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Research Articles

Who gets to be born? The anticipatory governance of pre-implantation genetic diagnosis technology in the United Kingdom from 1978–2001

Pages 507-527 | Received 22 Jul 2020, Accepted 24 Jul 2020, Published online: 06 Aug 2020

ABSTRACT

This paper focuses on explicating and understanding important State and societally-wide capacities of the nation-state to govern emerging technologies. It examines the governance around pre-implantation genetic diagnosis (PGD) from 1978-2001 in the United Kingdom. When analyzed as a whole, the informal and formal mechanisms in British society suggest a latent form of proto-anticipatory governance around PGD technology, and that there are important and understudied linkages between anticipatory governance (AG) and Responsible Innovation (RI) that need to be explored. Additionally, I contend that an overlooked element of anticipatory governance, ‘ensembelization,' should be considered the fourth capacity of anticipatory governance, just as ‘responsiveness’ is the fourth dimension of RI. The ongoing case of PGD governance, and more recently, gene editing governance, will perhaps be one of the most challenging, provocative, and important places for development and deployment of RI and AG capacities.

Introduction

Anticipatory governance calls for the development of society wide, distributed capacities for robust reflection on emerging science and technology in an effort to imagine and prepare for ‘things to come’ (Barben et al. Citation2008). It stands in contrast, and is a response to, common themes in discourse around emerging science and technology, themes such as the notion that ethics and law will always be outstripped by the pace of technological development (French Citation2011), and that society is ‘sleepwalking’ through socio-technical configurations with little attention to the implications of new technologies until it is ‘too late’ (Winner Citation1986). This paper argues that anticipatory governance is also the process of opening up existing ‘socio-technical contracts,’ understood as the various social, cultural, and technological configurations and assumptions related to a particular policy sphere. To support this argument, it shows that when analyzed as a whole, the informal and formal mechanisms in British society suggest a latent form of proto-anticipatory governance around pre-implantation genetic diagnosis (PGD) technology. Finally, it suggests that there are important and understudied linkages between anticipatory governance (AG) and responsible innovation (RI) that point to a need to expand the conceptualization of responsiveness.

The term ‘anticipatory governance’ signifies a movement away from attempts to ‘predict’ technological trajectories, and focus, rather, on society-wide capacity building in order to more robustly govern new and emerging technologies (Guston Citation2008). Anticipatory governance casts doubt upon the notion that modes by which new technologies emerge and disseminate throughout society are largely unpredictable. It is distinct from ‘predictive certainty.’ Rather than attempting to predict every potential problem associated with a new technology, an anticipatory governance approach draws upon and emerges out of a ‘distributed collection of social and epistemological capacities’ in an effort to build capacity and increase preparedness in the face of uncertainty (Barben et al. Citation2008, 992).

The anticipatory governance concept is comprised of three different components – foresight, engagement, and integration, and are outlined in Barben et al. (Citation2008). These three components represent different forms of capacity building for anticipatory governance. The foresight component is represented by the challenge of ‘anticipat[ing] and assess[ing] […] technologies that are still in the process of emerging.’ Foresight projects focus on ‘early intervention’ and utilize ‘methodologies that have a nuanced relation to futures.’ Foresight practices are connected with ‘decision making and governance’ and seek to imbue innovation systems with reflexivity (Barben et al. Citation2008, 986). Foresight practices are ‘non-predictive, non-probabilistic forms of considering a wide set of alternative futures and adopting a broad range of forward-looking methodologies’ (Michelson Citation2016, 52). ‘Talk about the future’ in the form of public deliberation exercises is also a key and critical element of building capacity for foresight (Barben et al. Citation2008).

Public involvement is also critical in the engagement component of anticipatory governance. Such public involvement should ‘go beyond opinion polls to more substantive engagement.’ Engagement requires a ‘commitment to upstream engagement’ in technology, with ‘upstream’ representing ‘a time when [the public] has very little substantive knowledge of the issues’ (Barben et al. Citation2008, 987). Engagement focuses on creating a two-way street between the public and decisionmakers and scientists. As Guston (Citation2014, 226) notes, engagement consists of the ‘substantive exchange of ideas among lay publics and between them and those who traditionally frame and set the agenda for, as well as conduct, scientific research.’

Integration efforts represent the integration of broader considerations related to the social and ethical contexts of technology ‘into laboratory and other technoscientific decision processes’ (Barben et al. Citation2008, 989). Integration work originally made use of ‘laboratory engagement studies’ (Fisher Citation2007) to situate material and experimental research practices as an important, and often overlooked, site of decisionmaking and governance around emerging science and technology. Thus, Barben et al. Citation2008 (988) note that laboratory researchers play ‘a considerable but often unacknowledged role […] in implementing and influencing research policies.’ Similarly, Guston frames integration as bridging the ‘two cultures’ to enable ‘substantive interchange […] aimed at long-term reflective capacity building’ (Guston Citation2014, 226). More recently, integration has been reconceptualized beyond social and natural science collaborations to include numerous forms of ‘expert engagement’ (Fisher et al. Citation2015).

The three dimensions of anticipatory governance do not operate separately in isolation, rather, they ‘must be taken together as an ‘ensemble,’ operating in a mutually reinforcing, intertwined effort of research and practice’ (Michelson Citation2016, 52). An anticipatory governance approach views these capacities as evolving ‘in concert’ in order to ‘inform and reflect on one another’ (Guston Citation2014, 226). Another way of conceptualizing this ensemblization is the metaphor of exercise. Physical exercise not only strengthens individual muscles, it can result in a more holistic, entire-body approach in which the various components of the body work together in concert to build ‘capacity to confront physical and mental challenges that are unknown’ (Guston Citation2014, 226).

