Fornece um panorama sobre os avanços biotecnológicos, dando ênfase aos aspectos jurídicos e éticos do impacto destes na área genética sobre o homem e o meio ambiente.

The need to regulate access to genetic resources and ensure a fair and equitable sharing of any resulting benefits was at the core of the development of the Convention on Biological Diversity (CBD). The CBD established a series of principles and requirements around access and benefit sharing (ABS) in order to increase transparency and equity in the international flow of genetic resources, yet few countries have been able to effectively implement them and ABS negotiations are often paralysed by differing interests. (...) -/- This book not only examines these complex challenges, but offers workable, policy-oriented solutions. International contributors cover theoretical approaches, new significant national legislation, the concept of traditional knowledge, provider and user country measures and common solutions. Exploring specific, salient examples from across the globe, the authors provide lessons for national regulation and the ongoing negotiations for an international ABS regime. Uniquely, this book also looks at the potential for 'horizontal' development of ABS law and policy, applying lessons from bilateral approaches to other national contexts. (shrink)

Featuring an impressive roster of contributors, this book will serve as a bold and irreplaceable source of information for legal scholars, lawyers, and ...

Technologies like CRISPR and gene drives are ushering in a new era of genetic engineering, wherein the technical means to modify DNA are cheaper, faster, more accurate, more widely accessible, and with more far-reaching effects than ever before. These cutting-edge technologies raise legal, ethical, cultural, and ecological questions that are so broad and consequential for both human and other-than-human life that they can be difficult to grasp. What is clear, however, is that the power to directly alter not just a (...) singular form of life but also the genetics of entire species and thus the composition of ecosystems is currently both inadequately regulated and undertheorized. In Gene Editing, Law, and the Environment, distinguished scholars from law, the life sciences, philosophy, environmental studies, science and technology studies, animal health, and religious studies examine what is at stake with these new biotechnologies for life and law, both human and beyond. (shrink)

Emerging technologies present a challenging but fascinating set of ethical, legal and regulatory issues. The articles selected for this volume provide a broad overview of the most influential historical and current thinking in this area and show that existing frameworks are often inadequate to address new technologies - such as biotechnology, nanotechnology, synthetic biology and robotics - and innovative new models are needed. This collection brings together invaluable, innovative and often complementary approaches for overcoming the unique challenges of emerging (...) technology ethics and governance. (shrink)

Biomedical Science Law & Practice is a practical strategic guide to the management of legal risks in biomedical science transactions, and commercialization of innovation and technology through strategic intellectual property licensing. This book provides a concise introduction to strategic legal risk management issues and strategic value creation in the entire biomedical science value chain, including legal liability issues from R&D, clinical trials, production of devices and market roll-out, protection of innovation through intellectual property (patents, copyrights, trade marks and trade secrets); (...) and commercialization of biomedical science innovation through strategic licensing and technology transfer, including unique licensing arrangements relating to genome. Checklists, sample agreements and biomedical patents and real life and hypothetical case studies used in the book facilitate learning at the operational or technical level of execution. (shrink)

The systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to “ordre public” or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. Human genome sequencing, (...) the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention. (shrink)

"Databases containing the accumulated genomic data of the research community are growing exponentially. This book contains cutting-edge insights from scholars, bioethicists and legal practitioners who work at the ever-changing intersection of law and bioinformatics"--Page 4 of cover.

This is a book about food, philosophy, and intellectual property rights. Taken separately, these are three well-known subjects; but it is uncommon to consider them together. Delivering a rich field of disputes, the book is comprised of 50 case studies, organized around eight themes: images; genericity and descriptiveness; language traps; procedures; menus, recipes, and creativity; boundaries; biotech; and empowerment. The introductory chapter frames the selection of cases and encourages readers to look beyond them, envisaging new lenses to look at food (...) vis-à-vis intellectual property. The terrain encompassed is wide-ranging and reaches out to fine-grained aspects of food products, recipes, and cooking. Conceived for a wide scope of readers, the volume ultimately interrogates the links between food and cultural identity, bringing to the fore the ethical, political, aesthetic worth of culinary arts and gastronomic experiences. This accessible book will be of value to scholars, students, practitioners and others with interests in the areas of intellectual property, food law and food studies. (shrink)

