This Newsletter covers Federal and State policy and legislative developments in the area of health. Copies of documents referred to can be obtained by clicking on the reference in this Newsletter or through Capital Monitor's collection at www.capitalmonitor.com.au or from the source quoted.

Major Announcements

Coronavirus (COVID-19)

15 October

TGA grants second provisional determination for a COVID-19 vaccine
The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA]. The granting of a provisional determination means that the TGA has made a decision that Pfizer is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG.
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COVID-19 testing explained
Diagnostic testing for COVID-19 infection is a key element in the strategy for limiting its spread, said NPS MedicineWise. In an early release article in Australian Prescriber, microbiologist and infectious diseases physicians Drs Anna Brischetto and Jenny Robson explain what the different tests are, when they should be used, what samples should be collected and how to interpret test results. 'For health professionals, choosing which test to use to diagnose COVID-19 disease will depend on the clinical presentation and the stage of the illness,' said Dr Brischetto. 'Nucleic acid assays using swabs from the nose and throat are the cornerstone of diagnosing acute COVID-19,'
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GPs vital in long-term care of COVID-19 patients
The Royal Australian College of General Practitioners (RACGP) is warning government that GPs will need adequate resources to manage the long-term care of COVID-19 positive patients. The RACGP has released a guide for GPs providing care to adult patients who have previously tested positive to COVID-19 or have a history suggestive of undiagnosed COVID-19 and have - or are at risk of - post-COVID-19 conditions. The guide was developed in collaboration with HealthPathways. RACGP Acting President Associate Professor Ayman Shenouda said that GPs would be managing the long-term impacts of the virus on some patients for years to come.
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14 October

NSW: Public health alert - Bargo
NSW Health is alerting the public that a newly confirmed case of COVID-19 lives in the Bargo area of south western Sydney. Investigations into the source of the infection are ongoing and contact tracing is underway. Close contacts of the case are isolating and being tested. People who live and/or work in the Bargo area are now urged to monitor for symptoms and get tested immediately if they develop.
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WA: COVID-19 update - Vega Dream update
The Vega Dream vessel has sailed from its anchorage off Port Hedland and is enroute to the Philippines. The clearance for the vessel's departure was given by the Australian Maritime Safety Authority. In line with its commitment to humanitarian care, the WA Department of Health offered assistance to the COVID-19 positive crew, however as medical intervention is not currently required, this was declined.
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WA: COVID-19 update - 14 October 2020
The WA Department of Health has reported one new case of COVID-19 in Western Australia. The confirmed case is a female in her 20s who travelled to Perth from England. She is in hotel quarantine in Perth. The State now has a total of 704 confirmed cases of COVID-19. There are 19 active cases being monitored and 676 people have recovered from the virus in WA.
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12 October

DEPT OF HEALTH: Coronavirus at a glance - Infographics provide a quick view of the COVID-19 situation in Australia on 9 & 10 October 2020 - Papers

CSIRO scientists publish new research on SARS-CoV- 2 virus 'survivability'
Researchers at CSIRO, Australia's national science agency, have found that SARS-CoV-2, the virus responsible for COVID-19, can survive for up to 28 days on common surfaces including banknotes, glass - such as that found on mobile phone screens - and stainless steel. The research, undertaken at the Australian Centre for Disease Preparedness (ACDP) in Geelong, found that SARS-CoV-2:
- survived longer at lower temperatures
- tended to survive longer on non-porous or smooth surfaces such as glass, stainless steel and vinyl, compared to porous complex surfaces such as cotton
- survived longer on paper banknotes than plastic banknotes.
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NSW: COVID-19 (Coronavirus) statistics
NSW Health has reported one new case of locally transmitted COVID-19. Five cases in overseas travellers in hotel quarantine were also diagnosed, bringing the total number of cases in NSW to 4,094. The locally acquired case is a household contact of a case. These cases are linked to another two previously reported cases, the source of which remains under investigation. There were 7,391 tests, compared with 12,823. Testing numbers have dropped recently, which is a concern as it limits the ability to find people with COVID-19 early and contain further spread.
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11 October

