Bioethical ambition,political opportunity and the European governance of patenting: The case of human embryonic stem cell science

Scientific progress in the life sciences is dependent on the governance of tensions between the economic potential of the innovation and the cultural response from society. Ownership of the scientific innovation through patenting is a necessary part of the realization of its economic value yet, in the case of human embryonic stem cell (hESC) science, ownership of the human body and human life may offend fundamental cultural values. In the case of transnational patenting governance by the European Patent Office (EPO) and the European Union (EU), cross-national cultural conflict in the field of hESC science has produced a political demand for a form of governance that can incorporate ethical as well as economic judgements in its decision making. This paper explores how bioethics has responded to this opportunity to establish itself as a form of expert authority for the negotiation and resolution of the cultural conflict. In so doing, it shows how the political struggle that has accompanied this bid for new governance territory has been influenced both by the political tensions between the EPO and EU systems of patenting governance and the resistance of competing experts in law and science to a bioethical presence.     

Deciding about your Health Care: The Ethicist as Policy-Maker

The author demonstrates that professional bioethics is culturally very risk averse when it comes to evaluating the possible ethical consequences of new technologies such as genetic testing, human embryonic stem cells, and reproductive cloning. Deeper involvement in the Federal regulatory process by bioethicists will exacerbate this tendency toward risk aversion. This cultural bias toward caution will tempt many bioethicists to look to the so-called precautionary principle for policy guidance. Adopting the precautionary principle would harm patients by slowing the development of new therapies. The author argues that bioethicists should reject the precautionary principle and instead rely on conscientious trial and error as a superior way to approach implementing new biomedical technologies ethically. Science Correspondent, Reason This revised version was published online in July 2006 with corrections to the Cover Date.     

Human embryonic stem cell science and policy: The case of Iran

The paper is based on a large qualitative study of ethics, policy and regulation of human embryonic stem cell (hESC) science in Iran. This case study in five academic research centres used semi-structured interviews to examine in depth the views of stem cell scientists, embryologists and ethics committee members on hESC research policy in this Shia Muslim country. Although Iran's policy approach has been considered 'intermediate', what is described here seems to be a 'more flexible' policy on hESC science. This article describes three arguments to explain why Iran has shaped such a policy. These are: (1) a flexibility of the Shia tradition has allowed for hESC science; (2) permissive policy related to other fields of biomedicine, such as new assisted reproductive technologies, facilitated approval of hESC research; and (3) a lack of public debate of bioscience in Iran influences how its hESC research policy is perceived. Based on the empirical data, this paper then expands and refines the conceptual bioethical basis for the co-production of science, policy, and society in Iran. The notion of co-production implies that scientists, policy-makers, and sometimes other societal actors cooperate in the exchange, production, and application of knowledge to make science policy.     

Bioethics on the Subcontinent: The Sindh Institute in Karachi

In this personal narrative the author recounts his experiences teaching bioethics in Pakistan. He notes the different moral, cultural and legal environments of Pakistan as compared to the United States, and in particular, the ways in which subtle interpretations of Sharia law shape bioethical reflections as well as the biomedical legal environment. As he argues, any attempt to export models of bioethics from one country to another with no attention to social and cultural differences is a recipe for failure. To presume that all ethical considerations are universal is to devalue moral traditions that differ from our own, and dismiss cultural values of other societies.     

Respect for cultural diversity in bioethics. Empirical,conceptual and normative constraints

In contemporary debates about the nature of bioethics there is a widespread view that bioethical decision making should involve certain knowledge of and respect for cultural diversity of persons to be affected. The aim of this article is to show that this view is untenable and misleading. It is argued that introducing the idea of respect for cultural diversity into bioethics encounters a series of conceptual and empirical constraints. While acknowledging that cultural diversity is something that decision makers in bioethical contexts should try to understand and, when possible, respect, it is argued that this cultural turn ignores the typically normative role of bioethics and thus threatens to undermine its very foundations.     

