New Zealand And Australia To Consider Joint Medicines Regulatory Body

Health Minister Annette King says the Government has instructed officials to begin investigating the possibility of a joint trans-Tasman medicines, medical devices and dietary supplements regulatory body.

The proposed agency would be responsible for approving products, setting standards and monitoring compliance, she said. It would replace the Australian regulator, the Therapeutic Goods Administration, and New Zealand's Medsafe, a unit of the Ministry of Health.

"Preliminary talks have begun with the Australian Government, but they are very much at a preliminary stage. Extensive consultation will be required, and, of course, there would also need to be new legislation in both Australia and New Zealand. A single set of regulations for Australia and New Zealand could potentially have many benefits for New Zealanders."

Mrs King said the investigation by officials would initially focus on the governance arrangements for the agency, which would be established by way of a treaty.

The Minister said that, in a related project, an Australian Taskforce reviewing administrative arrangements for health and safety regulations has developed proposals designed to improve efficiency across the therapeutic goods, food, gene technology and chemicals sectors. The taskforce has released a discussion paper, Working Together, which includes the proposal to establish a trans-Tasman Authority to be responsible for regulating therapeutic products for Australia and New Zealand.

Mrs King said the Taskforce paper also proposed that the Authority would perform contracted services, mainly for Australia, such as the assessment of chemical and gene technology products for other Australian regulators, and that the scheme might be further reviewed in five years with a view to incorporating trans-Tasman arrangements for setting food standards into the new Authority.

Mrs King said that the New Zealand Government participated in the Australian review on a 'without prejudice' basis, and it supported a stand-alone trans-Tasman therapeutic goods regulator.

"We have not yet considered whether we would accept the joint therapeutic goods regulator being part of a wider regulatory organisation as proposed in the Taskforce paper. Any changes to administrative arrangements for food standards would need further consideration and negotiation."

Mrs King said no commitment could be made on the regulation of gene technology in New Zealand till the report for the Royal Commission on Genetic
Modification was considered.

Mrs King said New Zealanders who wished to comment on the Taskforce discussion paper could obtain a copy of the paper from the Medsafe website
(www.medsafe.govt.nz), and could make submissions direct to the Australian taskforce.

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