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Regulating Nanomedicine—The Smallest of Our Concerns?

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Abstract

This paper, guided by the UNESCO Universal Declaration on Bioethics and Human Rights, assumes that regulators should aim to support the development of nanomedicine while, at the same time, putting in place whatever limits or safeguards are indicated by ethical considerations. Relative to this regulatory objective, it is argued that, notwithstanding the importance of precaution (characteristically, concerning health, safety, and the environment), ethical reflection needs to go both broader and deeper. It is suggested that, by attending to the basic matrix of ethical debate and the “bioethical triangle” through which the matrix is currently articulated, the breadth, depth, and conflictual plurality of ethical concerns about nanomedicine will be clarified. In this light, the conventional thinking about precaution is revisited and concerns about human dignity and informed consent (under conditions of extreme uncertainty) are analysed. The paper concludes that, once the range of ethical pluralism is grasped, the extent of the challenge facing regulators will be more clearly appreciated.

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Notes

  1. Compare Spinello [52]. Spinello employs three ethical approaches (utilitarian, contractarian rights-based, and Kantian duty-based), in conjunction with a post-Lessig [37] range of regulatory options, to review four key issues: namely, freedom of on-line expression, intellectual property in cyberspace, Internet privacy, and security.

  2. The terminology here comes from Beyleveld and Brownsword [6]. Compare Dworkin [17], especially at 233–237.

  3. For dwarf-throwing, see Conseil d’Etat (October 27, 1995) req. nos. 136–727 (Commune de Morsang-sur-Orge) and 143–578 (Ville d’Aix-en-Provence); and, for the Laserdrome, see Omega Spielhallen-und Automatenaufstellungs-GmbH v Oberbürgermeisterin der Bundesstadt Bonn (Case C-36/02, 14 October, 2004); OJ C 300, 04.12.2004 p.3.

  4. See, e.g., Lee and Stokes [36]. For helpful overviews of the EC jurisprudence, see Heyvaert [26, 27].

  5. But, nb van den Daele [59] for a caution concerning the way in which the precautionary principle can be deployed disingenuously in defence of cultural conservativism.

  6. There are, it should be said, some promising near-term applications. For example, the so-called Trojan Horse (a nano-based vehicle for anti-cancer drug delivery) is in phase I clinical trial at the University of Michigan: see Wilson [61] at 706. On other hand, we should not assume that research and innovation will translate into exploitation, use and application: see Edgerton [18].

  7. See, the European Group on Ethics in Science and New Technologies to the European Commission ([56] pp. 42–43) and Appendix I.

  8. The issue is identified in the Royal Society and the Royal Academy of Engineering (2006), at paragraph 6.5. However; it is given greater prominence in Schummer [50], Gordijn [25], and Evans [21]. This same issue is flagged up, too, in the COMEST Policy Recommendations [14] paragraph 5.4.

  9. For the principal regulatory options and their likely impact, see Room [48]; and, for an evaluation from a rights perspective, see Ashcroft et al. [1].

  10. For the background, see Jean et al. [33].

  11. See, e.g., Jasanoff [32]; and this question arises pervasively in Bauer and Gaskell [4].

  12. On these second and third considerations, see Bauer [3], esp at 8–11. See, too, the Nuffield Council on Bioethics [43] at 8: “it is always possible, in principle, to distinguish between the two distinct questions of ‘how bad?’ and ‘how likely?’ That is, we can and should separate the reasons for regarding an outcome as evil from the likelihood of its occurrence.”

  13. See the recurrent concern about these hazards in the Royal Society and the Royal Academy of Engineering [57]. Compare, too, Howard and Ikah [29] (it will be noted that there is not the hint of a questionmark here: precaution, it is argued, certainly is required).

  14. It is estimated that there are already more than 200 nanotechnology-based products in the consumer marketplace, see Wardak and Gorman [60].

  15. Compare the critical remarks concerning the US National Nanotechnology Initiative in Sandler and Kay [49] at 677–678; the Council for Science and Technology [55] paragraph 146; and, Einsiedel and Goldberg [19].

  16. See the important discussion of this phenomenon in Leader [35].

  17. Compare, too, Mehta [41]; and Barnett et al. [2].

  18. Compare Sheremata [51].

  19. This is a distinction that I discuss more fully in Brownsword [12] (in press).

  20. The relationship between a community of rights and a culture of trust is not entirely straightforward: see, O’Neill [44].

