Deborah Arnott presentation from E-Cigarette Summit 2014

1. Deborah Arnott
Chief Executive
Action on Smoking and Health (ASH)

2. Global context: E-cigarettes and the WHO FCTC
Deborah Arnott Chief Executive Action on Smoking & Health Ecigarette summit London 13th November 2014

3. Conflict of interest statement
•ASH (UK) receives core funding from British Heart Foundation and Cancer Research UK
•ASH (UK) receives project funding from the Ministry of Health
•ASH (UK) receives no commercial funding

4. This presentation
•Describes the WHO FCTC
•Explains how the WHO FCTC works
•Explains decisions taken by FCTC on electronic cigarettes
•Sets out next steps
•Looks at impact on UK regulation

5. What is the WHO FCTC
•World’s first international public health treaty
•Roadmap to comprehensive tobacco control at the international, national, regional and local levels.
•Objective to protect present and future generations from the harm caused by tobacco
•One of the most rapidly adopted UN treaties

6. What is the WHO FCTC
•In force 2005 – now 179 ‘Parties’ – countries committed to implementation
•Over 90% world population
•Over 70% cigarette producers and consumers
•Over 60% cigarette exporters
•Over 70% leaf producers
•9 out of 11 mega countries exceptions US + Indonesia

7. WHO FCTC: Key measures
•Sets out the minimum actions that governments must take to tackle tobacco use
•Parties are encouraged to exceed these
•Evidence-based

8. WHO FCTC development
•Conference of the Parties (COP) meets every two years
•COP = "supreme body" of the Convention, that is, its highest decision-making authority.
•Decisions made by consensus
•Adopts guidelines recommending more detailed action
•Adopts protocols (subsidiary treaties) only one so far on illicit trade in tobacco not yet in force.

9. How the EU operates in FCTC
•Member States don’t negotiate individually
•Develop coordinated positions – policy positions agreed by Health Working group in Brussels
•Commission led by DG Sanco officials plays a key role
•Presidency leads for the Member States in negotiations (at COP 6 presidency held by Italy – rotates every 6 months)

10. Role of civil society in FCTC
•Preamble: Emphasizes special contribution of NGOs and other members of civil society to tobacco control efforts
•Article 4.7: The participation of civil society is essential in achieving the objective of the Convention and its protocols.
•Rule 31 of the Rules of Procedure of the COP: NGOs as observers to the COP
•Specifically excludes tobacco industry from participation under Article 5.3

11. Framework Convention Alliance
•Global coalition - with WHO observer status
•Over 500 Non- Governmental Organizations (NGOs) from over 100 countries
•No commercial interests
•Works by consensus
•Powerful voice in FCTC negotiations

12. E-cigs and the FCTC: COP 5
COP 5 November 2012
•Paper on e-cigarettes from Secretariat
•Middle east and SE Asia regions wanted to set up group to draft guidelines
•Resisted by EU, Canada, China and Norway
Decision:
•‘to…identify options for the prevention and control of …electronic nicotine delivery systems (ENDS);
•examine emerging evidence on the health impacts of ENDS use; and report on the outcome to the sixth session of the Conference of Parties.

13. Convention Secretariat report to WHO COP 6: ENDS (1)
•Sets out regulatory objectives and specific regulatory options
•“the subject of a public health dispute among bona fide tobacco-control advocates.”
•“represent an evolving frontier, filled with promise and threat for tobacco control.”
•COP invited to note report and provide further guidance.

14. Convention Secretariat report to WHO COP 6: ENDS (2)
Regulatory objectives:
“(a) impede ENDS promotion to and uptake by non- smokers, pregnant women and youth;
(b) minimize potential health risks to ENDS users and non- users;
(c) prohibit unproven health claims from being made about ENDS; and
(d) protect existing tobacco-control efforts from commercial and other vested interests of the tobacco industry.”
For governments to bear in mind when designing regulatory strategies

15. Convention Secretariat report to WHO COP 6: ENDS (3)
Specific regulatory options for Parties to consider included:
•Laws prohibiting use indoors
•Restrictions on advertising promotion and sponsorship
•Health warnings commensurate with proven risk
•Product regulation e.g. nicotine to be of pharmacological grade, standardised delivery, minimise toxic contents and prohibit fruit, candy and alcohol flavours
•Monitor use including by sex and age
•Prohibition of sales to minors

16. BUT tweet less nuanced….

17. FCA COP 6 position on ENDS
•Parties should note WHO report to COP 6
•Consensus on specific regulatory approaches difficult because of differences in regulatory systems and national circumstances.
•Some overarching concerns and principles may be widely shared, and could be noted in a COP decision.
•Careful monitoring of new evidence and national regulatory experience is essential.
•Expert report needed for COP 7 on emerging scientific evidence and lessons learnt from national regulatory experience.

18. WHO FCTC COP 6 Decision
•Welcomes WHO report to COP 6
•Invites Parties to consider prohibiting or regulating e.g. as tobacco products, medicines, consumer products
•Urges Parties to consider banning or restricting advertising, promotion and sponsorship
•Invites Parties and WHO to monitor use

19. COP 6 Decision
Expert report for COP 7
•by WHO with independent scientists and concerned regulators; to include
•Evidence update on health impacts, role in quitting, impact on tobacco control
•Assessment of policy options to achieve the objectives outlined in paragraph 2 of this decision; and to
•consider methods to measure contents and emissions of these products.

20. COP 6 Decision Para 2
Objectives set out in para 2
Invites Parties to consider measures to:
•Prevent initiation by nonsmokers + youth
•Minimise health risks + protect non-users
•Prevent unproven health claims
•Protect tobacco control from commercial and vested interests
BUT leaves it up to Parties to decide

21. UK Regulation set by EU context By 2016 two options – unchanged by COP6…..
21
Tobacco Products Directive regulation of electronic cigarettes
MHRA licenced Nicotine Containing Products (NCPs) including e-cigs (to date only one regulated product, Voke, not yet on sale)
Products not available on prescription
Products available on prescription
20% VAT
5% VAT
Cross border advertising banned by 2016; up to Member States to decide on domestic advertising (billboards, Point of Sale, buses etc.)
Advertising allowed – under OTC rules so no celebrity endorsement or free samples and must be targeted at adult smokers etc.
Products widely available
Products available on general sale (GSL)
Can’t make health claims
Can make health claims
Upper limits for nicotine content will be set and in force.
MHRA regulation is flexible; there are no upper limits.
30% health warning on packs about nicotine on front and back of packs
No health warnings on packs but packs contain product safety information
Member States retain powers e.g. to regulate flavours, domestic advertising.
Flavours require a marketing authorisation
Age of sale of 18 for nicotine products likely to be in force by end of 2015.
Age of sale 18

22. Examples outside EU…..
Legal
•Afghanistan
•China
•El Salvador
•India (but likely to be banned soon)
•Philippines
•US
•……….
Banned partially or in total
•Argentina
•Australia
•Brazil
•Canada
•Hong Kong
•Russia
•Saudi Arabia
•Singapore
•Turkey
•…………

23. NEXT STEPS: COP 7
•New Delhi, India
•Second half of 2016 or early in 2017
•Slovakia: EU Presidency Jun-Dec 2016
•Malta: EU Presidency Jan-May 2017
•Policy options for ENDS regulation will be considered
•BUT not being developed as guidelines…