Patient Safety Law: From Silos to Systems

Patient safety has become a significant and pressing policy issue. Around the world, governments, the health care sector and the public are increasingly cognizant of the need to improve the safety of care delivered by their health systems. Pressure for change has been created by highly publicized incidents in a number of countries involving unsafe acts that were significant both in scale and consequence and a number of empirical studies that revealed the high rates of unsafe acts and their consequences. The costs of unsafe health care – both personal and fiscal – to individuals, their families and their communities and to the state are massive. In this research project we explored one particular avenue for change – that is, the use of legal instruments by governments to improve patient safety. We did this through a comparative review of the use of legal instruments or frameworks in other countries (specifically Australia, Denmark, New Zealand, the United Kingdom, and the United States) as well as two non-health care related sectors in Canada (transportation and occupational health and safety). We began this research by reviewing the legal instruments and undertaking extensive literature reviews. Further information was gathered through in-person interviews with policy-makers and academics in the countries studied, and from policy-makers and academics expert in the health, occupational health and safety, and transportation sectors in Canada. Once descriptions of the various countries and sectors were drafted, we held small-group meetings with local experts on particular aspects of patient safety. We then hosted a national consultation meeting. We subsequently drafted this final report and the appendices, which fully describe the results of the background research. Finally, we prepared a summary version of the report as well as posters and papers to be published and delivered at conferences and meetings with relevant groups.

Enabling open access to and re-use of publicly funded research data in Malaysian public universities : a legal and policy analysis

Numerous statements and declarations have been made over recent decades in support of open access to research data. The growing recognition of the importance of open access to research data has been accompanied by calls on public research funding agencies and universities to facilitate better access to publicly funded research data so that it can be re-used and redistributed as public goods. International and inter-governmental bodies such as the ICSU/CODATA, the OECD and the European Union are strong supporters of open access to and re-use of publicly funded research data. This thesis focuses on the research data created by university researchers in Malaysian public universities whose research activities are funded by the Federal Government of Malaysia. Malaysia, like many countries, has not yet formulated a policy on open access to and re-use of publicly funded research data. Therefore, the aim of this thesis is to develop a policy to support the objective of enabling open access to and re-use of publicly funded research data in Malaysian public universities. Policy development is very important if the objective of enabling open access to and re-use of publicly funded research data is to be successfully achieved. In developing the policy, this thesis identifies a myriad of legal impediments arising from intellectual property rights, confidentiality, privacy and national security laws, novelty requirements in patent law and lack of a legal duty to ensure data quality. Legal impediments such as these have the effect of restricting, obstructing, hindering or slowing down the objective of enabling open access to and re-use of publicly funded research data. A key focus in the formulation of the policy was the need to resolve the various legal impediments that have been identified. This thesis analyses the existing policies and guidelines of Malaysian public universities to ascertain to what extent the legal impediments have been resolved. An international perspective is adopted by making a comparative analysis of the policies of public research funding agencies and universities in the United Kingdom, the United States and Australia to understand how they have dealt with the identified legal impediments. These countries have led the way in introducing policies which support open access to and re-use of publicly funded research data. As well as proposing a policy supporting open access to and re-use of publicly funded research data in Malaysian public universities, this thesis provides procedures for the implementation of the policy and guidelines for addressing the legal impediments to open access and re-use.

Biobanking of blood and bone marrow : emerging challenges for custodians of public resources

The Australian Bone Marrow Donor Registry (ABMDR) is a publicly funded company that is part of an international network that facilitates unrelated bone marrow transplantation. This role means that the ABMDR has access to a large biospecimen repository, therefore making it a highly valuable research resource. Recognising the potential value of these biospecimens for research purposes, the ABMDR is in the process of determining whether, and how, to share its biospecimens with other biobanks. While this would undoubtedly be of value to the scientific community, and ultimately to the wider community, it would also inevitably transform the role of an institution whose primary role is therapeutic, and would compromise the degree of control that a custodian has over donated material. This article describe the challenges confronting the ABMDR, and organisations like it, in balancing their duties to donors, patients, researchers and the general public. These problems have led inevitably to the use of "property" rights language in the discussion of these issues but notions of gift, ownership, trusteeship and transfer might also be considered.

