Vaping reforms webinar - overview of regulatory changes

Speaker Key: 

BG Dr Bridget Gilmour Walsh

KG Kate Grlec

TG Dr Tony Gill

TM Tony Manderson

00:00:12 

BG

Good afternoon everyone and thank you for joining us for this session this afternoon. My name is Bridget Gilmour Walsh and I'm the principal legal and policy advisor for the TGA and have responsibility for vaping reform within the TGA. Today’s session is the first public webinar that we've hosted since the regulations implementing the first stage of the vaping reforms were made at the end of last year.

Our aim today is to provide that high-level overview of the reforms as a whole and we’re going to cover how the reforms will impact consumers, prescribers, pharmacists and other retailers, and importers, manufacturers and wholesalers. We'll also touch on the approach to compliance and enforcement, and I will at the end of the session hand over to my colleague, Kate Grlec, who will give an update on tobacco control and vaping cessation.

Here at the TGA we’re focused on the regulatory controls for vaping, but of course what’s happening with vaping reform at the moment is just one part of a broader package designed to combat vaping. And there's a range of measures that the government is putting in place, including greater vaping cessation support, which Kate is going to talk about.

00:01:38

Hopefully you'll all be aware, and that’s why you've tuned in today, that the Australian government has announced reforms to progressively ban all vapes within Australia, unless they’re therapeutic vapes. That is vapes that are used for therapeutic purpose, such as smoking cessation, that comply with the Therapeutic Goods Act. Therapeutic vapes will be only available from people authorised to supply prescription medicines under state and territory laws, which is mainly pharmacies. They'll also need to meet new product standards, as well as other requirements under the Therapeutic Goods Act.

One of the key messages for retailers is that once the changes are complete, tobacconists, vape stores and convenience stores will no longer be able to sell any type of vape. That includes zero nicotine vapes and the vaping devices that don't contain any substances. The Minister for Health and Ageing, Minister Butler, has outlined the broad intent and reasons for these changes on many occasions, and the quote there encapsulates the broad policy intent. The intent is to protect Australians, particularly young people, from the harms of vaping and nicotine dependence, whilst ensuring that people can access vape due to medical reasons.

00:03:00

I'll just mention there that in terms of the harms of vapes, vapes do carry a number of health risks, including nicotine addiction, nicotine poisoning, exposure to toxins, the potential for injuries and burns with batteries exploding, etc. There's really strong evidence now that vaping can be a gateway to smoking and, importantly, the long-term health effects of vaping are just not known.

Vapes have only been widely used globally for about 10 to 15 years, and many of the health risks specific to vaping are just not yet known. In that context, the policy position is to take a precautionary approach to their availability. But it's recognised that vapes do have a legitimate purpose for some people, particularly a cohort of smokers who’ve not been able to quit smoking by other means. Vapes will continue to be available for legitimate therapeutic purposes under medical supervision.

How have we gotten to where we got to? Most of you will probably be aware that there were regulatory changes to nicotine vapes made in October 2021. At that time, all nicotine vapes became prescription medicines, and so could only be accessed in Australia with a prescription from a doctor. And the broader intent of those reforms in October 2021 was, again, to prevent kids accessing vapes, but to make them available for genuine therapeutic purposes.

But it's really clear that the reforms are not meeting those aims and one of the reasons for this is the distinction between nicotine and other vapes. That regulatory system has prompted people to try to avoid the regulatory controls by labelling nicotine vapes as not containing nicotine or just labelling vapes as containing low nicotine or being silent as to whether nicotine is in the vapes.

00:05:20

In late 2022 the TGA conducted a public consultation on what further refinements to the scheme could be advanced to better support the original aims of the scheme. In response to that consultation, a lot of people said these reforms are not going far enough. You need to be taking action to regulate all vapes because there's health risks in all vapes and the regulatory distinction between some vapes and other vapes is causing enforcement difficulties. After considering that feedback and advice from public health experts, the Minister for Health and Aged Care announced action on vaping in May 2023.

Following that time, there was quite considerable negotiation with the states and territories to agree how to implement the broad reforms, and further targeted consultation in September 2023 to inform the precise content in the reforms. In November 2023, as you'll all be aware, the Minister for Health had Ageing outlined a plan to progressively reform the regulation of vapes over the course of 2024.

We’re currently in the first stage of implementing those reforms, which is to impose import restrictions on vapes. And import restrictions commenced for disposable vapes on 1 January this year, and on 1 March further import restrictions will be imposed.

