Dissenting Report - Mr Trent Zimmerman MP and Mr Tim Wilson MP

The Standing Committee on Health, Aged Care and Sport has undertaken a year-long inquiry into E-cigarettes. The level of interest in this issue from health experts and the broader Australian community is reflected in the large number of submissions and letters received by the Committee with 352 submissions lodged and over 1700 standard letters received from individual Australians.
The issue of whether there should be a change in the current regulation and effective prohibition of E-cigarettes containing nicotine is one that has provoked claim and counter claim. The Committee has received submissions and heard evidence from some of Australia’s leading health experts (and many from overseas) on both sides of the debate. Invariably, the contentions made by those participating in the inquiry have been supported by conflicting medical and statistical evidence.
In some respects, this reflects the fact that E-cigarettes have only been readily available in relatively recent times. During that period the technology involved in E-cigarettes has changed significantly and the range of products is considerable (represented by both the E-cigarette device and the liquids used in them).
Attitudes towards E-cigarettes are also influenced by, at times, competing approaches to the management of nicotine addiction and smoking. Some submissions placed greater emphasis on a precautionary approach and tended to oppose change to the current regulatory settings. Others came to the inquiry arguing for a harm minimisation approach leading to the conclusion that Ecigarettes containing nicotine should be available in Australia to assist people who have unsuccessfully tried other ways to quit smoking.
The Committee also heard evidence that Australia’s approach was significantly different to that adopted in other nations with similar cultures and health care systems. Specifically, the United Kingdom (UK), the European Union (EU), the United States of America (US) and New Zealand were frequently cited as jurisdictions in which (while not universal) there was far greater acknowledgement (from regulators and health experts) that E-cigarettes could play a legitimate and valuable role in reducing the negative consequences of smoking. E-cigarettes used with nicotine are legal in the UK, the EU and the US. New Zealand health authorities are advocating a similar approach and, at the time of writing, awaiting a decision from the new national government (the previous government had announced its intention to ‘legalise’ E-cigarettes with nicotine). While Australia should not automatically follow the lead of other nations, the difference in approaches of other health systems we respect, is striking.
Australia’s approach to E-cigarettes is complex and marked by contradictions:
The use of tobacco-based products for smoking is legal, yet a less harmful nicotine product is effectively prohibited;
While E-cigarettes containing nicotine cannot be legally bought in Australia, consumers are legally permitted to import nicotine for Ecigarettes through the Therapeutic Goods Administration’s (TGA) Personal Importation Scheme if they have a valid prescription from a general practitioner; and
E-cigarettes which do not contain nicotine can be legally bought and sold in most Australian states and territories, despite much of the concern about the health impact of E-cigarettes presented to this inquiry emanating from the non-nicotine elements of E-cigarette liquids (for example, colour and flavouring).
In the face of often contradictory evidence, this has been a difficult inquiry for the Committee. Having considered the evidence presented to the Committee, however, we have formed a very different view to that reflected in the majority report.

