Remedy to cut medicine red tape

By GREG ANSLEY in Canberra

The transtasman pharmaceutical and medical products industry will be controlled by a single joint authority under a proposal now before the New Zealand and Australian Governments.

With a decision expected within six months, legislation could be introduced next year and a new authority be running by mid- to late-2004.

The proposal, outlined in a discussion paper drafted by officials from both Governments, would rewrite the laws of both nations, streamline the flow of goods across the Tasman, pool technical expertise and rewrite advertising codes and rules for natural health products.

Similar in concept to the Australia New Zealand Food Authority already determining food standards in the two countries, the new agency would also govern clinical trials and remove the exemption for therapeutic goods from the transtasman mutual recognition arrangement.

A joint agency would promote closer economic relations with New Zealand, reduce trade barriers and assist the medicines and medical device industries on both sides of the Tasman, said Trish Worth, a spokeswoman for Australia's Minister for Health and Ageing, Kay Patterson.

It would provide a one-stop shop for companies to gain approval to enter both markets with common product labelling and standards.

The proposed agency would replace Australia's Therapeutic Goods Administration and New Zealand's Medsafe, and conform to a growing international trend to harmonise regulation to help lower the soaring costs of new medical treatments.

Because of the complexity of the issue, therapeutic goods were exempted from the four-year-old mutual recognition agreement, which removed regulatory barriers to goods traded across the Tasman.

The exemption expires next April.

In the meantime, officials have been instructed to investigate a possible joint agency following an in-principle agreement in 2000 between Wellington and Canberra for a new authority to regulate prescription and over-the-counter medicines, natural health products and medical devices.

Natural health products, officially termed complementary healthcare products, have been a particularly difficult area because of objections to their definition as medicines, and different regulatory approaches.

In Australia they are regulated under therapeutic goods legislation, but in NZ they are generally marketed as dietary supplements and controlled under food legislation.

The discussion paper proposes to embrace the products as therapeutic goods and regulate them in a three-tier system that would allow about 95 per cent to be licensed rapidly as low-risk products.

The remaining medium- and high-risk products would be subject to strict evaluation of safety, quality and effectiveness.

New rules would also apply to all other therapeutical products and devices.

The paper says that a single regulator with common rules for a single transtasman market would embrace all pre-market assessments and marketplace monitoring, enforcement and recalls.

Expected gains include easier and increased trade, lower compliance costs and combined expertise to protect both countries' ability to maintain a close watch on public health and safety.

This expertise, the paper says, is in short international supply and in great global demand.

A five-member board drawing from New Zealand and Australia, and overseen by the two nations' health ministers, will run the agency.