The latest issue of the Journal of Law and Medicine (Volume 19 Part 2) contains the following material:

EDITORIALIan Freckelton

  • Expert evidence accountability: New developments and challenges

Articles

Global artificial photosynthesis project: A scientific and legal introduction – Thomas Faunce

With the global human population set to exceed 10 billion by 2050, its collective energy consumption to rise from 400 to over 500 EJ/yr and with the natural environment under increasing pressure from these sources as well as from anthropogenic climate change, political solutions such as the creation of an efficient carbon price and trading scheme may arrive too late. In this context, the scientific community is exploring technological remedies. Central to these options is artificial photosynthesis – the creation, particularly through nanotechnology, of devices capable to doing what plants have done for millions of years – transforming sunlight, water and carbon dioxide into food and fuel. This article argues that a Global Artificial Photosynthesis (GAP) project can raise the public profile and encourage the pace, complexity and funding of scientific collaborations in artificial photosynthesis research. The legal structure of a GAP project will be critical to prevent issues such as state sovereignty over energy and food resources and corporate intellectual monopoly privileges unduly inhibiting the important contribution of artificial photosynthe- sis to global public health and environmental sustainability. The article presents an introduction to the scientific and legal concepts behind a GAP project.

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Is there still a place for gene patents in Australia? Implications of recent United States and European case law – Alexandra Ridley and Dianne Nicol

This article considers the ramifications of recent United States and European litigation relating to patents claiming rights to genes associated with hereditary forms of breast cancer (the so-called BRCA genes) for recently commenced Australian litigation relating to the same subject matter. The article is contextualised with brief summaries of the relevant patent law, the science of genetics, the history of the BRCA genes and an overview of the activities of the patent holder. The analysis of first instance and appeal decisions on the validity of the United States BRCA patents shows the final outcome is still highly uncertain in that jurisdiction, while the European litigation provides little assistance in predicting the outcome of the Australian action. This article concludes that the outcome of the Australian litigation is an issue that cannot be determined with any certainty due to the lack of specific, relevant precedents both in Australia and in other jurisdictions.

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Legal impediments to data linkage – V Xafis, C Thomson, AJ Braunack-Mayer, KM Duszynski and MS Gold

Large numbers of electronic health data collections have been accumulated by both government and non-government agencies and organisations. Such collections primarily assist with the management of health services and the provision of health care programs, with only a minority of these data collections also intended for research purposes. A number of constraints are placed on access to such data for the purposes of research, including data linkage. This article examines those factors arising from the intricacies of Australia’s privacy legislation landscape which impede access to such collections. The relevant issues discussed include issues relating to the existence of multiple privacy and health privacy Acts, the recommendations made by the Australian Law Reform Commission in relation to the Privacy Act 1988 (Cth) and the constraints placed on the conduct of data-linkage research which arise from legislation that relates specifically to certain data collections.

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Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: Methodological, ethical and legal concerns – Gregory J Boyle and George Hill

In 2007, WHO/UNAIDS recommended male circumcision as an HIV-preventive measure based on three sub-Saharan African randomised clinical trials (RCTs) into female-to-male sexual transmission. A related RCT investigated male-to-female transmission. However, the trials were compromised by inadequate equipoise; selection bias; inadequate blinding; problematic randomisation; trials stopped early with exaggerated treatment effects; and not investigating non-sexual transmission. Several questions remain unanswered. Why were the trials carried out in countries where more intact men were HIV-positive than in those where more circumcised men were HIV-positive? Why were men sampled from specific ethnic subgroups? Why were so many participants lost to follow-up? Why did men in the male circumcision groups receive additional counselling on safe sex practices? While the absolute reduction in HIV transmission associated with male circumcision across the three female-to-male trials was only about 1.3%, relative reduction was reported as 60%, but, after correction for lead-time bias, averaged 49%. In the Kenyan trial, male circumcision appears to have been associated with four new incident infections. In the Ugandan male-to-female trial, there appears to have been a 61% relative increase in HIV infection among female partners of HIV-positive circumcised men. Since male circumcision diverts resources from known preventive measures and increases risk-taking behaviours, any long-term benefit in reducing HIV transmission remains uncertain.

