Skip to main content
SpringerLink
Log in

Nanomedicine: Building a Bridge Between Science and Law

  • Original Paper
  • Published:
NanoEthics Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Notes

  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.

References

  1. Dewey J (1920) Reconstruction in philosophy, p 89. Available at www.forgottenbooks.com.org. Last visited 18 August 2012

  2. European Research Medical Council (ERMC) (2004) ESF ERMC forward look report. Available at: www.nanopharmaceuticals.org/files/nanomedicine.pdf. Last visited 5 July 2012

  3. Presentation on nanomedicine by Health Canada at 1st International workshop on nanomedicine (2010) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2009/12/event_detail_000095.jsp&mid=WC0b01ac058004d5c3. Last visited 12 Sept 2013

  4. Viola F (1974) “H.L.A. Hart e la struttura aperta del diritto” Interpretazione e applicazione del diritto tra scienza e politica. Edizioni Celup srl, Palermo

    Google Scholar 

  5. Oberdorster G, Maynard A, Donaldson K, Castranova V, Fitzpatrick J, Ausman KD, Carter J, Karn B, Kreyling W, Lai D, Olin S, Monteiro-Riviere N, Warheit D, Yang H, Foundation, A.A.R.F.I.R. (2005) Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy. Part Fibre Toxicol 2:8

    Article  Google Scholar 

  6. El-Ansary A, Al-Daihan S (2009) On the toxicity of therapeutically used nanoparticles: an overview. J Toxicol 2009:754810. doi:10.1155/2009/754810. Published online 2009 January 25. Last visited 5 July 2012

  7. De Giorgi U, Amadori D (2012) Fluorodeoxyglucose positron emission tomography for outcome prediction of mammalian target of rapamycin inhibitor therapy. J Clin Oncol 28(15):e236–e237

    Article  Google Scholar 

  8. De Jaeghere F, Alleman E, Kubel F et al (2000) Oral bioavailability of a poorly water soluble HIV-1 protease inhibitor incorporated into PH sensitive particles: effects of the particles size and nutritional state. J Control Release 68(2):291–298

  9. Harisinghani MG, Barentsz J, Hahn PF et al (2003) Nanoinvasive detection of clinically occult lymph-node metastases in prostate cancer. N Engl J Med 348(25):2491–2499

  10. Myhr AI, Dalmo RA (2007) Nanotechnology and risk: what are the issues? In: Nanoethics: the ethical and social implications on nanotechnology. Wiley, New Jersey, pp 150

  11. Buzea C, Pacheco II, Robbie K (2007) Nanomaterials and nanoparticles: sources and toxicity. Biointerphases 4(2):21

  12. Ortwin R (2007) “Precaution and analyses: two sides of the same coin? Introduction to talking point on the precautionary principle” 8 EMBO Reports at pp. 303–304 <http://www.nature.comembor/journal/v8/n4/full/7400950.html> last visited on 22 July 2010

  13. Doering R (2009) Food law: the precautionary principle is not the answer. Online source available at http://www.canadianmanufacturing.com. Last visited 19 July 2010

  14. Ostiguy C, Roberge B, Ménard L, Endo CA (2009) Best practices guide to synthetic risk nanoparticles management, p 56. Online source available at www.safenano.org. Last visited 22 July 2010

  15. Wilson RF (2006) Nanotechnology: the challenge of regulating known unknown risks. J Law Med Ethics 4(34):704–713

    Article  Google Scholar 

  16. Heselhaus S (2010) Nanomaterials and the precautionary principle in the EU. J Consum Policy 33:91–108

    Article  Google Scholar 

  17. Marchant GE, Sylvester DJ, Abbott KW (2008) Risk management principles for nanotechnologies. Nanoethics 2(1):43–60

    Article  Google Scholar 

  18. Stirling A (2007) Risk, precaution and science: towards a more constructive policy debate. Talking point on the precautionary principle. EMBO Reports, pp 303–304 Online source http://www.nature.comembor/journal/v8/n4/full/7400950.html. Last visited 22 July 2010

  19. Paradise J, Tisdale A W, Hall R F, Kokkoli E et al (2009) Developing oversight frameworks for nanobiotechnologies. J Law Med Ethics 37(4):608–705

  20. David KH, Thompson PB (2008) What can nanotechnology learn from biotechnology: social an ethical lessons for nanoscience from the debate over Agrifood Biotechnology and GMOs. Academic, Burlington, p 120

    Google Scholar 

  21. Metha MD (2004) From biotechnology to nanotechnology: what we can learn from earlier technologies? Bull Sci Technol Soc 4(1):38

    Google Scholar 

  22. Miller G. Who’s afraid of the precautionary principle? Online source available at http://nano.foe.org.au/. Accessed 6 July 2010

  23. Hodge GA, Bowman DM, Ludlow K (2007) New global frontiers in regulation: the age of nanotechnology. Edward Elgar Publishing, Cheltenham, p 223

  24. CEC 2008 - Communication Commission of the European Communities

  25. Hansen SF (2009) Regulation and risk-assessment of nanomaterials–too little too late? Technical University of Denmark, p 19. Source available at www.env.dtu.dk. Last visited 13 Aug 2010

  26. Denison RA (2005) A proposal to increase federal funding of nanotechnology risk research to at least $100 million annually. Online source available at http://www.myaccess.library.utoronto.ca www.enironmentaldefense.org/documents/4442_100milquestionl.pdf. Last visited 8 July 2010

