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)
9 July
Government website platform stands up under COVID-19 pressure
The Department of Finance said that GovCMS, the government website hosting and content management system, saw record numbers of visits on the platform at the height of the COVID-19 pandemic as Australians accessed critical online information to protect their health and safety. The GovCMS team were able to maintain the stability and resilience of the service. The platform automatically scaled up during huge spikes in traffic, and handled an unprecedented volume of visitors to websites. 'The GovCMS team ensured our website was always available and able to supply information to the public during the pandemic,' said Susie Smith, General Manager, Services Australia.
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TAS: State of Emergency Declaration extended
Tasmanian Premier Peter Gutwein said that: 'Today we have extended Tasmania's State of Emergency until 31 August. This aligns with the Public Health Emergency Declaration, which has already been put in place until 31 August. The directions issued under the Public Health Act have worked effectively to reduce transmission of COVID-19 in Tasmania, and have complemented directions made by the State Controller to exercise emergency powers, as well as special emergency powers, during this state of emergency. In light of the escalating situation in Victoria and the need to have appropriate response protocols in place in Tasmania, it is appropriate we extend emergency powers.'
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WA: COVID-19 update - 9 July 2020
The Department of Health has reported three new active cases of COVID-19 overnight, bringing the State's total to 627. The new cases are returned overseas travellers currently in hotel quarantine. Two are returning Western Australians and one is from interstate. There are now 16 active COVID-19 cases in Western Australia, all in hotel quarantine. To date, 602 people have recovered from the virus in WA. 586 people presented to WA COVID-19 clinics - 569 were assessed and 567 were swabbed.
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VIC: Stage 3 restrictions for Flemington and North Melbourne estates
Victorian Premier Daniel Andrews said that: 'Following a comprehensive testing blitz across the nine locked down public housing towers in Flemington and North Melbourne, the Chief Health Officer has provided advice about the next steps that can now be taken across both estates. Work is ongoing to identify all close contacts. Given such a high number of positive cases and the unknown source of much of the transmission, our health experts have advised that, just as with an aged care facility, all residents of 33 Alfred Street will be classed as close contacts who must isolate for 14 days in total.'
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8 July
Masks an option for COVID-19 hotspots
As metropolitan Melbourne enters a six-week lockdown period, the Australian Medical Association (AMA) is advising residents in Melbourne that mask use, where physical distancing cannot be guaranteed, is another useful tool, when combined with physical distancing, to limit COVID-19 transmission. Dr Tony Bartone, AMA President and a Melbourne GP, said masks offer some benefit when using public transport or in crowded locations such as shops, markets, and indeed anywhere where people cannot remain 1.5 metres apart. 'This is especially the case in those suburbs where we know community transmission is high,' Dr Bartone said.
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Victorian Government must provide public health response to pandemic, end discriminatory measures and withdraw hundreds of police from public housing
Human Rights Law Centre (HRLC) said that the legal and human rights groups condemn the heavy-handed, policing response to a public health emergency, rather than the much-needed support communities need to prevent COVID-19 transmission. We stand in solidarity with the 3000 people in hard lockdown. The deployment of hundreds of police and the coercive measures across public housing estates in North Melbourne and Flemington is a discriminatory response to the prior failings of the Victorian Government. This includes the failure to provide adequate public housing, translated health information, and culturally appropriate health care.
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Medibank to temporarily close stores in metropolitan Melbourne
Medibank said it: 'will temporarily close 17 retail stores in Melbourne from close of business on Wednesday 8 July for a period of six weeks. This follows the decision to close three stores in hot spot postcodes last week. The decision to close these stores follows the Victorian Premier's stage 3 stay-at-home order announced that as a result of an increase in COVID-19 cases. Stores located outside the restricted areas - in Geelong, Bendigo and Ballarat - will remain open. The store in Albury remains closed for the time being. Medibank Chief Customer Officer David Koczkar said that while employees and customers had welcomed being back in the store following the previous re-opening, closing stores in the impacted areas is necessary to protect their health and wellbeing.'
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ACT: Cautious step in ACT COVID-19 restrictions
ACT Chief Minister Andrew Barr said that following the introduction of border restrictions for people entering the ACT from Victoria and the metropolitan Melbourne lock-down, the health advice remains that the ACT can proceed with some minor changes outlined in stage three of the ACT's Easing of Restrictions roadmap from midday on Friday 10 July. The unfolding situation in Victoria is a significant concern, and that's why the ACT is taking a cautious approach with further easing of restrictions. The ACT will not be implementing a 1 person per 2 square metres rule at this time given the heightened COVID-19 risk. ACT will introduce new capacity limits to provide some flexibility for smaller venues. Venues will be able to cater for 25 patrons, or 1 person per four square metres of usable space (whichever is greater).
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NSW: COVID-19 (Coronavirus) statistics
The NSW Department of Health said that there have been eight new cases of COVID-19 diagnosed in NSW in the 24 hours to 8pm last night. Of the new cases, seven are returned travellers in hotel quarantine. The eighth case is a woman in her 30's from South Western Sydney who has tested positive for COVID-19. However, further testing is underway to determine if this is a recent, or a historical infection. Close contacts have been identified and are in home isolation. One previous case has been excluded following further analysis, meaning the total number of cases now stands at 3,251.
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ACT: COVID-19 update
The ACT Department of Health said that there have been three (3) new cases of COVID-19 recorded in the ACT in the past 24 hours, bringing the ACT's total to 111. The three individuals are one female and two males (aged in their 20s). Two of the individuals arrived in the ACT from a Melbourne hotspot on Thursday 2 July 2020, and the other is a household contact. A small number of close contacts have been identified and are being managed in accordance with the National Guidelines. A total of 105 cases have recovered from COVID-19 and have been released from self-isolation. There are no (0) COVID-19 patients in Canberra hospitals.
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WA: COVID-19 update
The Western Australia Department of Health has reported two new active cases of COVID-19 overnight, along with one historical case, bringing the State's total to 624. The two new cases are returned overseas travellers currently in hotel quarantine. Both cases are returning Western Australians from the metropolitan area. The historical case was identified through serology testing and relates to an overseas traveller who returned to Western Australia in April. There are now 13 active COVID-19 cases in Western Australia, all in hotel quarantine. To date, 602 people have recovered from the virus in WA. 630 people presented to WA COVID-19 clinics - 608 were assessed and 604 were swabbed.
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7 July
COVID-19: Senior Australians urged to stay vigilant
Senior Australians have been urged to stay vigilant as the fight to contain the spread of COVID- 19 continues. While the easing of restrictions across most States and Territories means those aged over 65 can start re-engaging in community, senior Victorians should closely follow advice as authorities work to contain emerging clusters. It comes as the Australian Health Protection Principal Committee (AHPPC) updated its advice for the management of health risk as COVID-19 measures lift. Minister for Aged Care and Senior Australians Richard Colbeck said vulnerable and older members of every community remained a priority as both Federal and State governments navigated the challenges of the pandemic.
