Emerging biotechnologies: full report - Nuffield Council on Bioethics
Emerging biotechnologies: full report - Nuffield Council on Bioethics
Emerging biotechnologies: full report - Nuffield Council on Bioethics
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E m e r g i n g b i o t e c h n o l o g i e s<br />
the regulatory landscape faced by small start-up firms, which lack the resources of, for example,<br />
the pharmaceutical giants. 597<br />
Problems of democratic accountability and public engagement<br />
8.29 Debates about public engagement and democratic accountability in the domain of emerging<br />
<str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> often turn around the divergent fears and percepti<strong>on</strong>s characteristic of specialist<br />
and public perspectives, exemplified by the case of GM crops and public c<strong>on</strong>cerns about the<br />
ethical c<strong>on</strong>sequences of particular innovati<strong>on</strong>s or particular scientific practices (such as stem<br />
cell research). This follows from something examined above: the framing of regulatory issues in<br />
terms of risk. It arises from the central features of emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> identified in this<br />
Report, features that arouse simultaneously popular feelings of trepidati<strong>on</strong> and expectati<strong>on</strong>.<br />
During discussi<strong>on</strong>s with UK regulators c<strong>on</strong>cerning the issue of public involvement, the ‘problem’<br />
of how to manage public percepti<strong>on</strong>s of innovati<strong>on</strong>s was raised, unsurprisingly given the<br />
experience around the prospect of introducing GM crops to the UK. 598 These are <strong>on</strong>ly particular<br />
instances of a recurrent set of issues faced in the domain of emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g>: how to<br />
ensure that the ‘public’ has an appropriate level of involvement with decisi<strong>on</strong>s about the public<br />
good, in a domain marked by powerful corporate interests, technocratic regulators who routinely<br />
use a vocabulary accessible <strong>on</strong>ly to the initiated, and in multinati<strong>on</strong>al instituti<strong>on</strong>s that suffer from<br />
a c<strong>on</strong>siderable democratic deficit.<br />
Problems of ‘breadth’ and ‘depth’<br />
8.30 Another dilemma is between narrowly focused regulati<strong>on</strong> involving expert bodies and sectorspecific<br />
regulators, and more generic regulati<strong>on</strong> that may apply well-established procedures.<br />
Technology-specific regulati<strong>on</strong> provides understanding and sensitivity to the situated issues,<br />
and allows c<strong>on</strong>stant regulatory inventiveness to adapt to uncertainty, although it requires a<br />
higher level of aut<strong>on</strong>omy (and therefore raises separate questi<strong>on</strong>s of accountability) and can<br />
become framed by shared interests between regulators and the regulated (for example, where<br />
the regulator’s income or existence is linked to the activity of those regulated). It may also be<br />
powerless in the face of a technological trajectory that escapes its remit. 599 C<strong>on</strong>versely, broader,<br />
more generic regulators may apply rules inflexibly and be less adaptive to new technologies 600<br />
but be capable of maintaining broader alignments and c<strong>on</strong>sistencies.<br />
Problems of balancing ‘soft’ and ‘hard’ regulati<strong>on</strong><br />
8.31 An almost unending problem of regulatory design is that of striking the right balance between<br />
‘soft’ and ‘hard’ regulati<strong>on</strong>: between regulati<strong>on</strong> that typically relies <strong>on</strong> voluntary codes and<br />
aut<strong>on</strong>omous professi<strong>on</strong>al instituti<strong>on</strong>s, and regulati<strong>on</strong> that relies <strong>on</strong> law and the unique power of<br />
the state to enforce it. ‘Hard’ regulati<strong>on</strong> may be more resource intensive, involving activities that<br />
may include licensing, m<strong>on</strong>itoring, inspecti<strong>on</strong> and enforcement, but this is not necessarily the<br />
case, and in the UK there is now an expectati<strong>on</strong> that the cost of regulati<strong>on</strong> should be met by<br />
those regulated, who are benefitting from the service provided by regulators. To express the<br />
distincti<strong>on</strong> between hard and soft regulati<strong>on</strong> as this dichotomy is to see immediately that no<br />
simple choice between ‘soft’ and ‘hard’ is possible. Any c<strong>on</strong>ceivable system is a mixture of the<br />
two: as we noted above, in the last analysis even the most hierarchical form of command<br />
regulati<strong>on</strong> depends to some degree <strong>on</strong> voluntary compliance; and effective systems of ‘soft’<br />
regulati<strong>on</strong> (such as those organised by professi<strong>on</strong>al bodies) depend ultimately <strong>on</strong> the ‘bite’ of<br />
some disciplinary sancti<strong>on</strong>s. There is no problem of working simultaneously with hard and soft<br />
regulati<strong>on</strong>. The big problem is deciding what in the case of any particular process is the most<br />
effective combinati<strong>on</strong>. Everything we have said above about regulati<strong>on</strong> – its often multi-level<br />
character, the influence of nati<strong>on</strong>al settings – suggests that the balance cannot be struck by<br />
597 Oral evidence from the fact-finding meeting <strong>on</strong> intellectual property, innovati<strong>on</strong> and markets, held by the Working Party, 24<br />
June 2011.<br />
598 Oral evidence from the fact-finding meeting <strong>on</strong> policy, regulati<strong>on</strong> and governance, held by the Working Party, 8 July 2011.<br />
599 The l<strong>on</strong>gitudinal regulati<strong>on</strong> of human embry<strong>on</strong>ic stem cells in the UK presented such a challenge in the 2000s.<br />
600 See paragraph 8.23.<br />
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