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Is it lawful to use Medicaid to pay for circumcision? – Peter W Adler

Since 1965, tens of millions of boys have been circumcised under the Medicaid program, most at birth, at a cost to the United States Federal Government, the States and taxpayers of billions of dollars. Although 18 States have ended coverage since 1982, the United States Government and 32 States continue to pay for non-therapeutic circumcision, even though no medical association in the world recommends it. Many cite American medical association policy that the procedure has potential medical benefits as well as disadvantages, and that the circumcision decision should be left to parents. This article shows that Medicaid coverage of circumcision is not a policy issue because it is prohibited by federal and State law. As American medical associations concede, non-therapeutic circumcision is unnecessary, elective, cosmetic surgery on healthy boys, usually performed for cultural, personal or religious reasons. The fundamental principle of Medicaid law is that Medicaid only covers necessary medical treatments after the diagnosis of a current medical condition. Physicians and hospitals face severe penalties for charging Medicaid for circumcisions. Medicaid officials and the Federal and State Governments are also required to end coverage. It is unlawful to circumcise and to allow the circumcision of healthy boys at the expense of the government and taxpayers.

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Psycho-social, ethical and legal arguments for and against the retrospective release of information about donors to donor-conceived individuals in Australia – Sonia Allan

In the February 2011 report on its inquiry into the past and present practices of donor conception in Australia, the Australian Senate Legal and Constitutional Affairs References Committee called for the introduction of legislation to regulate donor conception in all jurisdictions that do not have it in place “as a matter of priority”. It further called for the establishment, “as a matter of priority”, of a national register of donors to enable donor-conceived individuals to access identifying information about their donor. The Senate Committee left open the question as to whether the legislation and central register should have retrospective effect. This article focuses upon that question. It shows that arguments concerning the privacy, confidentiality and anonymity of some donors who may wish to remain anonymous are outweighed by the manifest injustice faced by donor-conceived individuals who are denied access to such information, as well as their families and donors who wish to exchange this information.

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Balancing public health and practitioner accountability in cases of medical manslaughter: Reconsidering the tests for criminal negligence-related offences in Australia after R v Patel – Nikita Tuckett

In 2010 Dr Jayant Patel was convicted of several offences on the basis of criminal negligence. Following the Queensland Court of Appeal’s 2011 endorsement of the trial judge’s decision, the case provides a timely opportunity to review prosecutions for medical negligence criminal offences throughout Australia and to critically examine the tests in assessing whether the balance has been correctly struck. The author argues that the thresholds required for prosecutions for criminal negligence for medical manslaughter are problematic and unduly onerous, and do not adequately strike the balance between the utilitarian value in health care and patient safety, on the one hand, and practitioner accountability and deterrence, on the other. This article considers reforms to remedy the imbalance, including a reformulation of the Criminal Code (Qld) and common law thresholds, proposals for the enactment of a separate offence of criminally negligent manslaughter and the utilisation of corporate prosecutions for manslaughter liability to broaden accountability in health care and promote patient safety on a systemic level.

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Trafficking in persons and victim health in Australia – Andreas Schloenhardt and Benjamin Klug

This article explores the health problems experienced by victims of trafficking in persons in Australia and analyses the domestic support schemes established to assist these victims. It focuses specifically on the health of adult, female victims who constitute the majority of identified victims, and who are the principal recipients of government support services. Domestic experiences and support schemes are reviewed in the light of international law and best practice guidelines. Recommendations are made to improve the health services available to victims of trafficking in persons in Australia.

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Sections

LEGAL ISSUESBernadette McSherry

  • Laws to detain individuals with substance dependency: Breaching human rights or restoring health? – Bernadette McSherry and Sarah Lenthall

MEDICAL ISSUESDanny Sullivan

  • Access to expensive anti-cancer drugs – Linda Mileshkin and Danny Sullivan

BIOETHICAL ISSUESGrant Gillett

  • Living and learning during an ethical crisis in medicine – Grant Gillett

NURSING ISSUESKim Forrester

  • The growing role of carers in the administration of medications – Kim Forrester

MEDICAL LAW REPORTERThomas Faunce

  • Condliff v North Staffordshire Primary Care Trust: Can human rights redress inequities in United Kingdom and Australian cost-containment-driven health care reforms? – Ruth Townsend and Thomas Faunce

LETTER TO THE EDITOR

  • Australian and New Zealand governments agree to proceed with the joint regulatory agency for therapeutic products – Jennifer Moore

BOOK REVIEW

  • Nagasaki: The Massacre of the Innocent and Unknowing by C Collie

For the pdf version of the table of contents, click here: JLM Vol 19 Pt 2 Contents.