Legal Regulation of New Technologies: Re-thinking Xenotechnologies in the Twenty-first Century

Chapter 13
Legal Regulation of New Technologies: Re-thinking Xenotechnologies in the Twenty-first Century

Marie Fox*

Introduction

A central preoccupation of contemporary health law is how law should respond to new technologies.¹ Indeed some commentators have even proposed that ‘Law and Technology’ may now comprise a new legal sub-discipline of interest to property, environmental, human rights, tort and international trade lawyers, as well as health lawyers.² New technologies currently attracting public concern and legal attention include nanotechnology,³ neurotechnology,⁴ and genetic and other forms of enhancement technology.⁵ In common with past technological innovations each is seen as holding out tremendous promise, but this hope is accompanied by significant risks that fuel demands for regulation. Yet, as Barbara Koening has argued, over time these technological innovations frequently become routine so that ethico-legal concerns about the technology tend to fade.⁶ Such a process can be traced, for instance, in the widespread use and subsequent normalisation of IVF technologies;⁷ although as Sarah Franklin’s recent history of IVF and stem cells reminds us, a certain ambivalence continues to characterise our response to these technologies.⁸ In the case of certain biotechnologies, however, law and other forces may conspire to prevent the technology becoming routine, so that the concerns they have historically evoked remain potent, although the particular form these concerns take may change through time. This chapter uses xenotransplantation as a case study in legal regulation, tracing a regulatory history which saw xenotechnologies9 become the subject of intense regulatory attention in the mid 1990s, but recede from public view over the past 20 years, even as scientific innovation in this field has continued apace. Throughout this period Sheila McLean’s work has played a pivotal role in shaping legal thinking about this technology in the UK, at a time when leading scientists in the field were working in this jurisdiction and, as with IVF, when the UK was perceived to be in the regulatory vanguard in framing responses to xenotechnologies. Reflecting her prominence in shaping the field of health law more broadly,¹⁰ McLean has contributed both to policy formation as a key member of UKXIRA (the regulatory body established to oversee this technology) while also offering a searching ethico-legal critique of the practice, notably in a commissioned co-authored report which was controversially supressed by the Department of Health,¹¹ and subsequently published as the seminal monograph in the field in 2005.¹² In light of the developments in the decade following publication of Xenotransplantation: Law and Ethics, I suggest that the failure of successive governments to implement McLean and Williamson’s proposals have contributed to the current unsatisfactory regulatory vacuum, demonstrating the prescience of McLean’s vision. However, I contend that the time for advocating legislation with the express purpose of regulating xenotransplantation along the lines that McLean and Williamson proposed may now have passed, and that there is a need to frame new regulatory approaches fit for purpose in the twenty-first century. Although xenotransplantation has faded from the regulatory agenda, as attention has switched to the technologies noted above,¹³ nevertheless productive scholarship on xenotransplantation has occurred, notably in the disciplines of anthropology and sociology. In this chapter I suggest that in framing an appropriate response to xenotechnologies in a changing regulatory environment¹⁴ legal scholars should take seriously the questions posed, and learn from the insights and methodologies drawn from other disciplines. Such scholarship has raised important questions about the values that should underpin technological innovation which are to date largely ignored in legal discussions of how to regulate innovative techniques such as what it means to be human,15 and how technologies serve to redefine the meaning of medicine, health and kinship.¹⁶

The Promissory Potential of the Xeno Era

The story of xenotechnologies – which may be broadly defined as the transplantation of body parts between different species, comprising both whole organ transplants and the use of animal cells or tissues – has a long genealogy dating back on some accounts to the mid-seventeenth century.¹⁷ Periodically since that time interest in xenotransplantation has been rekindled only to fade away, and as Lesley Sharp has shown, xenotransplantation served to underpin, but was then eclipsed by, the success of allotransplantation.¹⁸ Notable, albeit failed, experiments in xenotransplantation involving primate transplants to humans marked the middle years of the twentieth century, and culminated in the infamous ‘Baby Fae’ case in which a 14-day old human infant was given a baboon heart transplant and survived for 21 days before dying of heart failure caused by acute organ rejection. Negative reactions to this scandal caused interest in xenotransplantation to wane. However, approximately 20 years ago in the mid 1990s, the procedure became the focus of acute media, policy and legal attention, starting with a report by the Nuffield Council on Bioethics published in 1996, which noted: ‘Recent developments suggest that transplantation teams are making progress in controlling the immune response to animal transplants in order to prevent rejection … it is looking increasingly probable that many of the biological obstacles to xenotransplantation will eventually be overcome’.¹⁹

