6 July 2017

The Secretary House of Representatives Standing Committee on Health, Aged Care and Sport Parliament House CANBERRA ACT 2600

Dear Secretary,

INQUIRY INTO THE USE AND MARKETING OF ELECTORINIC CIGARETTES AND PERSONAL VAPORISERS IN AUSTRAIALIA

As a public policy consultant and analyst, who has long had a professional interest in promoting good policy and sensible regulation of smoking, alcohol and other forms of personal choice involving health risks, I welcome this Inquiry and the decision of the Minister for Health to give the Committee this reference.

While I will already be known to some members of the Committee, a brief outline of my background and expertise is in Appendix A.

My comments on the vaping issue, and the Inquiry’s Terms of Reference, are based on my experience and expertise as a long-time public policy professional with extensive political experience. I am not a clinician, scientist or consumer. I do not claim expertise or competence to discuss the validity or otherwise of the science.

I also have never smoked or vaped.

As a public policy and political professional, however, who has worked in the Australian health policy space for over 20 years, I should say at the outset I have never been involved with an issue that has generated such personal vitriol, anger, ad hominem attacks and complete disrespect for professional integrity and reputations as e-cigarettes and vaping. That includes the virulent attacks on the 2014 GP co-payment proposal, for which I became a leading public and media advocate at personal cost.

There is too much smoke and heat, and too little light, in the vaping debate. That is definitely not in the public interest. This Inquiry therefore is a welcome opportunity for a dispassionate, impartial look at the issues around vaping, nicotine, and appropriate legislation and regulation.

Definitions

Vaping products are also known as Electronic Nicotine Delivery Systems (ENDS). This includes nicotine-containing liquid and vaporisers, but it increasingly includes newer product innovations, including “heat-not-burn” devices containing tobacco.

1 Smokeless tobacco products, notably Swedish snus, also need to be considered. While not ENDS, snus has helped lower the Swedish smoking rate to a phenomenal five per cent. For the purposes of this submission, references to ENDS include snus and other smokeless products unless otherwise stated.

Defining ENDS this extends the product definition in the Vaporised Nicotine Products Bill 2017, currently a Private Senator’s Bill subject to a Senate legislation committee inquiry.

Purpose of this submission

Rather than address each Term of Reference sequentially in detail, this submission will argue a public policy case around them for allowing legal access to nicotine-containing ENDS, particularly:

 Questioning the erroneous conflating of nicotine and tobacco smoke as a single problem has made the consideration of ENDS more difficult than it could have been.  Noting smoking rates have flatlined and innovations that could reduce them further should be embraces, not rejected;  Noting the “precautionary principle” of public health, being used to justify suppressing legalised nicotine vaping, is being misapplied in Australia.  Expressing concern that Australia increasingly is out of step with comparable jurisdictions, especially the United Kingdom, New Zealand, the European Union and Canada; and  Proposing, if nicotine vaping is legalised, the Commonwealth, States and Territories should adopt a consensus position on related legislation and regulation.

It will also recommend an appropriate regulatory framework, with suggestions about an appropriate policy approach to implement it. There will be particular comment on the desirability of the Vaporised Nicotine Products Bill as potential Commonwealth legislation.

The health impact of e-cigarettes and personal vaporisers: presumptions in this submission Based on the emerging expert analysis, and scientific and clinical studies – especially the comprehensive scientific reports by Public Health England (2015) and Royal College of Physicians (2016) – the policy commentary in this submission makes the following presumptions about the underlying science:  Nicotine, separate from the chemicals and gases of tobacco smoke, is relatively safe to users in low-level doses.  However, ENDS vaping solutions, and heat-not-burn tobacco products, contain a range of chemical substances ingested in the vaping process. Therefore, ENDS themselves are not risk-free.  ENDS nevertheless are very significantly safer than combustible tobacco for direct users – at least 95 per cent safer than combustible cigarettes, according to both Public Health England and the Royal College of Physicians.  In respect to “dual use” of cigarettes and ENDS by smokers, there is a prima facie net health benefit to dual users if their cigarette consumption is reduced significantly in favour of ENDS.  International emerging evidence indicates the vaping cohort almost entirely consists of ex- smokers and dual users and that, beyond youthful experimentation, regular vaping incidence among minors is minimal; and

