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In this commentary, we present a brief history of the development of a national regulatory framework for xenotransplantation clinical research in Australia, including the reasons behind the imposition of a 5-year moratorium in 2005 and its subsequent lifting. We conclude with a summary of current relevant guidelines and standards., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objectives: Unwarranted clinical variations in radical prostatectomy (RP) procedures are frequently reported, yet less attention is given to the variations in associated costs. This issue can further widen disparities in access to care and provoke questions about the overall value of the procedure. The present paper aimed to delve into the disparities in hospital, medical provider and out-of-pocket costs for RP procedures in Australia, discussing plausible causes and potential policy opportunities. Methods: A retrospective cohort study using Medibank Private claims data for RP procedures conducted in Australian hospitals between 1 January 2015 and 31 December 2020 was undertaken. Results: Considerable variations in both medical provider and out-of-pocket costs were observed across the country, with variations evident between different states or territories. Particularly striking were the discrepancies in the costs charged by medical providers, with a notable contrast between the 10th and 90th percentiles revealing a substantial difference of A$9925. Hospitals in Australia exhibited relatively comparable charges for RP procedures. Conclusions: Initiatives such as enhancing transparency regarding individual medical provider costs and implementing fee regulations with healthcare providers may be useful in curbing the variations in RP procedure costs. What is known about the topic? Unwarranted clinical variations in radical prostatectomy procedures are well documented in the literature; however, variations in cost are less widely reported. What does this paper add? This paper aims to highlight the cost variations in radical prostatectomy procedures in Australia, discussing their plausible causes, implications and proposing potential policy opportunities. What are the implications for practitioners? Excessive fees imposed by medical providers may contribute to inequalities in healthcare access. Enhancing transparency of individual medical provider costs and implementing fee regulations may be useful in controlling unwarranted variations in procedure costs. This article belongs to the Special Issue: Value-based Healthcare. [ABSTRACT FROM AUTHOR]

What is known about the topic? The health workforce and health tasks are highly contested and largely controlled by regulation. Since the introduction of medical regulation in the mid-19th century, the practice of surgery has been largely dominated by medically trained surgeons. A small group of Australian podiatrists have defied these historic boundaries by creating their own colleges of training and convincing government and regulators of their safety and efficacy in surgical practice. The Podiatry Board of Australia commissioned an independent review of the regulation and regulatory practices of podiatric surgeons in Australia. What does this paper add? This paper discusses the implications of a regulatory review of the role of podiatric surgeons for professional role boundaries. What are the implications for practitioners? Despite historic role boundaries and definitions, with appropriate training, regulation, and financing, the health workforce can be mobilised in different ways to meet population needs, overcoming a professional monopoly over roles. [ABSTRACT FROM AUTHOR]

Background: The development of policies that promote and enable physical activity (PA) is a global health priority. Laws are an important policy instrument that can enable enduring beneficial outcomes for individuals, organizations, and environments through multiple mechanisms. This article presents a systematic process for mapping laws relevant to PA, which can be used to understand the role of laws as a powerful PA policy lever. Methods: Building on methods used in public health law research, we developed a protocol for scientific mapping of laws influencing the built environment for PA in Australia. The MonQcle online legal research platform was used for data coding, analysis, and presentation. Results: We describe the 10 key stages of legal mapping that we applied to examine state and territory laws that influence walking and cycling in Australia. Conclusions: Law is a neglected element of policy research for PA. There is a need for accessible legal data to drive the design, investment, and implementation of legal interventions to improve population PA. Legal mapping is a first step toward evaluation of such laws for PA. This paper provides a practical case study and guidance for the 10 stages in legal mapping of laws that influence the built environment for PA. [ABSTRACT FROM AUTHOR]

Posthumous conception, the ability to conceive a child after the death of one partner, is increasingly prevalent due to advances in Artificial Reproduction Technology (ART). This paper considers the complexities surrounding the practice in Australia, focusing primarily on the ethical and legal dimensions. It observes that state-based regulations in Australia create disparities in accessibility: some states prohibit the procedure without the deceased's written consent, while others permit it based on guidelines or lack explicit prohibitions. Addressing the juxtaposition of Will Theory and Interest Theory, it emphasises the ongoing debate on whether rights, particularly reproductive autonomy, outlive a person's demise. Finally, the paper highlights an evident inconsistency in Australian legislation and promotes a uniform approach across states. [ABSTRACT FROM AUTHOR]

The sale of raw drinking milk from cows is banned in Australia due to regulatory requirements that all milk must be pasteurised. Such a prohibition is based on concern about public health and safety risks, and was upheld in the most recent review of raw milk product regulation undertaken by Food Standards Australia New Zealand (FSANZ). However, this decision is not one that is universally accepted, with some people challenging the conclusion that raw milk is dangerous, and choosing to still source and drink it. In this paper, the contested regulation of raw milk is examined by questioning the normative assumption that the object in question, raw milk, is a singular entity, and one which is always dangerous. Drawing on analysis of six FSANZ documents released as part of its raw milk review, this paper discusses the practices that stabilise raw milk as always risky; processes that are found to wash away the possibility of other, potentially safe, versions of raw milk. It concludes by finding that such stabilisation has tangible impacts for public health policy and regulation, including limiting the parameters within which debate can occur, and precluding the possibility that other versions of raw milk could exist, or be accounted for in food safety regulation. [ABSTRACT FROM AUTHOR]

The focus of this methodological paper is to discuss the challenges of conducting fieldwork, using reflections from our experiences of accessing a research site for ethnographic data collection. The research project aimed to explore nurses’ social relations in their workplace and the inequities between and within these relations among nurses of diverse social positions. Due to the sensitive nature of this topic, access to the research site posed several challenges and was further complicated by the bureaucratic ethics process that governs clinical sites in Australia. Although this study was considered a low and negligible risk research, negotiating the ethics process was full of hitches and hindrances resulting in the refusal of access. This paper offers ethnographers a reflection on challenges in accessing clinical sites to conduct research and a discussion of strategies that may be useful to navigate and counter these challenges by managing social relations in the field. [ABSTRACT FROM AUTHOR]

