Contracts signed for rollout of COVID-19 vaccine

Contracts have been signed with companies to partner with the Australian Government to safely distribute COVID-19 vaccines to all Australians from March next year.
The contracts cover three vital aspects of the vaccine rollout:

  • Distribution and logistics— industry leading providers DHL and Linfox will undertake COVID-19 vaccine distribution.
  • Data—Accenture will provide tracking of vaccine doses as well as enabling overall program implementation monitoring.

In addition, PwC will be the Department of Health’s Program Delivery Partner for the vaccine rollout.
Finalisation of these contracts confirms Australia is on track to achieve a well-ordered, efficient and safe rollout of COVID-19 vaccine. Subject to approvals, the first vaccinations will be provided to health workers and aged care residents from March.
DHL and Linfox will work with the Department of Health to design and operate a national distribution network. They will support vaccination for all, including people in rural, remote and very remote areas and others who are hard to reach.
They will also be required to track and report the temperature of the vaccine at all times. The required temperature could be 2 to 8 degrees (standard cold chain temperatures) to as low as minus 70, which is needed for the Pfizer vaccine.
Purpose built dry ice containers will be supplied for moving the Pfizer vaccine around Australia, as part of the Government’s global distribution deal with Pfizer.
As well as transporting the vaccines from the point of acceptance from manufacturers to vaccination administration sites, the logistics partners will be responsible for transport and management of vaccination supplies such as needles, syringes, and personal protective equipment.
Data partner Accenture will design, develop, and implement a software solution to enable “point in time” visibility of COVID-19 vaccine doses across the delivery chain.
This will include receipt of the vaccine by health services, vaccination of patients, and subsequent monitoring for adverse reactions.
Vaccines will be a critical part of Australia’s ongoing response to COVID-19 and the Australia Government has secured over 117 million doses to cover the Australian population several times over.
Vaccines will complement the other vital health measures including social distancing, good hand hygiene, high testing rates and Australians mandatory hotel quarantine regime for international travellers.
Our advice remains that Australia remains on track for first vaccinations in March, and completion of whole of population in 2021.
Australia’s response to the COVID-19 pandemic remains the envy of the world.

Contracts signed for rollout of COVID-19 vaccine

Contracts have been signed with companies to partner with the Australian Government to safely distribute COVID-19 vaccines to all Australians from March next year.
The contracts cover three vital aspects of the vaccine rollout:

  • Distribution and logistics— industry leading providers DHL and Linfox will undertake COVID-19 vaccine distribution.
  • Data—Accenture will provide tracking of vaccine doses as well as enabling overall program implementation monitoring.

In addition, PwC will be the Department of Health’s Program Delivery Partner for the vaccine rollout.
Finalisation of these contracts confirms Australia is on track to achieve a well-ordered, efficient and safe rollout of COVID-19 vaccine. Subject to approvals, the first vaccinations will be provided to health workers and aged care residents from March.
DHL and Linfox will work with the Department of Health to design and operate a national distribution network. They will support vaccination for all, including people in rural, remote and very remote areas and others who are hard to reach.
They will also be required to track and report the temperature of the vaccine at all times. The required temperature could be 2 to 8 degrees (standard cold chain temperatures) to as low as minus 70, which is needed for the Pfizer vaccine.
Purpose built dry ice containers will be supplied for moving the Pfizer vaccine around Australia, as part of the Government’s global distribution deal with Pfizer.
As well as transporting the vaccines from the point of acceptance from manufacturers to vaccination administration sites, the logistics partners will be responsible for transport and management of vaccination supplies such as needles, syringes, and personal protective equipment.
Data partner Accenture will design, develop, and implement a software solution to enable “point in time” visibility of COVID-19 vaccine doses across the delivery chain.
This will include receipt of the vaccine by health services, vaccination of patients, and subsequent monitoring for adverse reactions.
Vaccines will be a critical part of Australia’s ongoing response to COVID-19 and the Australia Government has secured over 117 million doses to cover the Australian population several times over.
Vaccines will complement the other vital health measures including social distancing, good hand hygiene, high testing rates and Australians mandatory hotel quarantine regime for international travellers.
Our advice remains that Australia remains on track for first vaccinations in March, and completion of whole of population in 2021.
Australia’s response to the COVID-19 pandemic remains the envy of the world.

