Anne-Maree Farrell

Routine administration of Anti-D: the ethical case for offering pregnant women fetal RHD genotyping and a review of policy and practice

BackgroundSince its introduction in the 1960s Anti-D immunoglobulin (Anti-D Ig) has been highly successful in reducing the incidence of haemolytic disease of the fetus and newborn (HDFN) and achieving improvements to maternal and fetal health. It has protected women from other invasive interventions during pregnancy and prevented deaths and damage amongst newborns and is a technology which has been adopted worldwide. Currently about one third of pregnant women with the blood group Rhesus D (RhD) negative in the UK (approximately 40,000 women per year in England and Wales), receive antenatal Anti-D Ig in pregnancy when they do not require it because they are carrying a RhD negative fetus. Since 1997, a test using cell free fetal DNA (cffDNA) in maternal blood has been developed to identify the genotype of the fetus and can be used to predict the fetal RhD blood group.DiscussionThis paper considers whether it is ethically acceptable to continue administering antenatal Anti-D Ig to all RhD negative women when fetal RHD genotyping using maternal blood could identify those women who do not need this product.SummaryThe antenatal administration of Anti-D Ig to a third of RhD negative pregnant women who carry a RhD negative fetus and therefore do not need it raises important ethical issues. If fetal RHD genotyping using maternal blood was offered to all RhD negative pregnant women it would assist them to make an informed choice about whether or not to have antenatal Anti-D Ig.

Revaluing donor and recipient bodies in the globalised blood economy: Transitions in public policy on blood safety in the United Kingdom

The clinical use of blood has a long history, but its apparent stability belies the complexity of contemporary practices in this field. In this article, we explore how the production, supply and deployment of blood products are socially mediated, drawing on theoretical perspectives from recent work on ‘tissue economies’. We highlight the ways in which safety threats in the form of infections that might be transmitted through blood and plasma impact on this tissue economy and how these have led to a revaluation of donor bodies and restructuring of blood economies. Specifically, we consider these themes in relation to the management of recent threats to blood safety in the United Kingdom. We show that the tension between securing the supply of blood and its products and ensuring its safety may give rise to ethical concerns and reshape relations between donor and recipient bodies.

The Politics of Blood: Ethics, Innovation and the Regulation of Risk

1. Introduction 2. The governance of the blood system 3. Revisiting the gift relationship 4. Professional beliefs and scientific expertise 5. Risk and innovation 6. The rise of the recipient 7. The politics of precaution 8. Regulating risk 9. Conclusion.

IS THE GIFT STILL GOOD? EXAMINING THE POLITICS AND REGULATION OF BLOOD SAFETY IN THE EUROPEAN UNION

This paper examines the development of blood policy and regulation at European Union (EU) level. It provides a critical analysis of the gift relationship in blood donation and analyses key aspects of the Blood Directive.

Risky Bodies in the Plasma Bioeconomy: A Feminist Analysis

In 2003 the UK National Blood Service introduced a policy of ‘male donor preference’ which involved women’s plasma being discarded following blood collection. The policy was based on the view that data relating to the incidence of Transfusion-Related Acute Lung Injury (TRALI) was linked to transfusion with women’s plasma. While appearing to treat female donors as equal to male donors, exclusion criteria operate after donation at the stage of processing blood, thus perpetuating myths of universality even though only certain ‘extractions’ from women are retained for use in transfusion. Many women in the UK receive a plasma-derived product called Anti-D immunoglobulin which is manufactured from pooled male plasma. This article examines ways in which gender has significance for understanding blood relations, and how the blood economy is gendered. In our study of relations between blood donors and recipients, we explore how gendered bodies are produced through the discursive and material practices within blood services. We examine both how donation policies and the manufacturing and use of blood products produces gendered blood relations.