00:07:03

I'll just briefly outline here what the lawful supply pathways are going to look like once the reforms are fully implemented. The reforms won't be fully implemented until later this year. We’re doing them in stages, so this is what the picture will look like once the reforms are fully laid out. The first question to ask is, is the vape intended for therapeutic use? If the answer to that question is no, then it's basically going to be prohibited for anyone to import, supply or manufacture those vapes, with some very limited exceptions.

If it is for therapeutic use, then a further question needs to be asked. Which is, is it a disposable vape or is it not a disposable vape? Again, if it's a disposable vape, it's not going to be able to be imported, supplied or manufactured in Australia anymore. If it is a reusable therapeutic vape, then it can be accessed through lawful supply pathways under the Therapeutic Goods Act. Now the ordinary lawful supply pathway is for a therapeutic good to be registered on the Australian Register of Therapeutic Goods, once it's satisfied the requirements relating to safety, efficacy, performance and quality.

But we have at the moment no registered therapeutic vapes for smoking cessation or to treat nicotine addiction. And all vapes are coming into the country as unapproved goods, which means they have not been assessed by the TGA for quality, safety and efficacy. But they still have to comply with some minimum quality standards, which are much lower than the standard required to get a registered product. And to supply vapes in Australia now, people will have to notify the TGA that they meet those regulatory requirements. And to import vapes, licenses and permits will also be required under the customs legislation.

00:09:20

So, that’s a broad overview of how it will work when the reforms are fully rolled out, but at the moment we’re in stage one of the reforms. So, what changed on 1 January? Well, the importation of all disposable vapes was banned with very limited exceptions. Note that domestic supply of disposable vapes is not yet prohibited, so the sale of previously imported disposable vapes can continue under the current laws for the time being. The purpose is to allow people to run down stock and reduce the financial impact on people whose businesses are going to be impacted by this.

The Personal Importation Scheme for disposable vapes also ceased on 1 January, but note that the Personal Importation Scheme has not yet fully ceased, so non-disposable vapes can still be imported through the Personal Importation Scheme for the time being. On 1 January 2024 a new special access scheme pathway commenced to enable and nurse practitioners to prescribe therapeutic vapes without requiring pre-approval from the TGA. The purpose of that was to ensure that there are sufficient practitioners available to prescribe vapes to those people who need them for genuine therapeutic purposes. There were also some small changes to advertising requirements that mainly affect pharmacists.

What will change on 1 March 2024? The importation of all non-therapeutic vapes will be banned. But again, there will be some transition periods to allow existing stock within the country, that is stock imported before that date, to be sold on. The Personal Importation Scheme for all vapes, including vaping devices and vaping accessories, such as pods, will cease. So, you'll no longer be able to get on a New Zealand website and order a vape to be imported directly to your house, whether you have a prescription or not, that’s just going to end.

00:11:50

Manufacturers and sponsors will need to provide a notification to the TGA that their vape complies with the relevant product standards and the application forms are already available on the TGA website. In addition, importers must obtain both customs licenses and permits from the Office of Drug Control to import therapeutic vapes. Again, application forms are available on the ODC website.

On 1 March updates to the therapeutic goods product standard will also commence. This means that limits on flavours will commence from that date, at least for newly manufactured or newly imported goods. There will be a transition period to allow goods already in the market to be sold down for a short period. There’ll be small changes to the requirements related to therapeutic vaping devices. And, because the TGA will be engaging in pre-market processes, we'll be requiring people to notify us that they comply with the standards. So we will know who the lawful suppliers of vapes are and which products can be lawfully supplied.

We'll be able to publish a list, saying these are the vapes that have been notified to us as complying with the TGA product standards. That list will be available from 1 March.

00:13:16

The first stage of the reforms is all about changes to import controls. The second stage of the reforms is subject to primary legislation being made by the Australian Parliament, but subject to that legislation being introduced and passed, the intention is that that legislation would ban the domestic manufacture, supply, advertising and commercial possession of non-therapeutic and disposable vapes, with very limited exceptions. Until this legislation is implemented, the regulatory requirements for the domestic supply of disposable vapes have not changed. Those can still continue to be supplied, provided they meet regulatory requirements. And for nicotine disposable vapes, that means they can only be supplied in a pharmacy.

