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.

La costumbre en el Derecho Canónico Indiano

Resumen: El artículo estudia la vigencia de la costumbre en el mundo canónico indiano. Luego de presentar su evolución y desarrollo en el derecho universal analiza la doctrina sobre la materia a partir de autores indianos. Se expone la vigencia del derecho consuetudinario en diversos ámbitos de la vida eclesiástica americana concluyendo en afirmar el amplio imperio de este derecho en la Iglesia de Indias y, señalando que entorno al siglo XVIII se comienza a percibir cierta desconfianza hacia esta fuente del derecho canónico con normas que tienden a otorgar mayor contralor al legislador.

El modelo de sexualidad de la sociedad cristiana medieval: norma y transgresión

[ES]En estas páginas se analiza el modelo de sexualidad conyugal establecido por la Iglesia medieval para poder responder a la pregunta de qué era lícito y qué no en las relaciones sexuales. Así, entre otras cuestiones, se pasa revista a las posturas, a los momentos, las frecuencias, etc. Igualmente se exponen diversas estrategias arbitradas por la sociedad medieval para vivir en pareja y disfrutar del sexo al margen del matrimonio canónico, como la barraganía,el amancebamiento o el estupro.

Prevalência da Câmara dos Deputados no processo legislativo bicameral : a Lei de improbidade administrativa

Analisa a Constituição Federal e as Leis Ordinárias editadas em 2011 para saber se existe a prevalência de uma das Casas do Congresso Nacional na elaboração das leis. O estudo pretende, a partir da abordagem teórica e da análise das legislações publicadas, observando o processo legislativo bicameral para deliberação dos projetos, verificar as consequências para a definição do texto final das leis publicadas. Para tanto, propõe-se realizar estudo sobre o Poder Legislativo no Brasil e o modelo de sistema bicameral adotado. Também são analisadas todas as Constituições editadas no Brasil para saber os aspectos históricos e políticos em sua elaboração e os efeitos na definição das atribuições das Casas do Congresso Nacional, com repercussões no processo legislativo. É realizada a análise da tramitação legislativa da Lei de Improbidade Administrativa, expondo os textos adotados pelas Casas, com a definição do texto encaminhado para transformação em norma jurídica.

Necessidades de autocuidado à qualidade de vida de clientes com câncer de cabeça e pescoço: contribuição da enfermagem

Aborda-se a consulta de enfermagem como estratégia de pesquisa, visando identificar necessidades de autocuidado (AC) em clientes com câncer de cabeça e pescoço em tratamento paliativo ambulatorial. Tem-se como objetivos: identificar o perfil sociodemográfico e nosológico dos clientes com câncer de cabeça e pescoço atendidos no ambulatório para cuidados paliativos; identificar a qualidade de vida (QV) dessas pessoas através da consulta de enfermagem; avaliar as mudanças no sistema de autocuidado, considerando a intervenção de enfermagem. O estudo fundamenta-se nos conceitos, protocolos e instrumentos específicos da temática escolhida, e na Teoria do Déficit de Autocuidado de Orem. Escolheu-se o método quantitativo, descritivo, com delineamento pré-experimental tempo-série anterior e posterior em grupo único, que recebeu orientações para o autocuidado na consulta de enfermagem (CE). Foram sujeitos do estudo 77 clientes cadastrados no ambulatório especializado em tratamento paliativo, do INCA do Rio de Janeiro, no período de março a agosto de 2011. Variáveis sociodemográficas e nosológicas compõem o instrumento de produção de dados; enquanto as etapas da sistematização da assistência de enfermagem compõem o formulário para a implementação da CE. Para avaliar a QV aplicou-se o formulário QLQ30-H&N45, sendo os dados produzidos tratados mediante a estatística descritiva. Constatou-se, que a maioria dos 77 (100%) sujeitos do estudo é do sexo masculino e situam-se na faixa etária de 50 a 60 anos. Predominam os residentes na Baixada Fluminense, com ensino fundamental e aposentados. Têm união estável, cuidador informal e referem pouca realização de lazer. A maioria possuía hábito de tabagismo e alcoolismo. Quanto ao perfil nosológico, a maioria possui lesão tumoral inodora, sendo a cavidade oral o sítio mais acometido por câncer, e a metástase local a mais frequente. Quanto à capacidade para AC, a maioria se alimenta, se veste e se locomove sem auxilio. Ressalte-se que, na avaliação da QV, os escores predominantes apontam indicativos de controle de sintomas e funcionalidade. Foram formulados 33 diagnósticos de enfermagem, destacando-se nos domínios: físico, a deglutição prejudicada; no psicológico, a baixa autoestima crônica; no social, a interação social prejudicada; no cognitivo, conhecimento deficiente da doença. Concluiu-se que os objetivos da pesquisa foram alcançados, identificando-se que os clientes com câncer de cabeça e pescoço, em tratamento paliativo, possuem diferentes necessidades de autocuidado, sendo o enfermeiro o profissional responsável pela sua educação em saúde e consequente identificação de demandas para outros profissionais da equipe multiprofissional.

