16 News

The Government is responding to the independent regulatory decision of the TGA today with a range of measures to support the cessation of smoking, and to help prevent teenagers taking up pathways to smoking.
As noted in the TGA decision (https://www.tga.gov.au/scheduling-decision-final/notice-final-decision-amend-current-poisons-standard-nicotine), from 1 October 2021, consumers importing nicotine will require a doctor’s prescription to legally access nicotine e-cigarettes and liquid nicotine. Child resistant closures for liquid nicotine will also be mandatory.
The TGA’s decision follows extensive public consultation, and is consistent with the existing ban in all states and territories on the sale of nicotine e-cigarettes without a doctor’s prescription. This is an independent decision of Government, which is legally binding.
In response to today’s decision, the Government will be taking the following actions:

• The previously proposed Customs (Prohibited Imports) Regulations will not be proceeding due to the significant overlap with the TGA decision.
• In consultation with the RACGP, AMA and other medical experts, the Government will develop a Telehealth Smoking Cessation item that will be available 6 months prior to the 1 October implementation date.
  • As part of this work the Government will provide $1 million for an education campaign focussed on smoking cessation.

It is important to note that any doctor may currently prescribe nicotine containing e-cigarettes that can be used by consumers for personal importation. This is not widely understood, and it is an important matter of public information that over 30,000 GPs may currently, and in the future, prescribe nicotine-based e-cigarettes for smoking cessation.
Secondly, any of these GPs can also register with the TGA to become what is known as an ‘Authorised Prescriber’. A GP who is an Authorised Prescriber can issue prescriptions for e-cigarettes for dispensing at a local pharmacy as an alternate option to personal importation.
Nicotine containing e-cigarettes are currently illegal to sell in every State and Territory, and possession in all jurisdictions (except South Australia) is also illegal without a valid medical prescription. That means that there is a current situation that legally imported materials are then illegally possessed under state law. This decision will both reduce the risk of an on ramp for teenagers as highlighted by the delegate, while rectifying the issue of legal importation but illegal possession.
The TGA scheduling delegate’s reasons for the decision included, but were not limited to:

• The current available evidence does not support that e-cigarettes are a safer alternative to smoking cessation aids currently available.
  • There is also currently insufficient evidence to conclude whether e-cigarettes can benefit smokers in quitting.
• Risk of nicotine addiction for new or continuing users.
• The introduction of novel nicotine delivery system may have a negative impact on tobacco control and may re-normalise smoking.
• Exposure to nicotine in adolescents may have long-term consequences for brain development, potentially leading to learning and anxiety disorders.
• Unknown toxicity of long-term exposure to heated and inhaled chemicals.
• Risk of accidental exposure to children, particularly in relation to liquid nicotine.

The delegate outlined that restrictions on the availability of e-cigarettes are necessary to mitigate the potential uptake of smoking in young adults who would otherwise be at low risk of initiating nicotine addiction.
We have already seen rapid growth of youth uptake in vaping overseas and already emerging in Australia. Specifically:

• Between 2015 and 2019, current e-cigarette usage by U.S. youth increased by approximately 1,128,000 young people aged 14-19 years (71.9% increase). This has resulted in a total of over 4 million U.S high students currently using e-cigarettes.
• In Australia between 2016 and 2019, the number of current e-cigarette users aged 15-24 increased by approximately 72,000 (95.7% increase) for a total of approximately 147,000.
• In addition, recent research from the Australian National University has found e-cigarette users are three times more likely to take up traditional cigarette products.

