Is gene technology regulation a good model?
A recent senate inquiry recommended creation of a working party, including TGA representatives, to consider whether bulk (macro-scale) materials classified as safe need reassessment for use at the nanoscale level. The inquiry also examined the value of a distinct, permanent regulatory body for nanotechnology.34 This approach was taken with gene technology under the Gene Technology Act 2000 (Cwlth).35 This broad licensing strategy, encompassing regulatory industrial, agricultural and therapeutic applications, has worked well, but suffers from not explicitly emphasising Australia’s regulatory strength in cost-effectiveness evaluations. On the other hand, merely employing or adapting existing TGA, PBAC and MSAC models, with or without elements of self-regulation, may lead the public, prematurely, to assume that nanotherapeutics raises no unique risks or hazards. Risk assessment of nanotechnology is emerging as a complex and significant issue for public health in Australia. It is critical
