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.

Is The Burden of Medical Education Affecting Ethics of Medical Treatment?

A substantial number of medical students in India have to bear an enormous financial burden for earning a bachelor's degree in medicine referred to as MBBS (bachelor of medicine and bachelor of surgery). This degree program lasts for four and one-half years followed by one year of internship. A postgraduate degree, such as MD, has to be pursued separately on completion of a MBBS. Every medical college in India is part of a hospital where the medical students get clinical exposure during the course of their study. All or at least a number of medical colleges in a given state are affiliated to a university that mainly plays a role of an overseeing authority. The medical colleges usually have no official interaction with other disciplines of education such as science and engineering, perhaps because of their independent location and absence of emphasis on medical research. However, many of the medical colleges are adept in imparting high-quality and sound training in medical practices including diagnostics and treatment. The medical colleges in India are generally of two types, i.e., government owned and private. Since only a limited number of seats are available across India in the former category of colleges, only a small fraction of aspiring candidates can find admission in these colleges after performing competitively in the relevant entrance tests. A major advantage of studying in these colleges is the nominal tuition fees that have to be paid. On the other hand, a large majority of would-be medical graduates have to seek admission in the privately run medical institutes in which the tuition and other related fees can be mind boggling when compared to their public counterparts. Except for candidates of exceptionally affluent background, the only alternative for fulfilling the dream of becoming a doctor is by financing one's study through hefty bank loans that may take years to pay back. It is often heard from patients that they are asked by doctors to undergo a plethora of diagnostic tests for apparently minor illnesses, which may financially benefit those prescribing the tests. The present paper attempts to throw light on the extent of disparity in cost of a medical education between state-funded and privately managed medical colleges in India; the average salary of a new medical graduate, which is often ridiculously low when compared to what is offered in entry-level engineering and business jobs; and the possible repercussions of this apparently unjust economic situation regarding the exploitation of patients.

The question of ethical decision in marketing and ethics

Resumen: Mientras que el marketing está asociado con prácticas negativas que involucran la explotación y la deshonestidad, Anton Jamnik afirma la necesidad de crear una teoría ética para éste. El artículo intenta brindar, por un lado, un breve bosquejo de las principales corrientes de la literatura de la ética del marketing y, por otro, participar de su desarrollo. El autor analiza los desafíos éticos que sur girán en el futuro, provenientes de tres fuentes distintas: las innovaciones tecnológicas, la influencia de la competencia global y la expansión de las actividades de mercado en áreas no tradicionales. Esto requerirá el desarrollo de una ética normativa realista. Para concluir, explica que la ética del marketing debería analizar hasta qué punto ha sido exitosa a la hora de resolver los desafíos éticos del mundo actual.

Locating Business Ethics within Catholic Social Though

Resumen: El artículo describe las características principales del documento pontificio La vocación del líder empresarial: una reflexión, destacando su génesis y sus objetivos. Sin embargo, presenta también las debilidades que encuentra en el texto. En primer lugar, el autor critica el modo en que se tratan las cuestiones laborales, especialmente la falta de referencias a la noción de “empleador indirecto” de Juan Pablo II. Luego, postula que el documento tampoco presenta el problema de la organización del trabajo, tema que fue tratado tanto por el Papa Pío XI como por Juan Pablo II. Por otra parte, aclara que el documento hace referencia al derecho a un salario justo pero no aporta ideas acerca del modo en que debería articularse la relación entre los propietarios de la empresa y los trabajadores. Finalmente, el autor sostiene que el documento omite el problema del lobbying que tanto afecta a la moral del mercado

Salmon action plan consultation. River Lune - draft

In February 1996 "A Strategy for the Management of Salmon in England and Wales" was launched by the then National Rivers Authority. The strategy concentrates on four main objectives for the management of salmon fisheries in England and Wales. These are primarily aimed at securing the well being of the stock but in doing so will strive to improve catches and any associated economic returns to the fisheries: (i) Optimise the number of salmon returning to homewater fisheries. (ii) Maintain and improve the fitness and diversity of salmon stocks. , (iii) Optimise the total economic value of surplus stocks. (iv) Ensure necessary costs are met by beneficiaries. These four objectives will be addressed through local Salmon Action Plans (SAPs) which will be produced for each of the principle salmon rivers in England and Wales by the year 2001. Each plan will review the status of the stock and the fisheries on a particular river, seek to identify the main factors limiting performance, draw up and cost a list of options to address these, and, consult 0with local interest groups. This report is the draft version of the Salmon Action Plan for the River Lune.

