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 Chapter 8 - Regulation Chapter overview In this Chapter we sketch the main aims of regulation and argue that the difficult choices faced in the regulation of emerging <strong>biotechnologies</strong> are themselves examples of difficult choices made in most other important regulatory domains. Also in common with other domains, the regulation of emerging <strong>biotechnologies</strong> is framed predominantly by notions of risk of harm (in the dimensions of safety and security) and the likelihood of benefits. However, following from our conclusions in Chapter 3 that <strong>biotechnologies</strong> are characterised by radical uncertainty and that what constitutes risks and benefits has complex social dimensions (in addition to obvious physical harm) we argue that the focus on narrow conceptions of risk is inappropriate to the development of <strong>biotechnologies</strong> (as distinct from the use of biotechnology products). A number of other characteristics of regulation, notably its national organisation, its preoccupation with national values and imperatives, its uneasy relationship with layers of extra-national regulation, its ambiguous accountabilities and its diffusion within a blurred advisory-policy-regulatory complex of governance institutions lead to the multiplication of potentially conflicting framings of biotechnology with no obvious privileged ground on which to resolve them. We identify a number of concrete problems to which this gives rise: problems of coordination and consistency, of voluntary and involuntary circumvention, and of democratic accountability. We conclude that regulation cannot provide all the answers to securing benefits or averting harms from emerging <strong>biotechnologies</strong>, not least because emerging <strong>biotechnologies</strong> do not fit into risk-based regulatory models but require instead an approach guided by the virtue of caution which, in turn, requires a continuous and reflective engagement with broader societal interests. Introduction 8.1 Regulators in the field of <strong>biotechnologies</strong> work under at least two (somewhat contradictory) pressures. On the one hand, regulation is expected to manage and mitigate the ‘risks’ associated with emerging <strong>biotechnologies</strong>; on the other, it is expected to do this while enabling, or even facilitating, the delivery of substantial, possibly transformative benefits. As we characterised them in Chapter 3, emerging <strong>biotechnologies</strong> present special challenges of uncertainty, ambiguity and transformative potential that are substantially settled in the case of established technologies. <strong>Emerging</strong> <strong>biotechnologies</strong> therefore often come up against regulatory conditions that are maladapted to them and that may unnecessarily inhibit certain trajectories or compound uncertainty. 8.2 In this Chapter we start by describing what might be called the ‘dominant frame’ in the regulation of emerging <strong>biotechnologies</strong>: a frame that stresses particular notions of ‘risk’ and that shapes regulatory language, decisions and practice. We provide examples of regulatory systems that focus particularly on ‘risk’ and argue that the special challenges of emerging <strong>biotechnologies</strong> show this risk-based frame to be unduly restrictive. Appropriate regulation involves both more and less than the identification and management of measurable ‘risk’: more because risks may be narrowly conceived; less because pursuing this focus may obscure other considerations of importance. The purposes of regulation 8.3 Regulation is often understood as being animated by the aim of avoiding adverse consequences – physical, environmental, social or moral – of something that it is otherwise beneficial to do. These consequences, beneficial and adverse, are, of course, not necessarily of the same order. It is noteworthy that some <strong>biotechnologies</strong> are particularly associated with ‘ethical regulation’ that is not necessarily understood in terms of the protection of the interests of those directly involved (research participants, patients, consumers, the public, future generations, etc.) but goes to the public values of society more generally. 562 562 See, for example, the regulatory constraints imposed on human embryo research in the UK (see the ‘Warnock <strong>report</strong>’: Committee of Inquiry into Human Fertilisation and Embryology (1984) Report of the committee of inquiry into human fertilisation and embryology, available at: 136
