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Standing Committee on Health, Aged Care and Sport
08/09/2017
Use and marketing of electronic cigarettes and personal vaporisers in Australia

ARUNOGIRI, Dr Shalini, Chair, Faculty of Addiction Psychiatry, Royal Australian and New Zealand College of Psychiatrists

CHAPMAN, Emeritus Professor Simon, Private capacity

FLEMING, Mr Richard, General Manager, Enforcement ACT, Australian Competition and Consumer Commission

FREEMAN, Dr Becky, Private capacity

GARTNER, Associate Professor Coral, Private capacity

GROGAN, Mr Paul, Director, Public Policy; and Acting Chair, Tobacco Issues Committee, Cancer Council of Australia

HALL, Professor Wayne, Private capacity

KELSO, Professor Anne, Chief Executive Officer, National Health and Medical Research Council    

MASRI, Mr George, Assistant Secretary, Department of Health

ROBERTSON, Ms Samantha, Executive Director, National Health and Medical Research Council

SKERRITT, Dr John, Deputy Secretary, Department of Health

STUDDERT, Dr Lisa, Acting Deputy Secretary, Department of Health

SWANSON, Mr Maurice Gerard, Chief Executive Officer, National Heart Foundation of Australia (WA Division) and President, Australian Council on Smoking and Health

Committee met at 09:15

Evidence from Dr Freeman, Professor Gartner and Professor Hall was taken via teleconference—

CHAIR ( Mr Zimmerman ): Good morning everyone. I declare open this meeting of the health, aged care and sport committee of the House of the Representatives. Obviously, this roundtable this morning is in relation to our inquiry on e-cigarettes and personal vaporisers in Australia. Firstly, thank you all very much for joining us. This is probably the largest collective group that we have had before us. It is going to test us in terms of encouraging brevity all around. We have three people appearing by teleconference as well.

Before I begin can I have a member move that the meeting be allowed to film the proceedings today in accordance with the rules set down for committees, which includes not interfering with committee proceedings, not taking footage or still images of members, committee staff and witnesses, papers or laptop screens. It is so moved. As there is no opposition, I declare that carried.

This morning we have divided the session into two sections. The first session will look at the use and health impacts of electronic cigarettes and personal vaporisers. The second session will focus on frameworks for the regulation of e-cigarettes and personal vaporisers and their marketing. At the start of each session, I'll invite each of the organisations that are represented here today, or individualsif you are standing aloneto make a brief opening statement. Because of the volume of people we have here today, if it could be one person per organisationand 'brief' is a very important word in this context.

We have representatives appearing this morning from the Department of Health and the TGA, the National Health and Medical Research Council, the Australian Competition and Consumer Commission, the National Heart Foundation, the Cancer Council of Australia, the Royal Australia and New Zealand College of Psychiatrists and Professor Chapman. On the phone via teleconference we have Professor Wayne Hall, Associate Professor Coral Gartner and Dr Becky Freeman.

Can I just ask whether any witnesses have any objection to being recorded by media during today's proceedings? No? Good. I am not actually sure what I do if someone says they doso thank you for making it easy. Professor Hall, are you on the line?

Prof. Hall : I am, yes.

CHAIR: Professor Gartner?

Prof. Gartner : Yes.

CHAIR: Dr Freeman?

Dr Freeman : Yes.

CHAIR: Do any of you wish to comment on the capacity in which you appear?

Dr Skerritt : One of my responsibilities is the Therapeutic Goods Administration.

CHAIR: I just have to go through the formalities that I have to read at the beginning of each session, so I apologise for that. These hearings are formal proceedings of the parliament. The giving of false or misleading evidence is a serious matter and may be regarded as a contempt of parliament. I don't know whether Annabel Crabb discovered the jail we have for people who are in contempt of parliament. The evidence given today will be recorded by Hansard and it attracts parliamentary privilege.

We will commence the first session. As I said, I will start by inviting each organisation to make an opening statement. I might start with those physically in the room. Professor Chapman, would you like to go first?

Prof. Chapman : Yes. The submission that we have put in looks at three of the principal claims that have been made by proponents of the deregulation of e-cigarettes about safety, the efficacy of them in quitting and whether they are harm reducing. I'd be very pleased to go into detail about each of those areas this morning.

It is the view of myself and the co-authors of the submission we put in that the Therapeutic Goods Administration, since its formation, and the precursors to that organisation, have played an umpire role in the safety and regulatory areas of therapeutics in this country. Thalidomide was one of the very early issues that they dealt with. I believe that that group is really peerless in Australia when it comes to considering standards for safety and efficacy. It, of course, has a graduated system of releasing drugs through scheduling procedures and so forth. I think that would be the most suitable way of regulating a product like vaporisers in this country. I would be very happy to go into that later on this morning.

CHAIR: The Cancer Council?

Mr Grogan : Thanks again for the opportunity to engage on this issue. I have just a few points to really add emphasis to what is already in our written submission. We wanted to stress that, while Australia has a relatively low burden of tobacco harms compared with other countries, we are still underinvesting in things that have a good track record of evidence based success, including support for mass media communications which, in tandem with other measures such as tobacco excise, have really been over time the most successful measures which have brought us to a position of around 12.2 per cent of the population aged 14 and over as daily smokers. Bear in mind that, for example, in the period straight after World War II, around 75 per cent of Australian males smoked. We have a good track record, but we haven't done enough of what works. That is in our submission, but I wanted to add emphasis to that point.

One of the reasons that Australia does have relatively high life expectancyit is probably among the best in the worldis that we have had these outstanding statutory pillars of our health system, and the TGA is one of those, but we have also had a long history of really strong multipartisan support for the types of interventions that are supported by the evidence. We have done well. We can do better. But I do want to impart a very positive message that we have a number of things that we can continue to do well and do better based on pre-existing successes.

I also wanted to stress that I am certainly very proud of representing an organisation with a long history, and I would include our colleagues at the Heart Foundation in this. The committee that I currently chair is constituted by both organisations. I think it is fair to say that our two organisations in a nongovernment capacity have probably done more than any other nongovernment organisation to drive successful reforms in tobacco control over decades. If the evidence stacks up for support for availability of electronic cigarettesand currently it doesn't, based on the TGA framework and other mechanisms that would need to show that it was convincingwe would be among the loudest voices for it to be applied in appropriate circumstances. That evidence isn't there, but I think it is really important that we are seen as being up among the most effective advocates for reducing the harms of tobacco. That is borne out in our submission as well.

The only other thing I really wanted to emphasise is that there is a misconception, I think, that this is a heavily polarised debate and there is a yes camp and a no camp. In fact, probably the vast majority of health organisations are taking a precautionary principle, which is fundamental to public health. This is a scientific question that remains a question for research, and we support that research. I think it is unhelpful to be characterising this as there is a yes camp and a no camp and they are kind of 50-50, when, in fact, as I said, most health organisations would support the processes we already have in place and are watching the issue with interest.

CHAIR: Thank you. Mr Swanson?

Mr Swanson : Thank you, Chair, and thank you for the opportunity. I am not going to repeat what Paul said. Ours is a joint submission with Cancer Council of Australia. I think it is important to stress the role of the TGA and the NHMRC. If you read their submissionsand I am sure you haveit is very clear that there is insufficient evidence to recommend e-cigarettes or vaporisers as an aid to cessation. Those submissions also stress the importance of safety and the implementation of the precautionary principle in the question of whether these products should be made more freely available. Our position is very clearly that they should be regulated by the two evidence based pillars of our health system.

Other than those few words, I did want to share with you some examples of the marketing of e-cigarettes from the US. I'll just provide some laminated copies of advertisements. In the US at the moment there are approximately 7,500 different flavourings for these products and over 450 different brands. As you are probably aware, the FDA has now stepped in to regulate them. That is a good move by our colleagues in the US.

Clearly, if you are looking at the motives of the tobacco industry, this is not smoking cessation; this is product diversification. When you read the submission from Philip Morris, I think it gives the whole game away. They are trying to convince people here that they are all about a smoke-free Australia. But in markets that are still growing, those that have a low prevalence of smoking among women, they are going full bore with the marketing of their major brands. In the case of Philip Morris, the company is epitomised by Marlboro Red. That's what they are making their money from. This is simply a charade.

I just wanted to point out the type of marketing that I am sure most of you will find offensive: Blu e-cigarettes. If you look at the construction of those advertisements, it is almost identical to the claims and the techniques that big tobacco used until, in this country, we stopped them from being able to promote their products. Thank you.

CHAIR: Thank you. Who would like to take the lead from the Department of Health?

Dr Studdert : I will. I have a prepared statement. It is not that long.

CHAIR: Are you speaking both on behalf of the department and the TGA or separately?

Dr Studdert : I will speak for this session and my colleague in the TGA will speak

Dr Skerritt : It may help the committee if I just do my opening statement now and we don't have to go around it after morning tea.

CHAIR: Sure.

Dr Studdert : Australia can be proud of its overall progress in tobacco control over more than 30 years, which has seen smoking rates reduce steadily since the eighties when more than 35 per cent of all Australian men smoked. Today that figure is less than 15 per cent. Australia's success in reducing smoking is world leading. Nevertheless, tobacco use remains the leading cause of preventable death and illness among Australians, with enormous personal costs to individuals and families as well as costs to the health system. The most recent estimates indicate that tobacco use kills almost 19,000 Australians each year.

Tobacco control measures have always worked off a strong evidence base and been based on strong partnerships between governments, nongovernment health promotion groups, medical professions and community leaders. They have been comprehensive in their nature with combined efforts underpinned by the three pillars of harm minimisation, which are also the pillars of Australia's recently renewed National Drug Strategythose being demand reduction, supply reduction and harm reduction. We have also now long acted with a view to our position as a global leader in tobacco control and in a manner consistent with our obligations as a party to the World Health Organisation's Framework Convention on Tobacco Control.

The Australian government's Department of Health is aware that some stakeholders in the Australian community and overseas have supported e-cigarettes as a means of harm reduction. The department is also aware that a number of health agencies and organisations have urged caution in relation to e-cigarettes, including the United States Surgeon General and the World Health Organisation. In Australia many health agencies and organisations have similarly called for caution in relation to rapid endorsement and adoption of e-cigarettes, including the NHMRC, the Australian Medical Association, the Council Cancer of Australia, the National Heart Foundation, the Public Health Association of Australia, the Thoracic Society of Australia and New Zealand and the Lung Foundation Australia. We have already heard from some of these organisations. I note that all of these had longstanding roles as credible, trusted leaders and partners in tobacco related control and harm minimisation endeavours in Australia and internationally.

The department is concerned about the marketing and use of e-cigarettes and personal vaporisers due to the limited evidence on safety, particularly with regard to medium- and long-term effects on health and due to limited evidence on the efficacy as a means for smoking cessation or harm reduction.

As an adviser to government on a range of health mattersfrom Medicare to private health insurance, infectious disease risks, pharmaceuticals, emerging technologies, food safety and drugs, whether they be licit or illicit, for any matterthe department must also consider and provide advice on the risks and benefits on a whole-of-population basis. A holistic view of the Australian population must include the young, vulnerable population groups, smokers and non-smokers, amongst others, and must assess the weight of evidence across all aspectsfrom the chemicals themselves to the devices, the likely behavioural impacts and the potential for unintended risks and consequences.

As stated in our submission to this inquiry, the department retains evidence-based concerns that there are considerable risks and unknowns in relation to e-cigarettes and personal vaporisers that include their potential to serve as a pathway to nicotine addiction and/or tobacco use, particularly among youth, with whom we have had outstanding success with reducing smoking initiation, their potential to contribute to the renormalisation of smoking behaviours, and the unknown inhalation toxicity of their ingredients, including for those passively inhaling when in close proximity to a user.

With this approach in minda holistic, population-wide, evidence-based considerationthe department can only reach a view that a precautionary approach to e-cigarettes and personal vaporisers is warranted, consistent with the harm minimisation principles which underpin the National Tobacco Strategy and the National Drug Strategy.

While it is true that nicotine is available for use in e-cigarettes in a number of overseas jurisdictions, the department is of the view that this alone does not justify widespread access to nicotine for use in e-cigarettes in Australia, nor should this situation be seen to inhibit further substantial progress in tobacco control in Australia.

The current availability of conventional tobacco products, which we all know is an anomaly of history, does not provide a reasonable basis to expose the public to other harmful substances and products. Indeed, the lessons of history are that exposing humans to particular chemicals without rigorous safety testing, such as occurred with Thalidomide, or in particular human lungs to particular substances such as industrial air pollution, asbestos or tobacco smoke, does not generally end well. The Australian community now rightly assumes and expects the highest safety standards are applied to products that are inhaled or ingested, and we cannot abuse that trust.

Moreover, for departments and governments, there must be a view to the long-term risk and potential liability associated with regulatory decisions that are not based on gold-standard evidence assessments. That concludes my statement. We look forward to contributing to this morning's interactions.

CHAIR: Dr Skerritt.

Dr Skerritt : I thought, given that we are doing our opening statements at this stage, for completeness I'd talk now rather than after morning tea, in terms of an opening statement. I have just a couple of points.

The Therapeutic Goods Administration, or TGA, is not a regulator of cigarettes at large. They are regulated through state and territory legislation, as are e-cigarettes. There are two specific roles that the TGA does have. Just for clarity I should outline them. Firstly, we are a regulator of products for smoking cessation. The Therapeutic Goods Act describes fairly specifically why a product for smoking cessation would be in scope. Most importantly, it is not only products that have a known therapeutic role, it's goods:

(a) that are represented in any way

I am quoting from the act

to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:

(i) for therapeutic use.

That's a little bit circular in the way it has been written in legal terms but the main message is: if it is represented as that use it becomes a therapeutic good.

The second way that the TGA has a role in this area is, of course, scheduling, which is a national system of access controls to so-called poisons. Those poisons are chemicals and medicines essentially. Nicotine has a place in the sun as both a chemical and a medicine. And I'll come back to that.

