Moore Jennifer
Centre for Law and Policy in Emerging Technologies, Faculty of Law, University of Otago, Wellington.
J Law Med. 2011 Sep;19(1):112-27.
This article investigates the adequacy of New Zealand's regulation of medical products produced by nanotechnology and containing nanomaterials. There is concern that the novel and unique properties of some nanoscale chemical substances will bring unforeseen human and environmental health and safety risks. Given the possible market for nanomedicines and the growing evidence of their potential risks, it is important to have adequate regulation of nanomedicines in order to prevent adverse public health ramifications. This article argues that nanoparticles, invisible to the human eye, are illuminating and exacerbating legislative imperfections in the Medicines Act 1981 (NZ). This Act does not include a pre-market approval process for medical devices, nor does it include provisions for combination products. This approach is inconsistent with international norms. The article proposes amendment of the Medicines Act 1981 (NZ) to address these weaknesses and the novel challenges posed by nanomedicines.
本文探讨了新西兰对纳米技术生产且含有纳米材料的医疗产品监管的充分性。有人担心一些纳米级化学物质的新颖独特性质会带来不可预见的人类健康、环境健康及安全风险。鉴于纳米药物可能的市场以及其潜在风险的证据不断增加，对纳米药物进行充分监管以防止对公众健康产生不利影响至关重要。本文认为，肉眼不可见的纳米颗粒正揭示并加剧了1981年《药品法》（新西兰）中的立法缺陷。该法案既不包括医疗器械的上市前批准程序，也没有关于组合产品的规定。这种做法与国际规范不一致。本文提议修订1981年《药品法》（新西兰），以解决这些弱点以及纳米药物带来的新挑战。
