Patents, Ethics and Stem Cell Research : The Case of hESC Innovation in Australia, Europe and the United States

Embryonic stem cells offer potentially a ground-breaking insight into health and diseases and are said to offer hope in discovering cures for many ailments unimaginable few years ago. Human embryonic stem cells are undifferentiated, immature cells that possess an amazing ability to develop into almost any body cell such as heart muscle, bone, nerve and blood cells and possibly even organs in due course. This remarkable feature, enabling embryonic stem cells to proliferate indefinitely in vitro (in a test tube), has branded them as a so-called miracle cure . Their potential use in clinical applications provides hope to many sufferers of debilitating and fatal medical conditions. However, the emergence of stem cell research has resulted in intense debates about its promises and dangers. On the one hand, advocates hail its potential, ranging from alleviating and even curing fatal and debilitating diseases such as Parkinson s, diabetes, heart ailments and so forth. On the other hand, opponents decry its dangers, drawing attention to the inherent risks of human embryo destruction, cloning for research purposes and reproductive cloning eventually. Lately, however, the policy battles surrounding human embryonic stem cell innovation have shifted from being a controversial research to scuffles within intellectual property rights. In fact, the ability to obtain patents represents a pivotal factor in the economic success or failure of this new biotechnology. Although, stem cell patents tend to more or less satisfy the standard patentability requirements, they also raise serious ethical and moral questions about the meaning of the exclusions on ethical or moral grounds as found in European and to an extent American and Australian patent laws. At present there is a sort of a calamity over human embryonic stem cell patents in Europe and to an extent in Australia and the United States. This in turn has created a sense of urgency to engage all relevant parties in the discourse on how best to approach patenting of this new form of scientific innovation. In essence, this should become a highly favoured patenting priority. To the contrary, stem cell innovation and its reliance on patent protection risk turmoil, uncertainty, confusion and even a halt on not only stem cell research but also further emerging biotechnology research and development. The patent system is premised upon the fundamental principle of balance which ought to ensure that the temporary monopoly awarded to the inventor equals that of the social benefit provided by the disclosure of the invention. Ensuring and maintaining this balance within the patent system when patenting human embryonic stem cells is of crucial contemporary relevance. Yet, the patenting of human embryonic stem cells raises some fundamental moral, social and legal questions. Overall, the present approach of patenting human embryonic stem cell related inventions is unsatisfactory and ineffective. This draws attention to a specific question which provides for a conceptual framework for this work. That question is the following: how can the investigated patent offices successfully deal with patentability of human embryonic stem cells? This in turn points at the thorny issue of application of the morality clause in this field. In particular, the interpretation of the exclusions on ethical or moral grounds as found in Australian, American and European legislative and judicial precedents. The Thesis seeks to compare laws and legal practices surrounding patentability of human embryonic stem cells in Australia and the United States with that of Europe. By using Europe as the primary case study for lessons and guidance, the central goal of the Thesis then becomes the determination of the type of solutions available to Europe with prospects to apply such to Australia and the United States. The Dissertation purports to define the ethical implications that arise with patenting human embryonic stem cells and intends to offer resolutions to the key ethical dilemmas surrounding patentability of human embryonic stem cells and other morally controversial biotechnology inventions. In particular, the Thesis goal is to propose a functional framework that may be used as a benchmark for an informed discussion on the solution to resolving ethical and legal tensions that come with patentability of human embryonic stem cells in Australian, American and European patent worlds. Key research questions that arise from these objectives and which continuously thread throughout the monograph are: 1. How do common law countries such as Australia and the United States approach and deal with patentability of human embryonic stem cells in their jurisdictions? These practices are then compared to the situation in Europe as represented by the United Kingdom (first two chapters), the Court of Justice of the European Union and the European Patent Office decisions (Chapter 3 onwards) in order to obtain a full picture of the present patenting procedures on the European soil. 2. How are ethical and moral considerations taken into account at patent offices investigated when assessing patentability of human embryonic stem cell related inventions? In order to assess this part, the Thesis evaluates how ethical issues that arise with patent applications are dealt with by: a) Legislative history of the modern patent system from its inception in 15th Century England to present day patent laws. b) Australian, American and European patent offices presently and in the past, including other relevant legal precedents on the subject matter. c) Normative ethical theories. d) The notion of human dignity used as the lowest common denominator for the interpretation of the European morality clause. 3. Given the existence of the morality clause in form of Article 6(1) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions which corresponds to Article 53(a) European Patent Convention, a special emphasis is put on Europe as a guiding principle for Australia and the United States. Any room for improvement of the European morality clause and Europe s current manner of evaluating ethical tensions surrounding human embryonic stem cell inventions is examined. 4. A summary of options (as represented by Australia, the United States and Europe) available as a basis for the optimal examination procedure of human embryonic stem cell inventions is depicted, whereas the best of such alternatives is deduced in order to create a benchmark framework. This framework is then utilised on and promoted as a tool to assist Europe (as represented by the European Patent Office) in examining human embryonic stem cell patent applications. This method suggests a possibility of implementing an institution solution. 5. Ultimately, a question of whether such reformed European patent system can be used as a founding stone for a potential patent reform in Australia and the United States when examining human embryonic stem cells or other morally controversial inventions is surveyed. The author wishes to emphasise that the guiding thought while carrying out this work is to convey the significance of identifying, analysing and clarifying the ethical tensions surrounding patenting human embryonic stem cells and ultimately present a solution that adequately assesses patentability of human embryonic stem cell inventions and related biotechnologies. In answering the key questions above, the Thesis strives to contribute to the broader stem cell debate about how and to which extent ethical and social positions should be integrated into the patenting procedure in pluralistic and morally divided democracies of Europe and subsequently Australia and the United States.

