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Plenary Policy Panel:                                                                   

Standard setting, regulation and the authorisation of stem cell therapy provision

Disagreement exists among scientists about taking stem cell therapies to the clinic. Some scientists reject the provision of stem cell therapy in commercial clinics, but accept the need to use them for patients that are otherwise at the end-state-of-life. As expressed in the differences of countries’ regulation, there is also disagreement about the timing, costs, ethics, audit and follow-up studies of clinical applications. One issue is who should set the standards; another is, should these standards be applied in all countries, even if the conditions of health care resources and science infrastructure in countries vary.

The scientists, policymakers and science observers of this panel debate the standard setting by which stem cell therapies are regulated and authorised in an international context.


Paolo Bianco, University of Rome

Willem Fibbe, Leiden University Medical Centre

Hongyun Huang, Center of Neurorestoratology, Beijing Rehabilitation Hospital of Capital Medical University, China

Kamthorn Pruksananonda, Faculty of Medicine, Chulalongkorn University, Bankok

Alok Sharma, Neurogen, Mumbai

Geeta Shroff, Nutech Mediworld, New Delhi



Panel 1: ‘Resistance and alter-standardization in emerging medicine research: the role of global asymmetries’

Organiser: Achim Rosemann

The panel seeks to explore the emergence of organized networks of resistance and alter-standardization in regenerative medicine research, and to make sense of these processes from a comparative and historical perspective. The panel seeks to generate insights, into the ways in which these ‘subversive’ forms of clinical translation are informed by differentiated access to financial, technological and infrastructural resources, and enabled by the strategic use of global differences in wealth, health care and research regulation. We are interested not only in developments in regenerative medicine research, but also in insights from other forms of medicine research, from both contemporary and historical perspectives. For which reasons, and under which circumstances, for instance, is the use of established standards and hierarchies for evidence-based medicine contested, or has it been contested in the past? What contribution can the concept of bionetworking make in better understanding the emergence and characteristics of these forms of resistance?


Nicole Baur, School of Sociology, Anthropology and Philosophy, University of Exeter, Christine Hauskeller, Professor, School of Sociology, Anthropology and Philosophy, University of Exeter

Diachronous Harmonization. Ethical and technical problems implementing a stem cell clinical trial across Europe

In this talk we will report first findings from an empirical investigation of the process of multi-national clinical trials implementation in Europe. As part of a clinical trial team, we have the rare opportunity to study implementation while it happens in a 3000 patient phase 3 stem cell trial. Our findings show that the policies in place to harmonise medical practice in Europe can lead to serious delays before patient recruitment starts. We will especially focus on problems with the logistics and technological requirements following EMA regulations and the efficacy of the Voluntary Harmonisation Procedure (VHP).


John Paul Dimoia, Department of History, National University of Singapore

Dissonant Resonances: Post-Colonial Medical Standardization, and the Import of Practices in the First Decades of “International Medicine,” (1945-late 1990s)

In the overlapping, yet still disparate fields of the history of medicine, the history of the biosciences, and medical anthropology, there is a growing recognition that the first age of “international medicine” came about through the assembly of fragments of practices and institutions originating with the era of high colonialism. In other words, much of modern biomedicine not only originates with colonial relations, as Warwick Anderson has claimed in several distinct venues, but also it continues to persist, and the emergence of a new field of “global health” represents an attempt to grapple with this problem.
This paper proposes closely to look at two sites, Singapore / SEA (1965- ) and South Korea / NEA (1948- ), to offer a comparative view of how colonial influences make themselves felt in biomedical practice well after the creation of these “new” nations, and despite all attempts to avoid precisely such a problem. With both countries investing heavily in the biosciences in the early twenty-first century, it has become necessary to look at the regulatory institutions, environments, and practices upon which these two distinct communities based their ambitions, as both nations seek to be acknowledged as equals by their international partners.


