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)
18 February
Initial towns, suburbs and hubs for COVID-19 vaccine
People in priority groups who are most at risk and who need protection the most - will receive a vaccine first. The rollout will begin with the Pfizer/BioNTech vaccine, and following the approval by the Therapeutic Goods Administration (TGA), will include the AstraZeneca/Oxford vaccine from early March. The initial priority groups include aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers, said Minister for Health and Aged Care, Greg Hunt.
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NSW: COVID-19 (Coronavirus) statistics
NSW Health reported that NSW recorded: 'No new locally acquired and no overseas-acquired cases of COVID-19 in the 24 hours to 8pm last night, meaning the total number of cases in NSW since the beginning of the pandemic remains at 4,954. There were 20,906 tests reported to 8pm last night, compared with the previous day's total of 23,463. Today marks a record 32 days with no reported locally acquired cases in NSW and we would like to thank the community for getting tested and being vigilant with social distancing and mask-wearing.'
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17 February
Chief Medical Officer, Professor Paul Kelly's statement on COVID-19 hotspots
The Australian Government Chief Medical Officer, Professor Paul Kelly, declared the Greater Melbourne area a COVID-19 hotspot for the purposes of Commonwealth support from 11:59pm on 12 February 2021. This was for an initial period of three days, with review on 15 February. After assessment of the epidemiological situation, the declaration has been extended until 11:59pm on 17 February 2021. Since 12 February, an additional four cases have been confirmed to be infected with SARS-CoV-2 in the Greater Melbourne area. This brings the total number of cases associated with the outbreak at the Holiday Inn at Melbourne Airport to 17.
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We need a new approach to quarantine
The Greens say quarantine facilities need to be established out of cities and that facilities must be publicly funded and run. 'Our hotel quarantine system needs to be watertight. The UK, South Africa, Brazil variants are becoming the dominant variants in other parts of the world and we must keep these from getting out into our community,' Greens spokesperson on Health Senator Rachel Siewert said.
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NSW: COVID-19 vaccine program to begin on Monday
NSW Premier Gladys Berejiklian said that more than 35,000 critical staff in NSW will be among the first in Australia to receive the COVID-19 vaccine when the rollout begins on Monday, 22 February. The initial three-week vaccination phase will see all hotel quarantine workers given the Pfizer vaccine - including all workers within quarantine hotels, those screening arrivals at the airport, health staff, cleaners, NSW Police officers and security guards. Health care workers who have the greatest exposure to potential COVID-19 patients will also be included in the first round of jabs, which will be rolled out progressively.
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SA: Flinders COVID-19 Vaccine Hub fast-tracked
The COVID-19 vaccination hub at the Flinders Medical Centre has been fast-tracked to open alongside the hub at the Royal Adelaide Hospital. SA Minister for Health Stephen Wade said the fast-track, and the ability to roll out more vaccines quicker than expected, had been made possible by Federal Government advice that they were increasing the doses in the first month's delivery schedule.
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SA: First COVID-19 vaccine freezers arrive
The first freezers to store the Pfizer COVID-19 vaccine have arrived in South Australia and will be installed at the Royal Adelaide Hospital and Flinders Medical Centre hubs. SA Minister Wade said the investment of almost $30,000 puts South Australia in the best place possible to start vaccinating frontline health and quarantine workers as soon as we receive the vaccine from the Commonwealth Government.
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VIC: Statement from the Premier
Victorian Premier Daniel Andrews said that: '3,400 close contacts identified and isolated. Thousands of hours of painstaking interviews. 212,000 tests processed. 850,000 text messages into communities. An exacting, intricate and exhausting job against a more wicked enemy than we've known before. I want to thank those Victorians who've made it possible - and I want to thank every Victorian for their patience. Because of you, we've been able to track, trace and corner this mutant and more infectious strain of the virus. From 11:59pm tonight, we will largely return to the previous rules - while keeping a watchful eye on some of the riskier settings.'
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16 February
TGA approves AstraZeneca COVID-19 vaccine
Prime Minister Scott Morrison and Minister Hunt said that: 'The Therapeutic Goods Administration (TGA) has approved the AstraZeneca COVID-19 vaccine for use in Australia following a full and thorough assessment process. The vaccine has met the required standards for safety, quality and efficacy and will be provided free to Australians. This means Australia now has two safe and effective COVID-19 vaccines available. Initial supply into Australia will be imported from overseas. In the coming months, the AstraZeneca vaccine will be manufactured in Australia. Australia is one of a small number of countries in the world that can manufacture its own COVID-19 vaccine.'
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Ensuring senior Australians are vaccinated against COVID-19
Tens of thousands of aged care residents in Australia will soon receive their first vaccine dose against COVID-19. The Australian Government is ensuring those who are particularly vulnerable to the worst effects of the coronavirus receive the earliest protection, so priority is being given to residential aged care facility staff and residents. The vaccination program will begin in every state and territory and will include regional and rural aged care facilities. It is anticipated that the roll out to aged care facilities will take approximately six weeks. Minister Hunt said the vaccine implementation plan for residential aged care aimed to administer vaccines to more than 240 aged care facilities in the first week.
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AstraZeneca approval - time for vaccine rollout
Shadow Minister for Health and Ageing Mark Butler said that: 'It's great news for Australians that the TGA has approved the AstraZeneca vaccine - this is a huge effort by our regulators. The vaccine rollout should already be well underway. There are still a number of very serious questions about the rollout of the COVID-19 vaccine. How will the online booking system work? How will the vaccines be distributed to the states? When will we start to see jabs actually in people's arms?'
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Greens welcome AstraZeneca approval but say further diversity is needed
The Greens welcomed the news that AstraZeneca has been provisionally approved by the Therapeutic Goods Administration for use in Australia. 'However we cannot put all our eggs in one basket. It's clear with differing rates of efficacy and with new Covid-19 strains developing that we must continue to expand and diversify Australia's vaccine portfolio,' Australian Greens spokesperson on Health Senator Rachel Siewert said. 'Australia needs to build a diverse portfolio to rapidly pivot to deal with new strains and to develop herd immunity, including securing deals with Moderna and more Pfizer doses.
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NSW: COVID-19 (Coronavirus) statistics
NSW recorded no new locally acquired cases of COVID-19 in the 24 hours to 8pm last night. One new case was acquired overseas, bringing the total number of COVID-19 cases in NSW since the beginning of the pandemic to 4,950. There were 12,336 tests reported to 8pm last night, compared with the previous day's total of 15,695. NSW Health continues to strongly advise against non-essential travel to Victoria, and people subject to the restrictions in Victoria should not be travelling to NSW unless they are permitted to do so.
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NT: Northern Territory'S Covid-19 vaccine rollout to start soon
The Northern Territory Minister for Health Natasha Fyles said that the NT Government has announced the details for the first stage of the COVID-19 vaccine rollout in the Territory. Phase 1A of the rollout will commence, based on the latest advice from the Commonwealth Government. Phase 1A covers the most at-risk frontline workers, and the most at-risk vulnerable Territorians, according to the expert health advice. The Territory Government will deliver the vaccine to quarantine workers, border control workers and high-risk health care workers.
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15 February
First Pfizer vaccine doses arrive in Australia
More than 142,000 doses of the Pfizer/BioNTech COZVID-19 vaccine have arrived at Sydney airport in a major milestone in Australia's response to the pandemic. This is the first shipment of 20 million doses of the Pfizer vaccine the Government has secured as part of Australia's COVID-19 Vaccine and Treatment Strategy. The doses have been securely transported from the airport. The Therapeutic Goods Administration (TGA) will batch test the vaccines to ensure they meet Australia's strict quality standards. Prime Minister Morrison said the country was on track for the first and most vulnerable Australians to start receiving the vaccine from 22 February. 'The vaccine has landed and we're stepping up our fight against the pandemic,' the Prime Minister said.
