Ethical implementation of mitochondrial donation in Australia.

Australia has recently legalised mitochondrial donation. However, key ethical and legal issues still need to be addressed. This paper maps the relevant issues and offers some suggestions for how they ought to be resolved.

Regulatory and Policy Considerations Around Genome Editing in Agriculture.

The increasingly widespread use of genome editing brought with it a fierce debate about the most adequate regulation of this latest innovation in modern biotechnology and the products resulting from it. In almost all cases, this debate has become a repetition or continuation of the deliberations concerning genetically modified organisms (GMOs) of the 1990s and early 2000s.This chapter aims to untangle the historically influenced and often biased arguments of the debates by addressing the complex question of the correct interpretation of relevant underlying law and its applicability. In doing so, the chapter considers 25 countries and regions that have published results or ongoing investigations and discussions pertaining to the governance of genome editing in their jurisdictions: 16 have published policies or signed statements that exempt gene edited plants from GMO-regulations, as long as no foreign DNA or transgene remained in the final product. Such exemptions are based on the widely supported acceptance that the products of the underlying genome editing processes resemble those of "conventional breeding" techniques. These policies and statements often refer to the important role that modern precision biotechnologies, of which genome editing is one, play in addressing some of the world's overarching challenges, such as the loss of biodiversity, pest and disease control, and climate change; they are furthermore shown to exhibit an adherence to the four universal principles of good regulation: (a) proportionality, (b) non-discrimination, (c) predictability, and (d) enforceability. And while it is the right of jurisdictions to develop their own regulations independent from that of their neighbors, it is specifically the principle of "enforceability" that may become the ultimate litmus test of those regulations that do not grant exemptions from GMO-regulations.

The Impact of COVID-19 on Fertility Treatment in Australia.

On 25 March 2020, as part of the Australian response to the coronavirus pandemic, all non-essential elective surgery was indefinitely suspended. This had an immediate impact on the provision of fertility treatment because the vast majority of fertility treatments were classified as non-essential. The suspension ended on 27 April 2020, although other restrictions continued. Between June and August 2020, we conducted semi-structured interviews to determine the impact of these initial regulatory responses to the pandemic on the provision of fertility treatment in Australia during two key periods: the suspension of non-essential surgery and the re-opening. Changes to the practice of fertility treatment demonstrate the importance of planning for prioritisation and other matters to be addressed in preparation for possible future pandemics.

Genetic identity concerns in the regulation of novel reproductive technologies.

Confusion concerning a child's genetic identity is a common objection to the application of novel technologies to human embryos. Unsurprisingly then, concern for genetic identity has been used to justify successive waves of regulatory activity and is again appearing in debates about regulatory responses to emerging reproductive technologies. By examining the history of Australian law's understanding and responses to so-called genetic identity in the context of past and current scientific developments in reproductive technology, this paper investigates regulatory reform needed for still emerging reproductive technologies. While this paper presents and analyzes in some detail Australian regulation and the policy deliberations and scientific developments that led to them, the identified inconsistencies in the regulatory responses, and recommended reforms to address emerging reproductive technologies offered, address issues relevant to many countries responding to the same technologies.

(Re)Drawing the Line: Australian Regulation of Human-Animal Interspecies Embryos.

The mixing of human and animal cellular and genetic material is a promising area of science, but inherent societal and safety concerns make such mixing in embryos particularly controversial. The sensitive nature of this research, coupled with science's rapid development, creates problems for policymakers responsible for deciding what practices are and are not permitted in Australia. Australia's regulation in this area, last significantly amended in 2006, is in urgent need of reform. This article investigates what is happening in this fast moving area and the regulatory reforms necessary for Australian scientists to participate.

COMMERCIAL SURROGACY: WHAT ROLE FOR LAW IN AUSTRALIA?

This editorial begins by illuminating current conversations regarding the regulation of commercial surrogacy in Australia. It defines "commercial surrogacy" and explains the interaction between changes in social attitudes and changes to the law before setting out the current Australian law and practice in this area. An examination of current domestic law and practice reveals that surrogacy legislation in Australia is mired in inconsistencies and a lack of uniformity but that the one key common element is the prohibition of commercial surrogacy. The inability of couples to access commercial surrogacy within Australia has led to offshore reproductive tourism and unpredictable, contradictory decision-making as the Family Court attempts to apply legislation which was never intended to apply in this context. The editorial then turns to consider the international arena, discussing the approach of the Hague Conference on Private International Law before delving into a human rights analysis of commercial surrogacy arrangements. The adoption of a rights-based approach requires an analysis of this vexed issue from the perspective of the child, surrogate and intending parents. While questions surrounding the human rights implications of legalising commercial surrogacy continue to be the subject of passionate debate, the authors believe that the human rights of all parties are best protected through appropriate regulation rather than absolute prohibition.

Genes and gestation in Australian regulation of egg donation, surrogacy and mitochondrial donation.