2  Emerging evidence also indicates the danger of passive exposure to ENDS vapour is very low, and possibly negligible. Therefore, the major problem with ENDS vapour is it most likely merely an unsociable environmental nuisance rather than a serious danger to non-vapers. Other presumptions Whatever the validity of the claims there is a “gateway” effect from vaping to smoking for young people, ENDS are adult products intended for adults, and their sale and marketing to people under 18 should be prohibited. It is also presumed that the Committee can only recommend legislative and regulatory solutions in the Commonwealth’s jurisdiction, but may recommend policy and strategic approaches the Commonwealth may take as a national government in concert with the States and Territories. Weighting the scientific evidence In considering Term of Reference 2 on the health impacts of the use of e-cigarettes and personal vaporisers, the Committee can place particular weight on the 2016 report of the UK Royal College of Physicians, Nicotine without Smoke: Tobacco Harm Reduction1. The RCP report, prepared by the College’s expert Tobacco Advisory Group, reinforced the ground- breaking 2015 meta-analysis commissioned by Public Health England. The report is valuable for three reasons:  It was prepared by distinguished clinicians, scientists and harm reduction researchers with for one of the world’s leading clinical associations.  It cannot be accused of being tainted by special interests, especially so-called Big Tobacco; and  In 1962, it was the Royal College of Physicians that was the first scientific body to blow the whistle on the connection between smoking and lung cancer. Given that proud record, for the RCP to come out positively about the relative benefits of vaping is highly persuasive. That is not to say, however, that the growing body of evidence is definitive. What it does say is that there is a case for giving vaping the qualified benefit of the doubt now, rather than waiting years or even decades for categorical conclusions to be made. This is, of course, the opposite approach to that taken by Australian tobacco harm reduction policy- makers and leading advocates.

A PUBLIC POLICY CASE FOR LEGALISED NICOTINE VAPING Australia has led the world in tobacco harm reduction. As a country, national tobacco control measures and programmes have had great success over decades in lowering the national smoking rate, complemented by State and Territory regulation and programmes. The most recent wave of tobacco control was the introduction of plain packaging in 2012, a measure that in 2017 has been adopted in the United Kingdom, and is in the pipeline for a number of other countries. Plain packaging has been complemented by Commonwealth excise rises justified as driving smokers to quit, and a wave of state and territory legislation further restriction smoking in public places, and in motor vehicles.

1 file:///D:/Videos/Downloads/Nicotine%20without%20smoke_0.pdf

3 Public attitudes to smoking have also greatly changed since the first restrictions on cigarette advertising were imposed in the early 1970s. Smoking is seen for what it is: a dirty and dangerous habit, with high risks to users of lung cancer and a broad range of respiratory and cardio-vascular diseases, reducing both the length and quality of life. Furthermore, the dangers of passive exposure to tobacco smoke have been documented and proven, driving the extension of smoke-free regulation around Australia. What was once considered a normal social activity is now shamed, demonised and repressed, with good reason. Prevailing social attitudes now reject smoking, although there is understanding for smokers who are determined to get their nicotine fix. Generally smoke-free legislation has passed with little or no public opposition, and even though in many cases it has been applied too broadly – such as to private spaces like cars – it is widely accepted. Those who advocate the liberalisation of ENDS and smokeless tobacco products do not want to turn back the clock. What they seek is that policy responses to tobacco control and tobacco harm reduction stay abreast of positive innovations that complement existing measures. Likewise, no-one should be suggesting open slather on ENDS and smokeless tobacco products. Any product that contains chemicals and dangerous substances, even in low quantities, involves risk. What is sought is sensible and balanced regulation recognising that ENDS and smokeless tobacco have different characteristics to the cigarettes and other combustible tobacco products for which they can substitute or replace. Complete ENDS deregulation is not the aim. Tobacco smoke is the real villain, not nicotine Nicotine is a controlled poison in Australia, regulated under Schedule 7 of the Poisons Standard.2

Other than for nicotine-containing smoking cessation aids approved by the Therapeutic Goods Administration (TGA), or approved importation for personal use, under Schedule 7 the only way that nicotine lawfully is available in Australia is in “tobacco prepared and packed for smoking”.

In other words, deadly cigarettes are perfectly legal, but emerging ENDS and smokeless technologies offering viable and almost certainly safer alternative to them to them are not.

Opponents of ENDSs know that Schedule 7, as worded, makes nicotine-containing RRP almost impossible in Australia. Depending on how “smoking” is defined in terms of the Standard, the only possible RRP exceptions are heat-not-burn electronic tobacco products that on the market in Europe and Japan, and increasingly elsewhere.

Effectively, the anachronistic terms of Schedule 7 shut out access to emerging harm-reducing technology. The TGA, as the Commonwealth agency responsible for the Poisons Standard, has publicly endorsed the March 2015 National Health and Medical Research Council’s position statement on e-cigarettes that they should not be made available “until evidence of safety, quality and efficacy can be produced”.3

2 October 2015 reissue: https://www.comlaw.gov.au/Details/F2015L01534 3 Therapeutic Goods Administration, Electronic Cigarettes, 9 September 2015, https://www.tga.gov.au/community- qa/electronic-cigarettes

4 A 2016 application to treat e-liquid containing modest concentrations of nicotine in the same way as cigarettes was rejected comprehensively by the TGA in March 2017. Conforming with the NHMRC position statement, as well as the Department of Health’s interpretation of Australia’s obligations under the World Health Organisation’s Framework Convention on Tobacco Control, were factors in the TGA’s decision.