Holiday vigilance to protect older Australians in aged care

The health and safety of older Australians should be a priority this holiday season with families urged to keep in contact with those most in need – but to take appropriate precautions.
While restrictions have eased across Australia, providers and families living across the Northern Beaches and Penrith areas of Sydney must abide by the current visitation guidelines.
Until further notice all staff and visitors at residential facilities must wear a surgical mask.
Additionally, until at least Wednesday 30 December, all residential aged care facilities across the Northern Beaches LGA must exclude visitors, except those performing essential caring functions.
Up to two people are permitted to visit loved ones in residential aged care facilities in Greater Sydney including the local government areas of Central Coast and Wollongong.
The rule also applies for Greater Sydney residents visiting regional aged care facilities.

There are no restrictions on people from regional NSW visiting residents in regional facilities.
Updated advice for Residential Aged Care facilities and Home Care Service providers can be found here.
Minister for Senior Australians and Aged Care Services, Richard Colbeck, said aged care providers and families were required to follow the relevant visitation guidelines to ensure loved ones could maintain contact.
“We know where there is community transmission there is a serious risk of the virus spreading to aged care settings,” Minister Colbeck said.
“It is a difficult time for residents, families, providers and staff at facilities across this region but it’s vital we prioritise and protect our most vulnerable.
“Of course, we want families to maintain contact with their relatives in aged care, and a phone call or video call will mean a lot to those who can’t have visitors.
“Staff and management will continue to provide compassion and understanding, while also being a strong line of defence for those in their care from the coronavirus.”
Australian Government support for aged care providers in the Northern Beaches hotspot is already being provided, including asymptomatic testing, supplies of personal protective equipment as required, and workforce surge and support where needed.
A new three-tier escalation plan, backed by the Australian Health Protection Principal Committee (AHPPC), outlines how providers can respond to the COVID-19 threat level in the local community and ramp the response up or down as needed.
The AHPPC guidelines outline visitation recommendations providers can put in place if they are in a defined hotspot with localised outbreaks of cases (Tier 2) and when there is an outbreak of COVID-19 in the community (Tier 3).
“Residents must be protected in the least restrictive manner and their health needs must be balanced with their personal wellbeing,” Minister Colbeck said.
Additionally, Minister Colbeck said the Industry Code for Visiting Residential Aged Care Homes during COVID-19, developed in conjunction with consumer peak bodies sets out a nationally consistent, principles-based approach to maintaining residents’ visitation and communication – the Government welcomes the latest version of the code.
In conjunction with the new visitation guidelines, it offers clarity for residents and families.
“It is an important time of the year for families to re-connect, particularly as we return to COVID-normal environments with the current exception of the Sydney hotspots,” Minister Colbeck said.
“The social distancing measures we have all adopted will protect our families.
“Don’t visit if you are unwell, practise good hand and cough hygiene, and follow the advice available from staff at the aged care facility.”
All aged care providers are urged to ensure their outbreak management plan is up to date and ready to be activated. They must also be alert to any staff or care recipients experiencing respiratory and flu like symptoms.
The Visitation Guidelines for Residential Aged Care can be found here.
The COVID-19 escalation tiers and aged care provider responses can be found here.
The Older Persons COVID Support Line can offer information and support to seniors who need assistance or are feeling worried and isolated. The line can be reached on free call 1800 171 866.
Mental health support is available to all Australians by calling Lifeline (13 11 14) or BeyondBlue (1800 512 348) and further resources are available on the Department of Health’s Head to Health website.

