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Erschienen in: NanoEthics 2/2014

01.08.2014 | Original Paper

Nanomedicine: Building a Bridge Between Science and Law

verfasst von: Antonella Trisolino

Erschienen in: NanoEthics | Ausgabe 2/2014

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Abstract

This article aims to address challenges of translating emerging scientific technologies into legal terms and incorporate them into the existing North American regulatory regimes. A lack of full scientific knowledge about nanomedicine technologies results in the lack of development in legal discourse to describe products and to clearly set legal standards on their safety and efficacy. The increasing complexity and hybrid nature of technologies negatively impact the functionality of “law in action” leading to a legal uncertainty and ultimately to a public distrust. Nanomedicine is an illustrative example of how law lags behind increasingly fast-paced scientific technologies making it difficult to find a balance between innovation and safety. This article argues that the boundary crossing nature of nanomedicine through different domains of science triggers a methodological and epistemological debate within science and law, suggesting that a critical revision is required in our traditional methods to learn, create, and categorize knowledge from breakthrough scientific advances. The highly disruptive nature of nanomedicine places stress on traditional conceptual frameworks, classifications of knowledge, and existing regulations. The legal challenge to identify definitions or to classify nanoapplications brings to light a conceptual vacuum surrounding nanomedicine. Moving away from confusing policies and obsolete classificatory models, this article suggests to undertake changes that are only the first steps of a more in-depth “epistemological transformation” that addresses knowledge as the process of not only gathering data, but also, as the process of elaborating new conceptual bases to better fulfill the legal language and facilitate the legal task of finding definitions and formulating criteria more adherent with scientific advances. This should compel regulators to explore new paradigms and develop new methodologies to evaluate data on nanomedicine applications in order to provide sustainable bases for a responsible development of nanomedicine.

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Fußnoten
1
Oberdorster et al. [5]. See also [6]
 
2
Myhr and Dalmo [10]. See [11]
 
3
Ibidem
 
4
Marchant et al., ibidem at pp. 43–60.
 
5
Ibidem.
 
6
Ibidem
 
7
Duff R. & Trudo Lemmens see supra note 15 at p. 168
 
8
Ibidem
 
9
Ibidem
 
10
Canadian Biotechnology Advisory Committee on “Improving the Regulation of Genetically Modified Food and other Novel Foods in Canada” Report to the Government of Canada, Biotechnology Ministerial Coordinating Committee (2002) in Metha supra note 40.
 
11
Metha, supra note 40 at 37
 
12
Ibidem
 
13
Ibidem
 
14
Ibidem
 
15
Stirling, supra note 32.
 
16
Ibidem
 
17
Denison, supra note 51 at p. 4
 
18
Ibidem
 
19
Ibidem
 
20
Ibidem
 
21
Ibidem, at 609.
 
22
Fielder, Frederick A. and Reynolds Glenn H, supra nota 10.
 
23
Classes of devices. Washington, DC:Government Printing Office. Publication N.21USC c360 c(a)(2006 ed.). See also Hines [38]
 
24
Grounds for refusing application; approval of application; substantial evidence defined. Washington, DC: Government Printing Office. Publication N.21 USC § 355(d)(2006 ed.).
 
25
Ibidem supra nota 20
 
26
Ibidem supra nota 19
 
27
Bawa, R. supra nota 3
 
28
El-Ansary A. and Al-Daihan S, supra nota 4.
 
29
Ibidem
 
30
Bawa, R. supra nota 3 at p. 229.
 
31
Fielder, Frederick A. and Reynolds G H, supra nota 10 at 616.
 
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Metadaten
Titel
Nanomedicine: Building a Bridge Between Science and Law
verfasst von
Antonella Trisolino
Publikationsdatum
01.08.2014
Verlag
Springer Netherlands
Erschienen in
NanoEthics / Ausgabe 2/2014
Print ISSN: 1871-4757
Elektronische ISSN: 1871-4765
DOI
https://doi.org/10.1007/s11569-014-0193-y

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