Proposed NZ-Australia Therapeutic Products Agency
Proposals for a new agency to regulate therapeutic products for New Zealand and Australia are outlined in a discussion paper released today by Medsafe, a unit of the Ministry of Health.
The discussion paper sets out proposals for establishing a joint agency and for the regulatory scheme it would administer.
"The New Zealand Government has not yet made a final decision on whether to proceed with a joint agency, or on the specifics of the regulatory scheme. However, it is clear that regulatory change is required in New Zealand regardless of whether a joint agency is established because New Zealand's current regulations for medicines, medical devices and dietary supplements are outdated," said Medsafe spokesperson, Dr Stewart Jessamine.
"If a joint agency does go ahead, new legislation will be required in both Australia and New Zealand as well as a treaty between the two countries. The new Agency is therefore unlikely to commence operation until mid-2004 and new controls would not come into effect until that time," said Dr Jessamine.
Dr Jessamine said that New Zealand and Australia would benefit from combining their technical expertise and hence their capacity to regulate a diverse and increasingly sophisticated range of products, including medicines, medical devices, and complementary healthcare products such as vitamin, mineral and herbal preparations.
"A joint agency would enhance trade opportunities by providing a one-stop shop for companies to gain approval to enter both markets. The new agency would be accountable to both the Australian and New Zealand Governments, and both countries would have an equal voice in the governance of the agency," he said.
The joint agency would administer risk-based regulatory controls for therapeutic products so that prescription medicines and higher risk devices such as heart valves and pacemakers would be subject to tighter control than low risk products such as vitamins, herbal products, dressings or dentures.
"Consumers would continue to be able to buy a wide range of low risk products from health food stores, supermarkets and pharmacies as they can at present," Dr Jessamine said.
All therapeutic products would be required to meet minimum standards of safety, quality and effectiveness.
"The sorts of measures being proposed here are in line with world-wide trends in therapeutic product regulation," Dr Jessamine said. "They would help to address issues such as product design and quality, adequacy of labelling and consumer information, and truthfulness in advertising".
The public is encouraged to make submissions on the proposals to help inform the development of a new regulatory scheme. Submissions should be sent to the Ministry of Health by 2 August 2002.
Officials will report back to the Government in late 2002 on the proposals, the views expressed in the submissions, and a cost benefit analysis of the impact of the proposals. The Government will then make a final decision about whether to proceed with the joint agency.
The discussion document is available on the Joint Therapeutic Products Agency Project website (www.jtaproject.com) or from the Ministry of Health.