Australian Medical Professionals, National Security and Administrative Offshore Punishment of Asylum-Seekers: Regulatory Update Including the Medevac Legislation.

This article updates how Australia's national security concerns have intersected with the regulation of Australian medical practitioners in the area of mandatory, indefinite, administrative offshore detention of asylum-seekers. It outlines relevant recent decisions of the High Court, including dissenting opinions that such detention represents unconstitutional extra-judicial punishment with a primary deterrence aim. It evaluates recent amendments to the Australian Border Force Act 2015 (Cth) as well as exploring recent relevant legislation and administrative, political and judicial decisions made in both Papua New Guinea and the Republic of Nauru. It considers the Medical Evacuation legislation and the Australian Government's attempts to challenge judicial authority to transfer people off Nauru for medical treatment. The article concludes with an analysis of prospects for further Australian asylum seeker and refugee policy and legislative reform more coherent with basic principles of medical ethics and international human rights.

Citizens' Juries, Liquid Democracy and Legislative Reform of Australian Compulsory Insurance Schemes for Injury Compensation after Motor Vehicle Accidents.

In 2017/2018 the Australian Capital Territory held its first citizens' jury to deliberate changes to the Territory's Compulsory Third Party (CTP) insurance scheme, for injury compensation after motor vehicle accidents. Such citizens' juries were designed to aid the transition to next-generation parliamentary processes (such as liquid democracy - citizen direct electronic voting on laws or individual transfer of their vote to respected politicians) by enabling a variety of key stakeholders and interests to be actively represented in the process of statutory development. In effect such a process is a democratic alternative to the current model of corporate lobbyists covertly influencing the legislative process. This column investigates how the citizens' jury chose one from four proposed CTP models. It then critiques how, following the jury's recommendation, the Australian Capital Territory Government introduced the Motor Accidents Injuries Bill 2018 (ACT). Once enacted, this is designed to create a "no-fault" expedited scheme, but on our analysis, at the cost of certain adverse outcomes. These include greatly reducing an injured person's entitlements to fair compensation, a "whole person impairment threshold" that limits entitlements to treatment and care, wage loss and compensation for pain and suffering, removing the right to compensation for gratuitous care, and giving the insurance companies unfettered power over the provision of entitlements.

Legal Strategies to Cure the Plastic Planet: Corporate Marriage and Public Health Regulation of Single-Use Non-Biodegradeable Plastics.

The 2018 export ban of recyclables to China provides an additional important reason for Australia in particular to act internationally and domestically to reduce its plastic waste. The problems Australia faces from single-use non-biodegradable plastics are replicated in every nation on Earth. Focusing on the Australian context, this article examines regulatory approaches to the problem of plastic production, consumption and disposal and its negative impact on public and ecosystem health. It scrutinises the current legal framework for managing plastic waste at Commonwealth, State and international levels, advocating greater regulation. Its regulatory recommendations include a Pigouvian tax in the form of an excise on plastic production to alter consumer behaviour and raise revenue for further investment in reusable alternatives. They also involve mandatory corporate responsibility obligations, a concept we term "corporate marriage". Other alternative and additional measures to combat single-use plastic waste as utilised in other jurisdictions are proposed for Australian implementation.

Mercury Pollution from Coal-Fired Power Plants: A Critical Analysis of the Australian Regulatory Response to Public Health Risks.

This article explores the benefits likely to arise from Australia's ratification of the Minamata Convention on Mercury with regard to reducing public health risks from mercury emissions from coal-fired power plants. The current legislative frameworks regulating mercury pollution are critiqued, an exploration of the international approaches is undertaken, and recommendations are made aiming to produce a stronger, more stringent and long-term mercury protection policy for Australian communities.

Australia's First Official Illicit Pill Testing at Canberra's Groovin' the Moo Music Festival: Legal Hurdles and Future Prospects.

The first official pill testing at an Australian music festival was conducted at Groovin' The Moo in Canberra on 29 April 2018. As the trial was the first of its kind in Australia, it was not without legal hurdles and uncertainty. Primarily, there was concern over the legal consequences for patrons participating in the pill testing, as well as the legal liability of those facilitating and conducting the testing. This article will discuss the legal hurdles that were overcome in order to facilitate the trial, and the future consequences and position of pill testing at Australian festivals.

Regulating RNA Research and CRISPR Gene Drives to Combat Biosecurity Threats.