References

  1. Ashcroft R, Campbell AV, Capps B (2007) Ethical aspects of developments in neuroscience and drug addiction. In: Nutt D, Robbins TW, Stimson GW, Ince M, Jackson A (eds) Drugs and the Future. Academic Press, London, pp 439–465

    Google Scholar 

  2. Barnett J, Carr A, Clift R (2006) Going public: risk, trust and public understanding of nanotechnologies. In: Hunt G, Mehta M (eds) Nanotechnology: risk, ethics and law. Earthscan, London, pp 196–212

    Google Scholar 

  3. Bauer M (1995) Resistance to new technology and its effects on nuclear power, information technology and biotechnology. In: Bauer M (ed) Resistance to new technology. Cambridge, University Press: Cambridge, pp 1–41

    Google Scholar 

  4. Bauer MW, Gaskell G (eds) (2002) Biotechnology—the making of a global controversy. Cambridge University Press, Cambridge

  5. Best R, Khushf G (2006) The social conditions for nanomedicine: disruption, systems, and lock-in. J Law Med Ethics 34:733–740

    Article  Google Scholar 

  6. Beyleveld D, Brownsword R (2001) Human dignity in bioethics and biolaw. Oxford University Press, Oxford

    Google Scholar 

  7. Beyleveld D, Brownsword R (2007) Consent in the law. Hart, Oxford

    Google Scholar 

  8. Brownsword R (2004a) Three bioethical approaches: a triangle to be squared. Paper presented at international conference on the patentability of biotechnology organised by the Sasakawa Peace Foundation, Tokyo

  9. Brownsword R (2004b) Regulating human genetics: new dilemmas for a new millennium. Med Law Rev 12:14–39

    Article  Google Scholar 

  10. Brownsword R (2005a) Stem cells and cloning: where the regulatory consensus fails. New Engl Law Rev 39:535–571

    Google Scholar 

  11. Brownsword R (2005b) Human rights—what hope? Human dignity—what scope? In: Gunning J, Holm S (eds) Ethics, law and society, vol 1. Ashgate, Aldershot, pp 189–209

    Google Scholar 

  12. Brownsword R (2008) Rights, regulation and the technological revolution. Oxford University Press, Oxford (in press)

  13. Butler S (1985) Erewhon (first published 1872). Penguin Books, London

  14. COMEST (2007) Nanotechnology and ethics: policies and actions. UNESCO, Paris

    Google Scholar 

  15. Court EB, Salamanca-Buentello F, Singer PA, Daar AS (2007) Nanotechnology and the developing world. In: ten Have H (ed) Nanotechnologies, ethics and politics. UNESCO, Paris, pp 155–180

    Google Scholar 

  16. Davies JC (2006) Managing the effects of nanotechnology. Washington: Woodrow Wilson International Center for Scholars. http://www.wilsoncenter.org/events/docs/Effectsnanotechfinal.pdf. Cited August 30, 2007

  17. Dworkin RM (1993) Life’s dominion. Harper Collins, London

    Google Scholar 

  18. Edgerton D (2006) The shock of the old: technology and global history since 1900. Profile Books, London

    Google Scholar 

  19. Einsiedel EF, Goldberg L (2006) Dwarfing the social? Nanotechnology lessons from the biotechnology front. In: Hunt G, Mehta M (eds) Nanotechnology: risk, ethics and law. Earthscan, London, pp 213–221

    Google Scholar 

  20. European Technology Platform (2006) Nanomedicine: nanotechnology for health

  21. Evans D (2007) Ethics, nanotechnology and health. In: ten Have H (ed) Nanotechnologies, ethics and politics. UNESCO, Paris, pp 125–153

    Google Scholar 

  22. Frean A, Foster P (2007) Cheating students turn to ‘smart drugs’ for edge in exams. The Times June 23:16–17

    Google Scholar 

  23. Galligan DJ (2007) Citizens’ rights and participation in the regulation of biotechnology. In: Francioni F (ed) Biotechnologies and international human rights. Hart, Oxford, pp 335–359

    Google Scholar 

  24. Gordijn B (2006) Converging NBIC technologies for improving human performance: a critical assessment of the novelty and prospects of the project. J Law Med Ethics 34:726–732

    Article  Google Scholar 

  25. Gordijn B (2007) Ethical issues in nanomedicine. In: ten Have H (ed) Nanotechnologies, ethics and politics. UNESCO, Paris, pp 99–123

    Google Scholar 

  26. Heyvaert V (2006a) Guidance without constraint: assessing the impact of the precautionary principle on the european community’s chemicals policy. The Yearbook of European Environmental Law 6:27–60

    Google Scholar 

  27. Heyvaert V (2006b) Facing the consequences of the precautionary principle in european community law. Eur Law Rev 31:185–206

    Google Scholar 

  28. House of Commons Science and Technology Select Committee (2007) Government proposals for the regulation of hybrid and chimera embryos. Fifth Report of Session 2006–07, HC 272-I)

  29. Howard CV, Ikah DSK (2006) Nanotechnology and nanoparticle toxicity: a case for precaution. In: Hunt G, Mehta M (eds) Nanotechnology: risk, ethics and law. Earthscan, London, pp 154–166

    Google Scholar 

  30. Hunt G (2006) The global ethics of nanotechnology. In: Hunt G, Mehta M (eds) Nanotechnology: risk, ethics and law. Earthscan, London, pp 183–195

    Google Scholar 

  31. Hunt G, Mehta M (eds) (2006) Nanotechnology: risk, ethics and law. London: Earthscan

  32. Jasanoff S (1995) Product, process, or programme: three cultures and the regulation of biotechnology. In: Bauer M (ed) Resistance to new technology. Cambridge University Press, Cambridge, pp 311–331

