This week The Zap reports on news about patient safety, regulation of infant formula marketing, scope of practice matters, oral health reform, a push for a 10-year National Rural Health Strategy, and an award-winning program to support frail and elderly people in the community.
Meanwhile, the Federal Court has ordered Medtronic Australasia Pty Ltd to pay $22 million in the largest penalty to date for a breach of the Therapeutic Goods Act.
And privacy concerns are being raised about an artificial intelligence tool produced by Australian healthcare technology company Harrison.ai. It was developed using 800,000 chest x-rays mainly sourced from I-MED Radiology Network, Australia’s largest medical imaging provider.
Among the long list of consultations compiled by our columnist is an opportunity for Croakey readers to comment on a Federal bill to tackle misinformation and disinformation. But get in quick… the deadline is 30 September.
The quotable?
While the Senate inquiry process can be useful, submission deadlines of under a fortnight for complex pieces of legislation places incredible pressure on potential submitters, and probably detracts from the number and quality of submissions received.”
Charles Maskell-Knight writes:
Tuesday 17 September was World Patient Safety Day. This year the theme was ‘Improving diagnosis for patient safety’ with the slogan ‘Get it right, make it safe!’, “highlighting the critical importance of correct and timely diagnosis in ensuring patient safety and improving health outcomes”.
The Australian Commission on Safety and Quality in Health Care (ACSQHC) issued a media release marking the day, as did the Pharmaceutical Society of Australia (PSA), which encouraged patients to speak to their local pharmacist to learn more about the medications they use.
PSA National President Associate Professor Fei Sim FPS said: “World Patient Safety Day is a great reminder for all Australians to check that they know the doses of their regular medications, and to ask their local pharmacist about possible medicine interactions.”
Apart from these organisations the day did not receive a great deal of attention in Australia.
Ministers and government
In an article on the Government’s aged care “reforms” I noted that “for many years Health Ministers have delighted in lauding Australia’s health system as ‘world class’ or ‘world leading’”.
Minister Mark Butler was at it again on 20 September, reacting to a Commonwealth Fund report which ranked the Australian health system as best in the world (in front of the Netherlands, the United Kingdom, New Zealand, France, Sweden, Canada, Germany, Switzerland and the United States).
Butler said “Australians rightly deserve a world-class health system” – yet the Government is still not prepared to include a high-quality aged care system as one of the objectives of its proposed new Aged Care Act.
The Department of Health and Aged Care opened a consultation on Reforms to strengthen the National Mental Health Commission and National Suicide Prevention Office. Readers with a long memory may recall that in April last year Health Minister Mark Butler announced an investigation into allegations about the Commission’s culture and performance.
The report from that investigation was delivered in September 2023, and according to The Mandarin came out “looking like a horror show”, with staff reporting “deep distress… [including] anxiety, depression or suicidal ideation”.
In the budget this May the Government announced that the Commission would be transferring from the Prime Minister and Cabinet portfolio to the Health portfolio, and now the Department is consulting on how it should operate into the future.
You just can’t rush reform.
The Department also sought expressions of interest by 30 September from aged care providers interested in joining a pilot of quality indicators for in-home care.
The Department’s Chief Allied Health Officer, Anita Hobson-Powell, announced on LinkedIn that the MBS Review Advisory Committee (MRAC) had approved the review of the allied health services accessible under MBS Chronic Disease Management items.
The review will “assess whether allied health chronic disease management items should be amended to better support the management of chronic conditions for eligible patients”.
While MRAC’s webpage was amended several days later to include a reference to the review, no further detail is available.
The Therapeutic Goods Administration announced that the Federal Court had ordered Medtronic Australasia Pty Ltd to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020, as well as costs of $1 million. It is the largest penalty to date for a breach of the Therapeutic Goods Act.
The Australian Institute of Health and Welfare (AIHW) released the latest data from the National Suicide and Self-harm Monitoring System.
The Independent Health and Aged Care Pricing Authority released its Residential Aged Care Pricing Advice for the year starting 1 October.