  27. TGD - Technical Guidance Document on Identification and Naming of Substances in REACH

  28. Guidance for Identification and Naming of Substances in REACH, p 28. Online source available at guidance. http://echa.europa.eu/guidance_en.htm. Last visited 20 July 2010

  29. Gillert J, Knight L (2009) On the borderline between drugs and medical devices. Europe Pharmaceutical & Healthcare Newsletter. Online source available at http://bakerxchange.com/last. Last visited 22 July 2010

  30. MEDDEV 2.1/3.3 (2009) Borderlines products, drugs delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative. Online source available at http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/. Last visited 26 Aug 2010

  31. Sadrieh N, Espandiari P (2006) Nanotechnology and FDA: what are the scientific and regulatory considerations for products containing nanomaterials? Nanotechnol Law Bus. Available at http://heinonline.org. Last visited 23 July 2010

  32. Hines JZ, Lurie P, Yu E, Wolfe S (2001) Left to their own devices: breakdowns in United States Medical Device premarket review. PLoS Med. Online source available at http://www.plosmedicine.org. Last visited 22 July 2010

  33. Health Canada available at www.hc-sc.gc.ca. Last visited 22 July 2010

  34. FDA, Overview of the Office of Combination Products, FDA.GOV, http://www.fda.gov/oc/combination/overview.htm. Last visited 23 July 2010

  35. Downie J, Caulfield T, Flood CM (2007) Canadian health law and policy. LexisNexis, Canada, p 336

    Google Scholar 

  36. Mendel G (2008) Nanotechnology governance. Ala Law Rev 59:1360

    Google Scholar 

  37. Fielder FA, Reynolds GH (1994) Legal problems of nanomedicine: an overview. South Calif Interdiscip Law J 3:609

    Google Scholar 

  38. Hines JZ, Lurie P, Yu E, Wolfe S (2001) Left to their own devices: breakdowns in United States medical device premarket review. PLoS Med. Online source available at http://www.plosmedicine.org. Last visited 5 July 2012

  39. Nanotechnology: a report of The U.S. Food and Drug Administration Nanotechnology Task Force, 23 July 2007. http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm. Last visited July 2012

  40. Alderson NE. FDA regulation of nanotechnology products. http://www.fda.gov/nanotechnology/powerpointconversions/pcastmar04files/outline/index.html. Last visited 19 Apr 2007

  41. FDA Press Release April 20, 2012 http://www.fda.gov/NewsEvents/Newsroom/PressAnnoucements/ucm301125.html. Last visited 12 Sept 2013

  42. Sadrieh N. FDA Perspective on Nano-Containing Products. http://www.fda.gov/nanotechnology/powerpoint_conversions/ilsi-hesi-ann-mtg_files/outline/index.html. Last visited 2 Feb 2014

  43. Brunk CG, Haworth L, Lee B (1991) Values assumptions in risk-assessment: a case study in Alachlor controversy. Wilfried Laurier University Press, Waterloo, p 26

    Google Scholar 

  44. Oberdörster G, Oberdörster E, Oberdörster J (2005) Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect 113:823

  45. Denison RA (2005) A proposal to increase federal funding of nanotechnology risk research to at least $100 Million annually. Online source available at http://myaccess.library.utoronto.ca. Last visited 5 July 2012

  46. Desai N (2012) Challenges in development of nanoparticle-based therapeutics. AAPS J 14(2):282–295. doi:10.1208/512248-012-9339-4, Published online 2012 March 10

    Article  Google Scholar 

  47. FDA (2002) Guidance for industry: liposome drug products. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070570.pdf. Last visited 7 February 2014

  48. Miller J (2003) “Beyond biotechnology: FDA regulation of nanomedicine.” Columbia Sci Technol Law Rev 4(2). Published online January 15, 2003. URL: http://www.stlr.org/cite.cgi?volume=4&article=5 Last visited on 5 July 2012

  49. Dennis LV (2003) Nanotechnology: unique science requires unique solutions. Temple J Sci Technol Environ Law 18(25):107

    Google Scholar 

  50. Moghimi SM, Hunter AC, Murray JC (2005) Nanomedicine: current status and future prospects. FASEB J 19(3):311–330. doi:10.1096/fj.04-2747rev

  51. Ozdemir V, Husereau D, Hyland S et al (2009) Personalized medicine beyond genomics: new technologies, global health diplomacy and anticipatory governance. Curr Pharmagenomics Person Med 7:225

  52. Faunce TA (2007) Nanotechnology in global medicine and human biosecurity: private interests, policy, dilemmas, and the calibration of public health law. J Law Med Ethics 35:634

    Article  Google Scholar 

  53. European Commission–Enterprise and Industry Directorate General, Public Consultation on amendments to Annex I to Directive 20001/83/EC as regards advanced therapy medicinal products, Brussels 9 July 2008. Online source available at http://ec.europa.eu/index_it.htm. Last visited 28 August 2010

Download references

Author information

Authors and Affiliations

  1. Canadian Institutes of Health Research, University of Toronto, Via Grazia Deledda n.107, 00137, Rome, Italy

    Antonella Trisolino

Authors
  1. Antonella Trisolino
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Antonella Trisolino.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Trisolino, A. Nanomedicine: Building a Bridge Between Science and Law. Nanoethics 8, 141–163 (2014). https://doi.org/10.1007/s11569-014-0193-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11569-014-0193-y

Keywords

Search

Navigation