Panem et circenses : law, law and power in The Hunger Games

Like many cautionary tales, The Hunger Games takes as its major premise an observation about contemporary society, measuring its ballistic arc in order to present graphically its logical conclusions. The Hunger Games gazes back to the panem et circenses of Ancient Rome, staring equally cynically forward, following the trajectory of reality television to its unbearably barbaric end point – a sadistic voyeurism for an effete elite of consumers. At each end of the historical spectrum (and in the present), the prevailing social form is Arendt’s animal laborans. Consumer or consumed, Panem’s population is (with the exception of the inner circle) either deprived of the possibility of, or distracted from, political action. Within the confines of the Games themselves, Law is abandoned or de‐realised: Law – an elided Other in the pseudo‐Hobbesian nightmare that is the Arena. The Games are played out, as were gladiatorial combats and other diversions of the Roman Empire, against a background resonant of Juvenal’s concern for his contemporaries’ attachment to short term gratification at the expense the civic virtues of justice and caring which are (or would be) constitutive of a contemporary form of Arendt’s homo politicus. While the Games are, on their face, ‘reality’ they are (like the realities presented in contemporary reality television) a simulated reality, de‐realised in a Foucauldian set design constructed as a distraction for Capitol, and for the residents of the Districts, a constant reminder of their subservience to Capitol. Yet contemporary Western culture, for which manipulative reality TV is but a symptom of an underlying malaise, is inscribed at least as an incipient Panem, Its public/political space is diminished by the effective slavery of the poor, the pre‐occupation with and distractions of materiality and modern media, and the increasing concentration of power/wealth into a smaller proportion of the population.

Criminal Laws : Materials and Commentary on Criminal Law and Process in NSW [Fifth Edition]

"The success of Criminal Laws lies both in its distinctive features and in its appeal to a range of readerships. As one review put it, it is simultaneously a "textbook, casebook, handbook and reference work". As such it is ideal for criminal law and criminal justice courses as a teaching text, combining as it does primary sources with extensive critical commentary and a contextual perspective. It is likewise indispensable to practitioners for its detailed coverage of substantive law and its extensive references and inter-disciplinary approach make it a first point of call for researchers from all disciplines. This fifth edition strengthens these distinctive features. All chapters have been systematically updated to incorporate the plethora of legislative, case law, statistical and research material which has emerged since the previous edition. The critical, thematic, contextual and interdisciplinary perspectives have been continued."--Publisher's website. Table of Contents: 1. Some themes -- 2. Criminalisation -- 3. The criminal process -- 4. Components of criminal offences -- 5. Homicide: murder and involuntary manslaughter -- 6. Defences -- 7. Assault and sexual assault -- 8. Public order offences -- 9. Drugs offences -- 10. Dishonest acquisition -- 11. Extending criminal liability: complicity, conspiracy and association -- 12. Sentencing and penality.

'Devils and dust' : extending the 'uncivil politics of law and order' to the 'war on terror'

The ‘war on terror’ and ongoing terrorist attacks around the world have generated a growing body of literature on national and international measures to counteract terrorist activity. This detailed study investigates an aspect of contemporary counter-terrorism that has been largely overlooked; the impact of these measures on the continued viability of the democratic state.

Measuring the effects of small group deliberation on public attitudes towards sentencing : benefits and challenges

This article reports on the outcomes of small group deliberations on levels of punitiveness and public confidence in the sentencing functions of Australian criminal courts, conducted as part of a larger project investigating public attitudes to sentencing. One hypothesis of the project as a whole was that a more informed and involved public is likely to be less punitive in their views on the sentencing of offenders, and to express less cynical views about the role of sentencing courts. The aim of the small group deliberations as part of the broader project was to engender a more thoughtful and considered approach by participants to issues around sentencing. It was hypothesised that the opportunity to discuss, deliberate and consider would lead to a measurable reduction in punitiveness and an increase in people’s confidence in the courts. While the results do indeed indicate such changes in attitudes, the current study also shed light on some of the conceptual, methodological and practical challenges inherent in this type of research.

Trade, travel and disease : the role of law in pandemic preparedness

In 2009 the world experienced an influenza pandemic caused by the H1N1 virus. While the pandemic was milder then expected, it nonetheless provided the world with an opportunity to do real-time testing of pandemic preparedness. This paper examines the threats to human health posed by infectious diseases and the challenges for the global community in development of effective surveillance systems for emerging infectious diseases. In 2005 a new revised version of the International Health Regulations (IHR) was adopted. The requirements of the IHR (2005) are outlined and considered in light of the constraints facing resource-poor countries. Finally, the paper addresses the role of domestic law-making in supporting public health preparedness and articulates a number of ethical principles that should be considered when developing new public health laws.

Pandemic preparedness in Asia : a role for law and ethics?

Management of pandemic influenza relies on complex coordination of many different dimensions of the health and social care systems, emergency services, levels of national and local government, civil society, communications and media, and cultural expectations. Law is one small but important component of those arrangements, which touch on fundamental ethical debates. This review demonstrates that the Asian region is actively engaging those issues in diverse ways in light of their varied socioeconomic and cultural backgrounds, but scope remains for prioritising further research into these relationships.

