Donna Dickenson

The European Biomedical Ethics Practitioner Education Project (EBEPE), funded by the BIOMED programme of the European Commission, is a five-nation partnership to produce open learning materials for healthcare ethics education. Papers and case studies from a series of twelve conferences throughout the European Union, reflecting the ‘burning issues’ in the participants' healthcare systems, have been collected by a team based at Imperial College, London, where they are now being edited into a series of seven activity-based workbooks for individual or group study. These draft workbooks are now being read by a network of critical readers across Europe, whose comments will be incorporated into the final versions of the workbooks. The result will be the first European-wide and Europe-centred resource for teaching students, practitioners, and members of ethics committees. Topics covered include: • Resource allocation and rationing • The rights of children and young people • Long-term care of the elderly • Mental health and mental illness • Autonomy and patient choice • Decisions at the end of life • A study guide to using the workbooks The collaborative nature of the project has highlighted differentiated national approaches in medical ethics. Against the British and Dutch rights-orientated approach have emerged two other alternative models: the Nordic preference for administrative resolution of entitlement disputes, and the southern European emphasis on deontological codes. A genuinely European reconstruction of autonomy and rights, using hermeneutic, feminist and narrative approaches to counterbalance individualistic models, is emerging across the workbooks. The programme has also uncovered national differences in how ethics should be taught, with the workbooks' style being an experiential approach. Thus the EBEPE project is developing new models in both substantive and pedagogic senses, about both what should be taught and how it should be presented

One important sense of 'global ethics' concerns the applied ethical issues arising in the context of economic globalisation. This article contends that we are beginning to witness the economic commodification and, concomitantly, the globalisation, of human tissue and the human genome. Policy-makers and local research ethics committees need to be aware that the relevant ethical questions are no longer confined to their old national or subnational context. A shift from questions of personal autonomy and identity can therefore be expected-towards the more problematic issues of justice, exploitation and distribution. Here we can learn from the distinctions drawn in legal philosophy, such as the notion of property as a 'bundle' of rights, from which we may choose rights favouring the interests of vulnerable populations. We may also wish to apply the distinctions drawn by Calabresi and Melamed between pure property rules, modified alienability rules, and pure non-property regimes. Global ethics also concerns issues of value disparity across cultures, directing our attention to the moral beliefs of indigenous peoples, for example, whose DNA or tissue is increasingly of commercial importance. In examining case examples from Tonga and Aotearoa/new Zealand, I will consider the impact of indigenous belief systems and of neo-colonialism on indigenous peoples' perceptions of Western researchers. It is clear that many indigenous peoples reject both the pure property system and any modifications, insisting on a pure non-property regime. How can they then be protected in a globalised market system that so far favours the opposite end of the spectrum?

Medical criteria rooted in evidence-based medicine are often seen as a value-neutral ‘trump card’ which puts paid to any further debate about setting priorities for treatment. On this argument, doctors should stop providing treatment at the point when it becomes medically futile, and that is also the threshold at which the health purchaser should stop purchasing. This paper offers three kinds of ethical criteria as a counterweight to analysis based solely on medical criteria. The first set of arguments concerns futility, probability and utility; the second, justice and fairness; the third, consent and competence. The argument is illustrated by two recent case studies about futility and priority-setting: the US example of ‘Baby Ryan’ and the UK case of ‘Child B’

New technologies are transforming and reconfiguring the boundaries between patients, research participants and consumers, between research and clinical practice, and between public and private domains. From personalised medicine to big data and social media, these platforms facilitate new kinds of interactions, challenge longstanding understandings of privacy and consent, and raise fundamental questions about how the translational patient pathway should be organised.This editorial introduces the cross-journal article collection "Translation in healthcare: ethical, legal, and social implications", briefly outlining the genesis of the collection in the 2015 Translation in healthcare conference in Oxford, UK and providing an introduction to the contemporary ethical challenges of translational research in biology and medicine accompanied by a summary of the papers included in this collection.