The Lune catchment abstraction management strategy. Consultation document September 2003

This consultation document sets out the proposed future licensing strategy for the Lune Catchment Abstraction Management Strategy (CAMS) area. Following the three month consultation period, the Environment Agency will determine the final licensing strategy and publish it in the CAMS document. The strategy will provide an indication of whether new abstraction licences are likely to be available and the conditions that should be expected on licences. Water plays a vital role in the Lune catchment, providing water for public supply, supporting recreation, such as angling and canoeing, and providing sustainable flows to preserve numerous designated sites. There is minimal abstraction throughout much of the catchment, apart from the lower reaches of the River Lune. The document is split into five sections relating to the CAMS process. Sections 1 to 4 outline the CAMS process, and Section 5 outlines the proposed licensing strategy for the Lune CAMS areas. It is important to note that this strategy deals with groundwater and surface water abstractions separately; Sections 4 and 5 are split to differentiate between the surface water and groundwater results and strategy.

River Kent salmon action plan - consultation draft

In February 1996, the National Salmon Management Strategy was launched by the Environment Agency's predecessor the National Rivers Authority (NRA, 1996). The strategy concentrates on four main objectives for the management of salmon fisheries in England and Wales. These are primarily aimed at securing the well being of the stock, but in doing so will improve catches and the associated economic returns to the fisheries. The four main objectives are : (i) Optimise the number of salmon returning to home water fisheries, (ii) Maintain and improve fitness and diversity of salmon stocks. (Hi) Optimise the total economic value of surplus stocks, (iv) Ensure necessary costs are met by beneficiaries

River Camel SAP Consultation

This is the River Camel Salmon Action Plan produced by the Environment Agency in 2002. The report focuses on the River Camel Salmon Action Plan (SAP). The River Camel SAP follows the format of those completed for the Rivers Tamar, Lynher and Tavy. It is the 4th of 7 action plans that will be produced for salmon rivers managed by the Cornwall Area Fisheries, Recreation and Biodiversity Team. This strategy represents an entirely new approach to salmon management within the UK and introduces the concept of river-specific salmon spawning targets as a salmon management tool. In addition, for the first time, Salmon Action Plans have attempted to evaluate in economic terms, all of the contributory components of the salmon fishery. The River Camel Salmon Action Plan contains a description of the river catchment and highlights particular features that are relevant to the salmon population and associated fishery.

River Fowey SAP Consultation

This is the River Fowey Salmon Action Plan Consultation document produced by the Environment Agency in 2003. The report pays attention on the external consultation of the River Fowey Salmon Action Plan (SAP). The River Fowey SAP follows the format of those completed for the Rivers Tamar, Lynher, Tavy and Camel. It is the 5th of 7 action plans that will be produced for salmon rivers managed by the Cornwall Area Fisheries, Recreation and Biodiversity Team. This strategy represents an entirely new approach to salmon management within the UK and introduces the concept of river-specific salmon spawning targets as a salmon management tool. The River Fowey SAP contains a description of the river catchment and highlights particular features that are relevant to the salmon population and the associated fishery. Notably, there are historic workings for copper and china clay and two significant potable supply reservoirs (Siblyback and Colliford) which have been constructed within the catchment during the past 35 years. The whole of the Fowey catchment is set at the highest water quality grading of RE1 and this standard is met in all reaches of the River Fowey and its tributaries.

