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Public and Expert Voices in the Legal Regulation of Technology

01 Jan 2016-

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Introduction

  • In another sense, however, the targeted activity of any regulatory scheme will influence both its creation and eventual operation and here the highly specialist and complex nature of technology – and its associated risks – are certainly capable of raising distinct challenges.
  • The basis of such an argument is that public participation is able to broaden the regulator’s lens beyond the purely technical aspects of the particular regulatory regime, which in turn will allow the regulator to view issues from different perspectives (McGarity, 1990, p.112).

Human Fertilisation and Embryology

  • The HFEA’s functions include, first, licensing and monitoring: clinics that carry out IVF and donor insemination treatment; centres that carry out human embryo research; and, the storage of gametes and embryos.
  • The Government’s proposal was for the creation of a RATE board, charged with taking a more strategic role, supported by (non-executive) Expert Advisory Panels (EAPs) to ensure that expertise would be available in all areas of activity within its remit (ibid, paras. 3.10-3.16).
  • These recommendations were not accepted by the Government, however, who asserted that “such a framework would introduce a lack of accountability” (ibid, para 8), “would cause uncertainty about the scope of regulation” (ibid, para 11), and “would be confusing and open up the HFEA to increased litigation and judicial review” (ibid, para 11).
  • The McCracken report found that “There is almost universal praise for the Human Fertilisation and Embryology Act, and recognition that it is still fit for purpose” (McCracken, 2013, para 4.5).

The manufacture and distribution of chemicals

  • The ubiquitous use of chemicals (and chemical technologies) undoubtedly provides innumerable benefits to society but can also cause considerable damage to human health and/or the environment.
  • First, the central mechanism of chemicals control in the EU, the REACH Regulation (Regulation 1907/2006/EC (OJ L396/1 2006)) - an acronym for the Registration, Evaluation, Authorisation and Restriction of Chemicals - is not designed with a single objective in mind (see generally Vaughan, 2015).
  • In a modern context, the objectives of EU chemicals regulation have been extended to explicitly include the protection of human health and the environment, facilitate market integration and to promote innovation in the chemicals sector (Heyvaert, 2007, p.201).
  • First, the risk assessment which forms the basis of the registered information might highlight risks which can trigger evaluation, authorisation and restriction measures.

The disposal of hazardous waste

  • In June 1987 – following the discovery, in Africa and other parts of the developing world, of illicit dumps of imported hazardous waste – the United Nations Environment Programme (UNEP) established a working group tasked with elaborating a global convention on the control of transboundary movements of such wastes.
  • When the Basel Convention was formally adopted the Organization of African Unity (OAU) expressed its disappointment at the lack of a total ban, stating that the restrictions imposed by the Convention “could be circumvented because of the lack of competent administrators and administrative agencies” (Shearer, 1993, p151).
  • Such complexity and lack of clarity generates uncertainty.
  • As the examples examined in this chapter illustrate, discretion is heavily implicated in the interpretation of regulatory norms and the application of them to technological processes and practices.

Conclusion

  • This chapter began by outlining why public participation has been deemed a principle of good regulation, and explaining the tension between this objective and considerations of resource and expertise.
  • The chapter has shown that in each of these regimes certain viewpoints are prioritised in the exercise of the discretionary decision-making that the regimes inevitably contain.
  • Moreover, resource constraints mean that the latter two are effectively left to self-regulate, whilst public confidence in the HFEA is consistently attributed to its expert status.
  • This not only raises questions about the extent to which these regulatory regimes do in fact exert effective control over the activities in question, but also whether the limited scope for public participation diminishes the legitimacy of these decision-making processes.
  • By way of conclusion, it is worth returning to the false dichotomy between rules and discretion noted earlier.

