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
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
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
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
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.
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Liability was apportioned between the VMO, Dr.Brown, and the hospital on an 80/20 basis in favour of the hospital.
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