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Researchers study the psychological effect of pandemic conditions on people with pre-existing mood disorders
A collaborative study between Swinburne and University of Melbourne researchers has found that individuals with a pre-existing mood disorder reported higher levels of depression, anxiety and stress during the early stages of the COVID-19 pandemic when compared to individuals with no mental disorder. The study, which was conducted by researchers from Swinburne's Centre for Mental Health and the Melbourne Neuropsychiatry Centre as part of the COVID-19 and you: mental health in Australia now survey (COLLATE), has been published in the Journal of Affective Disorders.
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VIC: Statement from the Victorian Premier
'2020 has not been the year any of us wanted,' said Victorian Premier Daniel Andrews. 'Cancelled events. Plans put on pause. Uncertainty about what the future holds. And I guess that's why so many people want to pretend this is over. That they can go back to how things once were. Others don't have that luxury. In the last 36 hours we lost two more Victorian lives to this deadly virus. We don't yet know their names, their stories or the circumstances in which they died. All we do know is that - except for the company and compassion of the medical staff who cared for them - they would have died alone.'
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6 July
Six week trial - COVID-19 health professionals disability advisory service
COVID-19 Health Professionals Disability Advisory Service, a telephone advisory service established by the Department of Health, will be available from Tuesday, 7 July. The service will provide specialised advice exclusively for health professionals responsible for the medical care of people with disability diagnosed with COVID-19 or experiencing COVID-19 symptoms, said the National Disability Services (NDS). Healthdirect Australia has been engaged to manage the service - calls will be answered by health professionals with disability service qualifications and experience working with people with disability. Health professionals can call the service on 1800 131 330 between 7am - 11pm (AEST) 7 days a week.
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Australian Health Protection Principal Committee (AHPPC) statement on recommendations for managing of health risk as COVID-19 measures lift
The Australian Health Protection Principal Committee (AHPPC), on the advice of the Communicable Diseases Network Australia (CDNA), has revised the previous AHPPC statement on 30 March 2020 on managing vulnerable workers. AHPPC is pleased to note the continued stable low number of cases of COVID-19 in most communities in Australia. This has permitted progressive relaxation of travel and other physical distancing restrictions. As the current level of COVID-19 cases is low, people, even those at higher risk of becoming severely ill from COVID-19, can return to work and other settings with appropriate precautions in place.
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Rehabilitation from COVID-19 needs innovative planning
Australia must prepare for the 'aftershocks' from COVID-19 or risk leaving survivors of the virus struggling to rehabilitate, according to the authors of a Perspective published by the Medical Journal of Australia (MJA). Associate Professor Steven Faux, Director of Rehabilitation and Pain Medicine at St Vincent's Hospital, Sydney, and colleagues wrote that rehabilitation needs following COVID-19 were 'broad, complex and include cognitive, motor and respiratory sequelae to the infection, acute respiratory distress syndrome, and the thromboembolic response. In Wuhan, China, 36% of those with severe COVID-19 had neurological complications such as stroke, critical care neuropathy, and the complications of prolonged bed rest.'
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QLD: Statement
'We have had to make tough decisions for the health and wellbeing of Queenslanders which included closing our borders,' said Queensland Premier Annastacia Palaszczuk. 'We will continue to listen to the advice of our Chief Health Officer. Last week we made the decision to maintain the border closure with Victoria. I welcome today's decision to close the border between NSW and Victoria. We will continue to provide support to Victoria as they continue to deal with their COVID-19 response.'
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WA: COVID-19 update
The WA Department of Health has reported three new cases of COVID-19, bringing the State's total to 621. The new cases are all returned overseas travellers who flew into Perth on the 2nd of July. Two of the cases are interstate residents who travelled from Indonesia and the third is a Western Australian who was on a flight from Doha. Contact tracing is underway on both these flights to identify close contacts of the newly diagnosed cases. All these passengers are also in hotel quarantine. Flight details and the close contact rows in question have been uploaded on the HealthyWA website.
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5 July
NSW: COVID-19 (Coronavirus) statistics
There have been 14 new cases of COVID-19 diagnosed in NSW, bringing the total number of cases to 3,230, said NSW Health. All new cases were in returned overseas travellers now in hotel quarantine. Four residents of Newmarch House tested negative for COVID-19 on Saturday after displaying symptoms of respiratory illness. A passenger tested for COVID-19 after arriving in Sydney by train has returned a negative result. This person was a NSW resident who got on the XPT train in regional NSW, not Victoria, and then self-presented with influenza like illness at Central Station.
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VIC: Extra support for housing estates and hotspot postcodes
'As we continue our fight against coronavirus, the Victorian Government is ramping up support for those Victorians impacted by restrictions on public housing towers and hot zone postcodes,' said Victorian Premier Daniel Andrews. 'After an outbreak at the Flemington and North Melbourne housing estates, the Government closed and contained nine towers, requiring residents to stay inside their homes to help slow the spread. This vital measure will be in place for at least five days, ensuring we can test every single resident. Restrictions will be lifted when we can see we have successfully tested and tracked this virus. The Royal Melbourne Hospital staff will be onsite at both estates to ensure every resident can get tested.'
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4 July
NSW: COVID-19 (Coronavirus) statistics
There have been six new cases of COVID-19 diagnosed in NSW, bringing the total number of cases to 3,216. Five new cases were in returned travellers now in hotel quarantine. NSW Health has now confirmed that the sixth case is the possible case reported, in an 18-year-old male student from Green Point Christian College on the Central Coast. However, results indicate this is a past infection and not an active case. One previously reported case has now also been excluded following further investigation. A total of 16,556 tests were notified in the reporting period, compared with 17,848 tests in the previous 24 hours. NSW has carried out more than 900,000 COVID-19 tests.
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SA: Further boosts to ambulance capacity during COVID-19
A contingent of emergency service workers will be trained as volunteer ambulance personnel, to further boost the State's COVID-19 response capability. SA Minister for Health and Wellbeing Stephen Wade said this innovative move by the Government will boost ambulance operational resilience, particularly in regional areas. 'Training up these 24 State Emergency Service volunteers is part of the Marshall Liberal Government's strong plan to ensure South Australia is prepared should the COVID-19 threat escalate,' Minister Wade said.
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VIC: Statement from the Premier
'Today's numbers represent the second biggest increase in confirmed case since this began - and the biggest jump since 28 March,' said Victorian Premier Daniel Andrews. 'As these figures show, we are still on a knife's edge. Rather than spread across the state, we know many of these cases are located in specific communities. That means the need for targeted, swift action is stronger than ever before. In recent days, 23 cases across more than 12 households have been identified in the Flemington and North Melbourne public housing estates. This represents a challenge we've not yet encountered. This is not like an outbreak spread across multiple homes or multiple suburbs.'
