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Slow chemical registrations hurting farmers

03 May, 2010 10:47 AM
FARM chemical and animal health companies say they - and their farmer clients - are getting a raw deal from Australia's sluggish product registration system which keeps some new products waiting seven years, or longer, for approval.

The delays are so long that the average time taken to approve a new agricultural crop chemical is now 72 months (six years).

Officially, on paper, the industry-funded Australian Pesticides and Veterinary Medicines Authority (APVMA) has a target time to complete its registration approvals in just 13 to 15 months.

"I know of 19 innovative animal health products awaiting approval," said Animal Health Australia's chief executive officer, Dr Peter Holdsworth, who heads the peak body for veterinary product manufacturers.

"Another 20, already submitted for registration overseas, or already approved, will not be submitted for registration here because of the costly delays involved."

Meanwhile, permits for specialist minor use horticulture crop sprays can take years, too, with about 1000 different products estimated to be sitting in the queue awaiting the APVMA's stamp of approval for use on niche crops.

Typical of costly frustrations angering manufacturers - and potentially biting into farmer competitiveness - is the case of a new drench to fight intestinal worms which was largely developed in Australia at Kemps Creek in western Sydney.

Farmers worldwide are using the breakthrough product, but it remains off the shelf here more than two years after it was submitted for registration approval.

Zolvix, the first new active drench to internal parasites in 25 years, was approved in New Zealand about 14 months ago - a year after it was submitted for approval in Australia.

Last month its Swiss-based manufacturer, Novartis, launched Zolvix in the UK and has recently confirmed its registration across Europe and in Uruguay.

"It's ironic that this product was developed basically for the Australian market and was submitted to the Australian regulator first, but we seem to be one of the last countries to get approval for it," Dr Holdsworth said.

He said the APVMA also seemed incapable of taking account of reputable assessment data from similar agencies overseas including the US Food and Drug Administration, therefore products already rigorously assessed internationally had to be re-assessed again when introduced to Australia.

To encourage the APVMA to process applications more efficiently, manufacturers say they will happily pay more up-front fees for product registration and want changes to the fee structure so the authority gets paid as soon as the job is done.

At present they only pay a percentage of the true registration cost, but also continue paying a levy on product sales to drip feed ongoing funding for the APVMA's work.

Croplife Australia chief executive officer, Paula Mathewson, said the long delay in registrations was partly caused by an expanding workload dumped on the APVMA by the Federal Government, and a bureaucratic culture not geared to achieving swift approval solutions.

"Until recently they haven't even been allowed to use email to communicate information about products because they haven't had a network deemed secure enough to deal with the sensitive commercial information they handle - so correspondence is by snail mail," Ms Mathewson said.

"The APVMA has to get back to its core business of evaluating and approving products instead of being pressured to spend more time and money giving government policy advice or responding to claims from activists campaigning against endosulfan."

Animal Health Australia board member, Mike van Blom, said the APVMA also relied on information from external agencies like the Department of Health or the quarantine service who were not accountable to APVMA and didn't have to respond within the approval time frame.

In fact, Australian registration rules relating to agricultural export often forced APVMA to rely on a tangle of overseas agencies that had dubious significance to the local industry's requirements.

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comments


Date: Newest first | Oldest first
Please interview these rocket scientists and find out what in the name of zeus butt-hole takes them so long when across the Tasman it's old news.
Posted by THE FARMER, 3/05/2010 2:04:45 PM
A fish rots from the head down. It's time for a new chief executive, a board with the power to drive policy, and staff that understand performance.
Posted by dickytiger, 4/05/2010 9:56:50 AM
Having been involved in registering veterinary product in NZ and attempting to do so in Aus, there is a considerable difference in the bureaucracy and pedantics. There is however no reason to proceed headlong to register any product expediently particularly in regard to chemical poisons. There have been too many silver bullets that have turned out to cause disasters.
Posted by Richard Woolley, 4/05/2010 10:24:36 AM
You can't compare NZ with Australia. NZ allows the registration of products based on preliminary tox data and so they are able to register products much earlier. Australian authorities have always been much more conservative and will only register based on full tox data submission and this can add years to a submission. However, there still seems to be some terrible inefficiencies at APVMA level if European countries can register sooner when you consider that their product submission data reqts are probably similiar to Australia. Either speed up registration or add years to patent protection. Its the only way Australia could continue to benefit from innovative new chemical products in either animal, broadacre or horticultural industries.
Posted by Rosco, 4/05/2010 11:15:02 AM

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Zolvix has been in use in New Zealand for about 14 months.
Zolvix has been in use in New Zealand for about 14 months.
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