The Australia New Zealand Therapeutic Products Authority

The establishment of joint therapeutic products regulation in Australia and New Zealand under the Australia New Zealand Therapeutic Products Authority (ANZTPA) may prove to be an issue for the 42^nd Parliament. However, it is unlikely to be one that is progressed quickly. At present, the initiative for the joint scheme’s further development lies largely with the New Zealand Parliament, which must pass enabling legislation before the scheme can be set up in New Zealand. There are indications that industry and political pressures may delay the legislation for some time.

A treaty between Australia and New Zealand that would result in Australia’s Therapeutic Goods Association (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) being replaced by a single agency, the ANZTPA, was signed in December 2003. This agency would be accountable to both the New Zealand and Australian governments. In May 2005, an expert advisory committee was established to oversee the institution of standards for therapeutic products under the ANZTPA. To date, there have been two official delays to the harmonisation of regulations between Australian and New Zealand therapeutic goods regimes, as well as other setbacks related to the passing of enabling legislation in New Zealand.

There has been some political opposition in New Zealand to the establishment of joint therapeutic products regulation under the ANZTPA. Because complementary medicines are currently subject to fewer regulations in New Zealand than they are in Australia, it is expected that some New Zealand manufacturers will be required to significantly enhance their standards. It is also anticipated that ANZTPA will adopt the expert advisory committee’s recommendation that product sponsors provide evidence summaries for each listed product. At present, New Zealand sponsors are only obliged to provide evidence that their product works if they are audited. The proposed requirements, and their perceived threat to New Zealand’s complementary medicines industry, have contributed to a split in the New Zealand parliamentary select committee on the ANZTPA Bill. As a result, the committee was unable to recommend that the New Zealand Parliament pass the enabling legislation that would have seen the joint scheme established in New Zealand in early 2007. While the New Zealand Parliament could ignore its select committee and pass the Bill as it stands, a number of New Zealand parties are unlikely to support the Bill in its current form.

Documentation
Expert Committee on Complementary Medicines in the Health System, Complementary Medicines in the Australian Health System Report to the Parliamentary Secretary to the Minister for Health and Ageing, September 2003.
Therapeutic Goods Act 1989, Federal Register of Legislative Instruments, accessed 23 November 2007.
Therapeutic Goods Regulations 1990, Federal Register of Legislative Instruments, accessed 23 November 2007.
Kellie Bisset, ‘Drugs Test’, Weekend Australian, 12 May 2007.