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3 July
TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic
The COVID-19 pandemic has had a significant impact on regulatory bodies and business organisations around the world, said the TGA. Travel restrictions and ensuring a safe working environment for all staff currently prevents face-to-face on-site overseas GMP inspections from being conducted. Industry and regulatory bodies need to work together to help maintain appropriate regulatory oversight of GMP activities to ensure the continued quality, safety efficacy and continuity of supply of therapeutic products and services to protect patients. Following the publication of the GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic, below is further information designed to assist manufacturers who may undergo a remote inspection.
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GMP approach to overseas manufacturers of medicines and biologicals during the COVID- 19 pandemic
The COVID-19 pandemic has created many challenges to the ongoing Good Manufacturing Practice (GMP) regulation of medicine and biological manufacturers, said the TGA. Following the suspension of overseas GMP inspections and QMS audits, a significant amount of consideration was given to the appropriate level of regulatory oversight required to maintain an assurance of product quality without requiring wholesale changes to existing processes. These considerations needed to be agile yet sustainable as the length of time that international travel restrictions remain in place is difficult to predict
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Aged Care
9 July
Statement by Janet Anderson on response to COVID-19 situation in Victoria
The Aged Care Quality and Safety Commission reported that it is closely monitoring the situation in Victoria and providing support to aged care services in managing the increased risks of a COVID-19 outbreak. Regulatory officials from the Commission will commence telephoning all approved providers of residential services in Victoria The regulatory officials will be seeking assurances from providers that COVID response plans have been developed and are ready for immediate activation. This will include confirmation that services have arrangements in place to manage risks to consumers and staffing supply.
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8 July
Supporting older Australians
More than 6,100 older Australians will live independently for longer following a $325.7 million investment in new home care packages by the Government, said Minister for Health Greg Hunt. The extra 6,105 home care packages brings the total number of additional packages to over 50,000 since the 18-19 Budget, at a cost of more than $3 billion, said Minister for Aged Care and Senior Australians Richard Colbeck. Home care package numbers will increase to 164,135 in 2022-23. Prime Minister Scott Morrison said his government remained focused on the needs of older Australians.
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Extension to Royal Commission and extra home care packages both necessary - ACSA
The peak body for non-profit aged care providers Aged and Community Services Australia (ACSA) has welcomed the announcement of new home care packages and said the extension to the Royal Commission is necessary. 'There simply hasn't been the time or capacity to properly investigate the solutions to the reform challenges that aged care faces,' ACSA CEO Patricia Sparrow said. 'We must properly investigate the reforms needed to ensure aged care is delivering the care and support older Australians need, including how we will pay for this as a community.
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New Home Care packages a welcome but small step forward but delay in Royal Commission findings must not slow down reform
The 6,100 new Home Care Packages (HCPs) announced by the Prime Minister and Minister for Aged Care are a welcome step toward meeting increased demand for home care, but much more remains to be done now for older Australians in greatest need, according to Council on the Ageing Australia (COTA). COTA acknowledges that more than 50,000 new HCPs have now been funded by this Government since the 2018-19 Budget, a very substantial uplift in provision, but still well short of what we need, by the government's own standards.
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7 July
COVID-19: Senior Australians urged to stay vigilant
Senior Australians have been urged to stay vigilant as the fight to contain the spread of COVID- 19 continues. While the easing of restrictions across most States and Territories means those aged over 65 can start re-engaging in community, senior Victorians should closely follow advice as authorities work to contain emerging clusters. It comes as the Australian Health Protection Principal Committee (AHPPC) updated its advice for the management of health risk as COVID-19 measures lift. Minister Colbeck said vulnerable and older members of every community remained a priority as both Federal and State governments navigated the challenges of the pandemic.
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3 July
#ThanksforCaring: Aged Care Employee Day 2020 salutes superheroes and quiet achievers
#ThanksforCaring is the theme of Aged Care Employee Day 2020 (ACED 2020), with the call going out now to every community across the nation to honour aged care workers and volunteers and say 'thanks for caring' on Friday 7 August. It will feature a national social media campaign, focusing on videos, stories and photographs aiming to acknowledge thousands of dedicated employees. ACED 2020 will also include an online event honouring the winners of Leading Age Services Australia's Excellence in Age Services Awards in each State and Territory.
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Royal Commission into Aged Care Quality and Safety
None this edition.
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Allied Health
9 July
Government appoints new Commonwealth Chief Allied Health Officer
Minister for Regional Health, Regional Communications and Local Government Mark Coulton said that the appointment of Australia's new Chief Allied Health Officer, Dr Anne-marie Boxall, will help support the Australian Government's Primary Health Care 10-Year Plan, health workforce reforms and the $550 million Stronger Rural Health Strategy. Allied health professionals have essential roles in primary care and in the prevention, management and treatment of chronic disease across Australia, including in regional and rural areas. Additionally, increasing access to allied health services in the regions is vital to improving health outcomes for Australians living outside the major cities, and this appointment is a step towards that goal.
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Children's Health
9 July
Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil
Following further investigation, Pharmacare, in consultation with the Therapeutic Goods Administration (TGA), is recalling all affected batches of the 120 pastille pack size from retail stores. This issue does not affect the 60 pastille pack size which currently includes milk as a declared allergen on the label. Further information on the recall can be found in the System for Australian Recall Actions. Consumers and health professionals are advised that Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil (AUST L 313445) contain milk products. The current label for this product does not declare the presence of milk products, but does list the presence of other allergens.
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8 July
WA: Meningococcal disease in a child
The Western Australia Department of Health reported that a child has been diagnosed with meningococcal serogroup W disease and is recovering in hospital. Meningococcal disease is an uncommon, life-threatening illness caused by a bacterial infection of the blood and/or the membranes that line the spinal cord and brain, and occasionally of other sites, such as the throat, lungs or large joints. To date in 2020, six meningococcal cases have been reported in WA; three were serogroup W, two were serogroup Y and one was serogroup B.
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6 July
New guidelines for paediatric type 2 diabetes released
New guidelines for the screening, assessment and management of paediatric type 2 diabetes, which address the specifics for high-risk ethnic groups including Indigenous Australians, have been released to help physicians from Australia and New Zealand. The guidelines, published by the Medical Journal of Australia (MJA), were approved by the Australasian Paediatric Endocrine Group, and contain a dedicated section on consideration of care for children and adolescents from Indigenous background in Australia and New Zealand. 'Published international guidelines currently exist, but the challenges and specifics to care for children and adolescents with type 2 diabetes which should apply to Australasia have not been addressed to date,' wrote the guideline authors.
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Polio: Australian physicians show 'level of complacency'
Despite being declared polio-free in 2000, Australia consistently fails to reach some World Health Organization (WHO) benchmarks for adequate surveillance, showing a 'level of complacency among physicians', said the authors of a Perspective published by the MJA. There are only two countries in the world where wild poliomyelitis still exists - Afghanistan and Pakistan. However, oral vaccine strain virus can slowly accumulate mutations over time, which eventually revert to neurovirulence - these strains are known as vaccine-derived poliovirus (VDPV). Papua New Guinea reported an outbreak of VDPV in 2018, the Philippines had 15 cases in late 2019, and Malaysia reported three cases in 2019 and one so far in 2020.