Updating the treatment of nicotine under Schedule 7 is overdue, and the opportunity to do so with the recent listing amendment application has short-sightedly been rejected out of hand. That is regrettable.

Further holding out against change is short-sighted and irresponsible public policy. A more sensible approach would be to redefine the terms under which nicotine can lawfully be available to Australians in 2017 rather than 1917.

I made a submission to the TGA’s public consultations on the nicotine scheduling application, which goes into this issue in more depth. That is included as Appendix B to this submission.

The debate conflates nicotine and tobacco smoke

In 1976 late distinguished tobacco harm reduction expert, the late Professor Michael Russell, wrote in the British Medical Journal “People smoke for the nicotine, but die from the tar”4.

In Australia, however, the ENDS debate invariably equates smoking with nicotine, and does not distinguish nicotine from toxins in cigarette smoke.

More particularly, anti-vaping campaigners have used this conflation to equate ENDS with combustible tobacco and call for their continued suppression in Australia. This is misleading, and intellectually dishonest.

In 2010, a US Surgeon-General’s report advised there are over 7,000 toxins found in tobacco smoke, of which at least 70 are carcinogens5. E-cigarettes, on the other hand, either do not contain these toxins, or in many cases contain them at levels infinitely lower than for combustible tobacco6.

One of the problems with the anti-vaping arguments of the ENDS debate is the assertion that smoking = nicotine = death. Smoking and nicotine consumption are conflated by opponents to win the argument and influence public opinion.

The reality, however, is that of the actual components of cigarette smoke, nicotine is one of the least deadly components. There is no question that nicotine is a highly addictive euphoric drug, but evidence indicates that in the tiny doses in which it is inhaled it is not in itself dangerous, let alone deadly. According to research endorsed by Shirley Cramer CBE, Chief Executive of the UK Royal Society for Public Health, it is no more dangerous than the caffeine we love consuming in our coffee. In August 2015, she said:

4 BMJ 1976;1:1430–3. 5 US Surgeon-General, How Tobacco Smoke causes disease: what it means to you, US Centers for Disease Control, 2010: http://www.cdc.gov/tobacco/data_statistics/sgr/2010/consumer_booklet/pdfs/consumer.pdf 6 Presentation by pro-RRP expert and surgeon Dr Konstantinos Farsalinos, presentation of research pending publication to a seminar in Hong Kong, 10 December 2015.

5 Over 100,000 people die from smoking-related disease every year in the UK. While we have made good progress to reduce smoking rates, 1 in 5 of us still does. Most people smoke through habit and to get their nicotine hit. Clearly we would rather people didn’t smoke, but in line with NICE (National Institute of Clinical Excellence) guidance on reducing the harm from tobacco, using safer forms of nicotine such as NRT and e-cigarettes are effective in helping people quit.

Getting people onto nicotine rather than using tobacco would make a big difference to the public’s health – clearly there are issues in terms of having smokers addicted to nicotine, but this would move us on from having a serious and costly public health issue from smoking related disease to instead address the issue of addiction to a substance which in and of itself is not too dissimilar to caffeine addiction7.

Frankly, if nicotine indeed is as safe as caffeine, and the other chemical contents of e-cigarette vapour, in minute quantities, constitute little or no danger to active or passive vapers, there seems no compelling reason, besides behavioural norms and etiquette, to ban vaping from open and enclosed public places. That in itself would distinguish ENDS from combustible tobacco cigarettes, and give smokers another compelling reason to switch to ENDS and smokeless products from combustible cigarettes.

This is not to say that access to nicotine shouldn’t be deregulated. It is a poison, and rightly is on Schedule 7 to ensure access to it is both limited and regulated. All that it is being proposed is to make it available, in safe quantities, to ENDS vaping and smokeless tobacco products (like snus) as an alternative to smoking. Australian smoking rates have flatlined In June 2017, the Australian Institute of Health and Welfare released the latest National Drug Strategy Household Survey, including data on our drinking and smoking habits in the 2013-16 period.

On smoking, the good news is younger people are lighting up less than they were. The proportion of teenagers smoking daily fell from 3.4 to 1.5 per cent, while young people smoking less than 100 cigarettes in their lifetime – the statistical definition for “never smoked” – rose from 60 to 62 per cent.

Beyond that, however, the AIHW survey was disappointing in terms of tobacco control progress. In 2013-16, the overall daily smoking rate effectively flatlined, 2016’s 12.2 per cent of Australians being a statistically-insignificant fraction less than in 20138.

By contrast, in 2001-13 the daily smoking rate declined over seven percentage points, and back in 1991 a quarter of us had nicotine-stained fingers.

Furthermore, the small statistical decline was well below the overall growth of the Australian population over the same period. That indicates that while the prevalence rate barely declined, the actual population of Australian smokers increased between 2013 and 2016: surely not an outcome with which policy-makers and anti-tobacco advocates will be delighted.

