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)

16 April

Department of Health statement
The Therapeutic Goods Administration (TGA) and New South Wales Health authorities are investigating a death in NSW, as part of this process the TGA is seeking further clinical information including clinical test results from the New South Wales Health Department. The blood clotting disorders being investigated in connection with the AstraZeneca COVID-19 vaccine are very rare and differ from common blood clots or venous thromboembolism, which occur in around 50 Australians every day.
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15 April

Marine Rotational Force - Darwin - positive result for COVID-19 during initial screening
On 14 April, a US Marine who arrived in Australia as part of the 2021 Marine Rotational Force - Darwin (MRF-D) returned a positive result for COVID-19 during initial screening at the commencement of their mandatory 14-day quarantine period. The Marine was transferred to the NT Centre for National Resilience where they underwent confirmatory testing. They will continue to be monitored at the Centre and complete their quarantine there, said the Department of Defence.
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NSW: COVID-19 (Coronavirus) statistics
NSW Health recorded no new locally acquired cases of COVID-19 in the 24 hours to 8pm. Nine new cases were acquired overseas, bringing the total number of cases in NSW since the beginning of the pandemic to 5,167. There were 10,548 tests reported to 8pm, compared with the previous day's total of 12,260. There were 4,218 COVID-19 vaccines administered by NSW Health in the 24 hours to 8pm. The total number of vaccines administered by NSW Health is now 164,855.
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NT: Positive COVID-19 Case Update
One new positive COVID-19 case has been recorded in the Northern Territory in the past 24 hours. A 22-year-old male US Marine who arrived into the Northern Territory on 12 April 2021, has tested positive for COVID-19. The patient is mildly symptomatic and is under the care of the AUSMAT team at the NT Centre for National Resilience, said the NT Department of the Chief Minister and Cabinet.
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SA: New vaccine hubs to scale up SA's rollout
The COVID-19 vaccine rollout is set to reach more South Australians in the north and south of Adelaide, with the Government confirming it will establish two additional vaccination hubs at Elizabeth and Noarlunga. SA Premier Steven Marshall said more than 100,000 South Australians had now been vaccinated through the rollout. SA Minister for Health and Wellbeing Stephen Wade said the two sites, along with the upcoming establishment of hubs at the Adelaide Showgrounds, Port Lincoln, Mount Gambier and Kangaroo Island, will scale up the state's rollout to reach even more South Australians.
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SA: COVID-19 update
There have been two new cases of COVID-19, both reported from a medi-hotel. There have been a total of 677 cases notified in South Australia. The cases are a woman in her 20s and a man in his 30s, who both acquired their infections overseas and have been in medi-hotels since their arrival, said the SA Department of Health. A man in his 40s remains in the Royal Adelaide Hospital ICU, in a critical condition.
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WA: COVID-19 update 15 April 2021
The WA Department of Health has reported one new case of COVID-19 - a male in his 40s - who is in hotel quarantine after returning from overseas travel. The State's total number now stands at 965. WA Health is monitoring 18 active cases of COVID-19 and 938 people have recovered from the virus in WA.
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14 April