It is well known that there is a shortage of human ova for in vitro fertilization (IVF) purposes, but little attention has been paid to the way in which the demand for ova in stem-cell technologies is likely to exacerbate that shortfall and create a trade in human eggs. Because the 'Dolly' technology relies on enucleated ova in large quantities, allowing for considerable wastage, there is a serious threat that commercial and research demands for human eggs will grow exponentially from the combination of these two pressures. In the absence of legal regulation in the United Kingdom, and in the context of a globalized trade in human organs, we face a 'Wild West' situation in genetic and biotechnological research that involves human ova

Feminism offers three separate but equally important insights about human genetics and the new reproductive technologies. First, feminism is concerned with ways in which these new technologies have the potential to exploit women, particularly in the treatment of their reproductive tissue, while seeming to offer both sexes greater reproductive freedom. This risk has been largely ignored by much bioethics, which has concentrated on choice and autonomy at the expense of justice, giving it little to say about the concept of exploitation. Second, feminist scholars have developed complex and subtle analyses of how women's labour is incorporated into the global bioeconomy in a gendered manner. Although feminist perspectives vary on such issues as surrogate motherhood, they have provided important studies of how women's labour is commodified in the new reproductive technologies. Finally, feminist analysts and activists have been among the leaders in identifying and resisting the threats from commodification and commercialisation in genetic research and patenting, which often affect women disproportionately. In all three areas, feminist writers have drawn specific attention to medical, economic and political impacts on women that had not been adequately considered.

The rapid pace of change in the biosciences makes setting biotechnology policies and regulating the sciences difficult for governments, but no less necessary for that. Although government policies around the globe are sometimes classed as ‘pro-science’ or ‘anti-science’, that is a misleading oversimplification. Nurturing the ‘bioeconomy’ is a key goal for most national governments, leading in the UK to a comparatively loose regulatory policy, for example in relation to mitochondrial transfer and germline genetic modification. But in genetic patenting, a recent US court decision has reversed the trend towards privatisation of the human genome, which many scientists perceived as impeding their research. Opposition to permissive regulatory policies thus often comes not only from civic or religious groups, but also from within bioscience itself. In the area of vaccination against infectious disease, governments face an additional challenge from pandemics at the same time that financial austerity has prompted cutbacks in public health funding.

Available from UMI in association with The British Library. ;Typically we maintain two incompatible standards towards right action and good character, and the tension between these polarities creates the paradox of moral luck. In practice we regard actions as right or wrong, and character as good or bad, partly according to what happens as a result of the agent's decision. Yet we also think that people should not be held responsible for matters beyond their control. ;This split underpins Kant's assertion that only the good will is securely good, that its goodness is impervious to outcome ill-luck. Some commentators, such as Martha Nussbaum and to some extent Bernard Williams, think that this simply writes off the paradox. Williams asserts that the paradox is insoluble, and that its inescapability threatens the notion of agent responsibility. In contrast Thomas Nagel argues that agents' most cherished projects may be indeed be subject to luck, but that does not mean that their deepest motivations are moral. This, I suggest, is one of several means whereby we might limit the effect of the paradox without denying that the tension exists. But I also argue that it is wrong to accuse Kant of ignoring the paradox. ;Ethical consequentialists, on the other hand, appear to have no problem with moral luck, because the paradox depends on a dichotomy between the outside world and the locus of moral worth in the individual agent. But this turns out not to be true. The problem of moral luck is not some strange Kantian fixation, but a general dilemma: a variant on what Nagel terms "the problem of excess objectivity" which cuts across all of ethics and metaphysics. ;Retaining a broadly Kantian notion of agent-responsibility, but limiting what agents are responsible for, requires us to delineate the realm of ethics more narrowly than has been done by those who believe that the rational and/or prudential are coterminous with the ethical. This strategy for minimising the paradox's impact is explored in two areas from medical ethics, the allocation of scarce medical resources and informed consent, and two from public policy, secrecy and nuclear deterrence. Throughout, the analysis seeks to test Nagel's maxim that the best we can hope for is to act in such a manner that we would not have to revise our opinion of how we should have acted once the consequences of our actions become apparent.

