The joint Australian and New Zealand therapeutic goods agency is back on the agenda.
ANZTPA (Australia New Zealand Therapeutic Products Agency), the birth child of Australia's Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is once again being considered as a viable option for the uniform regulation of therapeutic goods in Australia and New Zealand.
On 29 January 2012 it was reported that the joint regulatory scheme moved one step closer when Ministers from both countries met in Melbourne for the first meeting of the Implementation Ministerial Council.
The meeting is reported to have discussed and agreed on key elements to establish a joint Trans-Tasman therapeutic products regulator. Those familiar with the industry will appreciate that discussions of a joint regulator have been on the agenda for some time.
The latest drive started on 20 June 2011, when the Australian Prime Minister Julia Gillard and New Zealand Prime Minister Jon Key announced that the New Zealand and Australian Governments had resumed their campaign to establish a trans-Tasman scheme for the regulation of therapeutic goods.
The scheme, which has an aspirational commencement date of 2016, is to be administered by ANZTPA and is aimed at "safeguarding public health and safety, while encouraging economic integration and benefiting industry in both countries".1
Both countries have, however, been exchanging industry know-how and resources since July 2011 in an effort to help set up the joint regulatory authority.
The idea of constructing such a scheme can be traced back to the Trans Tasman Mutual Recognition Arrangement (TTMRA) in 1996, which served as a basic tool in preventing excessive regulation associated with goods trade and the movement of skilled workers between Australia and New Zealand. The TTMRA did not, however, provide for the regulation of therapeutic goods due to vast differences in regulation policy between the two countries.
An alternative agreement for the regulation of these products was drafted and signed by both Governments in December 2003. The New Zealand Government was unable to gain sufficient support to enact the legislation required to give life to ANZTPA, which led to its suspension in July 2007. Although the scheme was unsuccessful at its first attempt, the foundations for its construction remained in place by virtue of the agreement signed by both Governments in December 2003, which allowed for negotiations to resume at any stage in the future.
The ANZTPA is unlikely to have a significant financial impact on the Australian and New Zealand therapeutic goods industries, as it is to be funded in a similar manner to the cost recovery strategies currently used by the existing regulators.
We will continue to provide updates on this new venture as they occur.
Footnotes
1 medsafe.govt.nz/hot/anztpa.asp
Clayton Utz communications are intended to provide commentary and general information. They should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this bulletin. Persons listed may not be admitted in all states and territories.
