Consolidating Pharmaceutical Regulation Down Under: Policy Options and Practical Realities
Frances H. Miller
Boston University School of Law Working Paper 06-36
Abstract
Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate, the costs of pharamceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). If this effort succeeds, it could serve as a model of cost-effective regulatory cooperation for the rest of a transparency-seeking world to emulate. If it does not, a unique opportunity to merge national pharaceutical regulatory operations to cope more effectively with 21st century global realities will have been lost.
Published in
26 University of Queensland Law Journal No. 1, 111 (2006)
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Frances H. Miller Contact Information
fmiller@bu.edu
Boston University School of Law
765 Commonwealth Ave
Boston, MA 02215
Phone: (617) 353-4469 (office)
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