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This is an author produced version of a paper published in:
The Routledge Handbook of Technology, Crime and Justice
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Book chapter :
Macdonald, S. & Bishop, P. (2016). Public and expert voices in the legal regulation of technology. The Routledge
Handbook of Technology, Crime and Justice, (pp. 577-593). Abingdon: Routledge.
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To appear in M R McGuire & T J Holt (eds) The Routledge Handbook of Technology, Crime and
Justice
Public and Expert Voices in the Legal Regulation of Technology
Patrick Bishop and Stuart Macdonald
Introduction
The law in isolation is seldom, if ever, an adequate regulatory device. As Black contends in her
exposition of decentred regulation: “… governments do not [] have a monopoly on regulation […]
regulation is occurring within and between other social actors” (Black, 2001, p103). Indeed, the use
of alternative instruments to achieve regulatory goals has proliferated in recent times; Thaler and
Sunstein’s influential nudge theory (Thaler and Sunstein, 2009) is one obvious manifestation of the
preference on the part of policy makers for non-regulatory solutions to social problems. But whilst
innovation in the design of policy instruments is laudable, there remains a place for more traditional
command and control regulation. As Macrory notes, “it remains equally important to ensure that the
qualities of transparency, accountability, and enforceability inherent in the more formal legal
structures are not lost” (Macrory, 2001, p647).
The focus of this chapter is the legal regulation of technology. In one sense, to distinguish between
the regulation of technology and the regulation of other things is a false dichotomy. Technology does
not exist in a vacuum and any regulation of it is essentially concerned with limiting and controlling
the uses that may be made of technology by humans. In short, any form of legal regulation is
concerned with behavioural control and regulating technology is no exception. In another sense,
however, the targeted activity of any regulatory scheme will influence both its creation and eventual
operation and here the highly specialist and complex nature of technology and its associated risks
are certainly capable of raising distinct challenges. The chapter examines three technological areas
which have been subjected to legal regulation: human fertilisation and embryology; the manufacture
and distribution of chemicals; and, the disposal of hazardous waste. Whilst these activities, and the
regimes which regulate them, are quite different, they do share two basic common features. First, the
activities themselves are necessary and/or socially beneficial. And, second, the activities also have the
potential to cause considerable harm at both the individual and societal level if left unregulated.
Efforts to regulate activities like these face various challenges. For a start, efforts at legal regulation of
technology struggle to keep apace with scientific advances. This has been characterised as a race
between the ‘hare’ of technology against the ‘tortoise’ of law (Stokes, 2012, p93). It is also apparent
that despite an initial period free of regulation, new high-tech products and processes are eventually
caught by a bespoke regulatory net or, failing that, fall within existing regulatory regimes with broad
and overlapping remits (Friedman, 2001).
A further challenge, which is the focus of this chapter, is managing the frequent tension between
public and expert opinion. Technological advancement is a key ingredient of the ‘new modernity’
conceptualised by Beck: in social science's understanding of modernity, the plough, the steam
locomotive and the microchip are visible indicators of a much deeper process, which comprises and
reshapes the entire social structure" (Beck, 1992, p.51). This reshaped social structure is “…
increasingly preoccupied with the future (and also with safety), which generates the notion of risk”
(Giddens, 1999, p.3). Any legal regime tasked with the regulation of risk is necessarily complex and
multifarious and involves the input of science and expertise (to provide assessments of risk) and the
public at large in order to gauge society’s response to particular dangers and their likelihood. These