The public health lobby’s response was predictable. “The national anti-campaign wheels have fallen off”, wrote strident campaigner Simon Chapman. He accused the Abbott- of

7 Press release, Nicotine “no more harmful to health than caffeine”, Royal Society of Public Health, 13 August 2015.

8 AIHW, National Drug Household Survey Key Findings 2016: http://www.aihw.gov.au/alcohol-and-other- drugs/data-sources/ndshs-2016/key-findings/

6 “mothballing Australia’s world famous national campaign” since 2013, effectively blaming the poor 2013-16 result on a conspiracy between the government and the sinister tobacco industry.

Plain packaging and excise hikes have shown no impact on headline smoking rates

What Professor Chapman and other tobacco control advocates should instead be concerned from the latest AIHW survey data is that flatlining smoking rates reflect the surprising ineffectiveness to date of the latest flagship tobacco control measures, cigarette plain packaging and big hikes in tobacco excise.

Of plain packaging’s 2012 introduction, then health minister Nicola Roxon assured us making health warnings even more graphic on standardised drab olive packs would turn people, especially the young, off smoking by making the habit less cool. When the defeated Labor in 2013, successive senior and junior health ministers, prior to this Inquiry, did not challenge the tobacco control orthodoxy and stressed their commitment to plain packaging.

Indeed, the Abbott-Turnbull government maintained the Commonwealth’s defence of its plain packaging regime from determined legal and World Trade Organisation challenges from the tobacco industry, and welcomed plain packaging’s ultimate victory in that litigation.

Unfortunately for the Commonwealth government and plain packaging advocates, these latest survey data, the first compiled entirely since plain packaging was imposed, tell another story. Instead of former minister Roxon’s predicted big fall in the number of smokers, the rate has flatlined, and even the youth smoking rate drop is lower than the longer-term trend.

Having been touted as a silver bullet, on this survey evidence at least plain packaging has done little in practice. The Turnbull government’s own evaluation, released last year, failed to provide hard evidence to justify the measure but still claimed it is “improving public health in Australia”: AIHW data suggest even that self-serving but unsubstantiated claim draws a long bow.

There is no suggestion here that plain packaging be reversed. That battle has been fought, and there is no point in revisiting it. But it is alarming that, so far, plain packaging has done nothing to justify the faith placed in it as a tobacco control and smoking-reduction measure. The indications are, instead, that if smokers are utterly determined to buy a tobacco product, how it’s packaged and graphic health warnings won’t stop them.

Forcing people to quit smoking via their hip pocket isn’t working either.

The survey period also coincided with the Gillard government’s imposing annual 12.5 per cent increases in tobacco excise for four years from 2013 – a policy extended to 2020 by Bill Shorten and borrowed by Treasurer . That hefty extension was estimated to bring in an extra $4 billion excise revenue over the budget period and a whopping $47 billion over the following decade.

Both Labor and the Coalition have dressed up this huge revenue grabs as a quitting measure, but the AIHW data show the only addiction it addresses is government’s addiction to our money. Evidently, it has not contributed to the reduction of smoking rates.

People determined to smoke are still doing it by hook or by crook. Alarmingly, the black market for contraband tobacco, or “chop-chop”, is burgeoning as legal cigarettes get much dearer. As a public health measure, therefore, the excise hike is not working, whatever it may be doing for the Budget bottom line.

International comparisons

7 Around the same time the AIHW Household Drug Strategy Household Survey 2016 was released, comparable smoking prevalence data was data was released in the United Kingdom and the United States.

As the consolidated tracking of national time series data shows below, the US and UK have experienced significant drops in headline smoking rates since 2013, while Australia’s rate has remained more or less static.

It is notable that both the UK and US allow legal access to nicotine vaping, although in the UK there is a much more benign official attitude to the practice. Indeed, the UK Office of National Statistics (ONS) estimates that there were 2.3 million current ENDS users in the UK in 2015, and several million more had tried vaping at some stage.

What makes these figures truly remarkable is that the ONS found that 2015 saw the highest proportion of quitters to smokers in over 40 years9.

Table source: Ass Prof Colin Mendelsohn

ENDS as a new tobacco control weapon

9 UK Office of National Statistics, Adult Smoking Habits in the UK: 2015, June 2017: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthandlifeexpectancies/bul letins/adultsmokinghabitsingreatbritain/2015

8 Given the apparent poor performance of the plain packaging and excise flagship measures, if not their outright ineffectiveness, it is becoming clear that fresh tobacco control and harm reduction measures can encourage more smokers to quit, and headline smoking rates to fall further.

The most obvious and immediately available measure is liberalised access to nicotine-containing ENDS.

If we want still lower smoking rates, the AIHW survey’s stark message is we must stop pretending much-vaunted repressive policies are working, while giving the benefit of the doubt to fresh innovations like vaping. Being truly open to reducing smoking-related harm requires open minds from governments and experts, not permanently closed ones.

