Australian Drug Recall Points to Flaws in Joint Regulation

29 April 2003--This week’s massive drug and complementary medicine recall by Australian manufacturer Pan Pharmaceuticals demonstrates the danger of combining New Zealand and Australian regulatory processes, according to industry analyst Ron Law.

The mass recall across the Tasman comes as the New Zealand Government is considering effectively handing over responsibility for regulating pharmaceutical and natural products to the Australians in a Trans-Tasman agency.

Mr Law is the former Executive Director of the National Nutritional Foods Association and has been working with regulatory bodies on both sides of the Tasman since 1998.

He warns New Zealand authorities should learn from this disaster, which has seen more than 200 products recalled, 1,650 export-only licenses revoked and several thousand more products come under suspicion. To date only a handful of products have been removed from New Zealand shelves.

The Health Select Committee is currently conducting an inquiry into Government’s proposal to establish a joint Trans-Tasman regulatory agency similar to the existing Australian Therapeutic Goods Agency (TGA).

“New Zealand is being led into joining with Australia on the premise that their systems offer quality and consumer confidence,” Mr Law said. “But you’d have to say a joint regulatory agency isn’t looking like such a good deal from the consumer’s point of view right now.”

Mr Law says there are serious unanswered questions about the Australian regulatory body.

“For a start, if Pan Pharmaceuticals manufactures between 30 and 70% of all products on the market in Australia, (as indicated by various reports from Australia) then why is it, that the Therapeutic Goods Agency, with a $50 million budget and 350 staff - didn’t pick up problems earlier? Where is the quality in the Australian regulatory system that is being cited as the basis for New Zealand adopting this regime?"

In 1998, the New Zealand Dietary Supplement industry had agreement with the Ministry of Health for suppliers to become licensed and all products to be registered electronically. Mr Law said, such a system would have made recalls a great deal simpler and given authorities more control in situations such as this. Mr Law added that it might be wise for the New Zealand Government to allow Australia some breathing space to sort its regulatory mess out before reconsidering a joint agency.


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