True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that (...) revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: those among businesses involved within the industry; those in relationships between industry and government; and those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry. (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)

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)

IntroductionNowadays, biotechnology has a significant influence on different aspects of human life. The applications of biotechnology are so broad, and the advantages so compelling, that virtually every industry is using this technology. Developments are under way in areas as diverse as pharmaceuticals, diagnostics, textiles, aquaculture, forestry, chemicals, household products, environmental cleanup, food processing, and forensics, to name a few. Biotechnology is enabling these industries to make new or better products, often with greater speed, efficiency, and flexibility. (...) Biotechnology is any technological application that uses biological systems, living organisms, or derivatives thereof to make or modify products or processes for specific use. It applies the knowledge of biology to enhance and improve the environment, health, and food supply. Using biotechnology, scientists work to develop environment-friendly alternatives to fossil fuels and plastics; new medicines, vaccines, and. (shrink)

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 ability of science to operate effectively within society is dependant on a number of factors. Science is totally reliant on the law for its regulation and control, while the boundaries in which science can operate are governed by legal constraints. These boundaries are strongly influenced by society which dictates acceptable levels of morals and ethics in which science can operate. Economic factors must be considered as industry requires reward in order to recoup its research and development investments and continue (...) competing in a competitive and growing market place. Thus the law must reconcile the different tensions raised by science, economics, politics, society and the law itself. This paper looks how this may be achieved at the international, regional and national level. (shrink)

Background -- Overview of legal sources -- Summary of recent prosecutions and investigations -- Applications of law and professional and trade association standards to physician relationships with industry -- Legal and ethical aspects of specific physician's industry financial relationships -- Approaching and adopting effective compliance plans.

This paper discusses the idea of forming a patent pool in order to address some of the licensing problems in the biotechnology industry. The pool would be an independent, non-profit corporation that would manage patents and have the authority to grant licenses. The patent pool would not be a purely altruistic venture, since it would charge licensing fees. The pool would charge the market price for licensing services and reimburse patent holders for licensing activities. The pool would also provide (...) patent holders with a minimum income based on a percentage of royalties generated from the pool. The pool would include patents on a variety of materials and methods that play an important role in biotechnology. It would also be international in scope, with the power to grant licenses in different countries. (shrink)

Basic human rights are supposed to protect people from abuse and harm. They are the means whereby we protect our humanity. One would expect, therefore, that basic human rights would be valid and sacred in any context, including industrial relations. However, the complexity of the employee–employer relationship obscures this issue, and it is not clear whether such rights can be protected or whether they are valid in the context of industrial relations. Since rights are relational, they are preconditioned on the (...) special nature of the relationship between employee and employer. Hence, the specific meaning that these rights have in industrial relations cannot be grounded in the notion of human rights as such, but rather depends on the special relationships between employers and employees. Though much legislation has been passed to regulate the relationship between employees and employers, the issues surrounding this relationship remain one of the most debated topics in business ethics. Our paper focuses specifically on the right to equal pay and the right to privacy. With respect to the right to property, the paper examines whether there is a conflict between general human rights and the fundamental right of employers to their property. The Israeli legislature has responded to this conflict by enacting ‘protective laws’ that legally outline and mandate certain human rights. Under these laws, employees are prevented and prohibited from waiving the rights granted to them by law, even if employed in private industries. Despite this legislative effort, market forces are at times stronger, and consequently some basic rights are not fully applied or implemented. (shrink)

Developing countries need to reform legislation to ensure the global supply firms in ready-made garment industry is adequately addressing obligations of social responsibility. Literature typically focuses on strategies for raising responsible standards in global buying firms within the RMG industry, but fails to focus on implementing strategies for suppliers in developing countries. This article addresses this gap by specifically focusing on the RMG industry in Bangladesh, the home of the third largest RMG supplier in the world. It concentrates on analysing (...) how and to what extent the law can assist in developing social responsibility performance of the RMG manufacturing firms in developing countries. It ultimately concludes that a new governance approach in laws can effectively increase the social responsibility practice standards of an industry where global buying firms are profit-driven and governmental agencies are either inadequate or corrupt. (shrink)