This edited volume covers new ground by bringing together perspectives from symbolic legislation theory on the one hand, and from biolaw and bioethics on the other hand. Symbolic legislation has a bad name. It usually refers to instances of legislation which are ineffective and that serve other political and social goals than the goals officially stated. Recently, a more positive notion of symbolic legislation has emerged in legislative theory. From this perspective, symbolic legislation is regarded as a positive alternative to (...) the more traditional, top-down legislative approach. The legislature no longer merely issues commands backed up with severe sanctions, as in instrumental legislation. Instead, lawmakers provide open and aspirational norms that are meant to change behavior not by means of threat, but indirectly, through debate and social interaction. Since the 1990s, biomedical developments have revived discussions on symbolic legislation. One of the reasons is that biomedical legislation touches on deep-rooted, symbolic-cultural representations of the biological aspects of human life. Moreover, as it is often impossible to reach consensus on these controversial questions, legislators have sought alternative ways to develop legal frameworks. Consequently, communicative and interactive approaches to legislation are prominent within the governance of medical biotechnology. The symbolic dimensions of biolaw are often overlooked. Yet, it is clear that the symbolic is at the heart of many legal-political debates on bioethical questions. Since the rise of biomedical technologies, human body materials have acquired a scientific, medical and even commercial value. These new approaches, which radically question existing legal symbolizations of the human body, raise the question whether and how the law should continue to reflect symbolic values and meanings. Moreover, how can we decide what these symbolic values are, given the fact that we live in a pluralistic society? (shrink)

This paper surveys the conceptions of law and of legislation to be found in the philosophy of Julian the Emperor. A hierarchy of levels of law is described, going from transcendent divine orders and paradigmatic laws down to the laws of nature, laws innate in human souls and regional laws. Julian’s ideal legislator is discussed, as inspired by transcendent, paradigmatic laws and as subordinate to law and its protector. An example of Julian’s legislation is discussed. Attention is paid to Julian’s (...) use of Plato’s Republic, Statesman, and Laws. (shrink)

La obra recoge, desde una perspectiva interdisciplinar, las aportaciones de un grupo de investigadores españoles e italianos que han trabajado conjuntamente durante varios años en distintas cuestiones en torno a las posibilidades y riesgos de los avances biotecnológicos y su incidencia en el campo de los derechos humanos. Los estudios y debates se han realizado en el marco del programa de doctorado internacional sobre "Derechos humanos: Problemas actuales" encabezado por las Universidades de Valencia y Palermo. El Profesor Jesús Ballesteros, Catedrático (...) de Filosofía del Derecho en la Universidad de Valencia, ha sido el encargado de dirigir y coordinar este proyecto. (shrink)

The first IVF baby was born in the 1970s. Less than 20 years later, we had cloning and GM food, and information and communication technologies had transformed everyday life. In 2000, the human genome was sequenced. More recently, there has been much discussion of the economic and social benefits of nanotechnology, and synthetic biology has also been generating controversy. This important volume is a timely contribution to increasing calls for regulation - or better regulation - of these and other new (...) technologies. Drawing on an international team of legal scholars, it reviews and develops the role of human rights in the regulation of new technologies. Three controversies at the intersection between human rights and new technology are given particular attention. First, how the expansive application of human rights could contribute to the creation of a brave new world of choice, where human dignity is fundamentally compromised; second, how new technologies, and our regulatory responses to them, could be a threat to human rights; and, third, how human rights could be used to create better regulation of these technologies. (shrink)

How should the law deal with the challenges of advancing biotechnology? This book is a philosophical and legal re-analysis.

