NZ orders recall for Pan products

12.00pm

New Zealand food authorities are recalling all Pan Pharmaceutical products sold here.

The NZ Food Safety Authority (NZFSA) today said it was still trying to determine what products made by Pan were on the market here.

On Monday, the Therapeutic Goods Association (TGA), Australia's national medicines watchdog, suspended Pan's licence and ordered the immediate withdrawal of 219 of Pan's products following a series of grave safety and quality breaches, including substitution of ingredients, manipulation of test results and substandard manufacturing processes.

The association said it was considering laying criminal charges against Pan, which is Australia's largest contract manufacturer of herbal, vitamin and nutritional supplements.

New Zealand was also recalling the 219 products in the Australian list, NZFSA policy and regulatory standards director Carole Inkster said today.

"The extent of (Pan's) manufacture on contract is the information we're waiting on from the Therapeutic Goods Administration in Australia," Ms Inkster told National Radio today.

"They haven't yet issued formal recalls for any other products than the 219. As soon as they do, we will pass that information on to the public and to retailers and manufacturers.

"The complexity for New Zealand is we have a healthy business sector that does manufacture in New Zealand. It's not all of those sort of products that are at risk in New Zealand."

Medsafe, the government agency responsible for the regulation of medicines, has said there were at least three Pan-made over-the-counter medicines available here - Mintec, and two No-Doze products.

Ms Inkster said those products were easy to trace as they were registered medicines.

"The larger and more complicated part of the programme is all those dietary supplements we don't register in New Zealand, and we just don't know whether they are here or not."

About 1650 'export-only' medicines and dietary supplements manufactured and sponsored by Pan Pharmaceuticals have been cancelled from the Australian Register of Therapeutic Goods.

Many products made by Pan, which has had its license suspended for six months, are distributed by other companies, such as Kordel, Nutralife, Red Seal, Thompson Nutrition and Vita Health.

"We need to be cautious about products, read the labels, look for Pan Pharmaceuticals and be cautious about those, and stop taking them if they're marketed by Pan," Ms Inkster said.

"We don't know how much wider it is and neither do the Australians. We're waiting on their investigation, they're the people on the ground with the information and working closely with the company. We've asked them to work with us as well."

The New Zealand Government is considering changes to rules covering how dietary supplements are sold. A joint New Zealand-Australia body to regulate the trade is a possibility.

"It (Pan) certainly provides some thought-provoking material for us to go forward with in terms of considering where we might go on that arrangement," Ms Inkster said.

Meanwhile an industry analyst said the recall of Pan Pharmaceuticals products shows why New Zealand should not enter into a trans-Tasman health supplement regulation scheme.

Industry analyst Ron Law, the former executive director of the National Nutritional Foods Association - a trade association for the New Zealand natural healthcare and therapeutic product industry - warned today that "effectively handing responsibility for regulating pharmaceutical and natural products over to the Australians" would be problematic.

"New Zealand is being led into joining with Australia on the premise that their systems offer quality and consumer confidence," Mr Law said in a statement.

"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."

There were many unanswered questions about the Australian body, which treats health supplements as medicines. In New Zealand, supplements are sold under food regulations.

Mr Law questioned the effectiveness of TGA's monitoring.

"If Pan Pharmaceuticals manufactures between 30 and 70 per cent of all products on the market in Australia, as indicated by various reports from Australia, then how come the (TGA) - with a A$50 million ($56.27 million) budget and 350 staff - didn't pick up problems earlier?"

Mr Law advocated health supplements being notified to the Health Ministry.

"...such a system would have made recalls a great deal simpler and given authorities more control in situations such as this," he said.

Green MP Sue Kedgley, a member of the health select committee, opposed the joint regulatory body, saying it would give all the control to Australian authorities.

She also criticised the TGA for not finding the Pan problem sooner.

"Australia has what is considered to be the most draconian regulations in the world. And this (Pan) has happened under that system," Ms Kedgley told NZPA.

"The point is it can happen anywhere, and what you need is regular random monitoring."

There was agreement a new system for regulating health supplements in this country was needed, but not in the way the Government advocated, she said.

"We need to make sure products are safe and consumers can feel reassured," she said.

"I'm not convinced that giving up our sovereignty in this highly expensive Australian way, is the best way. But I am certain that we do need a better system in New Zealand."

She said there needed to be a standard of good manufacturing practice, a register of all dietary supplements and a list of all the ingredients in all products.

"We can set up a reasonably simple and cost effective system in New Zealand," she said.

"This (proposed joint agency) is just prohibitively expensive, the compliance costs would be such that a very large percentage of manufacturers would be put out of business.

"You are leaving it all to the Australians, which really doesn't seem like a sensible thing to do."

The proposal is still before a select committee inquiry, but Ms Kedgley said the inquiry would likely be completed in the next couple of months.


- REUTERS

Therapeutic Goods Administration Australia