NSW: COVID-19 (Coronavirus) statistics
NSW Health has reported three new cases of locally transmitted COVID-19. Two cases in overseas travellers in hotel quarantine were diagnosed. One recently reported case has been excluded after further investigations, bringing the total number of cases in NSW to 4,088. There were 12,823 tests reported in the 24-hour reporting period, compared with 15,439. Two of the locally acquired cases are linked to a known case or cluster - one of these is linked to the Liverpool private clinic cluster, and the other is a social contact of a previously reported confirmed case of unknown source.
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VIC: Extra testing requirements as we move to COVID normal
Close contacts of people with coronavirus will be asked to get tested on day 11 of quarantine to help reduce the spread of the virus, as they step up protections for regional Victoria, said Victorian Premier Daniel Andrews. Those identified as close contacts by the Department of Health and Human Services must get tested on day 11 or thereafter of their quarantine period, or they will have their quarantine extended. Getting tested on day 11 of quarantine helps accurately identify whether it is safe for the close contact to be released from quarantine, without the risk of infecting other people, said Victorian Minister for Health Martin Foley.
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VIC: Clinical study aims to better understand COVID-19 immunity
The COVID PROFILE study, led by the Walter and Eliza Hall Institute, will use blood samples from people in Victoria to look in detail at immune responses to COVID-19, to reveal how people are protected - and how long people are protected - from future COVID-19 infection. This information is vital for vaccine development - and could explain whether future vaccines can be given once, or whether they will need to be regularly repeated, like the annual influenza vaccine. This information will be critical for planning for the long-term 'COVID-normal' both locally and internationally.
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10 October

NSW: COVID-19 (Coronavirus) statistics
NSW Health has reported two cases of locally transmitted COVID 19. One case, acquired overseas, is counted in the reporting period. One case reported in August has been excluded after further investigations, bringing the total number of cases in NSW to 4,084. There were 15,439 tests reported in the 24-hour reporting period, compared with 12,868 in the previous 24 hours. Of the three new cases:
- One was acquired overseas
- Two were locally acquired and under investigation.
A crew member who acquired COVID-19 overseas arrived in the Port of Newcastle from Brisbane on a ship with international mariners aboard.
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9 October

TGA grants provisional determination for COVID-19 vaccine
The TGA, part of the Department of Health, has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant]. The granting of a provisional determination means that the TGA has made a decision that AstraZeneca is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG.
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NSW: Public Health Alert
NSW Health is alerting the public to the following locations visited by new cases of COVID-19. These cases will be included in the 10th of October's numbers and contact tracing is underway. Anyone who attended the following venues is considered a casual contact and must monitor for symptoms and get tested immediately if they develop. After testing, they must remain in isolation until a negative test result is received:
- Surf Dive 'n' Ski at Castle Towers Shopping Centre Castle Hill - 5 October 2020, 12.00pm to 5.00pm
- Chemist Warehouse on the corner of Bridge and Rawson Streets, Epping - 6 October, 10.30am-11.00am
- Macquarie University Sports and Aquatic Centre outdoor pool area at North Ryde - 7 October 2020, 5.30am.
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VIC: Extra face masks from local suppliers to beat coronavirus
The Victorian Government is supporting local manufacturing while helping to drive down coronavirus numbers with more than one million additional reusable masks ordered to help protect Victorians, said Victorian Premier Andrews. An order of 1.2 million reusable masks has been placed with six Victorian companies accredited by Ethical Clothing Australia to help in the fight against this deadly virus. The masks will be distributed to the frontline workers and vulnerable communities, and they'll be made by Nobody Denim in Thornbury, The Ark/Thread Group in Burwood, Bluegum in Nunawading, Aquaterro in Pakenham, Styleprint in Kilsyth and Australian Defence Apparel in Thomastown and Bendigo, said Victorian Minister for Industry Support and Recovery Martin Pakula.
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VIC: Supporting Aboriginal communities through coronavirus
The Victorian Government is supporting Aboriginal organisations to lead local responses to the coronavirus pandemic. Victorian Minister for Aboriginal Affairs Gabrielle Williams announced more than $500,000 in grants under the first round of the $10 million Aboriginal Community Response and Recovery Fund. The Fund - announced in July - was set up to provide support for communities during the pandemic, including emergency relief, outreach and brokerage, social and wellbeing initiatives - as well as cultural strengthening and virtual celebration opportunities. Four Aboriginal organisations were successful in the first round.
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Aged Care