River Lynher SAP Consultation

This is the River Lynher Salmon Action Plan Consultation document produced by the Environment Agency in 1998. The report pays attention on the external consultation of the River Lynher Salmon Action Plan (SAP). The River Lynher SAP follows that for the River Tamar and is the second of seven action plans that will be produced for salmon rivers managed by the Cornwall area fisheries department. This strategy represents an entirely new approach to salmon management within the UK and introduces the concept of river-specific salmon spawning targets as a salmon management tool. The River Lynher SAP contains a description of the river catchment and highlights particular features that are relevant to the salmon population and the associated fishery. The analysis of recent and historical catches of salmon on the River Lynher from both the rod and net fisheries indicated the fishery's reliance upon post 1 June salmon. Historically, annual salmon catches (both rod and net) on the River Lynher have been found to consist of a much higher proportion of pre 1 June (spring) salmon. Evidence is provided that illustrates the extent of the decline within this stock component since the early 1980s.

River Plym SAP Consultation

This is the River Plym Salmon Action Plan Consultation document produced by the Environment Agency in 2003. The report pays attention on the external consultation of the River Plym Salmon Action Plan (SAP). This strategy represents an entirely new approach to salmon management within the UK and introduces the concept of river-specific salmon spawning targets as a salmon management tool. The River Plym SAP follows the format of those completed for the rivers Tamar, Lynher, Tavy, Camel and Fowey. It is the sixth of seven action plans that will be produced for salmon rivers managed by Cornwall Area. The River Plym SAP contains a description of the river catchment and highlights particular features that are relevant to the salmon population and the associated fishery. Notably, there are historic workings for china clay and a significant potable water supply at Burrator Reservoir. The main River Plym has been designated as River Ecosystem class 1 for its water quality objectives. This is the highest water quality target set for rivers. This standard has been met in all reaches of the main River Plym and River Meavy.

River Tamar SAP Consultation

This is the River Tamar Salmon Action Plan Consultation document produced by the Environment Agency in 1998. The report pays attention on the external consultation of the River Tamar Salmon Action Plan (SAP). This strategy represents an entirely new approach to salmon management within the UK and introduces the concept of river-specific salmon spawning targets as a salmon management tool. The River Tamar was one of the premier salmon rivers in the West Country, supporting fifteen licensed estuary nets, and the second highest rod catch behind the River Exe. The River Tamar SAP contains a description of the river catchment and highlights particular features that are relevant to the salmon population and the associated fishery.

River Tavy SAP Consultation

This is the River Tavy Salmon Action Plan Consultation document produced by the Environment Agency in 1999. The report pays attention on the external consultation of the River Tavy Salmon Action Plan (SAP). This strategy represents an entirely new approach to salmon management within the UK and introduces the concept of river-specific salmon spawning targets as a salmon management tool. In addition, salmon action plans have for the first time, attempted to evaluate in economic terms, all of the contributory components of the salmon fishery. The River Tavy Salmon Action Plan follows that for the River Tamar and River Lynher and is the third of seven action plans that will be produced for salmon rivers managed by the Cornwall Area FER department. The River Tavy SAP contains a description of the river catchment and highlights particular features that are relevant to the salmon population and the associated fishery.

River Yealm SAP Consultation

This is the River Yealm Salmon Action Plan Consultation document produced by the Environment Agency in 2003. The report pays attention on the external consultation of the River Yealm Salmon Action Plan (SAP). This strategy represents an entirely new approach to salmon management within the UK and introduces the concept of river-specific salmon spawning targets as a salmon management tool. The River Yealm Salmon Action Plan follows the format of those completed for the rivers Tamar, Lynher, Tavy, Camel, Fowey and Plym. It is the final one of seven action plans that will be produced for salmon rivers managed by Cornwall Area. The River Yealm SAP contains a description of the river catchment and highlights particular features that are relevant to the salmon population and the associated fishery. Notably there are potable water abstractions in the headwaters, workings for china clay on the main tributary, two inert waste landfill sites and an aggregate quarry adjacent to the main river and inputs from several Sewage Treatment Works (STW) and two industrial estates. The main River Yealm has been designated as River Ecosystem Class 1 for its water quality objectives. This is the highest water quality target set for rivers.