Recent technological breakthroughs in ribonucleic acid (RNA) research and the creation of synthetic gene drives using CRISPR/Cas9 have increased attention on the ethical and legal regulation of this field. RNA is now perceived as not merely a passive carrier of DNA information but especially through its propensity to mutate as a computation engine of cell biology, developmental biology and evolution. Synthetic Gene drives have been hailed as a potential strategy to reduce climate-change-mediated biosecurity threats such as spreading malaria and have attracted significant investment, with the Gates Foundation pledging US$75 million and the Defense Advanced Research Projects Agency awarding US$65 million. Calls for a global moratorium on RNA-mediated genetic engineering may overstate the potential risks of the developing technology, but form a background to the contest between "process"- and "product" -based approaches to regulation, the former purportedly favoured by the public and regulatory agencies and the latter favoured by the broad scientific community and corporate investors. At stake may be the democratic legitimacy of and equitable access to a technology that could be important to reduce the incidence of biosecurity threats both globally and in Australia.

Senate inquiry into price regulation on the prostheses list.

A recent Senate Inquiry investigated the Prostheses List (PL) which has been an integral part of the private health care system since its introduction in 1985. The PL sets the price of various prostheses products available for private health insurance patients. In recent years however, the PL has come under scrutiny due to the inflated prices of prostheses, lack of transparency from the list's creators and regulators, and increased premiums. This column critically analyses the recent Senate report, particularly as to whether it appropriately addressed the various concerns and issues raised in submissions and terms of reference of the inquiry and what ongoing role the PL should have in the Australian Healthcare System.

Analysis of Australia's New Biosecurity Legislation.

On 16 June 2016 the Biosecurity Act 2015 Cth came into force. This legislation replaced the Quarantine Act 1908 Cth which had regulated biosecurity in Australia for over a century. Impetus for the change arose from a number of reviews (the Nairn Report and later Beale Review) into Australia's biosecurity system. These identified systemic flaws that were causing the country to be vulnerable to incursions of foreign pests and diseases through the administration of an archaic regulatory regime. The Biosecurity Act 2015 Cth includes new terminology, increased powers for the regulator and additional requirements for industry. The responsible agency, the Department of Agriculture and Water Resources, has stated that the new biosecurity laws are designed to be user-friendly, to be flexible and responsive to changes in technology and future challenges, to remove cluttered and confusing sections of the Quarantine Act 1908 Cth and to achieve the difficult balance of making biosecurity regulation risk-based and equipping the regulator with strong enforcement powers while also being economically prudent and supportive of increasing Australian trade and market access. This column analyses such claims, including the short, and long-term implications of providing biosecurity officers with two sets of authorising legislative powers and sharing the responsibility of biosecurity emergencies with the Department of Health.

Australian Senate Committee Report on Transvaginal Mesh Devices.

On 28 March 2018 the Australian Senate Community Affairs References Committee issued its final report on transvaginal mesh devices. It found these devices have caused unnecessary physical and emotional pain and suffering to thousands of women who were not told by their doctors of the objective material risks associated with their use. The Senate Committee concurred with the description by the Public Health Association of Australia of the complications resulting from transvaginal mesh implants as constituting a serious public health issue requiring a response at both an individual and at a population level, including counselling, public education, clinical interventions and long-lasting protective mechanisms. The committee's inquiry highlighted significant shortcomings in Australia's reporting systems for medical devices, with flow-on consequences for the health system's ability to respond in a timely and effective way. Among other recommendations, the Senate Committee backed the establishment on a cost recovery basis of a national registry of high-risk implantable devices linked to a system of mandatory reporting of adverse events.

High Court of Australia and HIV/AIDS Disease Criminalisation: Aubrey v The Queen and Zaburoni v The Queen.

In 2017, the High Court of Australia in Aubrey v The Queen (2017) 91 ALJR 601; [2017] HCA 18 considered the term inflict grievous bodily harm, under common law, and expanded its interpretation to incorporate nonviolent and non-immediate infection of a disease, overturning a 120 year authority in R v Clarence (1888) 22 QBD 23. In the previous case of Zaburoni v The Queen (2016) 256 CLR 482; [2016] HCA 12, the High Court allowed an appeal from the Qld Supreme Court finding that repeated acts of unprotected sexual intercourse by a man who knew he was infected with HIV/AIDS, though callous and reckless, did not constitute intention to infect his female partner; consequently, he could be found guilty of a lesser offence of inflicting grievous bodily harm which carried a maximum 14-year prison sentence rather than life imprisonment. These decisions illustrate a court intersecting with an emerging trend to use legislation creating criminal offences to deter those who intentionally or recklessly infect others with life-shortening diseases.

The Essendon Football Club Supplements Saga: Exploring Natural Justice for Team Sanctions within Anti-Doping Regulations.