15 October

Operational update - Victorian Aged Care Response Centre
The Victorian Aged Care Response Centre continues to provide the robust response effort required to protect the most vulnerable senior Australians living in aged care from the COVID-19 pandemic, said the Department of Health and the Victorian Aged Care Response Centre (VACRC).
- The number of Category 1 facilities (critical outbreak) is now zero, from a high of 13 in early August.
- The work of the Response Centre has also seen the number of facilities with outbreaks continue to fall.
- The total number of aged care outbreaks since 1 January 2020 is 176; there are now 24 active outbreaks.
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Grief and trauma support for people impacted by dementia and COVID-19 welcomed
Dementia Australia has welcomed an announcement by the federal government to invest $12.4 million in a Grief and Trauma Response Package which will help to ensure support is available for those affected by COVID-19 across the aged care sector. The package includes access to training for aged care staff in trauma-informed care, including advice on self-care, and post-COVID-19 support for aged care residents living with dementia and those experiencing adverse physical, social and psychological impacts.
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14 October

Grief and trauma support for Australia's aged care sector
The Government is investing $12.4 million in a Grief and Trauma Response Package to ensure support is available for those affected by COVID-19 across the aged care sector. This is part of the $171.5 million COVID-19 response plan for aged care support programs announced in August 2020. Minister for Aged Care and Senior Australians Richard Colbeck said services would be established as quickly as possible to ensure people were able to access the support they need.
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Operational update - Victorian Aged Care Response Centre
The Victorian Aged Care Response Centre continues to provide the robust response effort required to protect the most vulnerable senior Australians living in aged care from the COVID-19 pandemic. The number of Category 1 facilities (critical outbreak) is now zero, from a high of 13 in early August. The work of the Response Centre has also seen the number of facilities with outbreaks continue to fall. The total number of aged care outbreaks since 1 January 2020 is 176; there are now 25 active outbreaks.
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Poor sleep health of unpaid carers adversely affecting wellbeing
The health and wellbeing of Australia's 2.65 million unpaid carers is being negatively impacted by significant sleep disruptions, with some reporting as little as 3-hours sleep per night. An online survey of 500 carers commissioned by Carers Australia and conducted by CQUniversity Australia and the Sleep Health Foundation earlier this year highlighted the prevalence of poor sleep among unpaid carers, with sleep durations well below the recommended hours per night.
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13 October

Operational update - Victorian Aged Care Response Centre
The Victorian Aged Care Response Centre continues to provide the robust response effort required to protect the most vulnerable senior Australians living in aged care from the COVID-19 pandemic. The number of Category 1 facilities (critical outbreak) is now zero, from a high of 13 in early August. The work of the Response Centre has also seen the number of facilities with outbreaks continue to fall. The total number of aged care outbreaks since 1 January 2020 is 176; there are now 26 active outbreaks.
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12 October