TGA would welcome an application for an e-cigarette for smoking cessation supported by data. It would be considered in the same way as we regulate smoking cessation products that are available, depending on the nature of the product, in pharmacies, in supermarkets, in convenience stores. Even the ones that sit in your local 7-Eleven have gone through rigorous assessment to check their safety, both in short- and long-term use, but also to check that they work, that their smoking cessation claims can be held up by evidence.

I do want to correct a statement that was made to the previous hearing of this committee that the application process is onerous and really expensive. Depending on the nature of a product, a smoking cessation product could be available over the counter or if it goes into the lungs it generally would become a prescription medicine. If it is an over-the-counter medicine, for example, the maximum application registration fee is $27,000; the annual one is $1,430 a yearabout the same as it costs for you to renew your car registration. I was going to say 'pay your electricity bills' but they're a bit higher.

I must admit that it is difficult to see how that would be a major impost on some of the significant multinational companies involved in this area. Even as a prescription medicineand those where the nicotine goes down into the lungs rather than absorbed in the mouth, and the oromucosal services are prescription medicinesit's a one-off cost of about $240,000 and then I think it is $3,230again, hardly onerous for a company that is expecting to have a major market presence.

As far as scheduling goes, it has been well known and referred to in many of the submissions that, again. on the advice of a committee of every state and territory and doctors, pharmacists and community members, the Therapeutic Goods Administration rejected an application for what effectively would have made high-concentration nicotine widely available in e-cigarettes. The decision was to maintain the status quo there. The point has been madeI am sure we can explain why that decision was madespecific criteria have to be taken into account based on public health.

But I just want to conclude by again dispelling one statement that has been made fairly regularly in a number of the submissions. People have said, 'Well, hold on, tobacco is not included in scheduling. In fact it is specifically excluded. So aren't you being a little bit funny keeping nicotine writ at large in it?' The exclusion of tobacco dates back at least as far as the sixties. In fact, it probably dates back further than that. At the time this national system of regulating poisons and medicines, chemicals and medicines, took the view that a range of products and substances that were in widespread community useand for which other regulatory systems, usually the state and territory back in those days, where the Commonwealth had lower reachwere also to be excluded.

So despite the claim that tobacco for smoking is out there on its own, I'll just read some of the other types of products and substances that are also excludedhardly harmless products and substances: children's chemistry sets, copper-containing paints, batteries, explosiveshardly harmlessmatches, photographic film printing inks. Again, it wasn't because these things were harmlessthat is actually reaching the wrong conclusionit was because they were in widespread use and there were established regulatory systems back in the sixties for managing those risks. I also look forward to the deliberations of the committee today. Thank you very much for inviting us to appear.

CHAIR: The ACCC.

Mr Fleming : Unlike a number of people around the table today, we have a general focus as a regulator. The prism we look at these kinds of products through is the Australian Consumer Law. The Australian Consumer Law was designed to remedy market failure. In this case, in relation to e-cigarettes and the action we took, the market failure was about information that consumers had when making decisions about whether they should purchase or use the devices and products.

Our submission sets out our role and our interest. Just in summary, in relation to our enforcement action against three on-line retailers last year, we conducted some testing of the vapour of the devicesI guess we wanted to distinguish the liquids that you put in the device; through the vaporisation process it changes its compositionand we found that there were certain chemicals in that vapour that were inconsistent with the representations being made by those manufacturers or those suppliers.

Just to give you a sense of what those representations were, things like 'all the taste without all the harmful chemicals and carcinogens', 'do not contain cancer-causing chemicals found in traditional cigarettes', and 'free from 4,000-plus chemicals present in traditional cigarettes'. So the issue we had wasn't the fact that they were in there but rather the representations were that they didn't contain anything at allanything like regular cigarettes. The Federal Court found for us in each of those matters and ordered penalties to be paid and a range of other remedies. That's our enforcement action.

We also are the national product safety regulator, and our submission sets out two main issues that we have, or concerns that we have, in relation to e-cigarettes. One is a broader issue we have with a whole range of devices using lithium batteries. That is first of all fires and, secondly, children swallowing batteries. The other issue is the use of nicotine liquid and the concerns that we have that children might access those as well. That is our general interest. I would be happy to take questions on that.

CHAIR: Ms Robertson.

Ms Robertson : One of the functions of the CEO under the NHMRC Act is to advise the community on matters relating to public health and medical research and the issue of e-cigarettes, and particularly what appears to be the rapid advertising and take-up prompted this issue to be raised through the council of the National Health and Medical Research Council. Council has representation from all the chief health or medical officers in all the states and territories. We have representation from the research community, as well as a number of other lay people that sit on the council itself.

The discussion was whether or not there was enough evidence there, whether or not we could actually come up with some sorts of guidelines, or what the NHMRC needed to do. It is important to distinguish between the different types of documents that NHMRC actually puts forward. Obviously we have guidelines, which make recommendations in relation to what the evidence says, but, in the particular case with electronic cigarettes, we ended up putting out a CEO statement simply on the basis that there really wasn't enough evidence out there to actually be making definitive recommendations for or against electronic cigarettes.

Therefore, we have actually done a literature review of the available evidence and we have put forward what the evidence says. So we are not advocating for or against but what we are saying is that a precautionary approach must be taken, simply on the basis that there is not enough evidence to say whether they are safe or not.

The other thing that NHMRC is doing is that we are also funding research into electronic cigarettes, which is our other function. We are currently funding research to the tune of $6,446,760.

CHAIR: That is the research you are currently undertaking?

Ms Robertson : That's right, currently funding.

CHAIR: I just note for the Hansard record that we have been joined by Professor Kelso.

Prof. Kelso : Please accept my apology for my late arrival. I have come from interstate.

CHAIR: That is okay. Thank you for joining us. I just need to confirmbecause I have to do this for all the witnesseswhether you have any objection to being recorded by the media.

Prof. Kelso : No.

CHAIR: The Royal Australian and New Zealand College of Psychiatrists.

Dr Arunogiri : We are a binational faculty in a binational college. We represent psychiatrists and training psychiatrists in Australia and New Zealand. On behalf of our college I would like to read from our statement in terms of our position, which is supported by our submission.

The college acknowledges that further research is required to ascertain the effectiveness of e-cigarettes and vaporisers as tools for smoking cessation and the extent of harm associated with e-cigarettes and vaporisers. The college believes that these products will provide a relatively'relatively' is a functional term theresafer way to deliver nicotine to those who are unable to stop smoking, thereby minimising the tobacco-related harms and reducing some of the health disparities experienced by people with mental illness.

Harm minimisation is an essential component of any policy framework that aims to improve health outcomes for people who smoke. Smoking rates are of particular concern to psychiatrists, whose patients smoke at disproportionately greater levels. This population group would greatly benefit from policies focused on harm minimisation. The RANZCP therefore supports a multi-pronged approach to tobacco-related harm reduction, encompassing a wide range of clinical interventions and public policy initiatives based on an appropriate balance between smoking cessation and harm minimisation approaches.

E-cigarettes and vaporisers should be treated as consumer products, not tobacco products or medicines. They should be controlled proportionate to their risks, whilst still allowing for individuals to have appropriate access to these products. Sensible regulations around e-cigarettes and vaporisers would, in our view, include strict safety, quality and manufacturing standards, strong restrictions on all types of discounting, promotion, advertising and sponsorship, minimal taxation, particularly in comparison to cigarettes, to ensure their affordability is comparative with tobacco products, prohibition of high-risk flavouring compounds, allowance of lower risk compounds, and a review of legislation after five to 10 years to ensure that regulations reflect up-to-date knowledge.

CHAIR: Thank you very much. I will move to those three witnesses that we have here via teleconference. I will start with Professor Hall. Professor Hall, I should have checked this earlier; were you able to hear all of the evidence that has been presented to date?

Prof. Hall : Yes.

CHAIR: Can I invite you to make an opening statement?

Prof. Hall : In line with comments made earlier recognising that there is a lot of common ground around the table, including between those of us who might disagree with

CHAIR: Professor Hall, we are turning up the audio a bit. You might need to speak into your phone a bit more loudly.

Prof. Hall : I would like to start off by recognising the common ground that I share with people with whom I disagree on the policy of e-cigarettes; that is, that we have been very successful in tobacco control in Australia since particularly the 1980s, with increased taxation bans on advertising, smoke-free policies and so on. I agree that the aim of our policy should be to eliminate cigarette smoking in the long run or to make it prevalent so that it alone is not an important public health problem. We have had a lot of success, but we still have a way to go, as the Cancer Council representative mentioned earlier. There is a question to be asked about whether more of the same is going to achieve the goal of effectively eliminating cigarette smoking. There is a law of diminishing returns about increasing taxes, in terms of impacts on black markets and so on.

With the current policy, I have no problem with the TGA as the appropriate body to regulate therapeutic products or products that make therapeutic claims, but our current policy does not regulate ENDS, because there are no ENDS legally on the market. We have a policy in effect which is the de facto prohibition of these products. We are treating them much like we do heroin. It's a much more restrictive policy towards nicotine products, for example, than medical cannabis, which the TGA is regulating in a much more liberal way at the moment, in the absence of evidence of efficacy. It gives much more weight to preventing uptake amongst new smokers, which is an appropriate concern about allowing current smokers to use this policythe paternalistic policy that denies adults the right to use the products. I think it is unjust to severely addicted smokers. It fails to regulate ENDS, because although it has reduced their use in Australia compared to other countries, we've got a fairly substantial black market here. We are beginning to criminalise the users of these products, which I think is an inappropriate public policy.

The other point that is worth making is that the choice isn't between the current policy and 'anything goes'. That's often suggested as though, if we allow advertising of these products, we have a free market where e-cigarettes are available. I wouldn't be in support of that policy. I think they should be treated as consumer goods and sold under fairly restrictive conditions as approved products. There are a variety of ways in which we could do that, and I would support the recommendations that the representative of the Australian and New Zealand College of Psychiatrists proposed.

CHAIR: Thank you, Professor Hall. Professor Gartner?

Prof. Gartner : The problem that we are dealing with is that tobacco cigarettes were allowed to become established as a legal consumer product. The idea of removing this defective product from general retail sale has been put in the too-hard basket, due to the number of addicted smokers in the population and resistance from industry. However, we now have products that could offer a genuine alternative for smokers that are significantly less harmful than cigarettes. This has the potential to be a game changer if they are carefully regulated as part of a comprehensive strategy to arrest smoking-related disease. So they would not be on their own, but they would be part of a comprehensive strategy that changes the market for nicotine products, including combustible tobacco products.

Regulation as a therapeutic good isn't the only option available, as Professor Hall pointed out. We don't need to allow a laissez-faire approach to these products, and I support very strong controls on how they are supplied and marketed. I believe we need a pragmatic approach that puts some common-sense controls on how these products are packaged, promoted and sold to reduce the risks to the public, but one that also allows smokers who are addicted to nicotine through combustible cigarettes to switch to these products rather than continuing to smoke.

CHAIR: Thank you. Dr Freeman?

Dr Freeman : Lucky last; thank you. The focus of my submission was on the advertising of e-cigarettes. I will address a few points in that area and build on what Maurice Swanson was discussing. We know that advertising of e-cigarettes is commonplace. We know particularly that online vendors that are highly accessible in Australia heavily promote their products. We know that point-of-sale displays are common in Australian retail shops that have yet to ban e-cigarette promotions at retail sales, and we know that e-cigarette ads can be readily found in Australian print media and include things like competitions to win tester packs and things like that.

We also know that the global tobacco industry has a long history of effectively marketing its dangerous products and they are also actively promoting cigarette alternatives on a global scale in an attempt to distract and divert regulators. Any changes in e-cigarette regulation must fully consider the misleading and harmful marketing and advertising practices of the electronic cigarette industry and the tobacco industry. We have seen through the prosecutions by the ACCC that three separate online e-cig retailers have already violated our strong advertising laws around e-cigarettes, yet these laws aren't enough to prevent misleading information from making its way to consumers. While we are not in the same situation as the US and the UK in terms of ads on television and radio, we still know that advertising is commonplace in Australia.

I would also like to address the submission made by Philip Morris International where they talk about their desire to be part of a smoke-free future, that they want to be seen as partners in public health and that they are interested in and committed to heat-not-burn products replacing their combustible market. They did not make any comment about when this complete replacement would happen, nor have they submitted any evaluation framework for how soon they would like these goals to be met. Just two days ago, they announced that they are continuing their $40 million partnership with Ferrari to sponsor their Formula One car and the Marlboro Red. To me that indicates very clearly that they are continuing to market their most dangerous product, their most valuable brand. The Marlboro brand is estimated to be worth $24.1 billion globally. They are continuing the promotion of those products through a global sporting event that is clearly aimed at young adults and young men, who are some of the heaviest smokers globally and most vulnerable to these promotions.

CHAIR: Thank you, Dr Freeman. I will open up the session to questions from committee members. I might start by saying that we have sought to divide this morning into two separate, distinct sessions: The first essentially looks at the use and health impacts of e-cigarettes, and the second looks at the framework for regulating e-cigarettes. The second makes some assumptions, in the sense that the second session is, I suppose, targeted to look at, if there were a change in policy, what the conditions would be for the regulatory framework for the marketing of those products.

Obviously, in the evidence we have received to date, the debate seems to be crystallised around a number of issues: firstly, whether there is a case for the legal availability of e-cigarettes as a harm minimisation mechanism; secondly, whether there is evidence that these products can be successfully used as a cessation mechanism for people who have a cigarette addiction. There is obviously some debate about where policy should head in both of those respects. The third issue is what the actual health impacts of using e-cigarettes are. We have received today conflicting evidence on all three of those subjects.

I might start by asking a process question of Professor Skerritt. There is a different process if someone wants to market an e-cigarette as a cessation device as distinct from a process which would allow them to be sold as a harm minimisation product. Is that a fair summation?

Dr Skerritt : We need to remember first of all that states and territories are the regulators of both tobacco products and e-cigarettes. I know the details have been submitted to this committee previously, so I don't need to rerun them. There are a range of approaches in different states and territories, ranging from not allowing products that resemble e-cigarettes through to more focus on nicotine-containing ones. As far as general marketing goes, they would have the say.