There's going to be new criminal offences to support the new regime. It's basically going to be illegal to deal with any non-therapeutic vape once this legislation comes into effect, assuming it's passed by the Australian Parliament. That's the second stage of the reforms.

The third stage of the reforms we'll be doing over the course of the year, but it's not envisaged that they will come into effect until the end of the year. But they're basically going to be to impress the regulatory standards for unapproved vaping products. The intention is that there will be plain packaging for vaping products, there will be requirements for pharmaceutical labelling. There will be rules that specify that vapes can only contain permitted ingredients, and that differs to the current position, which only specifies that vapes must not contain certain prohibited ingredients. And it's likely that the maximum nicotine concentration will be lower. The current nicotine concentration specified in TGO 110 is 100 mg/ml. That is high in comparison with international standards. Many international counterparts allow only 20 mg.

But the standards are proposed to commence later in the year, around December, to allow industry sufficient time to develop compliant products.

00:15:47

That’s the broad stages of the reforms that we’re going to be rolling out over the course of the year. I'm going to move now to talk about the impact on specific groups.

Turning to consumers. Consumers will start to notice that tobacconists, vape shops and convenience stores will no longer stock the disposable vapes they’ve been previously able to purchase. This might not be immediate because obviously there's still stock in the supply chain within Australia. But given that most disposable vapes are imported, the introduction of the import controls will in time limit the availability of disposable vapes.

Doctors and nurses can prescribe therapeutic vapes through a new unapproved product access pathway. There's a broad range of doctors and nurses that consumers can go to, to seek a prescription for a therapeutic vape. One key change for people out there who might be importing their vapes with a prescription from overseas websites, particularly New Zealand, is that from 1 January you can no longer import disposable vapes via this method. And from 1 March you won't be able to import any vapes through this method.

Anyone that’s using vapes as part of a smoking cessation strategy without a prescription should speak to their health professional as soon as possible. And anyone who has a vaping addiction, I'm conscious that there are some people who were never smokers, who are now addicted to vapes, they should also speak to their health professional as soon as possible about quitting and other options. Therapeutic vapes are only one option to treat nicotine dependence and your health professional can help you decide what’s right for you.

00:17:52

I'll just mention there that, as I said earlier in the presentation, vapes had not been approved by the TGA. There are no vapes for the treatment of nicotine addiction or for smoking cessation that have been approved by the TGA. By contrast, there are a range of other smoking cessation or nicotine treatment options that have been approved by the TGA, including some medication and nicotine replacement therapies, such as patches, gums, etc.

Now we recognise that they don't work for everyone, which is why vapes are still available. But it may be that your health professional thinks that it's more appropriate for people to access the TGA approved products which have been assessed for quality, safety and efficacy, rather than unapproved vapes that have not.

That’s the broad impact on consumers. One particular category of consumers is travellers entering Australia. There is going to be a traveller’s exemption that applies, to allow people to bring vapes into Australia by ship or aircraft with stricter quantity limits. If you're coming into Australia by a boat or by an aeroplane, you will be able to bring some vapes in, but there are going to be very strict quantity limits, and those are set out on the slides there. These have been set at quite a low level to avoid diversion. You're going to be allowed to bring in two vapes, two vape accessories and 200 ml of a vaping substance in liquid form. (Clarification: the travellers exemption allows up to 20 vape accessories.)

These quantity limits apply to disposable vapes from 1 January and to all other vapes from 1 March.

00:19:46

Turning to the impact on prescribers. As I've already mentioned, there are no therapeutic vapes for smoking cessation or the management of nicotine dependence that are included on the Australian Register of Therapeutic Goods. In other words, there are no vapes that have been assessed by the TGA for quality, safety and efficacy for these purposes.

Doctors and nurse practitioners can make these available through established pathways to access what we call unapproved or unregistered therapeutic goods. Doctors and nurse practitioner can prescribe therapeutic vapes for smoking cessation or the management of nicotine addiction through the Special Access C Scheme. And that’s something we've introduced from 1 January this year. Any doctor or nurse practitioner can write such a prescription without coming to the TGA for pre-approval.

And we've made some changes to the processes for SAS C to try and streamline the SAS C processes for prescribers. We've also kept open the existing pathways to prescribe unapproved vapes. Doctors can also continue to prescribe through the Authorised Prescriber Scheme and the SAS B scheme. Prescribers should be aware that they should only prescribe vapes that can be lawfully supplied. The vapes that can be lawfully supplied will change over the course of the years. So prescribers are going to need to keep up to date with information about lawful products from the TGA website, and we will be updating the website regularly, as well as doing targeted information sessions for prescribers and pharmacists.