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Testing of face masks and respirators
The Department of Health said that COVID-19 has caused a rapid rise in demand for the manufacturing, importation and sale of face masks and respirators, and there has been an associated increase in medical device inclusions in the Australian Register of Therapeutic Goods (ARTG). There has also been a growth in concerns regarding the quality and performance of these kinds of devices. The TGA Laboratories has developed capabilities to test surgical masks and respirators, to assess compliance with the requirements of key performance criteria. This testing, in conjunction with the Post-market Review of face masks, will provide the Australian community with information about the suitability of available face masks and respirators.
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VIC: COVID-19 Update
The Victorian Department of Families, Fairness and Housing (DFFH) has released updated guidance for disability service providers relevant to the current five day lockdown. The COVID-19 Circuit Break Actions - Factsheet for disability residential services (doc) is currently available at the top of the DFFH Disability Services Sector COVID-19 webpage and in summary NDS will provide updates regarding the disability sector when they become available. DFFH encourages providers to regularly check the DFFH Coronavirus daily update and the circuit breaker actions which lists the restrictions throughout Victoria during the lockdown.
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WA: COVID-19 update
The WA Department of Health has reported no new cases of COVID-19 overnight. The state's total number of confirmed cases remain at 910. At WA Health COVID clinics, 527 presented for testing - 521 were assessed and 521 swabbed. Details of all clinics are available on the HealthyWA. WA Health is monitoring 5 active cases of COVID-19 - 896 people have recovered from the virus in WA. To date, 22 cases of variant strains have been detected in Western Australia (15 B.1.1.7 strain and 7 B.1.351 strain). A total of 833,097 tests have been processed throughout the State. Of those, 124,135 were from regional WA. Visit WA Health's HealthyWA website for the latest information on COVID-19.
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SA: COVID-19 Update
There have been no new cases of COVID-19. There have been a total of 606 cases notified in South Australia. SA Health is continuing to respond to COVID-19 outbreaks in other jurisdictions. All South Australians who have symptoms of COVID-19 should get tested on the day symptoms appear. Symptoms include:
- fever or chills (in the absence of an alternative illness that explains these symptoms)
- an acute respiratory infection - e.g. cough, sore throat, runny nose, or shortness of breath
- loss of smell or alteration in the sense of taste
- diarrhoea and vomiting.
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ACT: Prepared for arrival of first vaccine
ACT Minister for Health Rachel Stephen-Smith said that Healthcare workers in the ACT and surrounding region who are most at risk from COVID-19 through their work will be some of the first people to receive the COVID-19 vaccine administered by the ACT Government. It is an important milestone in the ACT's management of the COVID-19 virus, but one that presents significant logistical challenges for all Governments in Australia. The ACT Government has begun speaking to people who qualify for a vaccine under phase 1a of Australia's COVID-19 vaccine national roll-out strategy in anticipation of the Pfizer vaccine arriving in Australia later this month.
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14 February
Government ensuring safe and secure delivery of COVID-19 vaccines
The Government's roll-out of the COVID-19 vaccines across the country is moving closer, with the plans for the complex distribution process and safe and secure storage of the vaccines well in hand. Deputy Prime Minister Michael McCormack and Minister for Regional Health, Regional Communities and Local Government Mark Coulton inspected DHL Supply Chain's large scale ultra-cold storage infrastructure. DHL's ultra-cold and secure storage facility will keep safe the supply of Australia's Pfizer-BioNTech vaccine, which needs to be stored at between minus 60 and 80 degrees. Australia will receive 20 million Pfizer-BioNTech doses in 2021.
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Vaccine rollout to support people from all backgrounds in Australia
The Government is ensuring the COVID-19 Vaccination Program meets the needs of everyone in Australia, including those from culturally, ethnically, and linguistically diverse communities, said Minister Hunt. To be successful, high uptake of COVID-19 vaccination will be required in Australia. Therefore it is critical that the vaccine program is designed and delivered in a manner which is accessible, inclusive and culturally safe. This includes ensuring that communications are developed and targeted for CALD communities and that information and services are delivered in appropriate languages and formats and within appropriate facilities and locations.
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NSW: COVID-19 (Coronavirus) statistics
NSW recorded no new locally acquired cases of COVID-19. Two new cases were acquired overseas, bringing the total number of COVID-19 cases in NSW since the beginning of the pandemic to 4,949, said NSW Health. There were 16,302 tests reported to 8pm, compared with the previous day's total of 13,088. This is the 28th consecutive day with no reported locally acquired cases. This is the first time NSW has gone 28 days without a locally acquired case since the beginning of the pandemic.
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VIC: Massive expansion of Victoria's public testing capacity
Victoria has more than tripled its coronavirus (COVID-19) testing capacity at public laboratories and can now process about 30,000 tests a day with the vast majority turned around in less than 24 hours. Victorian Minister for Health Martin Foley announced more resources and new equipment to boost Victoria's public pathology services - including five new high-throughput testing machines, which are now in operation. Pathology testing capacity in both public and private laboratories is essential to managing coronavirus outbreaks so Victoria's contact tracing teams can find cases quickly and slow the spread of this hyper-infectious virus.
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12 February
NSW: Victorian restrictions and border communities
NSW will not be closing its borders. However, NSW has tightened entry requirements for returning NSW residents with the signing of a new Public Health Order, after the announcement by the Victorian Government of a five-day 'circuit-breaker' lockdown. NSW residents in border communities will have different requirements, recognising the daily interaction of residents with Victoria. Under the state-wide Order, anyone arriving in NSW from Victoria after 11.59pm on Friday 12 February 2021 must remain at their home or place of residence for the five-day period announced by the Victorian Government, said NSW Health.
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Aged Care
18 February
Initial towns, suburbs and hubs for COVID-19 vaccine
People in priority groups who are most at risk and who need protection the most - will receive a vaccine first. The rollout will begin with the Pfizer/BioNTech vaccine, and following the approval by the Therapeutic Goods Administration (TGA), will include the AstraZeneca/Oxford vaccine from early March. The initial priority groups include aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers, said Minister for Health and Aged Care, Greg Hunt.
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NSW: Aged care simulation to tackle an ageing population
A real-life aged care simulation offered at TAFE NSW is equipping students with practical skills to tackle an industry crying out for qualified workers. The innovative masked simulation adopted from CQ University research, involves teachers donning silicone props including a face, hand and torso mask, becoming the persona of an elderly aged care resident so students can apply practical skills to complement their theory and work experience in their TAFE NSW community services course. The demand for specialised skills has also been heightened by the Aged Care Royal Commission, which raised the need to improve standards in the industry.
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16 February
Additional reform to protect older Australians in care
The Aged care legislation amendment (Serious Incident Response Scheme and other measures) Bill 2020 will ensure tangible steps toward the prevention of incidence of abuse and neglect of older Australians in care. The SIRS legislation will also provide a range of broader powers for the Aged Care Quality and Safety Commissioner, consistent with the Regulatory Powers Act. Minister for Senior Australians and Aged Care Services Richard Colbeck said the measures reaffirmed the Government's commitment to prioritising the needs of ageing Australians.
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12 February
Minister Hunt and high-profile experts headline LASA's Royal Commission Aged Care Transformed Forum
Leading Age Services Australia (LASA) will host a two-day Aged Care Transformed Forum, following the Royal Commission's Final Report including comprehensive analysis from Minister for Aged Care Greg Hunt and a raft of national experts. 'This seminal event will be analysing the Final Report and examining the implications of all aspects of how we deliver care, including quality and compliance, funding and finance, workforce and technology,' said LASA CEO Sean Rooney. 'This is an exceptional online Forum that will be vital for all aged care providers across the nation.'
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Royal Commission into Aged Care Quality and Safety
None this edition.
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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
None this edition.
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Construction and Health Infrastructure
None this edition.
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Dental
None this edition.