If a smoking cessation claim is made, or representedthat's why in my opening statement I said it doesn't always have to be as overt as you may think, regarding a representation of a product. This was brought in essentially to avoid traditional snake-oil salesmen in medicines, so that if a product is represented to cure a disease or an ailment, people couldn't avoid registration as a medicine just because they didn't say it in so many words themselves.

Leaving that aside, if a product is for smoking cessation, it does have to go through the Therapeutic Goods Administration's various pathways. Where it would end up on sale could, as I said, be anywhere from convenience stores through to prescription-only, depending on the nature of a product.

CHAIR: So if a state wanted to make e-cigarettes legally available, purchased over the counter or by any other mechanism, would it require the concurrence of the Commonwealth?

Dr Skerritt : I will defer that one to my colleague Lisa Studdert, because it is a matter for state and territory. There are some Commonwealth laws. These are more the subject of an upcoming Senate inquiry that do come into play.

Dr Studdert : The distinction, if we could seek it, is that we are talking about products that contain nicotine, which then does revert back to being a process that requires the scheduling committee's consideration, as has already occurred in one instance. There are certainly e-cigarette-type devices available now. If they don't contain nicotine, they are not captured by any therapeutic regulatory system, but of course there are consumer law considerations which our colleagues

CHAIR: But a state couldn't, of itself, permit the sale of an e-cigarette that contained nicotine without there being a national change in the way in which nicotine is treated?

Dr Studdert : I will let my colleagues explain the scheduling process, which is complex.

Dr Skerritt : While most regulation of therapeutic goodsmedicines, devices et ceterais wholly a Commonwealth responsibility, or largely a Commonwealth responsibility, many aspects of medicines regulation are given legislative life through individual state and territory laws. So the process of scheduling that determines whether a substance can be in a product that is prescription-only, over-the-counter, in a pharmacy or available on general sale is actually put into implementation through state and territory laws.

Some of those states and territories automatically adopt Commonwealth decisions; others have to make a specific piece of legislation. States and territories therefore do have the power to make their own decisions about chemicals and substances, but it is very rare. In fact the usual tradition has been for states and territories to add additional requirements. For example, we are all aware of the so-called opioid epidemic that this country has with prescription, powerful opioids. Some states and territories have decided, 'We are going to require a doctor to have to write that prescription in their own handwriting, just to make sure that they are not printing out large numbers of scripts.' So while, in theory, states and territories can go their own way with scheduling decisions, in practice, if anything, if they do go their own way, it is to add additional controls.

CHAIR: So a state or territory could act of itself, but that would be highly unlikely?

Dr Skerritt : I won't speculate as to whether something is likely or unlikely. Historically there have not been many incidences of it.

CHAIR: If a state chose to make nicotine available for use in e-cigarettes under its legislative authority, would nicotine be allowed to be imported into Australia for that purpose, or would it have to be manufactured in Australia?

Dr Skerritt : No, nicotine is not caught up in prohibited import legislation in general in the same way that opiates and cannabis are. It is a schedule 7 substance, because nicotine also has agricultural uses. The schedules are complicated. Australia is almost unique in mixing up both medicines and chemicals regulation in scheduling. It works. Schedule 7 covers agricultural substances that are toxic and, therefore, limited to specifically trained operators, generally with state permits. So there could be an interface with some of the agricultural uses of nicotine that the states would also have to consider. A state could, because scheduling is given life through state legislation. Where it would get messy is where some states adopt, by reference, Commonwealth decisions. They have to make an active decision either in their parliament or through a regulation. Again, it varies in every state how that could be made. I would have to take on notice the details of every state system, because we would be here all day going through it. In theory it could happen, but it wouldn't be a simple and straightforward process.

CHAIR: Let me rephrase the question. If the Australian government decided that, as a harm minimisation measureas distinct from a cessation measure, which is obviously a function of the TGAit wanted to make e-cigarettes available containing nicotine, what would need to occur for that policy to be put into effect?

Dr Skerritt : I'll talk about our side of things. It would require nicotine not to be treated as it currently is within the schedules. It would be most unusual for a specific policy decision by government to be made around one substance in the schedules. Government has taken the view traditionally that where substances sit and how we manage them in schedules are a decision of a senior medical officer or a senior toxicologist or both, acting upon the advice of a committee of states and territories that also contains pharmaceutical, medical and consumer experts. It would be unusualbut not beyond power if put into legislationfor one particular substance to be carved out in such a manner.

CHAIR: Dr Studdert, my understanding is that someone can currently import nicotine for use in an e-cigarette if they have a doctor's prescription; is that a fair summation?

Dr Skerritt : That again comes back to my patch. There is a personal import scheme, and a traveller's exemption scheme. Under personal import, if an individual has a doctor's prescription for a nicotine-containing e-cigarette, or any other nicotine-containing product, or more broadly, for particular prescription medicines that aren't on the register, providing it is a valid doctor's prescription and it is for three months personal use, and in any one year they don't import more than 15 months' worth, as far as the Commonwealth is concerned they are able to import that. However, various states have additional requirements. For example, in Queensland they would not be able to import it, because the Queensland government has decided that the express permission of their Director-General of Health would be required as well. This is where the states and territories have additional requirements, and it varies between state and territory.

CHAIR: If it is the view of regulators and the Australian government that there is no evidence of the efficacy of e-cigarettes containing nicotine in terms of a cessation device, and there are concerns about their health impacts, why do we allow people to import nicotine for that purpose, for personal use?

Dr Skerritt : The way to characterise the Commonwealth's view is that the evidence is mixed and, therefore, not overwhelming. Certainly, there are publications of referee-ed medical literature that say there is an association with a reduction in smoking. An equal number of publications say, 'No, the results were not conclusive', or alternatively that there may even be a gateway. So, the Commonwealth's position, and therefore our precaution, is based on the lack of conclusive evidence and the mixture of evidence.

The decision that unapproved medicines can be imported based on a doctor's prescription for individual patients is a general one. We provide approvals for about 60,000 a year unapproved medicines that are not on the Australian Register of Therapeutic Goods to be, in some cases, imported. In some cases, they are already locally available, to be provided by patients. In that situation, the individual doctor is taking the responsibility, both for making sure that there is informed consent and that it is appropriate, and that alternatives have not been effective in that case. Again, it's a system that has been in place for many years to provide a wider range of options for therapy. The individual doctor, who is the prescribing doctor, comes very much into the frame.

CHAIR: Professor Kelso or Ms Robertson, you mentioned the $6 million worth of research that the NHMRC is currently conducting into e-cigarette products. Could you outline what the nature of that research is and the timeframes and what you are hoping to achieve through that research?

Mr TIM WILSON: Who is doing that researchwhich institutions?

Ms Robertson : There is a study through the University of Queensland whose title is: 'Can using nicotine as a long-term substitute enhance smoking cessation only using it as a cessation aid?' There is a $1,053,910 grant being allocated to that study. That is going from 2011-2018. There is another one through the University of Queensland, going from 2014-2018, entitled: 'Public health policies and interventions to reduce tobacco-related harms among socially disadvantaged populations and low probability quitters'. That is $404,884. There is another one with the University of Sydney that is running from 2015 to 2019. The topic of that one is: 'Harnessing new media to translate prevention research evidence into practice and policy'. That is $309,436. The Cancer Council of Victoria has a grant that is running from 2015 to 2020 for a study which is entitled: 'Enhancing pharmacological and behavioural support to reduce smoking relapsea factorial randomised control trial'. That is $913,218. Another one for the Cancer Council of Victoria is: 'Understanding the impacts of vaporised nicotine products on smoking in Australia'. That is running from 2016 to 2021. That is $1,625,603. Another one, being done through the University of Queensland, and running from 2016 to 2020, is entitled: 'Cardio-metabolic health of people with severe and persistent mental illness'; that study looks at smoking as a factor. There is $187,322 going to that grant. There is another one through the University of New South Wales, from 2017 to 2021, entitled: 'Adding an electronic cigarette to standard behavioural treatment for low socio-economic status smokers'; another randomised trial. That is $1,381,127. Then we have a grant to the University of Western Australia from 2017 to 2019 to look at: 'The health effects of electronic cigarettes', involving a grant for $571,260.

CHAIR: One of the things that is striking in this inquiry is the approach of the health sector in other countriesI particularly refer to the United Kingdom; I am sure it is not universal. There seem to be distinctly different views by the health sectors in the United Kingdom and Australia in relation to this issue. Does anyone have an explanation as to why both government and health advocacy groups in the UK have taken what is seemingly a distinctly different approach to that which we find in Australia?

Prof. Chapman : I can probably have a go at that. I have worked in this field for about 40 years; 17 years of that time was spent as deputy editor and then editor of Tobacco Control, the main journal. From that position, you get a sense of the fashions in different countries for particular approaches to tobacco control. The United Kingdombut specifically Englandhas long taken a dominant, clinical approach toward tobacco control. By that I mean a dominance of dedicated clinics where individual smokers go along and see specialists and are given advice, but particularly pharmacological interventions: nicotine replacement therapy, Varenicline, Zyban, things like that.

Australia and the United Statesindeed most countrieshave tended to take what we call 'population focused' approaches to smoking cessation and to tobacco control generally: public policy approaches, mass-reach approaches, big, well-funded campaigns, price policy, advertising restrictions, smoke-free areasthat sort of thing. The United Kingdom was very slow to catch up with that. They are now well up with the rest of the world in doing that sort of stuff. The legacy of it is that many of the people who are in the leading positions of advising government policy over there are interventionistspeople whose first thoughts about tobacco control are about what kind of pill, what kind of drug, what kind of chemical intervention can be used. So it was natural to see England go aggressively down the path of embracing e-cigarettes. It is a different approach to most other countries. I do a lot of work stillin retirementadvising people, training and that sort of stuff. You don't find that emphasis anywhere elsemaybe in the United States to some extent, but nothing like the extent we see it in the UK.

Mr Swanson : I am sure you have read Professor Martin McKee's submission to the inquiry. He makes that point that the rest of Europe is completely different in their approach to the regulation and treatment of e-cigarettes. He also makes some disparaging remarks about England's public health findings, which are really the personal opinions of 12 individuals, not based on evidence, that have been promulgated around the world. It is important to keep that in mind.

CHAIR: Twelve influential people.

Prof. Chapman : I can say more about that process, if you like.

CHAIR: We might come back to it. I am conscious of making sure everyone gets a go.

Mr Grogan : Just one more comment from our perspective. To systematically research health outcomes on a national level is very complicated and involves multiple interacting factors. To go back to my preamble, it is safe to say that one of the reasons Australia does really well is that we have protection around the independence of the statutory authorities like the TGA. Not every country has those kinds of mechanisms. That is an important thing to factor into why we need to also think about what works in Australia domestically. We have an outstanding record, as Dr Studdert referred to, of really low smoking prevalence among young people, which it is critically important to protect.

Mr GEORGANAS: I have two questionsone to both the Heart Foundation and the Cancer Council, and one for Dr Skerritt. I will give Dr Skerritt a bit of a break, as he was answering most of the other questions. I will go to the Cancer Council and the Heart Foundation. In your opening remarks you made some comments about Australia being leaders in the world in reducing the addiction to tobacco, nicotine et cetera, and some of the good things that we have done. You quoted some figures: 75 per cent after World War II down to very minimal amounts, and that is due to the policies that are being put in by successive governments here in Australia. That downward trend I think is continuing, or will continue through forecasts that we have seen.

Taking all of that into account, all the good work that is being done to get people off tobacco, is there any scopewith changes to e-cigarette regulations, legalising et ceterato undermine any of that work that is being done? We have heard some comments that even though people will come off a tobacco product in terms of inhaling smoke and going onto an e-cigarette, there could also be an uptake directly to e-cigarettes instead of tobacco. Does that have the capacity to harm this good work that we are doing? I would like to hear a bit more about that. If there is deregulation of e-cigarettes, what would be the impacts on quitting?

Mr Swanson : I think it is fair to say that there is growing evidence of the gateway effect. That is of real concern to usthe number of papers being published that show an increased risk for young people if they try e-cigarettes. There's a greater risk of them then becoming smokers of traditional cigarettes. I am sure you are aware of the Journal of Paediatrics paperthe study was very well conductedthat reported a threefold increase in risk for young people if they had used e-cigarettes and then transitioned to traditional cigarettes.

The other point I would make about this quest for harm reduction is that if peopleand many of them do, from the data that we have seencontinue with dual use, that's not harm reduction because they are using e-cigarettes in circumstances where they can't smoke. There is a mountain of evidence that proves that, even if they reduce their cigarettes to somewhere between five and 10 a day, they do not significantly reduce their risk of chronic disease.

Mr GEORGANAS: Could I just ask a follow-on question from what you have just said? Couldn't the same be said of cessation products that are out there as well, like patches and gums?

Mr Swanson : If they are being used in that way.

CHAIR: Is there evidence, though?

Mr GEORGANAS: Is there evidence?

Prof. Chapman : I think that is a very good point. The point I would make openly is that, unfortunately, the gold standard smoking cessation products don't have a particularly good track record either. Taking nicotine replacement therapywhich is by far the most commonly used productwhen we are looking at real world studies as opposed to clinical trials and all the various artificial conditions which apply to those, such as the participants being paid to be in those trials and so forth, if you then look at 12-month follow-up, you are typically looking at around about a five per cent cessation rate under real world conditions of use in people who are using products like nicotine replacement therapy. If you flip that around, you are looking at something like a 95 per cent failure rate. There are not many drugs that doctors would prescribe with a 95 per cent failure rate.

In terms of the evidence that we have so far, the Cochrane collaboration, which is the world's foremost aggregator and synthesiser of evidence in a whole range of areas, have looked at e-cigarettes. They have described the evidence for e-cigarettes as 'very, very poor to very poor', meaning that the quality of those studies doesn't give you much to go on. The main problem with research is that it is a moving picture of the products that are being used. In the NHMRC studies, which have been described, presumably they will be using particular generation products, and by the end of those trials it may well be that those have been superseded by other products. So we will still have this question ongoing as to whether or not they are very successful.