Objective: This study set out to present data on out-of-pocket payments for Medicare mental health services provided by general practitioners (GP), psychiatrists, clinical psychologists and other psychologists, to explore how much is spent on out-of-pocket payments for mental health; if any trends could be seen; and what variations exist across regions. Methods: We performed secondary analysis of publicly available data on Medicare-subsidised GP, allied health and specialist health care across Australia. We merged and interrogated data covering the period 2013–19 and 2019–21 to create a data set covering eight full years of Medicare mental health services, arranged by profession and by region. Results: Out-of-pocket payments for mental health care in Australia have been rising consistently over the period 2013–21, at a considerably faster rate than overall expenditure on mental health care. There is wide variation in out-of-pocket payments depending on where you live. Conclusions: The impact of out-of-pocket payments on community access to mental health care is growing. This has implications, especially in poorer communities, for access to care. This should be an important consideration taken as the Australian Government considers next steps in national mental health reform, including the Better Access Program, currently under evaluation. What is known about the topic? A$35 m is spent on Medicare mental health services every week but there has been little research on the out-of-pocket payments charged to Australians. What does this paper add? Looking at Medicare data from 2013 to 2021, this paper answers three main questions: how much are out-of-pocket payments for mental health in Australia; what trends can be seen; and what variations exist? What are the implications for practitioners? Medicare's Better Access Program is under current review and this research can help practitioners, funders and policy-makers understand the significant investment made in mental health services. [ABSTRACT FROM AUTHOR]

Objective: To compare the historical staffing patterns and organisational characteristics of Australian residential aged care facilities (RACFs) against the new minimum staffing standards recommended by the Royal Commission into Aged Care Quality and Safety (RCACQS). Method: Retrospective data analysis was used to compare the staffing levels and characteristics of 1705 RACFs (for 4 years, 2016–19) with the three new mandatory staffing requirements. De-identified datasets were provided by the RCACQS, obtained under its legal authority. Results: Only 3.8% of RACFs have staffing levels at or above all three requirements. Although many (79.7%) already meet the requirement to have a registered nurse (RN) on-site for morning and afternoon shifts, few have staffing levels above requirements for total direct care per resident per day (10.4%) or care provided by an RN per resident per day (11.1%). Historical levels of on-site RNs, total direct care, and RN care vary significantly across facilities of different size, location and provider scale. Conclusion: The new staffing standards, to be mandatory by 2023, prescribe minimum requirements significantly higher than existing levels, particularly in care per resident per day. Each of the three requirements will likely have a differential effect for different types of RACFs. What is known about the topic?: International evidence suggests that introducing mandatory minimum staffing standards tends to increase the amount of care provided by staff in residential aged care facilities (RACFs). However, the impact of staffing standards is influenced by the stringency of the minimum threshold relative to existing staffing levels, the capacity of organisations to increase their staffing levels, and the specific way the regulation is formulated. What does this paper add?: This paper explores the potential implications of the three national minimum staffing standards, to be in force by October 2023, specifying total direct care, care received by a registered nurse (RN), and an RN on-site. By examining the existing staffing levels of Australian RACFs, it identifies the extent to which facilities already meet the new standards and the characteristics of facilities with staffing levels above and below the three requirements (individually and in combination). What are the implications for practitioners?: The study informs both policy and practice in relation to the likely effects of implementing the national minimum staffing standards for residential aged care in Australia. It demonstrates that the new minimum thresholds are likely to require substantial increases in staffing across the sector, both in terms of all direct care workers and RNs. It also shows that the three requirements are likely to have a differential effect for RACFs of different size, location and chain affiliation, thereby guiding policy about the future needs for Australia's aged care workforce. [ABSTRACT FROM AUTHOR]

The advertising of regulated health services to consumers is strictly regulated in Australia. The advertising prohibitions within the National Law that ban the use of testimonials relating to services provided by health practitioners have caused controversy, garnering mixed reactions from the health professions, health consumers and other stakeholders. Advertising that misleads health consumers may promote unnecessary and inappropriate engagement in health services and may therefore negatively affect consumers' ability to exercise autonomous decisions relating to their care. This article considers policy implications relating to advertising with a focus on the use of testimonials, particularly those that are online. Although there would seem to be appetite for amending the current legislative framework, there is uncertainty as to the form change may take and the effect this could have. What is known about the topic?: Testimonials relating to health care are a prohibited form of advertising, but a form still used by non-regulated health providers and those who are regulated but who are either ignorant of the law or defiant of its requirements. Views are split as to whether the restriction on consumer reviews of regulated health services is reasonable; frequently, arguments are put forward stating that the status quo inhibits consumers' ability to discuss their care. Other jurisdictions outside Australia permit the use of patient reviews and testimonials. What does this paper add?: This paper discusses the greater policy implications of the current restrictions within the National Law and analyses the arguments placed forward by different stakeholders from the health professions and those that consume health services. The ethical and market arguments surrounding advertising and testimonials are examined. Suggestions are then made as to the deficits in knowledge that presently exist relating to this area and the actions required before future policy may be developed. What are the implications for practitioners?: Practitioners should be aware of the current restrictions upon advertising within regulated health services. This paper develops an understanding of the complex arguments surrounding advertising and testimonials in health care, as well as when testimonials may be permitted and not subject to the current regulations. Before any amendment to the current legislation is actioned, regulators should consider instead the need to develop an evidence-based approach to understanding the effects of health advertising on the decision making of healthcare consumers. [ABSTRACT FROM AUTHOR]

The home care sector comprises one of Australia’s fastest growing workforces, yet few papers capture the overall landscape of Australian home care. This integrative review investigates home care with the aim of better understanding care recipients and their needs, funding, and regulation; care worker skills, tasks, demographics, employment conditions, and training needs. Over 2,700 pieces of literature were analyzed to inform this review. Results suggest sector fragmentation and a home care workforce who, although well-placed to improve outcomes for care recipients, are in need of better training and employment support. Suggestions for future research regarding Australian home care include studies that combine both aged and disability aspects of care, more research around care recipients, priority needs and strategies for addressing them, and how best to prepare home care workers for their roles. [ABSTRACT FROM AUTHOR]