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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
7 July
NT: Disability Advisory Committee: Historic first meeting
The Northern Territory Disability Advisory Committee held its first meeting having been postponed due to COVID-19, said NT Minister for Disabilities Natasha Fyles. The Committee is the first of its kind for the Northern Territory and is unique nationally, with strong representation from Aboriginal peoples and individuals from remote and very remote parts of the Territory. The Committee was appointed to represent people in the NT living with disabilities to provide advice to Government on issues affecting them. They will also assist in raising awareness of the rights of people with disability.
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6 July
Six week trial - COVID-19 health professionals disability advisory service
COVID-19 Health Professionals Disability Advisory Service, a telephone advisory service established by the Department of Health, will be available from Tuesday, 7 July. The service will provide specialised advice exclusively for health professionals responsible for the medical care of people with disability diagnosed with COVID-19 or experiencing COVID-19 symptoms, said the National Disability Services (NDS). Healthdirect Australia has been engaged to manage the service - calls will be answered by health professionals with disability service qualifications and experience working with people with disability. Health professionals can call the service on 1800 131 330 between 7am - 11pm (AEST) 7 days a week.
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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
9 July
Government website platform stands up under COVID-19 pressure
The Department of Finance said that GovCMS, the government website hosting and content management system, saw record numbers of visits on the platform at the height of the COVID-19 pandemic as Australians accessed critical online information to protect their health and safety. The GovCMS team were able to maintain the stability and resilience of the service. The platform automatically scaled up during huge spikes in traffic, and handled an unprecedented volume of visitors to websites. 'The GovCMS team ensured our website was always available and able to supply information to the public during the pandemic,' said Susie Smith, General Manager, Services Australia.
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Community Portal - expanded content and focus better supports Elders and community members
National Aboriginal Community Controlled Health Organisation (NACCHO) said that the Community Portal on the Australian Indigenous Health InfoNet Alcohol and Other Drugs Knowledge Centre has recently been updated to better meet the information needs of Elders and community members working to reduce harms from alcohol and other drug (AOD) use in their communities. The redevelopment of the Community Portal was guided by focus groups in Perth and Adelaide as well as feedback from a national user survey which found that people wanted to see a web resource that was strength-based, easy to use, and had a more visual format. The portal has refreshed its content with a focus on strength-based resources, information on healing and trauma and up front, factual information on mental health and addiction.
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6 July
Recall actions database
The System for Australian Recall Actions (SARA) provides consumers, health care professionals, sponsors, wholesalers, hospitals and retailers with access to information about recall actions occurring in Australia for therapeutic goods. The Database holds information on recall actions that have been undertaken in Australia since 1 July 2012. The Database is searchable for therapeutic good recall action notifications that include recalls, product defect corrections and hazard alerts (implanted medical devices and biologicals) and product defect alerts. Recall actions are included into the SARA two days (excluding weekends) after the decision between the responsible entity and the TGA, to commence the recall action.
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5 July
$4.5 million for Indigenous Health Website
The Government will provide almost $4.5 million to Edith Cowan University in Western Australia to continue support for its Australian Indigenous HealthInfoNet website and associated resources, said Minister for Health Greg Hunt. The website provides easy access to a wide range of information as well as a knowledge exchange and online discussions for Aboriginal and Torres Strait Islander people, said Minister for Indigenous Affairs Ken Wyatt. The funding consists of:
- More than $4 million for operational core funding for three years from 1 July 2020.
- $412,000 targeted to resources for alcohol and other drug issues, preventive health and chronic disease support.
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Education and Training
None this edition.
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Funding
None this edition.
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Health Professionals
6 July
Six week trial - COVID-19 health professionals disability advisory service
COVID-19 Health Professionals Disability Advisory Service, a telephone advisory service established by the Department of Health, will be available from Tuesday, 7 July. The service will provide specialised advice exclusively for health professionals responsible for the medical care of people with disability diagnosed with COVID-19 or experiencing COVID-19 symptoms, said the National Disability Services (NDS). Healthdirect Australia has been engaged to manage the service - calls will be answered by health professionals with disability service qualifications and experience working with people with disability. Health professionals can call the service on 1800 131 330 between 7am - 11pm (AEST) 7 days a week.
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3 July
Hospitals must coordinate with GPs to reduce preventable hospital admissions
The Australian health system potentially could save $2 billion a year, and help address many of the 750,000 preventable trips to hospitals that occur each year, if hospitals coordinate better with GPs to keep people out of hospital through vaccinations, lifestyle management, and care in the home. The Australian Medical Association (AMA) President, Dr Tony Bartone, released a new AMA Position Statement on Local Hospital Networks and GP-Led Primary Care Services Designed to Reduce Potentially Preventable Hospitalisations. Potentially preventable hospitalisations (PPHs) are those that could be avoided with timely and adequate care, either to prevent the condition occurring in the first place, or to manage it so it does not lead to hospital admission.
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Hospitals
9 July
Private and public hospitals can continue cooperating on covid-19
Private and public hospital operators, along with government health authorities in each Australian state and territory, will be able to continue working with each other in response to the COVID-19 pandemic, under the ACCC's proposed authorisation. The State and Territory Governments have applied for authorisation through the ACCC because without it, the coordination risks breaching competition law. The ACCC granted interim authorisation for the conduct. 'It is clear that there are significant public benefits from public and private health systems coordinating to respond to the pandemic,' ACCC Commissioner Stephen Ridgeway said. 'These authorisations will ensure arrangements can be made to support the timely deployment of critical resources.'
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Overnight hospital stays becoming shorter and same-day hospitalisations increasing
Australian Institute of Health and Welfare (AIHW) said staff are assisting other Government agencies, including the Department of Health, to monitor the COVID-19 (coronavirus) pandemic. This is our top priority and some of the work we had planned for 2020 has been delayed. We are still releasing some reports and other data products, especially those which were close to completion prior to the pandemic or contain information which is time-sensitive for policy makers and service-providers. The information in this media release is for a time period before the 2019-20 Summer bushfires and the COVID-19 pandemic.
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8 July
QLD: Gladstone's new ED a step closer, recruitment drive set to begin
Gladstone Hospital's new Emergency Department is one step closer to reality following practical completion of the $42 million project which created more than 60 construction jobs. Queensland Premier Annastacia Palaszczuk and Queensland Member for Gladstone Glenn Butcher were given a first-hand look of the impressive facility and announced a further $5 million in funding to create a further 30 jobs. 'I first announced we would build a modern new Gladstone ED when we were here for a Community Cabinet meeting in 2016 and I'm so excited to stand here today to see this important community health facility being delivered,' the Premier said.