Law, ethics and pandemic preparedness : the importance of cross-jurisdictional and cross-cultural perspectives

Objective To explore social equity, health planning, regulatory and ethical dilemmas in responding to a pandemic influenza (H5N1) outbreak, and the adequacy of protocols and standards such as the International Health Regulations (2005). Approach This paper analyses the role of legal and ethical considerations for pandemic preparedness, including an exploration of the relevance of cross-jurisdictional and cross-cultural perspectives in assessing the validity of goals for harmonisation of laws and policies both within and between nations. Australian and international experience is reviewed in various areas, including distribution of vaccines during a pandemic, the distribution of authority between national and local levels of government, and global and regional equity issues for poorer countries. Conclusion This paper finds that questions such as those of distributional justice (resource allocation) and regulatory frameworks raise important issues about the cultural and ethical acceptability of planning measures. Serious doubt is cast on a ‘one size fits all’ approach to international planning for managing a pandemic. It is concluded that a more nuanced approach than that contained in international guidelines may be required if an effective response is to be constructed internationally. Implications The paper commends the wisdom of reliance on ‘soft law���, international guidance that leaves plenty of room for each nation to construct its response in conformity with its own cultural and value requirements.

Emergency powers and pandemics : federalism and the management of public health emergencies in Australia

Under the International Health Regulations 2005 Australia is obliged to develop a domestic framework designed to equip it to respond to public health emergencies. The legislative arrangements for the declaration of a public health emergency in Australia are complex, vary across state jurisdictions and intersect with other emergency powers. The task of harmonising laws and other arrangements within a federal system poses both challenges and opportunities for flexibility and choice. This article argues that Australia's current multi-strand and multi-level response provides a coordinated framework which also accommodates desirable levels of flexibility and choice.

Health governance : law, regulation and policy

This special issue of Public Health is devoted to health governance, examining the role of law, regulation and policy in safeguarding the public's health. Each of us has devoted a career to thinking carefully about the role of law as a tool to prevent injury and disease and to promote the population's health and wellbeing. 1, 2, 3 and 4 In this Guest Editorial we first explain what we mean by the term ‘governance’, as well as the role of law in a well-regulated society. Next, we explore the increasingly important, and challenging, concept of what we call national and global federalism—the inter-relationships among the various levels of governance (local, national, supranational and transnational) and among various actors in national and global health. Third, we explain the origins of this journal symposium, which arises from three conferences on the topic in Hong Kong and Sydney. Finally, we offer a brief introduction to the articles that follow.

Legal rights during pandemics : federalism, rights and public health laws - a view from Australia

Pandemic influenza will cause significant social and economic disruption. Legal frameworks can play an important role in clarifying the rights and duties of individuals, communities and governments for times of crisis. In addressing legal frameworks, there is a need for jurisdictional clarity between different levels of government in responding to public health emergencies. Public health laws are also informed by our understandings of rights and responsibilities for individuals and communities, and the balancing of public health and public freedoms. Consideration of these issues is an essential part of planning for pandemic influenza.

When should private property rights give way to the public interest?

Since Queensland Wire Industries Pty Ltd v Broken Hill Pty Co Ltd (1989) 167 CLR 177 it has been recognised that corporations with substantial market power are subject to special responsibilities and restraints that corporations without market power are not. In NT Power Generation Pty Ltd v Power and Water Authority (2004) 219 CLR 90 McHugh A-CJ, Gummow, Callinan and Heydon JJ in their joint reasons stated (at [76]), that s 46 of the Competition and Consumer Act 2010 (Cth) (CCA) can operate not only to prevent firms with substantial market power from doing prohibited things, but also compel them positively to do things they do not want to do. Their Honours also stated (at [126]) that the proposition that a private property owner who declines to permit competitors to use the property is immune from s 46 is “intrinsically unsound”. However, the circumstances in which a firm with substantial power must accommodate competitors, and private property rights give way to the public interest are uncertain. The purpose of this Note is to consider recent developments in two areas of the CCA where the law requires private property rights to give way to the public interest. The first part of the Note considers two recent cases which clarify the circumstances in which s 46 of the CCA can be used to compel a firm with substantial market power to accommodate a competitor and allow the competitor to make use of private property rights in the public interest. Secondly, on 12 February 2014 the Minister for Small Business, the Hon Bruce Billson,released the Productivity Commission’s Final Report, on the National Access Regime in Pt IIIA of the CCA (National Access Regime, Inquiry Report No 66, Canberra). Pt IIIA provides for the processes by which third parties may obtain access to infrastructure owned by others in the public interest. The Report recommends that Pt IIIA be retained but makes a number of suggestions for its reform, some of which will be briefly considered.