The Politics of Risk and EU Governance of Human Material

This paper examines the politics of EU risk governance in relation to human material. It is argued that the political context has informed the way in which risks in relation to various types of human material have come to be defined as policy problems at EU level. In turn, this has influenced the design and/or persistence of institutional arrangements to manage such problems. It is further argued that this political context has resulted in a significant level of disconnection in risk governance in the area. This has happened in two ways. First, there has been a growing level of disconnection between institutional and stakeholder demands for a more expansive approach to risk governance in the area and the narrowly-circumscribed competence under Article 152(4)(a) EC, which permits the adoption of risk regulation regimes that set minimum standards of quality and safety in relation to blood, tissue/cells and organs. Second, it has led to the development of institutional arrangements that promote a bifurcated approach to risk governance, specifically in relation to blood and tissues/cells. Although a hybrid of traditional and new governance mechanisms have been employed to address this problem of disconnection, this has nevertheless added a further layer to already complex institutional arrangements for risk governance in the area. It is suggested that a more integrated approach to EU risk governance in relation to human material is needed. Implementing such an approach would contribute to greater clarity, transparency and accountability in decision-making processes, and this could enhance public trust in what is a politically-sensitive area of governance at EU level.

Translational bodies: exploring the socio-legal contours of human bodies past present and future

Historically, the human body has been the point of departure for understanding ourselves, and our relationship to nature and the wider universe. It has been the subject of traditions and taboos, art and science, and of medical research. Increasingly, the human body and its parts have been the focus of technological advances in medicine and science that challenge popular ideas of what is natural or conventionally acceptable, what can or should be subject to medical or legal intervention. Such translational bodies do not always follow a linear path; the expectations of some technological advances have often had unexpected repercussions. Against the background of such developments, the study of the human body has emerged as an exciting and multidisciplinary area of research within the broader field of socio-legal studies in health. Taking the human body as the point of departure, this special issue will draw, and critically reflect upon some of the work undertaken in the fiveyear Wellcome Strategic Programme The Human Body: Its Scope Limits and Future. The Programme has brought together an interdisciplinary and international group of scholars from sociology, law, bioethics and the life sciences. One of the main aims of the Programme has been to pursue research that explores how the human body has interacted with technological developments in medicine and science, not just as end-users of technology but at all stages of development; for example, the use of human biomaterials in medical and scientific technology and new enhancement technologies which may modify the human body and even re-direct evolution. In this regard, the socio-cultural context in which such developments have taken place, as well as the role of law and regulation, have been central to the work undertaken during the course of the Programme. An interdisciplinary conference to mark the end of the Programme, ‘Translational Bodies: Ethical, Legal and Social Issues’, was held in April 2014. Selected papers presented at the conference have now been brought

Addressing Organ Shortage: Are Nudges the Way Forward?

ABSTRACT This paper examines the use of nudges in organ donation, against a background of organ shortage. This is a complex and contested area of public policy where questions of legitimacy loom large. The legitimacy of nudges is assessed by reference to function, values-based and democratic criteria. Analysis of normative claims made about nudges revealed that such criteria were not fulfilled. Findings from UK experimental studies showed that nudge interventions had a short-term effect, limited to increasing organ donation registration rates. It was unclear how this might translate into donation of organs after death or successful organ transplants. One of the studies also revealed the importance attached to reciprocity in motivating people to register as organ donors. This calls into question whether there should more of a focus on developing a reciprocity model to encourage human tissue donation, rather than relying on altruistic intent as embodied in the gift relationship.

REGULATORY ‘DESIRABLES’ FOR NEW HEALTH TECHNOLOGIES

This paper examines the relationship between health, technology and regulation, focusing in particular on what happens in the context of innovation. Key elements identified that inform (or should inform) the regulation of new health technologies include the following: (1) hybridity, (2) regulatory certainty and stability; (3) a move away from risk-based regulation alone; and (4) regulatory legitimacy through participation and information.

Contextualising the Regulation of Health Technologies

Explores key themes in journal special issue on Contextualising the Regulation of Health Technologies