Advancing FTA negotiations and vaccine diplomacy
Minister for Trade, Tourism and Investment Dan Tehan will travel to Europe and the United Kingdom for further Free Trade Agreement (FTA) negotiations, to encourage investment in Australia and to discuss vaccine supply. Mr Tehan will discuss the Australia-EU FTA with European Commission Vice President and Trade Commissioner Valdis Dombrovskis and the Australia-UK FTA with Secretary of State for International Trade the Rt Hon Liz Truss MP.
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Close to 500 NSW facilities delivering COVID-19 vaccine rollout
The Australian Government is getting on with the job of rolling out COVID-19 vaccines to regional, remote and rural Australia, with almost 500 facilities in New South Wales signed up to administer the vaccine. Minister for Regional Health Mark Coulton visited a clinic in Gunnedah, NSW where the rollout is underway. 'I'm pleased to be at Barber Street Practice in Gunnedah to visit one of the many GP clinics across rural Australia which has signed up to deliver COVID-19 vaccinations,' Minister Coulton said.
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Batch release assessment of COVID-19 vaccines
The TGA ensures there is an independent quality assessment of every batch of vaccine supplied in Australia. This page provides information about the batch release assessment process for COVID-19 vaccines. During the evaluation process for provisional registration, the TGA reviews data to confirm that the manufacturing process is well controlled and sets up how the quality of the vaccine will be maintained in future batches.
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Australian Health Protection Principal Committee (AHPPC) statement on continuous learning in managed quarantine for international arrivals
Managed quarantine (including hotel quarantine) for international arrivals to Australia continues to be important in Australia's response to COVID-19. It helps to prevent transmission of COVID-19 and protect the Australian community. The Australian Health Protection Principal Committee (AHPPC) continues to monitor current quarantine arrangements and look for ways to continuously improve the system, in line with the National Hotel Quarantine principles.
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SA: COVID-19 Update 14 April 2021
There has been one new case of COVID-19, reported from a medi-hotel. There have been a total of 675 cases notified in South Australia, said the SA Department of Health. The case is a man in his 30s who acquired his infection overseas and has been in a medi-hotel since his arrival. A man in his 40s remains in the Royal Adelaide Hospital ICU, in a critical condition.
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WA: COVID-19 update 14 April 2021
The WA Department of Health has reported seven new cases of COVID-19 - all of whom are in hotel quarantine after arriving from overseas. The new cases include a mother in her 30s and her young daughter and five males in their 30s, 40s and 50s. The State's total number now stands at 964.
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13 April

AstraZeneca ChAdOx1-S COVID-19 vaccine
The Vaccine Safety Investigation Group (VSIG), a panel of expert advisors to the TGA has concluded that a recently reported case of thrombosis with thrombocytopenia is likely to be linked to vaccination. This is the second Australian report of a case of thrombosis with thrombocytopenia following the AstraZeneca COVID-19 vaccine. The case occurred in a woman in her 40s who was vaccinated in Western Australia. The person remains in hospital receiving treatment and is in a stable condition.
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QLD company's COVID tests get European approval
Queensland biotech firm AnteoTech has gained European accreditation for its rapid COVID-19 testing platform and will now move to commercialising products as it waits to receive accreditation from Australian health authorities. The outer Brisbane-based health tech developed a 15 minute COVID-19 test using proprietary binding technology coupled with assay detection systems which provides decision-making support for the early detection and isolation of infected patients, said InnovationAus.
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Greens call for Finance Minister's COVID advance to be used now for publicly-owned vaccine production
The Greens say the government should use unallocated discretionary funds set aside for COVID to begin work on a publicly-owned domestic vaccine manufacturer. If the Government fails to act, the Greens plan to move in the Senate to demand action on domestic vaccine production when Parliament resumes, said Leader of the Australian Greens Adam Bandt and Greens Health spokesperson Senator Rachel Siewert.
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NSW: COVID-19 (Coronavirus) statistics
NSW recorded no new locally acquired cases of COVID-19. Five new cases were acquired overseas, bringing the total number of cases in NSW since the beginning of the pandemic to 5,155. There were 5,510 tests, compared with the previous day's total of 7,198. There were 4,359 COVID-19 vaccines administered by NSW Health. The total number of vaccines administered by NSW Health is now 155,894.
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SA: COVID-19 Update 13 April 2021
There have been eight new cases of COVID-19, all reported from a medi-hotel. There have been a total of 674 cases notified in South Australia. The cases include a child, a woman in her 20s, two women in their 30s, a woman in her 40s, a woman in her 50s, a man in his 20s, and a man in his 30s. All eight people acquired their infections overseas and have been in medi-hotels since their arrival, said the SA Department of Health.
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WA: COVID-19 update
The WA Department of Health has reported three new cases of COVID-19 - a female in her 20s and a male in his 40s are in hotel quarantine after arriving from overseas. A Filipino seaman in his 50s, who was transferred from a bulk carrier anchored off the Pilbara coast, is in a COVID-19 isolation ward in Royal Perth Hospital. The State's total number now stands at 957. WA Health is monitoring 11 active cases of COVID-19 and 937 people have recovered from the virus in WA.
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WA: Chief Health Officer statement: Adverse reaction linked to AstraZeneca vaccine
The Therapeutic Goods Administration (TGA) has confirmed a case of thrombosis with thrombocytopenia syndrome (TTS) in a Western Australian is likely linked to the Astra Zeneca vaccine. The woman, aged in her 40's, is currently under specialist care in the Royal Darwin Hospital. She received the AstraZeneca vaccine in mid-March in a WA regional hospital, said the WA Department of Health.
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12 April