Like other previous scholarly approaches, such as upstream public engagement, constructive technology assessment, midstream modulation, and real-time technology assessment, anticipatory governance served an inspiration that informed the development of RI, which has been defined as ‘taking care of the future through collective stewardship of science and innovation in the present’ (Stilgoe, Owen, and Macnaghten Citation2013; cf. Owen, Macnaghten, and Stilgoe Citation2012). These two ideas have been explicitly linked in a number of places – for example, Nordmann (Citation2014) frames RI as the ‘art and craft of anticipation’ and Guston (Citation2014) offers the conceptualization of anticipatory governance as ‘a responsible innovation from the social sciences.’ Genus and Iskandarova (Citation2018) demonstrate that the two concepts are interlinked in practice – connecting RI research and policy with their ‘potential to foster effective anticipatory governance of science and innovation.’ Van Oudheusden (Citation2014) notes that anticipatory governance and RI are connected in a number of different ways, and highlights that a major 2011 Responsible Research and Innovation (RRI) report for the European Union explicitly links the two concepts. Van Oudheusden quotes from the report:

RRI is about trying to get better at anticipating problems, taking into account wider social, ethical and environmental issues and being able to create flexible and adaptive systems to deal with these unintended consequences. This is sometimes called ‘Anticipatory Governance’. (Sutcliffe Citation2011, 3)

More recently, Macnaghten (Citation2020) recognizes the intertwined nature of AG and RI, reflecting on the importance of capacity building: ‘Responsible innovation requires a certain kind of capacity building (akin to Guston’s Citation2014, understanding of anticipatory governance).’

As demonstrated in the literature, there are clear connections between anticipatory governance and RI – the two concepts are complimentary and synergistic. Although the concept of RI and what counts as RI ‘has been debated and variously defined’ since the 1970s (Fisher Citation2020), four characterizing tenets have emerged: anticipation, inclusion, reflexivity, and responsiveness (Stilgoe, Owen, and Macnaghten Citation2013). The components of RI align with the anticipatory governance framework in a variety of ways.

Stilgoe, Owen, and Macnaghten Citation2013 explicitly refer to anticipatory governance in sketching out the anticipation dimension of RI, referring to Barben et al.’s (Citation2008) piece, in which anticipation is distinct from narrow modes of prediction. The RI dimension of anticipation maps onto the foresight capacity of anticipatory governance in that ‘successful anticipation … requires understanding of the dynamics of promising that shape technological futures,’ socio-literary techniques inspired by science fiction can serve as democratizing forces, such processes should be ‘well-timed’ in order to be meaningful and scenarios generated from such exercises should be plausible. The other capacities of AG align with the RI dimensions in a compelling way. For example, there is significant overlap between the engagement AG capacity and the RI dimension of inclusiveness. The ‘bottom-up’ emphasis of both anticipatory governance (note the term governance versus government) and responsible innovation indicate a movement away from formalized top-down approaches and an emphasis on engaging not only stakeholders but broader members of the public in diverse and inclusive ways. For example, Stilgoe, Owen, and Macnaghten (Citation2013) note that ‘Observed bottom-up changes within innovation processes may engender greater inclusion.’ The integration AG capacity and reflexivity RI capacity also offer compelling connections, with Stilgoe, Owen, and Macnaghten (Citation2013) noting that the reflexivity domain includes multidisciplinary collaboration/training and embedded social scientists in laboratories – indeed, clear linkages between the two concepts are evident in the role that midstream modulation (Fisher and Mahajan Citation2006) plays in relation to reflexivity in several frameworks for RI (Stilgoe, Owen, and Macnaghten Citation2013; Von Schomberg Citation2011). Finally, I suggest that an underappreciated element of anticipatory governance, ‘ensembelization,’ can be considered the fourth capacity of anticipatory governance, just as ‘responsiveness’ is the fourth dimension of RI. The notion of ensembelization signifies the various capacities of anticipatory governance working in concert. Likewise, the responsiveness dimension of RI signifies much the same: it is the ‘capacity to change shape or direction in response to stakeholder and public values and changing circumstances’ and ‘involves responding to new knowledge as this emerges and to emerging perspectives, views and norms’ (Stilgoe, Owen, and Macnaghten Citation2013). As my analogy to ensemblization and the case study below both suggest, responsiveness relies on and emerges out of a plurality of foresight, engagement and integration sites and activities .

Table 1. Comparison of components of AG and RI.

There exist few studies examining anticipatory governance at the level of the nation-state. Michelson (Citation2016, 1–2) notes that ‘few extended, in depth treatments address how this idea has been, and can be implemented and institutionalized in practice, in a real-world high-profile context.’ The various components of anticipatory governance ‘in practice’ have been explored in a localized fashion via an array of institutions and experimental studies, ranging from integration exercises (e.g. Fisher and Mahajan Citation2006; Conley Citation2011; Richter et al. Citation2017), to foresight efforts (e.g. Rip and te Kulve Citation2008; Selin Citation2006), to public engagement exercises such as the National Citizen’s technology forums (e.g. Hamlett and Cobb Citation2006). Some efforts have also been made to explore how local city governments (Conley Citation2013) and an international community of scholars organized around a university center (Radatz et al. Citation2019) pursue the anticipatory governance of new and emerging technologies. Thus far, as Michelson (Citation2016) notes, however, there are limited case studies of anticipatory governance as it functions on the scale of national governance activity, and what accompanying anticipatory capacities might look like. This paper focuses on explicating and understanding important State and societally-wide capacities of the nation-state to govern emerging technologies. These anticipatory governance capacities of the nation-state will necessarily vary from one state to the next as well as from one technology to the next, just as civic epistemologies (Jasanoff Citation2005) (which anticipatory governance capacities help comprise) also change comparatively.

Anticipatory governance as a formalized academic framework did not yet exist when PGD technology was being explored, and while institutions and actors in the UK might not have had ‘anticipatory governance’ as an explicit goal in grappling with questions related to the governance of PGD, they were engaging in a spirit of anticipatory governance nonetheless. Therefore, this paper argues that the dynamics in the UK around PGD can be viewed and analyzed as a form of proto-anticipatory governance. ‘Proto’ here refers to tacit formal and informal societal capacities for governing emerging technologies, capacities that are not generally recognized as such. Within this case, nonetheless, many of the proactive, forward-looking, capacity building elements of anticipatory governance can be observed working ‘in concert’ (Guston Citation2014, 226). The features of this case study do not break down neatly into boxes of ‘foresight,’ ‘engagement,’ and ‘integration,’ and instead work as an ensemble, blending these themes together in ways that open up socio-technical contracts to greater scrutiny. Socio-technical contracts comprise the active negotiation and renegotiation of formal and informal social contracts around emerging technologies. This ongoing process of reconfiguring and evolving socio-technical contracts is in contrast to the fixed social contracts associated with enlightenment thinkers such as Locke. Thus, this paper argues that anticipatory governance is not simply an abstract academic framework meant to guide social-scientific interventions; rather the idea is rooted in existing, if latent, governance capacities for opening up if not reconfiguring socio-technical contracts. These capacities can be observed throughout governmental institutions and broader society.