This article considers genetic and legal relatedness for the purposes of Australian regulation of egg donation, surrogacy and parentage by examination of that regulation through the lens of mitochondrial (mt) donation. The article addresses whether mt donors would be a child's genetic parents following clinical use in that child's conception should mt donation be legalised for such use in Australia. It then considers how genetic and gestational relatedness are relevant in the discourse around legal parentage following egg donation and surrogacy and argues that the current approach is in need of reform so that intending parents of all children are deemed to be the resulting child's legal parents at birth.

Duty of care or a matter of conduct -- can a doctor refuse a person in need of urgent medical attention?

BACKGROUND: Medical practitioners may have their particular skills called upon outside a direct professional context. The responsibilities of medical practitioners outside their defined scope of clinical practice may not be clear to all clinicians. OBJECTIVE: To consider the possible legal consequences of a doctor refusing to assist a person in need of urgent medical attention both in terms of medical negligence and professional misconduct. DISCUSSION: Where an established clinical relationship does not exist, and a doctor does not wish to render aid, three particular scenarios may arise. A doctor may actively deny being a doctor, passively avoid identifying themselves as a doctor or acknowledge being a doctor, but refuse to render assistance. Aside from any ethical issues, how a doctor chooses to act and represent themselves may lead to different legal ramifications. There exists significant variation in state provisions relating to legal obligations to render aid, which may benefit from review and revision at a national level.

Prostate specific antigen - useful screening tool or potential liability?

BACKGROUND: The uncertainty regarding prostate specific antigen (PSA) screening for prostate cancer has not been alleviated, despite recent randomised controlled trials and position statements released by authoritative bodies. OBJECTIVE: This article summarises authoritative position statements by representative bodies in Australia and describes legal considerations for a general practitioner when deciding whether to order PSA tests as a screening tool for prostate cancer. DISCUSSION: Prostate specific antigen as a primary screening tool is generally not endorsed by most authoritative bodies in Australia, with the exception in some circumstances for men 55-69 years of age. Where asymptomatic patients request a PSA be undertaken, a GP can be justified both to order a PSA test or not to, such is the context of peer professional opinion provisions in Australian legislation and conflicting authoritative position statements regarding PSA.Where there is still ongoing uncertainty, the matter may be appropriately referred for specialist consideration.

Factors associated with return-to-work and health outcomes among survivors of road crashes in Victoria.

OBJECTIVE: To explore the relationships between injury, disability, work role and return-to-work outcomes following admission to hospital as a consequence of injury sustained in a road crash. DESIGN AND SETTING: Prospective cohort study of patients admitted to an adult trauma centre and two metropolitan teaching hospitals in Victoria, Australia. Participants were interviewed in hospital, 2.5 and eight months post-discharge. PARTICIPANTS: Participants were 60 employed and healthy adults aged 18 to 59 years admitted to hospital in the period February 2004 to March 2005. RESULTS: Despite differences in health between the lower extremity fracture and non-fracture groups eight months post-crash the proportions having returned to work was approximately 90%. Of those returning to work, 44% did so in a different role. After adjustment for baseline parameters, lower extremity injuries were associated with a slower rate of return to work (HR: 0.31; 95%CI: 0.16-0.58) as was holding a manual occupation (HR: 0.16; 95%CI: 0.09-0.57). There were marked differences in physical health between and within the injury groups at both follow-up periods. CONCLUSIONS: These results demonstrate that both injury type and severity and the nature of ones occupation have a considerable influence on the rate and pattern of return to work following injury. Further, persisting disability has a direct influence on the likelihood of returning to work. The implications of these findings and the types of data required to measure outcome post-injury are discussed.

Hitting the mark or falling short with nanotechnology regulation?

Regulation of all new technology ebbs and flows between periods of under- and over-regulation, often dependant on the viewpoint of the observer and the underlying objectives of the particular regulation. As illustrated by genetic modification (GM) applications, defining what constitutes appropriate regulation for a rapidly evolving technology can be difficult. Drawing upon the lessons of GM, we argue that nanotechnology will go through similar periods of inappropriate regulation. As with GM, future regulatory responses to nanotechnology will be shaped by perceptions of risk and willingness to accept varying levels of risk. With varying responses between jurisdictions appearing inevitable, we argue that the timing and type of regulation adopted for nanotechnology, and its appropriateness, will be crucial to its commercial success.

One size fits all? Australian regulation of nanoparticle exposure in the workplace.

Nanoparticles (NPs) are a relative newcomer to the Australian workplace. Available scientific data suggest that exposure to some NPs may have serious health consequences, in at least one case being similar to the effects of asbestos. This article explains what NPs are and the possible health effects of exposure to them. The adequacy of Australian regulation of NP exposure in the workplace is then examined. It finds that current Australian regulation of workplace dangers from chemical exposure based on size is inappropriate for NPs: in this instance at least, one size does not fit all.