Publication - Publication

Business and Regulatory Impact Assessment (BRIA) for the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill

Published: 7 Aug 2015
Part of:
Health and social care
ISBN:
9781785445651

The Business and Regulatory Impact Assessment (BRIA) for the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill.

113 page PDF

1.3 MB

113 page PDF

1.3 MB

Contents
Business and Regulatory Impact Assessment (BRIA) for the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill
Footnotes

113 page PDF

1.3 MB

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:

http://www.ons.gov.uk/ons/rel/ghs/opinions-and-lifestyle-survey/adult-smoking-habits-in-great-britain--2013/stb-opn-smoking-2013.html#tab-Use-of-e-cigarettes--and-the-relationship-to-smoking

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:

http://d25d2506sfb94s.cloudfront.net/cumulus_uploads/document/acw2ey8jk1/YG-Archive-140314-ASH-Scotland.pdf

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.

(http://www.cancerresearchuk.org/prod_consump/groups/cr_common/@nre/@pol/documents/generalcontent/cr_115991.pdf)

de Andrade, M., Hastings, G and Angus, K (2013). Promotion of electronic cigarettes: Tobacco marketing reinvented? British Medical Journal, 347.

(http://www.bmj.com/content/347/bmj.f7473?variant=full-text.pdf%2Bhtml&hwoasp=authn%3A1407329954%3A4130224%3A1354951930%3A0%3A0%3AT4OwOOq2YsSyibamPDnuYg%3D%3D)

Bauld, L., Angus, K, and de Andrade, Marisa (2014) E-cigarettes uptake and marketing. A report commissioned by Public Health England.

(https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/311491/Ecigarette_uptake_and_marketing.pdf

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)

43. https://www.cap.org.uk/News-reports/Mediacentre/2014/~/media/Files/CAP/Consultations/ecig%20consultation/Regulatory%20Statement.ashx

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/

53. http://d25d2506sfb94s.cloudfront.net/cumulus_uploads/document/4cpqacbzw8/YG-Archive-140314-ASH-Scotland.pdf

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/ )

64. http://www.scottish.parliament.uk/S4_Bills/Health%20Tobacco%20Nicotine%20etc.%20and%20Care%20Scotland%20Bill/b73s4-introd-en.pdf

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.

67. http://www.scottish.parliament.uk/S4_Bills/Health%20Tobacco%20Nicotine%20etc.%20and%20Care%20Scotland%20Bill/b73s4-introd-en.pdf

68. http://www.scottish.parliament.uk/S4_Bills/Health%20Tobacco%20Nicotine%20etc.%20and%20Care%20Scotland%20Bill/b73s4-introd-en.pdf

69. http://www.scottish.parliament.uk/S4_Bills/Health%20Tobacco%20Nicotine%20etc.%20and%20Care%20Scotland%20Bill/b73s4-introd-en.pdf

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:

http://www.gov.scot/Topics/Statistics/Browse/Health/scottish-health-survey/Publications/Supplementary2013

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

90. http://www.healthcareimprovementscotland.org/his/idoc.ashx?docid=3b248733-5f86-4379-9a28-35beae432004&version=-1

91. http://www.healthcareimprovementscotland.org/his/idoc.ashx?docid=3e877507-c77e-4bef-9566-852329abe425&version=-1

92. http://www.gov.scot/Publications/2012/03/6414

93. http://www.scottishhealthcouncil.org/publications/research/listening_and_learning.aspx#.VUASwxdFAhs

94. http://www.scottishhealthcouncil.org/publications/research/complaints_and_feedback_report.aspx#.VUAS1BdFAhs

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

97. http://www.cap.org.uk/News-reports/Mediacentre/2014/~/media/Files/CAP/Consultations/ecig%20consultation/Regulatory%20Statement.ashx

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

http://www.ons.gov.uk/ons/rel/ghs/opinions-and-lifestyle-survey/adult-smoking-habits-in-great-britain--2013/stb-opn-smoking-2013.html#tab-Use-of-e-cigarettes--and-the-relationship-to-smoking

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


Contact

Email: Person-Centred and Quality Team