Anticipatory capacities and reproductive technologies

For many people, reproduction is happening in a new, technologically-mediated way. Treatments such as sperm and egg donation, in-vitro-fertilization, cryopreservation of embryos and gametes, womb transplantation, surrogacy, mitochondrial transfer, and others, have impacted how society understands and thinks about genetic ties, heritable illness, parenthood, and reproduction in fundamental ways. New reproductive technologies enable the assessment of, the selection of, and (in the case of gene editing technologies) the editing of embryos that represent the types of people who will be born. While earlier techniques, such as sperm sorting and visual inspection of IVF embryos, enabled the selection of healthy gametes and embryos with some level of success, the ability to genetically assess an embryo prior to implantation in the womb emerged with the genesis of the pre-implantation genetic diagnosis (PGD) technique. PGD is the ability to biopsy a single cell from an in-vitro embryo and test it for characteristics such as sex and genetic mutations. While some feared that PGD and its associated newer technologies, such as gene editing, would ring in an age of new eugenics, others praised the technology as a way of enabling couples suffering from heritable genetic illnesses to have a healthy child of their own. Early on, in the United Kingdom, different elements of society, both formal institutions such as Parliament and regulatory agencies, and non-institutional entities such as advocacy groups and individual members of society, were engaging in questions around the future of PGD technologies, specifically around topics such as: Should it be allowed? Is it akin to eugenic selection? If it is allowed, who will regulate it? And who should have access to it and for what reasons and under what conditions?

As genetic analysis technology continues to evolve, societies are posed with the question of what PGD should be permitted for – by what standards should governance processes allow or disallow regulation? Should the severity of a particular disorder be the measure by which testing is permitted or prohibited? At what point in the development of the technology is it appropriate to intervene, and in what ways? It is in these blurred regulatory boundaries that robust capacities for anticipatory governance becomes essential.

How do societies navigate the complex governance issues accompanying PGD and other emerging technologies in an anticipatory way? How are socio-technical contracts negotiated amongst a multiplicity of stakeholders and competing societal values? The national regulation of PGD provides an empirical lens by which fundamental negotiations around what kinds of people should be born can be examined in light of emerging technological capacities that were previously non-existent. The United Kingdom’s Human Fertilisation and Embryology Authority (HFEA) is the body tasked with providing guidance and governance around assisted reproductive technologies, including PGD technologies.

As illustrations of anticipatory governance in practice, I focus on the role that the HFEA and other formal and informal societal institutions played in negotiating the ongoing socio-technical contract that emerged alongside the evolving suite of PGD technologies. While even today, PGD still resonates with many as a ‘new’ technology, the HFEA began engaging in foresight and engagement activities, consulting with the British public on PGD in 1993, when the technology was still in its nascent stages. However, it is a mistake to think about anticipatory governance as something that only resides within the HFEA. The paper also illuminates other anticipatory capacities, fairly traditional elements of democratic society that struggle to make sense of and negotiate around the emerging technology, such as the role of the media, community groups, and other formal and informal institutions. These multiple societal elements, elements that a healthy democracy is dependent upon (Brown Citation2009), when observed as a functioning whole, serve as a window into the societal deliberations around PGD and represent an ensemble of anticipatory capacities working together in concert. In providing an overview of the role that lay participants, advisory bodies, citizen activists, and citizen engagement efforts played in the governance of PGD, the paper aims to illuminate these elements as important deliberative capacities for anticipatory governance.

Anticipatory concerns emerging from British Parliament

As the birth of Louise Brown, the first baby conceived via in vitro fertilization, crept closer, Members of Parliament expressed their unease over potential risks related to the Steptoe and Edwards embryo transfer technique. Labor MP Leo Abse called the technique ‘exciting but perilous’ (Dunn Citation1978, 2). He requested that Shirley Williams, the Secretary for Education and Science, consult the advisory committee on ‘genetic manipulation research into the fertilizing of a human egg by a sperm in a laboratory.’ Abse wanted the committee to explore what sorts of control would be necessary in the emerging field and requested that the committee be expanded in order to the ‘ethical and social aspects’ of the research. Abse stated:

We are now moving to a time when an embryo could be sold in effect with a guarantee that the resulting baby would be free of genetic defect and the purchaser could select in advance the colour of the baby’s eyes and hair, its sex, its probable size of maturity, and its probable IQ. (Dunn Citation1978, 2)

While clinics, such as that of Steptoe and Edwards, were making progress in producing self-imposed guidelines of responsible practice, concerns about the welfare and rights of children produced through the new methods were being discussed in citizen organizations and in the media. For example, the National Association for the Childless called for a focus on rights. It advocated for a Royal Commission to further grapple with the policy and legal implications associated with the new technology. The Royal Commission, it argued, could make decisions regarding issues of legitimacy and parental rights (Hills Citation1978, 9).

Philosophical pluralism within the Warnock committee: the socio-technical integration of diverse backgrounds spanning the ‘two cultures’

Integration efforts at bridging the ‘two cultures’ in the British governance of reproductive technologies occurred early on. Following the 1978 birth of Louise Brown, the British government established an advisory committee, the Committee of Inquiry into Human Fertilisation and Embryology, chaired by philosopher Mary Warnock. The ‘Warnock Committee,’ as it became known, convened in 1982 and was tasked with grappling with the implications of the evolving suite of new assisted reproductive technologies, and providing advice for responsibly governing the new area. The Warnock Committee, rather than solely being a panel of scientists and medical professionals, was an interdisciplinary body of individuals. The report the committee produced ‘makes explicit its philosophical pluralism’ (LaTourelle Citation2014)

As Wilson (Citation2011) recounts, Warnock, in collaboration with Norman Fowler and a team of civil servants, went to work recruiting an array of the ‘great and good’ of Britain to serve on the committee. The committee Warnock recruited comprised a number of different professional and religious backgrounds, representing integration across disciplinary, technical, social, and religious domains. The committee consisted of seven individuals from the medical/scientific field, and eight from other fields, including social workers, an executive from the Immigrant’s Advice Service, theologians, a court recorder, and solicitors (Wilson Citation2011, 121–141). In her note to Norman Fowler and other government officials at the beginning of the report, Warnock wrote that the ‘professional expertise’ of members of the committee, in addition to their diverse religious backgrounds, ‘enhanced the report’ (Warnock Citation1984). The below table details the composition of the committee as it appears in the final report (Warnock Citation1984) .

