Abstract
Nanotechnology, an emerging technology, is creating innovative medicinal products for clinical use. The convergence of nanotechnologies with medicine is predicted to transform the health care sector, particularly pharmaceutical development. Jurisdictions, such as the European Union, the United States, Australia, and New Zealand, have witnessed the launch of medical products containing nanomaterials. Many of the nanomedicines on the market, in clinical testing, or under regulatory review, promise to improve existing products and treat diseases more effectively.
The purposes of this chapter are to (a) describe nanotechnology, in particular, its clinical applications; (b) analyze the application of medical products regulation in several jurisdictions (the European Union, United States, Australia, and New Zealand); and (c) assess the adequacy of this law for managing the potential risks posed by nanomedicines. There are gaps in the public health/health science evidence about the risks associated with nanomedicines, and there is concern that the novel properties of some nanomedicines will bring unforeseen human and environmental health and safety risks.
Analysts project that, by 2014, the market for medical products containing nanomaterials will be US$18 billion per year. Given the predicted market for nanomedicines, and the growing evidence of their potential risks, it is important to have adequate regulation of these products to prevent adverse public health outcomes. Regulators and clinicians will need to consider the risks posed by some nanomedicines against the potential benefits to patients who are prescribed these products.
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References
European Science Foundation (ESF). Nanomedicine: an ESF and European Medical Research Council Forward Look Report. Brussels: ESF; 2005.
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). Risk assessment of products of nanotechnologies. EU: SCENIHR; 2009 Jan.
Chowdhury N. Regulation of nanomedicines in the EU: distilling lessons from the pediatric and the advanced therapy medicinal products approaches. Nanomedicine. 2010;5:135–42.
European Medicines Agency. Reflection paper on nanotechnology-based medicinal products for human use. London: EMA; 2006.
Drew H, Bawa R. The carbon nanotube patent landscape in nanomedicine: an expert opinion. Expert Opin Ther Pat. 2007;17:1.
Maynard A, Bowman D, Hodge G. Introduction. In: Maynard A, Bowman D, Hodge G, editors. International handbook on regulating nanotechnologies. Cheltenham: EE; 2010.
Freitas Jr R. The Ideal gene delivery vector: chromallocytes, cell repair nanorobots for chromosome replacement therapy. J Evol Technol. 2007;16:1.
Kandlikar M, Gurumurthy R, Maynard A. Health risk assessment for nanoparticles: a case for using expert judgment. J Nanopart Res. 2007;9:137.
Maynard A. Nanotechnology: the next big thing or much ado about nothing? Ann Occ Hyg. 2007;51:1.
Maynard A. Safe handling of nanotechnology. Nature. 2006;444:266.
Oberdorster E, et al. Nanotoxicology: an emerging discipline evolving from study of ultrafine particles. Environ Health Perspect. 2005;113:813.
Maynard A, Kuempel ED. Airborne nanostructured particles and occupational health. J Nanopart Res. 2005;7:576.
Food and Drug Administration. Nanotechnology – A report of the US food and drug administration nanotechnology task force. Washington DC: FDA; 2007.
Environmental Protection Agency (EPA). EPA nanotechnology white paper. Washington DC: EPA; 2007.
Chaudhry Q et al. Final report: a scoping study to identify gaps in environmental regulation for the products and applications of nanotechnologies. London: Department for Environment, Food and Rural Affairs; 2006.
European Commission. Regulatory aspects of nanomaterials: summary of legislation in relation to health, safety and environment aspects of nanomaterials, regulatory research needs and related measures. Brussels: Commission of the European Communities; 2008.
Ludlow K, Bowman D, Hodge G. A review of possible impacts of nanotechnology on Australia’s regulatory framework. Melbourne: Monash Centre for Regulatory Studies; 2007.
Gavaghan C, Moore J. A review of possible impacts of manufactured nanomaterials on New Zealand’s regulatory system. Dunedin/Wellington: University of Otago; 2011.
Kimbrell G. Nanomaterial consumer products and FDA regulation: regulatory challenges and necessary amendments. Nanotech L Bus. 2006;3:329.
Friends of the Earth. Nanomaterials, sunscreens and cosmetics: small ingredients, big risks. Sydney: Friends of the Earth; 2006.
Davies JC. Managing the effects of nanotechnology. Washington, DC: Woodrow Wilson International Center for Scholars; 2006.
Bhogal N. Regulatory and scientific barriers to the safety evaluation of medical nanotechnologies. Nanomedicine. 2009;4:495.
Gaspar RS. Therapeutic products: regulating drugs and medical devices. In: Maynard A, Bowman D, Hodge G, editors. International handbook on regulating nanotechnologies. Cheltenham: EE; 2010. p. 291.
Taniguchi N. On the basic concept of ‘Nano-Technology’. In: Proceedings of the International Conference on Production Engineering Tokyo, Part II. England, Tokyo, Japan: Society of Precision Engineering; 1973.