Ethical Aspects of the Use of Stem Cell Derived Gametes for Reproduction

A lot of interest has been generated by the possibility of deriving gametes from embryonic stem cells and bone marrow stem cells. These stem cell derived gametes may become useful for research and for the treatment of infertility. In this article we consider prospectively the ethical issues that will arise if stem cell derived gametes are used in the clinic, making a distinction between concerns that only apply to embryonic stem cell derived gametes and concerns that are also relevant for gametes derived from adult stem cells. At present, it appears preferable to use non-embryonic stem cells for the derivation of gametes. Adult stem cell derived gametes do not present any problems with regard to the moral status of the human embryo, bypass the safety risks linked to SCNT and do not present any ambiguity or novel problems with regard to informed consent, psychological consequences for the child or genetic parenthood. A remaining ethical concern, however, regards the safety of the procedure in terms of the welfare of the resulting children. This should spark a thorough reflection on how far one must go to accommodate a person’s wish to have a genetically related child.     

Altruism,solidarity and affect in live kidney donation and breastmilk sharing

Social scientists have recently diverged from mainstream bioethical discussion on the topic of the medical use of human biological materials for therapeutic, reproductive and research purposes. Rather than justifying the donation and provision of biological materials solely in terms of alleviating physical, psychological and social suffering, saving or enhancing life, and advancing biomedical knowledge, this work looks beyond humanist bioethics to take a social justice approach to questions of the life sciences. In this article, I draw insight from these accounts to propose an approach to the sociology of live kidney and breastmilk donation that is situated at the interface of the new sociology of morality and affect studies. To do so, I examine the moral economy of tissue provision with respect to its organisation around the discourse of altruism and the gift. I then turn to recent work on tissue economies, which are in the business of creating and producing biovalue, to discuss the manipulation of affect and the entanglement of new forms of bio‐intimacy in the production and reproduction of somatic life. The aim of the article was to contribute to the study of the sociology of donation as a substantive field of specialisation within sociology.     

Psychoanalysis and bioethics: a Lacanian approach to bioethical discourse

This article aims to develop a Lacanian approach to bioethics. Point of departure is the fact that both psychoanalysis and bioethics are practices of language, combining diagnostics with therapy. Subsequently, I will point out how Lacanian linguistics may help us to elucidate the dynamics of both psychoanalytical and bioethical discourse, using the movie One flew over the Cuckoo’s Nest and Sophocles’ tragedy Antigone as key examples. Next, I will explain the ‘topology’ of the bioethical landscape with the help of Lacan’s three dimensions: the imaginary, the symbolical and the real. This will culminate in an assessment of the dynamics of bioethical discourse with the help of Lacan’s theorem of the four discourses. Bioethics, I will argue, is not a homogeneous discourse. Rather, four modalities of bioethical discourse can be distinguished, all of them displaying specific weaknesses and strengths, opportunities and threats. This will be elucidated with the help of two case studies, namely the debates on human reproductive technologies and on the use of animals as biomedical research models.     

A primer on stem cell research

Stem cell research holds promise for new treatments for diseases such as Parkinson's and injuries such as those to the spinal cord. Yet stem cell research remains steeped in controversy. This article defines key terms and outlines some of the basic concepts related to stem cell research in order to clarify concepts and correct misconceptions. It also briefly discusses what scientists, particularly those at the University of Minnesota, are learning about adult and embryonic stem cells and their potential for research and treatment.     

From bench to bedside? Biomedical scientists' expectations of stem cell science as a future therapy for diabetes

The movement of scientific research from the bench to the bedside is becoming an increasingly important aspect of modern 'biomedical societies'. There is, however, currently a dearth of social science research on the interaction between the laboratory and the clinic. The recent upsurge in global funding for stem cell research is largely premised on the promise of translating scientific understanding of stem cells into regenerative medicine. In this paper, we report on the views of biomedical scientists based in the United Kingdom who are involved in human embryonic stem cell research in the field of diabetes. We explore their views on the prospects and problems of translational research in the field of stem cell science. We discuss two main themes: institutional influences on interactions between scientists and clinicians, and stem cell science itself as the major barrier to therapies. We frame our discussion within the emerging literature of the sociology of expectations.     

Uncertainty,risks and ethics in unsuccessful in vitro fertilisation treatment cycles

In this article we explore the results of interviewing Portuguese couples involved in unsuccessful in vitro fertilisation (IVF) programmes. We argue that the references to uncertainties and risks of IVF procedures and their implications in the mobilisation and in the actions of different social and/or professional groups should be central topics in the debates of biomedicine and bioethics in a broader sense and in local ethics of clinical research and doctor–patient relationships. These debates should incorporated the experiences of women and men who try to have a biological child by using these techniques and produce reflection about the social, cultural, technical and medical changes that will be necessary so that these technologies are increasingly successful. The medical recognition of uncertainties, risks and complications can be an important element underlying a patient-friendly medicine, because it could minimise the feeling that many patients might have, especially women, that they are to blame.     