I would emphasise that the bar isn't particularly high in getting approval from TGA under real world conditions. It is a mystery to me why we haven't seen more applications than we have from people. It is not as if there is a huge, onerous standard as there might be, for example, for analgesic products or antibiotics or oral contraceptivesproducts like thatwhere we have a very, very high standard of efficacy demanded. With these products the level required isn't there. Yet we have not seen applications go forward. One has to ask: do those manufacturers know something that perhaps we don't know about how efficacious they are?

The point that Mr Swanson made about dual use is a very, very important problem. If you look at 100 people who are using e-cigarettes, the great majority of them will not be exclusively using e-cigarettes; they will also be smoking. Many of them will be doing it with the belief that they are reducing harm. They will say, 'I used to smoke 20 cigarettes a day. I'm now only smoking half of that; I'm smoking 10. Isn't it surely a no-brainer that I've got a 50 per cent reduction risk?' As Mr Swanson has alluded to, there are some very, very large cohort studies. One from Korea had something like 500,000 subjects in it, another one from Norway, from memory, had about 70,000 subjects and there were two from Scotland which were much smaller than those ones. You put them all together and you can see that across each of those studies people who reduced their smoking by 50 per cent or more did not have, when they were followed 10 or 15 years down the track, significantly reduced smoking related mortality.

I think there is uniformity on both sides of the debate from people who really know their stuff that if you are going to go over to e-cigarettes and you are hoping to have a significant harm reduction effect, you really do need to quit completely. Of course that is not happening. The tobacco industry, which have all bought into this area now, would be absolutely delighted with the data about the number of people who are still smoking as well as vaping. They're not basically marketing e-cigarettes for people to use instead of smoking but as well as smoking. It's a real winner for them.

CHAIR: Can I just clarify, Professor Chapman: your assertion is that the TGA has failed in properly assessing the efficacy of the NRT products it is allowing to be made available in Australia?

Prof. Chapman : Well, no, I don't think they have failed to assess it. That's the standard that applies

CHAIR: To properly assess?

Prof. Chapman : Yes. I am no fan of NRT. I have written a lot of stuff about it.

CHAIR: Is that a view shared by the Cancer Council and the Heart Foundation?

Mr Grogan : No. We were partners in a proposal many years back to look at NRT for the benefits in targeted communities.

Prof. Chapman : I was signatory to some of those submissions as well, but I have over the years changed my mind on how efficacious those products are.

Mr GEORGANAS: This is not so much a question; it is more seeking an explanation on products that go through the TGA that are cessation products and e-cigarettes. It is similar to what I asked earlier and is in relation to the difference between the product that is on the market that assists people to quit, whether it be sprays, chewing gum, lolliesa whole bunch of things. Again, if the producers of e-cigarettes wanted to make a cessation productthey are claiming it is a product that takes you off smoking tobaccowhat would have to be done? What sort of product would they have to sell? Would it be something where gradually the nicotine gets less and less?

Dr Skerritt : No.

Mr GEORGANAS: I am trying to clarify the difference between the products that are already out there and the e-cigarette.

Dr Skerritt : Just before I get on to that I would like to rebut, in part, and present a different view from where Professor Chapman has come from on one point. I think there is nothing inconsistent with a regulator approving a product that only works for five per cent of the population if that product works for that five per cent of the population and it's clearly understood and represented to do so. There are many, many precedents. I will give you examples at either end of the spectrum. We have approved, for example, a drug called Orlistat for weight loss. It is a pill you can buy over the counter.

Mr GEORGANAS: Please tell us more!

Dr Skerritt : Before you rush out and buy it, it really only seems to provide sustained weight loss in a few per cent of the population, and there are a lot of reasons. But isn't that a tremendous outcome for those people? The rest just get diarrhoea and have probably wasted 50 bucks, and they give it up after buying it once. But for a few per cent who it does seem to provide sustained weight loss to, for $50 it can be a life changer.

Similarly, for some of the mostright at the other end of the spectrumhard to treat cancers there are some medicines that we approve, and indeed in some cases the PBAC will make a decision also to fund, even if only a limited percentage of people get a year or even six months of life extension, because that's worth so much to them and their loved ones.

I believe there are cases where it is entirely warranted for a medicineespecially if it can achieve such a life changing thing like smoking cessationto be approved, even if it is only successful in five per cent of those groups. What has to happen is that people go in with their eyes open. For the five per cent that it works for, that is great. Others will give up buying the patches or the chewing gum, or whatever, and move on. They either move on to something elsemaybe called 'will power', if they want to give up smokingor continue smoking, sadly. Where I come from a slightly different place to Professor Chapman is that I believe that for those five per cent it is entirely warranted.

We recently approved a prescription weight loss medicine, again based on evidence that it was efficaciousefficacious in more than five per cent, but certainly not 50 per cent of people. Again, those doctors will have to work closely with those patients and say, 'This may only work for some patients, but let's give it a go for you. Discontinue after two months if it's not working'.

Mr GEORGANAS: I would just like to add that I'm one of those five per cent 13 years ago.

Dr Studdert : If I could just add to my colleague: the distinction with NRT is that, for those who are using it, there is really no increased risk to them becoming nicotine addicted; they are already there. You are hoping that they will be in the five per cent, but if they fail there is no increased risk, and there is limited leakage to non-smokers. Even now where we have got NRT available in supermarkets as patches and gums, you don't see young people going in and buying a patch to hang out on a Saturday night and be cool with their friends.

Dr Skerritt : Chewing gum.

Dr Studdert : Chewing gum or wearing a patch. I think that's a quite important distinction to make from where e-cigarettes may end up in the cessation outcome.

Dr Skerritt : Those are some tremendously valuable points. That reason for that is that, generally, what the patches and gums do is provide a low-level sustained response. Why e-cigarettes are indeed popular is that, in the same way a heroin injection gives a hit, you get a large amount of nicotine coming into the system. It gives you a nicotine hit. That's why there is a risk of diversion, usecall it what you wantfor non-smoking cessation purposes.

I realise, Deputy Chair, you asked about our process. Essentially, for a smoking cessation aid, whether it be an e-cigarette potentially or whether it be gum or a patch now, the applicant has to provide a dossier of information showingif the claim is smoking cessationefficacy in smoking cessation. My colleague Professor Chapman has made the point that it doesn't have to mean that it's efficacious in 99 per cent of a population. I go back to my earlier case and say: how big is the population and what are the potential harms? Every time we look at a medicine we look at benefits, how big the population is that it will benefit and what the potential harms are. If it was a product that would have a larger downside on the harm side, you would expect greater benefits. I am not going to try to pre-empt publicly an evaluation of a product that we haven't even received.

The process is a dossier of information. We are 100 per cent cost-recovered. We don't trouble the taxpayer. I've mentioned the fees which are not exorbitantin my biased viewof some tens of thousands if it is an over-the-counter medicine or a couple of hundred thousand if it is a prescription medicine. Where it fits depends on the nature of the product. Under medicine scheduling, which determines whether things are over the counter, general sale or prescription only, if nicotine from the product goes into the lungs, whether it is an inhaler or whether it is an electronic cigarette, it would usually be considered as a prescription medicine first off. If it is something that is only going under your tongue or to absorbed on the skin, it can be an over-the-counter product.

That is the current situation. It can be changed at any time by an application to the scheduling secretariat, which would then be assessed by this committee I've talked about before, called the Advisory Committee for Medicine Scheduling.

Mr GEORGANAS: Just one very quick last one: are you aware of any products for which application has been made to the TGA that would come under the vaping

Dr Skerritt : Come under the vaping or smoking cessation? The current framework for all medicines and all applications to the TGA, with the exception of particular medicines for a priority review pathway, is that we neither confirm nor deny publicly the receipt of such applications. Some companies, particularly publicly listed ones, do make a statement to the Stock Exchange or in terms of other promotional use. But we are not able to confirm or deny applications.

I would put on the record, though, because again it was misrepresented, if I may say so, in the Hansard of the last hearing of this group, there was a statement that an e-cigarette product had not been accepted by TGA for evaluation as an over-the-counter medicine. That product, because this is on the public record, was actually not a e-cigarette product, it was an inhaler more akin to an asthma puffer.

Mr TIM WILSON: Can I just start by saying I echo the sentiments of some people before, particularly about tobacco companies arguing somehow that they are interested in a tobacco-free world. I think it is pretty self-evident that they are not. But that doesn't diminish to me the argument that there may be justification for legalisation of e-cigarettes in this context because the thing that I struggle withthis is a broad question but I want everybody's responseis this: I went down to the Star of the Sea College in Brighton recently where a group of young Catholic girls were talking to me about harm minimisation in the context of heroin. They kept asking me how was it that politicians could argue against harm minimisation. We went through all the different arguments why it should and shouldn't be done in relation to heroin.

Where I struggle is this benchmark about whether these products should be legal or not legal. What I have heard across most people here today is around cessation, not harm minimisation. Can I get some clarityI have heard aspects of different perspectives of why people think thatwhy the benchmark should only be cessation rather than recognising harm minimisation?

Prof. Chapman : The statement has been made by many peopleit originated from the Group of 12 that has been talked aboutthat Public Health England acknowledged and the Royal College of Physicians in London also acknowledged that e-cigarettes are 95 per cent safer than cigarettes. If you look at the origins of that, it was basically a handpicked group of people who were brought together. There was no transparency about how those people were selected. Several of them had zero track record in tobacco control. Several of them had ties with tobacco companies into the past.

Questions are being raised. There was a very, very large piece in the British Medical JournalI think the Guardian also covered itquestioning that process. Basically people were asked to vote as to what they thought the level was, and the 95 per cent figure came outnot 94 per cent, not 90 per cent, not 97 but 95. Where that came from is anybody's guess, other than that process. The problem with that figure, of course, is that there is very little, if any, long-term data that informs that position.

If someone in 1920 had stood up on a soapbox in Hyde Park in London and said, 'Look, I've noticed that a lot of people are smoking these factory-made cigarettes that have been produced now since around 1905. The price of cigarettes went way, way down because they were factory-made rather than hand-rolled. And speaking to my medical friends, we're not seeing any problem whatsoever.' This would have been 15, 20 years on from the mass rise in smoking. They would have been right. There wouldn't have been very much evidence around at all about the time.

Of course the rest is history. It's now six, seven million people a year around the world die from smoking. Two out of three people who are long-term smokers will die from a smoking-caused disease et cetera. Lung cancer is the leading cause of cancer death globally.

The problem is that many of the diseases we get from tobacco use are not acute diseases. They are chronic diseases which take years, decades, to manifest themselves clinically. That being the case, with all the problems that we have had through the lack of regulation of cigarettes, it would seem to me to be completely foolhardy to try and see that as a virtue to have the same lack of regulation with e-cigarettes.

I think we owe it to future generations to make sure that we do regulate them and that the processes which are available to the TGA, as we have heard several times now, are available. They can change the scheduling. They could start them off tight, they could then, as new evidence came through, continuing down the track, say, 'No, we are not seeing too many problems.' They could be loosened up, that sort of stuff.

There is a huge amount of research that is now being published. My reading of that research is that e-cigarettes are almost certainly going to have far less carcinogenic risk than cigarettes but they may well have significant cardiovascular and respiratory risk. That sort of research is, as I said, really only just starting to come out. E-cigarettes have only been around for about 10 years and only have been around really for about five years in mass levels of use. That's very, very early days.

Mr TIM WILSON: Just to follow on from that thenthis is very much a question open to othersfor instance illicit drugs have comorbidities that come along with consumption as well. We all know that. The view generally from the health communitythere might be people who disagree with this hereis that we should continue to operate on a harm minimisation model. What makes this different so that you think it should be focused only a cessation model? I don't feel I have got that answer from the current contribution. Are there other contributions as well, or from you, Professor Chapman?

Prof. Chapman : I guess there is no precedent for any product where a person at point-blank range is inhaling on average 200 times as day, and up to 600 times a day, a mixture of micro-nanoparticles, heated vaporised flavouring agentsall that sort of stuff that is in that mixture. We can't point to anything else other than, of course, cigarette smoking, where the mixture is different. It has all the combusted stuff in it as well. But we can't look at it and go, 'Oh, yes, people have been doing something quite similar. It's probably not going to be at all harmful.' It really is a big challenge for people, for regulators, to know what to do about this. It is a modern, unique phenomenon.

CHAIR: There is a temptation to be out of sight, out of mind. Would any of our three witnesses on the phone like to respond to Mr Wilson's question?

Dr Freeman : I would just like to say thatwhat you are talking about, the concept of harm minimisation and why we aren't we applying that to e-cigarettesI think that we are. My concern is that they actually are not harm minimising unless you make a complete switch from smoking to e-cigarette use. It looks like a lot of people who use e-cigarettes continue to smoke. As Simon pointed out quite clearly, that doesn't have a harm-reducing effect. So in order for us to be convinced that yes, it is not about people quitting nicotine use per se, it is about them switching from combustiblethe most harmful product clearlyto what we hope is a less harmful product, considering the evidence. But the evidence doesn't seem to be there that the combustible cigarettes get completely replaced by electronic cigarettes.

Then clearly in the regulatory environment, with big tobacco pushing both of these products, it seems far less likely that a harm minimisation effect could be achieved.

CHAIR: Could I just put the proposition in response to that, thoughthis goes to Dr Skerritt's point beforeif five per cent are switching entirely to e-cigarettes, isn't that better than those five per cent smoking cigarettes? The committee has had hundreds of submissions from people who are saying that this was the only way in which they got off cigarettes. Isn't that a benefitif you accept that there is less harm from an e-cigarette?

Mr TIM WILSON: Continuing on from thatI agree with the comment Professor Chapman made before about the fact that if you reduce your consumption of cigarettes by 50 per cent you are not going to actually reduce your risk by 50 per centif the government at least keeps telling the Australian population every cigarette is doing you damage, we would at least acknowledge there is some reduction in the harm that is done, surely, or we're misleading the public. That's also a question to the people on the phone as well.