NSW: COVID-19 (Coronavirus) statistics
NSW recorded no new locally acquired cases of COVID-19. Nine new cases were acquired overseas, bringing the total number of cases in NSW since the beginning of the pandemic to 5,150. There were 7,198 tests reported, compared with the previous day's total of 7,927. NSW Health administered 25,009 vaccines in the week ending Sunday 11 April.
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QLD: QLD company's 15-min rapid COVID-19 test takes fight to Europe
Queensland company AnteoTech has won a vital European accreditation for its 15-minute COVID-19 rapid test. AnteoTech now has Conformitè Europëenne Mark registration for its innovative point-of-care COVID-19 antigen rapid test platform, EuGeni. This meets crucial health and safety conditions in Europe and the United Kingdom. Queensland Premier Annastacia Palaszczuk said the Queensland Government was proud to provide support to companies developing technology to fight COVID-19. Queensland Treasurer Cameron Dick said Queensland ingenuity was proving crucial in stopping the spread of COVID-19.
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11 April

Timor-Leste flood and COVID-19 response
Australia is working in partnership with its close friend and neighbour Timor-Leste to support its recovery from the devastating Easter weekend flooding and its impact on COVID- 19 preparedness. In response to a request for assistance from the Government of Timor-Leste, an emergency relief of $7 million will support the estimated 100,000 people affected by the deluge and address critical food security needs. This assistance is in addition to immediate support Australia provided on the ground in Dili to thousands of people sheltering in evacuation centres, said Minister for Foreign Affairs Marise Payne and Minister for International Development and the Pacific Zed Seselja.
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NSW: COVID-19 (Coronavirus) statistics
NSW recorded no new locally acquired cases of COVID-19. Six new cases were acquired overseas, bringing the total number of cases in NSW since the beginning of the pandemic to 5,141. There were 7,927 tests reported, compared with the previous day's total of 8,686. NSW Health's vaccination clinics generally operate Monday to Friday. Therefore, there is a limited number of vaccines administered on weekend days due to planned closures.
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QLD: Historic case linked to Brisbane COVID-19 cluster
A historic case with a link to a recent Brisbane cluster has been added to Queensland's COVID-19 cases, taking the total to 1,502, said the Queensland Department of Health. Chief Health Officer Dr Jeannette Young said the case, who attended the Byron Bay party, had been in self-isolation and there was no risk to the community. 'This case is linked to the second Brisbane cluster that originated from a Princess Alexandra Hospital nurse, taking the total number of cases linked to that cluster to 13,' Ms Young said. 'As this person had attended the party where COVID-19 spread to a number of people, they were placed into self-isolation at home and a testing routine commenced.'
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10 April

Sharing COVID-19 vaccines with neighbours
'Australia is committed to supporting our region to respond to COVID-19,' said Minister for Health and Aged Care Greg Hunt, Minister Payne and Minister Seselja. 'We will soon start sharing doses of our Australian manufactured AstraZeneca vaccine with our neighbours. We will support our partners to vaccinate quickly their highest-risk populations at a time when the international supply of vaccines is constrained. Initially, Australia will share at least 10,000 AstraZeneca COVID-19 doses per week and will scale up as required.'
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9 April