ETC. Group. No small matter ii: the case for a global moratorium, size matters! In: Occasional paper series, Vol 7, No 1. Canada: Action Group on Erosion, Technology and Concentration; 2003 Apr.
Jahnan-Dechent W, Simon U. Function follows form: shape complementarity and nanoparticle toxicity. Nanomedicine. 2008;3:591.
Hoet P, et al. Do nanomedicines require novel safety assessments to ensure their safety for long-term human use? Drug Saf. 2009;32:615.
Roco MC. Nanoscale science and engineering: unifying and transforming tools. AIChE J. 2004;50:890.
Maynard A, Bowman D, Hodge G. Conclusions, triggers, gaps, risk and trust. In: Maynard A, Bowman D, Hodge G, editors. The international handbook on regulating nanotechnologies. Cheltenham: EE; 2010. p. 562.
Bowman D, D’Silva J, van Calster G. Defining nanomaterials for the purpose of regulation within the European Union. Eur J Risk Reg. 2010;2:115.
Kreyling WG, Semmler-Behnke MK, Chaudhry Q. A complementary definition of nanomaterial. Nano Today. 2010;5:164.
Sparrow R. Talkin’ ‘bout a (Nanotechnological) revolution. IEEE Technol Soc Mag. 2008;2:37.
EU Cosmetics Directive 2009 75/757/EEC, Article 2(1)(k).
Regulation (EC) 257/97 Concerning Novel Foods and Novel Food Ingredients.
Poland C et al. Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study. Nature Nanotechnology. 2008;3:423.
Knowles EE. Nanotechnology: evolving occupational safety, health and environmental issues. Prof Saf. 2006;51:20.
Lam CW, et al. Pulmonary toxicity of single-wall carbon nanotubes in mice 7 and 90 days after intratracheal instillation. Toxicol Sci. 2004;76:126.
Aitken RJ, Creely KS, Tran CL. Nanoparticles: an occupational hygiene review. London: Institute of Occupational Medicine for the Health and Safety Executive; 2004.
Therapeutic Goods Administration. A review of the scientific literature on the safety of nanoparticulate titanium dioxide and zinc oxide in sunscreens. Canberra: Therapeutic Goods Administration; 2006.
Donaldson K, et al. Nanotoxicology. Occup Environ Med. 2004;60:717.
Oberdorster E. Manufactured nanomaterials (fullerenes, c59) induce oxidative stress in the brain of juvenile largemouth bass. Environ Health Persp. 2004;112:1057.
Powell MC, Kanarek MS. Nanomaterial health effects – part 1: background and current knowledge. Wis Med J. 2006;2:16.
Powell MC, Kamarek MS. Nanomaterial health effects – part 2: uncertainties and recommendations for the future. Wis Med J. 2006;2:18.
D’Silva J, van Calster G. Taking temperature – a review of European Union regulation in nanomedicine. Eur J Health Law. 2009;16:249.
Maynard A. Nanotechnology: a research strategy for addressing risk. Washington, DC: Woodrow Wilson Project on Emerging Technologies; 2006.
Ludlow K. One size fits all? Australian Regulation of Nanoparticle Exposure in the Workplace. JLM. 2007;15:136.
Hampton T. Researchers size up nanotechnology risks. JAMA. 2005;294:1880.
Wagner V, et al. The emerging nanomedicine landscape. Nat Biotechnol. 2006;24:1211.
Paradise J, et al. Exploring emerging nanobiotechnology drugs and medical devices. Food Drug Law J. 2008;62:407.
de Jong W, Roszek B and Geertsma R. Nanotechnology in medical applications: possible risks for human health. RIVM Dutch National Institute for Public Health and Environment Report. 2005.
European Parliament. Report on the proposal for a regulation on novel foods. Brussels: European Parliament; 2009.
Moen MD, et al. Liposomal Amphotericin B: a review of its use as empirical therapy in febrile neutropenia and in the treatment of invasive fungal infections. Drugs. 2009;68:360.
Bawarski WE, et al. Emerging nanopharmaceuticals, nanomedicine. Nanotech Biol Med. 2008;4:272.
Pautler M, Brenner S. Nanomedicine: promises and challenges for the future of public health. Int J Nanomedicine. 2010;5:803.
Liebert MA. New developments in medical nanotechnology. Biotechnol. 2008;27:225.
Omidi Y, Barar J. Induction of human alveolar epithelial cell growth factor receptors by dendrimeric nanostructures. Int J Toxicol. 2009;28:113.
Hardman R. A toxicologic review of quantum dots: toxicity depends on physio-chemical and environmental factors. Environ Health Perspect. 2006;114:164.
Faunce T. Nanosilver and global public health: international regulatory issues. Nanomedicine. 2010;5:607.
Wilhelmi B. Nanosilver: a test for nanotech regulation. Food Drug Law. 2008;62:89.
Trop M, et al. Silver-coated dressing acticoat caused raised liver enzymes and argyria-like symptoms in burn patient. J Trauma Inj Infect Crit Care. 2006;59:638.
