Access to essential medicines: Public health and international law

Historically, there have been intense conflicts over the ownership and exploitation of pharmaceutical drugs and diagnostic tests dealing with infectious diseases. Throughout the 1980’s, there was much scientific, legal, and ethical debate about which scientific group should be credited with the discovery of the human immunodeficiency virus, and the invention of the blood test devised to detect antibodies to the virus. In May 1983, Luc Montagnier, Françoise Barré-Sinoussi, and other French scientists from the Pasteur Institute in Paris, published a paper in Science, detailing the discovery of a virus called lymphadenopathy (LAV). A scientific rival, Robert Gallo of the National Cancer Institute, identified the AIDS virus and published his findings in the May 1984 issue of Science. In May 1985, the United States Patent and Trademark Office awarded the American patent for the AIDS blood test to Gallo and the Department of Health and Human Services. In December 1985, the Institut Pasteur sued the Department of Health and Human Services, contending that the French were the first to identify the AIDS virus and to invent the antibody test, and that the American test was dependent upon the French research. In March 1987, an agreement was brokered by President Ronald Reagan and French Prime Minister Jacques Chirac, which resulted in the Department of Health and Human Services and the Institut Pasteur sharing the patent rights to the blood test for AIDS. In 1992, the Federal Office of Research Integrity found that Gallo had committed scientific misconduct, by falsely reporting facts in his 1984 scientific paper. A subsequent investigation by the National Institutes of Health, the United States Congress, and the US attorney-general cleared Gallo of any wrongdoing. In 1994, the United States government and French government renegotiated their agreement regarding the AIDS blood test patent, in order to make the distribution of royalties more equitable... The dispute between Luc Montagnier and Robert Gallo was not an isolated case of scientific rivalry and patent races. It foreshadowed further patent conflicts over research in respect of HIV/AIDS. Michael Kirby, former Justice of the High Court of Australia diagnosed a clash between two distinct schools of philosophy - ‘scientists of the old school... working by serendipity with free sharing of knowledge and research’, and ‘those of the new school who saw the hope of progress as lying in huge investments in scientific experimentation.’ Indeed, the patent race between Robert Gallo and Luc Montagnier has been a precursor to broader trade disputes over access to essential medicines in the 1990s and 2000s. The dispute between Robert Gallo and Luc Montagnier captures in microcosm a number of themes of this book: the fierce competition for intellectual property rights; the clash between sovereign states over access to medicines; the pressing need to defend human rights, particularly the right to health; and the need for new incentives for research and development to combat infectious diseases as both an international and domestic issue.

Trick or treaty?: The Australian debate over the Anti-Counterfeiting Trade Agreement