In response to an increasing amount of policy papers stressing the need for integrating social and ethical aspects in Research and Development (R&D) practices, science studies scholars have conducted integrative research and experiments with science and innovation actors. One widely employed integration method is Midstream Modulation (MM), in which an ‘embedded humanist’ interacts in regular meetings with researchers to engage them with the social and ethical aspects of their work. While the possibility of using MM to enhance critical reflection has (...) been demonstrated in academic settings, few attempts have been made to examine its appropriateness in industry. This paper describes the outcomes of a case study aiming to find out firstly whether MM can effectively be deployed to encourage and facilitate researchers to actively include social and ethical aspects in their daily R&D practice, and secondly to what extent the integration activities could form an integral part of the engaged industrial researchers’ professional activities. Our data show that after MM, researchers display increased reflexive awareness on the social and ethical aspects of their work and acknowledge the relevance and utility of such aspects on their daily practice. Also, all participants considered actively reflecting on social and ethical aspects to be part of their work. Future research on the role of MM in industrial settings could focus on how to embed social and ethical integration as a regular part of innovation practice. We suggest that one possibility would be through aligning social and ethical aspects with innovation Key Performance Indicators. (shrink)

In response to an increasing amount of policy papers stressing the need for integrating social and ethical aspects in Research and Development (R&D) practices, science studies scholars have conducted integrative research and experiments with science and innovation actors. One widely employed integration method is Midstream Modulation (MM), in which an ‘embedded humanist’ interacts in regular meetings with researchers to engage them with the social and ethical aspects of their work. While the possibility of using MM to enhance critical reflection has (...) been demonstrated in academic settings, few attempts have been made to examine its appropriateness in industry. This paper describes the outcomes of a case study aiming to find out firstly whether MM can effectively be deployed to encourage and facilitate researchers to actively include social and ethical aspects in their daily R&D practice, and secondly to what extent the integration activities could form an integral part of the engaged industrial researchers’ professional activities. Our data show that after MM, researchers display increased reflexive awareness on the social and ethical aspects of their work and acknowledge the relevance and utility of such aspects on their daily practice. Also, all participants considered actively reflecting on social and ethical aspects to be part of their work. Future research on the role of MM in industrial settings could focus on how to embed social and ethical integration as a regular part of innovation practice. We suggest that one possibility would be through aligning social and ethical aspects with innovation Key Performance Indicators. (shrink)

This paper discusses strategic decision making in firms pursuing biotechnology innovation and the influence of risk regulation on firm strategy. Data from three research projects, involving interviews with over 60 managers from agricultural and food related biotechnology companies and also over 60 key participants in the regulatory process in the UK and EC, shows a diversity of strategy and opinion. While some industry representatives identified new risk regulations governing the release of genetically manipulated organisms (GMOs) as the primary (...) constraint on biotechnology innovation, the findings of the study painted a more complex picture. The controversies surrounding the issue of risk regulation and its impact on innovation are best understood if viewed in the context of other political and economic factors. We conclude that the actual impact of risk regulation on industry strategies is probably less than the rhetoric of industry lobbyists would suggest. At the same time, the very act of lobbying so forcefully could lead to a public backlash against industry that would be much more damaging than the regulation itself. (shrink)

In industrial societies where civil law and state institutions have become well established secular vehicles for governing the populace, it is widely assumed that the state no longer has an interest in fortifying the religious sector as a complementary source of social control. Thus, a distinction is drawn between the Islamic state that is ruled by religious law and the secular state of Western industrial societies in which religion is deemed to have lost its influence in the public sphere. This (...) dissertation argues that civil law is not religiously neutral and thus challenges a central premise of secularization theory. Introducing a new theoretical model that classifies civil law on the basis of its purpose-to protect religious liberty, engage or fortify the religious sector, or to advance universal norms-the author examines the impact of the three different types of legislation upon religious freedom and the individual autonomy of religious minorities in Sweden, an aggressively secularized industrial society. The author concludes that, viewed from the standpoint of a religious nonconformist, there is no discernible difference between living in a society that is overtly ruled by religious law (e.g., an Islamic state) and living in a "secular” society that is ruled by civil law either embedded with religious norms or designed to facilitate state appropriation of the religious sector as a complementary means of social control. In either environment, the author argues, the religious nonconformist will be forced to conform to the religious norms of the predominant religious group. (shrink)