In particular, the TGA delegate found:
I have considered the Irish HRB reports, which conclude that adolescents using e-cigarettes are between three to five times more at risk of future initiation of cigarette smoking when compared to those who have never smoked e-cigarettes.
The findings of the Irish HRB reports were consistent with the SCHEER report, which concluded that there is strong evidence that e-cigarettes are a gateway to smoking for young people. Similar conclusions were reached in the ANU report, which found that, across multiple settings, non-smokers who use e-cigarettes are consistently more likely than non-e-cigarettes users to initiate cigarette smoking.
I regard the reports of the Irish HRB, SCHEER and ANU to be independent, credible and relevant to my deliberations on nicotine addiction associated with e-cigarette use in adolescents. It follows that I have attached significant weight to these reports on the basis that these are current and comprehensive scientific reviews undertaken by leading international organisations. I note that the findings of the three reports are broadly consistent.
This can be characterised as seeking to avoid an ON RAMP for non-smokers, especially youth.
At the same time, today’s decision is designed to facilitate a simple and legal option to nicotine containing e-cigarettes for smoking cessation – to provide the OFF RAMP for smokers.
The RACGP smoking cessation guidelines stipulate that nicotine containing e-cigarettes are not first line treatment for smoking cessation. However, for people who have tried to achieve smoking cessation with approved pharmacotherapies but failed, and who are still motivated to quit smoking and have brought up e-cigarette usage with their healthcare practitioner, nicotine containing e-cigarettes may be a reasonable intervention to recommend.
Where appropriate, consumers will be able to continue using nicotine e-cigarettes as a smoking cessation aid based on their doctor’s advice. Consumers will be able to purchase nicotine e-cigarettes from overseas, online or from local pharmacies, with a prescription.
The decision also aligns with advice from Australia’s medical experts, including the National Health and Medical Research Council and Australian Health Protection Principal Committee (AHPPC), who have warned of the health dangers of e-cigarettes.
Around the world we have seen much evidence of young people being introduced to nicotine through vaping for the first time, and in July 2018, a Victorian toddler died from nicotine poisoning.
The former head of the Food and Drug Administration in the United States, Scott Gottlieb M.D, referred to use of e-cigarette use amongst American youth as an ‘epidemic’.
The Government supports the independence of the TGA in making decisions around medicine availability and the approval of medicines, medical devices and vaccines for supply to Australians based on expert health advice. Scheduling decisions of the TGA are not subject to disallowance either by the Parliament of the Minister.
The delegate also took into account the Senate Committee Report of 18 December 2020, in addition to international evidence. The decision includes a post-market review as recommended in the report, and follows majority support for the independent role of the TGA under its Act, and support for this course of action.

A significant lung cancer treatment option that costs approximately $88,000 a year will soon be available for as little as $6.60 per script, thanks to its expanded listing on the Pharmaceutical Benefits Scheme (PBS).
From 1 January 2021, Australians living with non-small cell lung cancer who have not had prior therapy will benefit from the listing of Tagrisso^® (osimertinib).
Without the PBS subsidy, patients might pay close to $8,000 per script or almost $88,000 per year for this treatment. An average of 1,120 patients per year could now pay as little as $41.30 per script, or $6.60 with a concession card.
Tagrisso^® is a ‘targeted therapy,’ which works on specific types of cancer cells where a specific mutation is present, to block the growth and spread of these cancer cells.
Following expert medical advice the Government is expanding access to this breakthrough medicine for the first-line treatment of patients with metastatic non-small cell lung cancer, who have a certain type of mutation in the lungs, known as Epidermal Growth Factor Receptor (EGFR) positive.
Tagrisso acts by blocking the activity of the EGFR, which causes growth and uncontrolled division of cancer cells.
An oral therapy, Tagrisso will help patients experience an improved quality of life, and see them able to access the treatment at home and not in the hospital.
The Australian Institute of Health and Welfare estimates that more than 13,000 new cases of lung cancer will be diagnosed in 2020. It is the fifth most common cancer diagnosed in Australia.
This listing has been recommended by the independent Pharmaceutical Benefits Advisory Committee (PBAC).
Since 2013, the Australian Government has approved more than 2,500 new or amended listings on the PBS.
This represents an average of around 30 listings or amendments per month – or one each day – at an overall investment by the Government of close to $12 billion.
The Government’s commitment to ensuring Australians can access affordable medicines, when they need them, remains rock solid.

Australian Greens Education spokesperson Senator Mehreen Faruqi has said that Alan Tudge’s appointment as Education Minister is a disturbing development.
Senator Faruqi said:
“Anyone who a federal court judge has found to have acted criminally is not fit to be a minister of the government.
“It’s no surprise that this is the sort of ‘talent’ the Prime Minister wants to elevate in the government’s efforts to defund and privatise education.
“This disturbing appointment shows how little the government values the education system.
“While many educators will be glad to see the back of Dan Tehan, sadly his replacement is no better.
“What we need is a return to free and universal early learning, fully-funded public schools, well-funded and fee-free TAFEs and universities, and serious government commitment to a world-class education system to drive our rebuild after the pandemic,” she said.
 