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SA: Royal Adelaide Hospital embarks on COVID-19 surveillance
Two separate COVID-19 surveillance projects are set to commence at the Royal Adelaide Hospital to further assess the prevalence of coronavirus in the community. Western Australia Minister for Health and Wellbeing Stephen Wade said the projects, one of which was testing elective surgery patients, would further protect South Australians from potential outbreaks. 'A comprehensive strategy to monitor and contain the possible spread of this nasty disease is a key plank in the Marshall Liberal Government's strong plan to protect South Australians from the impacts of COVID-19,' Minister Wade said.
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6 July
06 JUL 2020: DEPT OF HEALTH: PHI 50/20 - Hospital & Second-Tier Updates
4 July
SA: Further boosts to ambulance capacity during COVID-19
A contingent of emergency service workers will be trained as volunteer ambulance personnel, to further boost the State's COVID-19 response capability. SA Minister for Health and Wellbeing Stephen Wade said this innovative move by the Government will boost ambulance operational resilience, particularly in regional areas. 'Training up these 24 State Emergency Service volunteers is part of the Marshall Liberal Government's strong plan to ensure South Australia is prepared should the COVID-19 threat escalate,' Minister Wade said.
Download
3 July
Hospitals must coordinate with GPs to reduce preventable hospital admissions
The Australian health system potentially could save $2 billion a year, and help address many of the 750,000 preventable trips to hospitals that occur each year, if hospitals coordinate better with GPs to keep people out of hospital through vaccinations, lifestyle management, and care in the home. The Australian Medical Association (AMA) President, Dr Tony Bartone, released a new AMA Position Statement on Local Hospital Networks and GP-Led Primary Care Services Designed to Reduce Potentially Preventable Hospitalisations. Potentially preventable hospitalisations (PPHs) are those that could be avoided with timely and adequate care, either to prevent the condition occurring in the first place, or to manage it so it does not lead to hospital admission.
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Insurance
9 July
NEO-Millennials provide hope to health funds
It's official, private health insurance is in serious decline. At 31 March the proportion of Australians with hospital coverage (44%) was the lowest since 2007.1 Economists and commentators blame an exodus of young Australians for the decline in membership. However, health insurance data just released by the Roy Morgan Research Institute paints a different picture. Focused on Millennials, the data reveals two very different economic profiles - one with high levels of health cover, and another with low levels. 'What is revealed is a tale of two planets. On one planet 1.6 million NEO-Millennials are 29% more likely than the average Australian to have hospital cover. While on the other planet 1.9 million traditional Millennials are 39% less likely to have coverage,' said Roy Morgan CEO Michele Levine.
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06 JUL 2020: DEPT OF HEALTH: PHI 50/20 - Hospital & Second-Tier Updates
06 JUL 2020: DEPT OF HEALTH: PHI 49/20 - Reduced TGA regulatory charges for certain implantable medical devices listed on the Prostheses List
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Medicare
7 July
Medicare bulk-billing rate remains high at 86.1 per cent
Over the past 12 months, 86.1% of Australians did not have to pay to visit their GP, said Minister for Health Greg Hunt. Figures for the past 12 months show:
- An increase of more than 5.5 million free bulk-billed GP visits compared to the same period last year
- The number of fully subsidised services across Medicare rose with an additional 9.6 million bulk-billed services delivered for a total of 343.6 million.
The Government's commitment to Medicare and bulk billing remains rock solid. In March, to help reduce the risk of community transmission of COVID-19, the Government introduced new temporary Medicare Benefits Schedule (MBS) telehealth items.
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Men's Health
None this edition.
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Mental Health
7 July
Free suicide prevention training for the veteran community
Support for veteran health and wellbeing has been strengthened with the introduction of a free online suicide prevention training program, delivered in partnership with Open Arms - Veterans & Families Counselling and the Returned and Services League of Australia. Minister for Veterans' Affairs Darren Chester said Suicide Prevention Start is available to anyone who has contact with, or supports the veteran community. 'Veterans' mental health and wellbeing is everyone's business-governments, families, friends, employers, community organisations, ex-service organisations and the broader veteran community-and we must all work together,' Minister Chester said.
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Researchers study the psychological effect of pandemic conditions on people with pre-existing mood disorders
A collaborative study between Swinburne and University of Melbourne researchers has found that individuals with a pre-existing mood disorder reported higher levels of depression, anxiety and stress during the early stages of the COVID-19 pandemic when compared to individuals with no mental disorder. The study, which was conducted by researchers from Swinburne's Centre for Mental Health and the Melbourne Neuropsychiatry Centre as part of the COVID-19 and you: mental health in Australia now survey (COLLATE), has been published in the Journal of Affective Disorders.
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NSW: New Gidget House opens in Manly to help new and expectant parents
Expectant and new parents who are experiencing perinatal depression and anxiety (PNDA) will be able to access GP-referred, free psychological counselling sessions at a new Gidget House in the heart of Manly thanks to support from the NSW State Government. NSW Deputy Premier John Barilaro and NSW Minister for Mental Health Bronnie Taylor officially opened the new centre and announced that the NSW State Government is investing a further $1 million in the Gidget Foundation, on top of the $3 million previously committed. Mr Barilaro said the funding would improve outreach to parents and promote the vital importance of seeking help early if experiencing distress.
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WA: New Chief Medical Officer, Mental Health
Dr Sophie Davison has been appointed as Western Australia's first Chief Medical Officer, Mental Health, said WA Minister for Health Roger Cook. The WA State Government established the new position of Chief Medical Officer, Mental Health (CMOMH) within the Mental Health Commission to help strengthen its leadership role in the sector. Reporting directly to the Mental Health Commissioner, Dr Davison will contribute clinical expertise to strategic planning and policy development, strengthen consumer and community focused clinical care, and liaise with non-government services to support system integration across WA's public mental health, alcohol and other drug services.
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WA: $20 million funding to create specialist mental health hub
The WA State Government will invest $24.4 million as part of the WA Recovery Plan to provide an additional 20 mental health beds at Fremantle Hospital and supplement funding for the existing 20-bed expansion, said WA Minister Cook. The new unit will include a 10-bed older adult neurological behavioural unit, caring for patients with complex needs including neurological and psychiatric issues. Patients will benefit greatly from a shared model of care between psychiatry and geriatric professionals. There will also be a 10-bed adult ward, all single rooms with access to a courtyard.
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3 July
NSW: Keeping our most vulnerable injured workers supported
Each year NSW icare manages around 85,000 workers compensation claims for NSW businesses and government agencies. Among the most complex is a small but growing number of mental health claims. Psychological claims currently account for around six per cent of all workers compensation claims, however this relatively small proportion of claims has some of the most complex customer behaviours. For example, we know that injured workers with a mental health claim are almost 10 times more likely to attempt to hurt themselves or others in contrast to workers with physical injuries.
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Royal Commission into Victoria's Mental Health System
None this edition.
