publish a summary of these data in summer 2015.
39. For example, see reports drawing on research undertaken for Cancer Research UK prior to the CAP/BCAP rules being introduced: de Andrade, M., Hastings, G and Angus, K (2013). The Marketing of E-cigarettes. A report for Cancer Research UK.
de Andrade, M., Hastings, G and Angus, K (2013). Promotion of electronic cigarettes: Tobacco marketing reinvented? British Medical Journal, 347.
Bauld, L., Angus, K, and de Andrade, Marisa (2014) E-cigarettes uptake and marketing. A report commissioned by Public Health England.
40. These include the 2002 advertising ban; recent legislation to ban tobacco displays in shops; and the development of regulations on standardised packaging of tobacco products: http://www.legislation.gov.uk/ukpga/2002/36/contents
http://www.legislation.gov.uk/asp/2010/3/contents
https://www.gov.uk/government/consultations/standardised-packaging-of-tobacco-products.
41. http://www.scottish.parliament.uk/parliamentarybusiness/Bills/89934.aspx
42. The World Health Organisation undertook a study in 2014 that showed that comprehensive advertising, promotion and sponsorship bans on electronic cigarettes were in place in 39 countries (in which 31% of the world's population live).
(http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf?ua=1)
44. http://www.legislation.gov.uk/asp/2010/18/part/1/crossheading/age-verification-policy
45. http://www.scotss.org.uk/reference/etsep2014.pdf
46. MacGregor, J (2014) Youth Access to E cigarettes and associated products, Commissioned by Public Health England for the Trading Standards Institute.
47. ScotCen Social Research/NHS Health Scotland (2013) Final report: Licensing Act (Scotland) 2005, pp. 62-63. This report was part of the programme for Monitoring and Evaluating Scotland's Alcohol Strategy (MESAS)
http://www.healthscotland.com/scotlands-health/evaluation/planning/MESAS/MESASstudyportfolio.aspx.
48. SSI 2013/202 - The Sale of Tobacco (Prescribed Documents) (Scotland) Regulations 2013: http://www.legislation.gov.uk/ssi/2013/202/contents/made
SSI 2013/199 - The Sale of Alcohol to Children and Young Persons (Scotland) Amendment Regulations 2013: http://www.legislation.gov.uk/ssi/2013/199/pdfs/ssi_20130199_en.pdf
E.g., ScotCen Social Research/NHS Health Scotland (2013) Final report: Licensing Act (Scotland) 2005, p 68.
http://www.healthscotland.com/scotlands-health/evaluation/planning/MESAS/MESASstudyportfolio.aspx).
49. E.g., ScotCen Social Research/NHS Health Scotland (2013) Final report: Licensing Act (Scotland) 2005, p 68.
http://www.healthscotland.com/scotlands-health/evaluation/planning/MESAS/MESASstudyportfolio.aspx).
www.tobaccoretailersalliance.org.uk/index.php?option=com_content&view=article&id=23&Itemid=19
50. http://www.sehd.scot.nhs.uk/mels/CEL2012_01.pdf
51. http://www.scotland.gov.uk/Publications/2005/12/21153341/33417
52. http://www.smokefreegrounds.org/
54. http://www.tobaccoinaustralia.org.au/downloadchapters/
55. http://www.tobaccoinaustralia.org.au/downloadchapters/
56. http://www.gov.scot/Publications/2014/10/5471
57. http://www.gov.scot/Publications/2015/05/7711
58. http://www.youngscot.net/wp-content/uploads/2015/02/Youth-Comission-on-Smoking-Prevention.pdf
59. Scottish Schools Adolescent Lifestyle and Substance Use Survey (SALSUS), Smoking Among 13 and 15 year olds in Scotland 2013. http://www.isdscotland.org/Health-Topics/Public-Health/SALSUS/Latest-Report/
60. This is based on estimates provided to the Scottish Government in February 2015 by ECigIntelligence, using IRi data, where the estimated value of the Scottish market in 2015 was between £30m and £40m.