Alex Faulkner, Centre for Global Health Policy, University of Sussex

Special treatment? Exceptions, exemptions and evidence in the politics of regenerative medicine gatekeeping in the UK

The global field of cell-based and tissue-engineered regenerative medicine is diversifying, as a wide range of biological mechanisms and therapeutic delivery technologies are developed, tested, trialled and, occasionally, introduced into clinical practice. The field has become an international battleground for opposing forces of regulatory gatekeeping and innovation politics. This applies both to the arenas of legal regulation of market entry and to the regulation of healthcare commodities’ adoption by technology assessment and commissioning agencies. The UK’s legal regulatory activity in the field is conditioned by its position in the EU and especially, though not exclusively, the Advanced Therapy Medicinal Products Regulation of 2007; its (England’s) public healthcare adoption activity is undertaken notably by technology assessment-based policy body NICE (National Institute for Health and Care Excellence) and commissioning/service contractor NHS England. Both gatekeeping arenas are the site of a range of contests about whether, and if so, how, regenerative medical technologies might be accorded ‘special treatment’. The technical novelty, evidential uncertainty and high promise of technologies in the field exacerbate the normal tensions of balancing innovation and regulation. In what sense might regenerative medicine or cell therapy be treated in market regulation and healthcare system innovation as a special sector or zone? How does personalised regenerative therapy interact in relation to systemic standardisation? The paper analyses recent and current regulatory and gatekeeping strains of policy discourse and activity in terms of the tension between commensuration with inherited classificatory domains and technoscientific standards on the one hand, set against counter-movements of exceptionalism and exemptionalism on the other. The paper draws on former and current ESRC supported research projects and involvement in UK policy and technology assessment bodies.


Jean Harrington, NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London

Fragile entities: the construction of stem cell research

Emerging fields of medicine can be described as on-going spaces of deliberation regarding the interface between scientific knowledge and medical practice, a locus of strategic professional adaptations on the part of the actors involved and a forum of conflicts and negotiations of expertise. In this paper I shall discuss ‘resistance’ and the inherent emergence of alter-standardization along clinical research pathways using examples from regenerative stem cell medicine. I shall argue that the entities in Research Clinical Trials are ‘fragile’, made particular by biological and socio-technical practice, remaining susceptible to hierarchical influence.


Roger Jeffery, School of Social and Political Science, University of Edinburgh; Salla Sariola, Ethox, University of Oxford; Deapica Ravindran, IIT Madras

Clinical trials in South Asia: Insights from ‘normal science’ in emerging settings

A sizeable clinical trials ‘industry’ has emerged in South Asia – and predominantly in India – only since 2005. There are strong financial, nation building and reputational incentives for these trials to conform as nearly as possible to the RCT model and to adhere to GCP guidelines. Sponsors consider the possibility of registering new chemical entities for use in the USA, EU and Japan. Local and global CROs see taking part in multi-sited trials as the best way to position themselves in a global market and to build their own capacity.
Contrary to the arguments that these developments are simply ‘extractive’, in this paper we show how researchers in India invite these developments in their current, international forms. Although the growth of trials in India contributes to wider reshaping of the global economy, there is little sign of resistance, but rather of ‘buy-in’. We found neither criticism of RCTs, nor advocacy to adopt alternative research standards, nor processes of clinical translation exterior to the review procedures of drug regulatory authorities. Using data drawn from our study of clinical trials in South Asia, carried out from 2009-12, this paper discusses the more common complaints about how to move up the knowledge value chain, and consider the implications of the recent critiques of the Indian clinical trials industry and its regulation.