Respect for cultural diversity in bioethics is an ethical imperative

The field of bioethics continues to struggle with the problem of cultural diversity: can universal principles guide ethical decision making, regardless of the culture in which those decisions take place? Or should bioethical principles be derived from the moral traditions of local cultures? Ten Have and Gordijn (Medicine, Health Care and Philosophy 14:1–3, 2011) and Bracanovic (Medicine, Health Care and Philosophy 14:229–236, 2011) defend the universalist position, arguing that respect for cultural diversity in matters ethical will lead to a dangerous cultural relativity where vulnerable patients and research subjects will be harmed. We challenge the premises of moral universalism, showing how this approach imports and imposes moral notions of Western society and leads to harm in non-western cultures.     

Profitable Exchanges for Scientists: The Case of Swedish Human Embryonic Stem Cell Research

In this article two inter-related issues concerning the ongoing commercialisation of biomedical research are analyzed. One aim is to explain how scientists and clinicians at Swedish public institutions can make profits, both commercially and scientifically, by controlling rare human biological material, like embryos and embryonic stem cell lines. This control in no way presupposes legal ownership or other property rights as an initial condition. We show how ethically sensitive material (embryos and stem cell lines) have been used in Sweden as a foundation for a commercial stem cell enterprise--despite all official Swedish strictures against commercialisation in this area. We also show how political decisions may amplify the value of controlling this kind of biological material. Another aim of the article is to analyze and discuss the meaning of this kind of academic commercial enterprise in a wider context of research funding strategies. A conclusion that is drawn is that the academic turn to commercial funding sources is dependent on the decline of public funding.     

Setting the agenda for urban bioethics

Urban bioethics has two goals. First, it aims to focus attention on neglected bioethical problems that have particular salience in urban settings. Three problems are highlighted: socioeconomic inequality as a major determinant of health inequality, the foundations of an ethic for public health, and the impact of social context on the therapeutic alliance between patients and physicians. Second, urban bioethics serves as a vehicle for raising deep theoretical and methodological questions about the dominant assumptions and approaches of contemporary bioethics. Demands for cultural sensitivity, so pronounced in the urban context, compel us to reexamine the central commitment in bioethics to personal autonomy. The multiculturalism of urban life also argues for a dialogic approach to bioethical problem solving rather than the monologic approach that characterizes most bioethical thinking. Although my brief for redirecting bioethics will resonate with many critics who do not consider themselves urban bioethicsts, I argue that there are special advantages in using urban bioethics to expose the limitations of contemporary bioethical paradigms.     

Embryo futures and stem cell research: the management of informed uncertainty

In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.     

Embryonic Stem Cell Patents and Human Dignity

This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells.     

Bioethics in Germany: debates and infrastructure

In Germany the public awareness on ethical problems of the application of medicine and life sciences on human beings is very high. It can be observed that German Society is rather sensitive concerning bioethical issues. Politics supports this attitude. Many articles in professional journals as well as in newspapers cover bioethical issues. Conferences and workshops on a professional and an educational level deal with topics on ethics of life sciences and ethics in general. Moreover, in the case of bioethics many different disciplines contribute with relevant considerations to the process of opinion and judgment formation. This paper summarizes the main ethical and legal debates on bioethical issues in Germany, specifies the focus of leading German centres of bioethics and biolaw, and explains the tasks, services and networking of the German Reference Centre for Ethics in the Life Sciences (DRZE) which was founded by the Federal Government.     

A Small Bioethical World?

This essay discusses four challenges posed to a global bioethics by articles on: divergent national policies on compensation of egg donors for IVF, efforts to advance the development of international guidelines for the management of neonates on the edge of viability, bioethics training workshops in Uganda, a bioethicist’s reflection on a visit to Pakistan. The article then discusses several approaches to developing a global bioethics and how these approaches might meet the four challenges. The essay concludes with discussion of the author’s development of a “navigational approach” to policymaking for “fractious” bioethical policy problems and how this compares to other approaches to developing a global bioethics.