The purpose of this research is to adapt to the monopsony theory and disregard the neoclassical economic theory with regard to minimum wage policy. The other purposes of this study are to analyze the present minimum wage policy in Bangladesh. Is minimum wage system really effective? If so, what should be the standard for effective application of minimum wage legislation? The methodology of this study is qualitative. I have created a theoretical debate and developed hypotheses in this scholarship. The hypothesis (...) developed from the debate of neoclassical theory clarified that the minimum wage law might not have an adverse effect. Instead, a standard minimum wage law, along with an appropriate implementation process, may have a positive effect on society. This study finds inadequate mechanisms to implement minimum wage provisions under the Bangladesh labor legislation. Therefore, the present minimum wage policy has not been implemented to its fullest as required to protect workers’ right in Bangladesh. This paper also shows that a minimum wage policy will have an effect if strict adherence to the standard of ILO Conventions is complied with. This study also creates a balancing test between neoclassical theory and monopsony theory on the application of the minimum wage system. Finally, this manuscript has taken a stanch with monopsony theory favoring the application of minimum wage law in the garment manufacturing industry. It is an original research paper. The strength of this type of research is that it benefits the practitioner and the pertinent stakeholder to gain new insight. (shrink)

The WTO Agreement on Safeguards prescribes each member to adopt appropriate domestic legislation before it imposes safeguard measures. Historically, Jordan enacted its first WTO-compatible safeguard law, known as the National Production Protection Law No.4 of 1998 (“NPP Law”), in 1998 on the eve of Jordan’s accession to the WTO. Afterward, it amended its NPP Law of 1998. So now, Jordan’s safeguard system is based on the amended NPP Law No. 50 of 2002 and Regulation on Safeguard of National Production. -/- (...) The purpose of the paper is to examine Jordan's safeguard law. The paper analyzes safeguard investigation, safeguard review, and duration. In addition, the paper examines safeguard measures under the U.S.-Jordan Free Trade Agreement. (shrink)

us, I go at once to the heart of the subject, taking my stand on these propositions: That the right to cooperate is as unquestionable as the right to compete; that the right to compete involves the right to refrain from competition; that co operation is often a method of competition, and that competition is always, in the larger view, a method of co operation; that each is a legitimate, orderly, non invasive exercise of the individual will under the social (...) law of equal liberty; and that any man or institution attempting to prohibit or restrict either, by legislative enactment or by any form of invasive force, is, in so far as such man or institution may fairly be judged by such attempt, an enemy of liberty, an enemy of progress, an enemy of society, and an enemy of the human race. (shrink)

The European Union (EU) has developed a vast body of environmental law, relying on a treaty title setting out normatively and descriptively complex environmental principles and approaches, as well as on those parts of the treaties focusing on the internal market. This chapter provides some introductory insights into EU environmental law. It explores that the Industrial Emissions Directive (IED) shows the potential of an approach to governance that sets environmental norms in a collaborative, problem‐solving forum beyond the face of legislation. (...) The chapter shows harmonization is not a straightforward category in EU environmental law. Much was made of the decentralization and local or national flexibility in the predecessor to the IED. By comparison, the IED places greater emphasis on the mandatory application of EU‐wide environmental standards. However, both the initial decentralization and the recentralization are highly ambiguous. (shrink)