Artificial Intelligence (AI) carries the potential for unprecedented disruption in radiology, with possible positive and negative consequences. The integration of AI in radiology holds the potential to revolutionize healthcare practices by advancing diagnosis, quantification, and management of multiple medical conditions. Nevertheless, the ever‑growing availability of AI tools in radiology highlights an increasing need to critically evaluate claims for its utility and to differentiate safe product offerings from potentially harmful, or fundamentally unhelpful ones. This multi‑society paper, presenting the views of Radiology Societies in the USA, Canada, Europe, Australia, and New Zealand, defines the potential practical problems and ethical issues surrounding the incorporation of AI into radiological practice. In addition to delineating the main points of concern that developers, regulators, and purchasers of AI tools should consider prior to their introduction into clinical practice, this statement also suggests methods to monitor their stability and safety in clinical use, and their suitability for possible autonomous function. This statement is intended to serve as a useful summary of the practical issues which should be considered by all parties involved in the development of radiology AI resources, and their implementation as clinical tools. [ABSTRACT FROM AUTHOR]

Aims: The United Kingdom and Australia have developed highly divergent policy responses to electronic nicotine delivery systems (ENDS). To understand the historical origins of these differences, we describe the history of tobacco control in each country and the key roles played in setting ENDS policy in its early stages by public health regulations and policy networks, anti‐smoking organizations, 'vaper' activist networks and advocates of harm reduction policies towards injecting drug use. Methods: We analysed key government reports, policy statements from public health bodies and non‐government organizations (e.g. cancer councils and medical organizations) on ENDS; submissions to an Australian parliamentary inquiry; media coverage of policy debates in medical journals; and the history of tobacco control policy in Australia and England. Key discourses about ENDS were identified for each country. These were compared across countries during a multi‐day face‐to‐face meeting, where consensus was reached on the key commonalities and divergences in historical approaches to nicotine policy. This paper focuses on England, as different policy responses were apparent in constituent countries of the United Kingdom, and Scotland in particular. Results: Policymakers in Australia and England differ markedly in the priority that they have given to using ENDS to promote smoking cessation or restricting smokers' access to prevent uptake among young people. In understanding the origins of these divergent responses, we identified the following key differences between the two countries' approaches to nicotine regulation: an influential scientific network that favoured nicotine harm reduction in the United Kingdom and the absence of such a network in Australia; the success of different types of health activism both in England and in Europe in opposing more restrictive policies; and the greater influence on policy in England of the field of illicit drug harm reduction. Conclusions: An understanding of the different policy responses to electronic nicotine delivery systems (ENDS) in England and Australia requires an appreciation of how actors within the different policy structures, scientific networks and activist organizations in each country and region have interpreted the evidence and the priority that policymakers have given to the competing goals of preventing adolescent uptake and encouraging smokers to use ENDS to quit smoking. [ABSTRACT FROM AUTHOR]

Accreditation to demonstrate engagement with the National Safety and Quality Health Service Standards (Standards) is compulsory for most hospital and healthcare settings, but to date remains voluntary for private dental practices (PDPs). The regulatory framework governing the dental profession lacks a proactive element to drive improvements in quality and safety of care, and an accreditation scheme can strengthen existing regulation. The current model of accreditation operating in accordance with the Australian Health Service Safety and Quality Accreditation Scheme (Scheme) is based on the Standards, which were written for a hospital model of healthcare service. The majority of PDPs are small office-based businesses with clear leadership structure and employing six staff or fewer. The Scheme is overly bureaucratic given the simplicity of the PDP business model. This article considers whether accreditation has a proven track record of improving quality of service and offers opinions about how a more appropriate safety management program for PDPs may look. What is known about the topic?: There has been minimal research about the impact of accreditation schemes in improving patient safety in PDP. What does this paper add?: This paper proposes a redesign of the Scheme to make it more relevant to PDPs. The paper offers strategies to minimise duplication of purpose between accreditation and existing legislation; and to strengthen critical elements of accreditation to improve effects on patient safety. What are the implications for practitioners?: A redesigned accreditation scheme will support dental practitioners to implement a quality assurance system with improved efficiency, reduced administrative burden, and optimised patient safety. [ABSTRACT FROM AUTHOR]

An editorial is presented on the history of asbestos and gold mining in Southern Africa and Australia. It expresses the view that mining effects the health of miners, national archives impacted by Southern Africa's constitution, and miners are diagnosed with the asbestos disease and there's court case on energy services company Cape PLC.

Responsible gambling codes of practice and guidelines exist in most regulated gambling environments around the world, however, the extent to which they acknowledge and engage with concepts of cultural and linguistic diversity is significantly lacking, and in many cases, completely absent. If ‘responsible gambling’ is defined as the provision of safe, socially responsible and supportive gambling environments where the potential for harm is minimised, then acknowledgement and engagement with cultural diversity is critical to ‘responsible gambling’ practice. This paper will relate to the Australian context and analyse the extent to which state and territory responsible gambling codes of practice and legislation engage with concepts of cultural diversity. Cultural competency frameworks and strategies have developed internationally in response to the research evidence suggesting the need for culturally responsive services and practices to improve outcomes for culturally diverse groups in society. Cultural competency frameworks suggest that in order for a ‘system’ to be culturally competent it begins at the systemic level, that is, recognising that culturally competent behaviour and practice needs to have policy objectives, procedural requirements, monitoring mechanisms and resource capacity to be achieved. This paper will present a framework for culturally competent responsible gambling practice in Australia that can be implemented at the systemic level. Without a culturally competent ‘system’ the ability of people from culturally diverse backgrounds to make informed choices with respect to their gambling and to minimise harm from gambling in culturally diverse communities is greatly reduced. [ABSTRACT FROM PUBLISHER]