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Disabilities
18 February
Initial towns, suburbs and hubs for COVID-19 vaccine
People in priority groups who are most at risk and who need protection the most - will receive a vaccine first. The rollout will begin with the Pfizer/BioNTech vaccine, and following the approval by the Therapeutic Goods Administration (TGA), will include the AstraZeneca/Oxford vaccine from early March. The initial priority groups include aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers, said Minister for Health and Aged Care, Greg Hunt.
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17 February
National Disability Services: vaccine must be mandatory
'NDS member staff surveys and other correspondence have shown that voluntary take-up of the vaccine by disability support workers will be insufficient to afford the highest level of care for people with disability,' said National Disability Services (NDS) CEO David Moody. Disability support workers are the front line of support services, interacting each day with one of Australia's most vulnerable populations to the virus - a fact recognised by people with disability and their support workers being placed at the front of the vaccination queue.
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WA: Liberals commit to re-establishment of Disability Services Commission as a standalone department
Western Australia Shadow Minister for Disability Services Peter Collier has announced that the Liberal Party, if elected, will commit to the re-establishment of the Disability Services Commission as a standalone autonomous department with responsibility for the delivery of services to the disability sector throughout Western Australia. 'The decision by the Labor Government to dissolve the Disability Services Commission (DSC) and locate it in the mega Department of Communities has been an unmitigated disaster,' Mr Collier said.
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15 February
VIC: COVID-19 Update
The Victorian Department of Families, Fairness and Housing (DFFH) has released updated guidance for disability service providers relevant to the current five day lockdown. The COVID-19 Circuit Break Actions - Factsheet for disability residential services (doc) is currently available at the top of the DFFH Disability Services Sector COVID-19 webpage and in summary NDS will provide updates regarding the disability sector when they become available. DFFH encourages providers to regularly check the DFFH Coronavirus daily update and the circuit breaker actions which lists the restrictions throughout Victoria during the lockdown.
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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
None this edition.
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Education and Training
None this edition.
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Funding
17 February
Stride out to save a life
Australians are being urged to raise awareness about organ and tissue donation by strapping on their joggers and striding out as part of the 15th annual Gift of Life DonateLife Walk. Launching the Walk in Canberra with parliamentary colleagues, Minister responsible for the Organ and Tissue Authority Mark Coulton said the long-running event will this year be held virtually to ensure COVID-safety and nation-wide participation. 'Community events like Gift of Life's DonateLife Walk offer unique opportunities for Australians from all walks of life to spruik the benefits of organ and tissue donation and have fun while doing it,' Mr Coulton said.
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Health Professionals
18 February
Initial towns, suburbs and hubs for COVID-19 vaccine
People in priority groups who are most at risk and who need protection the most - will receive a vaccine first. The rollout will begin with the Pfizer/BioNTech vaccine, and following the approval by the Therapeutic Goods Administration (TGA), will include the AstraZeneca/Oxford vaccine from early March. The initial priority groups include aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers, said Minister for Health and Aged Care, Greg Hunt.
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16 February
RACGP welcomes TGA approval of AstraZeneca vaccine
The Royal Australian College of General Practitioners (RACGP) welcomed the approval of the AstraZeneca coronavirus vaccine by the medical regulator, paving the way for the roll-out to patients via general practice. The AstraZeneca vaccine has been granted provisional approval by the Therapeutic Goods Administration (TGA) for adults aged 18 and over. The regulator said the decision to immunise those aged over 65 should be made on a case-by-case basis. President Dr Karen Price said general practice stood ready and able to support the vaccine roll-out.
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Hospitals
17 February
QLD: Open for comment - private hospital services table of costs
WorkCover Queensland said it will introduce a consistent fee structure, in the form of a table of costs, for private hospital services for the treatment of patients with a workers' compensation claim. Consultation and feedback is key. Insights from research, analysis and consultation with other jurisdictions and key stakeholders, has indicated the introduction of the Private Hospital Services Table of Costs would minimise the disparity in fees and service standards and improve efficiency in billing.
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15 February
NSW: Security in hospitals review release
The NSW Government has released the final report into improvements to security in hospitals. Minister for Health Brad Hazzard thanked former Minister for Health and Police Peter Anderson for his statewide review and its recommendations to improve safety for staff, patients and visitors to hospitals. 'Peter Anderson visited rural, regional and metropolitan health facilities and spoke at length to frontline staff with one goal in mind: to help make our hospitals as safe as they possibly can be,' Mr Hazzard said.
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Insurance
18 February
DEPT OF HEALTH: PHI 11/21 second-tier updates - Following private hospitals' names &/or address updated to match their state license - Following hospitals approved for second-tier with effect 16 February 2021
15 February
A greater reform effort is needed to keep health insurance affordable
Medibank said that: 'All Australians benefit from private health insurance as it takes pressure off the public health system, provides greater consumer choice, and reduces costs for taxpayers. Private health insurance funds two in every five hospital admissions in Australia - admissions whose costs would otherwise be borne by an already pressured public health system. The Australian Government has announced a second wave of private health insurance reforms, with the aim of improving affordability, value and attractiveness of private health insurance, particularly for younger Australians. Today, we are releasing our response to the consultation on the suggested reforms.'
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Medicare
None this edition.
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Men's Health
None this edition.
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Mental Health
18 February
VIC: Date Set for Mental Health Royal Commission Final Report
The final report and recommendations of the Royal Commission into Victoria's Mental Health System will be tabled on Tuesday, 2 March, 2021 prior to an historic joint sitting of the Victorian Parliament. The Parliament will hear directly from Chair, Penny Armytage AM, Professor Patrick McGorry AO and a member of the Victorian community with lived experience of mental illness, said Victorian Premier Daniel Andrews and Victorian Minister for Mental Health James Merlino.
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16 February
QLD: Government's $7 million boost for Gold Coast mental health
Queensland Minister for Health Yvette D'Ath turned the first sod on a new $7 million Mental Health Crisis Stabilisation service at Robina Hospital. Minister D'Ath said the new service, incorporating 12 chairs in a new purpose-built building, would deliver an important expansion of mental health support services on the Gold Coast. This is in addition to an extra 8 mental health beds being delivered within the existing Robina Hospital. 'This will be one of the first health services in Australia to introduce a crisis stabilisation facility and model of care, which offers a more suitable environment for treatment than the Emergency Department,' Minister D'Ath said.
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15 February
VIC: Better mental health support for workers on its way
Delivering on a key election commitment, the Workplace Injury Rehabilitation and Compensation Amendment (Provisional Payments) Act 2020 removes barriers for workers seeking urgent mental health support. The new laws mean that Victorian workers who seek compensation for a mental health injury under WorkCover will receive payments for reasonable medical expenses while they await the outcome of their claim, said Victorian Minister for Workplace Safety Ingrid Stitt.
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Royal Commission into Victoria's Mental Health System
None this edition.
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Pharmaceuticals and Regulation
18 February
Initial towns, suburbs and hubs for COVID-19 vaccine
People in priority groups who are most at risk and who need protection the most - will receive a vaccine first. The rollout will begin with the Pfizer/BioNTech vaccine, and following the approval by the Therapeutic Goods Administration (TGA), will include the AstraZeneca/Oxford vaccine from early March. The initial priority groups include aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers, said Minister for Health and Aged Care Greg Hunt.
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Prescription medicines: registration of new chemical entities in Australia, 2020
Each year, the Therapeutic Goods Administration (TGA) registers approximately 40 new prescription medicines containing new active substances, 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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Greens welcome AstraZeneca approval but say further diversity is needed
The Greens welcome the news that AstraZeneca has been provisionally approved by the Therapeutic Goods Administration for use in Australia. 'However we cannot put all our eggs in one basket. It's clear with differing rates of efficacy and with new Covid-19 strains developing that we must continue to expand and diversify Australia's vaccine portfolio,' Australian Greens spokesperson on Health Senator Rachel Siewert said.