Legislation for dementia care needs to be continually rethought, if the rights of older persons and other persons with dementia are to be addressed properly. We propose a theoretical framework for understanding vulnerability and dependency, which enables us to problematize the currently prevailing legal conception of adults as always able — irrespective of health or age — to act autonomously in their everyday lives. Such an approach gives rise to difficult dilemmas when persons with dementia are forced to make decisions (...) on their own about basic living conditions, such as housing and care, without decision-making support. In Sweden, for example, such matters are frequently left to the person him- or herself to decide, often without any assistance from social workers, and with family members serving as caregivers of last resort.Using vulnerability theory as the framework for our discussion, we argue that policymakers should not apply a group-oriented approach (based on factors like age, legal status, or mental capacity) to persons suffering from dementia. The needs of such individuals are as complex and varied as they themselves are. We discuss our findings from an interdisciplinary (law/social work) research project in which we examine the dilemma that social workers face when they are required, under the terms of the Swedish Social Services Act, to determine whether persons with dementia are to be granted support.We argue further that a cross-disciplinary approach — in which vulnerability theory furnishes the framework — opens up for new ways of understanding and developing social welfare law and practice. This, we believe, can help us better address the rights, interests, and needs of people with dementia, of their families, and of professionals in the social welfare system. Finally, many of the problems faced by ageing societies in general can be understood on the basis of such an approach. (shrink)

English summary: As a functioning part of the human body and mind, our internal information technology systems belong to our physical makeup just as much as body parts and substances do to the realm of reproductive medicine, genetic information does to gene technology and brain scans do to neurological technology. Bio-information law concerns itself with the rights of these roving human components. German description: Bio- und Informationstechnologien generieren standig neue, bislang kaum fur moglich gehaltene Verhaltnisse, Verknupfungen und Anschlusse zwischen Technischem (...) und Lebendigem. Im Recht werfen diese technisch-lebendigen Assoziationen grundsatzliche Fragen auf, wenn es beispielsweise darum geht, welche Personlichkeits- oder Eigentumsrechte an extrakorporal gelagerten Korpersubstanzen oder auch an genetischer Information bestehen. Ebenso hat das Recht eine Antwort darauf zu finden, welche Bedeutung neuronalen Daten und Abbildungen von Hirnaktivitaten, etwa fur den Beweis psychischer Schadigungen im Schmerzensgeldprozess, zukommt. Und nicht zuletzt erhebt sich die keineswegs mehr abwegige Rechtsfrage, ob der Eingriff in ein informationstechnisches System als personlichkeitsverletzend gelten darf, weil dieses womoglich wie ein ausgelagerter Teil des Korpers zu behandeln ist. Malte Gruber untersucht, wie sich diese Problemstellungen auf die privatrechtlichen Deutungen von Person, Sache und Rechtsverhaltnis auswirken und dabei ein technologieubergreifendes Recht formieren: Bioinformationsrecht handelt von der engen, untrennbaren Verbindung informationstechnisch-artifizieller und korperlich-lebendiger, gewissermassen kunstlicher und naturlicher Prozesse, von Expansionstechnologien und bioartifiziellen Rechtsverhaltnissen, in denen sich die Personlichkeit des Menschen in technisierter Verfassung entfaltet. (shrink)

This paper describes the different dimensions of the relation between moral reflection and legislative processes. It discusses some examples of the institutionalisation of moral reflection. It is argued that the relation between ethics and law is still an actual and relevant question. Ethics also has to reflect on its own role in political life. The paper defends the relevance of a theological perspective on the relation between law and ethics. In the last part it is argued that the modality of (...) relation between ethics and law depends on the specific character of social domain. (shrink)

Law, often neglected in treatments of the Republic, is essential to the philosopher-kings’ rule. Only law accomplishes the partial divinization of citizens at which philosophical politics aims. Socrates’ interrogation of Thrasymachus and Glaucon reveals law to be a command whereby citizens participate in philosophical knowledge and limit the pleonexia congenital to humanity. Law does so primarily by instilling in souls a true opinion resistant to pleonectic passion, producing a state of political virtue. This primary work is supported by the musical (...) and poetical education, itself shaped by law for the sake of law. Law persuades and compels the soul by appealing to both reason and spiritedness, enabling them to overcome the appetites. The soul’s consequent acceptance of truth and resistance to the passions indeed makes it resemble divinity. In so transforming the citizens through the law, the philosopher-king also unifies the city and makes it happy under his rule. (shrink)

This book highlights some of the principles which should be considered by planners, legislative drafters, and policy-makers as they work to develop legal frameworks on access to genetic resources in their countries. Contextual information on the Convention on Biological Diversity and examples of how countries have approached the issue to date are provided.

