Upcoming Mallesons seminarsAll entities who register therapeutic goods or medical devices in Australia and/or New Zealand.
What do you need to do?Wait to see if the ANZTPA scheme is revived.
Kim O'Connell
Partner
T +61 2 9296 2188
The New Zealand government announced that the joint regulatory scheme and establishment of ANZTPA has been postponed. The main issue of contention was the inclusion of complementary medicines in the scheme.
New Zealand’s Select Committee last month failed to recommend that the Bill enacting the scheme be passed by the New Zealand Parliament. Split along party lines, the Committee could not reach agreement on a recommendation for or against the proposed scheme.
In an attempt to gain support, an amendment was proposed last month with the aim of exempting complementary medicines from the joint scheme and establishing a domestic body in New Zealand. However, despite efforts to secure support, the Bill remained short of two critical votes.
The way forward
While controversy in New Zealand surrounds the inclusion of complementary medicines, the Australian government remains firmly opposed to excluding complementary medicines from any future scheme.
In yesterday’s joint announcement by New Zealand’s Minister of State Services and the Minister of Health, it was clear that there is no current prospect of the implementing legislation being passed in New Zealand.
The Ministers indicated that the Australian Government has agreed to suspend negotiations on the joint authority. With a pending federal election in Australia later this year and an election due in New Zealand next year, there may well be further developments in the next 12 months.
In a somewhat ironic twist, New Zealand's Health Minister reportedly indicated yesterday that New Zealand could not continue with an unregulated market for medical devices and complementary medicines. He foreshadowed that an announcement would be made shortly on the next steps in implementing regulation.