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17 February
Notification of decision on application DIR 174 from Biocelect Pty Ltd for the commercial supply of a GM cholera vaccine, Vaxchora®
The Regulator has issued licence DIR 174 to Biocelect Pty Ltd, authorising import, transport, storage and disposal associated with commercial supply of a genetically modified (GM) cholera vaccine, Vaxchora®. Vaxchora® is a vaccine developed to prevent cholera disease in people who travel overseas to areas where cholera is present. These activities associated with GM vaccine supply are authorised to take place throughout Australia. This vaccine also requires approval from other agencies including the Therapeutic Goods Administration.
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Various medicines containing Artemisia annua and Artemisia absinthium
Consumers and health professionals are advised that multiple listed medicines are being recalled due to the presence of high levels of Artemisia annua or Artemisia absinthium. The medicines listed below pose an unacceptable risk if used during pregnancy. The TGA published a safety advisory for listed medicines containing Artemisia species. The safety advisory warned consumers of the potential risk of using these medicines during pregnancy.
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NSW: Greens MP introduces Bill to legalise cannabis in NSW
Greens drug law reform spokesperson Cate Faehrmann said she will introduce a Bill into the NSW Upper House to legalise and regulate the personal use of cannabis. This comes at a time when many jurisdictions around the world are moving to adopt various models of cannabis decriminalisation or legalisation for both medicinal and recreational use. 'It's time to legalise cannabis in NSW. More than one in three of us have used cannabis in our lifetimes, with more than two million Australians using cannabis in the past year,' said Cate Faehrmann.
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SA: Flinders COVID-19 Vaccine Hub fast-tracked
The COVID-19 vaccination hub at the Flinders Medical Centre has been fast-tracked to open alongside the hub at the Royal Adelaide Hospital. SA Minister for Health Stephen Wade said the fast-track, and the ability to roll out more vaccines quicker than expected, had been made possible by Federal Government advice that they were increasing the doses in the first month's delivery schedule.
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SA: First COVID-19 vaccine freezers arrive
The first freezers to store the Pfizer COVID-19 vaccine have arrived in South Australia and will be installed at the Royal Adelaide Hospital and Flinders Medical Centre hubs. SA Minister Wade said the investment of almost $30,000 puts South Australia in the best place possible to start vaccinating frontline health and quarantine workers as soon as SA receives the vaccine from the Commonwealth Government.
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16 February
TGA approves AstraZeneca COVID-19 vaccine
Prime Minister Scott Morrison and Minister Hunt said that the Therapeutic Goods Administration (TGA) approved the AstraZeneca COVID-19 vaccine for use in Australia following a full and thorough assessment process. The vaccine has met the required standards for safety, quality and efficacy and will be provided free to Australians. This means Australia now has two safe and effective COVID-19 vaccines available. Initial supply into Australia will be imported from overseas. In the coming months, the AstraZeneca vaccine will be manufactured in Australia.
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Federal Court finds Evolution Supplements Australia breached advertising laws
The Federal Court of Australia has found that Evolution Supplements Australia Pty Ltd and its sole director, Mr Cumhur Keskin, unlawfully advertised prescription only substances and therapeutic goods not in the Australian Register of Therapeutic Goods (ARTG) to consumers. The Court also found that Mr Keskin had failed to comply with a direction from the TGA, part of the Department of Health, to stop advertising these goods.
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AstraZeneca approval - time for vaccine rollout
Shadow Minister for Health and Ageing Mark Butler said that: 'It's great news for Australians that the TGA has approved the AstraZeneca vaccine - this is a huge effort by our regulators. The vaccine rollout should already be well underway. There are still a number of very serious questions about the rollout of the COVID-19 vaccine. How will the online booking system work? How will the vaccines be distributed to the states? When will we start to see jabs actually in people's arms?'
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Greens welcome AstraZeneca approval but say further diversity is needed
The Greens welcomed the news that AstraZeneca has been provisionally approved by the Therapeutic Goods Administration for use in Australia. 'However we cannot put all our eggs in one basket. It's clear with differing rates of efficacy and with new Covid-19 strains developing that we must continue to expand and diversify Australia's vaccine portfolio,' Greens Senator Siewert said. 'Australia needs to build a diverse portfolio to rapidly pivot to deal with new strains and to develop herd immunity, including securing deals with Moderna and more Pfizer doses.
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Research
17 February
Successful clinical trial for prostate cancer treatment includes lutetium-177 produced by ANSTO
The Peter MacCallum Cancer Centre has reported on the favourable results of a Phase 2 clinical trial of Lutetium PSMA (Lu-PSMA) for advanced prostate cancer undertaken at 11 clinical centres around Australia in 2018 -2019. The study was sponsored by the Australia and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), said the Australian Nuclear Science & Technology Organisation (ANSTO).
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16 February
Adding new cells to the mature central nervous system - Investigating their normal function and potential for repair
The National Health and Medical Research Council (NHMRC) said that people with Multiple Sclerosis (MS), the myelin that covers nerve fibres in the central nervous system (brain, optic nerves and spinal cord) is damaged, leading to impairment of cognitive, motor and sometimes sensory functions. 'Through an effective clinical collaboration we are currently undertaking an exciting clinical trial to deliver repetitive transcranial magnetic stimulation to people with MS. This noninvasive treatment's purpose is to promote new brain cell generation and brain lesion healing,' Associate Professor Kaylene Young said.
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15 February
Artificial intelligence in medicine: Lowering the barriers
Rapid advances in artificial intelligence in ophthalmology are a harbinger of things to come for other fields of medicine, according to the authors of a Perspective published online by the Medical Journal of Australia. Associate Professor Peter van Wijngaarden, Principal Investigator at the Centre for Eye Research Australia, and the University of Melbourne's Department of Surgery, and colleagues wrote that 'ophthalmology is at the vanguard of the development and clinical application of AI'.
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Non-invasive prenatal testing: Clinical utility and ethical concerns
AS non-invasive prenatal testing becomes more advanced, questions of informed consent, clinical utility and ethical concerns become more complicated for clinicians, and more anxiety-provoking for parents, according to the authors of an Ethics and Law article published online by the MJA. Non-invasive prenatal testing (NIPT), introduced in 2010, was 'revolutionary, with sensitivity, specificity and detection rates unmatched', according to the authors, led by Dr Joseph Thomas, a senior specialist in maternal-fetal medicine at Mater Health Services in Brisbane. 'NIPT was found to achieve a detection rate for Down syndrome of 99.7%, with a false positive rate of 0.04%,' Thomas and colleagues wrote.
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Rural, Regional and Remote Health
14 February
Government ensuring safe and secure delivery of COVID-19 vaccines
The Government's roll-out of the COVID-19 vaccines across the country is moving closer, with the plans for the complex distribution process and safe and secure storage of the vaccines well in hand. Deputy Prime Minister Michael McCormack and Minister for Regional Health Mark Coulton inspected DHL Supply Chain's large scale ultra-cold storage infrastructure. DHL's ultra-cold and secure storage facility will keep safe the supply of Australia's Pfizer-BioNTech vaccine, which needs to be stored at between minus 60 and 80 degrees. Australia will receive 20 million Pfizer-BioNTech doses in 2021.
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Women's Health
18 February
Family court abolition a terrible day for vulnerable families
The effective abolition of the Family Court went against the advice of over 150 organisation and experts in the family law field, who all opposed this radical and ill-thought-out proposal. It is very telling that the Government shut down debate so it could ram its legislation through the Senate in just two days. The Family Court is too important to be traded for short-term deals and this shameful vote will hurt some of Australia's most desperate and vulnerable people for years to come, said Shadow Attorney-General Mark Dreyfus.
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17 February
'Harmful amendments' slammed by gender equality and human rights groups
Fair Agenda and the Human Rights Law Centre have slammed proposed amendments to the South Australian Termination of Pregnancy Bill 2020, saying they will undermine compassionate and accessible healthcare. 'Abortion is healthcare and it's time for the South Australian Parliament to be on the right side of history and treat it accordingly. The amendments proposed to date are harmful and clearly designed to frustrate people's reproductive freedom. This reform should be passed without amendment,' said Monique Hurley, Senior Lawyer, Human Rights Law Centre.