Panel 2:  ‘Medical and wellness tourism’: bionetworking across boundaries

Organisers: Nattaka Chaisinthop and Masae Kato

The panel aims to explore the global bionetwork of ‘medical and wellness tourism’, a term which is certainly not unproblematic. Such travels are often embedded in and realised through global networks of clinics, hospitals, companies, research, regulatory and other institutions, whereby treatments may be promoted and organised in one location and carried out in another. Indeed, increasingly, one or more of the locations involved are in the virtual world, in on-line communities. The panel examines ‘bionetworking’ activities amongst service providers, companies, researchers, medical practitioners, regulators, patients and their families. ‘Bionetworking’ activities refer to all activities, which are necessary to produce, justify and legitimise a particular form of knowledge and its application in a specific locality. By examining these activities, which may include networking, collaborating, managing, trading, lobbying and others, the panel hopes to further understand how therapies and clinics that may be viewed as ‘unscientific’, ‘unnecessarily risky’ and even ‘dangerous’ in the eyes of some stake holders, could also be seen as ‘rational’, ‘necessary’ and ‘acceptable’ in certain contexts and localities. Through these discussions, the panel hopes to understand the phenomenon of ‘medical and wellness tourism’ in ways that reflect realities on the ground and are in touch with the experiences of those involved, as well as to further the debate on how best to provide oversight over such forms of travel.


Alessandro Blasimme, Département d’épidémiologie et de santé publique, Faculté de Médecine, Université de Toulouse

Global Travels for Stem Cells: new ethical challenges of medical tourism in the age of regenerative medicine

Thousands of clinical trials employing human stem cells of various kinds as material medica are underway all over the world. However, only a limited number of conditions can, at present, be demonstrably treated with stem cells. Much of the hype surrounding the clinical translation of stem cell science into therapeutic application, today, is still to a large degree speculative. Nevertheless, a lucrative market linked to stem cells is flourishing, as stem cell clinics continue to open and operate. To a large extent, this phenomenon poses new challenges with respect to medical tourism as we have known it thus far. Drawing on an STS methodology, I will present case studies from both the US (Colorado and Texas) and Europe (Germany and Italy) describing how patients travel from one regulatory environment to another seeking scientifically unsupported stem cell therapies, and how regulatory agencies try to tame the provision of such therapies. These case studies provide empirical support: 1) to the idea that stem cell tourism is a typically global phenomenon; and 2) to the idea that regulatory and healing practices are mutually co-produced.


Neil Lunt,*; Hanefeld, Johanna** and Horsfall, Daniel *
*Department of Social Policy and Social Work, University of York, ** Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine

Networks and Medical Tourism

A significant new element of a growing trade in healthcare has involved the movement of patients across borders for medical treatment; a phenomenon commonly termed ‘medical tourism’. This treatment may span the full range of medical services, but most commonly includes dental care, cosmetic surgery, elective surgery, and fertility treatment.

There has been a shift towards patients from richer, more developed nations also travelling to less developed countries to access health services, largely driven by the low-cost treatments available in the latter and helped by cheaper flights and internet sources of information. There are also strong intra-regional flows.

The world of medical tourism is one of speculation and anecdote and there is a dearth of empirical evidence and conceptual and theoretical insight. In seeking to begin to address this lacunae research at the University of York and the London School of Hygiene and Tropical Medicine sought to understand medical tourism decision making, patient safety and risk, industry development and economic implications.

Here we examine findings from our NIHR-funded study (2011-2013) of medical tourism and the UK. We examine the centrality of networks in understanding the emergence and practice of medical tourism. The paper discusses three dimensions of network activity that emerge from our study:
1) Knowledge networks: legitimating and promoting medical tourism
2) Demand-side networks: the decision-making and treatment pathways of medical tourists
3) Supply-side networks: clinical, provider and industry interrelations


Laurent Pordié, CNRS-Cermes3, Paris

The Nodal Points of Transnational Bionetworking

This paper examines location and network, circulation and connectivity, mobility and motionlessness in order to renew current understanding on therapeutic travel and the transnational production of medical knowledge and practice. For this purpose, the notion of “space of connectivity” is introduced to highlight the intersections of transnational networks and circuits. Circulations within these circuits converge in situated nodal points, such as clinics or medical classrooms, where connectivity between geographically mobile and immobile agents intensifies. These nodal points result from the crystallization of transnational social, material and technological formations in a particular place and at a particular moment in time. They are stabilized by motionless actors. By examining spatiality and temporality in various structures that target foreign interest and clientele in India, this paper will provide a theoretical frame for the study of transnational bionetworking.


