by Robert M. Tribe

The New Zealand Government announced on 16 July 2007 that it would not be proceeding with legislation designed to enable the establishment of a joint agency with Australia for the regulation of therapeutic products 1. That is, the establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA) will not proceed at this stage. This announcement followed a vigorous political and lobbying campaign in New Zealand against the legislation.

The Minister responsible for State Services in the New Zealand Government, Annette King, said the Therapeutics Products and Medicines Bill has been postponed, but will remain on the Order Paper to be revisited when sufficient parliamentary support is available. The Agreement between Australia and New Zealand will remain in place and can be ratified in the future following the passage of legislation.

King said the Government does not have the numbers in Parliament to put in place a sensible, acceptable compromise that would satisfy all parties at this time. The Australian Government has been informed of the situation and agrees that suspending negotiations on the joint authority is a sensible course of action. She said that while many people will be disappointed (the New Zealand Government) has not found a satisfactory way forward for this important legislation, it is not always possible in an MMP Parliament 2 to obtain enough votes.

King said the Government still strongly supports the vision of a joint trans-Tasman therapeutics authority because of the benefits to New Zealand, including greater consumer protection, enhanced innovation, making products available in a more timely way, and economies of scale in regulation. “Our vision has been for a world-class regulatory system that reflects the special nature of our relationship with Australia,” she said.

“Sadly, despite all the painstaking work done by officials on both sides of the Tasman, this important initiative cannot be advanced at this stage, but I am pleased Australia shares our commitment to a world-class scheme, and is open to resuming negotiations when the opportunity arises,” she said.

Health Minister Pete Hodgson said, “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.”


References:
1. www.beehive.govt.nz/viewdocument.aspx?documentID=30061
2. www.beehive.govt.nz/viewDocument.aspx?DocumentID=16176
3. www.tga.gov.au.tta/index.htm

About the Author
Bob Tribe is ISPE’s Regulatory Affairs Advisor for the Asia Pacific, based in Canberra, Australia. He joined ISPE from the Therapeutic Goods Administration (TGA) in Australia, where he served as Chief GMP Auditor for 23 years. During that time, he not only enhanced the TGA’s reputation as a leading GMP regulator internationally but also held leadership positions with the Pharmaceutical Inspection Cooperation Scheme (PIC/S), serving as vice chairman in 1998-1999 and chairman in 2000-2001. Recently, Tribe founded a company to provide consulting to GMP regulatory authorities around the world.