Rejeski D. FDA regulated products containing nanotechnology materials. Woodrow Wilson International Center for Scholars; 2006:14.
Roe D, et al. Antimicrobial surface functionalization of plastic catheters by silver nanoparticles. J Antimicrob Chemother. 2008;60:858.
SCENIHR. The appropriateness of existing methodologies to assess the potential risks associated with nanotechnologies. Brussels: European Commission; 2007.
SCENIHR. Opinion on the appropriateness of the risk assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risks of nanomaterials. Brussels: European Commission; 2007.
van Calster G, Bowman D and D’Silva J. Trust me, I’m a regulator: the inadequacy of EU legislative instruments for three nanotechnologies categories. In: Goodwin, Koops and Leenes, editors. Dimensions of technology regulation. Amsterdam: Wolf Legal Publishers; 2010. p. 205.
Pub L 94–295, 90 Stat 539 (1975).
Bowman D, Hodge G. A small matter of regulation: an international review of nanotechnology regulation. Columbia Sci Technol Law Rev. 2007;8:1.
FDA. Draft guidance for industry, considering whether an FDA-regulated product involves the application of nanotechnology. 2011.
Levy D and Watkins T. John key addresses Australian Parliament. [serial online]. 20 Jun 2011. Stuff News NZ.
Moore J. Letter to the journal of law and medicine: Australian and New Zealand Governments agree to proceed with a joint regulatory agency for therapeutic products. JLM. 2011;19(2):272–274.
TGA Act 1989 (Australia).
Peart N, McKrimmon F and Dawson J. Clinical trials. In: The law of research. Dunedin: University of Otago Press; 2003.
New Zealand Ministry of Health. Medicines and medical devices: discussion paper on the review of the medicines legislation. Wellington: Ministry of Health; 1994.
Medicines Act 1980 (NZ).
Moore J. Is New Zealand’s regulation of nanomedical products adequate? J Law Med. 2011;19/1:112–27.
Martindale S. Medsafe. Email to Jennifer Moore (jennifer.moore@otago.ac.nz) 2010 July 10.
Freitas R, Phoenix C. A personal nanomedical appliance to replace human blood. J Evol Technol. 2002;11:26.
21 CFR § 3.2(e) 2005.
Federal Food, Drug and Cosmetic Act 1938 (US), s 201(h).
Paradise J, et al. Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology. J Law Med Ethics. 2009;37:588.
Barlett Foote S, Berlin R. Can regulation be as innovative as science and technology? The FDA’s regulation of combination products. Minn J L Sci Tech. 2005;6:609.
Fender J. The FDA, and nano: big problems with tiny technology. Chic Kent Law Rev. 2008;82:1062.
International Risk Governance Council. Appropriate risk governance of nanotechnology applications in food and cosmetics. Geneva: IRGC; 2009.
Gaspar R. Regulatory issues surrounding nanomedicines: setting the scene for the next generation of nanopharmaceuticals. Nanomedicine. 2007;2:143.
Auffan M, et al. Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective. Nat Nanotechnol. 2009;4:624–41.
Further Readings
Aitken R, et al. Regulation of carbon nanotubes and other high aspect ratio nanoparticles: approaching this challenge from the perspective of asbestos. In: Maynard A, Bowman D, Hodge G, editors. International handbook on regulating nanotechnologies. Cheltenham: EE; 2010.
Bhogal N. Regulatory and scientific barriers to the safety evaluation of medical nanotechnologies. Nanomedicine. 2009;4(5):495–8.
Chemicals Legislation and Nanotechnology.
European Medicines Agency. Reflection paper on nanotechnology-based medicinal products for human use. London: European Medicines Agency; 2006. Available from: http://www.ema.europa.eu
For a review of some of the different applications of nanomedicine in the health sector, see:
Gavaghan C and Moore J. De minimis curat lex: New Zealand law and the challenge of the very small. European Journal of Law and Technology. 2011;2(3):1–11 Available from: http://ejlt.org/index.
Medicines Legislation and Nanomedicines.
Moore J. An evaluation of whether New Zealand’s occupational health and safety law adequately addresses the risks to workers exposed to nanotechnology and nanoparticles. NZ Journal of Employment Law. 2012;37(1)Special Issue:100–117.
Paradise J, et al. Exploring emerging nanobiotechnology drugs and medical devices. Food Drug Law J. 2008;62:407.
United States Food and Drug Administration. Nanotechnology. Available from: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm
Widmer M, Meili C. Approaching the nanoregulation problem in chemicals legislation in the EU and US. In: Maynard A, Bowman D, Hodge G, editors. International handbook on regulating nanotechnologies. Cheltenham: EE; 2010.
Workers’ Exposure to Nanoparticles and Occupational Health and Safety Legislation.
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Moore, J. (2013). Global Regulation of Nanotechnologies and Their Products in Medicine. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_119
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DOI: https://doi.org/10.1007/978-3-642-32338-6_119
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