O novo perfil da tutela dos direitos individuais homogêneos

A dissertação tem por objeto a análise das novas formas de tratamento processual dos direitos individuais homogêneos, os quais frequentemente dão ensejo à propositura de ações repetitivas, especialmente a partir da tendência pela adoção de procedimentos de agregação de ações em alguns países. Assim, analisam-se as ações-teste estabelecidas pela Alemanha (Musterverfahren), Inglaterra (Group Litigation Order) e o incidente de resolução de demandas repetitivas previsto no Projeto de novo Código de Processo Civil brasileiro (PL 8.046/2010). Como esta espécie de direitos também pode ser tutelada por ações coletivas, o trabalho contém um estudo sobre suas principais características, como a representatividade adequada e os diferentes sistemas de extensão dos efeitos produzidos pela coisa julgada formada nestas ações. Todo este debate é precedido da análise dos princípios constitucionais da isonomia e da segurança jurídica, do movimento mundial de aproximação entre os sistemas de civil law e common law, e da crescente tendência uniformizadora da jurisprudência brasileira.

A representação social da união estável na classe média do Rio de Janeiro

A união estável é uma forma de relação conjugal presente, como concubinato, em diversas sociedades desde a antiguidade, constituindo uma opção de vida conjugal que tem se tornado cada vez mais freqüente na atualidade. O novo Código Civil (2002), em coerência com as mudanças introduzidas pela Constituição de 1988, confere a esse tipo de vínculo o título de entidade familiar, passando ele a compor o Livro de Família deste diploma legal. O tratamento jurídico fez dessa forma de relação antiga um novo arranjo conjugal, fato com inúmeras implicações no âmbito da vida privada. Como fato novo, a união estável gera estranhamentos, provocando um processo de familiarização social através da sua ancoragem em forma de relações conjugais já existentes: o casamento ou o concubinato. A partir desse entendimento, o presente trabalho teve por objetivo descrever, analisar e comparar as representações sociais a respeito da união estável produzidas por homens e mulheres, em quatro condições distintas: casados, solteiros, em união estável, separados. A amostra da pesquisa empírica foi composta de 304 sujeitos, com 76 em cada situação conjugal considerada, sendo metade homens e metade mulheres. O instrumento utilizado foi um questionário composto de 41 questões, sendo 21 fechadas e 19 abertas. Dentre elas, 40 são questões substantivas relativas à união estável, com vistas à obtenção de dados que configurem circunstancialmente as representações sociais. O questionário é iniciado por uma questão específica de evocação livre à descrição de uma relação conjugal do tipo união estável, para identificação dos conteúdos temáticos básicos e da estrutura das representações, de modo a permitir sua comparação. Finalmente, uma questão, desmembrada em 6 itens, visa à caracterização sócio-demográfica do conjunto dos sujeitos. As evocações foram analisadas através do software EVOC, permitindo identificar a estrutura das representações sociais. As respostas às perguntas fechadas e abertas, estas após sua categorização, foram objeto de um tratamento estatístico descritivo simples. Os resultados demonstraram que o núcleo central das representações sociais dos quatro grupos investigados compõe-se basicamente pelos sentimentos de amor e respeito. Observou-se também um alto grau de informação a respeito da união estável e posicionamentos predominantemente favoráveis tanto a respeito da legalização quanto em relação a alguns de seus aspectos jurídicos considerados polêmicos, como a conversão da união estável em casamento. Este estudo evidenciou ainda que a representação social da união estável procede basicamente de uma ancoragem no casamento, embora se tenha observado também a perpetuação da crença existente no senso comum de que é mais fácil se separar na união estável do que casamento

Novos rumos da prova pericial

A autora parte da premissa de que a prova pericial dá ensejo a equívocos e, por isso, sua produção deve ser rigorosamente controlada. A partir do enfoque histórico, a autora demonstra como a separação de questões de fato e de direito serve de instrumento ao controle judicial da prova pericial, que deve ser promovido desde a fase da admissibilidade a da valoração, sempre levando em consideração o debate real entre as partes. A autora dedicou grande parte da pesquisa ao estudo do direito probatório da common law, aos precedentes Frye, Daubert, Joiner e Kumho, bem como a outros casos marcantes, para fundamentar seu entendimento de que é tão importante o exame da admissibilidade da prova, como da sua valoração. O controle em todas as etapas da prova pericial, possível de lege lata no Brasil, visa à obtenção de prova idônea, sem a qual não é possível chegar a um resultado legítimo amparado em dados racionais.

