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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].

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  1. School of Law, King’s College London, Strand, London, WC2R 2LS, UK

    Roger Brownsword

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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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