That is not happening in Australia in relation to ENDS and vaping.

The precautionary principle is being misapplied in relation to ENDS and vaping

In comparison to the UK and the EU, the prevailing approach of the Australian public health establishment, and Commonwealth, state and territory officials is to:

 Treat ENDS with suspicion and outright hostility as an apparent threat to progress made in reducing smoking rates over recent decades.  With some exceptions, adopting a “ban first and ask questions later” regulatory philosophy - Effectively, that means the Commonwealth passively ensuring, by not amending current poisons regulations, that ENDS with nicotine-containing solutions are unlawful in almost all circumstances and therefore not legally available in Australia. - At state and territory level, notably in Queensland and Victoria (and soon in South Australia), it means adopting harsh sale and advertising regulations that deem ENDS as combustible tobacco cigarettes.

In Britain and Europe, e-cigarettes are being given the benefit of the doubt until proven otherwise. In Australia, the prevailing view is to keep them out until proven absolutely safe – and nothing is absolutely safe.

No-one is saying that ENDS are absolutely free of risk. Nothing in this world is. But that risk needs to be kept in perspective. It increasingly is clear that they are far, far less risky than cigarettes, yet policy-makers and influential public health figures and organisations refuse to be persuaded.

The problem is that this complacent and King Canute-like attitude is depriving Australians of lawful access to products that an ever-increasing body of evidence indicates are infinitely less, even negligibly, risky compared to combustible tobacco cigarettes. Similarly, concerns are raised about ENDS and flavoured e-liquids merely containing one substance or another, even though that substance is also present in the natural environment, often in even greater quantities than in the e- cigarette or liquid.

The medical profession and public health experts rightly advocate the principle of primum non nocere: first do no harm. In public health circles it is also known as the “precautionary principle”.

The Australian Medical Association and other health professional groups are well-intentioned in regard to preventing the re-popularising of smoking. The policy problem they create in their

9 overzealousness is that, by applying the precautionary principle too rigidly, and depriving Australian smokers of access to nicotine delivery systems that have the potential both to reduce risk and improve health status, they inadvertently are doing harm to millions of Australians who still smoke, notwithstanding the aggressive turning of policy, regulatory and fiscal screws in recent years.

In other words, stopping access to e-cigarettes exposes people to the ongoing risk that we all say we want to end. People who may have quit or reduced smoking for vaping won’t to avoid losing their pleasurable nicotine fix, and will continue to be exposed to tobacco smoke and its deadly chemical cocktail.

And, of course, the financial and social costs to government, insurers and the community of treating that avoidable death and illness will continue, let alone the hidden social costs of family illness, incapacity and early death.

Expert opinion is not unanimously ban first, ask questions later, however. In a recent article in the scientific journal Addiction, Australian harm reduction experts Wayne Hall, Coral Gartner and Cynthia Forlini have argued that prohibiting smokers’ access to ENDS until there is sufficient evidence to be definitive is increasing harm, not reducing it10.

They are right. However well-intentioned, a “ban first, ask questions later” public approach is not only dangerous, but unethical if we are serious about reducing smoking-related death and illness, depriving people of a new means to removes themselves from the risk. Gartner, Hall and Forlini, however, and their pro e-cigarette colleagues like Dr Ron Borland of the Cancer Council of Victoria, are a minority in the Australian public health and scientific community: their research too often is shouted down or ignored by adherents of the prevailing prohibitionist view, and too often they feel intimidated about speaking out knowing they will be shouted down and personally attacked by their strident scientific and advocate opponents.

Such prevailing policy mindsets, that ignore evidence-based alternative views and deny smokers access to ENDS “until sufficient evidence is in”, should trouble ministers and MPs. If people lose their health or their lives because policy-makers and regulators are too timid to follow the UK and Europe, and at least consider giving ENDS the interim benefit of the doubt, isn’t that morally incompatible with the harm reduction mission that is supposed to be the basis of the public health policy they uphold?

In Australia, the precautionary principle is being misapplied.

Australia is lagging behind

The current situation in the United Kingdom, the European Union, Canada and, most importantly to Australia, New Zealand, has been set out comprehensively in Associate Professor Colin Mendelsohn’s submission to the Inquiry, and does not need to be restated extensively here.

Professor Mendelsohn’s wider international regulatory summary is also a valuable point of reference for the Committee, as is Mr Clive Bates of the United Kingdom’s submission.

In terms of our three most comparable countries, the United Kingdom, New Zealand and Canada, Australia is now well and truly out of step:

10 Hall, Gartner and Forlini, Ethical issues raised by a ban on the sale of electronic nicotine devices, Addiction, 2015, attachment 2 to Submission 116 to the Inquiry.