61. Data from the Young People in Scotland Survey in late 2014 showed that 2% of 11 to 18 years old in secondary schools reported using e-cigarettes at least once a week The Scottish Government will publish a summary analysis of these data in summer 2015.
62. A 40% profit margin for e-cigarettes was noted in, 'High margin options and growing fast, Scottish Grocer, March 2013: http://www.scottishgrocer.co.uk/2013/03/high-margin-options-and-growing-fast/
An estimated 40% profit margin figure was also provided to the Scottish Government by the National Federation of Retail Newsagents in a consultation meeting on 02/12/14. The minutes are available on the Scottish Government website.
63. West, R., Brown, J., Beard, E. 'Latest trends in electronic cigarette use in England. Smoking Toolkit Study' (updated January 2015): http://www.smokinginengland.info/latest-statistics/ )
65. SSI 2013/202 - The Sale of Tobacco (Prescribed Documents) (Scotland) Regulations 2013: http://www.legislation.gov.uk/ssi/2013/202/contents/made
SSI 2013/199 - The Sale of Alcohol to Children and Young Persons (Scotland) Amendment Regulations 2013: http://www.legislation.gov.uk/ssi/2013/199/pdfs/ssi_20130199_en.pdf
66. E.g., ScotCen Social Research/NHS Health Scotland (2013) Final report: Licensing Act (Scotland) 2005, p 68.
70. ASH Scotland (May 2014) Briefing paper on 'Electronic cigarettes/E-cigarettes': http://www.ashscotland.org.uk/media/6093/E-cigarettesbriefing.pdf
71. Scottish Government (2014) Scotland's People Annual report: Results from 2013 Scottish Household Survey (http://www.gov.scot/Publications/2014/08/7973/9)
72. http://www.scottish.parliament.uk/parliamentarybusiness/Bills/89934.aspx
73. See Scottish Health Survey 2013 Supplementary Web Tables Part 6 - Smoking:
74. "Among current users of electronic cigarettes, the principal reasons given by ex-smokers are "to help me stop smoking entirely" (56%) and "to help me keep off tobacco" (34%). The principal reasons given by current smokers are to "help me stop smoking entirely" (32%) and "to help me reduce the amount of tobacco I smoke, but not stop completely" (32%)." ASH (Action on Smoking and Health). 2014 Use of electronic cigarettes in Great Britain.
http://www.ash.org.uk/files/documents/ASH_891.pdf
75. These figures are drawn from unpublished data provided to the Scottish Government by the market research company Nielsen.
76. "Final report: Licensing Act (Scotland) 2005" (June 2013) of the Monitoring and Evaluating Scotland's Alcohol Strategy (MESAS) project led by NHS Health Scotland (http://www.healthscotland.com/scotlands-health/evaluation/planning/MESAS/MESASstudyportfolio.aspx).
77. ScotPHO Smoking Ready Reckoner - 2011 Edition - http://www.scotpho.org.uk/downloads/scotphoreports/scotpho120626_smokingreadyreckoner.pdf
78. ScotPHO Smoking Ready Reckoner - 2011 Edition - http://www.scotpho.org.uk/downloads/scotphoreports/scotpho120626_smokingreadyreckoner.pdf
79. http://www.midstaffspublicinquiry.com/sites/default/files/report/Executive%20summary.pdf
80. Department of Health (2013). A promise to learn - a commitment to act: improving the safety of patients in England. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/226703/Berwick_Report.pdf (
81. https://www.rcseng.ac.uk/policy/documents/CandourreviewFinal.pdf (Accessed 25th September 2014)
82. The Health Foundation (2011). Evidence scan: Levels of Harm. Available at: http://www.health.org.uk/publications/levels-of-harm/ (Accessed 21st September 2014),
83. Halligan, A. W. F. (2014). Implications for medical leaders of the proposed Duty of Candour. Clinical Risk, 20(1-2), 29-31.
84. Iedema, R., Allen, S., Sorensen, R., & Gallagher, T. H. (2011). What prevents incident disclosure, and what can be done to promote it? Joint Commission journal on quality and patient safety, 37(9), 409-417.
