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www.fdanews.com/articles/96353-plan-for-joint-australia-new-zealand-drug-authority-on-hold-again

Plan for Joint Australia-New Zealand Drug Authority On Hold (Again)

July 26, 2007

On July 17, New Zealand’s government publicly acknowledged that it lack parliamentary support to move forward with a combined Australia-New Zealand Therapeutic Products Authority (ANZTPA). Although the agreement between the two governments remains on the books and could be resurrected in the future, prospects for implementation in the next few years are very dim.

The merger, which first arose as a possibility 2003, was originally scheduled for July 2005 but had already been pushed back several times. The primary stumbling block was a seemingly minor issue: complementary medicines and health supplements that are currently available in New Zealand but might not have met the higher approval standards of the joint agency.

As we’ve written elsewhere, New Zealand is a peculiar market: allowing DTC advertising amidst the strictest cost-control regime in the developed world. Despite press reports to the contrary, ANZTPA was never likely to have much impact on either of these factors. Pharma companies are, therefore, not likely to see much of a difference from the merger’s failure.

Device makers, who would have been subject to regulatory approval in New Zealand for the first time, will continue to operate freely for the time being. Even without ANTZPA, however, this is likely to change soon. According to the country’s Minister of Health, “We will now consider the next steps, and announce them in due course. It is fair to say however, that New Zealanders, and indeed the select committee, are aware that the status quo of an unregulated market for medical devices and complementary medicines cannot remain.”