00:21:46

Another thing that we’re doing in consultation with our colleagues in the Population Health division is working with the RACGP to update the guidance on smoking cessation and the treatment of nicotine addiction for health practitioners. And so, the RACGP has done some initial guidance on that, which are published late last year and that is going to be finalised in the coming months. We’re also going to be doing a joint information session with the RACGP in the near future, probably later in February. This will include demonstrations of how the SAS and Authorised Prescriber online systems works, so that prescribers can understand this.

Turning to the impact on pharmacists and other retailers. As I've already mentioned, there are no vapes on the Australian Register of Therapeutic Goods. Pharmacists can dispense unapproved vapes, provided they’ve been prescribed by an authorised prescriber or by someone who has approval under the SAS B scheme or under the SAS C scheme. Pharmacists can dispense therapeutic vapes with evidence of an AP or a SAS B approval, or in accordance with the SAS C pathway.

00:23:19

We've been working to try and make these processes more streamlined and there’s a new validation tool that would enable pharmacists to confirm the validity of AP and SAS approvals and notifications, to enable them to dispense therapeutic vapes. You can see there the website that you can go to, to get more information about this. But the Pharmaceutical Society of Australia and the TGA are also going to present an information session for pharmacists with further details about this later in February.

Pharmacists should, of course, only dispense therapeutic vapes that comply with TGA requirements, and particularly those in Therapeutic Goods Order 110. But as the reforms are rolled out, it will become easier for pharmacists to identify therapeutic vapes that can be lawfully supplied. As I mentioned earlier, the TGA will be publishing the products that have been notified to the TGA as compliant with the relevant standards. Those are the products that once all the transitional arrangements have finished, they will be the only products that can be lawfully supplied in Australia.

Just an important point here for pharmacists. Pharmacists can have therapeutic vapes in their possession and, in advance of an AP or SAS B prescription being written or SAS C prescription being written. This differs to the ordinary supply arrangements for unapproved medicines, but we've implemented that procedure, so as to allow consumers to readily access vapes when they need them.

00:25:03

The impact on tobacconists, vape stores and convenience stores. The key message here is, as I outlined at the beginning of this presentation, once the reforms are fully implemented, tobacconists, vape shops, convenience stores will no longer be able to sell any type of vape in Australia. All vape sales will be confined to pharmacies, and this includes zero nicotine vapes and vaping devices. This ban won't start until later in 2024. Remember, I said that this is going to require primary legislation to be passed by the Australian Government. But the import restrictions are already partially in place and will come fully into effect on 1 March.

This means that tobacconists, vape stores and convenience stores may find it harder to get supplies of vapes for the time being. The key message for retailers is you should act now to minimise your financial losses, and familiarise yourself with the new laws, to ensure that you don't fall foul of them. We’re in a transition period now, which is allowing you to run down your stock. The government has been very clear that there’ll be no compensation for retailers as part of the changes, and retailers really should be taking advantage of the time we've got now, between the passage of legislation through the Federal Parliament, to run down their stocks and minimise their losses.

Turning to the impact on importers, manufacturers and wholesalers. We've already said that from 1 January 2024 it's unlawful to import disposable vapes, but it's not yet unlawful to sell them, so stock can be sold and continue to be lawfully sold in Australia, provided it was imported before 1 January 2024. From 1 March 2024 new requirements will apply for reusable vapes. Importers and manufacturers of therapeutic vapes must notify the TGA that the vapes comply with the relevant product standards before importing or supplying them.

00:27:37

Importers must also obtain a customs license and permit from the Office of Drug Control. All non-therapeutic vapes will be prohibited imports. It won't be possible to import any non-therapeutic vapes from 1 March. As I've said, there are transition periods, to allow businesses to run down stock that was imported or manufactured before these dates.

Pending passage of legislation through the Federal Parliament from mid-2024 it will be illegal to import, manufacture or supply any disposable or non-therapeutic vape. And there’ll be no transition period for those changes, so people should be planning that mid this year it will not be permissible to supply any vape, except for a therapeutic vape through a pharmacy.