E m e r g i n g b i o t e c h n o l o g i e s Biosafety and biosecurity 8.4 A particularly influential set of concerns for the regulation of emerging <strong>biotechnologies</strong> has been physical and environmental harm described under the rubrics of ‘biosafety’ and ‘biosecurity’. Of course, biosafety and biosecurity are not at all unique to emerging <strong>biotechnologies</strong> but they arise with particular force here because of the key characteristics of emerging <strong>biotechnologies</strong>: the way uncertainty, ambiguity and transformative potential simultaneously produce a culture of high expectations about benefits and high trepidation about harms, and where there are profound difficulties in predicting – or, indeed, identifying – either. C H A P T E R 8 8.5 While the terms ‘biosafety’ and ‘biosecurity’ have no universally accepted definition and their meaning varies contextually, 563 they can be understood in the following ways: ■ Biosafety relates to “the safe handling and containment of infectious microorganisms and hazardous biological materials”, 564 applicable to humans, animals and the environment. ■ Biosecurity relates to securing biological materials in the context of military and national security risks, for example in relation to biological warfare or biological terrorism. More generally, biosecurity can be understood as “the protection of living organisms from harmful effects brought about by other species, especially the transmission of disease”. 565 8.6 As a shorthand biosafety is sometimes thought of as being concerned with keeping hazardous biological materials away from people and biosecurity as being concerned with keeping people away from hazardous biological materials. 566 Biotechnologies present obvious biosafety issues given that they are intended to affect biological systems and some of these systems are capable of experiencing harm, either directly or indirectly. 567 However, what makes these issues particularly difficult to manage is the potential absence of a predictable, linear correlation between intervention and effect, and the uncertainty of the benefit or harm that might accrue. This is compounded as the combined effect of the special characteristics of emerging <strong>biotechnologies</strong> simultaneously create difficulties in anticipating the effect of possible regulatory designs or decisions (‘locking in’ or ‘crowding out’ a technology, for example). http://www.hfea.gov.uk/docs/Warnock_Report_of_the_Committee_of_Inquiry_into_Human_Fertilisation_and_Embryology_1 984.pdf) and in Europe Case C-34/10 Brüstle v Greenpeace eV (CJEU 18 October 2011), available at: http://curia.europa.eu/juris/liste.jsf?language=en&num=C-34/10#). 563 For example, biosecurity could be understood as a subset of biosafety: a procedure designed to limit the possibly of pathogens being acquired for criminal purposes could be easily understood as part of basic laboratory biosafety measures for the containment of hazardous material. In turn, biosecurity has been described as becoming “the master frame for debates about threats to human, animal, and plant-based ecologies and the policies and practices developed to anticipate and mitigate risk.” Maye D, Dibden J, Higgins V and Potter C (2012) Governing biosecurity in a neoliberal world: comparative perspectives from Australia and the United Kingdom Environment and Planning A 44: 150. 564 Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health (2009) Biosafety in microbiological and biomedical laboratories: 5th edition, available at: http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf, p1. 565 Lackie J (Editor) (2007) Chambers dictionary of science and technology (Edinburgh: Chambers), p123. However, there is no single accepted definition of the term (see: Health and Safety Executive (2007) Final <strong>report</strong> on potential breaches of biosecurity at the Pirbright site 2007, available at: http://www.hse.gov.uk/news/archive/07aug/final<strong>report</strong>.pdf, p10). However, it may be taken to imply both the “containment of ideas and information as well as bioagents” (Sture JF (2010) Dual use awareness and applied research ethics: a brief introduction to a social responsibility perspective for scientists, available at: http://www.brad.ac.uk/bioethics/media/SSIS/Bioethics/docs/Dual_Use_and_Soc_Resp_Guidance_FINAL.pdf) as is the case, for example, with knowledge concerning the synthesis of pathogens. See: Herfst S, Osterhaus ADME and Fouchier RAM (2012) The future of research and publication on altered H5N1 viruses Journal of Infectious Diseases 205: 1628-31. 566 Sture JF (2010) Dual use awareness and applied research ethics: a brief introduction to a social responsibility perspective for scientists, available at: http://www.brad.ac.uk/bioethics/media/SSIS/Bioethics/docs/Dual_Use_and_Soc_Resp_Guidance_FINAL.pdf, p7. 567 The objective of the Cartagena Protocol on Biosafety is to ensure an “adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity…” (Article 1). United Nations (2000) Text of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, available at: http://treaties.un.org/doc/Treaties/2000/01/20000129%2008-44%20PM/Ch_XXVII_08_ap.pdf. 137
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Emerging b
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Secretariat Hugh Whittall (Director
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Foreword 1 The use of living organi
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Terms of reference 1. To examine co
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Applying public ethics: towards a p
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E m e r g i n g b i o t e c h n o l
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Part 1 Understanding emerging <stro
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Chapter 2 Biotechnology promises an
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Chapter 3 The threefold challenge o
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Chapter 5 Public perspectives
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