A collection of essays on the human genome, European patent law, cloning, and genetic malpractice suits.

This article compares and contrasts the patenting of animals, humans, and biotechnological inventions in the United States, at the European Patent Office, and within the European Union. It shows that morality is not a concern of U.S. legislative instruments or courts and patents have been granted liberally on living organisms, from microorganisms to mammals, in North America since the 1980s. By way of contrast, both European legislative instruments enshrine a morality bar that must be employed to deny patentability. Their implementation, (...) however, is unpredictable due to a lack of detailed guidance on what morality means. The remit of the morality bar extends principally to humans, but the interests of animals must now also be factored into the equation. The manner in which this is done is unclear and patents on plants, although controversial among the public in general, do not unduly trouble lawmakers now that a significant time has elapsed since this Rubicon was crossed. This article explains and critically assesses these systems while identifying some of the ethical problems that are likely to emerge in due course focusing on the ad hoc regard paid to animals and the lack of a structured approach to considering their rights or welfare. (shrink)

This new edition of Law and Medical Ethics continues to chart the ever-widening field that the topics cover. The interplay between the health caring professions and the public during the period intervening since the last edition has, perhaps, been mainly dominated by wide-ranging changes in the administration of the National Health Service and of the professions themselves but these have been paralleled by important developments in medical jurisprudence.

As Alexander D’Entrees observed over forty years ago, the case for natural law “is not an easy one to put clearly and convincingly.” Furthermore, even if one can make the case for natural law in a clear and convincing manner, one should not expect such an argument to be clear and convincing for all time. Instead, the case for natural law must be an ongoing argument, addressing itself perpetually to the needs of the time as these needs shift and change. (...) In short, the case for natural law “must needs appear in a different light according to the angle in time or in place from which it is looked at.” With this precept in mind, I seek to examine Thomas Aquinas’s natural law teaching on the legislation of virtue in light of concerns that are especially acute from the perspective of contemporary liberalism. (shrink)

La contractualisation du vivant, tous règnes confondus, est aujourd'hui une réalité incontestable. Puisant ses racines dans la révolution scientifico-technique qui a constitué le vivant en réservoir de ressources biologiques exploitées à des fins diverses, le phénomène se matérialise par un foisonnement d'opérations dont le contrat est le maillon emblématique. Fondé sur l'analyse d'un corpus de quelque 120 contrats, l'ouvrage présente cette évolution selon une triple entrée. Une première partie brosse le contexte dans lequel se déploie la chaîne du vivant. Dans (...) une deuxième partie, les contrats sont analysés pour eux-mêmes, de façon technique. La troisième partie propose d'appréhender la contractualisation du vivant en termes de politique juridique. Trois constats ressortent de cette analyse. D'une part, la contractualisation contribue à uniformiser le vivant : il apparaît que par le prisme du contrat, les ressources biologiques végétales, animales et humaines sont, mutatis mutandis, l'objet d'opérations très similaires. D'autre part, et contre toute attente, les opérations scandant la circulation des ressources biologiques se coulent pour la plupart dans les catégories du droit des contrats, en dépit de l'irréductible spécificité de l'objet matériel, qui contraint souvent les parties à faire preuve d'inventivité dans l'élaboration de stipulations contractuelles adaptées à leurs besoins. Enfin, si originalité il y a, elle se manifeste tout particulièrement quand il s'agit de déterminer les enjeux de la contractualisation en termes de politique juridique, spécialement dans un domaine fortement empreint d'intérêt général. A cet égard, même si la loi demeure, à l'évidence, le cadre de référence obligé de la circulation des ressources biologiques, le contrat en apparaît comme un indispensable relais. (shrink)

A Bioética, que podemos qualificar, sem a menor dúvida, como uma ciência jovem - embora cheia de vigor, dinamismo e em plena expansão - se ocupa, desde as multifacetadas óticas das grandes perguntas que se formula a cada dia, o homem moderno, em torno da vida. Neste livro, os autores tratam de alguns aspectos conceituais que, às vezes, são obliterados no discurso bioético. Por exemplo, quais as relações que se interpõem entre Bioética e Direito, começando por delimitar cada uma destas (...) disciplinas. (shrink)