Considerations

In considering the issues presented to the Committee, we believe there are two fundamental questions relevant to the future regulation of E-cigarettes:
Are E-cigarettes less harmful than smoking and could their use by smokers reduce the health impacts of tobacco and help people quit smoking?
Would the legal availability of E-cigarettes containing nicotine act as a ‘gateway’ to smoking and increase the number of smokers, particularly in younger age groups?
The Committee heard considerable evidence about the health impacts of Ecigarettes, with many witnesses arguing that the long-term impacts of Ecigarettes are unknown. Disputed claims which emerged from the UK were that E-cigarettes are 95 per cent less harmful than smoking cigarettes, and pointed to the possible health impacts of additives used to colour and flavour E-cigarette liquids.
The Committee heard evidence that was, at times, contradictory. In particular, some witnesses argued that E-cigarettes were too harmful to be legally available, while concurrently arguing that there was insufficient research into their long-term health impacts.
We accept E-cigarettes have not been the subject of the several-decade longitudinal studies which are often required to determine the health impacts of products such as these. As many witnesses reminded the Committee, it took many years for the full consequences of smoking to become known and agreed.
This is made more challenging by the evolving nature of E-cigarette technology which makes having a single point of reference for assessing the impact of Ecigarettes challenging.
We have, however, formed the view that there is enough evidence to determine that it is highly improbable E-cigarettes will have the health consequences of smoking tobacco cigarettes, which will kill the majority of their long-term users. This is supported by the well-known carcinogenic consequences of burning tobacco, which does not occur in E-cigarettes.
It is worth noting that, to the best of our recollection, no witnesses argued Ecigarettes would have a greater health impact than smoking. The key question is whether E-cigarettes are less harmful to a significant degree. From the evidence presented four conclusions can be drawn:
The health impacts of E-cigarettes cannot be quantified with precision, however, based on the pharmacology of E-cigarette products and studies conducted to date, their health impacts are likely to be substantially less than those generated by smoking tobacco products. The January 2018 National Academy of Sciences (US) review found that there was conclusive evidence that the complete substitution of tobacco products with E-cigarettes reduced users’ exposure to toxicants and carcinogens.
While nicotine is highly addictive and there is some conjecture about its long-term health impacts, it is not of itself the principal health risk from either smoking or using E-cigarettes. In E-cigarettes the primary concern relates to the impact of additives, including colouring and flavouring.
The dual use of tobacco cigarettes and E-cigarettes is unlikely to deliver better health outcomes.
For nicotine addicts, however, who make the complete switch from smoking to E-cigarettes, it is likely that significant health benefits will be realised.
We accept that E-cigarettes are a valid mechanism for harm reduction for those addicted to nicotine. Harm minimisation is a well-established concept in Australia and other examples in the health sphere include the use of methadone for heroin addicts, needle and syringe exchange programs, and the safe sex messaging used to prevent the transmission of Human Immunodeficiency Virus (HIV) and other sexually transmitted infections.
The Royal College of Physicians of London highlighted, in their submission to the Committee, the role of another form of tobacco in reducing harm in Sweden. Snus, an oral form of tobacco, is widely accepted in Sweden and has resulted in that nation having the lowest smoking rates in Europe (7 per cent of the adult population).
In summary, E-cigarettes are not a safe product but they will cause considerably less harm than smoking. Their use by smokers who have tried and failed other ways of quitting could save their lives.
There are legitimate concerns about the health impacts of colour and flavouring used in E-cigarette liquids. In circumstances where E-cigarettes are widely available (legally in most states if they do not contain nicotine), the ‘legalisation’ of E-cigarettes with a notification system and disclosures in relation to content could assist regulators in improving the safety of E-cigarette products.
The Committee also heard differing opinions about whether E-cigarettes had therapeutic application as a means of allowing smokers to quit.
Goods that promote therapeutic outcomes are required to gain the approval of the TGA before they can be sold in Australia.
The TGA was unable to advise whether it had or had not received any applications for E-cigarette products to be made available for this purpose due to commercial-in-confidence provisions. A number of submittors, however, indicated the cost of bringing a product to market through TGA processes was a very expensive one in circumstances where E-cigarette products are changing as technology evolves.
While we support the TGA’s ongoing role in determining whether a product can be sold based on its therapeutic attributes, we note that:
A large number of individual Australians provided the Committee with details of their own experience in successfully using E-cigarettes as a means of quitting smoking. While the Committee submission process is not a scientific study, it would be wrong to simply dismiss the testimony of many people who have successfully used E-cigarettes in this way.
Evidence presented from the UK points to the possible benefits of Ecigarettes as a means of quitting. Approximately 1.5 million Ecigarette users in the UK are former smokers. Submittors pointed to other jurisdictions where similar results had been recorded.
Quitting smoking is hard. Many smokers will try multiple times to quit smoking and fail using existing nicotine replacement therapies, medication or other mechanisms. E-cigarettes provide an additional option for smokers.
Countries that have made E-cigarettes available have seen a decrease in smoking rates even without many of the complimentary regulations on combustible tobacco that exist in Australia, while consumption of tobacco in Australia has stabilised.
In summary, our view is that E-cigarettes have assisted many people to quit smoking and may have benefits at a population level as a cessation device. We accept, however, that the TGA should continue its role to assess individual products sold for therapeutic purposes.
A frequent concern about E-cigarettes was the possibility that their availability may serve as a ‘gateway’ into smoking, particularly for young people. Specifically, the Committee was presented with arguments that E-cigarettes could renormalise smoking and could lead to new nicotine addictions and a pathway to tobacco cigarettes.
Again, the Committee heard conflicting evidence from experts in the field.
Our view is that, while this risk needs further investigation and careful monitoring, international examples indicate that smoking rates among younger cohorts continue to fall in many countries where E-cigarettes are widely available.
For example, Cancer Research UK stated that despite the availability of E-cigarettes in the UK there has been ‘no increase in youth smoking of tobacco, which is another important measure in terms of establishing the gateway effect.’
Restrictions on the sale and marketing of E-cigarettes to younger people can help to alleviate this risk.
The risk of a ‘gateway’ effect needs to be weighed against the benefits of people quitting smoking via E-cigarettes. As one UK witness succinctly put it: ‘the gateway in is much, much smaller than the motorway out [of smoking].’

Conclusions

We have considered the possibility of the long-term, negative health impacts of Ecigarettes that could emerge over the coming years or decades. We have also had regard to, on balance, the weight of evidence indicating that using E-cigarettes is less harmful, potentially significantly so, than smoking tobacco cigarettes. As such, while E-cigarettes could be harmful, they are a better option than smoking and their use could save many thousands of lives.
We are also concerned that there is limited regulation of nicotine Ecigarettes, which are already available in Australia via online overseas retailers and the ‘black market’. Nicotine E-cigarettes are widely available, used, but unregulated. A regulated market would help improve product safety and provide more effective controls over E-cigarette marketing and promotion, particularly to young people.
We have therefore formed the conclusion that nicotine Ecigarettes should be available as a consumer good to Australians, subject to regulations which will limit their appeal to non-smokers and young people.
We recommend that:
Nicotine in E-cigarettes be made exempt from Schedule 7 of the Poisons Standard.
Legislation be passed to permit the sale, purchase and possession of Ecigarettes with restrictions based on those in place in the EU which include prohibitions on the sale of E-cigarettes to people under 18 years of age, restrictions on advertising and marketing, child proof and tamper proof packaging, a limit on the concentration of nicotine, safety features to reduce the harm of battery explosions, labelling which provides for the listing of ingredients contained in E-cigarette liquids and health warnings about the potential health consequences of using Ecigarettes.
The Australian government establish a notification system for Ecigarette products entering the market and a regulatory process for assessing and, if necessary, restricting colouring and flavouring used in E-cigarettes.
Mr Trent Zimmerman MPMr Tim Wilson MP
ChairCommittee Member

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