On 10 October 2016 the Essendon Football Club (EFC) performance-enhancing drugs regulatory saga concluded with the Swiss Federal Tribunal deciding not to "entertain" EFC's appeal of the Court of Arbitration of Sport's (CAS) guilty finding, thus supporting the World Anti-Doping Authority (WADA). The appeal is a unique decision as it is the first time a team (34 players from the one team) has been subject to CAS's jurisdiction for allegations of doping contrary to the World Anti-Doping Code. One significant concern throughout this regulatory saga was that the team-based nature of the infraction denied individual players natural justice. Central to these concerns is the fact that the players were advised by EFC to take part in the program and that its chief architect, sports scientist Stephen Dank, never gave sworn evidence that could be tested in cross-examination. This column investigates whether there are important lessons for team-based anti-doping infractions from the EFC saga.

REGULATION OF AUSTRALIAN MEDICAL PROFESSIONALS AND NATIONAL SECURITY: LESSONS FROM THREE CASE STUDIES.

In recent times, Australia's national security concerns have had controversial impacts on regulation of Australian medical practitioners in areas related to immigration detention. This column explores three recent case studies relevant to this issue. The first involves the enactment of the Australian Border Force Act 2015 (Cth), which has a significant impact on the regulation of medical professionals who work with people in immigration detention. The second involves the decision of the High Court of Australia in Plaintiff M68/2015 v Minister for Immigration and Border Protection [2016] HCA 1 that an amendment to Australian federal legislation justified sending children back to immigration detention centres in Papua New Guinea and Nauru. This legislation was previously heavily criticised by the Australian Human Rights Commissioner. The third concerns the deregistration of Tareq Kamleh, an Australian doctor of German-Palestinian heritage who came to public attention on ANZAC Day 2015 with his appearance online in a propaganda video for the Islamic State terrorist organisation al-Dawla al-Islamyia fil Iraq wa'al Sham, also known as Islamic State of Iraq and Syria (ISIS) or Daesh. Australia's professional regulatory system should presumptively respect professional virtues, such as loyalty to the relief of individual patient suffering, when dealing with doctors (whether in Australia or ISIS-occupied Syria) working under regimes whose principles appear inconsistent with those of ethics and human rights.

NuCoal Resources Ltd v New South Wales: The mining industry and potential health impacts of investor-state dispute settlement in Australia.

The Climate Council and Climate and Health Alliance have detailed the adverse health impacts of coal on Australian citizens and their environment. Such reports confirm established evidence that coal mining not only releases atmospheric toxins but destroys prime farming land and rivers. This column examines how the revocation of coal mining leases after proven corruption by disgraced New South Wales politicians, upheld by the High Court (NuCoal Resources Ltd v New South Wales (2015) 255 CLR 388; [2015] HCA 13), was challenged using mechanisms in the Australia-United States Free Trade Agreement, and potentially the Trans-Pacific Partnership Agreement (TPP). It is likely that foreign investors in the Australian coal mining and fracking industries will circumvent imprecise exceptions and use investor-state dispute settlement clauses in the TPP to initiate claims for damages before panels of conflicted investment arbitrators, alleging appropriation of their investments as a result of Australian legislation or policy taken against the coal industry on public health grounds. This issue is explored through analysis drawn from an extant investor-state dispute involving the mining industry in North America.

Corporatisation of Community Pharmacy and the Constitutional Prohibition of Civil Conscription for Medical Service Providers.

This column examines recommendations from the Harper Competition Policy Review relating to the opening up to corporate ownership of the community pharmacy sector in Australia. After studying the outcomes of similar proposals in other nations, it examines whether s 51(xxiiiA) of the Australian Constitution provides a prohibition against such a reduction of the small business option for those pharmacists wishing to develop a pharmacy business in Australia. An analysis of the services provided by community pharmacists finds that services such as the provision of advice on the safe and efficacious use of medicine, the prescribing and administering of vaccinations, the treatment of minor wounds and ailments, the provision of pharmacist-only medicines, and diabetes education all form part of the core function of community pharmacists. Given that these services are fundamentally medical in nature, community pharmacists as Commonwealth-regulated medical service providers for the purposes of s 51(xxiiiA) are thereby protected against Commonwealth policy or legislation facilitating civil conscription.

Seeding Australian Regulation of Genomics in the Cloud ­ Elizabeth Abbott and Thomas Faunce.

Cloud computing has facilitated a revolution in genome sequencing. As big data and personalised medicine increase in popularity in Australia, are the legal and regulatory regimes surrounding this nascent area of scientific research and clinical practice able to protect this private information? An examination of the current regulatory regime in Australia, including the Privacy Act 1988 (Cth) and medical research laws that govern cloud-based genomics research highlights that the key challenge of such research is to protect the interests of participants while also promoting collaborative research processes. This examination also highlights the potential effect that the Trans-Pacific Partnership Agreement's Electronic Commerce Chapter may have had on using the cloud for genomics and what the consequences may have been for researchers, clinicians and individuals. Lessons learnt here will be relevant to studying similar impacts from other trade and investment agreements such as the Trade in Services Agreement (TiSA).