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15 February
New online tool to help navigate IVF
The Government is strengthening support for couples trying to become pregnant through the launch of the YourIVFSuccess website. In Vitro Fertilisation - IVF - and other assisted reproductive technologies have helped hundreds of thousands of Australians experience the joy of becoming parents. Until now, there has not been an easy way for consumers to find and compare fertility clinics or to estimate their individual chance of success. Minister for Health and Aged Care Greg Hunt said that one in six Australian couples face difficulty trying to start a family. 'For a range of reasons, sometimes starting a family is not straightforward and this can be a confusing and distressing time,' Minister Hunt said.
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Increasing ovarian cancer care and support
As part of Ovarian Cancer Awareness Month, the Government will provide a further $1 million to Ovarian Cancer Australia for their work supporting those living with ovarian cancer said Minister Hunt. Each year in Australia, approximately 1,500 women are diagnosed with ovarian cancer. Tragically, more than 1,000 will die. While ovarian cancer is more commonly diagnosed in women over the age of 50, it can occur at any age. Ovarian Cancer Australia's Teal Support Program is built on a psychosocial support case management model, including using telehealth to provide care and support to both ovarian cancer patients and their families.
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Transcripts
Minister for Health Greg Hunt
18 FEB: Transcript of Press Conference, Canberra
Subjects: Vaccine rollout in Australia, Pfizer, AstraZeneca, COVID-19, Public health, Australian Technical Advisory Group on Immunisation
Minister for Senior Australians and Aged Care Services Richard Colbeck
17 FEB: Transcript of Interview with Fran Kelly, RN Breakfast
Subjects: COVID-19 vaccine roll out to aged care, Royal Commission final report, Sexual assault allegations, Workplace culture in Parliament House
Leader of the Australian Labor Party Anthony Albanese
17 FEB: Transcript of Doorstop Interview, Parliament House, Canberra
Subjects: TAFE and education, Alleged assault in Parliament House, Workplace culture in Parliament House, NSW Labor Party, Coronavirus vaccine rollout
Prime Minister Scott Morrison
16 FEB: Transcript of Speech delivered at Ovarian Cancer Australia Teal Ribbon Parliamentary Breakfast
Subjects: Ovarian cancer, PBS, Medical research, Funding, National Health and Medical Research Council, Women's health
Minister for Foreign Affairs Marise Payne
16 FEB: Transcript of Interview with Stephen Cenatiempo, 2CC Breakfast Show
Subjects: Vaccine rollout, Industrial relations, Gig economy, JobKeeper, The Pacific, China, Papua New Guinea
Deputy Leader of the Australian Labor Party Richard Marles
16 FEB: Transcript of Interview with Fran Kelly, ABC Radio National
Subjects: Right to feel safe working at Parliament House, Vaccine rollout, Regional quarantine, Minister for Home Affairs, Hotel quarantine workers, Australians overseas
Shadow Assistant Minister for Western Australia Patrick Gorman
16 FEB: Transcript of Interview with Glenn Barndon, Midwest & Wheatbelt Mornings
Subjects: Paternity leave, Geraldton, Vaccine rollout, Childcare
Minister for Health Greg Hunt
15 FEB: Transcript of Doorstop Interview, Canberra
Subjects: Victorian outbreak, Vaccine rollout, TGA, Coronavirus, Testing
Minister for Health Greg Hunt
15 FEB: Transcript of Interview with Jim Wilson, 2GB Drive
Subjects: Vaccine rollout, Coronavirus, Hotel quarantine, Victorian lockdown, TGA
Treasurer Josh Frydenberg
15 FEB: Transcript of Interview with Peter Stefanovic, First Edition, Sky News
Subjects: JobKeeper, Victorian lockdown, Coronavirus, Hotel quarantine, Contact tracing & testing, JobSeeker
Minister for Indigenous Australians Ken Wyatt
15 FEB: Transcript of Interview with Patricia Karvelas, Afternoon Briefing
Subjects: National Apology to the Stolen Generations, Closing the Gap, ILSC, TAS apology, COVID-19 vaccine
Deputy Leader of the Australian Labor Party Richard Marles
15 FEB: Transcript of Doorstop Interview, Parliament House, Canberra
Subjects: JobKeeper & JobSeeker cuts, Wage subsidy program, Employment, Labour market, Victorian lockdown
Shadow Minister for Women Tanya Plibersek
15 FEB: Transcript of Interview with Rebecca Levingston, ABC Radio Brisbane Mornings
Subjects: Coronavirus, Aged care, Federal Minister for Agriculture, Queensland, Federal election
Shadow Minister for Health and Ageing Mark Butler
15 FEB: Transcript of Doorstop Interview, Parliament House, Canberra
Subjects: Vaccine rollout, COVID-19, Hotel quarantine facilities & arrangements, Parliament House, Allegations of sexual assault
Shadow Minister for Early Childhood Education and Development Amanda Rishworth
15 FEB: Transcript of Interview with Tom Connell, Sky News
Subjects: Vaccine rollout, Coronavirus, Hotel quarantine, TGA
Minister for Health and Aged Care Greg Hunt and Chief Medical Officer Paul Kelly
14 FEB: Transcript of Doorstop Interview, Canberra
Subjects: CALD COVID vaccination plan, Vaccine arrival and rollout, Victoria's lockdown, New Zealand travel bubble, AHPPC, Victoria's contact tracing system
Department of Health
13 FEB: Transcript of Chief Medical Officer, Professor Paul Kelly's, Press Conference, Canberra
Subjects: Victoria's Holiday Inn COVID-19 cluster, Australian Health Protection Principal Committee, Hotel quarantine, Vaccine rollout
Prime Minister Scott Morrison and Minister for Health Greg Hunt
12 FEB: Transcript of Press Conference, Parkville, Victoria
Subjects: CSL, Vaccine production, COVID-19, Therapeutic Goods Administration, Family, Aged care, Employment, Victoria, Hotel quarantine workers
Minister for Finance Simon Birmingham
12 FEB: Transcript of Speech to the Australia-Israel Chamber of Commerce, Adelaide, South Australia
Subjects: COVID-19, Public health, Victorian lockdown, Vaccine rollouts, Israel, Manufacturing, Pacific Islands, JobKeeper
Minister for Home Affairs Peter Dutton and Deputy Leader of the Australian Labor Party Richard Marles
12 FEB: Transcript of Interview with Karl Stefanovic, Today Show
Subjects: Holiday Inn, Hotel quarantine, Vaccine rollout, Rorting of community safety grants, Federal Election
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Reports
COVID-19 Vaccination Program - Culturally and Linguistically Diverse Communities Implementation Plan
Department of Health
The Australian COVID-19 Vaccination Policy, endorsed by the National Cabinet on 13 November 2020, sets out key principles for the COVID-19 Vaccination Program (Program) roll-out, such as that COVID-19 vaccines will be made available for free to every person living in Australia. Further, it outlines how COVID-19 vaccines will be accessible on a rolling basis, dependent on vaccine delivery schedules and the identification of groups for most urgent vaccination.
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COVID-19 outbreaks in Australian residential aged care facilities - Report
Department of Health
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Clinical decision support software - Scope & examples - Draft Version 1.0, February 2021
Department of Health, Therapeutic Goods Administration (TGA)
From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. Information about the changes can be found in Regulatory changes for software based medical devices. Clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods (ARTG) unless otherwise exempt. Under the changes, an exemption has been introduced for some CDSS that is a medical device.
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Psychiatric Impairments and the Disability Support Pension - Selection of case studies from EJA member centres around Australia
Economic Justice Australia (EJA)
For people whose primary condition is a psychiatric impairment, the member community legal centre experience is that the eligibility criteria and application requirements make it more difficult for them to access the Disability Support Pension. Many people in this situation end up on JobSeeker Payment where they find it difficult to meet the mutual obligation requirements to remain eligible for payment.