    Google Scholar 

  33. Jean MS, Deleury E, Duquet D (2007) Early assessment and policy-making. In: ten Have H (ed) Nanotechnologies, ethics and politics. UNESCO, Paris, pp 205–219

    Google Scholar 

  34. Kass LR (2002) Life, liberty and the defense of dignity. Encounter Books, San Francisco

    Google Scholar 

  35. Leader S (2004) Collateralism. In: Brownsword R (ed) Human rights. Hart, Oxford, pp 53–67

    Google Scholar 

  36. Lee R, Stokes E (2005) Ecological modernisation and the precautionary principle. In: Gunning J, Holm S (eds) Ethics, law and society, vol 1. Ashgate, Aldershot, pp 103–113

    Google Scholar 

  37. Lessig L (1999) Code and other laws of cyberspace. Basic Books, New York

    Google Scholar 

  38. Levy N (2007) Neuroethics. Cambridge University Press, Cambridge

    Google Scholar 

  39. Manson N, O’Neill O (2007) Rethinking informed consent in bioethics. Cambridge University Press, Cambridge

    Google Scholar 

  40. Marchant GE, Sylvester DJ (2006) Transnational models for regulation of nanotechnology. J Law Med Ethics 34:714–725

    Article  Google Scholar 

  41. Mehta MD (2006) From biotechnology to nanotechnology: what can we learn from earlier technologies? In: Hunt G, Mehta M (eds) Nanotechnology: risk, ethics and law. Earthscan, London, pp 121–129

    Google Scholar 

  42. Michelman FI (2003) Constitutional legitimation for political acts. Mod Law Rev 66:1–15

    Article  Google Scholar 

  43. Nuffield Council on Bioethics (1999) Genetically modified crops: the ethical and social issues. Nuffield Council on Bioethics, London

    Google Scholar 

  44. O’Neill O (2002) Autonomy and trust in bioethics. Cambridge University Press, Cambridge

    Google Scholar 

  45. O’Neill O (2003) Some limits of informed consent. J Med Ethics 29:4–7

    Article  Google Scholar 

  46. Quebec Commission on the Ethics of Science and Technology (2006) Ethics and nanotechnologies: a basis for action

  47. President’s Council on Bioethics (2003) Beyond therapy. Dana, New York

    Google Scholar 

  48. Room R (2007) Social policy and psychoactive substances. In: Nutt D, Robbins TW, Stimson GW, Ince M, Jackson A (eds) Drugs and the future. Academic, London, pp 337–358

    Google Scholar 

  49. Sandler R, Kay WD (2006) The national nanotechnology initiative and the social good. J Law Med Ethics, 34:675–681

    Article  Google Scholar 

  50. Schummer J (2007) Identifying ethical issues of nanotechnologies. In: ten Have H (ed) Nanotechnologies, ethics and politics. UNESCO, Paris, pp 79–98

    Google Scholar 

  51. Sheremata L (2006) Nanotechnologies and the ethical conduct of research involving human subjects. In: Hunt G, Mehta M (eds) Nanotechnology: risk, ethics and law. Earthscan, London, pp 247–258

    Google Scholar 

  52. Spinello RA (2006) Cyberethics: morality and law in cyberspace, 3rd ed. Jones and Bartlett, Sudbury, MA

    Google Scholar 

  53. Standage T (ed) (2005) The future of technology. Profile Books, London

  54. Sunstein C (2005) Laws of fear. Cambridge University Press, Cambridge

    Google Scholar 

  55. The Council for Science and Technology (2007) Nanosciences and nanotechnologies: a review of government’s progress on its policy commitments. The Council for Science and Technology, London

    Google Scholar 

  56. The European Group on Ethics in Science and New Technologies to the European Commission (2007) Opinion on the ethical aspects of nanomedicine. Opinion no. 21

  57. The Royal Society and the Royal Academy of Engineering (2004) Nanoscience and nanotechnologies: opportunities and uncertainties. The Royal Society, London (RS Policy document 19/04)

    Google Scholar 

  58. UNESCO (2005) UNESCO universal declaration on bioethics and human rights

  59. van den Daele W (2007) Legal framework and political strategy in dealing with the risks of new technology: the two faces of the precautionary principle. In: Somsen H (ed) The regulatory challenge of biotechnology. Edward Elgar, Cheltenham, pp 118–138

    Google Scholar 

  60. Wardak A, Gorman ME (2006) Using trading zones and life cycle analysis to understand nanotechnology regulation. J Law Med Ethics 34:695–703

    Article  Google Scholar 

  61. Wilson RF (2006) Nanotechnology: the challenge of regulating known unknowns. J Law Med Ethics 34:704–713

    Article  Google Scholar 

  62. Winickoff D, Jasanoff S, Busch L, Grove-White R, Wynne B (2005) Adjudicating the GM food wars: Science, risk, and democracy in world trade law. Yale J Int Law 30:81–123

    Google Scholar 

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Brownsword, R. Regulating Nanomedicine—The Smallest of Our Concerns?. Nanoethics 2, 73–86 (2008). https://doi.org/10.1007/s11569-008-0030-2

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