The ACSQHC advertised a webcast on 17 October to mark the release of the first national standard of care for chronic obstructive pulmonary disease.
The Australian Bureau of Statistics (ABS) released the microdata behind its recent report on sun protection behaviours, based on a survey carried out during the 2023-24 summer and funded by the Cancer Councils of Australia. It found that while almost 40 percent of people aged 15 years and over used sunscreen on most days, almost seven percent had experienced sunburn in the last week.
Food Standards Australia and New Zealand opened consultation on a proposal “to consider varying maximum residue limits for residues of specific agricultural and veterinary chemicals that may occur in food commodities”. Submissions are due by 29 October.
This column does not report on every FSANZ consultation, because they are generally very specific and highly technical. However, at a macro level, it is noteworthy that half of the six current open consultations involve substances derived from genetically modified organisms.
When I was involved in the first quinquennial review of the Gene Technology Act almost 20 years ago, ‘Frankenfoods‘ were a hot topic, and States were rushing to implement bans on GM crops. How times have changed! The last mainland State with a ban on GM crops lifted it in 2021.
The Australian Competition and Consumer Commission (ACCC) released a draft determination refusing to re-authorise the Marketing in Australia of Infant Formula: Manufacturers and Importers Agreement (MAIF Agreement) and its associated guidelines. The ACCC said that “on the evidence before it, [it is] not satisfied that the MAIF Agreement is effective in protecting rates of breastfeeding”.
The Government had carried out a review of the MAIF, which reported in April 2024, concluding that the MAIF Agreement is no longer fit for purpose, and recommending the establishment of a stronger regulatory framework in the form of a legislated, prescribed, mandatory code.
The Australian Breastfeeding Association (ABA) welcomed the ACCC draft determination.
ABA Executive Officer Victoria Marshall-Cerins said the Association encourages the Government to move forward by adopting the review report’s recommendations regarding new statutory regulation of the marketing of infant formula in Australia.
“In framing the scope of any new legislation, we encourage the Government to ensure that it encompasses the full scope of the International Code of Marketing of Breast-milk Substitutes and subsequent WHA resolutions,” Marshall-Cerins said.
Consumer and public health groups
COTA Australia commented on a report from Anglicare which found that “older people are waiting an average of 15 months for home care and that the wait list for care has ballooned to 68,000, which is double what it was just one year ago”.
Acting CEO Corey Irlam said “when the Federal Government released its Aged Care Act legislation last week, it announced that by 1 July 2027 people will have to wait no more than three months for support at home; however, we now know that the Government’s wait time estimates don’t show the full picture, which is very concerning”.
“The figures the Federal Government is using are misleading at best,” Irlam said. “They don’t include the full waiting period from application to service commencement – only the middle waiting period from the time assessment is completed until a place is allocated to an individual.”
The Food for Health Alliance (FHA) urged the Government to act to protect children from unhealthy food and drink advertising, following a decision by the British Government to implement a ban on junk food marketing on television before 9pm and paid junk food advertising online from October next year.
FHA Executive Manager, Jane Martin, said the organisation and other public health groups had been pushing since 2006 for policies to “to prevent the processed food industry from bombarding kids with their ads through television and online”.
“Yet almost two decades later, we’re still grappling with the issue,” she said.
Peter Breadon, Director of the Health Program at the Grattan Institute, wrote an article for Pearls and Irritations on the need to “give Medicare some teeth” and extend it to cover dental services.
He argued that the experience of Medicare should inform the design of a new dental program, which should include public provision of services in areas with low workforce supply. It should also build in value for money, excluding cosmetic services and allowing oral health therapists to work at the top of their scope of practice.
The National Rural Health Alliance announced it had presented a petition to the Australian Parliament seeking “a 10-year National Rural Health Strategy as a compact between the Commonwealth and state and territory governments through a schedule to the National Health Reform Agreement, which embeds rural and remote policy and funded priorities for action”.
Trade unions
The Australian College of Rural and Remote Medicine (ACCRM) issued a statement on the Scope of Practice review.