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Pharmaceuticals
8 July
TGA issues fines of nearly $1.8 million for alleged illegal activity in 2019-20
The Therapeutic Goods Administration (TGA) has taken strong action against alleged illegal import, manufacture, supply and advertising of therapeutic goods in Australia during 2019-20. During the year, 187 infringement notices were issued for alleged breaches of the therapeutic goods legislation, totalling almost $1.8 million. In the same period, the TGA pursued civil court action against three companies, with the Federal Court of Australia ordering one company to pay the Commonwealth $10 million for breaches of therapeutic goods advertising requirements. A further five criminal matters were referred to the Commonwealth Department of Public Prosecution. These actions are an important part of the TGA's work to protect Australian consumers.
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7 July
The Original 3 Bullets capsules
The Original 3 Bullets capsules pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled The Original 3 Bullets capsules and found that and found that:
- the capsules contain the undeclared substance yohimbine.
Consumers are advised that yohimbine is a prescription-only (S4) medicine in Australia. The supply of The Original 3 Bullets capsules containing undisclosed yohimbine is illegal. The Original 3 Bullets capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.
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6 July
Better protection against meningococcal and pneumococcal diseases
The National Immunisation Program (NIP) has been amended from 1 July 2020 to improve protection for those most at risk against the potentially fatal meningococcal disease, said Minister for Health Greg Hunt. For the first time, the Meningococcal B vaccine is being made available for free to Aboriginal and Torres Strait Islander infants under two years, who are almost four times as likely to contract this disease as non-Indigenous children. Around 20,000 Indigenous children are expected to be vaccinated each year. Meningococcal disease is rare but can have serious effects, even for survivors, said Minister for Indigenous Affairs Ken Wyatt.
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Zostavax vaccine
The Therapeutic Goods Administration (TGA) has previously advised that Zostavax should not be used in people with compromised immune function, as it is associated with a risk of mild to serious complications (including death) from infection with the vaccine virus. Consumers and health professionals are advised that the TGA has received a report of a new case involving this adverse event in a patient on low doses of immunosuppressive medicine. The patient, who at the time of vaccination was taking hydroxychloroquine and a low dose of prednisolone to treat arthritis, died 3 weeks after receiving Zostavax.
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Recall actions database
The System for Australian Recall Actions (SARA) provides consumers, health care professionals, sponsors, wholesalers, hospitals and retailers with access to information about recall actions occurring in Australia for therapeutic goods. The Database holds information on recall actions that have been undertaken in Australia since 1 July 2012. The Database is searchable for therapeutic good recall action notifications that include recalls, product defect corrections and hazard alerts (implanted medical devices and biologicals) and product defect alerts. Recall actions are included into the SARA two days (excluding weekends) after the decision between the responsible entity and the TGA, to commence the recall action.
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06 JUL 2020: DEPT OF HEALTH: PHI 49/20 - Reduced TGA regulatory charges for certain implantable medical devices listed on the Prostheses List
3 July
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 can change, said the Department of Health. 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', said the TGA.
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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. They refer to these as New Chemical Entities (NCEs) or New Biological Entities (NBEs), said the Department of Health. 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. Throughout the year, they will be publishing information on the new prescription medicines as they are approved.
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Prescription medicines: registration of new generic medicines and biosimilar medicines
Throughout the year, they will be publishing information on new generic and biosimilar prescription medicines as they are approved. said the Department of Health. Please note that the sponsor name reflects the information in the Australian Register of Therapeutic Goods (ARTG) at the time of registration. As sponsors may change over time, consult the ARTG for full information in relation to these products, including full indications. 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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Research
9 July
Tackling one of Australia's deadliest cancers
One of Australia's lowest survival cancers will be the focus of the National Pancreatic Cancer Roadmap to be developed by Cancer Australia. For the first time in Australia, key priority areas for action over the next five years will be identified, with the aim of improving pancreatic cancer outcomes and survival for people affected by the disease. 'It is time to investigate why incidence of pancreatic cancer is rising for both men and women, why outcomes are still so poor and how we can increase survival from the disease,' Professor Dorothy Keefe CEO, Cancer Australia.
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Addressing Australian's national transfusion research priorities
National Health and Medical Research Council (NHMRC) said that Professor Erica Wood is head of the Transfusion Unit at Monash University. Her research describes how blood is used in Australia, and how its use can be improved and made safer and more cost effective. Through registry data and clinical trials, and studies of novel blood products, Professor Wood and her team aim to improve access and transfusion outcomes for patients. Professor Wood and her multidisciplinary team of leading Australian and international investigators will develop new models of blood supply and clinical demand, new decision support tools to guide practice, and investigate how best to provide feedback on transfusion practice.
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8 July
Continuing evidence-based care: Choosing Wisely releases pandemic guidance
Choosing Wisely Australia has released specific pandemic guidance, based on current evidence, to support health professionals as stewards of our finite health resources. 'There's never been a more important time for us to stop, reflect and discuss the necessity of health care at both an individual patient and a systems level,' said NPS MedicineWise Client Relations Manager and Choosing Wisely spokesperson Dr Robyn Lindner. 'We need to look at what the evidence tells us, talk with patients about unproven therapies or advice, and ensure patients are getting the right health care in the right way for them and their condition.'
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Rural, Regional and Remote Health
9 July
Chief Allied Health Officer appointment good news for rural health
The National Rural Health Alliance said that the appointment of Dr Anne-marie Boxall as the Australian Government's new Chief Allied Health Officer was good news for rural Australia. 'Dr Boxall is well-regarded across the sector and has an excellent understanding of rural, regional and remote health, including having worked as a senior policy advisor at the National Rural Health Alliance,' said CEO Dr Gabrielle O'Kane. 'A dedicated full-time Chief Allied Health Officer was one of the four recommendations of the former National Rural Health Commissioner, Professor Paul Worley, in his report on improving allied health services in rural, regional and remote Australia.'
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8 July
NSW Teaming up to build mental fitness in rural and regional communities
8 JUL: People across regional NSW will benefit from mental health and wellbeing workshops focused on 'prevention through connection', thanks to a four-way collaboration between the NSW Government funded Rural Adversity Mental Health Program (RAMHP) and Gotcha4Life, Landcare NSW and Surf Life Saving NSW. NSW Minister for Mental Health Bronnie Taylor said the partnership would bring together a wealth of experience and knowledge to provide support for regional communities who were facing ongoing challenges. The RAMHP is a major project of the Centre for Rural and Remote Mental Health (CRRMH) in partnership with each of the rural NSW Health Districts, and is funded by the NSW Government.
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3 July
Government appoints new National Rural Health Commissioner
The appointment of eminent rural health advocate, medical practitioner and researcher Associate Professor Ruth Stewart as Australia's next National Rural Health Commissioner further demonstrates the Government's commitment to improving health care in the bush. The Government recently extended and expanded the Office of the National Rural Health Commissioner to have a broader focus. Additionally, the Commissioner will be supported by two Deputy Commissioners to specifically look after allied health, nursing and Indigenous health. Minister for Health Greg Hunt said the Government is delighted to appoint Associate Professor Stewart to this important role. Minister for Regional Health Mark Coulton said Associate Professor Stewart has had a distinguished career in rural health.