Turning to compliance and enforcement. It's important to recognise that these reforms are part of a national strategy. The approach announced by the Commonwealth health minister on 2 May had been agreed by all state and territory health ministers. Since 2 May the TGA and other colleagues in the Department of Heath have been working with state and territory colleagues to work out how to implement the broad intent agreed by the health ministers. This has culminated in the establishment, amongst other things, at a national vaping working group, to deal with the enforcement of vapes.

It's agreed that the new requirements relating to the vapes will be jointly enforced, both at the Commonwealth, and state and territory levels. The states and territories have agreed to take responsibility for wholesale and retail enforcement and the national vaping working group will coordinate this effort, including with relevant police departments, who will also being involved in enforcement.

00:30:05

The bill that is proposed to be introduced into Parliament will include new compliance and enforcement measures. People who are importing or supplying vapes that are not therapeutic vapes that comply with the therapeutic goods requirements, can expect that there’ll be provisions that will allow those goods to be forfeited. New powers to give directions to people, e.g. to dispose vapes at their own cost or to dispose of unlawful vapes at their own cost. There’ll be significant criminal offences and civil penalty provisions to enable enforcement of this scheme. There's going to be a coordinated Commonwealth, state and territory multi-agency enforcement effort and there's going to be a whole suite of new enforcement tools.

In the MYEFO process that's just gone, the TGA has been given significant money for enforcement, as has the ABF and, if you're following the news in this area, you will see that several states have also announced significant new funding for enforcement in this area. That’s a broad overview of the regulatory reforms in this area. I'll now hand over to my colleague, Kate Grlec, who is going to give you an update on the tobacco control and vaping and smoking cessation measures. Over to you, Kate.

00:31:42

KG

Thanks, Bridget. Just confirming everyone can hear me. Obviously these vaping reforms… BG Kate, you may be on mute.

KG

No, I'm not on mute. Can you hear me?

TG

Yes, I can hear you, Kate.

KG

Perfect, thank you. The vaping reforms that are being undertaken are obviously not occurring in a vacuum. There's significant reform occurring within the tobacco control space. A key priority of both of these reforms are to reduce tobacco and vaping related harm. There's also a number of new or expanded quick supports being developed, to support people to quit both smoking and vaping, and also to stay quit. Noting that the addictive nature of both of these sorts of products can sometime require multiple attempts to quit.

I'll give just a quick update on the context of the reforms that are being brought in. Basically, all the reforms sit under the National Tobacco Strategy. This strategy was agreed by all Australian governments and published in May last year. It sets out the new national policy framework for tobacco control in Australia, and complements the existing policies and legal frameworks at the state and territory level. It outlines the shared goals, objectives, principles and targets for tobacco control between 2023 and 2030. Contains 11 priority areas and relevant today is priority area nine, which is to strengthen the regulations on e-cigarettes and novel and emerging products.

00:33:39

In regards to the tobacco reform underway, the Public Health Tobacco and Other Products Act passed through Parliament on 7 December. It will be in place from 1 April 2024 and includes a 12-month transition period from 1 April 2024 to 31 March 2025. This legislation in particular, it further strengthens the gains that Australia’s made within the tobacco control measures, such as plain packaging, and modernises the regulations of our tobacco products, to be able to limit any new and emerging products that could cause harm, that are coming through.

Again, in particular, we expect to see the new packaging requirements coming in on tobacco, such as the new graphic health warnings and the inclusion of health promotion inserts, which are little cards that will sit in the cigarette and other tobacco products to encourage and support people to quit. Again, in parallel to that vaping regulation, the Tobacco Act will also include an extension of advertising and sponsorship limitations to e-cigarettes. That will help keep our public safe from that sort of marketing techniques brought in by the tobacco industry.

00:35:09

As far as quit support measures that we are bringing in, the 2023/24 budget contains a number of measures to support tobacco and e-cigarette control, in particular $29.5 million over four years to increase cessation supports. Data has shown, as Bridget mentioned earlier, that vaping is a gateway drug to smoking, with young people who vape up to three times more likely to pick up smoking. The risk of transfer between the products is quite concerning.

Of the particular measures that we’re bringing in to support cessation, they'll include establishing an online quitting support hub, redeveloping and modernising the My QuitBuddy app to include vaping. We'll also be scaling up state and territory quit line and other quit services, to meet increased demand. We expect these measures to start commencing in the first half of 2024, and they'll augment all the existing services already being delivered by state and territory governments, as well.