Objective: Immediate action is an emergency power available to Australian health practitioner regulatory boards to protect the public. The aim of this study was to better understand the frequency, determinants and characteristics of immediate action use in Australia. Methods: This was a retrospective cohort study of 11 200 health practitioners named in notifications to the Australian Health Practitioner Regulation Agency (AHPRA) between January 2011 and December 2013. All cases were followed until December 2016 to determine their final outcome. Results: Of 13 939 finalised notifications, 3.7% involved immediate action and 9.7% resulted in restrictive final action. Among notifications where restrictive final action was taken, 79% did not involve prior immediate action. Among notifications where immediate action was taken, 48% did not result in restrictive final action. Compared with notifications from the public, the odds of immediate action were higher for notifications lodged by employers (mandatory notifications OR = 21.3, 95% CI 13.7–33.2; non-mandatory notifications OR = 10.9, 95% CI 6.7–17.8) and by other health practitioners (mandatory notifications OR = 11.6, 95% CI 7.6–17.8). Odds of immediate action were also higher if the notification was regulator-initiated (OR = 11.6, 95% CI 7.6–17.8), lodged by an external agency such as the police (OR = 11.8, 95% CI 7.7–18.1) or was a self-notification by the health practitioner themselves (OR = 9.4, 95% CI 5.5–16.0). The odds of immediate action were higher for notifications about substance abuse (OR = 9.9, 95% CI 6.9–14.2) and sexual misconduct (OR = 5.3, 95% CI 3.5–8.3) than for notifications about communication and clinical care. Conclusions: Health practitioner regulatory boards in Australia rarely used immediate action as a regulatory tool, but were more likely to do so in response to mandatory notifications or notifications pertaining to substance abuse or sexual misconduct. What is known about this topic: Health practitioner regulatory boards protect the public from harm and maintain quality and standards of health care. Where the perceived risk to public safety is high, boards may suspend or restrict the practice of health practitioners before an investigation has concluded. What does this paper add?: This paper is the first study in Australia, and the largest internationally, to examine the frequency, characteristics and predictors of the use of immediate action by health regulatory boards. Although immediate action is rarely used, it is most commonly employed in response to mandatory notifications or notifications pertaining to substance abuse or sexual misconduct. What are the implications for practitioners?: Immediate action is a vital regulatory tool. Failing to immediately sanction a health practitioner may expose the public to preventable harm, whereas imposing immediate action where allegations are unfounded can irreparably damage a health practitioner's career. We hope that this study will assist boards to balance the interests of the public with those of health practitioners. [ABSTRACT FROM AUTHOR]

Patients from racial/ethnic minority backgrounds can experience racism and race-based discrimination in the health system, enduring unfair and inferior treatment that negatively affects physical and mental health and well-being and may, in some cases, lead to premature and avoidable death. Racism within the health system also acts as a deterrent to health care access because individuals may choose to avoid healthcare settings for fear of repeated exposure to racism. Racism and its impacts in health are well documented and health care-related regulatory organisations and antidiscrimination commissions in Australia are the recipients of racism complaints that occur within the health system. However, the extent and nature of complaints of racism in healthcare settings (i.e. self-reported incidents of racism) and how they are managed by regulatory organisations and antidiscrimination commissions are not well understood. This paper provides a summary of existing approaches to complaints in the Australian health system related to healthcare regulatory organisations and antidiscrimination commissions. We offer recommendations for improvements to data collection and dissemination of racism complaints to better understand the nature and extent of racism and race-based discrimination in the health system, and thus inform changes to process and practices that will reduce the incidence of racism and improve health outcomes. [ABSTRACT FROM AUTHOR]

Aim(s) To understand how nurse managers facilitate learning in clinical workplaces. Background: Meeting staff learning needs in the complex workplaces of contemporary health care is paramount to the delivery of safe patient care. Hospitals employ a range of strategies to address these needs. However, nurse managers' contribution to staff learning at the unit level is underexplored in contemporary literature. Method(s): A Gadamerian philosophical hermeneutic framework guided data collection and analysis. Thirteen nurse managers from two Australian hospitals each participated in two interviews and a period of observation. Findings Nurse managers' learning facilitation practices were enacted with staff individually, within teams, and through artefacts, and were shaped by their identities, perspectives on staff learning, knowledge of staff performance, and motivations. Power was revealed as a uniquely enacted driver of their learning facilitation practices. Conclusion(s): This paper illuminates an aspect of nurse managers' practice that has been poorly acknowledged in contemporary nursing literature. Nurse managers' learning facilitation practices were found to be complex, fluid, and embedded in their everyday work routines. Implications for Nursing Management: Given current concerns about safety and quality in health care, this research opens up possibilities for definition and enrichment of nurse managers' practice as facilitators of learning. [ABSTRACT FROM AUTHOR]

The Royal Commission's recommendation for nursing home minimum time standards and the Australian Government's response do not support best practice resident care. We recommend that higher mandated minimum staffing levels and skills mix should be phased in by mid-2026. What is known about the topic?: The Australian Government has not committed to fully implementing the Commission's recommendations for mandated minimum staff time standards. What does this paper add?: We highlight issues with the Commission's recommendations and the Australian Government's response where they do not support sufficient minimum time to provide best practice care. What are the implications for practitioners?: Mandated evidence-based minimum staffing levels and skills mix should be phased in by mid-2026 to support best practice care. [ABSTRACT FROM AUTHOR]

A correction to a paper printed in a prior issue is presented, written by Berridge et al., which discusses policy around electronic nicotine delivery systems.

Aim: This paper explores how food regulators respond to food incidents and the barriers and enablers associated with doing so. Methods: Twenty‐six semi‐structured interviews lasting between 30 and 60 minutes were undertaken with Australian food regulators. Regulators worked across food policy development, implementation, enforcement and standards setting. These interviews ascertained food regulators' views on food safety and responses to real and hypothetical food incidents. Data were analysed using thematic analysis. Results: Food regulators reported that working together with other food regulators is an important part of effective food regulation and response to food incidents. Strategies for working together included clarifying expectations and developing formal documents such as a memorandum of understanding. However, challenges in working together were reported, including different risk thresholds, different political agendas and a lack of clarity on regulators' roles. Conclusions: A focus on partnerships and good communication between food regulators is likely to facilitate effective management of food incidents, and maximise the chances that food incidents do not lead to increased consumer morbidity and mortality as a result of a poor response to a food incident. [ABSTRACT FROM AUTHOR]