This paper connects to Jon Bing’s great vision of an integrated national legal information system. The intention of this paper is to variegate Bing’s vision of an integrated information system by shifting the focus to the lay users, thus to those, who are subject to the law. The modified vision is an integrated information system that supports intelligible access to law for the citizens. This presupposes however an unambiguous and transparent legal system. Accordingly, it is also stressed that intelligent legal (...) knowledge engineering has high potential to increase precision and rationality in law, and hence safeguard the predictability of law and legal certainty. The central hypothesis is that putting the person who is subject to the law at the centre provides more rational reason to aim for the greatest possible precision of law by exploiting the means and technologies of our time than to uphold strategic vagueness. On this basis, the paper proposes the development of a basic set of controllable and justiciable basic legal drafting standards on EU and on national level, and promotes a transparency by design approach for legal knowledge engineering in order to enhance precision, integrity, comprehensibility and accessibility of law. Similarly to Jon Bing’s vision, this modified vision of an integrated legal information systems is, most probably, also likely to remain unfulfilled. However, what would science be without visions and (science) fictions? (shrink)

Biobanks represent an invaluable research tool and, as a result of their intrinsic and extrinsic nature, may be looked upon as archives or repositories largely made up of libraries, or collections of content where the content is the biological material derived from different individuals or species, representing valuable tangible assets. Biobanks analyses aspects of the commons and common intellectual property relating to the concepts of private property, not only concerning data but biological materials as well, and the advantages and disadvantages (...) of patents in scientific research. Several recent initiatives in biomedical research have attempted to make their data freely available to others, so as to foster innovation. Many of these initiatives have adopted the open source model, which has gained widespread recognition in the computer industry. This title is structured into eight chapters and begins with an introduction, which is followed by chapters that discuss how the term 'biobank' came about in scientific literature; legal matters relating to biobanks; and intellectual and physical property. Later chapters comprehensively analyse the intellectual property of biobanks within the sphere of copyright; biotechnological inventions and research patentability; open data sharing in biobanks; and biobanks as commons or vault. Considers biobanks as both repositories and as collections of tangible assets Argues that the data in biobanks represents a high value intangible asset Explores regulatory gaps exploited by the private sector. (shrink)

This paper aims to clarify the nature and contents of 'civil ethics' and the source of the binding force of its obligations. This ethics should provide the criteria for evaluating the moral validity of social, legal and morally valid law. The article starts with observing that in morally pluralist Western societies civil ethics already exists, and has gradually started to play the role of guiding the law. It is argued that civil ethics should not be conceived as 'civic morals' which (...) is in fact rather 'state ethics', nor as 'public ethics' which is said to reach its perfection when it becomes law, nor as ethics applicable primarily to the basic structure of a society, but instead as a citizens' ethics. Subsequently the paper attempts to show what the contents of this ethics are, and which ethical theory would be able to ground its obligations. (shrink)

This book provides a clear, concise description of medical law; but it does more than that. It also provides an introduction to the ethical principles that can be used to challenge or support the law. It also provides a range of perspectives from which to analyse the law: feminist, religious and sociological perspectives are all used.

Examining the ways and extent to which systemic factors affect health outcomes with regard to quality, affordability and access to curative healthcare, this explorative book compares the relative merits of tax-funded Beveridge systems and insurance-based Bismarck systems. The Law and Policy of Healthcare Financing charts and compares healthcare system outcomes throughout 11 countries, from the UK to Colombia. Thematic chapters investigate the economic and legal explanations for the relevant similarities, variations and trends across the globe. Concluding that systemic factors may (...) be less significant than previously believed, this comprehensive book notes that no one system consistently outperforms the others, yet incentives and funding improvements may lift performances across all curative healthcare systems. Analytical and comparative, this book will be of interest to academics working in the fields of health law and health economics. Public authorities including health ministries, policymakers and international health organisations will also find this to be an invaluable resource. (shrink)