Christen Rachul, Health Law Institute, University of Alberta, Canada, and PhD Candidate, Applied Linguistics and Discourse Studies, Carleton University, Canada

Stem Cell Tourism, Social Networking and the Informed Patient

The market for direct-to-consumer stem cell treatments, often problematically referred to as “stem cell tourism,” continues to expand as patients seek alternatives for addressing a variety of health-related concerns. The “direct-to-consumer” nature of this industry is facilitated by a number of social networking forums, including (but not limited to) clinic websites, patient advocacy websites, news media, patient blogs, and more recently the use of the micro-blogging site, Twitter. An examination of these forums provides insight into some of the resources and perspectives available to patients as they make decisions about their health, and also demonstrates how the hype surrounding stem cells within the scientific community is also emerging in popular discourse.



Panel 3:  How ethics and religion shape stem cell research

Organisers:  Choon Key Chekar and Carolyn Heitmeyer

This panel explores how ethical and religious notions and institutions have conditioned the development of stem cell technologies and therapies over the last two decades by exploring the concept of ‘bionetworking’. This concept examines how the scientific knowledge in the life sciences is produced not only by science research itself but is also heavily influenced by norms and values including among a number of socio-economic institutions, regulations, and national science policies, which all are influenced and informed by ethical and religious values and norms.
In the 1990s, discussions were held across the life science world about whether and how to regulate human embryonic stem cell research. Some countries tightly regulated or even banned the use of embryos in research and religious organisations encouraged the use of adult, or mesenchymal stem cells in research and therapy provision as ‘ethically not problematic’ alternatives. Tight regulations subsequently also led to the encouragement of new developments in science, such as iPS and mesenchymal stem cells. In the public realm, we see both politicians and scientists opt in to particular ethical and/or religious arguments in support of certain forms of scientific research.
This panel asks how currently established forms of stem cell science have been shaped by ethical and religious notions prevalent among scientists, policy-makers and the public in various countries. In particular, it asks how networks of stem cell scientists and therapy providers seek to mobilise the supports from ethical (patients, feminists, the disabled), religious (Buddhist, Islamist, Roman Catholic, Protestant etc.), and other ideological organisations in their scientific and commercial pursuit.



Lorenzo Beltrame, Institute for Advanced Studies on Science, Technology and Society, Austria

‘This is a victory of our heritage’: Adult stem cells scientists and the Italian way to stem cell research


Religion and religious actors are important players in the so-called ‘stem cell wars’. In Italy, the role of the Roman Catholic Church played a very influential role in shaping Italian stem cell research regulation. Catholic opposition to the use of human embryos for research purposes led to the enactment of regulations hampering human embryonic stem cell (hESC) research. Deploying scientific arguments, the Catholic Church strongly supported research on adult stem cells (ASCs), characterizing them not only as an ethical alternative but also as more therapeutically effective than embryonic ones. In this paper I shall analyze the overlap between scientific and ethical/religious arguments from a different perspective: the mobilization of the latter by stem cell scientists, in order to support ASC research. Through the case of two relevant stem cell scientists – Girolamo Sirchia and Angelo Vescovi – this paper will analyze how Italian researchers characterized ASCs as consistent with the Catholic roots of the Italian social order and political identity. The paper also shows how scientists succeeded in mobilizing the material support of Catholic and other political actors for their research projects and thus how ASC research became the ‘Italian way’ to conducting stem cell research.

Kathrin Braun, University of Hanover

From ethical concerns to ethical exceptions? Ethics, public debate and stem cell research in Germany

Germany still has a relatively strict Embryo Protection Act, dating from 1990, that prohibits among other things the destruction of human embryos for research. Embryo protection is still considered a high-ranking moral good in Germany and public concerns about potential manipulation, utilization or commercialization of human embryos are still strong. This fact is often ascribed to the influence of the Catholic Church and the legacy of the Nazi past, in particular Nazi medical crimes. In this paper, I will argue that this, while not being wrong, is only part of the story. In fact, the Stem Cell Act of 2002 does allow embryonic stem cell research under certain circumstances and embryonic stem cell research is going on in Germany. The paper will argue that the Stem Cell Act is built on a model that has been employed before, in the case of abortion and pre-implantation genetic diagnosis: the model of rule and exception. Within this model, the exception is built into the rule itself, so that ethical principles and pragmatic provisions coexist within the same legal framework. In all of these cases, the rule-exception model operates as the institutional response to deeply entrenched ethical controversies in society. The role of ethics, in and through this model, changes from voicing concern to managing exceptions in that decision-making is delegated to a newly established ethics committee. Yet, the model implies a strong tendency of the exception of becoming the rule, a tendency that continues to incite public controversy and concern.