Government boosts funding for community pharmacies to support more rural and regional communities

The Coalition Government is providing more than $100 million for regional, rural and remote pharmacies to better support their communities through an expansion to a critical regional pharmacy program.
Over 400 additional pharmacies will be eligible for the Regional Pharmacy Maintenance Allowance (RPMA) program under changes announced today, with very remote pharmacies receiving significant additional funding to support the supply of medicines and healthcare in their community.
These changes will help ensure all Australians can access the medicines and pharmacy services they need, where and when they need them, and is a key outcome of the Seventh Community Pharmacy Agreement (7CPA) signed with the Pharmacy Guild of Australia in June 2020. The Pharmaceutical Society of Australia is also a Signatory to relevant parts of the Agreement.
Community pharmacies play a vital role in providing access to medicines and essential health services for the third of Australians who live in regional, rural and remote areas.
Our Government, through the RPMA, supports access to Pharmaceutical Benefits Scheme (PBS) medicines and pharmacy services for people in regional, rural and remote communities.
The Coalition is boosting its investment in the RPMA program from $16 million per year under the previous 6CPA to $21 million per year of the 7CPA through changes agreed to by the Pharmacy Guild of Australia.
The changes to the RPMA program will support more than 400 new pharmacies which will be eligible for the first time to participate from areas that were previously not eligible.
This will take the total number of pharmacies eligible for the RPMA to 1215 community pharmacies.
In addition, higher allowances will be available for up to 960 community pharmacies in rural, remote and very remote areas with low prescription volumes.
The RPMA program will transition to the Modified Monash Model of rural classification, from 1 January 2021, to align with other health workforce distribution programs.
Eligible pharmacies will receive between $3,000 to $51,328 per year under this expansion, depending on their remoteness classification and PBS prescription volumes.
The Government recognises the importance of maintaining the pharmacy network to provide a steady and reliable supply of medicines and other pharmacy services, in particular to people outside in the regions.
Community pharmacies stepped up to support their patients during 2020, and have kept their doors open during this year’s bushfires, drought, floods and COVID-19 pandemic.
All Australians benefit from equitable and sustainable access to effective medicines, including highly specialised, expensive and lifesaving medicines through the PBS.
Making sure all Australians have access to timely, safe and affordable medicines continues to be an Australian Government priority.
The RPMA is one of a range of pharmacy programs supported by a $1.2 billion investment in pharmacy programs under the 7CPA.
The overall investment in the 7CPA over the period 1 July 2020 to 30 June 2025 is expected to be $18.35 billion.
The Coalition Government has made approximately 2500 new and amended medicines listings on the PBS since 2013, at an overall investment of close to $12 billion.
Our Government’s commitment to ensuring Australians can access affordable medicines, when they need them, remains rock solid.
George Tambassis, National President, The Pharmacy Guild of Australia has welcomed the increased support for community pharmacy.
“The Pharmacy Guild of Australia welcomes this expansion of support for the vital work that community pharmacies in regional, rural and remote Australia perform every day.
“In many small towns across Australia, the local community pharmacy is the only health infrastructure, and it is imperative that appropriate support is given to enable those pharmacies to sustain their service to patients.”
“Direct contact with a health professional such as a community pharmacist is a benefit that all Australians should be able to have access to, wherever they live.”
“We thank the Government for agreeing to this increase in funding for the program, and we will support our Member pharmacies in making the transition to the new program,” Mr Tambassis said.