Each measure we expect to expand and improve iteratively over the next three years, to introduce new functionalities and capabilities and also incorporate any updates or evidence on best practice. In recognition of the important role that health professionals play in supporting people to quit both vaping and smoking, we’re working really closely with key stakeholders to enhance the capacity of the health system and the health workforce, to make sure that they’re actually able to provide that evidence-based cessation support.

The ways that we’re doing that is updating the evidence based clinical guidelines. Bridget mentioned this one earlier, we've got the RACGP, who have released a provisional guidance to support GPs. This includes new content on how to actually support people to quit vaping, but also how to prescribe vapes if they're going to be used as a therapeutic product. We’re also working with other health professional bodies, such as the Pharmaceutical Society of Australia, so they can update their cessation guidelines and make sure that the different areas of the health workforce is actually capable of providing that ongoing cessation support.

00:37:42

We'll be developing a targeted workforce education strategy. Again, just to make sure that we can equip and train the health professionals to provide evidence-based support. And both of these measures will be complemented by the broader work of the Quit Centre, who we have funded until 2025 to develop and deliver training, resources and tools to health professionals. Again, these will be updated regularly, in line with all the different regulations and legislation and also the rapidly changing environment that tobacco and vaping control sits within.

Lastly, another of those big pieces that we’re working on are two new public health campaigns for both tobacco and vaping. The 2023 budget again included $64.3 million over four years. And the two campaigns that will be delivered is a bit of a refresh of the national tobacco campaign, to become the national tobacco and e-cigarette campaign. It's one targeted particularly for adults, so 18 plus, and will include information for our most at-risk smokers.

Then the second campaign is a national youth vaping education campaign. Recognising that we need to design and target this campaign for the different motivations and behaviours, to ensure it's effective and impactful, especially in the young people, in the at-risk groups. Both campaigns will have advertising, television, radio, audio. And also, the youth vaping campaign will include educational activities aimed at youth. We'll start getting that out to align with the start of the new school year, but both of those campaigns we’re expecting them to launch probably in the first half of this year. In coming months there's going to be a number of new measures and things coming through. I think that is me.

00:40:13

TG

Good afternoon. My name is Doctor Tony Gill and I'll be moderating the questions through to Bridget and Kate. Bridget, we have a number of questions across a few areas. I might start with a couple around legal and compliance. One is that Minister Butler has said that these laws aren't going after users. Does this mean state legislation where it interacts with the Poisons Standard will change or will there be change to scheduling? Another question was are relevant authorities going to actually enforce these laws and regulations at store level?

BG

Just in terms of the Commonwealth legislation, there is no intention to criminalise possession for personal use. It is proposed that there will be offences for possession of vapes for commercial purposes in the new legislation going before the Commonwealth Parliament, but there will be exceptions for personal use and there's no intention to criminalise personal use.

I think the person who’s asking that question may be alluding to the fact that regulation of scheduled products, for possession of scheduled products is done under state and territory law currently. But those laws are a matter for the states and territories, although we are discussing alignment of the Commonwealth and state and territory laws as part of the reforms. Don't know if that fully answers the question. I could perhaps expand on what we’re going to be doing to enforcing the laws, including in shop fronts.

TG

I think you also did cover in the presentation about the working group of health and police ministers to try and work on that combined look at enforcement. There is a question from someone who agrees with the ban on disposables, but asks will there be a review conducted on the impact of the ban before proceeding to the second step of the reforms?

00:42:40

BG

No, because the reality is to progress reforms to the requirements for domestic manufacture and supply, a bill will need to be introduced into the Commonwealth Parliament in February at this stage is the intention, so we’re currently working on that bill. But there will be a review, as there is with any regulatory changes, of how they're operating after they’re implemented.

TG

And the last one from the legal side, zero nicotine e-liquid and devices that are non-therapeutically used for vaping. The questioner thought that this had to go to vote in Parliament, has this changed?

BG

We need to distinguish between import and domestic supply. The new import regulations that have been introduced apply to all vapes. It's currently prohibited to import a disposable vape, regardless of whether that contains nicotine or not. From 1 March it will be illegal to import non-therapeutic vapes and vaping devices, including zero nicotine vapes and vaping devices used for zero nicotine products unless they are marketed as products that have a therapeutic purpose, e.g. to treat smoking cessation or nicotine addiction.

