The Trans-Tasman Therapeutic Products Authority: Potential AUSFTA Impacts on Safety and Cost-Effectiveness Regulation for Medicines and Medical Devices in New Zealand
Victoria University of Wellington Law Review, Vol. 37, No. 3, 2006
29 Pages Posted: 23 May 2009
Date Written: September 22, 2006
Australia and New Zealand had agreed in principle to the creation of a single agency for the regulation of pharmaceuticals and other therapeutic products in a trans-Tasman market. The Australia New Zealand Therapeutic Products Authority ("ANZTPA") was being developed to replace both the Australian Therapeutic Goods Administration ("TGA") and the NZ Medicines and Medical Devices Safety Authority ("Medsafe"). The agreement was cancelled in 2007. This article explores the possibility that the ANZTPA in its original form, by inheriting significant 'linkage evergreening' obligations imposed on the TGA under the Australia-United States Free Trade Agreement ("AUSFTA"), may significantly impact upon the regulation of medicines and medical devices (as well as blood products) in New Zealand. It explores the related legal obligations and their likely consequences for New Zealand, particularly quality, safety and efficacy and cost-effectiveness evaluation processes in this area, such as those of The New Zealand Pharmaceutical Management Agency ("Pharmac").
Keywords: Linkage evergreening, pharmaceutical regulation, safety, cost-effectiveness, trade agreements, AUSFTA
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