Consumer groups are seeking better international coordination for the recall of potentially dangerous health care products after more than 1,300 of them were withdrawn from sale in Australia - but remain available to consumers in the 40 countries they have been exported to.

"We need a much better system of international alerts and consumer protection," said the senior policy officer with the Australian Consumers Association, Martyn Goddard.

It took all of o­ne week for the Therapeutic Goods Administration (TGA), an Australian government regulatory agency, to finalise a list of 1,369 products comprising vitamins, minerals and herbal products to be recalled from sale.

Last Friday, the TGA took out advertisements spanning five pages in major broadsheet newspapers listing all the products manufactured by Pan Pharmaceuticals that have been recalled. The list has also been posted o­nto the agency's website.

Pan Pharmaceuticals' annual report boasts that last year, it exported over o­ne-third of its production to over 200 customers in 40 countries around the world and has major regional offices in Hong Kong and Vietnam as well as the United States and Britain.

Manipulation and fabrication

The announcement by the TGA o­n April 28 to suspend the production licence of Pan Pharmaceuticals for six months followed an audit which found that there had been the "manipulation" and "fabrication" of assay results of finished products in order to comply with specifications.

It also found the substitution of beef cartilage for shark cartilage, and a failure to test raw materials.The results of the audit report were provided o­n April 23 to an "expert group'' to advise the TGA.

"The manufacturing breaches were of such consequence that it was considered that o­ngoing availability of Pan Pharmaceuticals Ltd's products represented very serious risks to the community. They advised that the risks would increase over time, and that they could be realised at any time," the TGA stated.

The trigger for the audit was the hospitalisation in January of 19 people. Another 68 experienced what the TGA described as "potentially life-threatening adverse reactions" to a manufactured motion sickness product, Travacalm.

The TGA testing had revealed that the concentration of o­ne active ingredient ranged from none to seven times the amount specified.

While Australian authorities have advised the regulators in other countries of their decision, they have no power to compel the Australian exporter to recall their products.

"We have advised any country that is o­n the export list of Pan Pharmaceuticals of a list of products to watch. It is up to those individual countries as to what they do in terms of recall," a spokesperson for the TGA said.

"I'm in Hong Kong, for example, at the moment it is big news over here but I don't think anyone has recalled anything,'' she said.

While the TGA has recalled the products in Australia, the regulatory authorities of other governments will have difficulty knowing what is in the detailed TGA audit report o­n Pan's operations.

"One of the problems with this case is that the full TGA audit report, as far as I am aware, isn't available. If it is not available to other agencies then they are going to need more than a press release in terms of them being able to take action," Goddard said.

Legally difficult

The peak industry group for complementary health care industry in Australia agrees there may be problems providing the audit report information to international agencies.

"I think it would be legally difficult and I don't think they could share the information with regards to the auditing with an international agency and I may be wrong o­n that I haven't had a really close look at that but I think that it may cause some problems," said Alan Crosthwaite,

technical director with the Complementary Healthcare Council of Australia.

Crosthwaite is critical of the TGA for being slow to identify the products that were cause for concern, but states clearly that there were no problems with other major manufacturers in what is estimated to be a US$1 billion a year industry.

"There was a very slow reaction to minimise the damage to the Australian export industry," he said. He supports claims that up to 5,000 jobs may be lost, from manufacturing companies to small shops.

While the federal parliamentary secretary for health, Trish Worth, has foreshadowed a tightening of the regulations governing complementary medicines industry, Crosthwaite believes this is an overreaction.

"It was a breakdown in the manufacturing process where the legislative provisions picked up the breakdown and acted in the interests of public health and safety," he said.

Goddard is unpersuaded and believes there is a need for legislative fine-tuning and a lot more effort in enforcement.

"Once the genie is out of the bottle it is very hard to get back in. The time to control this is

before it happens, there should be better control of manufacturing. We shouldn't have got ourselves into this," he said.

The fallout from the suspension of Pan Pharmaceutical manufacturing licence may well extend to Vietnam too.

Last year Pan gained an investment licence from the Vietnamese government, which it hoped would allow it to finalise negotiations for the establishment of a new manufacturing plant to supply the Asian market.

The Vietnamese Embassy was unavailable to comment o­n whether it would be reviewing the decision. - IPS