Electronic workplace surveillance and employee privacy : a comparative analysis of privacy protection in Australia and the United States

More than a century ago in their definitive work “The Right to Privacy” Samuel D. Warren and Louis D. Brandeis highlighted the challenges posed to individual privacy by advancing technology. Today’s workplace is characterised by its reliance on computer technology, particularly the use of email and the Internet to perform critical business functions. Increasingly these and other workplace activities are the focus of monitoring by employers. There is little formal regulation of electronic monitoring in Australian or United States workplaces. Without reasonable limits or controls, this has the potential to adversely affect employees’ privacy rights. Australia has a history of legislating to protect privacy rights, whereas the United States has relied on a combination of constitutional guarantees, federal and state statutes, and the common law. This thesis examines a number of existing and proposed statutory and other workplace privacy laws in Australia and the United States. The analysis demonstrates that existing measures fail to adequately regulate monitoring or provide employees with suitable remedies where unjustifiable intrusions occur. The thesis ultimately supports the view that enacting uniform legislation at the national level provides a more effective and comprehensive solution for both employers and employees. Chapter One provides a general introduction and briefly discusses issues relevant to electronic monitoring in the workplace. Chapter Two contains an overview of privacy law as it relates to electronic monitoring in Australian and United States workplaces. In Chapter Three there is an examination of the complaint process and remedies available to a hypothetical employee (Mary) who is concerned about protecting her privacy rights at work. Chapter Four provides an analysis of the major themes emerging from the research, and also discusses the draft national uniform legislation. Chapter Five details the proposed legislation in the form of the Workplace Surveillance and Monitoring Act, and Chapter Six contains the conclusion.

Questions of English : ethics, aesthetics, rhetoric, and the formation of the subject in England, Australia and the United States

The impact and content of English as a subject on the curriculum is once more the subject of lively debate. Questions of English sets out to map the development of English as a subject and how it has come to encompass the diversity of ideas that currently characterise it. Drawing on a combination of historical analysis and recent research findings Robin Peel, Annette Patterson and Jeanne Gerlach bring together and compare important new insights on curriculum development and teaching practice from England, Australia and the United States. They also discuss the development of teacher training, highlighting the variety of ways in which teachers build their own beliefs and knowledge about English.