Nik Brown and Sian Beynon-Jones have criticised the Nuffield Council’s uncritical acceptance of a series of announcements the previous year by the (now defunct) British Biotech firm Imutran, to the effect that it would imminently be in a position to transplant whole pig organs to humans following preclinical experiments with primates, and accused it of a panicked response to commercial predictions, never validated by peer review which were subsequently revealed to be, at best, hopelessly optimistic.²⁰ Yet, in retrospect, it is apparent that at this historical juncture the promissory scientific claims made by key scientific stakeholders were more likely to be accepted because this was an era in which the trials being conducted and the regulatory responses being devised was marked by a number of special features. Sharp has argued persuasively that globally the mid 1990s marked the end of a 30-year period dating back to the mid 1960s which can now be ‘celebrated as a golden era of bold surgical efforts’.²¹ Certainly in the UK, in this period predating the Alder Hey and Bristol organ retention scandals of the late 1990s, public concerns about transplantation were for the most part limited to the question of how to increase the supply of human organs which was radically outstripped by demand. Concerns that were shortly to emerge about how organs were taken and used in the absence of consent and about inappropriate commodification of body parts were relatively muted at this point, as hope in new technologies to address infertility, organ failure and a range of other medicalised problems was at its height. Alarm about the growing shortage of suitable human organs for transplantation purposes, coupled with awareness of the limitations of artificial organs, led to xenotransplantation being touted as a possible solution to the crisis,22 and to biotechnology companies investing considerable sums in the technique.²³ In response, a number of high-profile reports were commissioned. The Nuffield Council report in 1996 (hereafter ‘the Nuffield Report’) was swiftly followed by a report Ian Kennedy produced for the Department of Health (hereafter ‘the Kennedy Report’) which was equally accepting of the views of scientific stakeholders,²⁴ while at the supranational level the Council of Europe published a ‘State of the Art Report’ in 1997.²⁵ With hindsight it is ironic that these reports canvassing regulatory responses appeared at precisely the moment when this period of intensely visible activity in the xeno field was actually drawing to a close, and it is now possible to characterise both UK reports, as well as academic responses to them, as products of a particular time, whose authors were responding to a regulatory environment which has since altered significantly.

As Thérèse Murphy and Gearoid O’Cuinn have observed, legal discussions about how to regulate technology typically focus on ‘the force of law as prohibiting or enabling, on law’s capacity to protect and promote (whether that be protecting and promoting new health technologies, or the rights and dignity of individuals where these are seen to be threatened by such technologies, real or potential)’.²⁶ In practice they argue that this tends to mean that ‘… new health technologies produce calls for more law and, from others, for less law. There tends to be lots of talk of law acting as limit and, equally, lots of talk of the limits of law’;²⁷ however, there is less consideration of the values or purposes of law. Certainly this ‘more law’ view was the vision of law that underpinned both the Nuffield and Kennedy reports. The ‘more law’ stance is particularly evident in the emphasis in the Kennedy Report on the centrality of law to the regulatory scheme it proposes: ‘[S]ome form of regulatory system is essential. This system must be founded in law as the nature of our concerns regarding the protection of animal welfare and the control of risk to humans through, in particular infection, are such as to make legal regulation essential’.²⁸

This conclusion followed from an extensive overview of the legal provisions – at both national and EU level – that were then in place to govern the procedure. The Kennedy Advisory Group agreed that these provisions contained important lacunae, with the result that it was uncertain how far the law protected the welfare of both animal and human subjects:

[The] existing legal framework is inadequate to answer our concerns about risks to patients and the wider population … we recommend that the legislation which we propose take account of [the highly regarded regulatory procedures which exist to govern other aspects of healthcare] so as to ensure that a similar structure is put in place to regulate any procedure involving xenotransplantation.29

While the Nuffield Report agreed that some ‘regulatory framework’ was necessary to guarantee the safety and quality of animal organs and tissue³⁰ and to allay public concerns,³¹ it was more open as to the legal status of the regulatory entity, suggesting that a non-statutory body akin to the Gene Therapy Advisory Committee, which oversees ethical approval of gene therapy clinical trials, might suffice. The Kennedy Report, however, was categorical that its proposed ‘National Standing Body’ must have statutory backing: ‘We state here our view that new, specific primary legislation to regulate xenotransplantation is required in the interests of patients, public health and animal welfare’.³²