Ole  Doering, Charité Medical University, Berlin

How Do Ethics and Religion Shape Stem Cell Research? Some Observations from Sino-EU-German Collaborations in Stem-Cell-related Ethics

This presentation will introduce a framework of ethics that is regularly overlooked in bioethics. The tensions between this framework and the dominant international ethics ideology are expressly addressed in Germany but which remain marginal in the EU or China. It has contributed to structural and conceptual frustration: in the case of Germany this frustration has become evident in the processes of institutional and legislative development, namely regarding the regulation of scientific research that involves the destruction of human embryos.

Ethics is a multi-methodical enquiry into claimed normative validity. This reflection supports clarification of such claims, their theoretical rigor and practical soundness. In principle, it applies to any normative claim, be it made on scientific, moral (religious or non-religious) or pragmatic grounds. In the case of stem cell research in Germany, the ethical focus was diverted from “good practice” to “defining the moral matter”, namely when dealing with human embryos as an entity to be used for research. This discourse-management antagonised moral camps and alienated parts of science from society and different science networks within the science community, religious and other dogmatic and stakeholder camps displayed internal diversity and dissent, ultimately promoting more confusion than orientation. On the other hand, it created expectations regarding health and economic outcomes that have proven to be unrealistic and strategic. Owing to pressure from ideologised stakeholders, the actors and formal bodies involved in regulation of stem cell science who organised participatory processes to include legitimate interests were placed in a difficult position to evaluate a diversity of contradicting factual and moral claims. This presentation will explore some of the lessons learned from these developments.


Maria de Jesus Medina Arellano, Universidad Autonoma de Nayarit , Mexico

Stem Cell Science in Mexico: Secularism and Religion in the Constitutional Human Rights Framework

This paper aims to delineate the main features of the debate over stem cell science regulation in Mexico and shows the urgent need to create a legal framework to deal with problematic situations provoked by the legal vacuum in this area. The legal inertia in the Mexican Constitutional Human Rights landscape related to stem cell science regulation, which is mainly caused by the constant lobbying of politicians affiliated with the Roman Catholic hierarchy to endorse prohibitive policies in sensitive areas, such as stem cell science. It also attempts to argue that it is plausible to advance a permissive model of governance for the area of stem cell science by following the constitutional human rights framework in place in Mexico. It is possible to propose as an initial strategy the adoption of a principles-based approach to regulation, such as that applied in the United Kingdom, as a measure to protect patients who currently are undergoing unapproved stem cell interventions in Mexico.


Jens Schlieter, Science of Religion & Center for Global Studies, University of Berne

How do Religions Shape Stem Cell Research?: The Example of Buddhism in Asian Countries

Although the central position of the “non-harming” of any sentient beings, in combination with the traditional view that new human life begins at conception, could force Buddhists to take a rather restrictive stance on embryonic stem cell research, Buddhists in South, South-East and East Asian countries are divided in regard to stem cell issues. This does not only pertain to different interpretations of the respective ethical principles, values (e.g., how to cope with suffering and karma, or the absence of a strong concept of “human dignity”), and traditional accounts on when and how human life begins. Of central impact are, furthermore, conflicting views on “ethics” themselves, namely, if Buddhist ethics are conceptualized as flexible “training rules” only, or if the normative rules for monastic conduct (the Vinaya), where a rather strict view is espoused, shall be followed by all Buddhists. Finally, there are divergent views on how Buddhists shall bring their ethical framework into the regional or national legal procedures of stem cell research regulation. This, of course, is also structured by different incorporation regimes of religious specialists (and their views) in countries with considerable Buddhist population such as Thailand, Sri Lanka, Taiwan, China, Korea and Japan. Therefore, the contribution will argue that due to the characteristics of Buddhist ethics and discourse, and due to different national contexts, there is no direct causal relation between Buddhist views and recent stem cell research regulations of the respective countries. However, the more it comes to individual decision making (regional ethics committees, research institutions, or decision-making at the bed-side), Buddhist views — and religious views in general — are a crucial factor.