Motivação e discricionariedade: as razões de decidir e o contraditório como elementos legitimadores da atuação judicial

O objetivo do presente trabalho é demonstrar que uma releitura dos princípios do contraditório e do dever de motivar as decisões judiciais, sob a ótica da maior participação dos jurisdicionados, tem o condão de alcançar a esperada legitimidade democrática da atuação judicial. Para tanto, antes de adentrar ao cerne da questão, buscou-se analisar ordenamentos de tradições jurídicas distintas, civil law e common law, a fim de delinear as perspectivas que referidos sistemas enxergavam o dever de motivar a decisão judicial. O estudo convergiu para o momento atual do direito, iniciado na segunda metade do séc. XX com o movimento de constitucionalização e, consequentemente, judicialização dos direitos. Uma das maiores críticas ao momento vivido é o amplo espaço interpretativo do juiz, abrindo as portas para a discricionariedade, o que foi combatido e rechaçado tendo como parâmetro as origens do instituto. Passado referido ponto, discutiu-se sobre as evoluções e novas tendências que circundam os princípios do contraditório e do dever de motivar, cuja finalidade foi demonstrar a estreita conexão entre as normas. Conclusão inexorável foi que ambos compõem a base das garantias processuais que legitimam a atuação judicial democrática. Por fim, procurou-se tecer alguns comentários sobre os equívocos cometidos na interpretação do princípio do convencimento judicial, e como essa perspectiva pode ser alterada com as diretivas presentes no projeto do novo Código de Processo Civil, haja vista que suas previsões abraçam boa parte das ideias debatidas no presente trabalho.

Polski a amerykański dyskurs sądowy: śledcze i skargowe procedury przesłuchiwania świadków w procesach karnych

Wydział Anglistyki

Victims' rights in Ireland: influences, illusions and impacts

Following international trends victims of crime in Ireland have increasingly become a source of political, policy and to a lesser extent academic concern. Although it is assumed that the Irish victims’ rights movement is having a profound impact on the criminal justice system there are very few studies addressing this assumption or the genesis of the Irish movement. At the time a victims’ rights movement was established in Ireland there were movements already established in the U.S. and Britain. To determine which model Ireland followed, if any, in establishing its movement a comparative analysis of the emergence of the victims’ rights movements in these three common law jurisdictions was undertaken. This research examines possible victim policy transfer to test the transfer route perception that the victims’ movement began in the U.S., was transferred into Britain and then onto Ireland. At the same time that the victims’ rights movements were emerging in the U.S., Britain and Ireland, and asserting pressure on their national governments for beneficial changes for victims of crime, international organisations such as the U.N. and Council of Europe were being pressured by victims’ rights groups into introducing victim centered instruments of guidance and best practice for member states. Eventually the E.U. became involved and enacted a binding instrument in 2001. These victim centered instruments provide legal and service provision rights to Irish victims of crime, but they do not generate much academic interest. This research, in addition to providing a detailed account of the victim centered instruments, analyses the jurisprudence of the European Court of Human Rights, and identifies and analyses the primary victim centered statutory modifications and case law in Ireland over the past three decades. Lastly, the current law and practices in Ireland are evaluated against Ireland’s obligations under international and E.U. law.

Towards a new model of criminal justice system in the era of globalised criminality: the biggest challenges for criminal process legislation

The main objective of this thesis is the critical analysis of the evolution of the criminal justice systems throughout the past decade, with special attention to the fight against transnational terrorism. It is evident – for any observer - that such threats and the associated risk that terrorism entails, has changed significantly throughout the past decade. This perception has generated answers – many times radical ones – by States, as they have committed themselves to warrant the safety of their populations and to ease a growing sentiment of social panic. This thesis seeks to analyse the characteristics of this new threat and the responses that States have developed in the fight against terrorism since 9/11, which have questioned some of the essential principles and values in place in their own legal systems. In such sense, freedom and security are placed into perspective throughout the analysis of the specific antiterrorist legal reforms of five different States: Israel, Portugal, Spain, the United Kingdom and the United States of America. On the other hand, in light of those antiterrorist reforms, it will be questioned if it is possible to speak of the emergence of a new system of criminal justice (and of a process of a convergence between common law and civil law systems), built upon a control and preventive security framework, significantly different from traditional models. Finally, this research project has the fundamental objective to contribute to a better understanding on the economic, social and civilization costs of those legal reforms regarding human rights, the rule of law and democracy in modern States.