Congress's national-security legislation will often require clear and specific congressional authorization before the executive can undertake certain actions. The War Powers Resolution, for example, prohibits any law from authorizing military hostilities unless it "specifically authorizes" them. And the Foreign Intelligence Surveillance Act of 1978 required laws to amend FISA or repeal its "exclusive means" provision before they could authorize warrantless electronic surveillance. But efforts to legislate clear-statement regimes in national-security law have failed to induce compliance. The Clinton Administration inferred congressional (...) "authorization" for the 1999 Kosovo War from an appropriations statute that failed to specifically authorize the conflict. And the Bush Administration inferred congressional "authorization" for the NSA surveillance program from ambiguous language in the post-September 11th Authorization to Use Military Force. In both situations, executive-branch lawyers employed expansive theories of implied repeal and constitutional avoidance to evade the codified clear-statement requirements, and Congress and the courts acquiesced to the President's actions. Recent proposals to strengthen the clear-statement requirements in Congress's national-security framework legislation are unlikely to be effective without institutional mechanisms, such as points of order, that can deter future legislators from enacting vague or ambiguous legislation from which the executive might claim implicit congressional "authorization," and that can induce Congress to confront Presidents that act without specific congressional authorization. Simply enacting more narrow or explicit clear-statement requirements, or adding funding restrictions to Congress's framework legislation, fails to counter the aggressive interpretive doctrines that executives of both political parties have used to concoct congressional "authorization" from vague or ambiguous statutory language. (shrink)

In public debate over agricultural biotechnology, at issue hasbeen its self-proclaimed aim of further industrializingagriculture. Using languages of ’risk‘, critics and proponentshave engaged in an implicit ethics debate on the direction oftechnoscientific development. Critics have challenged thebiotechnological R&D agenda for attributing socio-agronomicproblems to genetic deficiencies, while perpetuating the hazardsof intensive monoculture. They diagnosed ominous links betweentechnological dependency and tangible harm from biotechnologyproducts.In response to scientific and public concerns, theEuropean Community enacted precautionary legislation for theintentional release of genetically modified organisms (...) (GMOs). Inits implementation, choices for managing and investigatingbiotechnological risk involve an implicit environmental ethics.Yet the official policy language downplays the inherent valuejudgments, by portraying risk regulation as a matter of’objective‘ science.In parallel with safety regulation, thestate has devised an official bioethics that judges where to’draw the line‘ in applying biotechnological knowledge, as ifthe science itself were value-free. Bioethics may also judge howto ’balance‘ risks and benefits, as if their definition were notan issue. This form of ethics serves to compensate for theunacknowledged value-choices and institutional commitmentsalready embedded in R&D priorities.Thus the state separates’risk‘ and ’ethics‘, while assigning both realms to specialists.The risk/ethics boundary encourages public deference to theexpert assessments of both safety regulators and professionalethicists. Biotechnology embodies a contentious model of controlover nature and society, yet this issue becomes displaced andfragmented into various administrative controls. At stake arethe prospects for democratizing the problem-definitions thatguide R&D priorities. (shrink)

Biotechnology is one of the fastest-growing areas of scientific, technical and industrial innovation and one of the most controversial. As developments have occurred such as genetic test therapies and the breeding of genetically modified food crops, so the public debates have become more heated and grave concerns have been expressed about access to genetic information, labelling of genetically modified foods and human and animal cloning. Across Europe, public opinion has become a crucial factor in the ability of governments and (...) biotech industries to exploit the new technology. This 2002 book presents the results of a unique cross-national and cross-disciplinary study of the relationship between the development of new biotechnology and public perception, media coverage and policy formulation. It outlines a conceptual framework for understanding these issues and contains a number of empirical studies including studies of the international controversies surrounding the cloning of Dolly the sheep and GM Soya. (shrink)

Biotechnology increases commercialization of food production, which competes with food for home use. Most people in the world grow their own food, and are more secure without the mediation of the market. To the extent that biotechnology enhances market competitiveness, world food security will decrease. This instability will result in a greater gap between rich and poor, increasing poverty of women and children, less ability and incentive to protect the environment, and greater need for militarization to maintain order. (...) Therefore, biotechnology should be discouraged. An active program to protect and strengthen local food production and to decrease reliance on industrial agriculture should be promoted. (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)