10  The United Kingdom has embraced vaping as a major tobacco harm reduction innovation. Regulation encourages its general retail sale, and does not restrict vaping in public places as does Australian regulation.  New Zealand, after a period of expert and public consultation, is moving to legalise nicotine vaping. The conservative New Zealand National party government, and the opposition Labour party, both have endorsed this major policy shift. The government has stated that it realises New Zealand cannot meet its Smokefree 2025 aspirational target without fresh thinking, and legalising nicotine vaping with a cautious regulatory framework is seen as essential and necessary. The New Zealand government also has acknowledged import bans on nicotine e-liquid purchased online or by mail order are virtually unenforceable.  Canada’s progressive Liberal government is legislating for similar reasons to New Zealand, with the support of the Conservative opposition.

In our three closest sister jurisdictions, therefore, ENDS and vaping are already, or soon will be, embraced as invaluable quit smoking and harm reduction tools. Even in the United States, where the President Obama’s Food and Drug Administration adopted a “deeming” position to crack down on e-cigarettes and the e-cigarette industry, the new Republican FDA leadership has put deeming on hold for at least the time being.

In Australia, the position is the opposite. Besides the Commonwealth’s intransigence on changing the Poisons Schedule, states and territories have cracked down, with varying degrees of severity, to constrict the sale of vaping products not containing nicotine, and, in several jurisdictions deeming them to be considered in identical fashion as combustible cigarettes for sale, marketing and public use purposes. Deeming dominates state and territory policy thinking.

Given the body of scientific evidence, and the movements of key national jurisdictions in a pro- vaping and ENDS direction, it is hard to comprehend why leading Australian experts and bureaucrats are viscerally opposed to vaping, and are willing to mislead and distort the honest picture to defend their position11. Nevertheless, they are: backed by bureaucratic authority or public and professional profiles, and rarely given hard questioning by the media or parliamentarians.

AN APPROPRIATE REGULATORY FRAMEWORK If wider access to nicotine-containing ENDS is adopted, there are two access options for policy- makers:

 Allow open access to nicotine-containing ENDS as a commercially-available alternative to combustible cigarettes; or  The Therapeutic Goods Administration approves ENDS products, individually or as a product category, as smoking cessation aids with limited availability on prescription through doctors and pharmacists.

On balance, and in the interests of good public policy promoting maximum tobacco harm reduction, open access is the way to go.

11 Recently, I wrote about the Secretary of the Department of health’s elision of the full picture of the regulatory situation in the UK, and the impending legalising of nicotine vaping in New Zealand and Canada: https://spectator.com.au/2017/06/health-department-head-sins/ Another example of anti-vaping advocates distorting reality to defend their case is Professor Simon Chapman’s most recent opinion article on vaping in The Sydney Morning Herald: http://www.smh.com.au/comment/keep-tga-control-of-ecigarettes-or-risk- repeating-the-smoking-health-disaster-20170619-gwtyux.html

11 Policy-makers and politicians should forget about the often-stated fears and claims about vaping gateways and “renormalising” smoking. If we are truly serious about normalising harm reduction from tobacco smoke and cigarettes, we must ensure that ENDS, both containing nicotine and nicotine-free, are unequivocally legal, commercially available under appropriate regulation, and affordable to adult Australians.

If ENDS are restricted to being a prescribable medicinal aid, as are nicotine patches and gum, they won’t be able to provide direct competition in the market-place with combustible tobacco cigarettes.

It would be far better to ensure ENDS are readily available to existing smokers at reasonable prices, taking significant market share off cigarettes. If it means vaping becomes socially acceptable, and accepted as normal, that should be seen as a good thing, not bad.

At the federal level, without primary legislation overriding existing poisons regulation, this would require delegated legislation to amend the nicotine provision conditions of Schedule 7 of the Poisons Standard. Once that was amended, however, relevant state and territory RRP-related policy and legislation should also reflect the change.

The necessary amending wording is straightforward, adding a new paragraph (d) to the existing words, as follows:

(d) (Nicotine) contained in liquid, atomised spray or non-combustible tobacco products and devices.

Such wording covers the range of ENDS available today in Australia (via restricted importation) and overseas, including heat-not-burn tobacco products and snus.

Provided states and territories followed through, that change to the Poisons Schedule would open the door to the legal retail sale in Australia of these items; provide a basis for product quality and safety standards; and recognise the technological and moral contradiction in the Poisons Standard that allows the open mass sale of the very nicotine product – combustible cigarettes – whose by- products bring death and illness to millions.

That simple amendment would represent not only be a major step forward for harm reduction, but a victory of common sense over ideology. It would improve and save lives.

Is special case primary legislation desirable?

The Senate private senator’s bill sponsored by Senators Leyonhjelm and Roberts to provide such overriding primary legislation is noted.

Other than the product definition issue raised at the outset of this submission, the legislation content is sound, including its proposed consequential amendments to the Tobacco Advertising Prohibition and Competition and Consumer Acts. It could do the job in terms of Commonwealth legislative responsibilities, although it would have no bearing on state and territory legislation.

