From July 1, 2020 it will be illegal for anyone to import nicotine liquid or salts into Australia unless they have a doctor’s prescription for the personal use of these substances. The announcement by Australia’s drug regulator, the Therapeutics Goods Administration (TGA) is causing apoplexy in the social media pages of Australia’s minnow vaping advocacy groups, ATHRA and Legalise Vaping Australia. They see it as nothing less than a de facto ban on nicotine vaping and are reaching deep into their lexicons of hysteria to condemn the announcement and their nemesis, health minister Greg Hunt.
The TGA’s website describes in detail what will be involved. Basically, someone wanting to use nicotine juice or salts in vaping equipment needs to contact their doctor and see if the doctor will agree to write a prescription authorising them to use vaporisable nicotine. The website states “it will need to be obtained on your behalf by a medical supplier or from a pharmacist who dispenses it for your use as the named patient. The company or the pharmacist will need to be given a copy of your prescription.”
The website provides this information to doctors:
Commercial companies wanting to import into, or manufacture nicotine juice or salts in Australia
“can apply online to the Office of Drug Control (ODC) for an import permit; the ODC will have a dedicated webpage including step-by-step instructions on making an application for a permit including attesting that your business complies with the conditions specified in the Therapeutic Goods Regulations for lawful importation of an unregistered medicine.
You can then sell to doctors (or pharmacists on their behalf) the e-cigarettes containing vaporiser nicotine on evidence of a TGA Special Access Scheme B approval or Authorised Prescriber Authority for supply to a named patient (along with the supporting prescription).”
This means that bona fide companies able to demonstrate that they meet the TGA’s standards of pharmaceutical quality assurance will be apply to apply to import or manufacture vapable nicotine, but it will only be available from pharmacists or possibly directly from an accredited medical supply company. Kitchen sink and bathtub mixing amateur “laboratories” need not apply.
So in a nutshell, anyone wanting to vape nicotine legally in Australia will do what millions of us do every day, and have done for decades: obtain what is in effect a license to use a particular drug (here nicotine). It’s called a prescription. It will authorise you to obtain from a licensed drug supplier (a pharmacist or a medical supply company) a supply of a particular drug (not carte blanche access to any or all vapable nicotine from any source).
I have used the same prescribed drug every day for about 15 years. I obtain 3 months supply and when that is finished, contact my GP who re-issues the script which I collect and get dispensed at a pharmacy 50 metres away. My GP monitors my health condition and occasionally changes the prescription by adjusting the dose up or down.
We all understand how this works and why it is a totally sensible approach to allowing access to drugs capable of being abused or causing harm when used incorrectly. But vaping advocates are on a mission that they believe places their cause above all other therapeutic regulation. They think they deserve to stand outside our drug regulatory system.
Nicotine, other than that in tobacco products, has long been subject to controls by the TGA. It scheduled all the various forms of nicotine replacement therapy as prescription-only when they first came on the market. As the years progressed and monitoring for adverse reactions showed NRT to have negligible problems, its scheduling was relaxed and some NRT forms are now available without prescription in pharmacies and supermarkets.
Vaping advocacy groups have always opposed TGA oversight of nicotine in e-cigarettes, fearing it would see regulatory controls on availability, advertising, flavouring, packaging and dosage. While endlessly publicly arguing that e-cigarettes are useful in quitting smoking, they also furiously backpedal and deny that this is a therapeutic claim, which it of course is, undeniably.
Instead, they want e-cigarettes regulated as a “consumer good”, whatever that might mean, to allow it to be sold almost anywhere as occurs now with tobacco. This is in fact a recipe for Claytons’ regulation (the regulation you have when you are not having regulation). When pressed to describe the regulation they agree with, they only talk about child-proof nicotine juice containers and claims about “sensible” advertising restrictions (you know, those same ones we used to have when tobacco advertising was allowed pre-1992 when magic barriers allowed only adult smokers to see the ads but rendered them invisible to children).
Occasionally, they have the temerity to toss in talk about responsible retailing by vape shops, when just as always occurred with the law saying that tobacconists could not sell to children, it is child’s play for kids to buy e-cigarettes.
A favourite meme that gets a regular workout from vaping advocates is the one that goes: cigarettes are deadly and are sold in every supermarket, corner store and petrol station, while benign old nicotine is to be “banned”.