Panel 4:  International Life Science Platforms and Bionetworking – Putting back the people in the platform

Organisers: Prasanna Patra and Margaret Sleeboom-Faulkner

Life science collaborations and life science related enterprises are rapidly expanding in Asia. These expansions seem to accompany ‘platforms’ (Keating & Cambrosio 2002) around which we find resources, actors and networks that support the growth of stem cell science. This panel focuses on the various types of stem cell ‘platform’ that have emerged in countries around the world and deliberates how stem cell platforms reach beyond local, national and transnational spheres to facilitate stem cell science enterprises, including stem cell research collaborations, stem cell product development, stem cell banking and stem cell transplantation and therapy provisions in Asia and beyond. We ask how stem cell platforms combine resources and stakeholders in stem cell related activities, and how these platforms negotiate challenges that emerge from particular national and global practices of science collaboration, technology transfer, governance structure and standardization. This panel explores the role of bionetworking in the mobilisation of resources, technologies, patients, human capital and cells and biomaterials from various origins and how it relates to life science platforms.


Kean Birch, Department of Social Science, York University, Canada

Assets, accounting and political-economic platforms in the bio-economy

The political economy of the life sciences has been theorized in different ways in recent years. Scholars have come up with a range of bio-concepts from ‘biovalue’ (Catherine Waldby) through ‘life as surplus’ (Melinda Cooper) to ‘lively capital’ (Kaushik Sunder Rajan). While there is value in this theoretical work, they also involve several problematic assumptions. This paper seeks to unpack these assumptions and offer an alternative way to conceptualize the (so-called) bio-economy. In particular, the paper seeks to understand how political-economic actors understand the life sciences and how political-economic practices, processes, institutions, etc. variously shape and are shaped by these understandings. The focus is on how political-economic actors shape and are shaped by concepts of corporate governance, practices of asset valuation, standardization processes, and so on. What this necessarily entails is a spatially-sensitive analysis highlighting the production of diverse scales, spaces, etc. of these actors, practices, etc. As such this paper seeks to extend debates about the changing political economy of research and innovation (CPERI) by thinking through what contribution the notion of ‘biomedical platforms’ (Keating and Cambrosio) might have to this broader theoretical project.


Klaus Hoyer, and Aaro Tupasela, University of Copenhagen

A platform for what? Exploring the social life of moral hopes and concerns in cross-national genetic research

This paper discusses the establishment of an International Breakpoint Mapping Consortium which seeks to construct a map of the human genome indicating all known chromosomal breakpoints. The consortium has a hub in Copenhagen but is dependent on global networking to acquire access to enough samples with what are often very rare breakpoints. The concept of ‘biomedical platform’, as it was developed and theorized by Keating and Cambrosio, referred to a socio-material infrastructure operating at the clinic/lab nexus through which resources are mobilized in technological innovation and practice. If we think of the research consortium as a platform, we hope to become attuned to the subtle interplay and co-production of social and material aspects of the configuration of processes allowing for these developments. Furthermore, we can use the notion of platform to explore what the platform consists of and what it produces. Based on interviews with researchers and donors affiliated with the consortium we ask a very basic question aimed at understanding the modus operandi of the platform: What can move and how? We explore what we call the flows, the non-flows and the overflows characterizing the platform. We argue that by looking carefully at what facilitates ‘travelling’ we not only get to move beyond the clinic/lab nexus, which was central to Keating and Cambrosio’s concerns; it also brings back in the human through attendance to social and moral preconditions and implications of the platform in the everyday lives of the contributors.