Synthetic biologists design and engineer organisms for a better and more sustainable future. While the manifold prospects are encouraging, concerns about the uncertain risks of genome editing affect public opinion as well as local regulations. As a consequence, biosafety and associated concepts, such as the Safe-by-design framework and genetic safeguard technologies, have gained notoriety and occupy a central position in the conversation about genetically modified organisms. Yet, as regulatory interest and academic research in genetic safeguard technologies advance, the implementation in (...) industrial biotechnology, a sector that is already employing engineered microorganisms, lags behind. The main goal of this work is to explore the utilization of genetic safeguard technologies for designing biosafety in industrial biotechnology. Based on our results, we posit that biosafety is a case of a changing value, by means of further specification of how to realize biosafety. Our investigation is inspired by the Value Sensitive Design framework, to investigate scientific and technological choices in their appropriate social context. Our findings discuss stakeholder norms for biosafety, reasonings about genetic safeguards, and how these impact the practice of designing for biosafety. We show that tensions between stakeholders occur at the level of norms, and that prior stakeholder alignment is crucial for value specification to happen in practice. Finally, we elaborate in different reasonings about genetic safeguards for biosafety and conclude that, in absence of a common multi-stakeholder effort, the differences in informal biosafety norms and the disparity in biosafety thinking could end up leading to design requirements for compliance instead of for safety. (shrink)

In recent years, the image of biotechnology has been transformed from one of danger and uncertainty to one of opportunity and familiarity. This article explores the process of issue definition by examining the efforts of private interests and public officials. An analysis of interview data, public documents, and other sources reveals four methods of issue definition: establishing the "biotechnology industry" as a collective voice, forging alliances with established public and private interests, associating biotechnology with popular issues on (...) the policy agenda, and discrediting opponents and critics of biotechnology. These methods of issue definition reveal the importance not only of defining a specific issue but also of influencing the context in which it is considered. (shrink)

We should now be able to come to some general conclusions about the main lines of Cuvier's development as a naturalist after his departure from Normandy. We have seen that Cuvier arrived in Paris aware of the importance of physiology in classification, yet without a fully worked out idea of how such an approach could organize a whole natural order. He was freshly receptive to the ideas of the new physiology developed by Xavier Bichat.Cuvier arrived in a Paris also torn (...) by many overlapping debates on the nature of classification, and in particular that between the natural and artificial systems. The very validity of the enterprise of classification was questioned in many quarters. Cuvier's achievement on his entry into the Parisian world of science was not simply to establish himself as a highly competent anatomist: far more important, he also began to use ideas from many different specialties to change completely the notion of what was involved in natural history.124 At the same time that he himself swung away from the guiding image of the field naturalist as the ideal of the specialty, he took ideas from the new physiology to answer questions about the order of the animal world, and from comparative anatomy to resurrect extinct creation — and to come to conclusions from that creation about the history of the forms of life and the manner of their succession. He showed himself able to alter the relationships between natural history and many other fields of study in a way that implied, rightly or wrongly, his own complete mastery over such a movement. Partly he was able to do this because the ideas he borrowed were not themselves logically articulated and thus could be easily adapted and refocused for many different specific purposes. The value of the heuristic possibilities inherent in the idea of life, for example, far outweighed its inability to generate full systems of classification. Cuvier also consistently refused to consider in science matters relating to the first causes of events. Freed from the consideration of first-order phenomena, he was able to use second-order explanations across a far wider field of applicability. Personal doubts about the validity of a theology that had used science in order to bolster its own claims were combined here with the strong influence of the Kantian critique of the limits of human reason.125Cuvier's characteristic mode of procedure was that of intellectual appropriation and a bold capacity for altering the relationships between different fields of knowledge, rather than, with the exception of taxonomy, the technique of expanding their subject matter. His claims to originality came, first, from this reappropriation and reorientation and, second, from the sheer scope of his work, which aimed at nothing less than the cataloging and classification of all animate objects.126 They rested also on his acute use of his assertion of a certain relationship with the past of his subject. Very often he would present this history in such a way as to obscure his own intellectual genealogy, and often too he would give differing accounts of the priority of use of an idea in order to distract attention from the questionable exactitude of his own claims to originality. Cuvier came to Paris at precisely the time when society and institutions were most profitably malleable for a newcomer; it was also a time when many scientific disciplines had reached a stage advanced in terms of their factual content, yet relatively inadequate in conceptual organization. They were ripe for takeover by large-scale organizing ideas such as the animal economy and the subordination of characteristics. Paleontology is a particularly good example of a specialty in this particular form of underdevelopment in 1795.Cuvier paid a high price for his initial success. His electic applications of large-scale organizing ideas tended to mean that little of his own work had complete coherence at all levels. Ideas, as we have seen, that proved capable of providing a complete reform of the larger groups of the animal kingdom were incapable of producing its detailed working-out in the taxonomy of smaller groups, which had to be supplied from observed analogical correlations. Further, his physiological approach to classification involved the breakdown of strict correspondence between organs and functions, which left the way open for workers such as Geoffroy St. Hilaire gradually to tilt the balance away from the study of the correlations of hierarchies of functions, and toward morphology as the basis of the order of nature. Cuvier's brilliant appropriations from physiology from the beginning, therefore, contained the seeds of conflict with Geoffroy.Cuvier's eclectic approach made it very nearly impossible for him to present a clear idea of the ways in which the life sciences could be said to be lawful. In spite of his efforts to assimilate them to the position of the physical sciences in this respect, he was forced in the end to accord only an ambiguous status as “laws” to observational correlations. From this area of failure came much of the attempt to give his own two laws — the correlation of parts and the subordination of characteristics — predictive qualities, particularly in relation to paleontological research.It is not surprising that Cuvier's title as the “legislator” of natural history should represent more a claim than a reality. How, then, was he able to emerge as the leading French naturalist of his day? First of all must be adduced the sheer scale of his undertakings. Then comes his expertise as a practical anatomist, and the range of different topics toward which he turned his interest. His collaborators cannot be given credit for his output nor, as we have seen, for slavish adherence to his ideas. Cuvier was able to successfully claim to have dominated the underdeveloped specialties, such as paleontology, and turned them into a major heuristic input into both geology and comparative anatomy; but in other fields, such as physiology, he appropriated concepts and encouraged research but made little impact on the field himself. His attempts in 1812 to head off, or neutralize and absorb the growth of morphological studies landed him in a dangerously rigid position, which despite his encouragement of the new physiological research under the Restoration made further elaboration of his own conceptual underpinnings almost impossible.Cuvier's authority in the scientific world would in any case have been great because of his substantive achievement in taxonomy, but the rest of his work had enough ambiguities and dislocations for it to need the support of his political and social power. Cuvier's detractors seized on a vital fragment of the truth when they accused him of finding the political dimension all-important: it obscured the disjunctions in his theories and at the same time gave him the authority to make new claims for the status of the observational sciences - and for their relations of power with their surrounding specialties. Cuvier's science both thrived on and was halted by the power games of intellectual appropriation, manipulation of the past to confirm the present, and continual claims for hegemony. (shrink)