The secretive 2011 Anti-Counterfeiting Trade Agreement – known in short by the catchy acronym ACTA – is a controversial trade pact designed to provide for stronger enforcement of intellectual property rights. The preamble to the treaty reads like pulp fiction – it raises moral panics about piracy, counterfeiting, organised crime, and border security. The agreement contains provisions on civil remedies and criminal offences; copyright law and trademark law; the regulation of the digital environment; and border measures. Memorably, Susan Sell called the international treaty a TRIPS Double-Plus Agreement, because its obligations far exceed those of the World Trade Organization's TRIPS Agreement 1994, and TRIPS-Plus Agreements, such as the Australia-United States Free Trade Agreement 2004. ACTA lacks the language of other international intellectual property agreements, which emphasise the need to balance the protection of intellectual property owners with the wider public interest in access to medicines, human development, and transfer of knowledge and technology. In Australia, there was much controversy both about the form and the substance of ACTA. While the Department of Foreign Affairs and Trade was a partisan supporter of the agreement, a wide range of stakeholders were openly critical. After holding hearings and taking note of the position of the European Parliament and the controversy in the United States, the Joint Standing Committee on Treaties in the Australian Parliament recommended the deferral of ratification of ACTA. This was striking as representatives of all the main parties agreed on the recommendation. The committee was concerned about the lack of transparency, due process, public participation, and substantive analysis of the treaty. There were also reservations about the ambiguity of the treaty text, and its potential implications for the digital economy, innovation and competition, plain packaging of tobacco products, and access to essential medicines. The treaty has provoked much soul-searching as to whether the Trick or Treaty reforms on the international treaty-making process in Australia have been compromised or undermined. Although ACTA stalled in the Australian Parliament, the debate over it is yet to conclude. There have been concerns in Australia and elsewhere that ACTA will be revived as a ‘zombie agreement’. Indeed, in March 2013, the Canadian government introduced a bill to ensure compliance with ACTA. Will it be also resurrected in Australia? Has it already been revived? There are three possibilities. First, the Australian government passed enhanced remedies with respect to piracy, counterfeiting and border measures in a separate piece of legislation – the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Second, the Department of Foreign Affairs and Trade remains supportive of ACTA. It is possible, after further analysis, that the next Australian Parliament – to be elected in September 2013 – will ratify the treaty. Third, Australia is involved in the Trans-Pacific Partnership negotiations. The government has argued that ACTA should be a template for the Intellectual Property Chapter in the Trans-Pacific Partnership. The United States Trade Representative would prefer a regime even stronger than ACTA. This chapter provides a portrait of the Australian debate over ACTA. It is the account of an interested participant in the policy proceedings. This chapter will first consider the deliberations and recommendations of the Joint Standing Committee on Treaties on ACTA. Second, there was a concern that ACTA had failed to provide appropriate safeguards with respect to civil liberties, human rights, consumer protection and privacy laws. Third, there was a concern about the lack of balance in the treaty’s copyright measures; the definition of piracy is overbroad; the suite of civil remedies, criminal offences and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations and remedies. Fourth, there was a worry that the provisions on trademark law, intermediary liability and counterfeiting could have an adverse impact upon consumer interests, competition policy and innovation in the digital economy. Fifth, there was significant debate about the impact of ACTA on pharmaceutical drugs, access to essential medicines and health-care. Sixth, there was concern over the lobbying by tobacco industries for ACTA – particularly given Australia’s leadership on tobacco control and the plain packaging of tobacco products. Seventh, there were concerns about the operation of border measures in ACTA. Eighth, the Joint Standing Committee on Treaties was concerned about the jurisdiction of the ACTA Committee, and the treaty’s protean nature. Finally, the chapter raises fundamental issues about the relationship between the executive and the Australian Parliament with respect to treaty-making. There is a need to reconsider the efficacy of the Trick or Treaty reforms passed by the Australian Parliament in the 1990s.

The path towards greening the Malaysian construction industry

Construction industry contributes significantly to environmental degradation, and governments in many countries which are endeavouring to address the situation. Malaysia is no exception. This paper examines the path towards green construction project delivery in Malaysia, focusing on current green policies and initiatives by governments. The historical waves in Malaysian approaches to tackling environmental issues are described, starting from the early 20th century, through the 1990s to the present, and the influence of these approaches on construction practices is analysed. Based on the findings of policy review, essential green construction practices aimed at mitigating the adverse effects of construction activities on the environment in Malaysia were identified. This paper paves the way for future studies in construction and sustainability in Malaysia, especially for the Southeast Asian region where sustainability practices are urgently needed.

Who Rules Japan? Popular Participation in the Japanese Legal Process

"The dramatic growth of the Japanese economy in the postwar period, and its meltdown in the 1990s, has attracted sustained interest in the power dynamics underlying the management of Japan’s administrative state. Scholars and commentators have long debated over who wields power in Japan, asking the fundamental question: who really governs Japan? This important volume revisits this question by turning its attention to the regulation and design of the Japanese legal system. With essays covering the new lay-judge system in Japanese criminal trials, labour dispute resolution panels, prison policy, gendered justice, government lawyers, welfare administration and administrative transparency, this comprehensive book explores the players and processes in Japan’s administration of justice."--publisher website