Thanks to Australia’s rural, regional and remote health workforce

Regional Australia has done exceptionally well in managing the COVID-19 pandemic and we are in a great position going into next year thanks to our world class health workforce.
Federal Regional Health Minister, Mark Coulton said the rural workforce – including doctors, nurses, midwives, pharmacists and allied health professionals – has continually risen to the challenges of COVID-19.
“I want to particularly thank the health workers who maintained essential services in rural and remote communities during a time of great uncertainty and under considerable pressure,” Minister Coulton said.
“For many, it meant additional time away from their families and making a personal sacrifice to ensure their communities and rural Australia more broadly remained safe.
“Australia’s rural health care workers have shouldered a great burden to deliver high quality care during this crisis for the benefit of all Australians.”
“The past year has thrown up many challenges, including drought, fires, floods and the pandemic which our health system has responded to and supported communities through.”
Minister Coulton said while there were currently small outbreaks, the Federal Government’s sustained response to the pandemic, in close cooperation with states and territories and health professionals, has been extremely successful in containing the virus.
“Our management of this crisis means our world class health system was not overwhelmed by the virus.
“Australia, particularly regional Australia, has fared extremely well in comparison to the rest of the world. All Australians have played their part in helping to stop the spread of this virus.
Minister Coulton said it was important to remain vigilant and COVID-safe over Christmas and beyond to help maintain our extraordinary success.
“While many are feeling tired at the end of a long, difficult year, we should spare a thought for those who will continue to provide vital health care over the holidays,” he said.
“I extend my thanks and acknowledge the many frontline health staff who will continue to work throughout the festive season to safeguard the health of all Australians, now and into the future.”

Mandatory improvement to button battery safety to save lives

The Morrison Government is delivering on its commitment to improve the safety of button batteries with the introduction of new mandatory safety and information standards to help protect Australian children.
In Australia three children have died from injuries sustained as a result of swallowing a button battery, and since December 2017, there have been at least 44 individual cases where young children have suffered severe injuries following the ingestion or insertion of button batteries.
This equates to one child sustaining a serious button battery injury every month, with some of them sustaining lifelong injuries.
As button batteries are used in a wide range and variety of products found in people’s homes a comprehensive and broad solution is required.
This is why the new mandatory safety and information standards will require:

  • secure battery compartments for consumer goods that contain button batteries, where the batteries are intended to be replaced, to prevent children from gaining access to the batteries;
  • compliance testing of consumer goods that contain button batteries, whether or not the batteries are intended to be replaced, to demonstrate the battery is secure and cannot be easily released;
  • child resistant packaging for button batteries, based on their risk profile, to prevent children from gaining access to the batteries; and
  • warnings and information to alert consumers that a button battery is included with the product.

No other country in the world has been able to design and deliver risk based mandatory regulation that applies to all consumer products containing button batteries.
Today’s announcement is also a timely reminder in the lead up to Christmas of the dangers of button batteries and to remind parents to be alert to any that may exist in children’s presents this year.
I commend the work of the ACCC who have shared the Morrison Government’s concern about the safety surrounding the use of button batteries and have moved swiftly to reach today’s outcome.
The ACCC has undertaken extensive consultation in developing these new standards including with industry, health professionals, consumer advocates, retailers, suppliers and government.
It is important to note that the majority of stakeholders who made submissions supported new mandatory safety and information standards.
A transition period of 18 months has been provided to allow industry to implement any manufacturing and design changes to products and packaging and undertake any testing necessary to ensure compliance with the new mandatory safety and information standards.
Further information about the new standards is available on the Product Safety Australia website at: https://www.productsafety.gov.au/product-safety-laws/safety-standards-bans/mandatory-standards