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NDIS Quarterly Report- Q2 2020-2021
National Disability Insurance Agency (NDIA)
The Australian Government has announced Australia's COVID-19 vaccine national roll-out strategy. Disability care workers and residents are intended to be in the first phase (phase 1a) of the national vaccination roll-out whilst those people with a disability, not living in a shared disability care residence are intended to be included in the phase 1b roll-out. The NDIA is working closely with the Department of Health on the roll-out.
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Australia's aged care system: The quality of care experience and community expectations
The Royal Commission into Aged Care Quality and Safety
Several national research projects were undertaken during the life of the Royal Commission into Aged Care Quality and Safety that have substantially improved understanding of the quality of aged care services and the community's expectations for higher quality care to be achieved in the future. This report summarises the results from those national research projects and provides additional analysis about how the results were distributed.
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Volume 214 - No 3 - Infant formula - IBD therapy - Bowel cancer screening
Medical Journal of Australia (MJA)
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Response to the Department of Health survey on the final recommendations in the Productivity Commission Inquiry into Mental Health
Mental Health Australia
This document is Mental Health Australia's response to the Australian Government's Department of Health survey seeking views on the final recommendations in the Productivity Commission Inquiry into Mental Health Final Report (PC Report), particularly with respect to priorities and implementation issues. The questions below are those included in the survey.
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Public hearing 11: People with cognitive disability in the criminal justice system
Royal Commission Into Violence, Abuse, Neglect & Exploitation of People with Disability
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NSW: Improvements to security in hospitals
NSW Department of Health
The following considers each of the recommendations from the Interim Report to either confirm that the recommendation remains unchanged, or modify those where further visits and consultations have brought new information to light, and to make new recommendations.
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Hansards
Federal
17 FEB 2021: REPS HANSARD: Adjournment - Mental Health
17 FEB 2021: REPS HANSARD: Questions Without Notice - COVID-19 - Vaccination
17 FEB 2021: REPS HANSARD: Bills - Health Insurance Amendment (Prescribed Fees) Bill 2021 - First Reading, Second Reading, Debate Adjourned
17 FEB 2021: REPS HANSARD: Federation Chamber - Constituency Statements - Defence Industry - COVID-19 - Health
17 FEB 2021: REPS HANSARD: Statements By Members - Nurses
17 FEB 2021: REPS HANSARD: Federation Chamber - Questions Without Notice - Additional Answers - COVID-19 - Employment
17 FEB 2021: REPS HANSARD: Statements By Members - Youth Suicide
17 FEB 2021: REPS HANSARD: Adjournment - Youth Suicide
17 FEB 2021: REPS HANSARD: Statements By Members - People with Disability
17 FEB 2021: REPS HANSARD: Federation Chamber - Constituency Statements - Kingston Electorate - Health Services
17 FEB 2021: SENATE HANSARD: Questions Without Notice - Regional Australia: Employment
17 FEB 2021: SENATE HANSARD: Questions Without Notice - JobSeeker Payment
17 FEB 2021: SENATE HANSARD: Documents - Royal Commissions Act 1902 - Royal Commission into Violence, Abuse, Neglect & Exploitation of People with Disability - Order for the Production of Documents
17 FEB 2021: SENATE HANSARD: Questions Without Notice - COVID-19: Vaccination
15 FEB 2021: SENATE HANSARD: Motions - South Australian Health and Medical Research Institute
ACT
11 FEB 2021: ACT ASSEMBLY HANSARD: Papers - Official Visitor for Disability Services - Annual Report
11 FEB 2021: ACT ASSEMBLY HANSARD: Questions Without Notice - Health Workers - Occupational Violence
11 FEB 2021: ACT ASSEMBLY HANSARD: Committees - Drugs of Dependence (Personal Use) Amendment Bill 2021 - Select Committee Membership -
11 FEB 2021: ACT ASSEMBLY HANSARD: Committees - Drugs of Dependence (Personal Use) Amendment Bill 2021 - Select Committee - Establishment
11 FEB 2021: ACT ASSEMBLY HANSARD: Adjournment - Health Care Consumers Association
11 FEB 2021: ACT ASSEMBLY HANSARD: Questions Without Notice - Hospitals - Waiting Times
11 FEB 2021: ACT ASSEMBLY HANSARD: Committees - Standing Committee on Health and Community Wellbeing - Statement by Chair
11 FEB 2021: ACT ASSEMBLY HANSARD: Ministerial Statement - Canberra Hospital Expansion - 11 FEB 2021
11 FEB 2021: ACT ASSEMBLY HANSARD: Questions Without Notice - Canberra Hospital - Emergency Patient Discharge
09 FEB 2021: ACT ASSEMBLY HANSARD: Questions Without Notice - Budget - Health Funding
09 FEB 2021: ACT ASSEMBLY HANSARD: Petitions - Health - Drug and alcohol treatment services - Petition 25-20
09 FEB 2021: ACT ASSEMBLY HANSARD: Petitions - Health - Drug and alcohol treatment services - Petition 3-21
09 FEB 2021: ACT ASSEMBLY HANSARD: Petitions - Health - Drug and alcohol treatment services - Petition 3-21
09 FEB 2021: ACT ASSEMBLY HANSARD: Questions Without Notice - Health - Nurse-Led Walk-In Centres
09 FEB 2021: ACT ASSEMBLY HANSARD: Motion to Take Note of Petitions - Health - Drug and alcohol treatment services - Petitions 3-21 & 25-20
NSW
17 FEB 2021: NSW ASSEMBLY HANSARD: Community Recognition Notices - Sutherland Hospital Intern Doctors
17 FEB 2021: NSW ASSEMBLY HANSARD: Question Time - Health Infrastructure Spending
17 FEB 2021: NSW ASSEMBLY HANSARD: Community Recognition Notices - Dr Brian Kearney of the Children's Hospital at Westmead
17 FEB 2021: NSW ASSEMBLY HANSARD: Private Members' Statements - Liverpool Hospital Surgery Waiting List
17 FEB 2021: NSW ASSEMBLY HANSARD: Private Members' Statements - Euthanasia
17 FEB 2021: NSW COUNCIL HANSARD: Adjournment Debate - Children & Mental Health
17 FEB 2021: NSW COUNCIL HANSARD: Bills - Public Health Amendment (Vaccination Compensation) Bill 2021 - First Reading, Second Reading
South Australia
17 FEB 2021: SA COUNCIL HANSARD: Question Time - Ambulance Services
17 FEB 2021: SA COUNCIL HANSARD: Question Time - Retirement Villages
17 FEB 2021: SA COUNCIL HANSARD: Question Time - COVID-19 Vaccine
17 FEB 2021: SA COUNCIL HANSARD: Question Time - COVID-19, Hotel Quarantine Workers
17 FEB 2021: SA ASSEMBLY HANSARD: Bills - Termination of Pregnancy Bill 2020 - Committee Stage
Victoria
17 FEB 2021: VIC ASSEMBLY HANSARD: Petitions - Yarram Medical Centre
17 FEB 2021: VIC ASSEMBLY HANSARD: Adjournment - Mental Health In Schools Program
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Court Cases
None this edition.
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New Regulations
Federal
National Health (Electronic National Residential Medication Chart Trial) Amendment Special Arrangement 1 of 2021
Legislative Instrument Compilation - F2021L00126
The purpose of the Amending Instrument is to amend the Schedule to this Special Arrangement to allow three additional electronic medication management software vendors (DigiMed, Sigma/MPS and Compact) and an additional 155 residential aged care facilities to participate in the trial.
Explanatory Statement
Australia New Zealand Food Standards Code
Legislative Instrument - F2021L00125
MRLs are regulatory standards which help to monitor that the agvet chemical product has been used in accordance with the approved label instructions. If an MRL is exceeded, it usually indicates a misuse of the chemical but does not normally indicate a public health or safety concern.