The Greens recognise the potential role of e-cigarettes in tobacco harm reduction but support a precautionary approach in the regulation of e-cigarettes.
The Greens support the recommendations of the majority Select Committee on Tobacco Harm Reduction report and have made some additional comments.
It is recognised that e-cigarettes can assist some to quit, but can also prolong smoking in others, and that further research of the benefits across a population, rather than on an individual-to-individual basis, is required.
The Greens share the view of many academics and public health officials that there is not enough evidence at a population level to claim that nicotine containing e-cigarettes have, on average, a positive benefit for all.
The Greens support calls to take a precautionary approach in the regulations of e-cigarettes to ensure we do not undo many years of outstanding public health campaigns to reduce the levels of tobacco smoking in Australia.
There remain deep concerns with the tobacco industry’s predatory tactics, particularly in encouraging and normalising vaping for young people and there are significant concerns about the active involvement of the big tobacco in the debate around regulatory reform of e-cigarettes in Australia.
It is very clear that e-cigarettes present an emerging market to the big tobacco industry, and subsequently they have an obvious interest in any regulatory reform that may restrict access and consumption.
The Greens support a prescription-based model for e-cigarettes containing nicotine until further research on the long-term impacts are completed.
The Greens recommend that GPs be urgently provided with opportunities to upskill in smoking cessation options, including the use of e-cigarettes, to ensure they are fully informed of all options when assisting patients.
The Australian Greens support the recommendations of the Majority Report and further recommend:
1. That any decision-making on e-cigarettes by the Australian Government be based on public health principles as part of a harm reduction approach, rather than commercial considerations.
2. The Australian Government continue to invest in evidence-based harm reduction strategies, incorporating new approaches as evidence of their long-term effectiveness becomes available.
3. Should the TGA recommend that nicotine containing e-cigarettes and nicotine liquids for use in e-cigarettes be available only via prescription, the Australian Government implement that decision and commit to reviewing that decision in two years’ time as more research and data becomes available.
4. GPs urgently upskill in smoking harm reduction and cessation options, including the use of nicotine containing e-cigarettes, to ensure they are fully informed of all options when assisting patients.
5. Prohibit the sale of nicotine containing e-cigarettes and nicotine liquids for use in e-cigarettes in convenience stores.
The full report can be found here.

“The economy continues to be underpinned by Government spending, with state governments’ investment in social housing and public transport responsible for a lot of the improved outlook,” Greens Economic Justice Spokesperson Senator Nick McKim said.
“But wages growth has been revised down following the Government’s announcement that they will reduce public sector wage increases.”
“Unemployment, underemployment and insecure work will continue to be persistent problems.”
“Tax cuts are not going to save the Australian economy. Instead Australia needs to get on board a green recovery with government spending on clean energy.”
“The transition is happening around the world, whether the Liberals and their fossil fuel donors like it or not.”
“MYEFO also shows that coal is doomed economically, with falling global demand as the world moves away from fossil fuels at a much faster rate than Australia.”
“It beggars belief that the Liberals are throwing taxpayers money at opening up new gas fields without the consent of Traditional Owners, rather than investing in renewables and helping fossil fuel communities to transition.”
“A $50m subsidy to the fracking industry is simply a crime against our climate.”
Australian Greens spokesperson on Family and Community Services Senator Rachel Siewert said:
This is yet another opportunity squandered to do what is best for our community and the economy and put money in the hands of those who need it most.
People in our community are facing Christmas and the new year with a cut to their JobSeeker payment that is dropping people further below the poverty line.
This is cruel and it is not good economic management. There is no economic ‘recovery’ unless no one is left behind.
People on JobSeeker, including single parents, disabled people and older women are being ignored, left behind in this so-called economic recovery.
We urgently need a permanent increase to Jobseeker that is above the poverty line.
The Greens are extremely worried about the impact the uncertainty of the Jobseeker rate is having on the mental health of Australians with the Christmas and New Year periods already difficult for so many people.