ACCRM’s final submission to the review “supported in principle system reforms to flexibly enable health team models that can optimally deliver care in rural and remote areas”, and argued that “that people in rural and remote areas deserve access to a doctor which whom they can have continuity of relationship”.
ACRRM said that Rural Generalist Medicine is “a critical part of the solution for maximising the potential of rural workforces to provide safe, high-quality care”.
As reported in Croakey, the Australian Medical Association (AMA) released a position statement on combatting racism in the health system.
AMA President Professor Steve Robson said “the results of the 2023 National Medical Training Survey showed 54 percent of Aboriginal and Torres Strait Islander trainee doctors reported having experienced or witnessed bullying, discrimination and harassment, including racism, compared with 21 percent of all trainees nationally.
“Research has also found that international medical graduates frequently report high levels of racism, discrimination, and prejudice from patients and colleagues… and that racist behaviour is directed at doctors from second or third generation migrant families even though they were born and have grown up in Australia.”
The AMA also released its submission to the Department of Health and Aged Care’s public consultation on improving commercial foods for infants and young children. The submission urged the Government to “adopt best practice standards for nutrition in commercial foods for infants and young children, and to put a stop to coercive and deceptive marketing of products”.
The Australian Psychology Society took credit for advocating for a package of measures to improve psychology education announced on 19 September by Assistant Minister for Mental Health Emma McBride, who was joined by APS president Dr Catriona Davis-McCabe.
The measures include approved supervisor training sessions to eligible psychologists; 500 additional postgraduate psychology places; and 500 one-year internships for provisional psychologists.
The Royal Australian College of GPs (RACGP) media team had a busy week.
On Monday the RACGP issued a media release calling on parties in the ACT election to commit to a review of the nurse-led walk-in centres in Canberra, claiming that they were “bleeding taxpayers’ money and their ability to provide the care people need is under question”.
On Tuesday the College praised ACT Labor’s commitments to exempt GP income from payroll tax; co-design a $4 million professional development and wellbeing fund to attract GP registrars; work with the RACGP and other GP organisations to support increased scope of practice for GPs, including an expanded role in the diagnosis and treatment of ADHD for GPs with an interest in this area; and establish an $11 million fund to encourage more bulk billing in the ACT and expand the availability of multidisciplinary care in local general practices.
At a national level the RACGP raised concerns about the Medical Board’s expedited pathway to allow overseas-trained GPs to practise in Australia.
College president Dr Nicole Higgins said “we have raised our concerns with the Medical Board and health minsters about whether the Board is ready to launch an expedited pathway”.
“The Board must have appropriate systems, processes, and resources available to ensure the new pathway truly ‘expedites’ the process. We have yet to see evidence of this.”
On Wednesday the RACGP welcomed the introduction by the South Australian Government of an RSV immunisation program for at risk infants.
It also announced that GPs would be visiting the NSW Parliament to urge the State Government to “provide an incentive payment to cover the pay cut GP registrars take when leaving hospital and starting private practice”, and “rule out risky alternatives that jeopardise patient safety by allowing health workers without medical training to do the work of GPs”.
Also on the ACT election, the Australian Primary Health Care Nurses Association (APNA) welcomed the commitment from ACT Labor to increase access to nurses in ACT public secondary schools.
Industry groups
The Australian Healthcare and Hospitals Association (AHHA) congratulated Northern Sydney Local Health District (NSLHD) and Sydney North Health Network on receiving an honorary mention at the International Hospital Federation Awards for a program to support frail and elderly people in the community.
James Inglis from NSLHD said the program “provides proactive and preventative healthcare to frail and older people across northern Sydney through a close network of hospital staff, GPs and community services so that they don’t end up in the emergency department unnecessarily”.
Since 2022, NSLHD’s Geriatric Outreach Service has dealt with 10,864 referrals for 6,712 patients, mostly from aged care homes, managing 75 percent without a hospital stay, saving about $10 million in 2023.
Day Hospitals Australia released a report Private Healthcare’s Fork in the Road, arguing that “to maintain the affordability of private healthcare and health insurance premiums, it is crucial to direct more day procedures to day hospitals and that day hospitals are remunerated adequately to ensure their continued viability”.