National Cabinet Statement
The National Cabinet met to discuss Australia's COVID-19 response and the Australian COVID- 19 Vaccine Strategy, said Prime Minister Scott Morrison. National Cabinet continues to work together to address issues and find solutions to the health and economic consequences of COVID-19. The Chief Medical Officer, Professor Paul Kelly, provided an update on the latest epidemiological data and medical advice in relation to COVID-19. There have been 29,390 confirmed cases in Australia and, sadly, 909 people have died. More than 16 million tests have been undertaken in Australia.
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Australia boosts assistance for Papua New Guinea's COVID-19 response
Australia is working closely with the Government of Papua New Guinea to support its COVID-19 response, deploying a second team of health and medical specialists, said Minister Payne. An Australian Medical Assistance Team (AUSMAT) of 17 specialists will depart on a Royal Australian Air Force (RAAF) flight, to work with PNG's National Control Centre for COVID-19 and provide supplementary expert advice to local health authorities. Australia has also procured an additional 40,000 GeneXpert rapid testing cartridges for PNG's COVID-19 response, with 20,000 to be delivered to PNG.
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Communication key to vaccine confidence
The Australian Medical Association (AMA) commends the Government for listening to medical advice on the AstraZeneca vaccine and taking a more cautious approach to the rollout, with emerging evidence there is a very low risk of clotting associated with the vaccine. 'I want to emphasise the AstraZeneca vaccine for people who are 50 and over is considered very safe and the benefits vastly outweigh any risks,' AMA President Dr Omar Khorshid said. 'The system has worked as it should. The expert advice has been given and the Government is acting in line with it. The clotting seen in few patients around the world is extremely rare.'
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PNG health package backed by Aussies
The Australian Council for International Development (ACFID) has warmly welcomed the Government's next step in responding to the PNG epidemic by providing 10,000 vaccines a week to Melanesian countries and Timor-Leste and a further health assistance package for PNG. In responding, ACFID has released polling conducted by YouGov (1-6 April) showing that 84 per cent of Australians agree that the Government should be supporting PNG to help stop the spread of COVID-19. ACFID CEO, Marc Purcell commented: 'The Government is swinging behind our friends in PNG. This is another critical step to tackling the epidemic.'
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NSW: Coronavirus (COVID-19) statistics
NSW recorded no new locally acquired cases of COVID-19 in the 24 hours to 8pm. Two new cases were acquired overseas, bringing the total number of cases in NSW since the beginning of the pandemic to 5,131. There were 14,078 tests reported to 8pm, compared with the previous day's total of 11,694, said the NSW Department of Health.
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VIC: More Victorians in offices, shows and theatres
From midnight Friday 9 April, Victoria will move to allowing 100 per cent of seated indoor and outdoor capacity for entertainment, cultural and sporting venues up to a maximum of 1,000 patrons per space. The revised COVID-Safe settings mark a major milestone for operators in Victoria who can now sell more tickets, fill more seats and host more patrons. Seated indoor and outdoor entertainment, cultural and sporting venues seeking attendance of more than 1,000 people per space must apply for consideration under the Public Events Framework, said Victorian Minister for Health Martin Foley.
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Aged Care

15 April

Reform in opioid regulation should not be at the expense of palliative care patients
Palliative Care Australia (PCA), the nation's peak body for palliative care, has reiterated its support for reform of opioid regulation in Australia, but restated its position that any changes must not impact access to appropriate opioids for palliative care patients.
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14 April

Dementia care is personal... It's about all of us
'Based on current statistics, it seems inevitable that every single family in this country will at some stage experience the torment and distress of a loved one being overtaken by dementia,' Dementia Australia Chair Professor Graeme Samuel will say in his address. 'With around 70 per cent of Australians living in residential aged care having some form of cognitive impairment, their families face enormous difficulties in providing support for relatives struggling with the memory loss and behavioural changes that accompany the disease.'
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13 April

AMA identifies savings of $21.2 billion in aged care hospital admissions
The Australian Medical Association (AMA) has estimated that over the year up until 30 June 2021, there will have been 27,569 admissions of residents from nursing homes to hospitals that were potentially avoidable, costing $312 million and accounting for 159,693 hospital patient days. The staggering figure is the first national estimate of potentially preventable admissions to hospitals from nursing homes alone. In total, new AMA modelling has identified $21.2 billion of savings that could be made over four years if immediate reforms were implemented to the aged care system.
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12 April