Aside from the huge body of evidence that nicotine is anything but benign, this argument relies on very specious arguments. As I wrote in an earlier blog
“The argument here runs (1) it is self-evident that cigarettes are far more dangerous than e-cigarettes (2) cigarettes have always been sold and are not banned from sale (3) therefore, consistency and coherency demand that e-cigarettes should also be allowed to be sold in the same way because of the precedent established with cigarettes.
This syllogism takes no account of the reasons why cigarettes are sold in the way they are today, and not in the way restricted substances like prescribed drugs are sold to consumers. Sales of cheap machine-made cigarettes burgeoned from the early twentieth century when there was no case against smoking, beyond that made by temperance groups. Tobacco control commenced more than 60 years later with the first tepid health warnings appearing in the USA in 1966. Across those years, tobacco consolidated its special exceptionalist regulatory status as being entirely exempt from ingredient controls. Even today, fully comprehensive tobacco control has been enacted in only a minority of nations …
Vaping advocates know that no nation will ban cigarettes any day soon. They know the legacy of cigarettes’ historical circumstances saw them (unlike pharmaceuticals, foods, beverages, cosmetics, agricultural, industrial and household chemicals) totally exempted from regulation. They know this historical legacy has tied two hands behind the backs of any thought that backwards time-travel could somehow magically allow this situation to be undone.
Importantly, they know that when proposing gold standard regulations for any product carrying serious risks, that the very last model any regulatory authority would reach for is that which applies to tobacco regulation. Yet knowing all that, they are happy to set their ethical bar to this lowest imaginable level and accuse supporters of tough regulation as being “incoherent”. We allow cigarettes to be sold everywhere, so therefore we should allow a putative less dangerous cigarette substitute to be subject to the same non-standards of regulation, they argue.
This reasoning is completely arse-up.
Instead, we should commence our comparison by saying “We made every conceivable error in the way we allowed cigarettes to be allowed into commerce, in the way we allowed them to be advertised, packaged and sold as if they were confectionary. We know that we were deceived by the tobacco industry with the harm reduction promises of filters and light/mild cigarettes. We now face a new opportunity to get regulation right with new products carrying unknown risks of daily, long-term use. Let’s learn from the disastrous history of tobacco regulation and not make the same mistakes again.”
ATHRA’s Colin Mendelsohn argues that the prescribing process involved is “so complex and time-consuming that no doctors will do it”.
Yet every day, every doctor writes out referrals to specialists, orders pathology, writes case notes, and occasionally applies for special access to restricted drugs for patients. For example, methadone, a prescribable opiate is a Schedule 8 drug. It is regularly used by more than 50,000 people in Australia, all of whom have been prescribed it by a doctor.
The TGA’s Special Access Scheme form that doctors could apply to use with nicotine juice is here.
What Australia’s vaping advocates are deeply worried about but seldom say publicly (because it reflects very poorly on their own failures to convince Australia’s doctors to prescribe e-cigarettes) is that there are currently only a handful of doctors across the country who are currently doing this. With 122,768 medical practitioners currently registered, this homeopathic strength participation rate is hardly a vote of confidence in e-cigarettes.
The track record of e-cigarettes in cessation is anything but spectacular (see sections 7, 8 & 9 in The dirty dozen: 12 myths about ecigarettes). And in some nations that have let e-cigarettes off the regulatory leash, uptake of vaping by young people has been rapid and rising. Here’s Canada, for example.
As with COVID-19 control, Greg Hunt and the government have listened to people with expertise about disease control. The table below shows the current state-of-play on regulation support among Australia’s health and medical agencies, and vaping advocacy groups. The government has plainly listened to the overwhelming consensus of Australia’s health and medical community when it comes to the regulation of e-cigarettes here.
Access to vaping nicotine has to date been a fiasco. It is illegal to supply nicotine juice or salts, while vaping equipment can legally be sold. Yet audits by NSW Health have found shops are often openly selling nicotine vaping products. There have been no controls at all on what people bring in from overseas by mail or courier. The new regulations are therefore a welcome step away from that chaos. Vaping interests will be already plotting ways to weaken the scheme to get vaping in the same position that cigarettes lucked into at the beginning of last century. The TGA will be monitoring the operation of its scheme closely.
How good is Australian tobacco control policy? Anticipating a barrage of vitriol from ecig retailers who have just had their legs cut out from under them on their harm reduction arguments. If you really need ecigs to quit then go and get them from your doctor with methadone and other replacement therapies.