Discussion around the scope of practice of all nurse practitioners (NPs) in Australia was a component of the recent review of NPs' eligibility to have broader access to the Medical Benefits Schedule (MBS). This review process has been prolonged and, while the MBS review officially concluded on the 30 June 2020, no information regarding decisions about expanded NP access to the MBS for patient rebates had been disclosed at the time of publication. It is anticipated that the MBS review will contribute little change to NP access to the MBS. The MBS is the primary funding process for private-sector medical services in Australia and is a barrier to the scope of practice of Australian NPs. Specifically, in the perioperative setting the lack of access to the 'assistance at operations' MBS item numbers limits the NP's scope of practice as it leaves the private sector surgical patient out-of-pocket when an NP provides surgical assisting services. This discussion paper considers the international non-medical surgical assistant experience and relates this to the Australian context exploring the complexities associated with the term advanced practice nursing, regulation of the NP compared to other clinicians, and the matters of funding and protectionism in the perioperative space. [ABSTRACT FROM AUTHOR]

Background: This paper investigates the content of Australian policies that address withholding or withdrawing life-sustaining treatment to analyse the guidance they provide to doctors about the allocation of resources. Methods: All publicly available non-institutional policies on withholding and withdrawing life-sustaining treatment were identified, including codes of conduct and government and professional organization guidelines. The policies that referred to resource allocation were isolated and analysed using qualitative thematic analysis. Eight Australian policies addressed both withholding and withdrawing life-sustaining treatment and resource allocation. Results: Four resource-related themes were identified: (1) doctors' ethical duties to consider resource allocation; (2) balancing ethical obligations to patient and society; (3) fair process and transparent resource allocation; and (4) legal guidance on distributive justice as a rationale to limit life-sustaining treatment. Conclusion: Of the policies that addressed resource allocation, this review found broad agreement about the existence of doctors' duties to consider the stewardship of scarce resources in decision-making. However, there was disparity in the guidance about how to reconcile competing duties to patient and society. There is a need to better address the difficult and confronting issue of the role of scarce resources in decisions about life-sustaining treatment. [ABSTRACT FROM AUTHOR]

Purpose: Employability assessment helps in deciding to pay or decline Australian total and permanent disability insurance claims, yet it has not been critically examined. This paper reviews employability assessment from forensic vocational assessment, life insurance/superannuation, and legal perspectives. Methods: In a scoping review, we searched six multidisciplinary databases and various industry-specific resources. Items pertinent to forensic employability/vocational assessment and life insurance total and permanent disability claims were included. Return-to-work assessment, the vocational assessor, medical or functional evaluation, and case law items were excluded. Quality appraisal measures were used for research studies and other items. From 104 full-text reviews, 39 items were included for thematic synthesis from the three perspectives of interest. Results: Our review found that employability assessment is derived from forensic vocational assessment, but methodology differs in claimant contact and psychosocial aspects. Employability assessment practice is informed by policy, market changes, and legal interpretation. Assessors may work for opposing sides in forensic or indirect settings therefore high standards and credentials must prevail. Conclusions: Foundational research into the effectiveness of employability assessment and the experience of claimants is warranted. Future research into methodology, assessor credentials, and legal aspects will broaden understanding of this relatively new topic. Employability assessment is an emergent and hitherto unexamined model that operates in the multi-billion-dollar Australian total and permanent disability insurance market. Total and permanent disability insurance policies and their legal interpretation are ever-changing and substantially inform employability assessment practice. Employability assessment lacks methodology and variables that are common elements in proven forensic vocational assessment models in the United States. Training and credentialing of rehabilitation professionals who conduct employability assessments are required to withstand legal scrutiny and meet international forensic standards. [ABSTRACT FROM AUTHOR]

Canada has been discussing whether to implement an orphan drug policy for more than 25 years. Recently, the federal government announced funding for orphan drugs starting in 2022, and the Canadian Senate has recommended that the country develop an orphan drug policy. This paper uses a list of orphan drugs approved by the United States Food and Drug Administration between 2008 and 2017, inclusive. It then compares Canada, which has no orphan drug policy, and Australia, which has had such a policy since 1997. There was no difference between the countries in the proportion of orphan drugs approved, the time drugs spent in the regulatory review process, and any delay in marketing the drugs in the respective countries compared to the United States. Both Canada and Australia approved virtually all of the drugs that offered a moderate to significant therapeutic improvement. If Canada hopes to provide faster access to orphan drugs, especially those that are therapeutically innovative, it will need to develop a policy that is significantly different from that in Australia. [ABSTRACT FROM AUTHOR]

This paper focuses on the potential for child-centred institutions to use situational crime prevention (SCP) strategies to prevent or reduce child sexual abuse material (CSAM) offending as a distinct form of child sexual abuse (CSA). We discuss the failure of the Royal Commission into Institutional Responses to Child Sexual Abuse in Australia to address the potential for CSAM offending to occur in child-centred institutions. Our premise is that CSAM offending is markedly shaped by the situation in which it occurs, rather than by any pre-existing preparedness to offend sexually against children. In this context, SCP for CSAM offending must be considered as part of overall strategies to combat CSA in institutional settings. However, we acknowledge that effective implementation of SCP in this area is not straightforward. We consider some of the challenges in implementing SCP at an institutional level. [ABSTRACT FROM AUTHOR]

Purpose – The purpose of this paper is to strengthen the theoretical understanding of the processes through which a new regulator seeks to gain legitimacy within an existing regulatory space. The authors do this by investigating the case of the Australian Charities and Not-for-profit Commission (ACNC). Design/methodology/approach – Synthesising legitimacy theory with the concept of regulatory space, the authors analyse formal public discourse surrounding the establishment and operations of the ACNC. Findings – Regulation is essentially a context-bound political process in which a new regulator needs to establish legitimacy to ensure its survival. It must convince its constituents that it has developed processes to operate effectively and professionally in addressing constituents’ needs, to bargain authoritatively with other regulators in establishing its operational boundaries, and to engage politically with government and constituents. Over a relatively short time, the ACNC built legitimacy, despite the political threats to its formal regulatory authority. Research limitations/implications – The conclusions are based on the analysis of one case. There is scope for further investigations of the processes by which new regulators establish their legitimacy in different contexts. Practical implications – The potential for a political threat to the authority of a new regulator, and the difficulty of achieving regulatory reform, particularly in a federated system such as Australia, highlight the necessity for a new regulator to develop a compelling discourse of legitimacy. Originality/value – The authors synthesise regulatory space and legitimacy perspectives, contributing to an understanding of the processes of regulation. [ABSTRACT FROM AUTHOR]

