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 8.22 Statutory regulators who work in a particular sector, such as the Human Fertilisation and Embryology Authority (HFEA, which regulates research involving human embryos and therefore holds the keys to the door of much stem cell research), have provided some stability and appreciation of issues within a particular sector, a value evidenced by support from even some of its most consistent critics in the face of current threats to its existence as an independent regulator. 590 This has made it possible to introduce a measure of regulatory flexibility in this an area where technologies continue to emerge, albeit flexibility that periodically comes up against the need to amend or clarify the framework legislation. 591 8.23 Other, more broad-based and traditionally ‘administrative’ regulators – such as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which regulates drugs and medical devices, may have less flexibility. It has been put to us in evidence that regulatory authorities in the UK tend to interpret international and European rules more restrictively than in other countries, leading to a well intentioned, but inflexible and sometimes counterproductive, regulatory environment. 592 For example, it was suggested that the UK’s capacity to produce vaccines for new strains of influenza is severely hampered by regulation that focuses on processes rather than products: it was argued that, although the seed strains for flu vaccines can be produced in a matter of weeks using genetic engineering techniques, laboratories in the UK use slower, conventional methods because the genetic modification of influenza strains for this purpose is impeded by the regulatory system, despite the products of both methods being genetically indistinguishable. On one view, this regulatory approach may inhibit the development of novel approaches (it can be understood as an example of regulatory influence helping to lock-in a sub-optimal technology); on another, the alternative of regulating products rather than processes may be more cumbersome and complex, and vulnerable to inconsistency. 8.24 Elsewhere the picture is even more diffused. A number of regulatory functions are exercised by groups that have grown out of advisory committees set up, ad hoc, to advise Government departments on specific issues: thus the Home Office Animal Procedures Committee ‘advises’ on the use of animals in research, and the Advisory Committee on Releases to the Environment ‘advises’ on GM field trials, where the power of approval is nominally retained by ministers, although, in practice, ministers tend to defer to the technically competent though democratically unaccountable committees. 593 The lines of accountability of these bodies are often as obscure as their origins, and they may be beholden to officials rather than ministers, with their membership drawn from nominated experts rather than via open public appointments. These committees in reality often, although not always, have a mixture of advisory and licensing or regulatory functions and, although nominally offering scientific expertise, may also extend into offering public policy and ethical advice. 594 8.25 Beyond committees that advise ministers who formally hold regulatory powers are further officially sanctioned and respected bodies. However, these bodies are not part of any formal 590 It is proposed, and powers have been secured in the Public Bodies Act 2011 (section 5 and Schedule 5), that along with a number of other ‘quangos’ the HFEA’s functions should be merged into other general regulators. This proposal comes after plans to merge the HFEA and HTA into a proposed Regulatory Authority for Tissue and Embryos were abandoned in the face of opposition in 2007 (see: Joint Committee on the Human Tissue and Embryos (Draft) Bill (2007) Human tissue and embryos (draft) Bill, available at: http://www.publications.parliament.uk/pa/jt200607/jtselect/jtembryos/169/169.pdf, at p34ff). See also the Draft Care and Support Bill, which would amend the Public Bodies Act 2011 to allow for the abolition of the HFEA and the HTA (section 75); this proposal is, however, subject to a public consultation which closed 28 September 2012, the results of which had not been published at the time of writing. See: Department of Health (11 July 2012) Draft Care and Support Bill published, available at: http://www.dh.gov.uk/health/2012/07/careandsupportbill and Department of Health (28 June 2012) Consultation launched on fertility and human tissue regulators, available at: http://www.dh.gov.uk/health/2012/06/consultation-regulators. 591 As in the case of human ‘cloning’ techniques and the creation of ‘human admixed embryos’. 592 Oral evidence from the fact-finding meeting on policy, regulation and governance, held by the Working Party, 8 July 2011. 593 A striking counterexample was offered by the refusal, in 2009, of the then Home Secretary Alan Johnson, to accept the advice of the Advisory Committee on the Misuse of Drugs regarding relative classification of alcohol, tobacco and illegal drugs, which, on the principle that this was treated by the Government not merely as a technical issue but one of broader social policy, might be applauded. The lie was given to the purely technical and advisory role of the SAC by the fact that this incident threw the entire SAC system into turmoil, resulting in a review by the GCSA and the development of new ‘rules of engagement’ re-reinforcing independence, tempered by responsibility (see: Government Office for Science (2012) Principles of scientific advice to government, available at: http://www.bis.gov.uk/go-science/principles-of-scientific-advice-togovernment) but not before drawing in the media and external bodies like the Royal Society. 594 For the origins and accountabilities of SACs, see footnote 480. 142