CHAIR: We might just go back to the people on the phone in the first instance.

Prof. Gartner : I would just like to add that there is observational data showing that daily use of vaping or e-cigarette use amongst smokers overseas is associated with increased likelihood to quit smoking. I've got a paper in front of me that's by Giovenco and Delnevo looking at population data from the US. I'll just read out the highlights from that. It says that over half of daily e-cigarette users in the sample had quit smoking in the last five years; daily e-cigarette users were three times more likely to be quit than 'never e-cigarette users'; and some e-cigarette users were the least likely to quit.

There are a couple of important issues in there. One is in regard to people who just use these intermittently, rather than persistently and daily. It doesn't seem to be associated with smoking cessation. We want to encourage people to switch completely. I think we all agree with that, that that is going to be the most harm-reducing option there. But to say that this is preventing quitting, this dual-use argument, doesn't seem to be the case because when you are looking at the overseas data the dual users, as they keep going, often do change their behaviour. It is not necessarily a persistent behaviour over more than a moderate time.

Dr Arunogiri : Harm reduction is a core part of the submission that we put forward. I think it is particularly salient for what the Cochrane group has called priority population groups, where internationally we have seen this huge reduction in terms of smoking prevalence, but there are particular populations where that hasn't been the case. These tend to be socially disadvantaged groups. In Australia and New Zealand definitely there are particular populations that are overrepresented: people with mental illness, broadly speaking, and then out of that people with severe mental illness.

If you look at particular populationspeople with schizophrenia, bipolar disorderthese rates are very high70 per cent estimates of people with schizophrenia have concurrent smoking. That rate has not gone down. So it is not parallel to population rates. This is where the harm-reduction space is actually quite salient for that particular group. It may not be as salient for the whole population, as we talked about. Perhaps willpower and other factors in terms of behavioural change come into play. But when there are other factors that are impacting on someone's ability or willingness to quit smoking, that's where harm reduction can have a role.

We support the principle of harm reduction in this case, as we do in the treatment of any other addictive disorders. I think there are few other options in terms of harm reduction in the tobacco-control space.

Mr TIM WILSON: If anybody has anything to contribute to those questions earlier, by the way, the feedback is very welcome.

Dr Studdert : On the question of harm minimisation, we have to be a little more sophisticated than talking about a simple binomial. Yes, for smokers, there is arguablyand we can return to thata harm minimisation effect by a transition to e-cigarettes completely. But we have to rememberthis is why I made the comment in our opening submissionthat for nearly 90 per cent of the population that are not currently smoking, it is not a harm minimiser to have access to and to open a pathway that would start exposing them to nicotine. That's not harm minimisation; it's quite a harm increase.

I would, Mr Wilson, like to pick up on your comment about the campaign 'every cigarette is doing you damage'. I think it is a misrepresentation to say that was an argument for reducing one cigarette at a time over a daily

Mr TIM WILSON: That was not the suggestion that was made. The point was

Dr Studdert : Sorry, I misunderstood.

Mr TIM WILSON: Obviously, if every cigarette is doing you damage, reducing the consumption, even if it is only half, surely has some benefit, even though it won't be 50 per cent. Saying there is a proportional, direct link percentage-wise is probably inaccurate.

Dr Studdert : I think we were going from the zero gain, which is no smoking, and a single cigarette from a no smoking position is going to do you damage.

Mr TIM WILSON: I am not disagreeing with that. The follow-on question I had was around

Prof. Gartner : Could I interrupt? I have just had a message from Professor Hall that his phone line was cut off. Could he be dialled back in?

CHAIR: I think we are doing that now. You can proceed, Mr Wilson.

Mr Masri : The National Drug Strategy, which all jurisdictions under the COAG arrangement are committed to, includes both illicit drugs and tobacco products. The harm minimisation has the three pillarsI think that has been referred to beforeof reduction in supply, reduction in demand and reduction in harm. Whilst there might be strong advocates for harm reduction in the context of illicit drugs, those advocates are also supportive of the present strategy of taking an evidence-based precautionary approach in relation to e-cigarettes and tobacco more generally. It is that sort of three-pillared approach that is shared amongst both the Commonwealth jurisdiction and the state and territory jurisdiction, in the context of the various policy frameworks for drugs, including tobacco.

Mr TIM WILSON: The general thrust was that everybody would broadly agree that cessation is the best outcome, but obviously some people will be in between consumption and cessation, and the challenge has always been about how you approach harm minimisation and why that isn't part of it, and why we are approaching it in some areas but not in others. I don't want to take over from you, Chair, but it seems that Adjunct Professor John Skerritt has something to say.

Dr Skerritt : I wanted to go back to the challenge you have with any issue to do with population healthand it is a numbers game. The concern that the Commonwealth and the states have expressed, but maybe not as starkly, is this dilemma: could you say that a small percentage of people would stop smoking, adults who are already smoking, and maybe even that a smaller but still beneficial population would stop smoking entirely if they went on to access e-cigarettes? The thing we have to balance it up against is whether, at the other end, you'd be introducing more young people to smokingthis so-called gateway effect.

In other, more considered fora than perhaps a parliamentary inquiry, the World Health Organisation has looked into this in some detail. A recent statement from the World Health Organisation said that you also have to think about your overall smoking prevalence. Countries like Australia, fortunately, have a low prevalence of smoking on a global scale. Because of this balance between the risk of people starting smoking versus hope that a number will stop smoking at the other end of their lifeadults versus teenagers and young adultsthe World Health Organisation made a statement that countries with a low prevalence of smoking should not open up the market to e-cigarettes.

In an ideal world, you could say, 'These things do provide adequate smoking cessation for a limited number of the population.' Our colleague from the college of psychiatrists has said, 'There are these populationspeople who have schizophrenia, where 70 per cent smoke.' These people are seeing their doctors regularly for medication and for other behavioural therapies. If these products are able to be smoking cessation products, why wouldn't, as part of a doctor's consultation, an e-cigarette be prescribed to those people who are coming along to get their other medicinesAbilify, or whateverfor schizophrenia and other behavioural therapies? It could be easily packaged in without these prescription products being available to teenagers and young adults as a pathway to smoking. So we can have it both ways, if we are clever.

The main issue where e-cigarettes are very differentmy colleagues said it wouldn't be normal to have a Saturday night nicotine patch partyis, of course

Mr TIM WILSON: Don't send me the invite; let's put it that way!

Dr Skerritt : We won't invite you, Mr Wilson! The main area is, of course, in various shapes or forms, they resemble a cigarette; the means of administration is also very cigarette-like. The exhaling of vapours is also cigarette-like. So it is a different animal in that sense. Especially for groups who, for example, are seeing their GP or psychiatrist reasonably regularly, an avenue to prescription access to these products would be potentially an attractive option.

CHAIR: Have we got Professor Hall back on the line?

Prof. Hall : Yes, you have.

CHAIR: I invited you to comment earlier on a question which you probably didn't hear. Mr Wilson, do you want to throw your question to Professor Hall?

Mr TIM WILSON: About harm minimisation?

CHAIR: Yes.

Mr TIM WILSON: The question was that, ordinarily, with a lot of, say, illicit drugs obviously cessation is always the best outcome, but harm minimisation is considered to be at least part of that journey towards cessation, or a preferable outcome to consumption. Why is there a gap and a benchmark we've set related to smoking and the access to e-cigarettes around simply achieving cessation rather than looking at harm minimisation?

Prof. Hall : Why the difference in policy?

Mr TIM WILSON: Yes.

Prof. Hall : Because the debate has been framed as it has for this whole hearing as though the only question is whether they are effective as a cessation aid. If that is the way you frame the policy issue then this doesn't get a look-in.

I would have liked to have intervened much earlier in what I thought was a fairly disparaging attack on colleagues in the UKthe group of 12 who were in the pay of the tobacco industry, for example. The UK experience deserves to be taken a lot more seriously than that. They now have a smoking prevalence which is pretty much the same as it is here in Australia, despite having a policy which has been heavily criticised throughout this hearing. I think the evidence is fairly good, from their observational studies, that a substantial number of smokers in the UK have quit using this particular product. There are concerns, clearly, about long-term use. We don't know what the health risks are. But it is a minority of smokers who engage with these products on a daily basis in the long term. I think we need to put that in perspective.

The other point is that the UK is one example, and I certainly wouldn't want to see us adopt the pretty much so-called light touch regulation they have in place there. But there are two other countries that are in the process of abandoning the policy that we now have in Australia. New Zealand and Canada have decided to allow the limited sale of e-cigarettes as consumer products, under tight regulation. That's just not getting a hearing here. It is not that the group of 12 has somehow persuaded or brainwashed them into having this particular policy.

The UK policy is much wider than the views of people who have been primarily in the smoking cessation business, although that is certainly part of the story. The Royal College of Physicians cannot be dismissed as easily as that, as a credible body, or Action on Smoking and Health or the UK Cancer Council. These are all reputable bodies whose views are being wiped away by disparaging comments about a single study that was published in the BMJ which had people involved in it who had tobacco industry funding.

Mr TIM WILSON: One of the arguments that has regularly been used around tobacco consumption and its dangers is not just the impact on the primary consumer but also on second-hand smoking. Do we see any advantage around the health consequences to others from people switching from consumption of e-cigarettesaway from ordinary, shall we say, cigarettes towards e-cigarettes as part of reducing harm to others?

Mr Swanson : Can I make a comment in relation to that broader issue of harm? The main reason why we have very low rates of smoking in young people is because they do not see adults smoking; yet there are only two states that I am aware of that have regulated the use of e-cigarettes in areas that are now non-smoking areas. For example, in WA we have not done that. That is a policy gap. But if we don't address that policy gap, we will have people using those devices in previously non-smoking areas and we will be exposing children to the role modelling of vaping, which, as Professor Skerritt said, is almost identical to smoking. If you read the Philip Morris submission, they extol the virtues of these new products. Why? Because they are almost identical to the motions, the behaviours, the cloud of vapour that you have with ordinary smoking. I think it is a real risk that we are exposing the community to.

Mr TIM WILSON: I asked a question about second-hand smoking.

Ms Robertson : I would like to comment, if I may, on some of the comments that people are raising in relation to harm minimisation. Essentially, while e-cigarettes may expose users to fewer toxic chemicals than, say, a tobacco cigarette, the extent to which it reduces harm has actually not been determined by the evidence. E-cigarettes are not likely to be risk free, and they may expose users to chemicals and toxins at levels that have the potential to cause health effects. These include things like propylene glycol, glycerol and ethylene glycol. They may form toxic or cancer-causing compounds when vaporised.

Some of the chemicals in the air liquid are also used in food production. These are some of the flavourings that you talk about. While they are generally considered safe when eaten, that does not mean that these chemicals are safe when inhaled as a vapour directly into the lungs. A number of studies have actually reported harmful effects when certain flavourings that are approved for use in food production are inhaled. There is growing evidence to suggest that the long-term inhalation of flavourings that is used in most air liquids is most likely to pose a health risk.

With respect to the issue around passive smoking that you were talking about, studies are actually showing that e-cigarettes expose both users and bystanders to particulate matter, which is very small particles that may worsen existing illnesses or increase the risk of developing diseases such as cardiovascular or respiratory diseases. The World Health Organisation has warned that exposure to any level of particulate matter may be harmful, and that levels of exposure should be minimised.

CHAIR: We will go to Mr Zappia; otherwise we will run out of time. He has been very patient. There is obviously an overlap between the subject matters we are considering in the first and second session, so we will have some latitude to keep a similar train of thought.

Mr ZAPPIA: Mr Wilson's comments went down the very path that I wanted to pursue, anyway. I will ask two very specific questions. The first is to Professor Skerritt. In respect of the UK, the USA and any European countries that have currently approved the use of e-cigarettes, to your knowledge did they go through a similar TGA approval process to what would be required here in Australia?

Dr Skerritt : The products are different in different countries. What the UK have done is to open up two pathways. They have said to people, 'If you are going to make smoking cessation claims, it needs to go through as a medicine,' the same way as a TGA pathway. 'If you are going to market them as general consumer goods without smoking cessation claims, they can go through a different category.' Coincidentally, the medicines regulator, our equivalent, the MHRA, has been given the job to manage both types of products.

So products have been through both routes. The advantage of the medicines route is that, in the same way we have the PBS, the National Health Service, or NHS in the UK, can then subsidise, fund and provide, through the clinics that Professor Chapman talked about, these products. There is a range of views in the UK, as there is hereperhaps the weight of views is slightly different to what it is here; perhaps not. We have heard from some in the UK that, while on the surface of things companies have put through a consumer product without smoking cessation or any health claims, the underground media, if I can characterise it as suchso social media, Facebook postsare harder to regulate. You can regulate an ad going on ITV on the 9 o'clock show, you can regulate what goes on a billboard or what goes into The Times or The Guardian. But Facebook-type mediawhich may or may not, depending whether you are a conspiracy theorist, have been seeded by Big Tobaccoare talking about these products, which have obeyed all the rules and gone through as consumer products without any claims of smoking cessation. People can say what they want in social media. There have been strong claims to the effect of, 'By the way, do you know these products are great for smoking cessation?' Whether those comments have come from average people posting on Facebook or whether they have been planted on Facebook is for others to speculate. So that is the situation in the UK; there are the two pathways.

To use the US as a contrasting example, our equivalent, the US FDAwhich is much larger than usalso has responsibility for regulating tobacco, and has had for a decade or so. Recently they have been clear that e-cigarettes will go through their tobacco regulatory framework and that criteria will be applied to those products and the claims they make. So, in contrast to the UK, where it is a very light touch consumer product situation, FDA is still regulating e-cigarettes. The new commissioner of the FDA recently announced an initiative to make sure that advertising and promotion, and hopefully use by young adults and teenagers, are reduced or minimised, because there is a disturbing increase in the use of these products by young adults in the US. But it is not true to say these products are not regulated in the US. They are just regulated in a different way.

Mr ZAPPIA: I assume that in reaching that decision, particularly in the USA, they have gone through an assessment process that you would consider adequate?