Table 2. Composition of the Warnock Committee.

The decision of the government to appoint an integrated expert advisory group – the Royal Commission – to explore the social, legal, and ethical issues presented by advances in reproductive technologies was underscored by overarching themes in British policymaking, such as faith in the state and, by extension, the law in reining in ‘runaway social forces’ (Jasanoff Citation2005). Tied to this perspective is the value placed in empirical evidence and trustworthy experts in synthesizing that evidence to provide wise policy recommendations in the face of uncertain technological futures (Jasanoff Citation2005).

Warnock’s inquiry was comprised of a group of sixteen individuals that, as the final report notes, had ‘professional expertise’ (Warnock Citation1984). While the notion of British professional expertise does place high importance on experience in one’s profession, it goes beyond an individual’s membership in a particular professional body and is rooted within the British aristocratic context – a historical context that places high value on individual excellence, one that that ties expertise to individuals as opposed to professions (e.g. being a barrister does not necessarily equate to being an expert of law, one must have demonstrated character, experience, and good judgment in order to provide expert advice). The British expert must demonstrate both aristos, excellence, in their field, and also kratos – the demonstrated capacity to engage in wise governance. It is through the British expert’s character, experience, and achievements that enables him or her to ‘possess the transcendental capacity for discernment’ (Jasanoff Citation2005) enabling integration across disciplinary boundaries. As Jasanoff notes, it is the British expert’s ‘function’ to not only apply his or her technical skill and knowledge to problem solving, but to also ‘discern the public’s needs and to define the public good’ (Warnock Citation1984). Indeed, in the spirit of philosophical pluralism, the Committee viewed its role as ‘discover[ing] the public good,’ noting in the forward, ‘it was our task to attempt to discover the public good, in the widest sense, and to make recommendations in the light of that’ (Warnock Citation1984).

The Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984), widely known as the ‘Warnock Report,’ was developed following consultation of the Royal Commission with a variety of individuals and groups, including religious bodies, scientists, and professional associations. The report opened with a reflection on the concept of ethics, and noted that for the committee’s purposes, the concept would need to extend beyond notions of proper, or ‘acceptable,’ professional practice, to foundational questions related to the underlying principles upon which regulation and law ‘would rest’ (Warnock Citation1984). Thus, the committee was ‘obliged’ to operate under a ‘less restrictive’ understanding of ethics in order to conduct its inquiry. Furthermore, the report argued, that in dealing with the matters at hand, ‘reason and sentiment’ are not necessarily contradictory. However, because ‘moral indignation, or acute uneasiness, may often take the place of argument,’ the report presented the arguments for the committee’s recommendations, and also counterarguments as well. The committee emphasized presenting both sides of each argument because it believed its task was, as noted above, ‘to discover the public good’ (Warnock Citation1984).

The report noted that the main commonality linking the developments within the ‘still developing, and rapidly changing’ ‘sphere of activity’ that it was studying was ‘the anxiety they generated in the public mind’ (Warnock Citation1984). The report, in discussing the establishment of the committee, described the public atmosphere at the time of its establishment. The ‘new horizons’ that Louise Brown’s birth opened up also created new public anxieties and trepidation. The report sought to make ‘practical proposals, capable of implementation’ (Warnock Citation1984). It made sixty-three recommendations regarding assisted reproductive technologies (ART). It recommended that commercial surrogate motherhood be made illegal. The report allowed research on spare and deliberately created embryos until the fourteenth day of the embryo’s development. According to bioethicist Albert Jonsen (Citation2005), the Warnock Report stands as a ‘bioethical milestone,’ principally for its support of the fourteen-day research limit on developing embryos. It recommended the establishment of a regulatory body that would regulate both ART research and practice, arguing that of all of the recommendations that it made, the establishment of a statutory body, ‘within whose powers would fall the licensing and monitoring of provision for infertility treatment and of research on the human embryo,’ would be the most critical. The committee recommended that the body comprise professional representatives from the medical and scientific communities, but that it also integrate members of the lay public in its representation: ‘None of our other recommendations can have any practical impact until such a body is set up’ (Warnock Citation1984).

Although the capacity for analyzing the genetic traits of human embryos was virtually nonexistent at the time of the Warnock Report, published in 1984, it discussed, in a few small sections, the possible issues associated with future genetic analysis technologies and the accompanying societal concerns regarding social and ethical impacts. One section of the report specifically focused on the use of assisted reproductive technologies in preventing genetic defects, and although PGD on human embryos was not yet a reality, the report did allude to the possibility of creating ‘normal’ embryos by technological means:

12.15 If it should become possible to identify at a very early stage of embryonic development certain genetic defects; and to insert a replacement gene which will remedy the defect, a genetically normal embryo could be created. It is argued that this would provide the means to prevent certain genetic diseases.

The report tied the issue of ‘normal’ embryo creation to historically embedded societal fears around the issue of eugenics and selective breeding (Warnock Citation1985, 74).

The 1990 Human Fertilisation and Embryology Act was based on recommendations from the Warnock Committee’s report and provided the framework for the establishment of the Human Fertilisation and Embryology Authority (HFEA), the statutory body responsible for the regulation of assisted reproductive technologies and embryo research. The HFEA’s tenure as independent regulator officially began in July 1991.

Engagement exercises via public consultations and a parliamentary ban

The 1990 Human Fertilisation and Embryology Act, which established the HFEA, also does not directly address the regulation of pre-implantation genetic diagnosis or prenatal diagnosis. However, dating back to as early as 1993, the HFEA has held public consultations in an effort to gauge patient, public, clinical, and scientific sentiment and to provide guidance on the issue, as originally advised in the Warnock Report. In 1993, PGD would make its way into the British public consciousness on the waves of concern accompanying a much older issue – the desire of parents to have a baby of a specific sex.