Luca Marelli, Research Unit in Biomedical Humanities of the European Institute of Oncology (IEO), European School of Molecular Medicine (SEMM) and University of Milan

Reprogramming Platforms: Charting Regimes of induced Pluripotent Stem Cell-based Innovation in the United States

The Nobel Prize-winning discovery that adult differentiated cells can be reprogrammed to a state of pluripotency, to yield induced Pluripotent Stem Cells (iPSC), has represented a major breakthrough in the field of stem cell research, bearing its significance on the decisive spur it gave to a whole new frontier of research into cutting-edge clinical applications. Furthermore, as a key site of techno-scientific innovation, iPSC research has been invested with high socio-economic expectations, progressively positioning itself, through the mobilization of several biomedical platforms (Keating and Cambrosio 2003), as a pillar of stem cell-based bio-economies (Gottweis, Salter and Waldby 2009).
Drawing from comparative ethnographic fieldwork, this paper aims to explore the co-production (Jasanoff 2004) of governance structures, modes of accountability and standardization practices within two of the main iPSC platforms in the United States, the Harvard Stem Cell Institute and The New York Stem Cell Foundation. In so doing, it will ask how the consolidation of new alliances and collaborations among scientists, clinicians, biotech companies, disease foundations and venture philanthropists is also brought to bear in the public sphere, by challenging established sociopolitical configurations, and redrawing the boundaries of the polity having jurisdiction over science and health care policy.


Mauro Turrini, “Marie Curie” Research Fellow at CETCOPRA, Université Paris 1 “Panthéon-Sorbonne”

Controversies and Politics around the Rise of a Prenatal Diagnosis Biomedical Platform

What are the political implications of biomedical platforms that have been introduced as part of the technological development pattern that biomedicine has taken? This paper intends to elaborate this question by analyzing a specific case-study, namely the controversy that was generated by the introduction of a new technique based on molecular genetics, the comparative genomic hybridization (CGH) array, in the field of prenatal diagnosis. Up until this point, prenatal diagnosis was marked by a stable division of labour and a low level of automation. The advent of this so-called “molecular turn” has prompted an unprecedented interaction between medicine and biology, science and technology, innovation and routine.
This paper draws on material that highlights the global scientific debate as reported in the scientific literature as well as position statements and guidelines issued by American and European medical societies. This material is enriched by the results of qualitative research aimed at exploring the laboratory work and reconstructing the intense debate that took place in Italy in 2011 and 2012.

The tension surrounding accommodating the new and old platforms provides the political terrain on which the dispute is articulated through the transformation of the medical division of labour, the pace and the extent of the transfer of medical evaluation to automated equipment, the relationship between the companies that design the technology and biomedical practices, the relationship between research and routine, and the relationship with other adjacent medical practices.


Panel 5:  Cord Blood Banking and Bionetworking: Different stakes in different countries

Organiser: Hung-Chieh (Jessica) Chang

Cord blood banking involves the storage and use of cord blood, and adult stem cells from various sources, such as cord, cord blood, adipose, placenta and teeth.  The emerging hybrid banking models are blurring the boundary between public and private cord blood bank, and led to alternative ways of utilisation, as well as science collaboration. There is increased interest in the social, ethical and political aspects of cord blood banking as a place where scientific, economic, governmental, and personal expectations converge. It attracts various stakeholders with common, or competing, interests, such as government, science, business, medicine, patients, donors and customers. In addition, collaborations are implemented within and across diverse cultural, scientific, regulatory and economic frameworks. This panel intends to address issues involving cord blood banking from different areas, including social, bioethical, feminist, and regulatory issues around cord blood banking in Asia and beyond. Moreover, we will discuss how collaboration among different stakeholders influences the flow of stem cells in research, science, therapy, and the tissue economy. How is cord blood banking and science collaboration related to various social and regulatory frameworks? How is cord blood banking related to science, societies, and subjectivity?