Corporate Governance in the 21st Century: Japan's Gradual Transformation

The 'lost' decade of economic stagnation in Japan during the 1990s has become a 'found decade' for regulatory and institutional reform. With nearly all areas of the 'law in the books' reviewed, revised and rewritten, the Japanese legal system is no longer the system that foreign commentators felt they were finally starting to understand by the 1980s. Nowhere is this more evident than in corporate governance. Corporate and securities legislation has been comprehensively revamped over 1993-2007, creating a more flexible and transparent regime for shareholders and managers. Financial markets law and regulatory institutions have changed, too, creating a new context for Japan's 'main banks' as alternative or additional outside monitors of managerial performance in borrowing firms. Even the legislation surrounding labour regulations has been amended, reinforcing the lifelong security privileges for elite employee-stakeholders, yet also hastening the growth of other atypical employment relationships. But how do such legislative reforms affecting key players in Japanese firms, covering areas central to the design of Japanese capitlaism, play out in the 'law in action'? Overall, this book argues that a significant gradual transformation has occurred. Although this is evident also in other advanced industrialised democracies, such as Germany, Japan reveals especially complex interactions in the various fields that sometimes emphasise different ways of achieving such transformation.

Litigiousness in Japan: Land of the rising law suit?

For over two decades, Japanese politicians and bureaucrats have struggled to resurrect a lifeless economy. With the 1990s marred by crippling financial crisis, a spate of corporate insolvencies, ongoing scandals in Japan’s premier economic ministries, rising unemployment and low to negative growth, policy-makers responded with successive legislative reforms aimed at restructuring public administration and private governance of the economy. The Big Bang financial reforms, large-scale reform of Japanese corporate law, and a restructured bureaucracy are representative examples of this reform effort.

Mapping genes for osteoporosis-Old dogs and new tricks

In stark contrast to its horticultural origins, modern genetics is an extremely technology-driven field. Almost all the major advances in the field over the past 20 years have followed technological developments that have permitted change in study designs. The development of PCR in the 1980s led to RFLP mapping of monogenic diseases. The development of fluorescent-tagged genotyping methods led to linkage mapping approaches for common diseases that dominated the 1990s. The development of microarray SNP genotyping has led to the genome-wide association study era of the new millennium. And now the development of next-generation sequencing technologies is about to open up a new era of gene-mapping, enabling many potential new study designs. This review aims to present the strengths and weaknesses of the current approaches, and present some new ideas about gene-mapping approaches that are likely to advance our knowledge of the genes involved in heritable bone traits such as bone mineral density (BMD) and fracture.

A new protest movement: Flexn your message through dance

Flexing, or Flex, is a street dance style that originated in Jamaica in the 1990s and grew up on the streets of Brooklyn, East New York. Performed to dancehall and reggae music, it has since evolved into a protest movement - an avenue for “flexors” to rally against social injustice, police brutality and racism.

Introduction: Epitope mimicry as a component cause of autoimmune disease

The causes of autoimmune diseases have yet to be fully elucidated. Autoantibodies, autoreactive T cell responses, the presence of a predisposing major histocompatibility complex (MHC) haplotype and responsiveness to corticosteroids are features, and some are possibly contributory causes of autoimmune disease. The most challenging question is how autoimmune diseases are triggered. Molecular mimicry of host cell determinants by epitopes of infectious agents with ensuing cross-reactivity is one of the most popular yet still controversial theories for the initiation of autoimmune diseases [1]. Throughout the 1990s, hundreds of research articles focusing to various extents on epitope mimicry, as it is more accurately described in an immunological context, were published annually. Many of these articles presented data that were consistent with the hypothesis of mimicry but that did not actually prove the theory. Other equally convincing reports indicated that epitope mimicry was not the cause of the autoimmune disease despite sequence similarity between molecules of infectious agents and the host. Some 20 years ago, Rothman [2] proposed a model for disease causation and I have used this as a framework to examine the role of epitope mimicry in the development of autoimmune disease. The thesis of Rothman’s model is that an effect, in this instance autoimmune disease, arises as a result of a cause. In most cases, multiple-component causes contribute synergistically to yield the effect, and each of these components alone is insufficient as a cause. Logically, some component causes, such as the presence of a particular autoimmune response, are also necessary causes.