In January 1993, The Guardian announced that the HFEA was calling for a public debate ‘over whether Britain wants a Brave New World Society in which people can choose the sex of their babies’ (Mihill Citation1993). The HFEA debates were in part ignited by and coincided with the activities of two doctors, offering sex selection for £650 a time, catalyzed the British debates around PGD for social sex selection. Doctor Alan Rose, a chemical pathologist, aged sixty-six and retired from the National Health Service, and Doctor Pete Liu, a thirty-nine-year-old biochemist from Imperial College, opened the London Gender Clinic in North London. The doctors stated that they were providing a service that gave couples ‘a choice they should be allowed to make.’ While their stated goal was to help couples ‘balance’ their families, Rose and Liu did admit that about two-thirds of the 200 women they had treated up to that point were Asian and expressed a desire for male babies. Most of the other couples they treated expressed a preference for a girl (Mihill Citation1993).

Fearing that Rose and Liu’s work could lead to babies being ‘sold like hamburgers,’ Members of Parliament called for a ban on clinics that were providing sex selection services. Conservative MP for Harlow, Jerry Hayes, stated that Rose and Liu were operating off of a ‘principle whereby you’re franchising babies.’ Tory MP for Basildon, David Amess, said that it was ‘arrogant beyond belief’ for scientists to ‘play God,’ further noting that ‘Commercial exploitation of the desire of parents to have a child of a particular sex is grubby beyond belief’ (Mihill Citation1994).

At a press conference, Rose stated that his clinic had already interviewed approximately 500 couples for treatment. The Guardian reported that telephones had been ringing ‘continually’ at the clinic, as more couples expressed interest in bringing ‘balance’ to their family (Mihill Citation1994).

The newspaper accounts made it clear: the desire for sex selection was not isolated to one or two couples. Hundreds of couples were interested in pursuing the treatment, and with the issue’s increasing notoriety in the media, even more people were outreaching to Rose and Liu for their assistance in balancing their family. Coupled with the concerns voiced by Members of Parliament, the new statutory body was at a significant crossroads. Was the two-year-old HFEA prepared to confront the task of navigating public fears and crafting public policy in light of the concerns illuminated by Rose and Liu’s practices? Did the young HFEA have the capacity to navigate the social and political transition from the present governance framework into a future one?

An exercise in engagement: the HFEA consultation on sex selection

The HFEA did not have power to regulate Rose and Liu’s sex selection practice, since they were only using the sperm of the male partner, and were not using donated sperm. The HFEA would only have remit to regulate if Rose and Liu were using donated sperm. However, in response to Rose and Liu’s new center, Colin Campbell, then chairman of the HFEA, stated, ‘This is a matter of serious public concern which should be fully debated before decisions are made.’ The HFEA had already been working on a consultation document regarding the ethics of PGD sex selection technology, and, following the opening of the London Gender Clinic, brought the document forward for consultation with the public (Mihill Citation1993).

The HFEA’s 1993 consultation grappled with the issue of limits and the responsible use of increasing technological capacities around PGD and provided overviews of pro and con arguments around the social, ethical, and medical implications of its use, specifically in relation to sex selection. PGD for sex selection was the primary focus of the consultation, as only one inherited disease, cystic fibrosis, could be ‘unequivocally identified’ via PGD at the time (HFEA Citation1993, 7). The public response to the consultation document also came out ‘strongly against’ social sex selection, with sixty-seven percent of public respondents opposed. One major concern expressed by public respondents regarded ‘reinforcing sexual stereotypes to the disadvantage of women,’ and ‘lead[ing] to a widespread preference for male children.’ Another prominent theme in public feedback focused around fears of ‘the start of a “slippery slope” towards selecting the “perfect child.”’ Public responses also indicated concerns regarding the impact of social sex selection on the family, such as psychological effects on the child. Other concerns centered around the disparate impact on certain ethnic communities, and that social sex selection was ‘not a proper use of medical resources, skills, and time.’

The HFEA, in sharing its views with the Department of Health, recommended that PGD for sex selection ‘in principle’ be allowed for medical reasons when there is a risk of a ‘life threatening sex-linked disease.’ The Authority did not recommend techniques such as sperm sorting be used for medical reasons, due to limited data regarding successful outcomes. The HFEA emphasized that the public supported its views: ‘Accordingly, while the arguments on this issue are complex, the view of the Authority on sex selection for social reasons is strongly supported by the public who responded to our consultation exercise.’

The outcome of the 1993 engagement exercise via public consultation resulted in the 5th edition of the HFEA’s Code of Practice being updated to not license social sex selection of embryos, but it would license PGD for sex selection on medical grounds. The HFEA recognized that the issue was not a stagnant one, and would likely be subject to ongoing review in light of changing scientific and social developments. The HFEA would need to continually revisit the issue via foresight and engagement exercises given the evolving and rapidly changing nature of the technology. The HFEA’s 1993 consultation indicated a reopening of the socio-technical contract around reproductive technologies in Britain. While the Warnock Report originally discussed genetic analysis technologies and their implications to a limited extent, the 1993 consultation served as the first major engagement of the British public regarding the governance of PGD technologies.

The 1993 consultation illustrates the foresight responsibilities of the HFEA as being both backward-looking and forward-looking, backward looking in that it is responsible for taking account of and managing the current state of scientific development in the realm of reproductive technologies (e.g. the licensing of clinics performing PGD and the enforcement of the law as it currently stands), but it is also a forward-looking entity in that has made efforts to actively engage the British public around issues of genetics, reproduction, and technology in an ongoing way through public consultations, advisory committees, and a code of practice that evolves in light of feedback from engagement exercises and evolving technological capacities. Here, we can observe an administrative agency attempting to look forward in an anticipatory way as it navigates, negotiates, and renegotiates fundamental policy issues centered around the earliest stages of human life.

1999 consultation: the disability community emerges as a vocal critic

The HFEA kept the issue of PGD under review, and six years after its original consultation on sex-selection, it again took the issue to the public in 1999, a move that signified that the ‘gene screening debate [went] public’ in the UK (BBC Citation1999). It was now possible to accurately test for other genetic conditions, beyond those that were sex-specific. With these new capacities came a new set of considerations for British society. The HFEA ‘anticipat[ed] a future where much more will be possible in genetic screening and there will be increasing demand for it. There are difficult ethical issues to be tackled before it becomes more widespread’ (Boseley Citation1999). While the HFEA had been reviewing and consulting the public on issues of PGD since 1993, increasing knowledge of and capacity to test for genetic conditions at the embryonic stage gave it reason to bring the issues to the public sphere via another public consultation. Ruth Deech, then chairman of the HFEA felt that it was ‘time the public had a say,’ stating that ‘New scientific and medical advances, especially in the field of genetics, often cause public unease and present us with complex social, ethical and regulatory questions’ (Boseley Citation1999).