Looking at it from a public policy perspective, however, the Senate bill would disrupt the therapeutic goods and poisons regulation as a whole. In that regard, legislation that creates special cases and disrupts the consistent treatment of poisonous substances is not optimum public policy. It would simply leave the door open to other special cases and more inconsistent disruption.

12 On the other hand, passing primary legislation would cut through the trenchant bureaucratic resistance to change, and TGA red tape quickly and decisively. It would be a political rather than a pure policy solution, but the problems it would address are also political.

If the Government could be confident of achieving the same outcome by regulating within the present framework, and confident such regulations would not be disallowed in the Senate, the standard regulatory path therefore is preferable.

If, however, that is not possible, legislative disruption through the Senate bill or similar should be considered on public interest grounds: namely, the public policy goal of reducing Australians’ continued exposure to deadly tobacco smoke by legalising alternative and low-risk nicotine delivery systems can reduce tobacco-related mortality and morbidity. In short: save lives.

Sale of ENDS to minors

ENDS are products for adults. If access to them is liberalised for adults, they must not be sold, distributed or marketed to persons under the age of 18.

This is one way in which e-cigarettes must be treated the same as combustible tobacco cigarettes.

Regulating ENDS in a legalised open market

ENDS containing nicotine should be legal and readily available but, contrary to the views of some in the vaping community who resent any regulation of their activity, they must not be unregulated.

As in the UK and Europe, Australia should implement practical but stringent product safety and quality standards for e-cigarettes and similar products. This includes manufacturing standards, especially in ensuring that cartridges of “e-juice” are not tampered with, and that vapers do not risk serious injury by mixing their own potentially dangerous nicotine doses.

Preventing backyard operators from manufacturing shoddy devices, e-juice and e-juice cartridges is also an important consumer protection consideration.

Fiscal treatment of ENDS

Ideally, ENDS would not attract excise over GST, as do tobacco products. On the other hand, government needs to have some compensation for foregone revenue, and excise based on nicotine or non-combustible tobacco content would be justifiable.

If they do carry excise, however, it is imperative that the rate be lower than for combustible tobacco products for the same reason.

Whatever the fiscal treatment, there needs to be a price advantage to the ENDS choice to make that choice worthwhile to consumers. If ENDS are treated fiscally as if traditional cigarettes, especially with the current excessive annual excise hikes, there would be no incentive for smokers to switch to them, defeating the purpose of allowing them in the first place.

Defining the appropriate tax and excise treatment for ENDS is, however, a second-order issue to their full legalisation, if the principle of applying a more favourable treatment than cigarettes is adopted.

13 State and territory regulations

Where state and territory legislation is incompatible with legalised ENDS available for open sale, it should be wound back or repealed. The Commonwealth’s role should be to give national leadership to obtain nationally-consistent state and territory regulation in place of the hodgepodge that exists now.

The ministerial Intergovernmental Committee on Drugs, and the Australian Health Ministers Council, are the appropriate bodies to lead and coordinated inter-jurisdictional action. New Zealand, as a standing member of both bodies, can contribute its expertise as it moves forward with legislating and regulating lawful nicotine vaping.

Those state and territory jurisdictions considering restricting, or further restricting, current access to and use of ENDS should place a halt on making policy decisions, and passing related legislation, until the Commonwealth government makes a policy response to the report of this Inquiry.

Furthermore, the expert consultancy advice commissioned for the ministerial Intergovernmental Committee on Drugs in 2015 but never publicly released, should be set aside on the grounds of bias and consultant conflicts of interest12. It should not be a basis for ministerial decision-making on vaping or ENDS regulation.

Regulations that specifically equate ENDS with combustible cigarettes, as in Queensland, should especially be reviewed.

In respect of the sale, distribution, promotion and marketing of ENDS, and vaping in public places, ideally there also should be national regulatory consistency. If, however, evidence continues to consolidate showing that passive vaping has negligible or no health risk to third parties, states and territories should wind back their regulation of vaping indoors and in public places to the minimum reasonably needed to ensure public safety – erring on the side of minimal.

This would create a positive incentive for smokers to switch to vaping, by removing them from the social stigma smoking now carries. Instead, governments could leave decisions on where to vape to individuals and businesses, using social norms of etiquette and good and considerate behaviour, to make their own decisions. A pub owner, for example, could be left to decide whether patrons could vape on all or some of his premises, rather than comply with a blanket state prohibition.

Regardless, it is up to vapers to treat non-vapers around them with courtesy and consideration in return for the privilege of legalised access. An “up yours” attitude from diehard libertarian vapers achieves nothing but antagonising and alienating sympathetic non-users, and plays to the unfortunate media stereotype of vapers as anti-social loner nerds.

Behaviours affecting others in public, like vaping, are not an absolute right, and users must always respect the rights of others to enjoy their ambient environment. If the state is to be persuaded to regulate behaviour less rigorously, this must be a given for users.