As products of the "new biotechnology," genetically modified organisms have provoked a wide-ranging risk debate on potential harm, especially from herbicide-tolerant crops. In response to this legitimacy problem, the European Community adopted precautionary legislation, which left open the definition of environmental harm. When the U.K. proposed Europe-wide market approval of a herbicide-tolerant oilseed rape, the proposal encountered dissent from some countries and environmentalist groups. Further debate on normative judgments became necessary to implement the precaution ary legislation. In dispute were (...) several regulatory boundaries—of administrative re sponsibility, causality, acceptability, and evidence. The boundary disputes expressed divergentframings of biotechnological risk, each with its implicit model of the socionatu ral order. In this way, the disputes can illuminate the sorts of risk framings that have already become embedded and standardized in other regulatory sectors. (shrink)

Third World countries should exploit the genetic information stored in their flora and fauna to develop independent and highly competitive biotechnological and pharmaceutical industries. The necessary condition for this policy to succeed is the reshaping of their universities and hospitals—to turn them into high-caliber research institutions dedicated to the creation of original knowledge and biomedical invention. Part of the service of the Third World foreign debt should be co-invested with the lending banks in high technology enterprises. This should be (...) complemented with an active program of investments in First World biotech companies and university research departments which could contribute to the solving of problems connected with the First World. These strategic alliances would allow effective training of molecular biologists, improvement of South American universities, and education of biotechnologists, managers, and lawyers in the complexities of high-technology business. The establishment of real joint ventures between developed and underdeveloped countries might contribute to change the present strained relations between the North and the South, and science and technology could become real forces of social and economic development. (shrink)