In conventional thinking, the promise of scientific progress gives automatic and unquestioned legitimacy to any new development in biotechnology. It is the nearest thing we have in a morally relativistic society to the concept of the common good. This chapter begins by examining a recent case study, so-called ‘mitochondrial transfer’ or three-person IVF, in which policymakers appeared to accept that this new technology should be effectively deregulated because that would serve UK national scientific progress and the national interest, despite serious unanswered concerns about its effectiveness and safety. The historical and philosophical underpinnings of the concept of the common good should make us more sceptical of the manner in which the concept can be perverted by particular interests. But there are also hopeful signs that the common good and the biomedical commons are being taken seriously in new models for governance of genomics and biotechnology more generally.

In this chapter I argue that the old common law concept of the commons can make a major contribution to how we regulate human tissue and genetic information in the twenty-first century. But if we want to use this concept, we will have to act fast, because private corporate interests have already realised the relevance of the commons for holdings in human tissue and genetic information. Instead of a commonly created and held resource, however, they have sought to create one derived from many persons' mutual labour but owned privately: what I call, with deliberate irony, a 'corporate commons'.

Can't Regulate, Won't Regulate? As the global trade in human eggs continues to expand with logarithmic momentum, it is frequently argued that we could not regulate it even if we wanted to. Not all commentators do want to, of course. Many view regulation as counterproductive: reports have suggested that FDA governance has had the perverse effect of increasing levels of reproductive tourism to Latin America. Most of the other chapters in this volume are broadly in favour of letting market forces take their course, with varying degrees of control. I will examine whether reproductive freedom and choice really are all-important. Before I begin that analysis, however, I need to clear away the argument that we cannot control black markets in human body parts, including eggs, even if we want to. This argument is common to commentators from many positions in the political spectrum. Some writers assert that “baby markets,” comprising egg sale, surrogacy, and paid adoption, are so firmly established that prohibiting or regulating them salves our collective conscience but amounts to no more than hypocritical pretense. Other commentators claim that the burgeoning demand for eggs simply makes even an honest attempt to ban markets unrealistic or imply that the natural and laudable desire for “procreative liberty” would inevitably drive couples to defy paternalistic legal bans. On any of these accounts, regulating global markets in human tissue is said to be a lost cause. I argue the opposite.

In common law, the traditional rule has been that there is no property in excised human tissue. In an era of widespread commodification of tissue, however, the practical reasons behind this position are increasingly outdated, while the philosophical grounds are paradoxical. This no-property rule has been construed so as to deprive tissue providers of ongoing rights, whereas researchers, universities, and biotechnology companies are prone to assume that once they acquire proprietary rights, those rights are complete and undifferentiated. That position can and should be remedied, drawing on a modified Lockean concept of property in what we have laboured to create, and a more sophisticated jurisprudential understanding of property in the body as a bundle of rights. Particularly in the case of women’s tissues, such as ova and umbilical cord blood, this model can offer more effective protection against the global ‘enclosures’ of bodily tissue.

Although the term commodification is sometimes criticised as imprecise or overused, in fact it has a complex philosophical ancestry and can never be used too much, because the phenomena that it describes are still gaining ground. The issues that commodification raises in relation to reproductive technologies include whether it is wrong to commodify human tissues generally and gametes particularly, and whether the person as subject and the person as object can be distinguished in modern biomedicine. This chapter examines three areas in which commodification is a serious concern for important reproductive technologies: the sale of eggs for IVF and research, the banking of umbilical cord blood, and the use of gestational surrogates both domestically and internationally. Sales of human eggs for IVF or research are frequently disguised as “gifts”, which conceals the very real bodily risks and harms associated with ovarian hyperstimulation and egg harvesting undergone by egg “donors.” Umbilical cord banking is a fast-growing industry, with donated cord blood trading globally at very high prices; women who consent to banking of cord blood ostensibly for the potential future benefit of their child may not be informed of the likelihood that it will be traded in commercial markets or that the method used for harvesting may increase risks of jaundice in their babies. Commercial surrogacy also exploits altruism but in addition involves wrongful sale of babies, particularly in the international context. In each example, the commodification of women’s reproductive labour is masked by the manner in which ‘the lady vanishes’ under a gift model, ignoring the true economic value of their labour.