Acknowledging pressure on the Parliamentary timetable, it conceded that a non-statutory body would suffice in the short term but only until legislation could be enacted. Equally, it was clear that a Code of Practice or other non-statutory guidance was simply not adequate. The Kennedy Report proceeded to outline the onerous and specialist duties that should be entrusted to this statutory body. These were to include standard-setting and overview tasks; advising on research to be carried out (in relation to infection risks, immunology and physiology) and assessing whether it was safe and ethical for trials on humans to begin; defining measures to measure public health risks; setting animal welfare standards in conjunction with the Home Office; and devising arrangements for long-term surveillance and follow up of xenotransplant recipients. The proposed statutory body was also to be responsible for implementation measures such as approving and licensing clinical sites and animal facilities and approving applications for clinical trials subject to various conditions and keeping under review developments in the field.³³ This list of statutory functions is strikingly similar to those carried out by the Human Fertilisation and Embryology Authority (HFEA), and in terms of membership, the Kennedy Advisory Group’s recommendations echo those of the Warnock Committee in proposing that to command public respect, along with that of animal welfare groups and the medical scientific community, ‘… its membership must reflect an appropriate range of expertise and interests’.³⁴ These recommendations for a statutory body with wide-ranging powers were generally applauded by commentators at the time,³⁵ and the failure of the Labour Government to give legislative backing to the interim regulatory body – UKXIRA – established in the wake of the Nuffield and Kennedy reports, lies at the heart of McLean and Williamson’s critique of the legal governance of xenotransplantation in their monograph. In an analysis clearly informed by McLean’s experience of serving on UKXIRA during its tenure from 1997 to 2007, they argue that its regulatory role was hampered by its status as a non-departmental public body. Specifically its inability to impose sanctions meant that in order to secure compliance it needed to ‘work in co-operation with industry and its impact and success as an advisory body [were] dependent upon good relations with industry’.36 In addition, McLean and Williamson criticised UKXIRA for lacking a clear remit to consider the ethical issues associated with xenotransplantation in a ‘strategic, thoroughgoing’ manner, instead addressing these issues in a ‘relatively cursory’ fashion.³⁷ In their view this resulted in part from the somewhat limited conception of the ethical issues posed by xenotransplantation, as laid out in the Kennedy Report.³⁸ In a more radical critique of UKXIRA, Beynon-Jones and Brown accuse it of following Kennedy and Nuffield in uncritically accepting the views of scientific stakeholders and failing to interrogate spurious scientific claims.³⁹ In the monograph’s conclusion McLean and Williamson were unequivocal. Given the uncertainties and risks generated by xenotransplantation for putative human recipients, animals used as ‘donors’, the broader public and future generations, and the limited remit and powers of UKXIRA, they echoed Kennedy in insisting that: ‘Statutory backing for the regulatory body is imperative. Not only does it give the regulator “teeth”, but a statutory remit would build into the system the safeguards which come from the compatibility requirement with the Human Rights Act 1998’.⁴⁰

Their recommendations for regulating the procedure have effectively become orthodoxy in the field. Thus, a similar approach was advocated by Sara Fovargue who concluded her 2012 monograph by arguing that: ‘a specialist xenotransplantation regulatory authority should be established in every county before clinical use, in order to protect individual and public health’.⁴¹ Whether such bodies should be placed on a statutory footing is left unclear, but in a subsequent essay Fovargue argues that the criminal law may justifiably be used to ensure compliance with surveillance schemes deemed necessary to protect individual and public health from the risks posted by xenotransplantation and that a dedicated xenotransplant statute is necessary for this purpose.⁴²

Certainly, the subsequent fate of the non-statutory UKXIRA suggests that McLean and Williamson were correct to argue that a statutory footing for the regulator was necessary. While the Coalition Government’s so-called ‘Bonfire of the Quangos’ in 2010, which aimed at tackling the budget deficit by abolishing or merging hundreds of quangos,⁴³ demonstrated that statutory backing was no guarantee of longevity, it is worth noting that in the health field the statutory HFEA and Human Tissue Authority (HTA) were ultimately spared abolition or merger,44 while the Human Genetics Commission (which like UKXIRA was a non-departmental public body) was abolished following the review of public bodies. By that stage UKXIRA was already history having been unceremoniously disbanded in January 2007. Compounding concerns about the regulatory vacuum following the demise of UKXIRA was the Government’s failure to offer a convincing justification for its somewhat ad hoc abolition, which seemed to reflect the lack of any coherent rationale for the regulation of health technologies.⁴⁵ Announcing the decision, health minister Andy Burnham pointed to significant regulatory developments since the deliberations of the Kennedy Report. Whereas the Advisory Group had concluded that the definition of ‘medicinal products’ in the relevant EU directive did not encompass xenotransplantation, and that general oversight by RECs (Research Ethics Committees) was inadequate for this task, Burnham highlighted the impact of the 2003 EU Directive on medicinal products (Commission Directive 2003/63/EU) and the subsequent Medicines for Human Use (Clinical Trials) Regulations 2004, contending that ‘they make specific provision for xenotransplantation proposals’.⁴⁶