According to the Standard Picture of how law works, the content of the law that is created by legal texts such as statutes and constitutional provisions is determined by the meaning of these texts. Most proponents of this picture claim more specifically that the relevant notion of meaning in play is the communicative content of legal texts and that communicative content is itself determined by considerations of the intentions of legal authorities. In recent years, the Standard Picture has become the (...) subject of heated philosophical debate. Focusing on statutes as the paradigmatic type of legal texts, this thesis aims to contribute to this debate in two central ways. First, it argues that the aforementioned ‘intention-based’ versions of the Standard Picture lack convincing responses to three important objections that have been raised by critics. First, they lack an adequate account of how legislative bodies can be reasonably ascribed the intentions that they would need according to such versions. Second, they fail to explain important aspects of legal practice. Third, they provide at best a parochial theory of the content of the law that is generated by statutes. The second contribution is to provide a more sustained defence of the Standard Picture by developing a new ‘commitment-based’ version of this view. This version is based on an alternative theory of communication and claims that communicative content is not determined by considerations of intentions but rather by the commitments that are incurred by means of communicative acts. It is argued that this version can deal with the objections that have been raised by critics and therefore provides a more robust version of the Standard Picture. (shrink)

Silence in court: the devaluation of the stories of nurses in the narratives of health lawThis paper sets out to address one of the major findings from an extensive analysis of case law involving nurses from 1904 to 1999. The 180 cases were collected from the civil, coronial, professional and industrial jurisdictions of Australia, Canada and the UK. It specifically examines the way in which nurses’ voices and experiences are excluded from legislation and case law, and the resultant effect which (...) this has on the status of the nurse in clinical and healthcare decision‐making. It addresses two of the many issues which emerged from the research, but which are particularly problematic for nurses. The first is that doctors are not necessarily required to heed the clinical concerns of nurses, and the second is that nurses are not necessarily expected to intervene to prevent imminent harm to the patient. This paper also suggests some possible solutions to these issues. (shrink)

This article considers Dworkin's influential argument against legislative intent in chapter 9 of Law's Empire. The argument proves much less than is often assumed for it fails to address the possibility that the institution of the legislature may form and act on intentions. Indeed, analysis of Dworkin's argument lends support to that possibility. Dworkin aims to refute legislative intent in order to elucidate his own theory of statutory interpretation. That theory fails to explain plausibly legislative action. Dworkin's argument does not (...) refute legislative intent but instead suggests there is reason to think that the legislature is capable of intentional action. (shrink)

This chapter contains sections titled: Decision‐making about New Technologies Case Studies for Biotechnology Guidance from the Public References and Further Reading.

Increasingly, taxonomies are being developed and used by industry practitioners to facilitate information interoperability and retrieval. Within a single industrial domain, there exist many taxonomies that are intended for different applications. Industry specific taxonomies often represent the vocabularies that are commonly used by the practitioners. Their jobs are multi-faceted, which include checking for code and regulatory compliance. As such, it will be very desirable if industry practitioners are able to easily locate and browse regulations of interest. In practice, multiple sources (...) of government regulations exist and they are often organized and classified by the needs of the issuing agencies that enforce them rather than the needs of the communities that use them. One way to bridge these two distinct needs is to develop methods and tools that enable practitioners to browse and retrieve government regulations using their own terms and vocabularies, for example, via existing industry taxonomies. The mapping from a single taxonomy to a single regulation is a trivial keyword matching task. We examine a relatedness analysis approach for mapping a single taxonomy to multiple regulations. We then present an approach for mapping multiple taxonomies to a single regulation by measuring the relatedness of concepts. Cosine similarity, Jaccard coefficient and market basket analysis are used to measure the semantic relatedness between concepts from two different taxonomies. Preliminary evaluations of the three relatedness analysis measures are performed using examples from the civil engineering and building industry. These examples illustrate the potential benefits of regulatory usage from the mapping between various taxonomies and regulations. (shrink)