drivers of regulatory design and approach will often (if not inevitably) exist in mutual tension. This
chapter will explore this tension via an analysis of three distinct regulatory regimes. These regimes
have been chosen as they each have different structures and legislative underpinnings: UK domestic
law (Human Fertilisation and Embryology Act 1990), EU law (REACH Regulation 2006) and
international law (Basel Convention 1989). Before turning to these, the chapter begins by examining
the role public participation plays in legal regulation in general, and the tension between this objective
and considerations of resource and expertise.
Public and expert voices in regulatory design: the theory
The literature on principles of ‘good regulation’ reveals a high level of consensus regarding the
importance of public participation (Baldwin, Cave and Lodge, 2012; Regulating Better, 2004;
Mandelkern Group on Better Regulation, 2001; Regulatory Performance Indicators, 1999). In
environmental matters the importance of public participation has been fully recognised at the
international level (Aarhus, 1998). The rationale for enhanced participatory rights is rooted in
democratic concerns, particularly in the context of non-majoritarian regulatory bodies. As Abbot and
Lee have noted:
The political nature of environmental decisions, together with their frequent delegation to
unelected experts, requires public participation to enhance the procedural legitimacy of
decisions, since electoral legitimacy is weak. (Abbot and Lee, 2003, p.84)
In addition to justifications based on democracy, there is also ample support for the view that
decisions and policies made as a result of a participatory process produce higher quality results than
would be the case absent any public input (Abbot and Lee, 2003, p.83; McGarity, 1990, p.112). The
basis of such an argument is that public participation is able to broaden the regulator’s lens beyond
the purely technical aspects of the particular regulatory regime, which in turn will allow the regulator
to view issues from different perspectives (McGarity, 1990, p.112). Theoretical support for this may
be gleaned from the social science research methodology known as ‘triangulation’, which involves the
“use of more than one approach to the investigation of a research question in order to enhance
confidence in the ensuing findings” (Bryman, 2004, p.1143). It is also important to note that, despite
the often technical nature of regulatory regimes, expertise alone is incapable of providing a complete
solution to most regulatory challenges. As McGarity has opined: “… many, if not most, important
health and environmental questions are in fact not resolvable by the experts. The available
information and the state of the scientific art is often so poor that the experts can at best hazard highly
uncertain educated guesses.” (McGarity,1990, p.105). Even where experts are able to provide a
reasonably accurate assessment of risks this in no way provides an answer to the vexed societal
question of how much risk is acceptable. In this regard the public “can provide useful information on
matters such as public fears and values” (Abbot and Lee, 2003, p.82). Finally, involvement in the
decision making process provides interested parties with a better understanding of how decisions are
made which in turn has the potential to reduce the scope for judicial review (McGarity, 1990, p.112).
In spite of these benefits, there are two sets of concerns about public participation. The first are
practical, and focus on operational efficiency. In a world of finite resources, it is inevitable that cost
minimisation and efficiency concerns will permeate the design and operation of any regulatory
regime. As discussed below, this is certainly the case with the three areas of regulation considered in
this chapter. In such a context, it is generally accepted that public participation will have considerable
resource implications, both in terms of money and time (Abbot and Lee, 2003, p.87; McGarity, 1990,
p.112). Moreover, an over-emphasis on participation as a condition precedent of regulatory action has

To appear in M R McGuire & T J Holt (eds) The Routledge Handbook of Technology, Crime and
Justice
the potential to damage a regulator’s ability to respond to issues in a timely manner: “more
participation might lead to less effective decision making and eventually to stagnation in the
regulatory system (Baldwin, Cave and Lodge, 2012, p.29).
By contrast, the second set of concerns focuses not on resources but on the ability of the public to
engage in what are often technical, even esoteric debates. As Eden has noted:
[O]ne of the circumstances that can militate against this admirable objective is where
discussions are dominated by ‘experts’ of one sort or another. This precludes wide public
involvement by defining the discussions as the exclusive preserve of ‘experts’ (Eden, 1996,
p.183).
This view is shared by a number of commentators (Baldwin, Cave and Lodge, 2012, p.29; Lee and
Abbot, 2003, p.84; McGarity, 1990, p.113). However, whilst members of the public “have not always
had the power or the confidence of their own ‘expertise’ to raise their criticisms forcefully” (Eden,
1996, p.191), Baldwin, Cave and Lodge point out that in Beck’s ‘risk society’ there is a “new political
dialogue built on the death of deference to those claiming special expertise” (Baldwin, Cave and
Lodge, 2012, p.30). Moreover, any attempt to preclude public debate on the basis that only experts’
are capable of reaching an appropriate decision undermines the democratic foundations on which
public participation is based and the legitimacy of any subsequent decisions.
Having outlined this tension between public participation on the one hand and operational efficiency
and expertise on the other, the chapter will now examine how these considerations have been
managed in three contrasting regulatory regimes specific to differing technological contexts.
Human Fertilisation and Embryology
Following the birth in the UK in 1978 of the first child conceived through in vitro fertilisation (IVF),
a Committee of Inquiry was established in 1982 under the chairmanship of Dame Mary Warnock to
consider the social, ethical and legal implications of the advances in human fertilisation and
embryology and to make recommendations on the policies and safeguards that should be applied.
When it was published in 1984, one of the Warnock report’s principal recommendations was the
creation of an independent regulatory authority (Department of Health & Social Security, 1984). This
body would have both executive and advisory functions, and would include not only representation
from the scientific and medical communities but also lay members in order to ensure public
confidence and participation (ibid, para 13.4).
Following the Warnock report’s recommendations, the Human Fertilisation and Embryology Act
1990 (the 1990 Act) established the Human Fertilisation and Embryology Authority (HFEA). The
HFEA’s functions include, first, licensing and monitoring: clinics that carry out IVF and donor
insemination treatment; centres that carry out human embryo research; and, the storage of gametes
and embryos. Activities which infringe this regulatory framework, such as unlicensed treatment,
constitute a criminal offence (1990 Act, s 41). Second, the HFEA issues a Code of Practice and
maintains formal registers of information about donors, fertility treatments and children born as a
result of these treatments. And, third, the HFEA publicises its role and provides advice and

