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 ------------------------------------------------------------------------------------------------ d. For other applications, the hydrophilicity and surface charge density could be relevant. e. As for most other drug formulations, the purity, sterility and stability will also be a relevant characteristic of nanoparticle drugs, and as with other kinds of drugs, it will be necessary to determine if the therapeutic action in vitro is also valid in vivo. Since nanomaterials often display properties that are strongly dependent on their environment, the last consideration is more significant in the nanomaterial context than for other pharmaceuticals, whose action may be less sensitive to the details of their physicochemical environment. Such considerations thus go beyond mere particle size, and moreover, given the possibility of ‘combination products’ as mentioned above, regulatory considerations and definitions are likely to be appropriately more complex and nuanced, especially when they begin to involve biologicals and biotechnology products in addition to nanotechnology. 26 26
Stewardship in Nanotechnology Development: Ethical and Societal Issues SATYEN BAINDUR, PHD Ottawa Policy Research Associates, Inc. OPRA Report 2006-4-1 Issued April 2006 ------------------------------------------------------------------------------------------------ Building Regulatory Expertise Currently, the entire paradigm governing regulatory approval of health-related products on the one hand, as well as the safety and environmental health considerations regarding general consumer products on the other hand, is based on a biological and chemical disciplinary background. The assays and protocols required to secure regulatory approval are largely determined in terms of chemistry. As biotechnology, and in particular, proteomics and genomics have developed, some of the protocols have evolved beyond mere chemistry, to involve combinatorial and computer science oriented issues in addition. However, nanotechnology holds the promise of combining materials science with biology in ways unlikely to have been seen by most regulators before, and it will likely be necessary to require some supplementation of physical science concepts in their disciplinary backgrounds, as well as in the overall disciplinary orientation of the regulatory and approval regime. The educational backgrounds of the Health Physicists of today – who primarily deal with safety issues surrounding radioactive materials – has more of the balance between biology and physics, of the type that is likely to be needed in the case of nanomaterials. However, their training is oriented primarily to the health effects of radiation, and the different types and amounts of radioactivity to be expected from different types of sources 19 . The educational backgrounds of future regulators for nanotechnology will need to have components of materials science (‘nanoscience’) where Health Physicists have nuclear science, and knowledge of the emerging nanotoxicology, where Health Physicists have knowledge of radiation effects. 27 19 Radioactivity is not a principal concern in the context of nanomaterials – though certain kinds of radioactive dusts could have particles in the nanoscale range. Some concepts in radio-aerosol science and radioactive material safety are likely, however, also to have relevance in Nanomaterial Health & Safety Issues. 27
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Development Ethical and Societal Issues Satyen Baindur PhD

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