Dr Skerritt : The assessment process is different; it is in the context of the assessment process for a cigarette. It is not a specific assessment process around smoking cessation. It does have aspects of its assessment that relate to harm. The details of the framework for e-cigarettes in the US are still being developed. As you know, often broad laws come in, and the regulations and guidances in a transition period take some while to develop. We do not have chapter and verse of the US approach, because the approach is still being finalised. It is not a medicines approach; it is a regulation of cigarette-type products approach.

Mr ZAPPIA: We have heard about studies, mostly studies of existing cigarette smokers or of people who continue to do both. Has there been, to anyone's knowledge, a study which exclusively looks at people who have used only e-cigarettes? I realise it is a relatively new product and we are in the early stages but even so, over the last decade some useful information might have come out of such a study if it were carried out.

Prof. Chapman : Are you looking for studies about health effects?

Mr ZAPPIA: Yes, health effects on a person who has used only and solely e-cigarettes.

Prof. Chapman : The submissions you have contain many individuals who are saying: 'Since I have gone onto e-cigarettes, my health has improved'.

Mr ZAPPIA: 'Since I've gone onto'is not the question I am asking.

Mr Grogan : We can take that on notice.

Mr ZAPPIA: Thank you.

CHAIR: I want to touch on an issue that has been raised frequently: the potential of e-cigarettes to be a gateway to smoking. Again, we have had conflicting evidence about this. Would people like to comment on what they believe the evidence is for it becoming a gateway?

Prof. Gartner : I'll jump in on that. There does seem to be, in the prospective studies that have been done, an association between experimenting with e-cigarettes amongst young people and then experimenting with tobacco cigarettes. There are a few things we need to keep in mind with these studies. Firstly, amongst the proportion of young people who try vaping then smoking, would be a proportion who would have tried smoking without trying vaping. There is a common liability to experiment with substance use. That doesn't explain everyone, but a proportion. So not the entire sample goes on to experiment with cigarettes who would not have done so otherwise. It is plausible that vaping may increase the likelihood of experimenting with smokingagain the familiarity with the behaviour that we've heard about. Also, there might be some curiosityif you've tried one, what's the other one like? We don't know how many of those would go on to become regular smokers, because the studies that have been done are just looking at low-level use, the prevalence of smoking in the samples is so low. They aren't able to look at regular smoking. They are only looking at any use in the past month, or at any use ever.

I would like to point out the baseline waves of these longitudinal studies; they have generally been conducted in locations and at times when there weren't age restrictions on the sale of these vaping products. So, it is somewhat unsurprising that young people might experiment with a product that is easier to access in that sort of context. Age 18-plus age restrictions are coming in, in a lot of jurisdictions, both in Australia and overseas. That is a very sensible approach to this product. We might see a change in the pattern, now that more restrictions are coming in on children's access to these products. Again, I emphasise that the number of young people who are regularly vaping or smoking appears to be low and may be decreasing.

Prof. Hall : I agree with what Coral Gartner has just said about the evidence base. I would add two points. So far, the countries that have had the most laissez-faire regulation of these products, the UK and the US, have not seen increases in smoking prevalence in young people. If anything, it has gone down. If there are gateway effects, they are yet to be manifest in overall smoking prevalence. The UK smoking prevalence, which was considerably higher than that in Australia five or so years ago, is now equivalent to ours. So, if there is a gateway effect, it hasn't been apparent so far.

The second point, and one that I reiterate in support of the one Coral has just madeis that this is an argument for regulation and age restrictions, and the way these products are marketed, and not an argument of prohibition of adult use, which is what is being used in this situation. I strongly support age restrictions on sales, and restricting outlets to reduce access by young people. The misinformation that is out there that there is effectively no difference in risk between e-cigarettes and conventional combustible cigarettes would encourage young people to move on to these products. We need to be wary of sending that unintended message.

CHAIR: Professor Hall, you stated that there is no increase in the prevalence of smoking amongst young people in the UK and the United States. Does anyone disagree with that?

Prof. Chapman : There is also a significant decrease in smoking in Australia in young people, where there is negligible e-cigarette use. The wider point is thisthe falling smoking prevalence in countries like the UK, the USA and Australia reflects a mixture of a whole lot of influences. The de-normalisation of smoking has been pointed outpeople aren't seeing a lot of smoking, or role modelling of it. The price of cigarettes has gone up considerably in Australia. We have mass-reach campaigns which are targeted at adult smokers, but which children see. We have school education programs. The combined effects of all those things working synergistically together are pulling smoking down historically to record low levels.

CHAIR: Recognising that this is a relatively new product in those jurisdictions where it is legal, is there evidence of e-cigarettes becoming a gateway for regular smoking?

Prof. Chapman : The second part to my answer was going to go there, which is that those who say that it cannot possibly have any gateway effect because smoking is going down while e-cigarette use is rising, would demand that the impact of e-cigarettes on smoking prevalence is so big that it overwhelms all the other factors I have just spoken about. Nobody is arguing that the power of e-cigarettes to drive up smoking prevalence is going to knock out the effects of de-normalisation, the rising price of cigarettes or campaignsall those things combined. Of all the measures we have in the tobacco control kit, probably the one that most people would say works least well is age restrictions. Those of us who used to smoke know where we used to get our cigarettes. I used to buy them when I was a smoker, as a kid. A UK study that I remember, published recently, was a secret shopper thing where kids went into shops and, found that 40 per cent of vaping shops sell e-cigarettes to kids. If that has been put up as sensible, strong, good regulation, it is the weaker end of what we could do.

Prof. Hall : That's a misrepresentation of what I said on two points.

CHAIR: Professor Hall, we can't hear you very well. I will throw to Ms Robertson from the NHMRC first and then I will come back to you.

Ms Robertson : Thank you. There is some evidence from longitudinal studies that suggests that the use of e-cigarettes in non-smokers is associated with future uptake of tobacco cigarette smoking. That association remains even with the studies that have been looked at, and controlled for other risk factors, that might make people more likely to take up smoking. One of these longitudinal studies was in the US. It was a longitudinal examination of US college students. Another one, from 2016, was published in the Journal of Adolescent Mental Health. It did a review of longitudinal studies around whether vaping is a gateway to smoking. There is some evidence there.

Mr TIM WILSON: What was the date of the first studies around college students?

Ms Robertson : The college students study was published in 2017; the other one was published in 2016. If you have access to the NHMRC statement, it is references 50 and 53.

Dr Freeman : The latest study from the UK on electronic cigarettes showed that they increased cigarette smoking in UK adolescents. This was a 12-month prospective study, the first prospective study to come out of the UK, published last month, into tobacco control. It concluded that every use of cigarettes was robustly associated with initiation, but much more modestly related to escalation of cigarette usethat means more regular daily smoking. Australia has been least successful in reducing the smoking rate amongst 18 to 24-year-olds. We often think of children and young people exclusively under the age of 18, and we ignore that important transition age group between 18 and 24. It is a misservice from tobacco control in general that we haven't done well at reducing smoking rates effectively in that group. We know that e-cigarette advertising and promotions are directly marketed to this age group as well.

CHAIR: Mr Grogan, and then we will finish this session.

Mr Grogan : I just make the point that the main reason for the outstanding success in prevalence in younger people in Australia is because it reflects a change in the adult population. We would expect, because of the great successes in Australia and other countries like Australia, that they have relatively low and historically low prevalence in younger people because of those successes in the adult population.

Let's not confuse that, though, with the risks of harming people who might not have otherwise been harmed, which is what we are talking about here. When we see those studiesthey are significant, and we have put a couple in our submissionof younger people who initiated e-cigarette use or were not just smoking, in all likelihood they certainly weren't likely to benefit from a harm minimisation approach because they weren't at risk of harm in the first place, and now they are potentially at risk of harms on two fronts. The first is the direct effects of vaping and the second, of course, is the flow-on effects of tobacco use in tandem or as a subsequent outcome of initiation. It is easy to confuse the things, but I don't think we should confuse what we have succeeded at at a population level and should do more of, with the risk of harming people that otherwise might not have been harmed.

CHAIR: Professor Hall, I am going to leave the last comment to you for this session and then we are going to break for morning tea.

Prof. Hall : We have two views here. One is that the gateway effect is really large, serious and of concern and justifies prohibition on sale to adults. Then when that's challenged, it is: well, who would suggest that the gateway is going to overcome all of the other policies that reduce smoking prevalence? I think that's exactly the pointthat so far the evidence in the UK is that smoking prevalence has continued to go down amongst young people, despite the ready availability of these products. I don't think any of us were suggesting that age restrictions were the sole way of reducing this problem. Restricting where these products can be sold I think would be a clear policy priority, so that they are much more accessible to smokers than they are to young people. I certainly support that.

CHAIR: Thank you. We will now take a break. Thank you all for your participation so far this morning.

Proceedings suspended from 11 : 17 to 11 : 37

CHAIR: We will get underway. Our second session was designed to look at the marketing and regulatory framework for e-cigarettes. As I said at the outset, there is an assumption that you have something to market and regulate. So we will operate on that basis.

I might ask the first question. There is obviously an overlap with what we were talking about before. One of the issues that have constantly been raised, including this morning, is that basically Mr Swanson said that the US have 7½ thousand different flavours of e-cigarettes available, and one of the concerns is effectively, obviously, what goes into the mix in these products. Ms Robertson referred to some of the chemicals that are found in e-cigarettes, as did the ACCC. Is it possible to produce an e-cigarette product and regulate it accordingly that eliminates the products that have been raised as causes of concern? I'll take silence as yes. Ms Robertson, do you want to have a crack at that?

Ms Robertson : To be quite honest, the answer is that I don't know.

CHAIR: For example, the particular products, the chemicals that you raised, is it possible to have an e-cigarette product without those chemicals?

Ms Robertson : I would be guessing, and I don't wish to do that.

CHAIR: Does anyone else have an informed view on this?

Mr Grogan : If I could just add one comment, scientifically those sorts of questions still take a long time to answer. Dr Skerritt made the point there are a number of harmful agents for which it takes a long time for the evidence of harm to accrue. So whatever the answer to that is, it would still take a long time to answer it.

CHAIR: There are obviously some chemicals which have known effects?

Mr Grogan : There are studieswe can submit some as supplementary informationthat I've seen just recently around toxicology and other things.

CHAIR: Let me rephrase the question then. Is there a regulatory system in existence in other countries which regulates what actually goes into an e-cigarette product?

Prof. Chapman : The US FDA, from my understanding, is proceeding to examine everything that goes into them.

Prof. Gartner : Also there are some restrictions under the European Union tobacco products directive.

Dr Skerritt : Can I add one thing? One of the challenges you have is human behaviour. Broadly speaking, you can have two types of an e-cigarette-type product. You can have an integral type with almost a disposable form with a cartridge. If you, by some miracleand I think we don't know what the miracle ishad a set of totally benign things in that cartridge, if it were a disposable product that gets thrown out, increasingly because of cost and other reasons, we are seeing products with refillable cartridges. Then you'd have the issue that you might design a product and you might market a product as being nicotine free or whatever else free, with something fairly benign in the cartridge, but next time it gets refilled who knows what goes in it? It could be nicotine. It could be some of these other substances that we have expressed concerns about when they're in a volatile state.

There's this other issue. This is where it gets complicated because of the state regulation. My group only gets involved if it is nicotine and smoking-cessation claims. At the state level, some states have said, 'Look, we don't like anything that looks like an e-cigarette because of a broader renormalisation.' I am old enough to remember as a kid we used to run around the playground with these white lollies that had a red thing on the end and as a six-year-oldI won't mention the trade namewe always used to pretend we were smoking.

Mr TIM WILSON: FADS.

Dr Skerritt : Mr Wilson, you have mentioned the name and put it into Hansard. The challenge is, of course, you might start with a product that is: 'Don't worry, this is something benign in its tank,' but someone can put something else in its tank.

CHAIR: That leads me to my second question. There is obviously a broader debate for legislators at any point in time when something that is illegal becomes so readily available that you effectively decide that you give up trying to enforce a particular outcome. I am just wondering at what point we say that e-cigarettes are now so readily available that we have a concern about effectively an unregulated environment where people are basically importing nicotine in a form which can be dangerous if not mixed properlycan be dangerous on contact with skin et cetera et ceterabecause of flavourings and additives which are completely unregulated, and whether there is in fact a greater health risk that arises from people effectively becoming their own home chemists as distinct from a regulated environment where you are controlling, to some degree, what's in the marketplace. Does anyone have any comments about that? Professor Chapman?

Prof. Chapman : If you look at the e-cigarette industry, if I can call it that, it obviously includes big tobacco companies. They don't have so much of a presence in Australia but internationally they are increasingly having a presence in this area. Then you have some large companies who are solely dedicated to the manufacture of e-cigarettes and the juices that go in it. Then you have a whole lot of what you could characterise, I suppose, as very, very small backyard, kitchen-chemist type stuff. Who knows what can be said about the stuff that is being imported from China, that sort of thing?

We have got this whole issue of exploding products. There is barely a week goes by when you don't see a new report for clinical presentation in an emergency situation, that sort of thing. The argument is always thrown back: 'Oh, yes, but other products with batteries explode as well'. Yes, they do. For example, with the Samsung 7, I think there were 28 cases of explosion before Samsung acted to have a worldwide recall of the Samsung 7, at a massive expense to the company. That wouldn't be possible at the moment with the free-for-all situation that we see with a lot of the stuff that has been sold in high streets. So it's a huge challenge about what to do about it.

CHAIR: Does anyone else have any comments on that issue?

Prof. Hall : I would like to comment. That seems to me a good argument for regulation that Simon has just made. We don't have any regulation at the moment. We pretend that we do. We ban these products and we leave the users and the consumers of them to the mercy of the marketplace for all the sorts of reasons that Simon Chapman just outlined. I think it make a good case for allowing a limited range of these approved products to be marketed and evaluated. We can't do any evaluation at the moment. It's very, very difficult to do research on these, because technically some of these individuals are treated as criminals for importing these products from overseas without prescriptions or approval.

