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The Therapeutic Goods Administration’s false promise for struggling smokers

By Marija Polic - posted Tuesday, 17 October 2017

Currently in Australia, 240, 000 people use nicotine vapourisers – and don’t know they’re breaking the law. It is illegal to use or possess nicotine substances for personal vapourisers or e-cigarettes. The illegality is uniform across all states and territories, with varying punishments. In WA the maximum penalty is $45,000, or imprisonment, or both. Unless you obtain a special prescription.

This in and of itself is a terrible policy, for many reasons. Namely, because e-cigarettes are scientifically proven to be around 95% safer than conventional cigarettes, stated in ‘E-cigarettes: an evidence update’ by Public Health England (PHE). In addition, e-cigarettes are a fantastic option long-term for public health policy and the taxpayer: In the US a survey of 161 054 people over 15 years clearly demonstrated a positive correlation between the cessation of smoking (defined as a period of three months of more), or attempts to quit smoking compared with those using other methods, and the use of e-cigarettes.

The science is clear: nicotine itself isn’t harmful. It is the toxic chemicals, tars and gases you inhale from the tobacco that are harmful and carcinogenic.


Clearly, going by both scientific and policy-based evidence, our government and smokers attempting to improve their health would benefit immensely from taking nicotine off the schedule – allowing it to be legal and accessible for all adult Australians. This would then mean that a prescription will no longer be required for the use and purchase of this life-saving technology which consists only of pure nicotine without the toxic chemicals.

However, the policies being introduced and discussed by some are anything but sensible. One of the central elements of the debate over how e-cigarettes would be made more accessible includes the suggestion of a federal regulatory network. This is also known to be a proposed licensing system that would be operated by the Therapeutic Goods Administration (TGA), and it is a poor policy proposal for several reasons. Any form of licensing or regulation on nicotine substances in Australia is an unwise move considering the significant cost burden it would place on Medicare.

The second reason such a regulatory framework is a poor policy proposal is that the regulations and hurdles facing those using nicotine – appointments, the need to run to a 7/11 or a pharmacy (which have limited operating hours) – would deter smokers from seeking treatment and using e-cigarettes. Nicotine is already available in Australia either by prescription or through a compound pharmacy. The provider in Australia responsible for administering this is Nicopharm. Yet the lack of accessibility with this model means it is simply ineffective as a way for smoking adults attempting to improve their health. The costs of approval from a framework that would seek to extend the arm of the TGA over a different model would be similarly off-putting for those trying to quit.

A related point is that because more of a regulatory framework would be introduced to extend this proposal, the bureaucratic cost would be substantial. Costs would have to consider approving scripts, authority for scripts, potentially setting up new boards and commissions for these approvals and more staff to oversee the implementation of these provisions. It is simply not something that is fit for Medicare. The individual cost will also be high: through the cost to visit the doctor and get a prescription charged to Medicare through bulk billing – but also the cost to the individual if the doctor doesn’t bulk bill.

Thirdly, it is wasteful to impose a regulatory framework on a technology that has proven to be so effective when consumers overwhelmingly support e-cigarettes as an avenue to quit smoking. These provisions would assume that a ‘one-size-fits-all’ model for smokers would work in allowing e-cigarettes to be more regulated in taking them off the schedule. “Vaping” allows different flavours and strengths to be used by different smokers with very different needs. You would think that given the variety of stop smoking aids (patches, gum, inhalers) and the different strengths in which they are available. The diversity of choice makes vapourisers successful, and the government and TGA would recognise the importance of tailoring health products to suit the patient’s need.

Something that fundamentally works on a scientific and policy level should not be subjected to a leviathan of standards that are set so high any company attempting to market e-cigarettes is essentially set up to fail. The Australian government, including all states and territories, as well as opposition and minor parties, should seriously consider reforming the accessibility of nicotine. Without imposing stifling red tape on consumers and patients who simply wish to improve their health by quitting smoking.


Finally, it is worth pointing out that we already have therapeutic products in Australia - including gum, lozenges, sprays and patches. The trouble is, they have clearly failed.

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About the Author

Marija Polic is a research associate with the Australian Taxpayers’ Alliance and a dispensary technician with 4 years of experience as a pharmacy assistant.

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