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Australia New Zealand Therapeutic Products Authority (ANZPTA Project On Hold
3 September 2007
On 16 July 2007 the New Zealand State Services Minister announced that: "The Government is not proceeding at this stage with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products."

 

The New Zealand Government apparently did not have the numbers in Parliament to put in place a policy that would satisfy all parties at the time. As however both the Australian and New Zealand governments strongly supported "the vision of a joint trans-Tasman therapeutics authority" both governments are open to resuming negotiations when the opportunity arises.

 

Current Situation in Australia and New Zealand
In Australia the Therapeutic Goods Administration ("TGA") is responsible for administering the Therapeutic Goods Act 1989, ("Act") that provides a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and to ensure the quality, safety and performance of medical devices.

 

Complementary medicines are regulated under the Act, which requires such medicines to meet safety and quality standards both before and after the products enter the marketplace and also requires sponsors of complementary medicines to hold evidence to support any therapeutic claims made for their products.

 

In New Zealand the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is responsible for regulating therapeutic product in New Zealand. Medsafe is responsible for administering the Medicines Act 1981 and Regulations 1984, and parts of the Misuse of Drugs Act 1975 and Regulations 1977.

 

In New Zealand there is currently no requirement for complementary medicines to undergo any independent scrutiny of quality and safety before they enter the market place and this is out of line with international best practice. Further, New Zealand’s current regulatory capacity is not sustainable.

 


Background

 

The 1998 Trans Tasman mutual Recognition Agreement exempted therapeutic products until both the Australian and New Zealand governments could agree upon further co-operative arrangements.

 

In 2003 the governments of Australia and New Zealand signed an agreement to establish a joint therapeutic products and regulatory scheme to replace the current legislation in both countries. The TGA and Medsafe were to be replaced by the Australia New Zealand Therapeutic Products Authority (ANZTPA) to implement the new regulatory scheme for both countries.

 


It was proposed that ANZTPA would regulate the safety, quality and effectiveness of therapeutic products including their manufacture, supply, import, export and promotion in both Australia and New Zealand.

 

Under the proposed joint regulatory scheme consumers would have an assurance of quality and safety of complementary medicines and would be provided with truthful information about a product’s therapeutic health benefits to help them make more informed choices.

 


There would also be advantages for both countries having regard to efficiencies, technical expertise, resources and costs.

 


What Went Wrong?

 

By failing to recommend the Bill enacting the scheme to be passed by the New Zealand Parliament, it seems New Zealand’s Select Committee yielded to lobbyist pressure against including complementary medicines in the proposed scheme. However with New Zealand’s Health Minister indicating that "the status quo of an unregulated market for medical devices and complementary medicines cannot remain", many expect and indeed hope that the scheme will be implemented eventually.

 

See the following link for further details of the scheme and media releases concerning its postponement: http://www.anztpa.org
Jill Newton