Following New Zealand's rejection of the proposed legislation to enact the Australian and New Zealand Therapeutic Products Authority ("ANZTPA"), the Australian and New Zealand Governments have announced that plans to create a joint trans-Tasman therapeutic products authority have been suspended. Accordingly, the implementation of a trans-Tasman therapeutic products authority is now most unlikely in the foreseeable future, if at all, in its current form.
What happened?
On 15 June 2007, a New Zealand Select Committee reported that it could not recommend the passing of the Therapeutic Products and Medicines Bill. This Bill represents the implementing legislation for the regulation of therapeutic products in New Zealand, and gives effect to the Agreement between the Australian and New Zealand Governments for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products. The main criticism and reason for the Select Committee's decision related to the perceived inappropriateness of imposing a pharmaceutical model of regulation on complementary medicines in New Zealand.
Following this, on 16 July 2007, the New Zealand Government announced that it would not be proceeding with the Bill and would suspend negotiations on the joint agency. This decision was made in recognition that the New Zealand Government does not currently have sufficient support in the New Zealand Parliament to ensure the passage of the Bill, as was demonstrated in the Select Committee's Report.
Given New Zealand's political situation, the Australian Government in turn announced on 18 July 2007 that negotiations on the joint agency would be postponed, but that it expects the 2003 Agreement between Australia and New Zealand to establish the joint agency to remain in place.
There has been strong industry reaction to the decision to suspend the joint agency. The Researched Medicines Industry Association of New Zealand believes that New Zealanders will now face major delays in acquiring new prescription medicines, which are available elsewhere in the world, while Medicines Australia expressed its disappointment at the missed opportunity to develop a world-class regulatory agency.
Where to now?
Since 1998 there have been numerous consultations with industry, health professionals, consumer groups and other interested parties on the establishment of a trans-Tasman therapeutic products authority. Significantly for industry, this regime sought to facilitate trade and reduce compliance costs. The new system would also have allowed each country to update regulatory standards to ensure that they accord with international best practice, particularly with regard to emerging therapeutic technologies and products.
Both the Australian and New Zealand Governments have said that they remain dedicated to creating a joint regulatory regime. The New Zealand State Services Minister, the Hon Annette King, announced that the New Zealand Bill will remain on the Order Paper to be revisited when sufficient parliamentary support is available.
There is mutual recognition by both the Australian and New Zealand Governments and the pharmaceutical industry associations that the work done on the ANZTPA legislation will not be wasted. The set back on implementation of ANZTPA, however, means that regulatory reform in both New Zealand and Australia appears unlikely in the near future.
It remains to be seen whether Australia and New Zealand will independently implement some of the reforms proposed to be included under ANZTPA. In Australia, reform in certain areas, such as the regulation of in vitro diagnostic devices, has long been on the agenda. In New Zealand, the Government has recognised the current shortcomings of its regulatory regime and, in particular, has stated that the current unregulated market for medical devices and complementary medicines cannot remain.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
