Registration of clinical trials: Challenges for global regulation

In 2004 the International Committee of Medical Journal Editors (ICMJE) issued a statement indicating that from 1 July 2005 registration in a publicly accessible trials registry would be a condition of publication in an ICMJE member journal. The World Health Organisation is coordinating the International Clinical Trials Registry Platform (ICTRP) as a means of providing a standardised framework for registration. This article considers the practical challenges and opportunities that arise from these developments and considers the relevance of trial registration for women and minorities and for developing countries.

Globalisation and Health : Challenges for Health Law and Bioethics

This timely collection explores ethical and legal dilemmas in healthcare arising from globalization. Conflicts between public interests and individual rights, the challenge of regulating professionals and access to health services, and the effects of a global market all feature prominently in contemporary debates in this area. As a result of globalization, issues in health law and bioethics can no longer be understood solely within political boundaries that define traditional notions of individuals and communities. Rather, solutions for emerging problems require a global conception of rights and obligations, including the re-evaluation of ethical frameworks and legal regimes that currently govern exchanges in healthcare. Leading scholars in bioethics, law, medicine and philosophy from various jurisdictions engage these themes in this volume, and demonstrate the need for transnational solutions in a global age of healthcare.

The IHR (2005), disease surveillance, and the individual in global health politics

Since the revisions to the International Health Regulations (IHR) in 2005, much attention has turned to two concerns relating to infectious disease control. The first is how to assist states to strengthen their capacity to identify and verify public health emergencies of international concern (PHEIC). The second is the question of how the World Health Organization (WHO) will operate its expanded mandate under the revised IHR. Very little attention has been paid to the potential individual power that has been afforded under the IHR revisions – primarily through the first inclusion of human rights principles into the instrument and the allowance for the WHO to receive non-state surveillance intelligence and informal reports of health emergencies. These inclusions mark the individual as a powerful actor, but also recognise the vulnerability of the individual to the whim of the state in outbreak response and containment. In this paper we examine why these changes to the IHR occurred and explore the consequence of expanding the sovereignty-as-responsibility concept to disease outbreak response. To this end our paper considers both the strengths and weaknesses of incorporating reports from non-official sources and including human rights principles in the IHR framework.

What contribution can International Relations make to the evolving global health agenda?

This article presents two approaches that have dominated International Relations in their approach to the international politics of health. The statist approach, which is primarily security-focused, seeks to link health initiatives to a foreign or defence policy remit. The globalist approach, in contrast, seeks to advance health not because of its intrinsic security value but because it advances the well-being and rights of individuals. This article charts the evolution of these approaches and demonstrates why both have the potential to shape our understanding of the evolving global health agenda. It examines how the statist and globalist perspectives have helped shape contemporary initiatives in global health governance and suggests that there is evidence of an emerging convergence between the two perspectives. This convergence is particularly clear in the articulation of a number of UN initiatives in this area—especially the One World, One Health Strategic Framework and the Oslo Ministerial Declaration (2007) which inspired the first UN General Assembly resolution on global health and foreign policy in 2009 and the UN Secretary-General's note ‘Global health and foreign policy: strategic opportunities and challenges'. What remains to be seen is whether this convergence will deliver on securing states’ interest long enough to promote the interests of the individuals who require global efforts to deliver local health improvements.

Book reviews : "Biosecurity interventions: global health and security in question"

International Relations’ engagement with global health governance has proliferated in the last decade. There are a number of excellent works that seek to understand how the relationship between politics and health shapes and informs people’s lives and governments’ policies. However, the overt securitization of health by the IR field has, Biosecurity interventions argues, remained relatively unproblematized...

Global Politics of Health

International responses to the outbreak of SARS, the spread of HIV/AIDS, and the promotion of health as a human right all demonstrate how global politics have a profound effect on the way we think about and respond to major health challenges. Despite a growing interest in the relationship between health and international relations there has yet to be a systematic study of the links between them. Global Health Issues aims to fill this gap – ultimately showing how world politics can be good, or bad, for your health. This book calls for a more nuanced understanding of the nature of the current global health crisis and the political dilemmas faced by those responsible for the development and implementation of responses to it. By charting these debates and showing how they shape the way actors think about key issues relating to health, such as people movement; infectious disease; the business of health; and the consequences of war; this volume provides an innovative and comprehensive introduction to health and international relations for students of global politics, health studies and related disciplines.