information to patients, donors and clinics. The HFEA currently has 12 members.
1
These members
have a range of expertise, including medicine, law, religion and philosophy. To encourage an
independent view, the HFEA requires that at least half of its members (including the Chair and
Deputy) are not doctors or scientists involved in human embryo research or fertility treatment.
Whilst stating that the 1990 Act had worked well enabling science and medicine to flourish within
agreed parameters and promoting public confidence the Government decided in 2005 that a review
of the law and regulation in this area was “timely and desirable” in the light of technological
developments in assisted reproduction and changing public attitudes (Department of Health, 2006,
paras 1.2-1.3). When it reported in 2006, one of the review’s key outcomes was to reiterate the
Government’s commitment (first announced in 2004) to creating the Regulatory Authority for Tissue
and Embryos (RATE). The intention was that RATE would replace the HFEA and the Human Tissue
Authority (HTA) with a single regulator with responsibilities across the range of human tissues, cells
and blood (ibid, para 1.4). It was suggested that this merger would prevent overlapping regulation and
ensure the application of “common principles and standards” across these “closely linked areas” (ibid,
para 3.2). The Government’s proposal was for the creation of a RATE board, charged with taking a
more strategic role, supported by (non-executive) Expert Advisory Panels (EAPs) to ensure that
expertise would be available in all areas of activity within its remit (ibid, paras. 3.10-3.16).
Following the publication of a draft Bill in May 2007, a Joint Parliamentary Scrutiny Committee was
established. The Joint Committee’s report, in July 2007, found “overwhelming and convincing”
evidence against establishing RATE (Joint Committee on the Human Tissue and Embryos (Draft)
Bill, 2007, para 92). The Committee stated that, whilst there were some synergies between the work
of the HFEA and HTA (ibid, para 60) and a merger offered some potential efficiencies and cost
savings (ibid, para 61), there were also significant risks. The broad remit of RATE could result in a
loss of both specialist expertise (ibid, para 76) and HFEA’s national and international reputation (ibid,
para 73). There are also significant differences between the work of the HFEA and HTA (ibid, para
69), and public confidence could be affected by the loss of a dedicated authority for embryos which
are widely regarded as meriting a special status (ibid, para 65). Moreover, RATE’s proposed structure
could result in it being little more than a rubberstamping authority, with the EAPs functioning
effectively as the HFEA and the HTA (ibid, para 85), and it would be possible to achieve some
efficiencies without a formal merger (ibid, para 82). Following the Joint Committee’s report the
Government decided not to proceed with RATE, and focussed instead on how the two authorities
could work together to streamline their operations (Secretary of State for Health, 2007, para 17).
The Joint Committee’s report also expressed concern that the draft Bill lacked “the explicit
underpinning ethical framework which in 1990 was provided by the Warnock Report (Joint
Committee on the Human Tissue and Embryos (Draft) Bill, 2007, para 44). This was due, in part, to
the fact that the Act being created was an amending statute. In other words:
Nowhere was a blank piece of paper offered for reform, in a way that allowed for a thorough
and fundamental rethinking of the kind of regulation which might best suit this area or the
1
In January 2013 the HFEA reduced the size of its board from 19 members to 12. It reports that this smaller
board size is now widely recognised to be more effective (Human Fertilisation and Embryology Authority,
2014, p16). It has also gradually reduced its staff complement, from 86 in 2010/11 to 64 by the end of the
2013/14 financial year (ibid).

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