Twelve aged care consumer peaks propose aged care reform plan
Twelve leading aged care consumer organisations, led by the Council on the Ageing (COTA) Australia, have issued a detailed joint response to the Final Report of the Aged Care Royal Commission, identifying the key reforms the Government must implement in the upcoming Federal Budget to ensure its response to the Royal Commission gets off to a flying start. In their joint statement the consumer organisations set out the package of urgent reforms the Government must deliver in the next 12-18 months to build a high quality aged care system that's grounded in human rights and which treats older people with respect for their diversity and capacities.
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Royal Commission into Aged Care Quality and Safety

12 April

Twelve aged care consumer peaks propose aged care reform plan
Twelve leading aged care consumer organisations, led by the Council on the Ageing (COTA) Australia, have issued a detailed joint response to the Final Report of the Aged Care Royal Commission, identifying the key reforms the Government must implement in the upcoming Federal Budget to ensure its response to the Royal Commission gets off to a flying start. In their joint statement the consumer organisations set out the package of urgent reforms the Government must deliver in the next 12-18 months to build a high quality aged care system that's grounded in human rights and which treats older people with respect for their diversity and capacities.
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Allied Health

None this edition.

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Children's Health

None this edition.

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Clinical Governance

15 April

Learning from consumer experience improves health care
The health system in Australia would benefit significantly by paying more attention to the lessons learned from patient experience, the Consumers Health Forum says. This is a key message from the latest edition of the Health Voices ejournal published which covers the recent Shifting Gears Australasian summit conference of the Consumers Health Forum.
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14 April

WA: Proof of concept to identify new HR system for WA Health
The Western Australian Government's $8.5 million investment to identify and prepare for a new integrated human resource (HR), payroll and rostering solution for the Western Australian health system has entered its second stage. Following an open tender and comprehensive stage one evaluation process, Deloitte has been invited to take part in a period of proof of concept testing, said WA Minister for Health Roger Cook.
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13 April

TAS: How many elective surgeries will Labor deliver?
Labor will not confirm how many elective surgeries Tasmanians will receive under their plan. Bastien Seidel has side stepped questions on elective surgery numbers for days, which suggests the real number falls well short of the Liberals 22,300 surgeries and endoscopies over four years. Labor do not see this as a priority and it's no surprise that last time in Government, Tasmanians were left waiting as long as 10 years for a surgery, said Tasmanian Minister for Health Sarah Courtney.
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TAS: Dr Seidel challenges Liberals to health debate
Tasmanian Shadow Health Minister Dr Bastian Seidel has thrown down the gauntlet to Peter Gutwein, Sarah Courtney and the Liberal Party, challenging them to a debate on the key election issue of health. Dr Seidel said he would be available to debate them anywhere, anytime. 'I am more than willing to put my years of record as a doctor up against Peter Gutwein, Sarah Courtney and their army of advisors,' Dr Seidel said.
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Construction and Health Infrastructure

None this edition.

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Dental

None this edition.

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Disabilities

15 April

Ugly compulsory independent assessments should be cancelled not just delayed
NDIS Minister Linda Reynolds must stop all compulsory independent assessments for people who participate in the NDIS and rollback vicious cuts to the scheme. Minister Reynolds has announced a delay in the so-called 'independent' assessments, but it does not go far enough. The assessments plan is an anti-disability monster and as the new Liberal gatekeeper of the NDIS she needs to put a stake in its heart - not just delay it, said Shadow Minister for the National Disability Insurance Scheme Bill Shorten.
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Pause to NDIS changes must be permanent
Australian Greens Disability spokesperson Senator Jordon Steele-John said the Government's plans to stall the introduction of compulsory independent assessments was an acknowledgement of the broad opposition to the controversial changes from disabled people and peak advocacy organisations.
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13 April

Minister Reynolds must call off disability razor gang
New NDIS Minister Linda Reynolds must stop hiding and come clean on a freshly revealed secret plan to slash services to Australians with disability. A new Sustainability Action Taskforce has told staff to 'slow' down getting Australians with disability on the NDIS and to slow their funding. It's time Minister Reynolds stopped treating the NDIS as a demotion and started burying Stuart Robert's terrible legacy, said Shadow Minister for the National Disability Insurance Scheme Bill Shorten and Shadow Assistant Minister for Government Services & the NDIS Kimberley Kitching.
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Royal Commission into Violence, Abuse, Neglect and Exploitation of People with Disability

None this edition.