Recognising the work of our carers
The enormous contribution of carers is being celebrated as part of National Carers Week. Minister Colbeck said more than 2.65 million carers give their time, effort and love to look after a partner, family member or friend who needs them. 'The commitment of carers across Australia to support senior and vulnerable Australians should not be underestimated,' Minister Colbeck said. 'Carers are integral to the quality of life and independence of many Australians and make an important economic contribution to the community.'
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Carers of people with dementia likely to experience similar discrimination
A Joint Position Statement issued by Carers Australia and Dementia Australia during National Carers Week has spoken about the discrimination faced, not only by people living with dementia, but also by their family and friend carers. 'It is vital that the unpaid carers of people living with dementia are able to live a life free from discrimination,' said Carers Australia CEO, Ms Liz Callaghan and Dementia Australia CEO Maree McCabe.
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Caring for our carers
Often the discussion about caring is based on caring for children, said the Workplace Gender Equality Agency (WGEA). However, caring goes well beyond just caring for children. It includes providing support or care to someone who:
- Has a disability,
- Has a mental health illness,
- Has a medical problem (including ongoing or fatal illnesses), or
- Is frail from old age.
It is important that all carers receive the right support from family, friends and their workplaces to ensure that they are well enough to look after their loved ones.
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NSW: New 10 year strategy to support 850,000 carers
The NSW Government's new 10-year strategy released during National Carers Week will ensure the states 850,000 carers will receive better support and recognition to improve their financial and physical wellbeing. NSW Minister for Families, Communities and Disability Services Gareth Ward said the strategy aims to help carers overcome the challenges involved with caring for loved ones. 'National Carers Week is a significant time to recognise and celebrate the outstanding contribution unpaid carers make to our communities,' Mr Ward said.
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11 October

Operational update - Victorian Aged Care Response Centre
Current at 11 October 2020, 2pm, said the Victorian Aged Care Response Centre continues to provide the robust response effort required to protect the most vulnerable senior Australians living in aged care from the COVID-19 pandemic. The number of Category 1 facilities (critical outbreak) is now zero, from a high of 13 in early August. The work of the Response Centre has also seen the number of facilities with outbreaks continue to fall. The total number of aged care outbreaks since 1 January 2020 is 176; there are now 32 active outbreaks.
Download

10 October

Operational update - Victorian Aged Care Response Centre
Current at 10 October 2020, 2pm, the Victorian Aged Care Response Centre continues to provide the robust response effort required to protect the most vulnerable senior Australians living in aged care from the COVID-19 pandemic. The number of Category 1 facilities (critical outbreak) is now zero, from a high of 13 in early August. The work of the Response Centre has also seen the number of facilities with outbreaks continue to fall. The total number of aged care outbreaks since 1 January 2020 is 176; there are now 35 active outbreaks.
Download

9 October

Aged care research centre to draw on world's best practice
Flinders University has been awarded the contract to develop the first stage of the Government's new $34 million Aged Care Centre for Growth and Translation Research. Minister Colbeck said the centre, would draw on world best practice and examine new ways to deliver care for senior Australians, and training and education for aged care providers. Stage 1 will establish the model for the centre and set the research priorities for the first year of operation.
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Royal Commission into Aged Care Quality and Safety

None this edition.

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Allied Health

14 October

ACT: Major parties endorse greater role for occupational therapists
The ACT Division of Occupational Therapy Australia (OTA) has welcomed several undertakings from the major parties contesting the ACT election. Correspondence detailing issues of concern to occupational therapists in the ACT was sent on 11 September to the ACT Labor Party, Canberra Liberals and ACT Greens. The ACT Greens have recognised occupational therapists as having a 'core' role in mental health service provision. The Canberra Liberals have recognised a holistic role for occupational therapists in the ACT.. The ACT Labor Party did not respond directly to OTA's correspondence, opting instead to forward its Health Policy Statement.
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Children's Health

None this edition.

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Clinical Governance

13 October

ARPANSA renews 35-year partnership with World Health Organization
The World Health Organization (WHO) plays a critical role in the direction and coordination of international health systems and public health policy. The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is proud to be continuing its 35-year partnership with WHO as a collaborating centre for radiation protection. 'In the current global health crisis, it is important that the work of the WHO continues to be supported internationally', said Dr Rick Tinker, Director, Assessment and Advice at ARPANSA.
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Construction and Health Infrastructure

None this edition.

