Development Ethical and Societal Issues Satyen Baindur PhD

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Stewardship in Nanotechnology Development: Ethical and Societal Issues SATYEN BAINDUR, PHD Ottawa Policy Research Associates, Inc. OPRA Report 2006-4-1 Issued April 2006 ------------------------------------------------------------------------------------------------ In the international context, a concern that has been expressed is that commercialization of nanotechnology might lead to loss of markets for traditional raw materials, both primary – such as coal or iron ore; and agricultural, such as cotton or silk – that countries of the global South currently rely upon for export revenue. The loss of such markets may lead to further impoverishment of the global South, and thus further depress health conditions in these countries. Such a situation would further exacerbate any ‘nanodivide’ that comes to exist, and this is an especially grave ethical concern in sub-Saharan Africa. Thus in an enlightened stance, one would maintain awareness of such issues. It is necessary also to keep in mind the time scale over which such issues could arise, if at all. Significant economic impacts from most technologies are usually seen over a period of decades. However, there is the view that nanotechnologies might lead to compressed technological development time (a steeper S-curve), and this may well be true, or become true, for some nanotechnologies. 22 22
Stewardship in Nanotechnology Development: Ethical and Societal Issues SATYEN BAINDUR, PHD Ottawa Policy Research Associates, Inc. OPRA Report 2006-4-1 Issued April 2006 ------------------------------------------------------------------------------------------------ Bio-Nano Combination Products While regulatory and policy interest exists for applications and products involving nanomaterials across the board, interest is especially high in healthcare and biomedical applications. A particularly salient issue in the context of biomedical nanotechnology is that some products are turning out to span traditionally defined product classes. The potential of nanotechnology, in convergence with biotechnology and information technology gives rise to such possibilities. For example, some nanotechnology-based products can be simultaneously medical devices, as well as pharmaceuticals, and some may in addition include biologically active species. These have come to be called ‘combination products’, and some jurisdictions have begun to address their regulation issues based on the primary mode of action, defined as the most important therapeutic effect; the combined action of all modes being necessary for the full impact of the product (US FDA 2005). Combination products are made of multiple constituents: drug-device, drugbiologic, device-biologic or drug-device-biologic; that are physically or chemically combined, co-packaged in a kit, or separately cross-labeled products. All components work as a system and are critical to achieve the desired therapeutic effect. An example in the context of nano-oncology (‘cancer nanotechnology’) would be a drug-device-biological combination as follows (this is a hypothetical but realistic example): • A nanotube based microfluidic drug delivery device • A therapeutic agent carried within the nanotube (drug) • A quantum dot based imaging device • A low-density-lipoprotein or oligonucleotide-based targeting agent (biological) All of these could conceivably be packed into the same drug-biological-device combination. Should such a device be developed, for example, it could be useful in both therapy and image assisted surgery for a metastasizing tumour. In this case, there are 23 23
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Development Ethical and Societal Issues Satyen Baindur PhD

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