Introduction to "Business innovation and disruption in the music industry"

Similar to most other creative industries, the evolution of the music industry is heavily shaped by media technologies. This was equally true in 1999, when the global recorded music industry had experienced two decades of continuous growth largely driven by the rapid transition from vinyl records to Compact Discs. The transition encouraged avid music listeners to purchase much of their music collections all over again in order to listen to their favourite music with ‘digital sound’. As a consequence of this successful product innovation, recorded music sales (unit measure) more than doubled between the early 1980s and the end of the 1990s. It was with this backdrop that the first peer-to-peer file sharing service was developed and released to the mainstream music market in 1999 by the college student Shawn Fanning. The service was named Napster and it marks the beginning of an era that is now a classic example of how an innovation is able to disrupt an entire industry and make large swathes of existing industry competences obsolete. File sharing services such as Napster, followed by a range of similar services in its path, reduced physical unit sales in the music industry to levels that had not been seen since the 1970s. The severe impact of the internet on physical sales shocked many music industry executives who spent much of the 2000s vigorously trying to reverse the decline and make the disruptive technologies go away. At the end, they learned that their efforts were to no avail and the impact on the music industry proved to be transformative, irreversible and, to many music industry professionals, also devastating. Thousands of people lost their livelihood, large and small music companies have folded or been forced into mergers or acquisitions. But as always during periods of disruption, the past 15 years have also been very innovative, spurring a plethora of new music business models. These new business models have mainly emerged outside the music industry and the innovators have been often been required to be both persuasive and persistent in order to get acceptance from the risk-averse and cash-poor music industry establishment. Apple was one such change agent that in 2003 was the first company to open up a functioning and legal market for online music. iTunes Music Store was the first online retail outlet that was able to offer the music catalogues from all the major music companies; it used an entirely novel pricing model, and it allowed consumers to de-bundle the music album and only buy the songs that they actually liked. Songs had previously been bundled by physical necessity as discs or cassettes, but with iTunes Music Store, the institutionalized album bundle slowly started to fall apart. The consequences had an immediate impact on music retailing and within just a few years, many brick and mortar record stores were forced out of business in markets across the world. The transformation also had disruptive consequences beyond music retailing and redefined music companies’ organizational structures, work processes and routines, as well as professional roles. iTunes Music Store in one sense was a disruptive innovation, but it was at the same time relatively incremental, since the major labels’ positions and power structures remained largely unscathed. The rights holders still controlled their intellectual properties and the structures that guided the royalties paid per song that was sold were predictable, transparent and in line with established music industry practices.

New Curriculum History

"Rereading the historical record indicates that it is no longer so easy to argue that history is simply prior to its forms. Since the mid-1990s a new wave of research has formed around wider debates in the humanities and social sciences, such as decentering the subject, new analytics of power, reconsideration of one-dimensional time and three-dimensional space, attention to beyond-archival sources, alterity, Otherness, the invisible, and more. In addition, broader and contradictory impulses around the question of the nation - transnational, post-national, proto-national, and neo-national movements – have unearthed a new series of problematics and focused scholarly attention on traveling discourses, national imaginaries, and less formal processes of socialization, bonding, and subjectification. New Curriculum History challenges prior occlusions in the field, building upon and departing from previous waves of scholarship, extending the focus beyond the insularity of public schooling, the traditional framework of the self-contained nation-state, and the psychology of the schooled individual. Drawing on global studies, historical sociology, postcolonial studies, critical race theory, visual culture theory, disability studies, psychoanalytics, Cambridge school structuralisms, poststructuralisms, and infra- and transnational approaches the volume holds together not despite but because of differences and incommensurabilities in rereading historical records. Audience: Scholars and students in curriculum studies, history, education, philosophy, and cultural studies will be interested in these chapters for their methodological range, their innovations and their deterritorializations."--publisher website