The HFEA in conjunction with the Advisory Committee on Genetic Testing (ACGT) (later subsumed by the Human Genetics Commission) established a joint working party (JWP) in order to review the HFEA’s interim PGD licensing guidelines (HFEA Citation2001, 9). The JWP conducted a public consultation and integrated the feedback garnered from the consultation in providing its final recommendations, and while overall it felt that the licensing structure was effective, recommended ‘developments in a number of areas’ based on public response. Recommendations included: expanding the array of peer reviewers consulted in the licensing application process to include ‘clinical geneticists, molecular geneticists, cytogeneticists, and genetic counsellors’ (HFEA Citation2001, 2); that clinics should provide a paragraph ‘describing in lay terms’ the condition as well as the experiences and impact on individuals affected with the condition (HFEA Citation2001, 3); that there be a multidisciplinary team in place to provide service to patients at all licensed clinics, including ‘reproductive specialists, embryologists, clinical geneticists, genetic counsellors, cytogeneticists, and molecular biologists’ (HFEA Citation2001, 3).

The JWP also indicated in its recommendations that the perception of the seriousness/risk level of a condition by the prospective parents seeking PGD should also be considered in the decision-making process. As advocated for by respondents in the consultation, in order to assist patients in making an informed decision, the JWP recommended that the information provided should include information ‘provided by disabled people and their families about their experiences living with disability’ (HFEA Citation2001, 7). While the 1999 consultation did provide the opportunity for various segments of the public to respond, some groups felt that disabled communities were not being properly integrated into the process. Some felt that it was simply too little too late, and others believed that any use of PGD equaled to discrimination against disabled people. For example, the anti-abortion group, Life, rallied against use of PGD, contending that new capacities for detecting genetic defects would only push the country towards a culture of greater discriminatory practices (BBC Citation1999). Angela Corless, the spokeswoman for Life, stated that genetic testing, in concert with other reproductive technologies, is ‘done in order to search out and destroy less than able babies and so it is discrimination against disabled people before birth’ (BBC Citation1999).

A ‘talk-centric’ approach to engagement and integration of diverse voices

When the HFEA consulted the public about embryo screening in 1999, members of the disabled community asserted that the ‘real experts’ – disabled persons – were not being consulted by the HFEA about the use and regulation of PGD technology. Tom Shakespeare, a member of the disabled community, argued against Juliet Tizzard, then the director of the Progress Educational Trust (Shakespeare and Tizzard Citation1999). Shakespeare and Tizzard engaged in a debate, via letters that they had written to each other, that were published in the Guardian as an illustration to the public of the perspectives of advocates and critics of PGD.

Shakespeare stated that the HFEA consultation was a waste of time, and that consultation of the public at this policy juncture ‘seem[ed] rather tokenistic.’ Shakespeare noted that there appeared to be a widespread perception that disability was synonymous with tragedy: ‘Society in general – and doctors in particular – tend to think that disability invariably equals tragedy. But many of us lead happy and successful lives.’ Shakespeare commented that the part of the issue was one of framing: ‘if you asked people “Do you think we should take another step towards designer babies?” they might give a different answer.’

Tizzard critiqued Shakespeare, stating that the issue was one of definition and use of the term ‘designer baby,’ arguing that Shakespeare does not ‘explain what this mythical “designer baby” is’ or how PGD is further enabling its creation: ‘Embryo screening has been with us for nearly a decade: can you point to anyone who has used it frivolously?’ Tizzard argued that reproductive technologies have been subject to democratic scrutiny since 1989, when they were being debated in Parliament. ‘Ethics and regulation are not lagging behind genetic science. They’re very much ahead of the game.’ PGD is already subject to ‘strict controls,’ argued Tizzard, and with the consultation and subsequent licensing framework processes, it will be even further regulated.

But I don’t believe they should decide who gets PGD and who doesn’t. We are all quite responsible enough to make our own reproductive decisions. The trouble starts not when we have reproductive choice, but when politicians and regulators stop trusting us to exercise it responsibly.

Shakespeare challenged Tizzard’s view that the decision to use PGD should be a solely individual choice within a ‘reproductive free market,’ and that PGD could be used to prevent ‘severe disability’: ‘Who decides what “severe disability” is? Why don't we listen to those who live with impairment, and often have very successful lives despite it?’ Shakespeare argued that it seemed as if medical experts have dominated the discussion and the public was not being involved in the way it should be. ‘Many don’t have that trust [of medical experts], and don’t see these developments as progress.’ Shakespeare felt that the current path of permissiveness was leading society to a dark place: ‘What can be done has been done’ in reproductive medicine up to the present. ‘This is the road that leads to genetic cleansing.’

The issue of designer babies and whether society was enabling their creation did not wane in the public eye following the 1999 consultation and Shakespeare and Tizzard’s debate. The issue continued to grab headlines, and newspapers were peppered with sensational headlines such as the February 2000 headline: ‘Who Would Deny Us This? Embryo Screening has Sparked a Furious Ethical Debate’ (Atkins Citation2000). This particular article chronicled the experiences of a couple, Susie and Kevin Duce, seeking to have a baby free of spinal muscular atrophy (SMA), a disorder that they both carried the recessive gene for. Susie commented that ‘PGD is only about having a “designer baby” if “designer” means one that lives.’

The article argued that PGD was not about creating designer babies, rather, bringing healthy babies into the world when there is a high chance they will inherit a serious genetic condition:

Concern about genetic manipulation is understandable. A couple of years ago we were panicking about cloned sheep and posthumous fathering. Last week, there was the furore over the news that women’s eggs can now legally be frozen then defrosted for use years later. But PGD isn’t about creating a blue-eyed super race. It is currently only used – in Britain, at least – to screen out specific, highly disabling (and usually lethal) disorders like SMA, cystic fibrosis and haemophilia.

While some people will never agree with embryo screening, such as those who believe that life begins at conception, or those who disagree with it for ethical reasons, ‘those who fear future abuse of these advances probably needn’t worry’ because the HFEA had already prohibited non-medical uses. ‘Furthermore, HFEA is currently circulating a document to ask us – the public – what we think of PGD’ (Atkins Citation2000).