BACKGROUND: The paper is a research review focusing on occupational safety in the construction industry. OBJECTIVE: The purpose is to present research that highlights the areas of occupational safety and risks and to identify areas where research is lacking. METHODS: 146 articles from scientific journals, mainly covering the construction industry in Europe, Canada, USA, Australia and Japan have been studied. The findings are presented under 11 categories: accident statistics; individual factors; legislation and regulations; ethical considerations; risk management; leadership, management, organization; competence; safety design; cost-benefit calculations; programs and models; and technical solutions. RESULTS: The research is dominated by initiatives from researchers and government authorities, while the construction industry only appears as the object for the research. There is a scarcity of research on integrated systems encompassing subcontractors, as well as a lack of research with sociological perspectives on accidents. Furthermore, only a few studies have applied a gender perspective on safety in construction, i.e. there is a need of further research in this particular area. CONCLUSIONS: A range of initiatives have been taken to increase safety in the construction industry and the initiatives are mainly reported to be successful. There are some cultural differences, but basically researchers present similar results regardless of country. [ABSTRACT FROM AUTHOR]

This paper argues for a re-examination of mental health responses to refugee youth seeking asylum in high-income countries. Reviewing international literature related to mental health and social care services for refugee children and youth and drawing upon Foucault's concepts of power, truth and discourse, we explore and question the predominance of the bio-medical model in responding to refugee children's distress. We demonstrate that, despite notable initiatives and developments in social work theory and practice, the bio-medical model has, in many ways, become a 'regime of truth', with the power to define refugees' problems and thus shape the policies and services that affect their lives. While not denying that many refugee youth and their families may benefit from such therapeutic interventions, it is our contention that working with this population requires a significant expansion, diversification and transformation of the current paradigm informing social work practice to incorporate the multiple and unique cultures and contexts of this population. We conclude with a discussion of promising practices and interventions with refugee youth and families. [ABSTRACT FROM AUTHOR]

This paper describes the development, content and implementation of two pieces of Australian tobacco control legislation: one to standardise the packaging of tobacco products and the other to introduce new, enlarged graphic health warnings. It describes the process of legislative drafting, public consultation and parliamentary consideration. It summarises exactly how tobacco products have been required to look since late 2012. Finally, it describes implementation, most particularly, the extent to which packs compliant with the legislation became available to consumers over time. [ABSTRACT FROM AUTHOR]

Australia's Royal Commission into Aged Care Quality and Safety has concluded. The Commission's final report described a sector failing to deliver care that older Australians deserve despite the best efforts of many staff. Throughout the Commission, staffing was a frequent concern, with the size and composition of the direct care workforce a prominent focus. Throughout the Commission, many stakeholders campaigned for mandated staffing levels in skills mix in nursing homes and the Commission's report and Commonwealth Government response included recommendations for these. While this is a necessary step toward wider reform, the Royal Commission's recommendation and the Australian Government's response must support the delivery of best practice care more strongly. This column argues that the minimum standard for nursing home staff care time must be higher, and that higher minimum staffing levels and more clearly defined skills mix are critical to the delivery of safe, respectful, dignified person-centred care. [ABSTRACT FROM AUTHOR]

Objective: To explore the ways in which the Coronavirus disease‐19 (COVID‐19) pandemic has affected Australians who live and travel in cross‐border regions in the course of their daily lives. Design: Semi‐structured interviews were undertaken with participants by telephone. The analysis utilised qualitative exploratory methods and provided rich data through immersive and reflexive analysis. Setting: Interviews of people across Australia. Participants: Of 90 people interviewed in relation to their experiences of the COVID‐19 pandemic, 13 described challenges related to border crossing that impacted their usual work and personal life. Main outcome Measure: Description of challenges faced by Australians living close to state borders due to internal border closures in the early period of COVID‐19 (2020). Results: Policy changes surrounding border closures negatively impacted people's wellbeing in Australia with three key interconnected themes identified for Australians living in cross‐border regions. First, border closures presented participants of these communities with physical barriers which reduced access to healthcare and employment. Second, participants reported how restrictions on travel to neighboring states and territories impacted their mental wellbeing. Finally, many Australians in cross‐border regions faced financial struggles exacerbated by border closures. Conclusion: Normally, interstate borders are largely invisible with formalities relevant to few circumstances. Since the emergence of the COVID‐19 pandemic, Australians who used to regularly cross these borders in the course of their daily activities were no longer able or willing to do so due to the uncertain circumstances surrounding border policy. This study elaborates on the impact of these closures on people's physical, financial, and emotional state. [ABSTRACT FROM AUTHOR]

This paper is a critical review of past and present languages policies in Australian schooling. We highlight the One Literacy movement that contravenes the human rights of Australia’s Aboriginal students. This in turn impacts students’ right to freedom of opinion and expression as stated in Article 19 of the Universal Declaration of Human Rights. The One Literacy movement operates by equating Standard Australian English literacy acquisition with Australia’s global competitiveness and economic success. There is only one pathway through the Australian English curriculum with common assessments and standards. However, the Australian Curriculum provides three distinctive pathways when students from an English-speaking background learn languages other than English. We reveal this double standard, where current educational policies prioritise the languages of trade (e.g. Chinese) and accommodate speakers of these languages. Meanwhile Aboriginal-language-speaking students are not provided with the same accommodations. For educational equity, there should be a distinctive English language learner pathway that recognises that the majority of remote Aboriginal students from the Northern Territory are learning English as an additional language. We advocate for these changes because all children have a right to an appropriate education that will enable them to flourish as learners and citizens. [ABSTRACT FROM PUBLISHER]

This article proposes a responsive regulatory approach to reducing Australia's population consumption of sugar from sugar-sweetened beverages, which are a major source of free sugars in the diet and a notable contributor to Australia's burden of obesity-related disease. It focuses on reformulation and labelling initiatives; two of the core ways in which sugar-sweetened beverages are regulated for public health purposes in Australia (and globally). Pointing to poor industry participation, weak targets, and minimal enforcement mechanisms, this article argues that the current voluntary regulatory initiatives are significantly underperforming and are insufficient to achieve their stated public health objectives. In the absence of robust industry action, stronger regulation is required. Responsive regulation, which advocates for increasingly stringent sanctions and government control in response to industry failure, offers government a roadmap to strengthen existing voluntary initiatives in the interest of securing better population health outcomes. [ABSTRACT FROM AUTHOR]

The author reflects on the challenging regulation of complementary medicines to clinicians. He cites the study by Cohen et al. that notes the difficulties in assessing the effectiveness of complex but self-medication products. The author believes that Australia would globally lead in developing evidence-based ingredients and products to help consumers and health professionals.

Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decision-making principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives. [ABSTRACT FROM AUTHOR]

Australian providers of aged care are facing a rapidly ageing population and growth in demand for services. Beyond a sheer increase in consumers and major regulatory changes from Federal Government, many customers are becoming progressively discontented with a medically dominated model of care provision. This period of turbulence presents an opportunity for new entrants and forward-thinking organisations to disrupt the market by designing a more compelling value offering. Under this line of inquiry, the researchers conducted a qualitative content analysis study of over 37 Australian aged care organisations, clustering providers into six business model typologies. The study revealed that providers of aged care are becoming increasingly aware of emerging customer needs, and, in addressing these needs, are seeking to establish innovative models of care provision. This paper therefore presents a future model of care, along with implications for practice and policy. [ABSTRACT FROM PUBLISHER]

Purpose In 2010, Australia introduced the National Registration and Accreditation Scheme for the health professions (the Australian scheme) creating a legislative framework for a national system of health workforce regulation, delivering a model of collective (and multi-level) government involvement in regulatory activities. The purpose of this paper is to examine how its governance arrangement compares to different national systems and other health regulatory bodies in Australia.Design/methodology/approach This qualitative case study is informed by documentary analysis in conjunction with policy mapping. This is part of a larger project investigating the policy pathway which led to establishment of the Scheme. The authors compare the Scheme with other Australian health standard setting and regulatory bodies.Findings The Australian scheme’s governance model supported existing constitutional arrangements, and enabled local variations. This facilitated the enduring interest of ministers (and governments) on matters of health workforce and articulated the activities of the new regulatory player. It maintains involvement of the six states and two territories, with the Commonwealth Government, and profession-specific boards and accreditation agencies. This resulted in a unique governance framework delivering a new model of collective ministerial responsibility. The governance design is complex, but forges a new way to embed existing constitutional arrangements within a tripartite arrangement that also delivers National Boards specific to individual health professions and an organisation to administer regulatory activities.Originality/value This study demonstrates that effective design of governance arrangements for regulatory bodies needs to address regulatory tasks to be undertaken as well as the existing roles, and ongoing interests of governments in participating in those regulatory activities. It highlights that a unique arrangement, while appearing problematic in theory may in practice deliver intended regulatory outcomes. [ABSTRACT FROM AUTHOR]

It has been suggested that complementary medicines are currently 'under-regulated' in some countries due to their potential for harm as a direct result from side-effects or interactions; from delaying more effective care; or from the economic cost of purchasing an ineffective or inappropriate treatment. The requirement of additional labelling on complementary medicine products has been suggested in Australia and may provide additional information to consumers at the point of purchase. This paper details a unique way of testing the potential effects on consumer behaviour of including either a traffic light logo or regulatory statement on labels. Using a discrete choice experiment, data were collected in 2012 in a sample of 521 Australians with either type 2 diabetes or cardiovascular disease. We find that additional labelling can affect consumer behaviour, but in unpredictable ways. The results of this experiment are informative to further the dialogue concerning possible regulatory mechanisms., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Electronic health records (EHRs) have been widely adopted in Australian public sector healthcare and will remain an ongoing, essential data system. However, recent substantial data breaches from hacked business data systems in Australian enterprises, as well as international healthcare providers, mean that EHR data breaches are increasingly likely in Australia. Risks include medical identity theft and extortion attempts based on threats to release sensitive patient information. Hacking is now a foreseeable additional risk of medical treatment. Risk mitigation for the consequences of data breaches needs to be considered, as well as support for patients (and families) and healthcare workers. This includes identity theft protection services, cybersecurity insurance, and psychological support. [ABSTRACT FROM AUTHOR]

High quality education programs are essential for preparing the next generation of Chinese medicine (CM) practitioners. Currently, training in CM occurs within differing health and education policy contexts. There has been little analysis of the factors influencing the form and status of CM education in different regions. Such a task is important for understanding how CM is evolving internationally and predicting future workforce characteristics. This paper compares the status of CM education in Australia and Hong Kong across a range of dimensions: historical and current positions in the national higher education system, regulatory context and relationship to the health system, and public and professional legitimacy. The analysis highlights the different ways in which CM education is developing in these settings, with Hong Kong providing somewhat greater access to clinical training opportunities for CM students. However, common trends and challenges shape CM education in both regions, including marginalisation from mainstream health professions, a small but established presence in universities, and an emphasis on biomedical research. Three factors stand out as significant for the evolution of CM education in Australia and Hong Kong and may have international implications: continuing biomedical dominance, increased competition between universities, and strengthened links with mainland China. [ABSTRACT FROM AUTHOR]

The paper makes three claims: first that regulatory state making and market making in higher education is intertwined through a project of market citizenship that shapes the 'publicness' of higher education. Second, we argue that these projects of market citizenship are variegated and in Australia has taken the form of accommodation-via regulation tools-between social democratic and market elements, and finally we argue that the effect of this new regulatory state is a strategy to depoliticise the governance of higher education. Policy making appears to be the application of a set of technical rules rather than political decisions about the allocation of values. [ABSTRACT FROM AUTHOR]

