KEY POINTS:
From herbal medicines to Herceptin, from condoms to heart valves, a controversial regulatory proposal to hook up with Australia would cast a large net over New Zealand health products, supplements and medicines.
Government agencies on both sides of the Tasman have been working for more than a decade
on creating a transtasman agency to regulate medicines, medical devices and complementary medicines.
Since details emerged in 2002, the scheme has been attacked, politically and now in a series of protest marches - yet State Services Minister Annette King is pushing ahead, even if Labour is short of support in the House.
Supporters say the proposal will improve public safety; detractors say it will force hundreds of products off shelves, leaving New Zealanders with less choice, destroying jobs and closing businesses. Claim and counter-claim are flying, ahead of a likely parliamentary show-down within weeks.
What is the proposal?
To create the Australia New Zealand Therapeutic Products Authority, in line with a transtasman treaty signed by ministers in 2003. This would replace Australia's Therapeutic Goods Administration and New Zealand's Medsafe.
Based in Canberra and Wellington, it would be run by a managing director and governed by a board overseen by a two-member council comprising the two countries' health ministers.
What would it regulate?
All medicines, medical and surgical devices and complementary/alternative medicines.
This includes prescription and over-the-counter medicines, contact lenses, pacemakers, endoscopes, blood products and, most controversially, the likes of most herbal and traditional medicines, sunscreens, homeopathic remedies, aromatherapy, vitamins, minerals and other dietary supplements - but not products prepared by traditional Maori healers for individual clients.
Why regulate low-risk products?
Dietary supplements currently come under food legislation.
The joint agency would bring regulation of supplements into line with Australia. They and other complementary medicines would have to meet minimum safety and quality standards, and any claims of therapeutic benefit would have to be backed by scientific evidence.
At present only weak, generalised claims are permitted.
The Government argues that complementary medicines can pose a risk. Medsafe's principal technical adviser, Dr Stewart Jessamine, said the record of adverse reactions to medicines contained reports of around 300 cases related to complementary medicines in the past 10 to 15 years.
The new regime was to allow consumers to be confident of the consistent quality of products.
Once a manufacturer's factory was approved, low-risk products could be processed through internet-based self-certification if the ingredients were on the permitted list, Dr Jessamine said.
The levels of regulation were matched to the level of risk posed, so prescription drugs were more heavily controlled. But opponents, who want a purely domestic licensing regime, say the proposed scheme is far too heavy-handed for the low risk posed by complementary medicines.
A website opposing the new regime, Health Freedom New Zealand, asserts that no deaths have been caused by these medicines.
What products will go?
The website claims about 60 per cent of New Zealand's favourite supplements will be forced off the market.
The website's office referred Herald inquiries to Patrick Fahy, a consultant to the natural health industry.
"The Therapeutic Goods Administration is basically Fortress Australia," he said.
"It's great for Australia but it's a trade barrier to companies ... in the United States who have a lot of products they export to New Zealand, like the body-building products.
"They won't be available because companies in the US are saying, 'We don't want to comply with the TGA because it's a small market and it's not cost-effective'."
But large manufacturers in New Zealand that were Australian owned or already exported to Australia - and which supported the proposed agency - would benefit.
Mr Fahy said many products and small-to-medium-sized manufacturers would be forced out by the requirement for audits to check compliance with good manufacturing practice at a cost of thousands of dollars, and the omission of more than 700 ingredients used in New Zealand from the proposed list of permitted substances.
Dr Jessamine: "The current permitted ingredients list has over 4000 ingredients including all the common minerals and vitamins. Most of the [complementary medicine] products in health food shops have ingredients already on the list."
What about sunscreens?
Global cosmetics giant Johnson & Johnson claims more than 80 sunscreen-containing products from a range of manufacturers, including 19 products from its own Nutragena and Piz Buin brands, will be affected. The managing director of the company's Pacific division, Craig Towers, said it was not worthwhile for it to re-label products to comply with Australia's licensing regime, which would apply under the transtasman agency.
Under a current transtasman standard, which is enforced in Australia but not in New Zealand until after the new agency starts work, the maximum sun protection factor (SPF) claim is 30-plus.
Johnson & Johnson sells an SPF 55-rated product, considered its best sunscreen, in New Zealand but not Australia. "We have sunscreens in Australia, but we don't have our latest technology sunscreens there," said Mr Towers.
Dr Jessamine said Australia had 1100 sunscreen products, so New Zealanders would still have plenty of choice after the transtasman agency took over.
"Thirty-plus" was set as the maximum claim because the numbers are confusing. The effect of SPF starts to flatten off," Dr Jessamine said, "so 60 is not twice the protection of 30."