Introduction: Japan’s gradual transformation in corporate governance

Japan has recovered from a ‘lost decade’ of economic stagnation over the 1990s. Anyway, it has been a ‘found decade’ for civil and criminal justice law reform, especially in corporate and securities law. Yet, have liberalisation and globalisation in those fields led to major changes in the ‘law in action’? Does this represent ‘Americanisation’ of Japan’s corporate governance system, focusing on shareholders rather than other key stakeholders such as ‘main banks’, core employees, and partners within diffuse corporate groups (keiretsu)? This version of our introductory chapter explains how our forthcoming book argues for a more complex ‘gradual transformation’. Such shifts are also found in many other post-industrial economies, but Japan appears to give greater emphasis given to certain modes of achieving change. The book brings together contributions from academics and practitioners from Japan, Australia, New Zealand, Canada and the United States. An early chapter introduces methodology for effective cross-country comparisons and for evaluating the burgeoning but divergent literature on Japanese corporate governance. The concluding chapter compares continuities and changes in Japan’s largest companies now and two decades ago. Other chapters cover ‘lifelong employment’, main banks, the untold story of closely-held companies, the limited uptake of the Committee-based governance form, and the procedural, substantive and FDI policy dimensions of takeovers law and practice.

Corporate governance and law reform in Japan: From the lost decade to the end of history?

Japan is in the midst of massive law reform. Mired in ongoing recession since the early 1990s, Japan has been implementing a new regulatory blueprint to kickstart a sluggish economy through structural change. A key element to this reform process is a rethink of corporate governance and its stakeholder relations. With a patchwork of legislative initiatives in areas as diverse as corporate law, finance, labour relations, consumer protection, public administration and civil justice, this new model is beginning to take shape. But to what extent does this model represent a break from the past? Some commentators are breathlessly predicting the "Americanisation" of Japanese law. They see the triumph of Western-style capitalism - the "End of History", to borrow the words of Francis Fukuyama - with its emphasis on market-based, arms-length transactions. Others are more cautious, advancing the view that there new reforms are merely "creative twists" on what is a uniquely (although slowly evolving) strand of Japanese capitalism. This paper takes issue with both interpretations. It argues that the new reforms merely follow Japan's long tradition of 'adopting and adapting' foreign models to suit domestic purposes. They are neither the wholesale importation of "Anglo-Saxon" regulatory principles nor a thin veneer over a 'uniquely unique' form of Confucian cultural capitalism. Rather, they represent a specific and largely political solution (conservative reformism) to a current economic problem (recession). The larger themes of this paper are 'change' and 'continuity'. 'Change' suggests evolution to something identifiable; 'continuity' suggests adhering to an existing state of affairs. Although notionally opposites, 'change' and 'continuity' have something in common - they both suggest some form of predictability and coherence in regulatory reform. Our paper, by contrast, submits that Japanese corporate governance reform or, indeed, law reform more generally in Japan, is context-specific, multi-layered (with different dimensions not necessarily pulling all in the same direction for example, in relations with key outside suppliers), and therefore more random or 'chaotic'.

From council dog catcher to critical scholar

Carol and I just missed each other in the early 1990s: Carol left Manchester for Australia in 1990, while I an·iv·ed in Manchester from Australia in 1993. Sixteen years later and on the very opposite side of the world, we found ourselves sharing an adjacent room during the 2009 Agri-Food Research Network conference in Auckland. Carol was already an accomplished sociologist; I was a newbie PhD student, presenting on a thesis topic that was only just starting to take shape...

Private governance of public rights in Japan: Revisiting the Japanese governance debate

Dramatic growth in the Japanese economy in the postwar period – and its meltdown in the 1990s – has attracted sustained interest in the power dynamics underlying the management of Japan’s administrative state. For a long time, scholars and commentators have debated about who wields power in Japan. The question has been asked in different ways. In the 1970s and 1980s, the question was usually posed as: who orchestrated Japan’s economic miracle in the 1960s and 1970s? Today, the question is usually reframed to: who is accountable for the policy failures that plunged Japan into financial crisis and recession during the 1990s? Yet the core issue remains the same – who governs Japan? (Johnson 1995)...