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AMA will support new National Rural Health Commissioner on big challenges ahead
The Australian Medical Association (AMA) President, Dr Tony Bartone, said that Associate Professor Ruth Stewart is a fitting appointment as National Rural Health Commissioner at a time when rural and regional Australia continues to face significant challenges to achieve improved access to quality medical and health services. Dr Bartone said that Associate Professor Stewart is a highly respected member of the profession who has made a substantial contribution to rural and remote health over many years through her work as a clinician, academic, and leading health reform advocate. 'The key role of the Commissioner is to ensure that rural health issues are always included in Government decision-making and health policy development,' Dr Bartone said.
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Peak body welcomes new National Rural Health Commissioner
The National Rural Health Alliance welcomed the appointment of Associate Professor Ruth Stewart as the new National Rural Health Commissioner. 'Associate Professor Stewart is an excellent choice as she has a long and distinguished career advocating for better health outcomes for people in rural, regional and remote Australia', said National Rural Health Alliance CEO Dr Gabrielle O'Kane. 'The Alliance already has a good relationship with Associate Professor Stewart, including when she was the President of the Australian College for Rural and Remote Medicine, one of our member organisations.'
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SARRAH welcomes appointment of new National Rural Health Commissioner
Services for Australian Rural and Remote Allied Health (SARRAH) is the peak body advocating for allied health services and access in rural and remote Australia. SARRAH welcomes the announcement of Associate Professor Ruth Stewart as Australia's incoming National Rural Health Commissioner and look forward to building on the constructive relationship SARRAH enjoyed with her predecessor Professor Paul Worley. They again want to acknowledge the commitment of the Government, and Minister for Regional Health Mark Coulton especially for legislating to continue the Commissioner role, and also for expanding the Office.
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Women's Health
8 July
Queensland women utilise safe and convenient Urinary Tract Infection service at their local community pharmacy
The Australian Institute of Health and Welfare (AIHW) released new hospital data last week confirming that more than one-third of patients presenting at Emergency Departments (EDs) only require lower urgency care. The Pharmacy Guild of Australia, Queensland Branch, welcomed AIHW's recommendations that pharmacists and other primary healthcare professionals be mobilised to appropriately manage a large percentage of emergency patient presentations at already overcrowded public hospitals. With Queensland emergency department presentations increasing by 13.26% from 2014-15 to 2018-191, the Pharmacy Guild of Australia, Queensland Branch Vice President Chris Owen said he is 'pleased with the opportunity for community pharmacists to further support the healthcare system.'
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ACT: Supporting women's health, wellbeing and safety
ACT Minister for Women Yvette Berry said that the ACT Government is providing funding for seventeen projects that will support the health, wellbeing and safety of women in Canberra through a $180,000 grant program. 'Today I announced the 17 individuals, organisations and community groups to receive funding through the Women's Participation and Safety Grants program. $80,000 is targeted to projects that focus on women's participation, improving outcomes for women and advancing gender equality in the ACT. Prioritising these issues supports the work of the ACT Women's Plan 2016-2026. One of the recipients, Women with Disabilities ACT, will receive funding to establish a peer support group for their members who are currently parents or plan to be parents.'
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Transcripts
Prime Minister Scott Morrison
08 JUL: Transcript of Press Conference, Australian Parliament House, ACT
Subjects: COVID-19, VIC outbreak, ADF, State border, Health restrictions, In-home aged care, Budget, Aged care Royal Commission, Tourism, AFL
Minister for Health Greg Hunt
08 JUL: Transcript of Interview with Stephen Quartermain & Kate Stevenson, 3AW
Subjects: Victoria coronavirus outbreak, Public safety, Government assistance to Victoria, Social distancing, Lockdown measures
Deputy Chief Medical Officer
08 JUL: Transcript of Press Conference, Canberra
Subjects: Victorian COVID-19 outbreak, ACT COVID-19 cases, Mental health, Safety of schools, AHPPC, Compulsory hotel quarantine, National Cabinet, Mask-use, WHO
Minister for Health Greg Hunt
07 JUL: Transcript of Interview with Lisa Millar, ABC News Breakfast
Subjects: Victorian Government, COVID-19 outbreak in Melbourne, NSW & Victorian border closure, Regional communities, ADF, Suburbs, Testing, Community transmission
Minister for Health Greg Hunt
07 JUL: Transcript of Interview with Chris Kenny, Sky News
Subjects: Victorian COVID-19 outbreak, Mass gatherings, Social distancing measures, COVIDSafe app, Border closures
Minister for Health Greg Hunt
07 JUL: Transcript of Interview with Karl Stefanovic, The Today Show
Subjects: Melbourne outbreak, COVID-19, Public housing lockdowns, VIC border closure, Health restrictions, Social distancing
Minister for the National Disability Insurance Scheme Stuart Robert
07 JUL: Transcript of Q&A Speech, National Press Club, Canberra
Subjects: Income compliance program, Service Australia operations, COVIDSafe app, Victoria lockdown, NDIS, myGov, Cyber security, Public service experience, Digital identity
Minister for the National Disability Insurance Scheme Stuart Robert
07 JUL: Speech at the National Press Club, Canberra
Subjects: Services Australia, Centrelink, Welfare, Bushfires, COVID-19, Medicare, Digital transformation
Prime Minister Scott Morrison
06 JUL: Transcript of Interview with Jim Wilson, 2GB
Subjects: COVID-19, NSW Premier, NSW & Vic border, Essential workers, Albury-Wodonga, ADF, International flights, Treasurer, JobKeeper, Global recession
Minister for Regional Health Mark Coulton
03 JUL: Transcript of Interview with Dominic Ingersole, 2BS Radio
Subjects: Appointment of new National Rural Health Commissioner, Nursing, Allied health, Indigenous health, Rural & remote regions, Access to healthcare, Public health
Deputy Chief Medical Officer
03 JUL: Transcript of Deputy CMO, Professor Michael Kidd's Press Conference, Canberra
Subjects: COVID-19, Health, VIC outbreak, Melbourne, Testing, ADF, Community transmission
Deputy Chief Medical Officer
03 JUL: Transcript of Deputy CMO, Professor Michael Kidd's Interview with Waleed Aly, Susie Youssef & Joel Creasey, The Project
Subjects: COVID-19, VIC outbreak, Testing, Lockdown, Health restrictions, Domestic travel
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Reports
Australian Public Assessment Report for Infliximab (rmc) - Proprietary Product Name: Remsima, Emisima, Flixceli, Inflectra - Sponsor: Pharmbio Pty Ltd
Department of Health, Therapeutic Goods Administration (TGA)
This AusPAR describes the application by Pharmbio Pty Ltd (the sponsor during the TGA evaluation process. It has the following approved therapeutic use:
- Rheumatoid Arthritis in adults
- Inflectra in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in:
- Patients with active disease despite treatment with methotrexate
- Patients with active disease who have not previously received methotrexate.