The report concludes that “in many cases, the price gap between overnight hospitals and day hospitals for a given treatment is increasing… This demonstrates the market power of the larger private hospital groups relative to private health insurers”.
The Pharmacy Guild welcomed a commitment from the ACT Labor Party to “expand pharmacists’ scope of practice… in line with recent changes in New South Wales” if re-elected.
ACT Branch President Simon Blacker said that “when one in 10 Canberrans are waiting three or more weeks for a GP appointment and emergency departments are overburdened, allowing pharmacists to provide a broader range of services for patients is essential”.
The Guild also promoted a range of resources to assist pharmacists choosing not to sell vapes over the counter from 1 October to communicate their decision.
Unfortunately the resources are only available to Guild members – the rest of us will have to wait until we see them in a pharmacy near us.
I look forward to posters explaining why pharmacies can only sell products with a demonstrated therapeutic benefit, placed in front of displays of homeopathic preparations.
Finally, the Guild issued a release marking national Wear It Red Day, an initiative of Painaustralia, the national peak advocacy body for those living with chronic pain.
Painaustralia CEO Giulia Jones said the day is intended to “send a strong message to the community and to our leaders that community pharmacies are essential to ensuring consumers get the proper pain management they deserve”.
The day is sponsored by Panadol.
Politicians and parliamentary committees
The Senate inquiry into issues related to menopause and perimenopause released its report, including 25 recommendations.
Sarah White, CEO of Jean Hailes for Women’s Health, reviewed the report for Croakey, concluding that “while it may not present groundbreaking revelations, its very existence highlights a critical point: the gaps in our knowledge and approach to women’s health are not insurmountable challenges, but rather a reflection of longstanding neglect”.
A Government response to the report is due the week before Christmas.
In other Senate committee news, the Aged Care Bill was referred for an inquiry on 16 September, with submissions due on 30 September and a report on 31 October; and the Communications Legislation Amendment (Combatting Misinformation and Disinformation) Bill 2024 was referred for an inquiry on 19 September, with submissions due on 30 September – even though the reporting date is 25 November 2024.
While the Senate inquiry process can be useful, submission deadlines of under a fortnight for complex pieces of legislation places incredible pressure on potential submitters, and probably detracts from the number and quality of submissions received.
International organisations
The Commonwealth Fund (US-based health policy thinktank) released its regular publication comparing health system performance in ten countries, examining 70 health system performance measures in the five areas of access to care; care process; administrative efficiency; equity, and health outcomes.
While the report is intended to highlight areas of improvement in the US system, it is often used as a league table of health system performance.
In the 2024 edition, the highest ranked countries are Australia, the Netherlands, and the United Kingdom, although as the report notes “differences in overall performance between most countries are relatively small”.
“The only clear outlier is the US, where health system performance is dramatically lower”.
The report concludes that “the US continues to be in a class by itself in the underperformance of its healthcare sector”.
“While the other nine countries differ in the details of their systems and in their performance on domains, unlike the US, they all have found a way to meet their residents’ most basic healthcare needs, including universal coverage.”
The report ranks Australia highly on equity, health outcomes, and administrative efficiency.
However, on access to care – including affordability and availability – we are ranked ninth out of 10.
The report observes that “roughly half of Australian patients who do not choose to purchase voluntary health insurance may have to wait longer to receive services”.
“Affordability is also a noted problem, although new billing incentives have led to improvement in recent years,” it says.
Finally
Potentially the biggest health sector story of the week was broken by Cam Wilson at Crikey, but so far does not seem to have been picked up by other media outlets.
According to the story, Australian healthcare technology company Harrison.ai has produced a tool that “can read chest X-rays and help clinicians detect observations like collapsed lungs or stents”, and the company claims it is now “available to one in three radiologists in Australia and clinics in Europe, UK, APAC and US”.
It appears that the artificial intelligence (AI) model underpinning the tool was trained on 800,000 chest x-rays mainly sourced from I-MED Radiology Network, Australia’s largest medical imaging provider.