Aim To discuss the methods of a study which will aim to determine the usability of a medical device not yet approved for use in a clinical trial. Background The Blood Loss Estimation and Evaluation of Drape (BLEED) pilot aims to determine the usability of a drape which measures blood loss during third stage labour. Third stage blood loss is usually estimated visually. This method has been found to be inaccurate. The drape has been tested in developing countries overseas and has been found to more accurately measure third stage blood loss when compared with visual methods. The usability of the drape has not yet been evaluated. Review methods Before starting the BLEED pilot study, the risks to the participants were evaluated and the drape was determined to pose minimal risk of harm for participants. The pilot study will involve recruitment of women and health professionals who will use the drape to measure third stage blood loss and then complete a survey about their opinion of the drape's usability. The data will be used to determine the suitability of using the drape in a clinical trial. Discussion The benefits of pursing this programme of research outweigh the challenges. The drape has been validated as more accurate than visual estimation for evaluating blood loss during third stage labour, yet the usability has not been established and a clinical trial is needed. This programme of research will determine if routine use of this drape in research and practice is justified. Conclusion This work will assist health professionals who are considering ways to improve clinical outcomes and will particularly inform researchers who are interested in piloting new devices in maternity care. While adherence to monitoring requirements and governance of clinical trials is essential, the system has become complicated for investigator-initiated research using devices. Despite these challenges, the authors of this paper believe that this research programme is justified. Implications for practice The complexity of navigating documentation and governance required for clinical trials may deter some healthcare professionals who plan to initiate research that involves the use of a medical device. While adherence to monitoring requirements and governance of clinical research is essential, research involving the evaluation of emerging medical technologies can be complicated, particularly for an investigator-initiated (clinician) researcher who does not have the support of a biotech company. These issues may deter clinician researchers from initiating trials and impede their ability to implement clinical research. Despite the challenges, the effectiveness and safety of technologies must be evaluated for their effectiveness in improving clinical outcomes for patients. [ABSTRACT FROM AUTHOR]

Unhealthy food environments are known to be major drivers of diet-related non-communicable diseases globally, and there is an imperative for major food companies to be publicly accountable for their actions to improve the healthiness of food environments. This paper examines the prevalence of publicly available policies and commitments of major packaged food and soft drink manufacturers, and fast-food restaurants in Australia, New Zealand and Fiji with respect to reducing food marketing to children and product (re)formulation. In each country, the most prominent companies in each sector were selected. Company policies, commitments and relevant industry initiatives were gleaned from company and industry association websites. In Australia and New Zealand, there are a higher proportion of companies with publicly available marketing and formulation policies than in Fiji. However, even in Australia, a large proportion of the most prominent food companies do not have publicly available policies. Where they exist, policies on food marketing to children generally focus on those aged less than 12, do not apply to all types of media, marketing channels and techniques, and do not provide transparency with respect to the products to which the policies apply. Product formulation policies, where they exist, focus mostly on salt reduction and changes to the make-up of overall product portfolios, and do not generally address saturated fat, added sugar and energy reduction. In the absence of strong policies and corresponding actions by the private sector, it is likely that government action (e.g. through co-regulation or legislation) will be needed to drive improved company performance. [ABSTRACT FROM AUTHOR]

In 2016, the Australian Government legislated to allow cannabis to be prescribed to patients as an unapproved medicine under the special access provisions of the Therapeutic Goods Act. This paper compares the Australian regulatory approach with other national approaches, outlines the main provisions of the Special Access Scheme for medical cannabis, describes how the program has evolved since 2017, includes an analysis of adverse events reported to the Therapeutic Goods Administration, and discusses the barriers that remain for patients who wish to access medical cannabis. It assesses how well the Australian program has addressed the challenges of providing patients with easier access to medical cannabis while ensuring that high-quality products are used safely and effectively under medical guidance. [ABSTRACT FROM AUTHOR]

This column examines conscientious objection and institutional objection in Australian voluntary assistance in dying. It reviews the current legislative regimes and then examines these practices from an ethical perspective, and raises particular concerns and suggestions with how conscientious objection and institutional objection should be operationalised. [ABSTRACT FROM AUTHOR]

Objective. The aim of this study was to describe Australia's government-supported clinical knowledge and information resource portals and their alignment with government policies for digital health within an Australian context, and to clarify the role of hospital libraries in the public health system as an adjunct to state and territory portals. Methods. Government-supported clinical resource portals in Australian states and territories were examined and benchmarked. A comprehensive search of Australian state, territory, and federal government websites was conducted for strategies, policies, and projects relating to medical research, digital health, and health workforce education. These documents were screened for reference to clinical knowledge and information resource portals, clinical decision support tools, hospital libraries, or educational resources for the health workforce. Additionally, information was derived from relevant published Australian studies to provide context and additional information about access to evidence in public hospitals. Results. Clinical resource portals are a vital part of evidence-based health care in Australia; however, there are inconsistencies in these portals due to differences in policy, funding, and strategy between Australia's states and territories. Libraries in the healthcare sector play a key role in ensuring centralised clinical knowledge and information resource portals are easily available to clinicians, and in building on the initial portal collection, curate bespoke library collections for their individual organisations. Conclusion. This investigation highlights the importance of government-supported clinical knowledge and information resource portals and the role they play in the provision of safe, quality, evidence-based health care. These portals, in conjunction with hospital library activities, are an integral part of the clinical governance framework. [ABSTRACT FROM AUTHOR]

The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulations, often driven by the local economy and market dynamics, exist, the overall trend in the AP region is toward international harmonization and global convergence. More markets are now participating in the International Council on Harmonization (ICH), and there is growing interest in identifying and incorporating best practices from competent regulatory agencies. These include expedited pathways to speed access to new medicines, and incentives and other means to encourage innovation. In this paper, we provide a summary of recent activities in select AP markets. [ABSTRACT FROM AUTHOR]

This paper presents a review of the literature, including government legislations, policies, guidelines, and recommendations available in the European Union, the United States of America, and Australia pertaining to the availability, development, and distribution of written medicine information (WMI) for prescription medicines. The online databases searched were Embase, International Pharmaceutical Abstracts, Medline, and PubMed, together with Google as the Internet search engine. The design and content of WMI documents have similarities and differences across all the 3 geographical regions. All the 3 regions have legislations in place to evaluate and regulate WMI documents for health care professionals (HCPs) and, to some degree, for patients; however, the degree of regulation varies between the 3 regions. The regulations around the content and information design of WMI impacts how well the WMI performs and consequently influences patients' knowledge and medication-taking behavior. Legislation in certain areas could be seen as more beneficial and can be implemented across the 3 regions. Furthermore, the required legislation on the evaluation of the content of WMIs can be seen in some areas to be more stringent and comprehensive, which when taken onboard across the 3 regions can be valuable when creating WMIs for both patients and HCPs. [ABSTRACT FROM AUTHOR]