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Dental

None this edition.

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Disabilities

14 October

Budget delivers for hard of hearing
The Australian Government will implement key initiatives from the Roadmap for Hearing Health, investing $21.2 million over five years. Addressing a meeting of the Hearing Health Sector Alliance, Minister for Regional Health Mark Coulton said the Government's investment reflects its ongoing commitment to improving access to hearing support services for vulnerable Australians. 'With more than 3.6 million Australians currently affected by hearing loss and that number expected to reach 7.8 million by 2060, it is vital we have the services and support that allow them to best live to their potential,' Minister Coulton said.
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13 October

TAS: Supporting Tasmanians with disability through COVID-19
Tasmanian disability service providers will benefit from a Plan which provides guidance on how to manage the impacts of COVID-19 and keep people with a disability safe. The Tasmanian Coronavirus (COVID-19) Disability Service Providers Preparedness and Response Plan (the Plan) comes in response to the Australian Government's Management and Operational Plan for People with Disability in line with the Australian Health Sector Emergency Response Plan for Coronavirus, said Tasmanian Minister for Disability Services Jeremy Rockliff.
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12 October

Improving the National Disability Insurance Scheme
The National Disability Insurance Agency (NDIA) will shortly release an engagement and consultation schedule to support the implementation of independent assessments. Sessions will be conducted nationwide, aligned to coronavirus (COVID-19) restrictions. Independent assessments give a simpler, faster and fairer basis for making decisions about access to the NDIS and plans. Independent assessments will not be needed every year or at every plan review. They'll be needed only when there is a major change in your life or plan.
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Royal Commission into Violence, Abuse, Neglect and Exploitation of People with Disability

Royal Commission into Violence, Abuse, Neglect & Exploitation of People with Disability
14 OCT: Transcript of Proceedings - Hearing Block 7, Day 3
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E-Health

None this edition.

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Education and Training

10 October

GP trainees need certainty following exam disruption
The Australian Medical Association (AMA) has called for certainty for the more than 1000 future Australian GPs whose futures have been thrown into doubt by the cancellation of the national RACGP Registrar exams, due to technical difficulties. The cancellation, which has caused severe distress, inconvenience and uncertainty for GP Registrars and the practices supporting them, dominated discussion at the meeting of the AMA Council of General Practice. '2020 has already been a year of terrible uncertainty for medical trainees due to COVID-19. A technology failure leading to exam cancellations at the last minute is the last thing that GP Registrars needed,' AMA President Dr Omar Khorshid said.
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Funding

14 October

$500,000 support for clinical trial manufacturing
A first-of-its-kind facility in Brisbane, backed by the Government, will see Australian start-ups able to manufacture potentially life-changing products for clinical trials here at home. The T3 Cleanrooms at the Translational Research Institute will support the development of new medical technologies and pharmaceuticals - fast-tracking job creating innovations in Australia. Minister for Industry, Science and Technology Karen Andrews said the $500,000 in federal funding demonstrates the Government's commitment to medical product manufacturing.
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Health Professionals

15 October

GPs vital in long-term care of COVID-19 patients
The Royal Australian College of General Practitioners (RACGP) is warning government that GPs will need adequate resources to manage the long-term care of COVID-19 positive patients. The RACGP has released a guide for GPs providing care to adult patients who have previously tested positive to COVID-19 or have a history suggestive of undiagnosed COVID-19 and have - or are at risk of - post-COVID-19 conditions. The guide was developed in collaboration with HealthPathways. RACGP Acting President Associate Professor Ayman Shenouda said that GPs would be managing the long-term impacts of the virus on some patients for years to come.
Download