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E-Health

12 April

Perils of recording telehealth consultations
The COVID-19 pandemic has necessitated rapid uptake and use of telehealth, unmasking a 'number of concerns potentially not previously contemplated by clinicians, patients and legislators', according to the authors of an Ethics and Law article published by the Medical Journal of Australia (MJA). 'Recording of clinical conversations or processes may enhance patient and clinician participation, self-reference, research, education and funding,' wrote the authors, led by Dr Caitlin Farmer, a radiology registrar at Monash Health, and Dr Patrick Mahar, a dermatologist at the Skin Health Institute and the Royal Children's Hospital Melbourne. 'In certain jurisdictions, however, clinical consultations or meetings may be lawfully recorded with or without participants' knowledge.'
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Education and Training

14 April

WA: Connecting WA's growing disability and aged care sector with job-ready workers
Developed in partnership with industry to meet its workforce needs, the Ageing and Disability Job Ready pilot program is part of the State Government's $5.5 billion investment to upskill the WA workforce and enhance employment and training opportunities following COVID-19. Applications for the program are now open with the first intake of students scheduled to start on April 23, 2021. The program is free for all job seekers, young people and concession-eligible students, said WA Minister for Education and Training Sue Ellery and WA Minister for Disability Services and Seniors and Ageing Don Punch.
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Funding

15 April

VIC: More than $200 million down the toilet in Labor's failed Ice Action Plan
Hundreds of millions of dollars poured into the Victorian Government's Ice Action Plan has failed to put a dent in Victoria's drugs crisis. Drug addiction is ruining lives and livelihoods of more and more Victorians every day. Reports have revealed Ice addiction is killing at least two Geelong residents every week, with data showing local residents are nearly three times as likely to die from illicit drugs than the state average, said Victorian Shadow Minister for Mental Health Emma Kealy.
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Health Professionals

None this edition.

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Hospitals

15 April

VIC: Helping protect hospitals from cyber attacks
Victorian hospitals and health services will share in $30 million to upgrade and modernise their IT infrastructure to help guard against cyber-attacks, thanks to the State Government. Victorian Minister for Health Martin Foley announced 28 hospitals and health services across Victoria that will receive funding as part of the Clinical Technology Refresh program. The program delivers funding to refresh older network infrastructure and replace end-of-life systems required to support safe delivery of patient care. Hospitals across Melbourne will share $21.67 million of the funding while regional and rural health services will share in $8.32 million.
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VIC: Better care and jobs: Work begins on Wangaratta Hospital
Work is underway on a bigger and better Wangaratta Hospital, which will deliver around 60 new jobs and ensure people living in Victoria's northeast can access the high-quality and safe care they need, closer to home. Victorian Minister Foley and Victorian Attorney-General Jaclyn Symes announced the $22.9 million project is on track to be completed in November 2022. 'This significant redevelopment will ensure Wangaratta Hospital can meet the needs of a growing community with increased capacity, reducing the need for patients to travel to Melbourne for care,' said Minister Foley.
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13 April

TAS: Major boost in frontline medical staff will slash out-of-control waiting lists at North West Regional Hospital
A Labor Government will significantly boost frontline medical staff at the North West Regional Hospital after seven years of cuts and neglect under the Liberals. Tasmanian Labor Leader Rebecca White said 25 additional permanent nurses and 12 new permanent specialist doctors would be employed at a cost of $23.4 million over the next four years to help slash waiting lists and solve the disaster the Gutwein Government has created for both patients and staff in the region.
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WA: Important staffing boost for WA hospitals
Nursing staff will increase as 100 new graduates begin starting shifts at hospitals across Western Australia. The new starters are among 600 new nurses set to join the WA health system over the next two years. There will be 300 new nurses this year, including 100 general graduate nurses and midwives, 100 newly qualified enrolled nurses and 100 graduate nurses for mental health service, said WA Minister for Health Roger Cook.
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12 April