E m e r g i n g b i o t e c h n o l o g i e s structure of accountability, but are able to exert influence directly in relation to the field of practitioners. These include bodies like the UK Genetic Testing Network, which advises on genetic tests for use in the National Health Service, self-described public benefit organisations such as the BioBricks® Foundation, and membership bodies and trade organisations (e.g. the British In Vitro Diagnostics Association 595 ) that produce voluntary and self-addressed standards and guidelines, alongside international organisations such as the Organisation for Economic Co-operation and Development or the World Health Organization. Problems of the regulatory system C H A P T E R 8 8.26 In arriving at a system of regulation there are always dilemmas to be confronted and trade-offs to be made. These are not unique to emerging <strong>biotechnologies</strong>. In fact they are strikingly common. What is clear is that regulation of novel <strong>biotechnologies</strong> has itself to develop and adapt to the technologies, but in a way that cannot leave those technologies unaffected. Furthermore, it is unlikely to do so in perfect step with the technology. This means that <strong>biotechnologies</strong> may emerge under pre-existing regulatory systems that are not well adapted, and may be slow to adapt to them (gene-based vaccines and the MHRA, for example), or outside them entirely. Either of these conditions may increase the uncertainty or even result in crowding out an emerging biotechnology. Since the technologies serve potentially important social aims, questions of regulatory design may therefore also raise important issues of social choice. Problems of coordination 8.27 The search for effective coordination has been described as the search for the ‘philosopher’s stone’ of regulation. 596 As this image suggests, the search has proved elusive, and emerging <strong>biotechnologies</strong> are no exception. The fundamental reason for this is that there is no intellectually coercive solution to the problem of how to coordinate the complex institutions of biotechnology regulation, which may be national, supranational, public and private. The ‘problem’ of coordination is, in essence, a dilemma: in designing or assessing regulatory institutions there is an obligation to choose between central control (with its attendant surveillance advantages but control inefficiencies) and distribution of authority (with its attendant control advantages but surveillance problems), with a potential result being oscillation under the pressure of crisis between centralisation and distribution of regulatory authority. Problems of evasion, circumvention and involuntary rule breach 8.28 Systems of regulation are systems of surveillance and restraint. If individuals and institutions were completely compliant with both the letter and spirit of rules no institutions of regulation would be required other than those needed to formulate the rules in the first place. The very complexity of the regulatory systems governing emerging <strong>biotechnologies</strong> shows that the regulatory system is constructed on the premise that evasion (the conscious breach of rules), and circumvention (the creative avoidance of restrictions short of rule breaking), are constants in the innovation system. We do not have to imagine a world of recalcitrant rule evaders to see why surveillance is needed. Many breaches of regulation are due to the often dizzying complexity of rules and the problem of matching particular sets of rules (which must be confirmed at one moment in time) with the constant flow of new issues produced by the dynamism of the world of biotechnology research. One of the points made to us during our evidence gathering meetings, by entrepreneurs in particular, was the intimidating complexity of 595 See, for example, The British In Vitro Diagnostics Association (2008) BIVDA code of conduct, available at: http://www.bivda.co.uk/Portals/0/Documents/BIVDA_CoC_leaflet.pdf. Expulsion from a professional body can be a powerful regulatory measure, depending on the level of the recognition of membership and the extent to which membership or accreditation in the case of services and facilities is given a formal acknowledgment in other regulatory systems. 596 Seidman H (1975) Politics, position, and power: the dynamics of federal organization (New York: Oxford University Press), p190. 143
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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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Emerging biotechnologies: full report - Nuffield Council on Bioethics

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