13 October

PBS Practice Review - The role of DMARDs in the management of rheumatoid arthritis
NPS MedicineWise, in collaboration with the Australian Rheumatology Association, will be sending out PBS Practice Review reports to around 450 rheumatologists and relevant immunologists across Australia. For prescribers, these reports contain their individualised data on their prescribing of Disease Modifying Anti-Rheumatic Drugs (DMARDs) and other medicines used to manage rheumatoid arthritis.
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10 October

GP trainees need certainty following exam disruption
The Australian Medical Association (AMA) has called for certainty for the more than 1000 future Australian GPs whose futures have been thrown into doubt by the cancellation of the national RACGP Registrar exams, due to technical difficulties. The cancellation, which has caused severe distress, inconvenience and uncertainty for GP Registrars and the practices supporting them, dominated discussion at the meeting of the AMA Council of General Practice. '2020 has already been a year of terrible uncertainty for medical trainees due to COVID-19. A technology failure leading to exam cancellations at the last minute is the last thing that GP Registrars needed,' AMA President Dr Omar Khorshid said.
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Hospitals

13 October

Virtual hospital a new way of caring
'Virtual models of healthcare are an essential component of Australia's future health infrastructure', said Alison Verhoeven, Chief Executive of the Australian Healthcare and Hospitals Association (AHHA). 'Established as the first virtual hospital in NSW, rpavirtual was launched in early 2020 as a sustainable solution to increasing demand for healthcare in Sydney-and then the COVID-19 crisis hit', said RPA Virtual Hospital General Manager Miranda Shaw.
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12 October

QLD: Opposition plan to reduce surgery waiting lists
A Queensland Opposition Government will invest $300 million in a surgery blitz to clear the backlog of Queenslanders stranded on Labor's growing waiting list. The plan to reduce waiting lists runs parallel with the Opposition's $1.3 billion investment to recruit nearly 4500 more nurses, doctors, paramedics and allied health workers. The Opposition's $300 million will fast-track the surgeries of nearly 56,000 patients across Queensland through a partnership with the private sector to reduce waiting lists. Queensland Leader of the Opposition Deb Frecklington said her plan would ensure Queenslanders can get the surgery they need when they need it.
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9 October

NSW: $750 million RPA Hospital redevelopment fast-tracked
The $750 million redevelopment of Royal Prince Alfred Hospital has been brought forward by one year, after the NSW Government accelerated the project. NSW Premier Gladys Berejiklian said early and enabling works are expected to begin in the next six months on the major redevelopment which will be a game-changer for staff and patients. 'The $750 million investment will ensure the hospital continues to serve Sydney's growing community into the future,' Ms Berejiklian said. NSW Treasurer Dominic Perrottet said the acceleration of the project will create thousands of jobs, which is crucial to the state's COVID-19 Recovery Plan.
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Insurance

None this edition.

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Medicare

None this edition.

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Men's Health

None this edition.

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Mental Health

15 October

Women more likely to seek mental health treatment
New Medibank Group data shows the number of women admitted to hospital last financial year for mental health treatment across Australia was more than double that of men. Medibank and ahm supported more than 46,000 mental health-related hospital admissions for women nationally to June 2020, while men accounted for just under 20,000. The figures reflect that men are less likely to access care and support for mental health needs, while many women are more proactive in seeking help.
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14 October

Caring for mental and physical health during the pandemic
The Government recognises it is a very challenging time for many Australians, with the effects of the COVID-19 pandemic on daily life and work having taken a considerable toll on the mental health of individuals and communities. This is especially so in Victoria, which has endured the worst of the second wave of the COVID-19 pandemic and is subject to further restrictions. Nationally, since 16 March, there has been a 15% increase in the number of Medicare-subsidised mental health services delivered, with 7.4 million services provided and $819 million paid in benefits, said Minister for Health Greg Hunt.
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13 October

