In recent years, regulatory processes governing the approval of new health technologies have undergone changes aimed at expediting access. Some of these changes involve the adaptation of established standards of evidence for safety and efficacy, which we refer to as evidence-adapted regulatory pathways (EARPs). While EARPs have provided more timely access to potentially beneficial interventions, critics argue that reducing evidentiary thresholds threatens regulatory integrity, compromises safety, and undermines evidence-based medicine. In this article, we argue that regulatory processes and the therapeutic choices they enable are deeply socially constructed, and that discourse—particularly promissory discourse—plays a constitutive role in shaping regulation and its outcomes. We offer a typology of existing pathways to access health technologies, examine the growth of EARPs internationally and identify some recurring themes in the associated scholarly and public-facing discourses. We show that EARPs are often portrayed in a ‘promissory’ manner that obscures risks and uncertainties. We argue that this promissory discourse can (i) distort patients’ and clinicians’ understandings of evidence and decisions about clinical use and (ii) create undue pressure on funders. We suggest avenues for further research and policy development that could help regulators, in collaboration with clinicians and consumers, to promote socially responsible discourse around EARPs.

This column discusses whether desktop legal research must be reviewed by a human research ethics committee (HREC). We have been made aware that some HRECs have interpreted the National Statement on Ethical Conduct in Human Research as compelling legal researchers to seek ethics review for desktop legal research. We argue that this literal interpretation of the National Statement erroneously treats desktop legal research as "human research". Including desktop legal research in the definition of "human research" damages the public interest. We call on the Council of Australian Law Deans and the authors of the National Statement to make it clear that HREC review is not required for desktop legal research.

Human embryo research can provide important scientific insights to help humanity. But it also poses ethical questions that remain contested. Since 2002, Australian law has limited human embryo research under strict licensing conditions, but there has been no formal review in almost 15years. The development of stem cell-based embryo models that closely resemble human embryos, and improved culturing techniques that allow human embryos to be grown to potentially beyond 14days, have pushed the limits of current legislation. We argue that a comprehensive review is needed to address recent scientific advances and to better account for public sentiment.

Human embryo research can provide important scientific insights to enhance medical knowledge, improve health care and advance human flourishing. This research also poses unresolved legal and ethical questions. Since 2002, Australia has had legislation in place that limits the use of human embryos for research through strict licensing conditions. However, there has been no formal review of these laws in almost 15 years and the scientific landscape has shifted dramatically. The development of stem cell-based embryo models that closely resemble human embryos, and culturing techniques that allow human embryos to be grown to potentially beyond 14-days post-fertilisation, is pushing the limits of the current legislative framework. We argue that a comprehensive review is needed to address recent scientific developments and to better account for contemporary public values.

Studies of social security law in 21st centuryAustralia have justifiably focused on the Robodebt scandal. However, an earlier welfare matter, described herein as 'the omissions affair', equally illustrates the injustices endured by Australian welfare recipients, as well as the power dynamics in Australias'criminal justice system. Between 1991 and 2011, some 15,000 criminal convictions were recorded against apparently innocent people for social security offences-though these matters have long been f'orgotten'. The first aim of this article is to analyse the decisions of the High Court of Australia that elucidated the principles establishing these wrongful convictions. The second aim is to consider the varied impacts of these convictions, whether they could be appealed today, and what reforms, if any, could help avoid the recurrence of such miscarriages in future. The article concludes by suggesting how the omissions affair played an important role in the eventual development of the Robodebt scheme.

Over recent years, dozens of legal challenges have been instituted in response to government action during the COVID-19 pandemic. While public health orders have been challenged on several grounds, few cases have succeeded. Fewer cases still have called into question decisions made by the Therapeutic Goods Administration (TGA) to approve the COVID-19 vaccines. This section provides a brief update on one recent, partially successful COVID-19 health directions case before examining two applications in the Federal Court of Australia seeking judicial review of the TGA's approval of the COVID-19 vaccines. The section argues that, while both TGA applications were dismissed for lack of standing, they illustrate how and why third parties will ordinarily not be entitled to challenge administrative decisions about therapeutic goods.

Recently, the Therapeutic Goods Administration (TGA) updated its guidance on cosmetic injectables advertising. The updates confirm that all direct or indirect advertising of cosmetic injectable products, including botulinum toxins or dermal fillers, is prohibited in Australia. While some commentators have lamented these updates, they present no changes to the law. As cosmetic injectables are prescription-only medicines, they have long been subject to the statutory prohibition on direct-to-consumer advertising of medicines in Australia. The updates, however, signal a real change to the TGA's enforcement stance and attitude. In this way, the updated guidance illustrates the practical application of the TGA's responsive and risk-based approach to regulation - a focus of this column. The changes also bring into view some of the emerging dangers associated with cosmetic injectables and related cosmetic treatments. This column explores the regulation of cosmetic injectables, the TGA's changing approach, and its implications.

While sexual boundary violations by doctors (SBVs) are viewed with utmost seriousness by disciplinary bodies and tribunals, complaints of SBVs in Australia continue to increase. In 2023, the Australian Health Practitioner Regulation Agency (Ahpra) outlined a "blueprint" to protect patients better from sexual misconduct in healthcare: reform being considered in 2024, by Australian health ministers. Few analyses or studies have offered an overview of the prevalence, effects, and causes of SBVs, nor the duties, liabilities, possible disciplinary action against, and potential treatment of, doctors who commit them. This column offers such an overview, and considers, additionally, whether doctors who may have psychiatric disorders associated with their boundary violations would be suitable candidates for treatment. Ultimately, we contend that a purely "responsive" approach is inadequate, and preventive measures such as screening and more effective education should be considered in medical schools as a way of reducing the incidence of SBVs.

Clustered regularly interspaced short palindromic repeats and other genome editing technologies have the potential to transform the lives of people affected by genetic disorders for the better. However, it is widely recognised that they also raise large ethical and policy questions. The focus of this article is on how national genome editing policy might be developed in ways that give proper recognition to these big questions. The article first considers some of the regulatory challenges involved in dealing these big ethical and social questions, and also economic issues. It then reviews the outcomes of a series of major reports on genome editing from international expert bodies, with a particular focus on the work of the World Health Organization’s expert committee on genome editing. The article then summarises five policy themes that have emerged from this review of the international reports together with a review of other literature, and the authors’ engagement with members of the Australian public and with a wide range of experts across multiple disciplines. Each theme is accompanied by one to three pointers for policymakers to consider in developing genome editing policy.

In response to the COVID-19 pandemic, governments worldwide introduced vaccine mandates and ‘passports’, creating tension between individual liberties and public health. This article provides an overview of the history of vaccine mandates in Australia and the United Kingdom, before examining the COVID-19 period, when Australian states introduced various conditional mandates while the United Kingdom largely avoided doing so. This article considers several medico-legal and human rights arguments for and against the imposition of conditional mandates. Although this article concludes that vaccine coercion is both legally and morally justified, it acknowledges the right to refuse medical treatment, freedom of thought, conscience, and opinion, and the right to bodily integrity as important precepts deserving serious consideration. In many cases, alternatives to coercion are preferable. This article has ongoing relevance, both for COVID-19 (as new variants and treatments emerge) and beyond, including for the use of coercion in childhood vaccination and future pandemics.