00:44:23

Now the domestic ban on those products, those regulations have been made and some have come into force and the others will come into force on 1 March. You're right that the domestic ban on these products, so the ban on the manufacture and supply of non-therapeutic vapes, it's dependent on Commonwealth parliament passing legislation to give effect to that ban.

TG

There's a question which relate to the Therapeutic Goods Order and the notification to TGA. Giving them together, is there a list of approved local test laboratories for these, for vapes? Is there a maximum volume of liquid per pod? And if the product has been notified to the TGA, who is assessing them for approval?

BG

I'll make two comments there and then hand over to my colleagues, Tony Manderson, who’s responsible for the contents of TGO 110 and doing all of the detailed work on it. The first point to make is most of the requirements have not yet changed, although there's been some changes to flavours and colours that will take effect on 1 March. That’s the first thing to note. Many of the changes proposed to the standards are not going to take effect until later in the year.

The second point I'll make is that there's no TGA approval of nicotine vaping products. TGA is not going to be doing a pre-market assessment of these products. All that the TGA is receiving is a notification that the importer or manufacturer has evidence that the products comply with the standards. It's not an approval by the TGA, rather manufacturers and importers are notifying the TGA that they comply with the relevant standards. And I'll just hand over to Tony, who might want to expand on that.

00:46:27

TM

I don't think I want to add much more there, Bridget. No, we haven't published a list of testing facilities. We don't specify on the standard what certification they require, so there's no need for that to occur. Just reiterating what was said, that it is a notification to TGA, so almost a declaration of compliance. We are able to do post-notification compliance monitoring and we can do auditing to make sure that documentation is held. But there is no pre-market assessment of those notifications. But we will be publishing a list of products that have notified that they comply with the applicable standards.

TG

There is a question on the environmental impact. What environmental impact evaluation is being conducted? The questioner mentions the RACGP preferences pre-filled pods that, unlike some open systems, these are single-use plastic.

BG

Waste issues are certainly something that we’re considering as part of the reforms and one of the impetus to banning the disposable vaping devices containing the e-liquids was a concern around waste. Of course, the broad regulatory parameters which seek to confine vapes to therapeutic use are trying to address the waste stemming from vapes. We are in discussions with the Environment Department and their state and territory counterparts about how to manage the serious waste that does come from vapes, noting that there are real disposal issues, especially when it contains nicotine and because of the batteries that can cause fires etc. if they’re not appropriately disposed of. Those issues are being considered alongside the reforms and cessation measures.

00:48:40

TG

There are a couple of questions on prescribing and supply through pharmacy. Noting that there are the future webinars for health professionals, and also for pharmacists. We probably won't have time to cover them all, but they'll obviously come up in a later session. One of the question is what if a GP does not wish to prescribe a vape?

BG

That is a matter of clinical judgement for the GP and, Tony, you might want to add to that yourself, being a medical doctor.

TG

If a doctor is not prepared to prescribe, then there is no legal requirement for them to prescribe. The questioner did ask about protections, but it's like some other medications that some doctors are not prepared to prescribe. Therefore, people will go to another doctor to get prescriptions for that particular medication. There's no legal requirement that GPs have to prescribe. There was a related about whether vapes available in pharmacies might be different to those prescribed, will it be in the power of the TGA and pharmacies to go against the prescription issued by a qualified doctor? I might be able to say a few words.

It might depend on the prescription, whether it actually nominates a particular product or whether it just talks about a nicotine strength, so there can be some discussion on that. There was a question about whether prescribers saying they can't prescribe yet under SAS C as no vapes are on the approved list. As of 1 January SAS C is open for both smoking cessation and nicotine dependence. It is not dependent because of the wording that the SAS C on particular products, so I could answer that question.

00:50:59

Maybe one last question here. Once the first sponsor is able to include a reusable vaping device in the ARTG, will unapproved vapes be able to continue to be available under SAS or will all users need to source vapes including in the ARTG?

BG

I suppose that’s a matter for future consideration because it's hypothetical at this stage. But as a general proposition, SAS and AP can be available, even though there's one particular product registered. Particular products may not be suitable for particular classes of users, and that is the general position. Say there was only a nicotine vape with a very high nicotine concentration that was registered, but people wanted to use a lower concentration product, it might be appropriate to keep using an unapproved product that better meets their needs.

TG I think that covers through the questions we have had up to a certain point. But noting the time is 4:28, I think I'll pass back to Nishi.

00:52:19