Deborah Arnott

Chief Executive

Action on Smoking and Health (ASH)

Global context: E-cigarettes

and the WHO FCTC

Deborah Arnott Chief Executive

Action on Smoking & Health

Ecigarette summit London 13th November 2014

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

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

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

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

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

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.

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)

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

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

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.

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.

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

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

BUT tweet less nuanced….

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.

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

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.

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

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

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

• …………

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…