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

See all articles by Thomas Alured Faunce

Thomas Alured Faunce

Australian National University

Kellie Johnston

affiliation not provided to SSRN

Hilary J. Bambrick

affiliation not provided to SSRN

Date Written: September 22, 2006

Abstract

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

Suggested Citation

Faunce, Thomas Alured and Johnston, Kellie and Bambrick, Hilary J., The Trans-Tasman Therapeutic Products Authority: Potential AUSFTA Impacts on Safety and Cost-Effectiveness Regulation for Medicines and Medical Devices in New Zealand (September 22, 2006). Victoria University of Wellington Law Review, Vol. 37, No. 3, 2006. Available at SSRN: https://ssrn.com/abstract=1408833

Thomas Alured Faunce (Contact Author)

Australian National University ( email )

Canberra, Australian Capital Territory 0200
Australia
61 2 61253563 (Phone)

Kellie Johnston

affiliation not provided to SSRN ( email )

Hilary J. Bambrick

affiliation not provided to SSRN

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