Feminism and Global Justice

This book attempts to persuade a new generation of scholars, criminologists, activists, and policy makers sympathetic to the quest for global justice to open the envelope, to step out of their comfort zones and typical frames of analysis to gaze at a world full of injustice against the female sex, much of it systemic, linked to culture, custom and religion. In some instances the sources of these injustices intersect with those that produce global inequality, imperialism and racism. This book also investigates circumstances where the globalising forces cultivate male on male violence in the anomic spaces of supercapitalism – the border zones of Mexico and the United States, and the frontier mining communities in the Australian desert. However systemic gendered injustices, such as forced marriage of child female brides, sati the cremation of widows, genital cutting, honour crimes, rape and domestic violence against women, are forms of violence only experienced by the female sex. The book does not shirk away from female violence either. Carrington argues that if feminism wants to have a voice in the public, cultural, political and criminological debates about heightened, albeit often exaggerated, social concerns about growing female violence and engagement in terrorism, then new directions in theorising female violence are required. Feminist silences about the violent crimes, atrocities and acts of terrorism committed by the female sex leave anti-feminist explanations uncontested. This allows a discursive space for feminist backlash ideologues to flourish. This book contests those ideologies to offer counter explanations for the rise in female violence and female terrorism, in a global context where systemic gendered violence against women is alarming and entrenched. The world needs feminism to take hold across the globe, now more than ever.

Vulnerability : an issue for law and policy in pandemic planning?

The 2009 H!Nl 'swine flu' pandemic was the first influenza pandemic of the twenty-first centmy. Unlike the first influenza pandemic of the twentieth century, the so-called 'Spanish flu' which killed millions of people worldwide, the 2009 pandemic was relatively mild. While the mildness of the 2009 pandemic meant that the 'Yorld was spared from the impact of a high-mortality event that would cause widespread social and economic disruption, the 2009 pandemic did provide an opportunity to road-test pandemic readiness. In other work we have assessed Australia's pandemic plans and emergency management legislation, finding that both provide flexible and adaptive forms of regulation that are capable of adapting to the scale and severity of a pandemic or other public health emergency. 1 In this chapter we consider whether pandemic planning adequately addresses the needs of vulnerable individuals and groups, both within countries and between them. Central to this is the question of whether vulnerability is itself a useful concept for both law and policy, and if so, the implications of expressly incorporating the concept of vulnerability into pandemic planning.

The rise and fall of the international law of maritime terrorism : the ghost of piracy is still hunting!

Maritime terrorism is a serious threat to global security. A major debate in this regard is the treating of acts of maritime terrorism as piracy by some scholars and a rejection of this view by others. Moreover, the international law of maritime terrorism suffers from fundamental definitional issues, much like the international law of terrorism. This article examines the current international law of maritime terrorism with a particular emphasis on the debate regarding the applicability of the international law of piracy in the case of maritime terrorism. It argues that the international law of piracy is not applicable in the enforcement and prosecution of maritime terrorists on the high seas. International treaties on terrorism and the post-September 11 developments relating to international laws on terrorism have created a workable international legal framework for combating maritime terrorism, despite some bottlenecks.

Global Human Trafficking : Critical Issues and Contexts

Human trafficking has moved from relative obscurity to a major area of research, policy and teaching over the past ten years. Research has sprung from criminology, public policy, women’s and gender studies, sociology, anthropology, and law, but has been somewhat hindered by the failure of scholars to engage beyond their own disciplines and favoured methodologies. Recent research has begun to improve efforts to understand the causes of the problem, the experiences of victims, policy efforts, and their consequences in specific cultural and historical contexts. Global Human Trafficking: Critical issues and contexts foregrounds recent empirical work on human trafficking from an interdisciplinary, critical perspective. The collection includes classroom-friendly features, such as introductory chapters that provide essential background for understanding the trafficking literature, textboxes explaining key concepts, discussion questions for each chapter, and lists of additional resources, including films, websites, and additional readings for each chapter. The authors include both eminent and emerging scholars from around the world, drawn from law, anthropology, criminology, sociology, cultural studies, and political science and the book will be useful for undergraduate and graduate courses in these areas, as well as for scholars interested in trafficking.

