Journal of Law and Medicine最新文献

Uncertainties and controversies surround "shaken baby syndrome" or infant "abusive head trauma". We explore Vinaccia v The Queen (2022) 70 VR 36; [2022] VSCA 107 and other selected cases from Australia, the United Kingdom and the United States. On expert opinion alone, a "triad" of clinical signs (severe retinal haemorrhages, subdural haematoma and encephalopathy) is dogmatically attributed diagnostically to severe deliberate shaking with or without head trauma. However, the evidence for this mechanism is of the lowest scientific level and of low to very low quality and therefore unreliable. Consequently, expert opinion should not determine legal outcomes in prosecuted cases. Expert witnesses should reveal the basis of their opinions and the uncertainties and controversies of the diagnosis. Further, the reliability of admissions of guilt while in custody should be considered cautiously. We suggest abandonment of the inherently inculpatory diagnostic terms "shaken baby syndrome" and "abusive head trauma" and their appropriate replacement with "infantile retinodural haemorrhage".

This column discusses the Anatomy Act 1977 (NSW) and its regulatory environment. The column begins with examining the history of anatomy regulation in the United Kingdom and Australia. It then goes on to analyse the history of the current anatomy regulation in New South Wales, pointing out areas for reform.

The realisation of the right to health is vulnerable to the interventions of strangers, acting on the belief that certain health care should not be permissible under the law or accessible in practice. In Australia, the key arena for such interventions has been abortion services. Drawing on empirical research undertaken by the authors, this article examines the impact of these interventions and the effectiveness of "safe access zone" laws that now operate nationwide to constrain them. After examining the unsuccessful constitutional challenge to these laws in the High Court of Australia, it considers whether safe access zones may have utility in other health care contexts.

This article analyses the status of medical device recipients under Australian law. The 2021 Gill v Ethicon Sàrl litigation in the Federal Court of Australia has brought the issue to the fore. Moving from the Court's findings, the article dissects the specific vulnerability of medical device recipients and explores the under-researched distinction between patients and consumers under Australian law. The analysis spans the regulatory landscape for medical devices prior to marketing approval, the statutory protections and causes of actions available to consumers under the Australian Consumer Law, and the safeguards for patients developed under medical law (particularly medical negligence). In addition to doctrinal clarifications, the article provides a discussion of key policy considerations that frame the various regimes. Patients and consumers share characteristics, but their legal protections differ in terms of focus and objectives. Medical device recipients straddle both worlds, requiring the highest levels of care and disclosure.

Gain of Function refers to genetic modification to enhance certain properties of a biological agent. "Dual use research" refers to experiments which have a primary goal of benefitting humanity, but which could produce harm if misapplied. So, for example, a virus which was being genetically modified (GM) for altruistic reasons might become more transmissible or resistant to vaccines or antimicrobial medications. Such a GM virus has bioterrorism potential. The UN Biological Weapons Convention has not been universally approved and 10 States are not signatories to the Convention. The control of such experiments is variously controlled in certain jurisdictions but in Australia these experiments are well regulated through the Gene Technology Act 2000 (Cth), the National Health Security Act 2007 (Cth) and the Crimes (Biological Weapons) Act 1976 (Cth). The controls on such experiments in Europe and the United States are less precise. There are examples in the United States and Europe where the security provisions to contain microorganisms undergoing research including genetic modification have been breached. This threatens the health and safety of laboratory workers and the wider community.

Law and the legal environment are important factors in the epidemiology and prevention of sexually transmissible infections (STIs) and blood-borne viruses (BBVs). However, there has been no sustained effort to monitor the legal environment surrounding STIs and BBVs. This article presents the first data on the incidence and impacts of unmet legal needs for those affected by an STI or BBV in Australia using a survey administered to a sample of the Australian sexual health and BBV workforce. Migration, Housing, Money/Debt, Health (including complaints about health services), and Crime (accused/offender) were reported as the five most common legal need areas, with 60% of respondents describing these legal problems as generating a "severe" impact on health. These results indicate that unmet legal needs generate significant negative impacts in terms of individual health, on public health, and the ability to provide sustainable services such as testing and treatment to those facing unmet legal needs.

The Convention on the Rights of Persons with Disabilities (CRPD) restates human rights through the lens of disability. One of the key rights relates to equality before the law. This has been interpreted as requiring the abolition of substitute decision-making regimes. As a signatory, Australia has agreed to implement the rights set out in the CRPD. In Australia, the laws relating to substitute decision-making and legal capacity vary from State to State. This article examines how the laws in Victoria compare to Australia's CRPD obligations and, hence, whether Victoria is compliant with or in breach of the CRPD. It concludes that, while on the surface Victoria is in breach of Australia's CRPD obligations, Victorian legislation is making significant efforts to operationalise a human rights approach to decision-making.

The rising cost of private health insurance and constraints within public health systems are global concerns. Genetic testing presents a transformative opportunity for health care to enhance health outcomes and optimise resource allocation through personalised medicine, early diagnosis, targeted treatments, managed care, and improved drug development. However, ethical and policy issues arise, including privacy, discrimination and equitable access to testing. Balancing these against potential health benefits poses a complex challenge. While some advocate for restricting health insurers from using genetic data, others argue that well-regulated private insurance can ensure affordability, improved health outcomes, and innovative care adoption. This article explores examples of improved health outcomes through genetic testing, identifies areas of risk related to insurers' use of genetic data, evaluates the adequacy of New Zealand's legal framework, and emphasises the need for ethical and equitable policy solutions. The broader issues of data governance, biases in algorithms, and implications of artificial intelligence and machine learning warrant separate exploration.

At the time the COVID-19 pandemic was declared there was no vaccine and other medical products were insufficient to meet demands. At the time intellectual property was considered a limitation to an effective pandemic response and the World Trade Organization considered a waiver of intellectual property addressed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The lesson from the COVID-19 pandemic and TRIPS waiver is that given enough time sufficient medical products will be delivered, albeit there remain some complicated delivery challenges and vaccine hesitancy issues. This column addresses the moment before that medical product saturation and the inherent limitation imposed by industry policies. The column concludes that the private sectors' motivating factors need to be integrated into the design of global public health pandemic responses from the start.

There is an increasing demand for the return of raw genomic data by research participants in translational genomic research. This article discusses the scope and application of privacy and freedom of information legislative provisions in Australia. Whether there is a right to access a copy of such data under Australian privacy legislation is contingent on whether raw genomic data can identify an individual and this article explores the opportunities for genomic data to be linked to individuals. We conclude that despite the complexity and overlapping nature of privacy laws in Australia, there is a clear right on the part of research participants to access their raw genomic data.