CHAIR: Dr Skerritt is shaking his head vigorously.

Dr Skerritt : It is the 'B' word that I think is used a little bit too loosely.

Prof. Hall : I am talking, John, about people who are not

CHAIR: I'll come back to you, Professor Hall. I will go to Professor Skerritt.

Dr Skerritt : I think the word 'ban' is used a little bit too loosely here. In the same way we don't ban human beings in Australia from being truck drivers if they pass the test, there is a test for these products to be able to enter the market as therapeutic goods for smoking cessation. That's the pathway we have now. So these products are not banned in this country. I would urge caution in the use of that word.

CHAIR: I suppose the flipside is that, as of today, you cannot legally buy an e-cigarette in Australia.

Prof. Hall : Exactly.

CHAIR: Professor Hall, do you want to add something further?

Prof. Hall : It is exactly that point. It might not be a ban in that sense, in that there is, in theory, a legal route to the approval of these products, but, as you said, at the moment there is a de facto ban. They are prohibited for use by adults. All the justifications that we have heard are ones that are really designed to protect children, not adults.

Mr GEORGANAS: The producers or the people that want to sell this product would have the same opportunity as for other cessation products, to go through the TGA. The same opportunity is offered to them as well, isn't it?

Prof. Hall : If they have the sort of income. I don't think a $200,000 fee is a trivial amount. It might not be if you are a pharmaceutical company or a tobacco company. If you are a small start-upand some of these companies are not well fundedthey are not going to put their products up.

Prof. Chapman : On that point, there are many hugely worthy causes in health and medicine where people over millennia have said, 'I've got a product that you should take because I swear it will do you good.' If claims were being made like that, as they are occasionally still, about cancer cures, asthma cures or HIV-AIDS cures, people would be shown the door quick smart. You don't come along and say, 'This is too big a problem, too important a problem, for it to be tied up in red tape and regulation; we should just effectively let it through.' We say, 'No, bring your claims to the appropriate regulatory authority and see what they have to say about it.'

I am not sympathetic at all to the argument that a backyard or kitchen chemist can't afford to bring their product along to the TGA because of the prohibitive price entry barriers. I think it is a safeguard, and a good one, that companies who can afford to do that probably have quality control procedures, certification and that sort of stuff in place.

CHAIR: I suppose the question I was going to ask was whether you are marketing it as a cessation product or whether you are marketing it as part of a harm reduction mechanism.

Mr TIM WILSON: Or as a consumer good.

CHAIR: Or as a consumer good. My last question before I throw to others is about looking at what is happening globally. It is obviously an area where there are a number of developments. Without absolving you of your position in principle, is there a regulatory framework internationally which you think is best practice as far as it goes, that currently allows e-cigarettes to be legally sold within their jurisdiction?

Prof. Hall : Chair, can I intervene there? I need to leave the conference at 12.30, and I would like to express a view on that.

CHAIR: Please go ahead.

Prof. Hall : I don't know if there is a best practice model that is out there because these products are fairly new. I certainly wouldn't want to endorse the light regulation approach in the UK, that these products are available anywhere, and are widely used in public places and so on. I think the models that we should look to are countries like Canada and New Zealand, which have very similar smoking prevalence to Australia, very similar tobacco control policies, and until very recently followed the Australian policy, which was effectively to insist that these products only be available as smoking cessation devices.

They are now planning to allow a parallel track for consumer goods for a limited range of these, under fairly tight regulations. I am not exactly aware of the regulations, but I'd be surprised if they didn't include restrictions on the products that could be sold, on the range of outlets where they could be sold, which should be fairly limited, and consumer protection around childproof containers and so on. Insofar as there are health messages from authorities, it would be ones that discouraged long-term dual use, except as a route to cessation. That would restrict the public use in the same places as cigarettes are currently restricted, and also restrict the range of flavours that would be available.

That sort of policy would reduce some of the complaints we hear from smokers who want to access these products, and would enable us to do some research on their safety and risks, which we are not able to do very easily at the moment. The effective ban put on these products makes it very difficult to research, even on their value as cessation products.

Mr Grogan : From my organisation's point of view, I can half answer the questionyou will see what I mean when I half answer the question. In very broad terms, we certainly defer to the TGA as a very strong model by international standards. We say that in respect of other therapeutic goods, and sunscreen is a good example. We led in changing the way sunscreen was promoted and marketed, as a non-government organisation, when we led on the whole slip, slop

CHAIR: Slip, slop, slap.

Mr Grogan : Back in the 1970s. Some people may be aware that there were some very isolated issues with sunscreen use over the last summer, where there were some dermatological harms, and it was complicated by social media and other things. We were very direct in saying that we were holding up the TGA as an ideal mechanism, and that those sunscreens were approved for use by the TGA, because that is an area where claims could be made that are not substantiated. I say that because we would apply the same principles here as well.

I can't answer the second half of your question, which is: what's an ideal mechanism that will get these products through? That is the catch-22 for us; we would still defer to the TGAand, as I said in my opening remarks, it is one of the great pillars of Australia's health system which really contributes to that level of rigor that we are very happy to stand beside as a non-government organisation; it is very active in both these areas.

CHAIR: Mr Grogan, does the Cancer Council believe the science is settled on whether mobile phones can trigger cancer?

Mr Grogan : We are differing again, just on that, on the monograph that came out of the International Agency for Research on Cancer, which was three years ago. Certainly, the weight of evidence shows that there have been no significant cancer-related harms in adults, but we are still cautious around younger populations because of brain plasticity and other things. The evidence is pretty clear, using the criteria of the international agency on cancer research, that there haven't been any significant studies that have shown an association in adult populations.

CHAIR: My last question, before I throw to other committee members, is this: Dr Studdert, have you or the department had a look at what is happening in New Zealand?

Dr Studdert : We are aware of it and we will continue to monitor it.

CHAIR: Do you have any commentary about the adequacy of their regime?

Dr Studdert : No, not at this stage.

Mr TIM WILSON: For the record, I used the word 'fads', which was the latter incarnation of the use of the confectionery talked about. I also have no problem saying that it was earlier called 'fags'. That was the earlier incarnation, and it has other connotations, none of which anyone should be ashamed ofalso because I am a big fan of free speech.

Is there any international evidence that you are aware of around substitution? Obviously, at least one aspect of the objective regarding the availability of e-cigarettes to reduce harm is that because we have gone to a point of taxing another legal product so much that it is now outside some people's affordability, or certainly significantly eats into their disposable income, having a lower or higher tax environment for e-cigarettes might give a disproportionate effect. Would that actually encourage people to substitute?

Prof. Gartner : There is a study that was done. Frank Chaloupka, at the University of Illinois, looked at substitution effects; and, yes, e-cigarettes can be a substitute for tobacco cigarettes if they are available at a lower rate. Using a differential price model where the less harmful product was available at a lower cost could very well encourage particularly low-income smokers to switch to the lower harm product.

Mr TIM WILSON: Does anybody else have any opinion, depending on the differential tax arrangements that might apply between e-cigarettes and traditional tobacco products that would lead to substitution?

Prof. Hall : Yes. There was the Swedish experience with the product Snus, which is an oral form of tobacco; it had a differential tax on thata much lower rate of tax than on conventional cigarettes. There was widespread adoption of those amongst male smokers, at least, in Sweden, with a substantial reduction in tobacco-related harm. That's very well-documented, I think.

Mr ZAPPIA: Professor Skerritt, you said earlier that there were 60,000 different drugs that are available through prescription and allowed each year. Do you know how many doctors are currently prescribing, or how many scripts are being issued for e-cigarettes?

Dr Skerritt : I mentioned before that annually there are about 60,000 prescriptions approved or notified to us through the special access scheme. I would have to take on noticeand I am happy to do soparticularly about special access scheme B, where we can interrogate the data. I don't have figures. I have seen the figures on the top 10 or 20, and nicotine, or e-cigarettes containing nicotine, is not in the top 10 or 20. I would be surprised if the answer was zero, but I don't know the number.

Mr ZAPPIA: Based even on that, I am trying to get my head around whether it is something that is prevalent amongst the community or whether it is really more likely to be quite rare. I am happy to wait for the figures, but have you made any observations and do you want to comment?

Dr Skerritt : My only comment, Mr Zappia, is that if it was highly prevalent it would be in the top 10 or 20 prescriptions. I would suggest that most people, the overwhelming number of people who are accessing e-cigarettes containing nicotine in this country, are not doing so under doctor's prescription at the moment.

Mr ZAPPIA: Which leads me to the next question, and I don't know if anybody can answer it: if somebody came into the country from the USA or Europe, where they can purchase e-cigarettes, is there any restriction on them bringing them in and the quantities they bring in?

Dr Skerritt : If they have just been to Heathrow airport, as you can, there is an e-cigarette shop at Heathrow. If you had been to Heathrow and you had filled up your bag with nicotine-containing e-cigarettes, and you land in a country without an Australian doctor's prescription, you actually are running close to the law on whether that is appropriate, legal or not. I say 'close to the law' because it is about our colleagues in Border Protection, who clearly manage our borders and what people bring in. You can imagine the challenge that their operational level staff have if people bring in all sorts of things.

Mr ZAPPIA: Let's assume that you are detected.

Dr Skerritt : If I am detected it would be within their rights to take that product away from me, because I don't have an Australian's doctor's prescriptionif I didn't have an Australian doctor's prescription for that product.

Dr Studdert : For nicotine.

Dr Skerritt : If it was a nicotine-containing e-cigarette.

Dr Studdert : It is the nicotine.

Dr Skerritt : It is the nicotine in most cases.

Mr ZAPPIA: This is not your area, but I would be interested in any feedback: is it the case that currently e-cigarettes are being confiscated at the airport?

Dr Skerritt : I couldn't answer that. As I say, while we do administer some of the import regulations relating more to narcotic drugs and other things, there are such a wide range of weird and wonderful things that people turn up with at our major airports and, clearly, their enforcement activity is directed towards different things.

Every year, for example, we have a very successful program, working closely with Customs and Border Force, relating to people who are illegally importing prescription drugs. That is highly successful in terms of (a) raising awareness and (b) picking up some people who are doing this habitually without prescription. I can't comment on the number or frequency of seizures of e-cigarettes. I don't know if such statistics would exist.

Mr ZAPPIA: Lastlythis is for any of the panel membersif e-cigarettes were available on prescription, would any of you have any major concerns with that?

Mr Swanson : Assuming they were approved for therapeutic use by the TGA.

Mr Grogan : Not at all. I don't want to get caught up in trying to conduct a quick systematic review in a roundtable conversation, but you would think that to get to that stage there are still a lot of unanswered questions around who is the cohort who will be harm-minimised, what is the quantity, how you qualify and quantify those things. There are a lot of unanswered questions. If those checks and balances are in place, then that would give clear comfort that the benefits and the controls are there.

Prof. Chapman : Professor Hall's opening remarks this morning were that there is obviously a lot of common ground between some people who are loosely described as cautious or precautionary and others who are described as more liberal about this. I think that is true. My position, speaking as an N-of-one, is that it wouldn't worry me at all. What would concern me is the UK situation, where advertising is rampanttheir very light touch, minimal regulation of the products. It shows by their widespread use. The widespread use there is most prominent not just in the caricature of the very heavy smoker who desperately needs to get off cigarettes, but in younger people, particularly in the early twenties age group.

Mr ZAPPIA: I asked the question for two reasons. Again, I go back to Professor Skerritt's comments that sometimes we approve drugs or medicines that only assist five per cent of the population. This may be the case for e-cigarettes. Therefore, the trust is put into the hands of the doctor prescribing. My real question is: how confident are you that doctors would have the expertise to know when to prescribe and when not to prescribe, given that it is a relatively new area?

Mr Masri : The other factor to take into account is that it is prescribed in the context of a product for cessation. There would be other supports, presumably, as part of that to assist the individual to cease smokingcounselling support through quit lines and so on. It would be seen in a broad context as well.

Mr ZAPPIA: Is anyone aware of a country that currently only allows e-cigarettes on prescription?

Dr Skerritt : I know there are broad restrictions, similar to Australia, in Singapore, for example, and a number of other countries worldwide. I can't answer as to whether there have been prescriptions in Singapore for e-cigarettes. We would have to take that on notice.

Dr Freeman : John Hopkins has a registry online of all the e-cigarette regulations around the globe. It is comprehensive and up-to-date. I don't see any in there that have a prescription-only model.

Mr GEORGANAS: I have three questions; I will go through them individually. One is advertising. Currently tobacco has a complete ban on advertising. Earlier Mr Swanson gave us a copy of this form of advertisingI take it in the US?

Mr Swanson : Mostly, yes.

Mr GEORGANAS: Does this resemble or mirror advertising for another product very similar to tobacco? I would say, looking at this, it is not targeted at me, that's for sure.

Mr TIM WILSON: There is something there for everyone.

Mr GEORGANAS: Who would this be targeted at?

Mr Swanson : The ads that I used in those examples have different targets in mind. The obvious one is adolescent boys. With the one from Sports Illustrated it is clear who their target is.

CHAIR: Which one is the Sports Illustrated one?

Mr Swanson : The one in the top right-hand corner. The one in the bottom right-hand corner is probably not so much young men. The point I made earlier is that the appeals we have seen used by e-cigarette manufacturers are almost identical to those that were used in the bad old days, when tobacco advertising was not regulated.

Mr GEORGANAS: So this would not be an advertisement for someone quitting?

Mr Swanson : The ones on the left-hand side are all about the 7,500 flavourings that are available in the US. To me that is product diversification. It has nothing to do with cessation. Equally, I don't think the ones on the right-hand side have anything to do with that. Perhaps the one in the middle, 'Spring forward into better habit', is a harm-minimisation sell. It is unclear who the one at the bottom is aimed at

Mr TIM WILSON: The back-to-school one?

Mr Swanson : Again, it is a sex appeal variety of flavours and brands and lifestyle.

CHAIR: There is even one for train spotters.

Mr GEORGANAS: So would it be looking at a brand-new market to sell a product?