Research training and national innovation systems in Australia, Finland and the United States : a policy and systems study supported by 30 case studies of research students in the fields of geospatial science, wireless communication, biosciences, and materials science and engineering

Reforms to the national research and research training system by the Commonwealth Government of Australia sought to effectively connect research conducted in universities to Australia's national innovation system. Research training has a key role in ensuring an adequate supply of highly skilled people for the national innovation system. During their studies, research students produce and disseminate a massive amount of new knowledge. Prior to this study, there was no research that examined the contribution of research training to Australia's national innovation system despite the existence of policy initiatives aiming to enhance this contribution. Given Australia's below average (but improving) innovation performance compared to other OECD countries, the inclusion of Finland and the United States provided further insights into the key research question. This study examined three obvious ways that research training contributes to the national innovation systems in the three countries: the international mobility and migration of research students and graduates, knowledge production and distribution by research students, and the impact of research training as advanced human capital formation on economic growth. Findings have informed the concept of a research training culture of innovation that aims to enhance the contribution of research training to Australia's national innovation system. Key features include internationally competitive research and research training environments; research training programs that equip students with economically-relevant knowledge and the capabilities required by employers operating in knowledge-based economies; attractive research careers in different sectors; a national commitment to R&D as indicated by high levels of gross and business R&D expenditure; high private and social rates of return from research training; and the horizontal coordination of key organisations that create policy for, and/or invest in research training.

Air navigation services in Australia and the United States : a comparative case study

The central document governing the global organization of Air Navigation Services (ANS) is the Convention on International Civil Aviation, commonly referred to as the “Chicago Convention,” whose original version was signed in that city in 1944. In the Convention, Contracting States agreed to ensure the minimum standards of ANS established by ICAO, a specialized United Nations agency created by the Convention. Emanating from obligations under the Chicago Convention, ANS has traditionally provided by departments of national governments. However, there is a widespread trend toward transferring delivery of ANS services outside of line departments of national governments to independent agencies or corporations. The Civil Air Navigation Services Organisation (CANSO), which is the trade association for independent ANS providers, currently counts approximately 60 members, and is steadily growing. However, whatever delivery mechanisms are chosen, national governments remain ultimately responsible for ensuring that adequate ANS services are available. The provision by governments of ANS reflects the responsibility of the state for safety, international relations, and indirectly, the macroeconomic benefits of ensuring a sound infrastructure for aviation. ANS is a “public good” and an “essential good” provided to all aircraft using a country’s airfields and airspace. However, ANS also represents a service that directly benefits only a limited number of users, notably aircraft owners and operators. The idea that the users of the system, rather than the taxpaying public, should incur the costs associated with ANS provision is inherent in the commercialization process. However, ICAO sets out broad principles for the establishment of user charges, which member states are expected to comply with. ICAO states that only distance flown and aircraft weights are acceptable parameters for use in a charging system. These two factors are considered to be easy to measure, bear a reasonable relationship to the value of service received, and do not discriminate due to factors such as where the flight originated or the nation of aircraft registration.

Creating meaning: the cancer survivorship experiences of young adults in Australia, England and the United States

This cross-cultural research examined the phenomenon of cancer survivorship through an analysis of the experiences of adolescents and young adults diagnosed with cancer in Australia, England and the United States of America. The research enhances understanding of how meaning and identity develop in relation to cancer interpretively and socioculturally, and the implications for quality of life in adulthood. In so doing, the study explored the existential challenges young people confront when negotiating illness, identity formation and meaning-making, amid the complex matrix of youth and life stage transitions, cultural norms and practices, and varied healthcare environments.

Prostitution Ideology and Trafficking Policy: The Impact of Political Approaches to Domestic Sex Work on Human Trafficking Policy in Australia and the United States

Debates over the legitimacy and legality of prostitution have characterised human trafficking discourse for the last two decades. This article identifies the extent to which competing perspectives concerning the legitimacy of prostitution have influenced anti-trafficking policy in Australia and the United States, and argues that each nation-state’s approach to domestic sex work has influenced trafficking legislation. The legal status of prostitution in each country, and feminist influences on prostitution law reform, have had a significant impact on the nature of the legislation adopted.