Contracting Freedom: Governance and East Indian Indenture in the British Atlantic, 1838-1917

This is a dissertation about identity and governance, and how they are mutually constituted. Between 1838 and 1917, the British brought approximately half a million East Indian laborers to the Atlantic to work on sugar plantations. The dissertation argues that contrary to previous historiographical assumptions, indentured East Indians were an amorphous mass of people drawn from various regions of British India. They were brought together not by their innate "Indian-ness" upon their arrival in the Caribbean, but by the common experience of indenture recruitment, transportation and plantation life. Ideas of innate "Indian-ness" were products of an imperial discourse that emerged from and shaped official approaches to governing East Indians in the Atlantic. Government officials and planters promoted visions of East Indians as "primitive" subjects who engaged in child marriage and wife murder. Officials mobilized ideas about gender to sustain racialized stereotypes of East Indian subjects. East Indian women were thought to be promiscuous, and East Indian men were violent and depraved (especially in response to East Indian women's promiscuity). By pointing to these stereotypes about East Indians, government officials and planters could highlight the promise of indenture as a civilizing mechanism. This dissertation links the study of governance and subject formation to complicate ideas of colonial rule as static. It uncovers how colonial processes evolved to handle the challenges posed by migrant populations.

The primary architects of indenture, Caribbean governments, the British Colonial Office, and planters hoped that East Indian indentured laborers would form a stable and easily-governed labor force. They anticipated that the presence of these laborers would undermine the demands of Afro-Creole workers for higher wages and shorter working hours. Indenture, however, was controversial among British liberals who saw it as potentially hindering the creation of a free labor market, and abolitionists who also feared that indenture was a new form of slavery. Using court records, newspapers, legislative documents, bureaucratic correspondence, memoirs, novels, and travel accounts from archives and libraries in Britain, Guyana, and Trinidad and Tobago, this dissertation explores how indenture was envisioned and constantly re-envisioned in response to its critics. It chronicles how the struggles between the planter class and the colonial state for authority over indentured laborers affected the way that indenture functioned in the British Atlantic. In addition to focusing on indenture's official origins, this dissertation examines the actions of East Indian indentured subjects as they are recorded in the imperial archive to explore how these people experienced indenture.

Indenture contracts were central to the justification of indenture and to the creation of a pliable labor force in the Atlantic. According to English common law, only free parties could enter into contracts. Indenture contracts limited the period of indenture and affirmed that laborers would be remunerated for their labor. While the architects of indenture pointed to contracts as evidence that indenture was not slavery, contracts in reality prevented laborers from participating in the free labor market and kept the wages of indentured laborers low. Further, in late nineteenth-century Britain, contracts were civil matters. In the British Atlantic, indentured laborers who violated the terms of their contracts faced criminal trials and their associated punishments such as imprisonment and hard labor. Officials used indenture contracts to exploit the labor and limit the mobility of indentured laborers in a manner that was reminiscent of slavery but that instead established indentured laborers as subjects with limited rights. The dissertation chronicles how indenture contracts spawned a complex inter-imperial bureaucracy in British India, Britain, and the Caribbean that was responsible for the transportation and governance of East Indian indentured laborers overseas.

Property in body parts and products of the human body

An intriguing question, which until recently had not been directly explored by the courts, is the extent to which English law recognises body parts and products of the human body as property capable of ownership. Although the common law currently recognises no general property in a dead body (and only limited possessory rights in respect of it), this apparent “no-property rule” provides no justification, it is submitted, for denying proprietary status to parts or products of a living human body. The recent decision of the Court of Appeal in Yearworth v. North Bristol NHS Trust ([2009] EWCA Civ 37) lends strong support to the view that genetic material (as the product of a living human body) is capable of ownership, at least in the context of a claim in the tort of negligence and bailment. This article examines the various issues by reference to both English and Commonwealth authority.

Forfeiture relief

Looks at the common law forfeiture rule, preventing a person who has unlawfully killed another from profiting from the death, and the granting of relief under the Forfeiture Act 1982. Reviews case law on the forfeiture rule, its modification under s.2 in the interests of justice and the provision under s.3 that the rule does not preclude an application under the Inheritance (Provision for Family and Dependants) Act 1975. Reviews the Chancery Division ruling in Land v Land (Deceased), highlighting the ability for a claimant to choose whether to seek relief from forfeiture under s.2 of the 1982 Act or pursue a claim for reasonable financial provision from a deceased's estate under s.2 of the 1975 Act.