TAS: Tasmanian Opposition will bring back essential health services including maternity and permanent medical staff to the Mersey Community Hospital
The Mersey Community Hospital will be transformed into a National Centre for Rural Health and Integrated Maternity Care under a Tasmanian Opposition Government. Tasmanian Leader Ms White said Labor's vision would see the Mersey Hospital take advantage of its unique position as a national leader in high-quality clinical care, build on its regional and rural health workforce and deliver additional funding for building upgrades. 'The Mersey Community Hospital provides critical health care to the community,' Ms White said. 'Across the north-west the importance of the Mersey and North-West Regional Hospital cannot be underestimated.'
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VIC: Nutritious and diverse food for Victorian hospitals
Victorian public hospital patients will have access to higher quality, more culturally diverse and locally sourced food, with new standards for health services to be introduced by the Government. The new nutrition and quality food standards will be finalised and put in place by the end of this year. Delivering on another key election commitment, the Government had a panel of experts in clinical and food service dietetics, food service management and procurement review the current standards and make recommendations to better serve Victorian patients and residential aged care residents, said Victorian Acting Premier James Merlino and Victorian Minister Foley.
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Insurance

9 April

PHI 19/21 update on Prostheses List Reforms
The Department of Health would like to thank all stakeholders who have contributed to discussions about reforms and improvements to the Prostheses List (PL), including those individuals and organisations who submitted a response to the recent consultation paper. The Consultation Paper was released on 18 December 2020 and closed for comment on 15 February 2021. The Paper sought feedback about better defining the scope of the PL, reducing benefits, and consolidating the PL.
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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 April

ACT: Office for Mental Health and Wellbeing on track to drive positive change
The Office for Mental Health and Wellbeing Mid-Term Review considered the office's model, its key achievements to date and heard directly from key stakeholders and community members about its value. The review received community feedback through surveys, interviews and meetings with key stakeholders. It found that the office was filling a critical gap by pursuing system integration and systemic quality improvements in the ACT, which should in the longer term contribute to better mental health and wellbeing outcomes for the community, ACT Minister for Mental Health Emma Davidson said.
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Royal Commission into Victoria's Mental Health System

None this edition.

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Pharmaceuticals and Regulation

14 April

Batch release assessment of COVID-19 vaccines
The Therapeutic Goods Administration (TGA) ensures there is an independent quality assessment of every batch of vaccine supplied in Australia. This page provides information about the batch release assessment process for COVID-19 vaccines. During the evaluation process for provisional registration, the TGA reviews data to confirm that the manufacturing process is well controlled and sets up how the quality of the vaccine will be maintained in future batches.
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Prescription medicines: new or extended uses, or new combinations of registered medicines
Over time, the approved therapeutic uses of prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG) can change, said the TGA. Changes commonly include 'new uses' or 'extended uses'. A new use is where an already registered medicine is approved for an additional therapeutic use. An extended use is where an already registered medicine is approved to treat a broader range of patients, e.g. a wider age range. New or extended uses are called 'extensions of indications'.
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Prescription medicines: registration of new generic medicines and biosimilar medicines
Throughout the year, the TGA be publishing information on new generic and biosimilar prescription medicines as they are approved. Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision.
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Prescription medicines: registration of new chemical entities in Australia
Each year, TGA registers approximately 40 new prescription medicines containing new active substances. These are referred to as New Chemical Entities (NCEs) or New Biological Entities (NBEs). Some of these NCEs/NBEs are innovative or 'first-in-class', and have been made available to the public for the first time outside the controlled environment of a clinical trial. This decision by TGA to register a NCE/NBE often comes after years of research and development and following a comprehensive review by TGA scientists and clinicians of the medicine's quality, safety and efficacy.
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Notification of decision on application DIR 179 from Novotech (Australia) Pty Limited - Clinical
trial with a genetically modified Vaccinia virus based treatment for solid cancerous tumours
The Office of the Gene Technology Regulator has issued licence DIR 179 to Novotech (Australia) Pty Limited, authorising the clinical trial with a genetically modified Vaccinia virus based treatment for solid cancerous tumours. The Risk Assessment and Risk Management Plan (RARMP) and the licence were finalised taking into account input received during consultation.
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