Explanatory Statement
Private Health Insurance (Prostheses) Rules (No. 1) 2021
Legislative Instrument - F2021L00123
The Private Health Insurance (Prostheses) Rules (No. 1) 2021 (Prostheses Rules) are made for the purposes of section 333-20(1) of the Act. Listed prostheses and their minimum benefits are set out in the Schedule to the Prostheses Rules. The list of prostheses in the Schedule is commonly referred to as the Prostheses List.
Explanatory Statement
ACT
Public Health (Emergency) Declaration Further Extension 2021 (No 1)
Notifiable instrument NI2021-83
Further extends the period during which the Public Health (Emergency) Declaration 2020 (No 1) [NI2020-153] is in force for a period of 90 days.
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Western Australia
12 FEB 2021: WA, COOK: Health - Health Services Act 2016 - Health Services (Health Service Provider Land) Amendment Order 2021 - SL 2021/23
12 FEB 2021: WA, COOK: Health - Health Services Act 2016 - Health Services (Health Service Providers) Amendment Order 2021 - SL 2021/22
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Proclamations
None this edition.
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Gazette Notices
None this edition.
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Consolidated Legislation
Aged Care (Transitional Provisions) Act 1997
Act Compilation - C2021C00119
Act No. 223 of 1997 as amended, taking into account amendments up to Aged Care Legislation Amendment (Improved Home Care Payment Administration No. 1) Act 2020 An Act to deal with transitional matters in connection with the Aged Care (Living Longer Living Better) Act 2013, and for other purposes.
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Aged Care Act 1997
Legislative Instrument Compilation - C2021C00118
Act No. 112 of 1997 as amended, taking into account amendments up to Aged Care Legislation Amendment (Improved Home Care Payment Administration No. 1) Act 2020 An Act relating to aged care, and for other purposes.
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Health Insurance (Extended Medicare Safety Net) Determination 2017
Legislative Instrument Compilation - F2021C00157
Determinations/Health as amended, taking into account amendments up to Health Insurance (Extended Medicare Safety Net) Amendment (Indexation) Determination 2020.
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National Health (Highly specialised drugs program) Special Arrangement 2010
Consolidated Legislative Instrument - F2021C00140
PB 116 of 2010 Arrangements as amended, taking into account amendments up to National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2021 (No. 1) (PB 4 of 2021).
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Therapeutic Goods Regulations 1990
Legislative Instrument Compilation - F2021C00135
SR 1990 No. 394 Regulations as amended, taking into account amendments up to Therapeutic Goods Legislation Amendment (2020 Measures No. 2) Regulations 2020.
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New Bills
Federal
A Bill for an Act to amend the law relating to aged care, and for related purposes.
The Aged Care Legislation Amendment (Serious Incident Response Scheme and Other Measures) Bill 2020 (the Bill) amends the Aged Care Act 1997 (Aged Care Act) and the Aged Care Quality and Safety Commission Act 2018 (Quality and Safety Commission Act) to introduce a Serious Incident Response Scheme (SIRS) for residential aged care and flexible care delivered in a residential aged care setting. The Australian Government has no tolerance for abuse and neglect in aged care.
The Bill implements key recommendations in the Australian Law Reform Commission's report Elder Abuse - A National Legal Response and the Review of National Aged Care Quality Regulatory Processes by Ms Kate Carnell AO and Professor Ron Paterson ONZM. The Bill is also consistent with the National Plan to Respond to the Abuse of Older Australians and aims to address issues raised in the Counsel Assisting's final submissions to the Royal Commission into Aged Care Quality and Safety. A prevalence and feasibility study is currently being undertaken to inform future Government decisions on the potential introduction of a SIRS in home and community aged care.
The SIRS introduced by the Bill is similar to the incident management and disclosure protection scheme added to the National Disability Insurance Scheme Act 2013 in 2017, with amendments to address specific needs of aged care.
The SIRS will replace current responsibilities of approved providers of residential aged care and flexible care delivered in a residential aged care setting (approved provider) in relation to reportable assaults and unexplained absences in the Aged Care Act. The Bill will require approved providers to manage incidents and take reasonable steps to prevent incidents, including through implementing and maintaining effective organisation-wide governance systems for management and reporting of incidents of abuse and neglect.
Reps: Intro 02/12/20, 2R 02/12/20, 02/02/21, Passed 02/02/21
Senate: Intro 03/02/21, 2R 03/02/21, 04/02/21, 15/02/21, Passed 15/02/21
Assent TBA, Act No. TBA
Commencement:
- Sections 1 to 3 and anything in this Act not elsewhere covered by this table - The day this Act receives the Royal Assent.
- Schedules 1 and 2 - The later of: (a) 1 April 2021; and (b) the eighth day after the day this Act receives the Royal Assent.
- Schedule 3 - The later of: (a) immediately after the commencement of the provisions covered by table item 2; and (b) immediately after the commencement of the Federal Circuit and Family Court of Australia Act 2020. However, the provisions do not commence at all if the event mentioned in paragraph (b) does not occur.
A Bill for an Act to amend the Health Insurance Act 1973, and for related purposes
The Health Insurance Amendment (Prescribed Fees) Bill 2021 (the Bill) simplifies administrative processes for recognition of specialists and consultant physicians for Medicare purposes under the Health Insurance Act 1973 (the Act) by removing the requirement to pay a $30.00 prescribed fee to gain recognition by Medicare.
The current Commonwealth legislative framework to recognise specialists and consultant physicians for Medicare purposes is implemented in legislation that includes the following:
- the Act, and
- Health Insurance Regulations 2018 (Regulations).
The Act provides a pathway for recognising specialists and consultant physicians for Medicare purposes.
Reps: Intro 17/02/21, 2R 17/02/21, Passed TBA
Senate: Intro TBA, 2R TBA, Passed TBA
Assent TBA, Act No. TBA
Commencement: The whole of this Act - 1 July 2021. 1 July 2021
New South Wales
A Private Member's Bill (Faehrmann) An Act to legalise cannabis and cannabis products; to regulate the sale, supply and advertising of cannabis and cannabis products; and for other purposes.
The objects of this Bill are to -
(a) legalise cannabis or cannabis products produced and distributed under the licensing scheme established by the proposed Act, and
(b) legalise cannabis grown for personal use in particular circumstances, and
(c) establish the New South Wales Cannabis Authority, and
(d) regulate the use of cannabis and cannabis products, particularly in relation to protection of persons under 18 years of age and the smoking of cannabis or cannabis products in public places, and
(e) regulate the packaging, labelling and storage requirements for cannabis and cannabis products and prohibit certain advertising and promotions in relation to cannabis and cannabis products, and
(f) provide for administrative review of a decision made by the New South Wales Cannabis Authority in relation to licences under the proposed Act, and
(g) provide for persons to be authorised to enforce and monitor compliance with the proposed Act, and
(h) make other minor and consequential amendments.
LC: Notice of Motion 17/11/20
LC: 1R 17/02/21, 2R 17/02/21, Passed TBA
LA: 1R TBA, 2R TBA, Passed TBA
Assent TBA, Act No. TBA
Commencement: This Act commences on the date of assent to this Act.
A Private Member's Bill (Nile) for An Act to amend the Public Health Act 2010 to provide for the payment of compensation to workers who suffer injury, loss or damage as a result of a requirement to be vaccinated.
The object of this Bill is to amend the Public Health Act 2010 to provide for the payment of compensation to workers who suffer injury, loss or damage as a result of a requirement to be vaccinated.
LC: Notice of Motion 16/02/21
LC: 1R 17/02/21, 2R 17/02/21, Passed TBA
LA: 1R TBA, 2R TBA, Passed TBA
Assent TBA, Act No. TBA
Commencement: This Act commences on the date of assent to this Act.
Northern Territory
A Bill for an Act to amend the Medicines, Poisons and Therapeutic Goods Act 2012.