AUSTRALIAN COMPETITION AND CONSUMER COMMISSION v ACN 117 372 915: SHOULD CONSUMER LAW REGULATE DOCTOR-PATIENT RELATIONS IN A CORPORATISED HEALTH CARE SYSTEM?

In April 2015, North J of the Federal Court of Australia made a finding of unconscionable conduct against Advanced Medical Institute, a promoter and provider of erectile dysfunction treatment, in a case concerning unfair contract terms (Australian Competition and Consumer Commission vACN 117 372 915 Pty Ltd (in liq) (formerly Advanced Medical Institute Pty Ltd) [2015] FCA 368). The contract required a minimum 12-month commitment, with costs exceeding treatments available from general practitioners, and made refunds available only after all possible treatment plans were exhausted which included penile injections. This column analyses that case, particularly in respect to the consumer law standards of practice under which it was litigated. Those standards refer to patients as "consumers" yet North J made extensive reference to the Good Medical Practice: A Code of Conduct for Doctors in Australia, a text which refers to "patients", as evidence of what constitutes appropriate professional conduct or practice for the health profession. This column considers whether legislative and judicial categorisation of patients (a class of people presumptively suffering, sick and vulnerable) as "consumers" undermines the formal and informal protections accorded to patients under normative systems of medical ethics such as those represented by the Code. The case, it is argued, also illuminates the contemporary tensions between the ethical, legal and human rights standards required of doctors in their treatment of patients and the commercial interests of businesses.

AUSTRALIAN COMPETITION AND CONSUMER COMMISSION v PFIZER: EVERGREENING AND MARKET POWER AS A BLOCKBUSTER DRUG GOES OFF PATENT.

In Australian Competition and Consumer Commission v Pfizer Australia Pty Ltd [2015] FCA 113, the ACCC alleged that Pfizer's "Project LEAP" involved a scheme to lock pharmacists into substituting its generic version of the high sales volume anti-cholesterol drug, patent-expired atorvastatin (Lipitor), which took advantage of a substantial degree of market power for a purpose proscribed by s 46(1)(c) of the Competition and Consumer Act 2010 (Cth). The ACCC also claimed that Pfizer's actions constituted a course of exclusive dealing pursuant to s 47(1)(d) and (e) for the proscribed purpose of lessening competition. Flick J in the Federal Court of Australia, in a judgment heavy with quotations but sparse in reasoning, dismissed the ACCC's Amended Originating Application alleging abuse of market power and ordered the ACCC to pay Pfizer's costs. The ACCC has now appealed the decision. This column explores this case in the context of Pfizer's broader strategies to preserve its income globally from this high sales volume drug in the period following its patent expiration.

Sustainable fuel, food, fertilizer and ecosystems through a global artificial photosynthetic system: overcoming anticompetitive barriers.

This article discusses challenges that artificial photosynthetic (AP) systems will face when entering and competing in a global market characterized by established fossil fuel technology. It provides a perspective on the neoliberal principles underpinning much policy entrenching such environmentally destructive technology and outlines how competition law could aid overcoming these hurdles for AP development. In particular, it critiques the potential for competition law to promote a global AP initiative with greater emphasis on atmospheric carbon dioxide and nitrogen fixation (as well as solar-driven water splitting) to produce an equitable, globally distributed source of human food, fertilizer and biosphere sustainability, as well as hydrogen-based fuel. Some relevant strategies of competition law evaluated in this context include greater citizen-consumer involvement in shaping market values, legal requirements to factor services from the natural environment (i.e. provision of clean air, water, soil pollution degradation) into corporate costs, reform of corporate taxation and requirements to balance maximization of shareholder profit with contribution to a nominated public good, a global financial transactions tax, as well as prohibiting horizontal cartels, vertical agreements and unilateral misuse of market power.

MYRIAD VOICES AGAINST GENE PATENTS IN THE HIGH COURT.

The Australian High Court's recent landmark decision in D'Arcy v Myriad Genetics Inc overturned the decision by the Federal Court in Cancer Voices Australia v Myriad Genetics Inc regarding patenting of genetic material. The Federal Court had found that isolated DNA and RNA can constitute a patentable invention under s 18(1)(a) of the Patents Act 1990 (Cth). The decision by the High Court unanimously reversed this and declared it was appropriate to look to the policy implications at the heart of the legal question: are genes a category of things that can be patented? This column critically examines the implications of the High Court decision for both research and public health in Australia.