Greens call for JobKeeper & JobSeeker extension after NSW COVID outbreak

Leader of the Australian Greens Adam Bandt MP has today called on the government to defer the looming cuts to JobKeeper and JobSeeker in light of the growing COVID outbreak in NSW.
The Coronavirus Supplement is due to drop $200 a month in just 10 days, before being entirely cancelled come March 31.
“With lockdowns and travel bans throwing the country’s Christmas plans into chaos, Scott Morrison must immediately ditch the looming cuts to JobSeeker and JobKeeper,” Mr Bandt said.
“This is no time for Scott Morrison to play Scrooge, cutting payments by $200 a month while people and businesses face an uncertain Christmas.
“Instead of going missing in action as the pandemic bites again, Scott Morrison should pull the levers he’s got and postpone the cuts to payments.
“Where the bloody hell is he?
“While we all hope that lockdowns in NSW will last for days, not weeks, millions of people have been struck with uncertainty over whether they’ll be able to pay the bills come New Year’s Eve.
“You can’t cut the coronavirus supplement while the pandemic is continuing. This $200 could mean the difference between having food on the table or going hungry, and between making rent or facing eviction when protections end.
“People across the country are staying home and shutting their doors to limit the spread of coronavirus, but Scott Morrison isn’t doing his bit. JobSeeker and JobKeeper shouldn’t have been cut during the Victorian lockdown, and they shouldn’t be dropped now either.
“With just 10 days before the coronavirus supplement comes crashing down, Scott Morrison needs to stop the drop. Cutting income supports is always cruel, but Scott Morrison has picked the worst possible time to do it.”

Conservative thinktank planning for the end of coal shows urgency for transition planning

The release of a report planning for the end of coal by the right-leaning Blueprint Institute shows that all sides of politics were now calling for a managed transition out of coal, Leader of the Australian Greens Adam Bandt MP said.
“The time of coal is over and the time for clean energy has begun,” Mr Bandt said. “When even conservative think tanks are putting forward proposals to leave coal, you can tell this transition is unstoppable.
“A safe climate requires us to get out of coal by 2030, but how we do it matters. Germany was able to transition out of coal without a single worker forcibly losing their job, but a bad approach could put thousands out of work and see a few coal barons get massive taxpayer-funded payouts.
“We have to manage coal closures to look after workers and communities while ensuring a reliable energy system. If we leave it to the corporate boardrooms of coal companies, they will push for the lowest cost option and put profits ahead of the community.
“The Greens prefer a regulated closure of coal plants overseen by a national transition authority, but we’re up for a discussion about the best way to manage the change.
“The Greens welcome a discussion about a just transition out of coal, because by continuing to pretend fossil fuel use will continue for decades, the Coalition government and Labor Party are throwing coal communities on the scrapheap.
“In Australia, we have seen transition done badly, and we must avoid that with coal communities. In some previous industry closures without government transition support, only a third of the workforce found secure work, a third ended up in precarious insecure work and the last third never found ongoing employment ever again.
“Australia owes coal workers and communities a debt of thanks for helping power our country up to this point, and we owe them a planned transition out of coal with secure jobs in other industries.”