A mercurial treaty: The Trans-Pacific Partnership (# TPP) and the United States

According to the United States Trade Representative (USTR), Ron Kirk, the Trans-Pacific Partnership is “an ambitious, next-generation, Asia-Pacific trade agreement that reflects U.S. priorities and values”.

Polyphasic characterization of four new plant pathogenic Phyllosticta species from China, Japan, and the United States

The black rot disease of Vitis species and other host genera of Vitacease is caused by Phyllosticta ampelicida and allied taxa which is considered to be a species complex. In this paper, we introduce four new species of Phyllosticta, including two from the P. ampelicida complex, based on a polyphasic characterization including disease symptoms and host association, morphology, and molecular phylogeny. The phylogenetic analysis was conducted based on the ribosomal internal transcribed spacer (ITS) region and a combined multi-locus alignment of the ITS, actin (ACT), partial translation elongation factor 1-alpha (TEF-1), and glyceraldehydes 3-phosphate dehydrogenase (GPDH) gene regions. Our study confirms the phylogenetic distinctions of the four new species, as well as their phenotypic differences with known species in the genus.

A manual of previously recorded non-indigenous invasive and native transplanted animal species of the Laurentian Great Lakes and coastal United States

This manual presents geographic information by state of occurrence, and descriptions of the socio-economic impact created by the invasion of non-indigenous and native transplanted animal species in the Laurentian Great Lakes and the coastal waters of the United States. It is not a comprehensive literature review, but rather is intended as a primer for those unfamiliar with the socio-economic impacts of invasive aquatic and marine animals. Readers should also note that the information contained in this manual is current as of its publication date. New information and new species are routinely being added to the wider literature base. Most of the information was gathered from a number of web sites maintained by government agencies, commissions, academic institutions and museums. Additional information was taken from the primary and secondary literature. This manual focuses on socio-economic consequences of invasive species. Thus, ecological impacts, when noted in the literature, are not discussed unless a connection to socio-economic factors can be made. For a majority of the species listed, either the impact of their invasion is not understood, or it is not published in sources surveyed. In the species summaries, sources of information are cited except for information from the U.S. Geological Survey’s (USGS) Nonindigenous Aquatic Species Database http://nas.er.usgs.gov. This website formed the base information used in creating tables on geographic distribution, and in many of the species summaries provided. Thus, whenever information is given without specific author/source and date citation, it has come from this comprehensive source. (PDF contains 90 pages)

Analysis of the differences between the rates of inflation associated with two aggregate price level: The case of the euro area and the United States

Idioma: Inglés Abstract: This project focuses on two indicators of prices, the GDP deflator and the consumer price index (CPI), and analyzes the differences and similarities they present. These price indexes have been chosen taking into account its great representativeness and importance to economic and social level, and its direct relationship to the overall functioning of the economy and, in particular, inflation. It should be also mentioned that this study was conducted for cases of the euro area and the United States, as the impact of these economies in the economic and social situation at international level is very significant.

Collaborative Pacific Halibut, Hippoglossus stenolepis, Bycatch Control by Canada and the United States

ABSTRACT—Bycatch mortality of Pacific halibut, Hippoglossus stenolepis, in nontarget fisheries is composed primarily of immature fish, and substantial reductions in yield to directed halibut fisheries result from this bycatch. Distant-water bottomtrawl fleets operating off the North American coast, beginning in the mid 1960’s, experienced bycatch mortality of over 12,000 t annually. Substantial progress on reducing this bycatch was not achieved until the of extension fisheries jurisdictions by the United States and Canada in 1977. Bycatch began to increase again during the expansion of domestic catching capacity for groundfish, and by the early 1990’s it had returned to levels seen during the period of foreign fishing. Collaborative action by Canada and the United States through the International Pacific Halibut Commission has resulted in substantial reductions in bycatch mortality in some areas. Methods of control have operated at global, fleet, and individual vessel levels. We evaluate the hierarchy of effectiveness for these control measures and identify regulatory needs for optimum effects. New monitoring technologies offer the promise of more cost-effective approaches to bycatch reduction.