Christine Hauskeller, Sociology, Philosophy and Anthropology, University of Exter, UK, and Lorenzo Beltrame, Institute for Advanced Studies on Science, Technology and Society (IAS-STS), Austria

Umbilical Cord Blood Banking: A Hybrid Bioeconomy

The practices of Umbilical Cord Blood (UCB) banking involve diverse and in some aspects contrasting modes in which biovalue is produced. Usually, the opposition between public and private UCB banks is characterized as marked by two competing and opposed kinds of economy, a gift and redistributive versus a market economy. Accordingly, UCB is managed as either a public resource or a private good. In this article we argue that this opposition is both empirically and analytically unsatisfactory. Based on fieldwork across some medical-professional organizations in UCB banking and clinical application (Eurocord and NetCord), we show how the network of actors, objects and practices involved in biobanking creates different kinds of value criss-crossing the boundary between public and private. Drawing on the notion of bionetworking and our case studies, we illustrate how the interrelation between technical, ethical, economic and logistical considerations plays out and generates a field of practices where redistributive and market economies coexist and hybridize each other.


Sarah Chan, Institute for Science, Ethics and Innovation, University of Manchester

Ethical issues in globalised stem cell banks: public goods and private rights


Laura Machin, Lancaster Medical School, UK, and Tak Matsushige, National Institute of Public Health, Japan

Exploring Perceptions of ‘Quality’ Surrounding Umbilical Cord Blood Therapies in Japan and the UK

Cord blood therapies are relatively novel in the UK and Japan compared to other countries, such as Spain and America. Hence, the policy and practices surrounding the treatments are still emerging (Brown et al, 2011). Recently, a connection between cord blood collection and banking practices and the perceived ‘transplant quality’ of a cord blood unit has emerged from policy discussions on a proposed ‘best practice tariff’ to reimburse hospitals for securing ‘high quality collections’. However, how those working in transplant centres deem the collection and banking processes as influencing the ‘quality’ of cord blood units, and how they decide which banks to import a cord blood unit from is unknown. In essence, do the notions of ‘quality’ in cord blood collection, banking, and therapies differ across countries like Japan and the UK? Emerging findings from a funded three year study to explore how those working in Japanese and UK transplant centres perceive ‘quality’ in cord blood in a global context, and the factors that influence their perceptions, will be presented.


Suli Sui,

Peking Union Medical College, China

The construction and development of cord blood (UCB) bank in China:  collaboration and competition of the network

In China, the development of umbilical cord blood (UCB) bank grow up rapidly. There are private storage and public storage in UCB banks. Personal storage of UCB has expanded dramatically comparing with the public storage. Almost all the UCB banks have both public storage and private storage, combining public bank and private bank in one and accepting the inter cooperation mode of ‘Private raise Public’. In fact, during the development of the UCB bank, there are many kind of national network, including the cooperation and competition. Like the cooperation relationship between the bank and bio-company, bank and the hospital, bank and the research institution, bank and insurance company, bank and the donor under situation of donation , bank and the client under the situation of business, and so on. Also, the competition exists among the banks. Each bank has its strategy to expend more network to occupy market, to establish the more connection with hospital in order to get access to maternity department and get more chance to collect CUB, also the price competition for the private storage, and so on. Meanwhile the national policy and regulation play the role on the governance of the UCB bank, which is also the important part of the network of the construction and development of the UCB bank in China.


Ros Williams, Sociology, University of York , UK

Cords of collaboration: rhetorics and platforms in the UK’s public blood stem cell inventory

The UK’s public blood stem cell infrastructure has undergone significant transformation in recent years as umbilical cord blood has joined adult donors as a viable clinical stem cell source. The ‘co-labour’ of ostensibly public institutions has established ‘platforms of collaboration’ from which co-labourers can provide a public inventory of stem cells. This is underwritten by the need to augment both health and economic outcomes through their co-labour. Collaborators legitimize their work through appeals to a public good in both economic and health terms through ‘rhetorical devices’ of Buying British and an ‘unmet need’ amongst UK ethnic minorities. By way of this, the paper demonstrates how collaboration in a public healthcare setting is contoured by an interest in both collaborators’ capacity for economic growth alongside a drive to improve health equity.