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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 />

8.38 Finally, and most importantly, the virtue of cauti<strong>on</strong> involves a respect for the importance of<br />

undertaking all these processes under the oversight of a variety of c<strong>on</strong>tending social and<br />

political perspectives, where these exist. 618 (This relates to the various methods of public<br />

participati<strong>on</strong> and inclusive deliberati<strong>on</strong> we have discussed in Chapter 5.)<br />

Reframing surveillance<br />

8.39 The c<strong>on</strong>victi<strong>on</strong> that cauti<strong>on</strong> can be exercised simply through attenti<strong>on</strong> to issues of risk c<strong>on</strong>nects<br />

to a sec<strong>on</strong>d distorti<strong>on</strong>, involving the instituti<strong>on</strong>al design of systems of regulati<strong>on</strong>. The c<strong>on</strong>cern<br />

with issues of risk leads to a temptati<strong>on</strong> to design systems of surveillance and c<strong>on</strong>trol that seek<br />

comprehensively to m<strong>on</strong>itor all relevant activity. This temptati<strong>on</strong> is particularly str<strong>on</strong>g in the<br />

wake of panics about the possible c<strong>on</strong>sequences of particular innovati<strong>on</strong>s 619 and c<strong>on</strong>nects to<br />

the questi<strong>on</strong> of whether and how to manage public percepti<strong>on</strong>s and public <str<strong>on</strong>g>report</str<strong>on</strong>g>ing of emerging<br />

<str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g>. This overemphasis <strong>on</strong> surveillance is not a property of emerging<br />

biotechnology regulati<strong>on</strong> al<strong>on</strong>e. An overwhelming c<strong>on</strong>cern with comprehensive surveillance is<br />

virtually a defining character of the regulatory systems that have emerged in the UK in recent<br />

decades. 620 It is hardly likely, therefore, that emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> would be an excepti<strong>on</strong> to<br />

this trend although, in view of our characterisati<strong>on</strong> of the problem posed by emerging<br />

<str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g>, it leaves entirely unexamined the questi<strong>on</strong> of whether such measures are<br />

either necessary, sufficient or in any way appropriate to meet the objectives of regulati<strong>on</strong> in<br />

such c<strong>on</strong>texts.<br />

C H A P T E R 8<br />

Reframing command and c<strong>on</strong>trol<br />

8.40 To those attempting to work with regulati<strong>on</strong> in emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> and, indeed, to the<br />

outside observer, the instituti<strong>on</strong>al world of biotechnology regulati<strong>on</strong> can look a mess: a complex<br />

patchwork of public, private, semi-public, nati<strong>on</strong>al and supranati<strong>on</strong>al instituti<strong>on</strong>s and practices<br />

with significant duplicati<strong>on</strong>s and gaps. The temptati<strong>on</strong> to try to rati<strong>on</strong>alise this into something<br />

closer to a single system of command and c<strong>on</strong>trol is very str<strong>on</strong>g, as the widespread resort to<br />

command and c<strong>on</strong>trol as a resp<strong>on</strong>se to regulatory failures in other domains shows. 621 But<br />

setting aside the well known limits to command and c<strong>on</strong>trol regulati<strong>on</strong>, there is a more pertinent<br />

point still: the ‘mess’ of emerging <str<strong>on</strong>g>biotechnologies</str<strong>on</strong>g> regulati<strong>on</strong> is a perfectly normal state of affairs<br />

in any complex regulatory domain. Attempting to subdue it to a single hierarchical regulatory<br />

template, especially <strong>on</strong>e driven by the kind of restrictive understanding of risk described<br />

above, 622 is to pursue an illusi<strong>on</strong>.<br />

Reframing regulatory design<br />

8.41 The twin temptati<strong>on</strong>s of surveillance and command and c<strong>on</strong>trol link to a fourth temptati<strong>on</strong> to be<br />

avoided. The world of regulatory design is replete with summary prescripti<strong>on</strong>s of how to design<br />

regulatory systems to cope with regulatory problems. Some of the most fashi<strong>on</strong>able in recent<br />

years have included:<br />

618 European Envir<strong>on</strong>ment Agency (2001) Late less<strong>on</strong>s from early warnings: the precauti<strong>on</strong>ary principle 1896-2000, available at:<br />

http://www.eea.europa.eu/publicati<strong>on</strong>s/envir<strong>on</strong>mental_issue_<str<strong>on</strong>g>report</str<strong>on</strong>g>_2001_22.<br />

619 See, for example, the generally unfavourable resp<strong>on</strong>se to GM crops in Europe and the extensive m<strong>on</strong>itoring and c<strong>on</strong>trol<br />

systems associated with GM crops in the European Uni<strong>on</strong>. This is an archetypal example and has formed the basis of a<br />

significant academic and industrial resp<strong>on</strong>se to new technologies, wherein relevant stakeholders seek to ‘learn less<strong>on</strong>s’ from<br />

the GM crop debate during the 1990s, partly with the aim of avoiding such a regulatory outcome. See: Einsiedel EF and<br />

Goldenberg L (2004) Dwarfing the social? Nanotechnology less<strong>on</strong>s from the biotechnology fr<strong>on</strong>t Bulletin of Science,<br />

Technology & Society 24: 28-33; Mehta MD (2004) From biotechnology to nanotechnology: what can we learn from earlier<br />

technologies? Bulletin of Science, Technology & Society 24: 34-9. More recent technological developments – such as the<br />

nascent DNA sequence synthesis industry – seem to be pushing str<strong>on</strong>gly for self-regulati<strong>on</strong>. See: Schmidt M and Giersch G<br />

(2011) DNA synthesis and security, in DNA microarrays, synthesis and synthetic DNA, Campbell MJ (Editor) (New York:<br />

Nova Science).<br />

620 See: Moran M (2003) The British regulatory state: high modernism and hyper-innovati<strong>on</strong> (Oxford: Oxford University Press).<br />

621 Such as financial services, following the 2007-8 crash.<br />

622 See paragraphs 8.7 to 8.8.<br />

147

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