85. Kaldjian, L. C., Jones, E. W., & Rosenthal, G. (2006). Facilitating and impeding factors for physicians' error disclosure: a structured literature review. Joint Commission Journal on Quality and Patient Safety, 32(4), 188-198.
86. Kaldjian, L. C., Jones, E. W., & Rosenthal, G. (2006). Facilitating and impeding factors for physicians' error disclosure: a structured literature review. Joint Commission Journal on Quality and Patient Safety, 32(4), 188-198.
87. Etchegaray, JM., Gallagher, TH., Bell, SK et al. (2012). Error disclosure: a new domain for safety culture assessment. BMJ Quality and Safety, 21, 594-599.
88. http://www.safetyandquality.gov.au/publications/australian-open-disclosure-framework/
89. Nursing and Midwifery Council and General Medical Council (2014). 'Openness and honesty when things go wrong: the professional duty of candour. A draft for consultation' http://offlinehbpl.hbpl.co.uk/NewsAttachments/PGH/Openness_and_honesty_draft.pdf
92. http://www.gov.scot/Publications/2012/03/6414
93. http://www.scottishhealthcouncil.org/publications/research/listening_and_learning.aspx#.VUASwxdFAhs
95. http://www.isdscotland.org/Health-Topics/Hospital-Care/Inpatient-and-Day-Case-Activity/
96. http://www.scotland.gov.uk/Topics/Statistics/Browse/Health/Data/HomeCare/HSCDHomecare
98. ECigIntelligence: Territory report : e-cigs in the UK - Market and regulatory analysis October 2014.
99. Quelch, J and Rodriguez, M. (2014) E-cigarettes: Marketing versus Public Health, Harvard Business Review, 16 September 2014.
100. Correspondence with ECITA Feb 2015
102. http://www.conveniencestore.co.uk/news/e-cigarette-sales-hit-a-wall-in-grocery-stores/511008.article
103. ECigIntelligence: Territory report : e-cigs in the UK - Market and regulatory analysis October 2014.
104. Ibid.
105. http://www.conveniencestore.co.uk/news/e-cigarette-sales-hit-a-wall-in-grocery-stores/511008.article
106. This estimate is consistent with
107. Bauld L et al E-cigarette uptake and marketing : A report commissioned by Public Health England . May 2014
108. E.g http://www.ecigarettedirect.co.uk/extra-info/save-money.html
109. ECigIntelligence: Electronic cigarette market in Scotland : February 2015
110. ASH (Action on Smoking and Health). 2014 Use of electronic cigarettes in Great Britain. http://www.ash.org.uk/files/documents/ASH_891.pdf
111. Dockrell M, Morrison R, Bauld L, McNeill A. (2013) E-cigarettes: prevalence and attitudes in Great Britain. Nicotine and Tobacco Research 2013 Oct;15(10):1737-44. (http://www.ncbi.nlm.nih.gov/pubmed/23703732).
112. Preliminary figures from the Office of National Statistics, based on data collected January-March 2014, showed that, in the UK, 12% of current smokers, 5% of ex-smokers and 0% of non-smokers used e-cigarettes
113. Population Estimates Summary for the UK, mid-2013 http://www.ons.gov.uk/ons/taxonomy/index.html?nscl=Population#tab-data-tables
114. Hajek P, Etter JF, Benowitz N, Eissenberg T, McRobbie H. (2014) "Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit", Addiction, 109: 11: 1801-1810. http://www.ncbi.nlm.nih.gov/pubmed/25078252
This review of international studies (up to February 2014) published in a leading journal summarised prevalence data from published sources. It found that prior to 2009, e-cigarette use was negligible but thereafter increased rapidly across Europe and the USA. Some surveys suggest that users are younger, more educated and have a higher income, which is consistent with the expected profile of early adopters of novel consumer products.
115. ECigIntelligence: Territory report : e-cigs in the UK - Market and regulatory analysis October 2014.
116. Scottish Grocer , March 2013
117. As noted in the BRIA many retailers already operate a voluntary ban on sales to under 18s
118. Neilsen 2015
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