Trans-Tasman agency

In December 2003 the Australian and New Zealand Governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices and prescription, over-the-counter and complementary medicines.

The single agency, which will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), will be accountable to both the Australian and New Zealand Governments. The agency is expected to commence operation in 2005.

"The signing of this Treaty demonstrates a strong commitment by both countries to the continuation of our long-standing relationship and is a further step in the development of a more integrated trans-Tasman economy," New Zealand Health Minister, Annette King, said at the signing ceremony.

"It is particularly fitting that this decision should be taken in the 20th anniversary year of the commencement of the Australia New Zealand Closer Economic Relations Agreement."

Australian Parliamentary Secretary for Health, Trish Worth, said the Treaty is a historic step in regulatory arrangements between Australia and New Zealand.

"The joint regulatory scheme and its administration by a single joint agency represents a significant advance in trans-Tasman regulatory co-operation and will effectively integrate the therapeutic products regulatory systems of both countries, comprising an unprecedented level of international co-operation," Ms Worth said.

The Treaty sets out the governance and accountability arrangements for the new agency, and how it is to be established. It also provides a framework for the joint regulatory scheme for therapeutic products.

"The Treaty is the result of years of collaboration between TGA and Medsafe and extensive consultation with stakeholders in both countries regarding the new regulatory scheme," Mrs King and Ms Worth said.

"This consultative approach will continue with further consultation to occur with stakeholders during the development of the legislation that will give effect to the regulatory scheme, to be developed before the joint agency commences operation," Ms Worth said.

The Hon Trish Worth MP, Parliamentary Secretary
to the Minister for Health and Ageing (left) and
the Hon Annette King, Minister of Health, New Zealand,
at the Treaty signing ceremony

The Australian government has also released the report of the Review of Administrative Arrangements for Commonwealth Public Health and Safety that recommended the establishment of the joint therapeutics scheme with New Zealand.

"Consistent with a recommendation in the Review, the administrative arrangements for the joint agency will include the Office of the Gene Technology Regulator and the Office of Chemical Safety which includes the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), although these regulators will only operate in Australia," Ms Worth said.

An exposure draft of the Bill will be released with a six-week consultation period. The key Ministerial Rules will also be released for consultation. When released, both documents will be available on the Trans Tasman Therapeutic Products Agency Project website <http://www.anztpa.org>.