Wilson writes “if the radiology company sought consent from its patients to use their scans to train commercial AI models, there doesn’t appear to be any public evidence and patients do not appear to know about it”.
“Even if it did,” he says, “the companies’ handling of the data may not satisfy Australian privacy law.”
Responding to a request from Crikey for comment, a spokesperson for Attorney-General Mark Dreyfus said “the use of health information to train AI models raises privacy concerns about the lawful handling of personal information”.
I-MED has now released a statement claiming that all data supplied to Harrison.ai had been de-identified, and that “I-MED Radiology takes the protection of patient privacy very seriously”.
As far as I can tell, Harrison.ai is yet to respond to the story.
Consultations and inquiries
Here is our weekly list of requests by government bodies and parliamentary committees for responses to consultations or submissions to inquiries, arranged in order of submission deadlines. Please let us know if there are any to add for next week’s column.
Australian Commission on Safety and Quality in Health Care
National Safety and Quality Medical Imaging Standards (to replace the Diagnostic Imaging Accreditation Scheme Standards).
27 September
Department of Health and Aged Care
Draft of the National Roadmap to Improve the Health and Mental Health of Autistic People
27 September
Senate standing committee on community affairs
Aged care bill
30 September
Senate standing committee on environment and communications
Communications Legislation Amendment (Combatting Misinformation and Disinformation) Bill
30 September
Department of Health and Aged Care
Review of MBS health assessment items
30 September
Department of Health and Aged Care
How the Australian CDC plans to use data
30 September
House of Representatives Standing Committee on Health, Aged Care and Sport
The health impacts of alcohol and other drugs in Australia
30 September
Therapeutic Goods Administration
Consultation on temporary labelling exemptions for paracetamol
30 September
The Medical Board of Australia
Introduction of health checks for late career doctors
4 October
Department of Health and Aged Care
Review of the Stoma Appliance Scheme Schedule
6 October
Therapeutic Goods Administration
Draft guidance on the new regulatory requirements and transition arrangements for medical devices containing medicinal substances or materials of animal, microbial, or recombinant origin
9 October
Department of Health and Aged Care
Survey on the functionality and user experience of MBS Online
11 October
Therapeutic Goods Administration
Future regulation of assistive technologies
13 October
Therapeutic Goods Administration
Clarifying and strengthening the regulation of Artificial Intelligence (AI)
13 October
Department of Health and Aged Care
Safe and Responsible Artificial Intelligence in Health Care – Legislation and Regulation Review (See also the Joint Committee on Public Accounts and Audit Inquiry into the use and governance of artificial intelligence systems by public sector entities.)
14 October
Independent review of complexity in the National Registration and Accreditation Scheme (NRAS)
Consultation paper
14 October
Therapeutic Goods Administration
Proposed changes to the Australian Essential Principles for Safety and Performance of medical devices
16 October
Ahpra Accreditation Committee
Guidance on developing professional capabilities
18 October
Department of Health and Aged Care
Draft 24-hour movement recommendations for adults and older Australians
18 October
Department of Health and Aged Care
Draft National Nursing Workforce Strategy
20 October
National Mental Health Commission (National Suicide Prevention Office)
Draft National Suicide Prevention Strategy
27 October
Food Standards Australia and New Zealand
Varying maximum residue limits (MRLs) for residues of specific agricultural and veterinary chemicals that may occur in food commodities
29 October.
Department of Health and Aged Care
Proposed amendments to the Gene Technology Act 2000
8 November
Department of Health and Aged Care
Reforms to strengthen the National Mental Health Commission and National Suicide Prevention Office
11 November
Charles Maskell-Knight PSM was a senior public servant in the Commonwealth Department of Health for over 25 years before retiring in 2021. He worked as a senior adviser to the Aged Care Royal Commission in 2019-20. He is a member of Croakey Health Media; we thank and acknowledge him for providing this column as a probono service to our readers. Follow on X/Twitter at @CharlesAndrewMK.
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