12 I wrote about this for the Catallaxy Files website, including a link to the expert consultants’ previously- unreleased discussion paper for their closed consultations: http://catallaxyfiles.com/2016/05/29/regulating-e- cigarettes-read-all-about-it/ I also commented on the apparent bias in the consultancy team against e- cigarettes: http://catallaxyfiles.com/2016/04/18/e-cig-policy-review/

14 CONCLUSION

In Prime Minister’s Questions in the House of Commons on 16 December 2015, then British Prime Minister David Cameron was asked whether he would highlight “the role that e-cigarettes can play in helping people give up tobacco for good”. He replied:

Certainly, speaking as someone who has been through this battle a number of times, eventually relatively successfully, lots of people find different ways of doing it, and clearly for some people e-cigarettes are successful.

We need to be guided by the experts, and we should look at the report from Public Health England, but it is promising that over one million people are estimated to have used e-cigarettes to help them quit or have replaced smoking with e-cigarettes completely.

We should be making it clear that this a very legitimate path for many people to improve their health and therefore the health of the nation13.

As an ex-smoker as well as a politician, Mr Cameron grasped that promoting tobacco harm reduction means putting ideology aside and embracing a full range of alternatives to the source of risk. It is very welcome that he has recommitted his Conservative government to this approach.

It is equally pleasing that British public health authorities, and even the UK Action on Smoking and Health anti-tobacco advocacy group, have grasped this too.

Mr Cameron put this view while at the same time his government legislated for the plain packaging of cigarettes, a policy position lauded by tobacco control advocates in Australia. He believed traditional tobacco control and vaping could co-exist and complement each other.

Now New Zealand and Canada are now set to join the United Kingdom and the European Union by pursuing legalisation, regulation and open sale of nicotine-containing ENDS rather than banning them, and those countries also will benefit from the policy and regulatory standards work already being done in the UK and EU, and from the widening application of vaping into quit smoking programmes in the British National Health Service.

However well-intentioned they may be, it’s the UK’s and EU’s counterparts in Australia who are out of step on ENDS and harm reduction. They are holding back positive disruptive innovations, but in doing so they are risking lives and people’s health in their zeal to protect their life’s work in which they have invested so much personally. It is human to think like that, but it is counter-productive to good policy and good health outcomes.

Yet there are many Australian current smokers, struggling ex-smokers, and an influential minority of anti-smoking and public health experts who would be highly supportive of governments if Australian jurisdictions followed the British and EU leads. It would not be politically detrimental to a

Whatever view on the safety and efficacy of e-cigarettes and ENDS ultimately is vindicated, if Commonwealth, state and territory ministers and MPs are at least open to contestable views they would be serving the public interest. The prevailing “ban first, ask questions later” policy mindset needs to be tested and debated rationally, courteously and honestly using empirical evidence as it continues to emerge.

13 House of Commons debates, Hansard, 16 December 2015: http://www.publications.parliament.uk/pa/cm201516/cmhansrd/cm151216/debtext/151216-0001.htm

15 Dissent against that prevailing mindset too often is shouted down, however, although uncontested and untested policy of any sort is invariably very poor policy.

Whether politicians have the will to open up this particular public health debate, however, is a question only they can answer. Hopefully this Committee will lead the way.

Terry Barnes Principal, Cormorant Policy Advice Fellow, Institute of Economic Affairs (UK) 6 July 2017

16 APPENDIX A

About the author – Terry Barnes

I have an extensive background in politics and policy-making as a federal and state government official, and as a senior ministerial adviser to two Australian heath ministers, Michael Wooldridge and .

My chief expertise is in social policy, particularly health and aged care.

Health policy based on reducing harm has interested me over a long time, and I have worked in developing and implementing policy with a harm reduction emphasis, including narcotic drugs and HIV policy. I have also advocated Private Health Insurance incentives promoting people to take greater personal responsibility for their behavioural choices, especially in relation to smoking, alcohol consumption and improving diet and exercise.

Since 2007 I have run my own practice as a policy and regulatory analyst and consultant. In this capacity, in 2013-15 I was centrally involved in the policy debate over mandatory co-payments for GP services, after I was commissioned to write a discussion paper for a private health think tank, the Australian Centre for Health Research.

In 2015 was appointed as a part-time fellow in lifestyle economics of the UK Institute for Economic Affairs14. As an IEA fellow, I have complete freedom to write and advocate, and this submission represents my personal views, not those of the IEA or any third party.

I write and comment on harm reduction and ENDS in Australian media and policy circles, but I have never smoked or vaped. My concern simply is ensuring those who do and want to quit have the widest possible range of alternatives to smoking, and that new harm-reducing innovations are accepted as soon as there is sufficient empirical scientific evidence to justify them.

14 www.iea.org.uk – Like Australian think tanks, the IEA is an independent organisation that receives donations from a wide range of private sector sources and philanthropy.

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