In the German legislation on embryo protection, the scope of protection is defined by its membership to the human species and by the embryo’s inherent potential to develop into a born human being. Both criteria refer to well-known bioethical arguments: the argument from species membership and the potentiality argument. With recent progresses in biotechnology it has, however, become possible manipulate the development potential of human embryos and to blur the boundaries between species. Hence, we must ask, whether both criteria (...) (and with them the arguments) can still hold their ground in bioethics and biomedical law. In my article, I argue, that the aforementioned biotechnological techniques do not require to abandon the arguments from species membership and potentiality. There is, however, a need to clarify what the criteria of species membership and inherent potentiality actually refer to in the relevant laws, i. e. the embryo protection law and the stem cell law. (shrink)

This article details how patent law works to create discrete, immutable biological ‘objects’. This socio-legal maneuver is necessary to distinguish these artifacts from the unwieldy realm of the natural world. The creation of ‘objects’ also serves the interests of capital, where a stable, unchanging, immutable object goes hand in hand with commodification. Yet this stabilization is incomplete. Pointing to a variety of different examples, this article illustrates how biotech patents do not speak to specific, immutable things. Biotech patents, rather, are (...) better understood as ontologically fluid, which is to say their identity cannot be ‘fixed’ — or, at least, not without undermining the very existence of today’s biotechnology regime. The article concludes by speaking briefly about how this mutability is perpetuating certain inequalities, particularly between holders of various property forms. (shrink)

HIV-related state laws are being created transnationally though the use of omnibus model laws. In 2004, the US Agency for International Development funded the creation of one such guidance text known as the USAID/Action for West Africa Region Model Law, or N'Djamena Model Law, which led to the rapid spread of HIV/AIDS laws, including the criminalisation of HIV transmission, across much of West and Central Africa . In this article, I explicate how an epidemic of highly problematic legislation spread across (...) the region as a result of a text-mediated work process enabled through model laws. I theorise the textual genre of model laws arguing that these texts are best understood as ‘preoperative documents’ which, when activated, can lead to swift legislative reform in and beyond the field of HIV/AIDS governance. The legislative process being investigated was made visible through participant observation, archival research, textual analysis and informant interviews with national and international stakeholders . This involved ethnographic research in Canada, the USA, Switzerland, Austria, South Africa and Senegal . The untold policy processes and narratives explored in this article make evident how the work of contesting problematic HIV/AIDS model laws and newly drafted state laws involves both creating new texts and contesting the legitimacy and efficacy of others. (shrink)

Purpose of this article is to tell foreign readers about novels made in Russian intellectual property law in 2014. As is known modern Russian revolution in the field of intellectual property legislation occurred January 1, 2008 when Russian intellectual property legislation was codified, included in the text of part fourth of the Civil Code of the Russian Federation. Part fourth of the Russian CC entered into force on January 1, 2008. At the same day seven sectoral intellectual property laws were (...) repealed. Second Revolution in this field took place during 2014: Federal law №35-FZ, 2014, substantially amending the Fourth part on the CC, entered into force on October the 1st of 2014. Scientific aim: The essence and evaluation of these amendments is the subject matter of this paper. Methods: The research is based on the analysis of the new amendments and articles added to the part fourth of the CC. Findings: Codification of the sectoral legislation en bloc in CC is a unique phenomenon. The author believes that such a construction of intellectual property law was made correctly and at the proper time. Factually the Federal Law №35-FZ is the eleventh law amending the text of the part fourth of the CC. But all previous amendments were small and not substantial. As far as amendments introduced by the law №35-FZ are concerned, they are numerous and very, very substantial. Before entering into force of the law №35-FZ, the Part fourth of the CC contained 328 articles. The law 35-FZ amends 169 articles of it and adds seven new articles. I am convinced that the law is a rather big step towards building a modern system of intellectual property legislation in Russia. Conclusions: More than 150 amendments were introduced by the law №35-FZ. Author estimates about 80% of them as positive and about 20% as negative and erroneous. These amendments do not contradict the international intellectual property agreements signed by the Russian Federation. Generally their purpose is to enhance and clarify the Russian intellectual property legislation and to narrow the gap between Russian and European intellectual property laws. The author of this article deals with intellectual property laws more than 50 years on. This paper is a short English version of various articles on this topic published in Russian, in journals: «The business and the law» and «The patents and licenses». (shrink)