In her reflections on embryo screening in The Guardian, PGD patient Leah Wild contended that debates around designer babies are ultimately a debate of what disabilities and diseases society is prepared to allow screening for, versus those it is not (Wild Citation2000). From Wild’s perspective, ‘designer babies’ are a good thing, but also something that will have major implications for society, as the technology provides the capacity to determine who we do and do not want to be born (Wild Citation2000). Wild had a condition known as a ‘balanced translocation,’ in which fragments from two of her chromosomes broke off and traded places. While the condition had no implications for Wild’s health, the chances were very high that her resulting child would inherit the translocations, leading either to a miscarriage or early death.

That same week, it had been announced that the sequencing of the human genome was near completion. Wild acknowledged that the progress with the human genome will make PGD easier and more accessible.

For despite Bill Clinton’s claim that ‘our children’s children will know the term cancer only as a constellation of stars’, human genetic engineering is not, in the short term, at least, about preventing and curing disease. It’s about whom we want to be born. (Wild Citation2000)

Wild labeled herself, and others in similar shoes, ‘genetically disadvantaged,’ noting that her choices are different from others of normal reproductive health.

I either make this genetic selection, or risk further multiple miscarriages and accept infertility. I would prefer not to have to. No one in her right mind would opt for the procedure of PGD instead of what is quaintly called ‘the old fashioned method.’

Wild posed the question of limits. What sorts of limits should there be ‘in this brave new world of human genome sequencing’? What sorts of conditions should be tested for? When should they be tested for and under what circumstances?

From where I’m lying – feet up in stirrups – this is not an abstract philosophical debate. Nor is it a merely a matter of enabling people to benefit from medical advances. As with the choices being made about testing for Down’s syndrome, these are not medical but political matters. It is up to us, with the knowledge given to us by the scientists, to decide.

We must begin to vigorously debate the limits of acceptable genomicide. To pretend that the human genome is all about saving, rather than destroying, lives is to be blind to the brutal truth about our very human, flawed condition. (Wild Citation2000)

Even with many serious conditions, those that Wild calls ‘genetically disadvantaged’ can live fulfilled lives with preventative treatment (take for example the BRCA 1 and 2 breast cancer mutations – just because someone has the mutation does not make having it a ‘death sentence’). Thus, what is an acceptably severe condition that PGD would then be permitted for? Who decides?

The perspectives illuminated in Shakespeare and Tizzard’s debate, and Wild’s article, indicate a ‘democratized public sphere’ in which multiple minority viewpoints come to the table where British negotiations around the use of PGD technologies are shaped (Chambers Citation2000, 204). They represent the deliberative nature of negotiations around PGD in the United Kingdom, and what Chambers (Citation2000, 204) calls the ‘talk-centric’ approach to governance (in contrast to a voting-centric approach) – where the focus shifts from the voting booth and majority-rules as the primary means of expression of public preferences, to an expansion of the public sphere, where multiple perspectives, especially minority viewpoints, such as the viewpoints of the disability community, or of PGD patients such as Wild, can be voiced and give shape to broader social deliberations on decision-making. It signifies a capacity for multiple voices, including marginalized groups, to ‘participate in shaping, influencing, and criticizing public opinion’ (Chambers Citation2000, 204).

The question of what kind of society do we want to live in thus becomes much more complex than the one originally confronted by the HFEA. The perspectives voiced by other aspects of society brought up additional complexities but also indicate robust deliberative capacities in negotiations around PGD. Dryzek defines deliberative capacity as ‘the extent to which a political system possesses structures to host deliberation that is authentic, inclusive, and consequential’ (Dryzek Citation2009, 1382). The disability community played a significant role in critiquing majority views on PGD and added a unique perspective into the public deliberations on the subject. The critique, as Shakespeare’s comments suggest, highlighted that the ramifications of PGD might be larger than many might perceive. That while it might seem relatively straightforward that social sex selection is wrong, and that the medical field ought to alleviate genetic diseases, the critique points out that the issue is more complicated, and that the established framework might not integrate disabled voices in the way that it should. Instead, the critique indicates that the perception that the disabled community is bad off is a fiction that society has manufactured. That idea that society might want to eliminate babies that might be born disabled, would be as offensive as the idea that society might want to eliminate people of a certain race. To the disability community, the idea was equivalent. The question of what kind of future society wants to deal with then becomes a radically different one.

Tizzard and Shakespeare’s public debate provides a vivid example of the deliberative negotiations and normative pluralism accompanying PGD, and Shakespeare’s critique of the lack of inclusion of voices from the disability community raises a question regarding the extent to which normative pluralism should or should not be incorporated into anticipatory governance. While Tizzard and Shakespeare’s public debate within the media might represent a broader anticipatory capacity of engagement within the public sphere, other than bringing attention to the issue of PGD to the general public, it is unclear that the debate led to any specific changes in policy or composition of licensing committees to include individuals from the disability community. Thus, the example of Tizzard and Shakespeare’s debate makes salient the question of normative pluralism and where, and how, it should play a role in terms of building anticipatory capacity. Is it enough that the debate occurred in the public domain, and raised new questions regarding perspectives on PGD and disability? Or, did the exercise not go far enough in the sense that formal policy did not change? The question of normative pluralism, and how the integration of diverse stakeholder voices should be incorporated, not only to open up but also to close down sociotechnical contracts (Van Mierlo, Beers, and Hoes Citation2020; cf. Stirling Citation2008), is an ongoing question that both anticipatory governance and responsible innovation frameworks will have to confront as they conceptually mature.

Discussion

The HFEA, then, in conjunction with the various publics that critique and engage with it, is tasked with negotiating a weighty socio-technical transition; one in which it must craft a governance framework that adequately transitions present society into a future one in light of ongoing societal deliberations around the issue of PGD and what it represents more broadly in terms of the new socio-technical orders that are being created. In a sense, it has partial stewardship over the evolving socio-technical contract, and must engage in both responsiveness to new issues and leverage anticipatory capacities to reflect on future potentialities and scenarios in a robust and reflexive fashion. It must assess the present state of PGD technologies, as well as grapple with how the technology could evolve in the future, in addition to having to evaluate whether the technology is being shaped and used responsibly. The entrance of voices such as the disability community into the debate reiterated the notion that despite the seemingly ‘objective’ realities that science provides regarding the physical world, such as the detection of cancer genes in an embryo, or the use of donated sperm or eggs to achieve pregnancy, raise fundamental normative questions such as, Should parents have the right to choose the genetic traits of their child? Who decides? Lori Andrews (Citation2003, 106) notes that ‘Twelve percent of potential parents, for example, say that they would abort a fetus with a genetic propensity toward obesity.’ Broader and more complex normative questions will continue to emerge as technological capacity increases. For example, if embryos with obesity genes can be eliminated, some may ask why an entity such as the National Health Service should pay for people suffering from issues related to obesity? The same goes for those with breast cancer (BRCA) mutations, and so on.