Report into COVID-19 outbreaks at St Basil’s and Epping Gardens

The Australian Government has released the findings of the independent review into COVID-19 outbreaks at two Victorian aged care facilities: Heritage Care’s Epping Gardens and St Basil’s Home for the Aged.
Minister for Health, Greg Hunt said the report underlined the critical elements that led to the tragic outbreaks at the height of the second wave of community transmission across Melbourne following the Victorian Hotel Quarantine failures as outlined in today’s Inquiry.
It highlights the vital role the Commonwealth played to support the residents, staff and management affected by the outbreaks and underlines the lessons from both incidents.
Forty-five residents at St Basil’s Home for the Aged and 38 residents at Heritage Care’s Epping Gardens passed away.
“In extending our sincere condolences to the families of those who died, this investigation serves as a platform for understanding and action,” Minister Hunt said.
“I would like to acknowledge the role of residents and families in the preparation of the report during what clearly has been a very difficult time.”
As part of the Government’s considerations, a briefing for families with the authors of the report has been arranged ahead of its release.
“The health and wellbeing of senior Australians – and the workers who care for them – is of the utmost importance to the Australian Government,” Minister Hunt said.
“We continue to work day and night to safeguard the most vulnerable in our community.”
Minister Colbeck said the Australian Government has been adapting the National Response Plan for COVID-19 in aged care since early 2020 and, with the aged care sector, state and territory governments and health authorities, incorporating lessons learned from Australia and other countries.
The review into the two Victorian outbreaks was commissioned to give a voice to those who were directly affected by the tragic events. Its authors are members of the AHPPC’s Aged Care Advisory Group (ACAG) and have been informing the Australian Government since the pandemic started on an ongoing basis.
“It’s important we understand what occurred and what can be learned to make sure we can prevent similar outbreaks now and into the future,” he said.
Both St Basil’s Home for the Aged and Heritage Care’s Epping Gardens remain subject to a Notice to Agree (NTA) issued by the Aged Care Quality and Safety Commission.
A Notice to Agree is a serious enforcement measure which, if ignored, can lead to the approval to provide Australian Government subsidies being revoked, and comes at a cost to the provider.
Minister Colbeck said establishing the Victorian Aged Care Response Centre (VACRC) and significant actions by the Commonwealth Government to support providers to respond to emergency event in aged care is acknowledged in this report.
At the height of the second wave in Victoria, advice from the VACRC, is that there were more than 7,000 aged care staff furloughed who had either contracted COVID-19 or were close contacts.
To find replacements for this many staff was a mammoth task.
During the outbreak, according to VACRC data, more than 36,000 shifts were filled by replacement staff.
“The coordinating role of the VACRC was found to be a major driver in facilitating effective interagency communications,” Minister Colbeck said.
On 21 August 2020, National Cabinet endorsed the Commonwealth, State and Territory Plan to Boost Aged Care Preparedness for a Rapid Emergency Response to COVID-19.
A key component of the plan is the establishment of Aged Care Emergency Response Operations Centres. Within each jurisdictions’ public health response structure, a dedicated aged care emergency response team has been established and key personnel identified at the state and Commonwealth level.
“All jurisdictions have provided assurances that their Aged Care Emergency Response Centres can be stood up within 48 hours,” Minister Colbeck said.
The Australian Government will continue to work collaboratively with the states, the aged care sector, and public health authorities, to adapt and refine the approach to outbreaks in six key areas:

  • Leadership and management
  • Communication
  • Emergency planning and preparation
  • Infection prevention and control capacity and capability
  • Pathology testing
  • Surge workforce.

The Australian Government has now invested $1.8 billion to support older Australians in aged care since the start of the pandemic. This includes $132.2 million in response to the Aged Care Royal Commission’s recommendations on COVID-19.
Minister Colbeck acknowledges the work of report authors Professor Lyn Gilbert and Adjunct Professor Alan Lilly and all of the people who have taken part or supported these independent reviews.
As members of ACAG, the desire of the authors was to ensure the key findings from their research could be incorporated directly into advice to the sector.
Having been closely considered by the AHPPC and ACAG, where it has not already occurred, key learnings of the review will be implemented.
Every age care provider and facility leader in Australia should read this report – it is a powerful additional source of advice and information.
The report on the independent reviews of COVID-19 outbreaks at Heritage Care’s Epping Gardens and St Basil’s Home for the Aged can be found here.
The release of the report may be confronting for anyone affected by the impact of the pandemic on Australia’s aged care sector. The following support is available:

  • The Older Persons Advocacy Network can be reached on 1800 700 600
  • The Australian Centre for Grief and Bereavement can be reached on 1800 22 22 00
  • The Essential Network for health professionals– a website and mobile application by the Black Dog Institute available at blackdoginstitute.org.au/ten or via the Google Play and Apple Store
  • Smiling Mind – a mobile application which offers practical tools to support good mental health during challenging times available via the Google Play and Apple Store.

Aged care workers can also access mental health supports available to all Australians including:

  • Beyond Blue Coronavirus Mental Wellbeing Support Service which can be reached on 1800 512 348 or at coronavirus.beyondblue.org.au.
  • Lifeline which can be reached on 13 11 14
  • Head to Health – provides access to free and low cost digital and phone mental health services and supports, available at headtohealth.gov.au

Preventing nicotine uptake by young Australians with prescription based vaping

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.