Outback beef farmers build resilience with mental health programs
Global supply chains are under stress and Australia's beef exporters are fighting hard to keep export markets open. Australian organic beef company, OBE Organic is also fighting hard to help farmers stay resilient, with a mental health and social media program that's inspiring loyal customers from around the world. AusTrade diplomats in Saudi Arabia recently negotiated an extension to beef shelf-life regulations from 70 to 120 days. This opened up sea freight options and allowed OBE Organic to continue shipping to Saudi Arabia.
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Small businesses reminded to reach out on World Mental Health Day
The Australian Small Business and Family Enterprise Ombudsman Kate Carnell has urged struggling small business owners to reach out for help on World Mental Health Day (October 10). 'This year, the World Mental Health Day focus is to campaign for greater investment in mental health services as the COVID crisis takes a heavy toll on wellbeing globally,' Ms Carnell said. 'The enormity of the lockdowns and the psychological distress this has caused for small business owners cannot be underestimated.'
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12 October

NSW: Improving mental health one workplace at a time
As part of SafeWork Month 2020, a number of prominent business and industry leaders have been appointed to help drive positive change by breaking down the barriers and stigma associated with mental health in NSW workplaces. NSW Minister for Better Regulation and Innovation Kevin Anderson and NSW Minister for Mental Health Bronnie Taylor announced the NSW Government has appointed 12 ambassadors to champion the importance of good mental health in the workplace. Mr Anderson said the ambassadors will play a critical role in assisting the NSW Government meet its target of 90,000 business taking effective action to create work environments which benefit mental health by 2022.
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NSW: Lifeline opens its doors in Dubbo
Western NSW residents will have even greater access to mental health support with the opening of a new Lifeline centre in Dubbo. NSW Minister Taylor will open the new, purpose-built centre, thanks to $600,000 in special funding from the Government. 'We want people living in the Central West to be able to access timely support from counsellors who understand their local community and the pressures they might be under,' Mrs Taylor said. NSW Member for Dubbo Dugald Saunders said the centre comes at a critical time for his community.
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Royal Commission into Victoria's Mental Health System

None this edition.

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Pharmaceuticals

15 October

Valerian (Valeriana officinalis)
Consumers and health professionals are advised that the Therapeutic Goods Administration (TGA) is investigating the safety of Valerian (Valeriana officinalis) following a small number of reports of liver injury. Valeriana officinalis is a medicinal herb with a long history of traditional use for conditions such as nervousness, trembling and headaches. Modern uses include to improve sleep and reduce sleeplessness, to reduce mild anxiety, and for other conditions such as menopause symptoms.
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TGA grants second provisional determination for a COVID-19 vaccine
The TGA, part of the Department of Health, has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA]. The granting of a provisional determination means that the TGA has made a decision that Pfizer is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG).
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Changes to the process for including Class I non-sterile, non-measuring devices in the ARTG
From 1 October 2020, the process by which the TGA includes Class I non-measuring, nonsterile medical devices in the Australian Register of Therapeutic Goods (ARTG) has changed. These changes do not at this stage apply to Class 1 IVD medical devices, Class I Export Only and Class I IVD Export Only devices.
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14 October

The ACSS Consortium welcomes the UK as its newest member
The heads of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium are pleased to announce that the United Kingdom (UK) therapeutic products regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), is joining as a new member. As one of the world's leading regulators of therapeutic products, the MHRA will bring additional resources and expertise to this well-established collaboration group. The MHRA will officially commence working with consortium partners as a full member on 1 January 2021, with a period of shadowing before then, said TGA.
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12 October

YongGang tablets
The TGA has tested a product labelled YongGang tablets and found that:
- YongGang tablets contain the undeclared substance sildenafil; and
- Consumers are advised that sildenafil is a prescription only (S4) medicine in Australia.
The supply of YongGang tablets containing the undisclosed sildenafil is illegal. YongGang tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA
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Is your advertising for therapeutic goods compliant?
The following checklist has been designed to assist advertisers to assess their consumer advertising for compliance with the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). It does not apply to labels, consumer medicine information or patient information leaflets. The checklist should be used in conjunction with the Act, the Code and published guidance, said the TGA.
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