The purpose of this Bill is to amend the Medicines, Poisons and Therapeutic Goods Act 2012 to:
- create a new and specific medicine management protocol called a COVID-19 Vaccine Administration Protocol (CVAP) for administering the vaccines;
- the CVAP will not include the Act's current requirements for declaration in advance by gazetted instrument, of all the places where the COVID-19 vaccine as a Scheduled Substance can be made available. This will allow a more flexible, culturally appropriate and responsive roll-out of the COVID-19 vaccines across the Northern Territory;
- provide the ability to manage the spectrum of COVID-19 vaccines as they become available and their characteristics
- allow a range of suitably qualified and trained healthcare workers to administer the COVID-19 vaccines with a range of options to maximise community access
- make it an offence to breach the CVAP including its mandatory training to maximise community, consumer and patient safety.
Intro 16/02/21, 2R 16/02/21, Passed TBA
Assent TBA, Act No. TBA
Commencement: This Act commences on the day after the day on which the Administrator's assent to this Act is declared.
Download: Explanatory Statement | 2R Speech | Committee Report
Queensland
A Bill for An Act to amend the Justice and Other Legislation (COVID-19 Emergency Response) Amendment Act 2020, the Mental Health Act 2016, the Public Health Act 2005 and the Public Health and Other Legislation (Public Health Emergency) Amendment Act 2020 for particular purposes.
On 29 January 2020, a public health emergency was declared under section 319 of the Public Health Act 2005 due to the outbreak of COVID-19 in China, its pandemic potential due to cases spreading to other countries and the public health implications within Queensland resulting from recently arrived travellers from the epicentre of the outbreak. The public health emergency was declared for all of Queensland. Under section 323 of the Public Health Act, the declared public health emergency has been extended until 31 December 2020 through the making of several regulations and may need to be further extended.
The Bill achieves the policy objectives by amending various Acts to ensure that any sunset clauses or expiry provisions relating to the amendments made to Chapter 8 of the Public Health Act and Chapter 18B of the Mental Health Act do not take effect until the end of the day on 30 September 2021. The extension of these expiry dates will allow the Queensland Government's health response to continue for a further six months.
Intro 03/12/20, Referred to the Health and Environment Committee for consideration 03/12/20, Report tabled 12/02/21, 2R TBA, Passed TBA
Assent TBA, Act No. TBA
Commencement: This Act commences on the day this Act receives the Royal Assent, except that Part 4, division 3 commences on 1 October 2021.
South Australia
A Bill for An Act to reform the law relating to pregnancy terminations, to regulate the conduct of health practitioners in relation to pregnancy terminations and to make related amendments to the Criminal Law Consolidation Act 1935 and the Intervention Orders (Prevention of Abuse) Act 2009.
LC: 1R 14/10/20, 2R 14/10/20, 12/11/20, 02/12/20, Passed 02/12/20
LA: 1R 03/12/20, 2R 16/02/21, 17/02/21, Passed TBA
LC: Final Stages TBA
Assent TBA, Act No. TBA
Commencement: This Act comes into operation on a day to be fixed by proclamation.
Victoria
A Bill for An Act to amend the Public Health and Wellbeing Act 2008 in relation to state of emergency declarations in respect of the COVID-19 pandemic and for other purposes.
The main purposes of the Bill are to amend the Public Health and Wellbeing Act 2008 -
- to lengthen the total period for which a state of emergency declaration may continue in force in respect of the COVID-19 pandemic from 12 months to 21 months; and
- to extend the period of operation of the COVID-19 temporary measures under Part 13 to 16 December 2021.
LA: 1R 02/02/21, 2R 03/02/21, 18/02/21, Passed TBA
LC: 1R TBA, 2R TBA, Passed TBA
Assent TBA, Act No. TBA
Commencement: This Act comes into operation on the day after the day on which it receives the Royal Assent.
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New Acts
Australian Immunisation Register Amendment (Reporting) Act 2021
An Act to amend the Australian Immunisation Register Act 2015, and for related purposes.
The amendments to the Australian Immunisation Register Act 2015 (AIR Act) create a requirement for recognised vaccination providers to report to the Australian Immunisation Register (AIR) information relating to vaccinations they administer and vaccines they are notified about that were given outside Australia. The Bill also creates a power for the Secretary of the Department of Health to require a recognised vaccination provider to give information if they do not comply with this reporting requirement.
A staged implementation is proposed, which will be prescribed in the Australian Immunisation Register Rule 2015, with the mandatory reporting of:
- COVID-19 vaccinations (should one or more safe and effective vaccines meet all necessary regulatory requirements for supply in the Australian market) and influenza vaccinations from 1 March 2021; and
- All National Immunisation Program (NIP) vaccinations from 1 July 2021.
In summary, the key amendments in the AIR Bill:
- introduce provisions under which recognised vaccination providers are required to report certain information in relation to certain vaccinations administered, both within and outside Australia;
- authorise the collection and use of Commonwealth assigned identifiers, known as a 'provider identification information';
- introduce civil penalties should vaccination providers not comply with the legislated requirements; and
- provide power for the Secretary of the Department of Health to require a recognised vaccination provider to produce information if they do not comply with this reporting requirement.
Reps: Intro 03/12/20, 2R 03/12/20, 03/02/21, Passed 03/02/21
Senate: Intro 04/02/21, 2R 04/02/21, Passed 04/02/21
Assent 15/02/21, Act No. 1 of 2021
Commencement:
- Sections 1 to 3 and anything in this Act not elsewhere covered by this table - The day this Act receives the Royal Assent.
- Schedule 1, Part 1 - The day after this Act receives the Royal Assent.
- Schedule 1, Part 2 - The later of: (a) immediately after the commencement of the provisions covered by table item 2; and (b) immediately after the commencement of the Federal Circuit and Family Court of Australia Act 2020. However, the provisions do not commence at all if the event mentioned in paragraph (b) does not occur.
Aged Care Legislation Amendment (Serious Incident Response Scheme and Other Measures) Act 2021
An Act to amend the law in relation to home care subsidy, and for related purposes.
The Act amends the Aged Care Act 1997 (the Aged Care Act) and the Aged Care (Transitional Provisions) Act 1997 (the TP Act).
The purpose of the Aged Care Legislation Amendment (Improved Home Care Payment Administration No. 2) Bill 2020 (the Bill) is to improve the administration arrangements of paying home care subsidy to approved providers.
The Act introduces more contemporary business practices into home care subsidy payment arrangements and brings these arrangements into alignment with other Government programs.
Approved providers are currently required to provide a monthly statement to their home care recipients that shows the care recipient's available funds, how the funds are being spent (i.e. care and services delivered) and the amount of unspent funds.
The measures in the Act improve financial accountability and allow for better transparency over the actual use of funds for home care service delivery by requiring approved providers to also report to the Commonwealth the cost of care and services delivered to the home care recipient each month in order for the subsidies to be paid to the approved provider.
On 12 November 2020, the Senate Selection of Bills Committee referred the Bill to the Community Affairs Legislation Committee for inquiry and report by 27 November 2020.
Reps: Intro 21/10/20, 2R 21/10/20, 09/12/20, Referred to Federation Chamber 09/12/20, Federation Chamber 2R 09/12/20, Federation Chamber Passed (with 6 Government amendments) 09/12/20, Reps Passed 09/12/20
Senate: Intro 02/02/21, 2R 02/02/21, Passed 02/02/21
Awaiting assent
Assent 16/02/21, Act No. 2 of 2021
Commencement:
- Sections 1 to 3 and anything in this Act not elsewhere covered by this table - The day this Act receives the Royal Assent.
- Schedule 1, Parts 1 and 2 - A single day to be fixed by Proclamation. However, if the commencement of the provisions is not fixed by a Proclamation registered on the Federal Register of Legislation established under the Legislation Act 2003, within the period of 6 months beginning on the day this Act receives the Royal Assent, the provisions are repealed on the day after the end of that period.
- Schedule 1, Part 3 - Immediately after the commencement of the provisions covered by table item 2. However, if the provisions covered by table item 2 do not commence, the provisions covered by this table item are repealed at the same time as the provisions covered by table item 2 are repealed.
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