Paradigm shifts : global copyright politics and disability rights

Governments around the world need to take immediate coordinated action to reverse the 'book famine.' Disability rights don't conflict with 'normal exploitation' but copyright owners have been wary about all of the possible solutions to providing greater access. The Marrakesh Treaty promises to level out some of the disparity of access between people in developed and developing nations and remove the need for each jurisdiction to digitise a separate copy of each book. It is one of the only international agreements to mandate positive exceptions and may be the start of a pardigm shift in global copyright politics, made all the more remarkable in the face of heated opposition by global copyright industry representatives. It's not a legal problem, but one of political will. Resistance comes from a conflict with ideology: exceptions should be limited and international law should set only minimum standards.

Levels and trends of PBDEs and HBCDs in the global environment : status at the end of 2012

In this paper, we have compiled and reviewed the most recent literature, published from January2010 to December 2012, relating to the human exposure, environmental distribution, behaviour, fate and concentration time trends of polybrominated diphenyl ether (PBDE) and hexabromocyclododecane (HBCD) flame retardants, in order to establish their current trends and priorities for future study. Due to the large volume of literature included, we have provided full detail of the reviewed studies as Electronic Supplementary Information and here summarise the most relevant findings. Decreasing time trends for penta-mix PBDE congeners were seen for soils in northern Europe, sewage sludge in Sweden and the USA, carp from a US river, trout from three of the Great Lakes and in Arctic and UK marine mammals and many birds, but increasing time trends continue in Arctic polar bears and some birds at high trophic levels in northern Europe. This is a result of the time delay inherent in long-range atmospheric transport processes. In general, concentrations of BDE209 (the major component of the deca-mix PBDE product) are continuing to increase. Of major concern is the possible/likely debromination of the large reservoir of BDE209 in soils and sediments worldwide, to yield lower brominated congeners which are both more mobile and more toxic, and we have compiled the most recent evidence for the occurrence of this degradation process. Numerous studies reported here reinforce the importance o f this future concern. Time trends for HBCDs are mixed, with both increases and decreases evident in different matrices and locations and, notably, with increasing occurrence in birds of prey.

An Australian perspective on the ALI-III global principles for cooperation in International insolvency cases

In 2012, Professor Ian Fletcher (United Kingdom) and Professor Bob Wessels (The Netherlands) presented a Report to the American Law Institute and the International Insolvency Institute entitled Transnational Insolvency: Global Principles for Cooperation in International Insolvency Cases (“Global Principles”). This followed their appointment as Joint Reporters to investigate whether the essential provisions of the American Law Institute Principles of Cooperation among the North American Free Trade Agreement Countries with their annexed Guidelines Applicable to Court-to-Court Communication in Cross-border Cases may, with certain necessary modifications, be acceptable for use by jurisdictions across the world. This article comments on the Global Principles from the perspective of a jurisdiction which has adopted the UNCITRAL Model Law on Cross-border Insolvency (“Model Law”). In 2008, Australia enacted a standalone statute, the Cross-border Insolvency Act 2008 (Cth) to which is annexed the Model Law. In that process, it made minimal changes to the Model Law text. Against the background of the 2008 Act, related procedural laws as well as Australia’s general insolvency statutes and recent cross-border insolvency jurisprudence, this article comments on the potential relevance of the Transnational Insolvency Report as a point of reference for Australian courts and insolvency administrators when addressing international insolvency cases. By comparing the Global Principles with the Model Law as closely adopted in Australia, this analysis is a resource for other Model Law jurisdictions when considering the potential relevance of the Global Principles for their own international insolvency practice.

Meta-regulation approach to raise social accountability In global supply firms

This Article proposes a meta-regulation approach to address the gap between the objectives, commitment, practice and outcome in the accountability practice of the global supply chain in the developing countries. The literatures on the accountability practice in the global supply chains typically focuses on the strategies for raising corporate social accountability standards in multinational buying firms and seldom focuses on this strategies in the outsourced firms in the developing countries. This article tries to fill this void by examining the situation in Bangladesh, the third largest RMG supply country in the world. It conceptualizes a meta-regulation approach with the aim of raising social accountability practice in this industry. It shows that this regulation approach is suitable to effectively raise this practice standard in a perspective where the non-legal drivers are meagrely low, global buying firms are highly profit driven and the governmental agencies are either inadequate or highly corrupt.