Thus, as technological capacities continue to increase, and entangled social and ethical orders are distributed, it becomes increasingly important that societies be equipped with capacities to anticipate and respond to the potential complexities that emerging technologies such as PGD can be expected to present. The issue at stake in the case examined is not simply about who is going to be a parent, but it is about what kind of parental rights one has, and in particular, what kinds of parental complaints justify medical intervention in the resulting child, whether the intervention is PGD, gene editing, etc. The matter points to a renegotiation of a socio-technical contract that implicates parental consent, policies crafted by bodies such as the HFEA and norms and values voiced by advocates, activists, and proponents. It becomes a complex negotiation of the unbinding and rebinding of traditional sensibilities of how babies and children come to be in the world, one that modern societies are only partially equipped to manage equitably.

When the concept of capacities is meditated upon in these terms, the question at hand becomes what kind of future do we want to live in, and how well equipped is society for responding to these questions? What kinds of debates are emerging versus the kinds that an anticipatory governance approach would demand? What might suggest that anticipatory societal capacities are robust, and that a society is managing transitions into new socio-technical arrangements well or poorly? Indications would certainly include the substantive issues that get discussed and whether they get a full hearing, but also procedural ones such as whose voices are included and how robust new socio-technical contracts are deemed to be.

In the case of PGD, is the HFEA ahead of the game or behind the curve in helping judge what kinds of PGD should be permitted? It is clear that the HFEA struggles with an inability to control what happens in genetics research laboratories outside of its remit of regulation. It cannot, in a sense, ‘fix’ the socio-technical contract because laboratories are constantly bringing about new visions and capabilities for what is possible and what can be done in terms of genetic analysis. The HFEA has not been able to stabilize a particular framework in grappling with PGD. It started developing a framework in 1993 with the notion that social sex selection should be banned, however as new cases arose, boundaries such as between what comprises social versus medical selection broke down. The question then evolved to become one of severity, therefore new questions of what conditions are severe enough to permit PGD remains in flux. In part, the question remains due to the strength of the ‘talk-centric’ public sphere, an anticipatory capacity, where a diversity of viewpoints on the issue are juxtaposed against each other, from the advocacy and critique from members of the disability community, such as Shakespeare, to the patient advocates, such as Wild, who just want to have a ‘normal baby.’ Thus the continued ensemblization of capacities that are themselves rooted in dynamic foundations points to the need for institutions such as the HFEA to continually engage in responsiveness by ongoing reevaluation and revisitation of an unstable socio-technical contract.

PGD presents a classic case of a technology whose societal embedment can fundamentally transform settled social orders. The cases explored in this paper represent the negotiation of a principal question in light of an emerging and transformative technology, that is, what kind of society do we want to live in? What kinds of people will society permit to be born? Therefore, the question of what kinds of capacities societies need to create or further support in regards to anticipatory governance is an important one, if societies are to continually respond to the complexities presented by new and emerging technologies as they navigate from the present to the future.

Conclusion

This paper provides evidence suggesting that anticipatory governance is not simply an abstract academic framework meant to guide social scientific interventions; rather the idea is rooted in existing, if latent, governance capacities that can be observed throughout governmental institutions and broader society. This lends weight to and helps ground the anticipatory governance scholarly framework – as well as responsible innovation frameworks that are based upon it – in observable civic epistemologies.

Macnaghten (Citation2020) notes that the RI dimension of responsiveness ‘demands the development of policy and governance mechanisms aimed at the practical implementation of responsible innovation as well as openness and leadership within science policy organisations to facilitate the empowerment of social agency in technological decision-making.’ What this account does is demonstrate efforts by both the state and non-governmental entities in engaging in a variety of anticipatory governance elements, in order to implement and shape, in an ongoing and iterative way, an ethos of responsible innovation within an evolving socio-technical contract. The ensembelization of these elements, and the ongoing and iterative nature of revisiting procedures and policy around PGD makes a compelling case that these capacities working in concert align with and shed light upon the responsiveness dimension of RI. In particular the case offers a study in the dimension of responsiveness, via policy, licensing procedures, and public debate and engagement. Responsiveness is thus shown to be a concept that requires and encompasses a multiplicity of actors, processes, and capacities.

In representating how diverse stakeholder and policymaking entities go about engaging in the stewardship of the future – in this case of future people yet to be born – it demonstrates ensemblization in action. While the ensemblization of AG capacities does not in itself point to any one particular way to resolve ruptured sociotechnical contracts, it does help open them up to reflexive scrutiny and is thus one mechanism needed for ‘taking care of the future through collective stewardship of science and innovation in the present’ (Stilgoe, Owen, and Macnaghten Citation2013). The stakes are high, and the ongoing case of PGD governance, and more recently, gene editing governance, will perhaps be one of the most challenging, provocative, and important places for development and deployment of RI and AG capacities.

Acknowledgments

Thank you to Clark Miller, David Guston, and Erik Fisher for their feedback on early drafts of this piece. My appreciation also goes out to Monamie Bhadra Haines and Brenda Trinidad who have supported this project for ten years. Thank you to the anonymous reviewers for their excellent suggestions, and special thanks to Erik Fisher for his comments on the penultimate and final drafts of this paper.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Notes on contributor

Shannon N. Conley earned a PhD in Political Science from Arizona State University. She is currently an Assistant Professor in the School of Integrated Sciences at James Madison University. Her research focuses on responsible innovation, ethics, and the governance of new and emerging technologies in the context of new and emerging reproductive technologies. She also conducts research around expertise acquisition and is a member of the Studies of Experience and Expertise (SEE) community. She has particular interest in developing a scholarly community focused on STS (Science and Technology Studies) as a critical pedagogy.

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