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Virtual public hearings: Practice guideline 6
Royal Commission Into Aged Care Quality & Safety
This Practice Guideline relates to the conduct of public hearings of the Royal Commission into Aged Care Quality and Safety (Royal Commission) which the Royal Commissioners determine should be conducted virtually in part or in full.
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Health and ageing of Australia's prisoners 2018
Australian Institute of Health & Welfare AIHW
This report presents data on the health-care needs of prisoners who participated in the 2018 National Prisoner Health Data Collection (NPHDC), with a focus on how these needs differ for younger and older prison entrants.
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Australian public assessment report for Ixekizumab - Taltz
Department of Health, Therapeutic Goods Administration (TGA)
This AusPAR describes the application by Eli Lilly Australia Pty Ltd (the sponsor) to register Taltz (ixekizumab) 80 mg/mL solution for injection for the following proposed extensions of indications:
- Ankylosing spondylitis (radiographic axial spondyloarthritis).
- Taltz is indicated for the treatment of active ankylosing spondylitis in adult patients.
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease predominantly affecting the axial skeleton including the sacroiliac joints (SIJ) and the spine.
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Fees and charges: summary
Department of Health
The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.
• A fee is charged for a service, such as a product evaluation.
• A charge is a form of tax on regulated industry and is applied annually based on a 1 July to 30 June financial year.
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Australian Public Assessment Report for Ribociclib succinate - Proprietary Product Name: Kisqali - Sponsor: Novartis Pharmaceuticals Australia Pty Ltd
Department of Health, Therapeutic Goods Administration (TGA)
This AusPAR describes the application by Novartis Pharmaceuticals Australia Pty Ltd (the sponsor) to register Kisqali ribociclib succinate. The proposed indication for ribociclib is:
- Kisqali in combination with letrozole is indicated for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as an initial endocrine-based therapy. The dosage form proposed is a film coated tablet containing 200 mg of ribociclib base presented in a blister pack.
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Clearance code tables guidance - Manufacturing steps - Guidance
Department of Health, Therapeutic Goods Administration (TGA)
This guidance helps you navigate the TGA Code Tables to interpret manufacturing steps used to obtain evidence of Good Manufacturing Practice (GMP) via the GMP clearance desktop pathway. This guidance aims to:
- provide a list of common manufacturing steps that validate within the various TGA product registration/listing systems
- provide an interpretation for the common manufacturing steps from a GMP clearance perspective
- provide clarification around common manufacturing step group terms and the individual manufacturing steps associated with each group which validate in the product registration/listing systems.
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Submitting data in the eCTD format
Department of Health
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Hansards
Tasmania
25 JUN 2020: TAS ASSEMBLY HANSARD: Matter of Public Importance - COVID-19 Emergency
25 JUN 2020: TAS COUNCIL HANSARD: Questions - COVID-19 - Testing Essential Travellers
24 JUN 2020: TAS ASSEMBLY HANSARD: Matter of Public Importance - COVID-19 Emergency
24 JUN 2020: TAS COUNCIL HANSARD: Questions - COVID-19 - Antenatal and Postnatal Mental Health and Wellbeing - North-West Coast
24 JUN 2020: TAS COUNCIL HANSARD: Questions Upon Notice - COVID-19 - Wellbeing of Patients - Mental Health Facilities
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Court Cases
None this edition.
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New Regulations
Federal
Health Insurance Legislation Amendment (2020 Measures No. 1) Regulations 2020
Legislative Instrument - F2020L00882
The purpose of the Health Insurance Legislation Amendment (2020 Measures No. 1) Regulations 2020 (the Regulations) is to remove nine Medicare Benefits Schedule (MBS) cardiac items from the DIST and to remove nine cardiac MBS items from the GMST from 1 August 2020. These amendments are part of the Government's response to changes recommended by the clinician-led MBS Review Taskforce (the MBS Review Taskforce).
Explanatory Statement
Australian Capital Territory
Public Health (COVID-19 Interstate Hotspots) Emergency Direction 2020 (No 2)
Notifiable Instrument - NI2020-390
This instrument alleviates the emergency declared under the Public Health (Emergency) Declaration 2020 (No 1) [NI2020-153] (the declared emergency) on 16 March 2020, to give the directions as set out in the schedule. This instrument commences at 11.59pm on 4 July 2020.
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Proclamations
None this edition.
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Gazette Notices
New South Wales
05 JUL 2020: NSW GOVERNMENT GAZETTE No. 147: Extraordinary Gazette - Public Health Act 2010 - Section 21 - Public Health (COVID-19 Interstate Hotspots) Amendment Order 2020
Victoria
05 JUL 2020: VIC SPECIAL GAZETTE No. S 343: Public Health and Wellbeing Act 2008 - Section 200 - Direction From Deputy Chief Health Officer In Accordance With Emergency Powers Arising From Declared State Of Emergency Area Directions (No. 2)
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Consolidated Legislation
Biosecurity (Human Biosecurity Emergency) (Human Coronavirus with Pandemic Potential) (Emergency Requirements for Remote Communities) Determination 2020
Consolidated Legislative Instrument - F2020C00556
Determinations/Other as amended, taking into account amendments up to Biosecurity (Human Biosecurity Emergency) (Human Coronavirus with Pandemic Potential) (Emergency Requirements for Remote Communities) Amendment (No. 6) Determination 2020
Administered by: Health
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Subsidy Principles 2014 Authoritative Version
Consolidated Legislative Instrument - F2020C00560
In force - Latest Version Principles as amended, taking into account amendments up to Aged Care Legislation Amendment (Subsidies COVID-19 Support) Instrument 2020
Administered by: Health
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Aged Care (Transitional Provisions) Principles 2014
Legislative Instrument Compilation - F2020C00552
Principles as amended, taking into account amendments up to Aged Care Legislation Amendment (Subsidies - COVID-19 Support) Instrument 2020.
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Health Insurance (Section 3C General Medical Services - Other Medical Practitioner) Determination 2018
Legislative Instrument Compilation - F2020C00548
Determinations/Health as amended, taking into account amendments up to Health Insurance Legislation Amendment (Consequential Change to Incorporated GMST Clauses and Eye Movement Desensitisation and Reprocessing) Determination 2020.
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Private Health Insurance (Health Insurance Business) Rules 2018 Authoritative Version
Consolidated Legislative Instrument - F2020C00562
In force - Latest Version Rules/Other as amended, taking into account amendments up to Private Health Insurance Legislation Amendment Rules (No. 4) 2020
Administered by: Health
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Health Insurance Act 1973 Authoritative Version
Consolidated Legislative Instrument - C2020C00198
In force - Latest Version Act No. 42 of 1974 as amended, taking into account amendments up to Health Insurance Amendment (General Practitioners and Quality Assurance) Act 2020 An Act providing for Payments by way of Medical Benefits and Payments for Hospital Services and for other purposes
Administered by: Health
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New Bills
None this edition.
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New Acts
None this edition.
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