Mr Swanson : Obviously, here.

Mr GEORGANAS: Are we seeing any evidence of this in our social media here in Australia?

Dr Freeman : I am happy to talk about that. Building on what Maurice was talking about, you can immediately go online and literally pull up dozens of images from Instagram, Facebook, Snapchat, WhatsappI could just keep listing social media platforms. It is very easy to see images, not only of the brands that are available to smoke, but the act of using them and how to use them, and the generation of large clouds of vapingall these sorts of things. They meet up; it is a very social activity. The marketers of these products bank on that. They bank on closely built social networks so that they can easily spread information on behalf of the companies about the productswhat sales they have on, what coupons are available, what new flavours are on the market, that sort of thing.

As for the imagery you can see, if you were to do a quick search yourself, and even if you were to restrict that to Australian-based retailers, you would see things like cartoon images to illustrate flavours. You would see black-and-white images reminiscent of old Hollywood. You would also see the ability to make your own recipe, DIY equipment, things like that. You could build a strawberry chocolate sundae, if that's what you wanted, out of an e-cigarette. The proposed Canadian regulation, which I think Wayne brought up, currently under review, is concerned about flavours. In addition to regulating the product itself, they are going to regulate what sorts of flavours are permissible.

Mr GEORGANAS: How does advertising in Australia for products that are on the market for the cessation for tobacco differentiate from the things we have in front of us?

Dr Skerritt : TGA is the regulator of therapeutic goods advertising, so it comes down to us. Those products can be advertised. You will have seen ads for smoking cessation products on bus shelters and so forth. There is a strict advertising framework, for example, that controls it. It would be hard to get bikini models or Thomas the Tank Engine involved in a smoking cessation ad. As the regulatorand it is a detailed framework through a thing known as a code, which is a legislative instrumentwe can get companies to take down their advertising. One of the recommendations from our recent review of medicines regulationespecially with the forms of new media, including social media, which is so hard to regulateis that we have the powers to make sure that advertising of any medicines is appropriate. But there is a well-established regulatory framework for advertising smoking cessation products as rigorous as the one there for all over-the-counter medicines. If anything, it is becoming more rigorous.

Dr Freeman : A few years ago, for example, a nicotine replacement product ad was on television and on billboards featured a woman riding a motorcycle. It was very glamorous, very 'rock-n-roll', you could say. It was subject to a complaint to the Advertising Standards Bureau, which ruled that yes, the ad stepped outside the lines of what is acceptable for a therapeutical good to use for advertising. So there are checks and balances in place for that sort of thing. But it is a complaint-based system. Ads are not pre-approved before they go up. They can be shown everywhere. A whole campaign could run and, unless someone complained about it, nothing would be done.

Dr Skerritt : I would just put a correction in. Currently advertisements in certain forms of media do require pre-approvals. As a regulator, we can take action against advertisingwe don't have to sit back and wait for our phone to ring or our email or letter to arrivethat obviously oversteps the margins. We see this, for example, with the promotion of some complementary medicines, where the claims, or at least the hint, that they have the ability to cure serious diseases and so forth go beyond the claims they are allowed to make. There are many partners, including those involved in self-regulation. The Advertising Standards Bureau becomes involved in self-regulation of the advertising industry. Just for the record, while it depends on complaints, it is not based only on complaints. We are able to take action against advertisers that overstep the line.

Mr GEORGANAS: Mr Fleming, in your opening statement you spoke about some misrepresentation of products. When they were investigated there were more, or fewer, products than was being claimed. Do you want to tell us about that?

Mr Fleming : Yes. Last year we conducted a survey of online e-cigarette retailers. We purchased a number of products. We looked at the representations on the packets and on websites. The claims that were made that concerned us fell into the three main categories. One was the absolute claim: 'does not contain X', when our testing showed it did. Another was the comparative claim: 'does not contain harmful chemicals', when it did. Another comparative representation was: 'does not contain the same chemicals as found in regular cigarettes', when it did. They were on the margins, because they were easy to find. We developed testing with the NMI to test the vapour for these products. So when someone makes a claim that a product doesn't contain the chemicals, we conduct a test. We demonstrate that it does. We take it to court. That's a simple case. There is less clarity around some of the more interpretive aspects where a consumer might take away a different impression from the advertising than someone else. Our focus is on those absolute claims.

Mr GEORGANAS: In this case was any action taken?

Mr Fleming : Yes. We took three small suppliers to court, and the Federal Court found that all three of them breached the Competition and Consumer Act, and ordered penalties and a range of other remedies against not only the businesses involved in selling the products, but also the directors, or those running the companies.

Mr GEORGANAS: Thank you.

Mr TIM WILSON: It is obvious, based on all the evidence we have had so far, that we basically have two products: we have the delivery mechanism and then we have the product for consumption. Please correct me if I am wrong, but there is currently no restriction on the delivery mechanism in terms of advertising but, since it is not an approved good, there would not be the availability of the capsule to come about. Is there any evidence overseas where the delivery mechanism is provided to people 'free'I am using the bunny ears, parentheses, around thisto encourage people to consume the nicotine product, considering some countries have seen that with cigarettes?

A few years ago, I was at the Paleo Rock Festival in Switzerland and someone gave me a pack of cigarettesthey were doling them out, which was a bit weird. Have you seen that anywhere in the world? In addition, we know that with some pharmaceuticals where it is unlawful or illegal to advertise, it doesn't stop people talking about problems and then going to see their doctor as a way of getting prescription-based products in response. That comes down to their relationship with their doctor and what the doctor chooses to prescribe but, funnily enough, it often closely relates to the advertiser's product. Could you envisage a scenario where that might occur as part of dealing with some issues around harm?

Dr Skerritt : I'll start since you mentioned advertising of medicines, but I'm sure others will have a view. I will defer to my colleagues. Again, in discussions with my British counterparts, I understandI can't quote the study, but maybe others here canthat for the ones that use a tank and it gets refills and so forth, there have been examples where the device has been given away for free.

Mr TIM WILSON: Freely distributed?

Dr Skerritt : Free distribution of the device and then the product. I'm sure my public health colleagues will be able to back that up with more specificity than what I have been told verbally by colleagues.

On the subject of awareness of a disease as a pathway to selling a particular product, that is an issue that is closely looked at but certainly is not banned. It is closely looked at through a code of conduct from, for example, Medicines Australia, the peak body for new prescription drugs. It is also something that we can look at if it becomes an overt advertisement for a prescription medicine, because advertising of prescription medicines in this country, as it is in most OECD countries, with the exception of the US and New Zealand, is not permitted.

But it is not a view among most regulators and public health professionals that it is all bad. For example, we know that, especially in areas such as men's health, there is either a denial or a reluctance to be aware of particular symptoms. So where appropriately managed and not all around, 'You must therefore have my product', raising awareness of certain health issues and encouraging people to see their doctorfor example, if they are breathless always going up the steps and, therefore, there may be cardiac issues that often don't manifest until someone has a stroke or a heart attackis not all bad, but there are frameworks that make sure that it doesn't go beyond the pale.

Mr TIM WILSON: Just to clarify that: it would not be an unreasonable conclusion from that point that there could be an environment where advertising occurred to encourage people to look at alternative options, which may be interpreted as having some sort of positive effect?

Dr Skerritt : That is speculation, but if I go back to

Mr TIM WILSON: I am just reflecting on your comments. I am not trying to

Dr Skerritt : I am not going to try to speculate about e-cigarettes, but

Mr TIM WILSON: No, I am talking about the existing

Dr Skerritt : With prescription medicines there have been some cases where clearly it has been all about selling product X, but there have been other cases where, from a public health point of view, it actually has raised awareness of conditions and encouraged people to go to a doctor if they've had early signs of a problem. So there have been positives.

Mr TIM WILSON: Does anybody else have any comment?

Dr Freeman : Did you want me to address the giveaway question?

Mr TIM WILSON: Please.

Dr Freeman : Sorry, I lost track of whether we had got a clear answer to that.

Mr TIM WILSON: We got a verbal anecdotal answer, it would be fair to say, but not an evidence based one. I am not being disrespectful.

Dr Freeman : This is actually happening in Australia. It is not just something that happens in the US and the UK. There is an ad, for example, in Take 5 magazine where you could win $200 worth of disposable e-cigarettes, and there were 25 of these to be won.

CHAIR: I think that almost concludes our questioning, which means that we might get an early mark today. I just wondered, because you haven't had as many questions, Dr Arunogiri, whether you had any closing remarks. I might give that to you.

Dr Arunogiri : Just in closing, I think our college was unique, I suppose, in terms of some media reports about us breaking away from the other colleges in our statement. We would like to reiterate that we advocate for the rights of our patients and the needs of our patients, being people with mental illness, as well as people with addictionso tobacco addiction and other addictive disorders where we know that cigarette smoking is overly represented. In saying that, we do not advocate for breaking away from the regulatory framework or the cautious approach that I think the other colleges have also supported. I would just like to reiterate that.

CHAIR: Would it be fair summation that your college would argue that there is a case for greater availability in Australia in a regulated way? Is that a fair summation?

Dr Arunogiri : Absolutely. I would agree that there is a role for harm reduction within the tobacco control discussion.

CHAIR: In terms of the regulatory environment, would the availability of e-cigarettes through prescription onshore, as distinct from having to import with a prescription, provide accessibility for the type of people that you have talked about in terms of the cohort that have higher addictions, or is the concept of going to a doctor for a script to get an e-cigarette a barrier that a lot wouldn't go through?

Dr Arunogiri : I think there are two concerns. One is around cost, and perhaps having something go through the process to become a prescription medication. The question is around cost and accessibility for a group that may not be able to afford that medication, even if it is on prescription. That is one concern.

I think the other concern is the one you raised around barriersbarriers to access and barriers to being able to get a prescription. There is also, I think, a broader sociocultural question around how smokers see their smoking, and people who currently smoke cigarettes, who may not necessarily see it as an illness for which they need to go and get medication. So there may be another population that may not actually engage in that process.

CHAIR: Unless anyone has got any burning closing remarks they want to make? I think Dr Skerritt does.

Dr Skerritt : Very briefly. Again, it is not the Therapeutic Goods Administration; it is the Pharmaceutical Benefits Advisory Committee making a recommendation to the minister of the day. One of the potential advantages of a prescription route, should a product receive approval by TGA and be deemed as cost-effective, for example, in certain groups of people by the Pharmaceutical Benefits Advisory Committee, is that many people with mental illness are on pensions and other things and, therefore, they would be eligible for these products at a concessional rate, which currently I think is still just under $7 per prescription$6.90. So if it were a prescription medicine and so assessed by PBAC, these people could be getting maybe a month's supply of these products, depending on the decision by the minister and a recommendation of PBAC, for $6.90.

Mr ZAPPIA: Professor, are you suggesting that is a good thing or a bad thing?

Dr Skerritt : I am suggesting that it is a good thing in that cost would not be a barrier. You compare the cost of $6.90 with the cost of a month's smoking for a heavy smoker. It is a bit more than $6.90.

Mr ZAPPIA: The reason I asked the question was: do you see it as an avenue that may be exploited and then the product?

Dr Skerritt : No. Look, I'm an official; I don't have an opinion. I'm just wanting to state factually

CHAIR: That has been very evident this morning, Professor Skerritt.

Dr Skerritt : Regarding prescription medicines that, once a medicine is approved by the Therapeutic Goods Administration, it is available, potentiallyand that's a recommendation by PBAC and a decision by a ministerfor the concession rate of under $7 a prescription. The whole idea, whether it is an antibiotic or an antipsychoticand some of these antipsychotics go for $500 per month if they aren't subsidised by governmentis affordable medicines for people who need them.

CHAIR: I conclude by going back to my first question and it is to either Professor Skerritt or Dr Studdert. If the government of the day decided that it wanted to permit the legal sale of e-cigarettes as part of a harm minimisation strategy, as distinct from a cessation product, with a regulated environment, say, akin to what is happening in New Zealand, how would the government do that?

Dr Studdert : There are a number of facets to that.

CHAIR: How would the minister do itI should say?

Dr Skerritt : The government.

Dr Studdert : There would have to be advice to the minister about the scheduling issue in relation to the nicotine. There would be considerations around accesswho would access it and how, and whether it is through a prescription pathway. Our system, as Professor Skerritt will say, in terms of prescription medicines is very much driven by the market. We don't initiate applications

CHAIR: So it is non-prescription.

Dr Studdert : Again, there has to be a product that a sponsor, as we call themit is actually very difficult to

CHAIR: What is the degree of discretion a minister for health has?

Dr Studdert : It is very limited, actually, under our current regulatory framework. That is, to some extent, there for a reason.

CHAIR: So, for example, using an analogythe decision which some of us are perplexed bytaking codeine out of cold and flu tablets is not something where there is ministerial discretion?

Dr Studdert : There is no discretion for the minister on that one, no.

Mr Masri : The other factor to take into account is that it is not all in the Commonwealth's domain. When you are looking at regulation of e-cigarettes with or without nicotine, you have to have regard, I guess, to the state and territory jurisdictions and responsibilities around advertising, smoke-free areas, the context in which age limits might apply and so on. We definitely have to engage quite extensively with our states and territories.

CHAIR: The Commonwealth, presumably, would have a head of power, if it were so minded to do something radical, through the Corporations power or something like that to regulate?

Dr Skerritt : I am not sure.

CHAIR: That's probably a question beyond any of our competence, not being constitutional lawyers.

As there are no further questions, can I thank everyone for their participation today. It has been very instructive and very useful. I particularly thank those who are on the telephone for their patience and forbearance this morning. Thank you for your participation.

If you have any additional information or took some questions on notice, and I think Professor Skerritt didand the committee secretary, I am sure, will remind you, if you didif that additional information could be provided to the committee secretary by Thursday, 21 September? The Heart Foundation tabled a document and I would suggest someone might like to move that it be regarded as an exhibit.

Mr GEORGANAS: I so move.

CHAIR: Moved by Mr Georganas and adopted. Thank you again for your participation. I declare this hearing closed.

Committee adjourned at 12 : 26