Regulatory framework questioned in Pan fiasco

Recent revelations about Pan Pharmaceuticals and Curacel International have thrown the efficacy of Australia's regulatory system into question, with potentially thousands of product lines facing recall and criminal charges being filed.

The Therapeutic Goods Administration (TGA) has suspended Sydney-based Pan Pharmaceuticals' manufacturing licence following an investigation prompted by reports of excessive side-effects from proprietary travel sickness pills.

Manufacturer Curacel was fined $AUD84,000 for producing and marketing counterfeit medicines earlier this month.

The situation was described today by NSW Minister for Science and Medical Research, Frank Sartor, as having "massive consequences": "the community expects good rules for these things, and they have to be strict -- but the rules are only half of it. The practice is the other half and it is just as important," he said.

Steve Haynes, director of strategic relations for lobby group Medicines Australia, agreed with Sartor, noting that the revelations could well result in the TGA being forced to raise the standards required by supplementary medicine manufacturers.

"The benchmark required for clinical trials of prescription medicines is much, much higher than required by these companies. The likely outcome is that the safety benchmark will be upped to a similar standard to the rest of the industry to avoid what has been described as shonky manufacturing," he argued.

"People spend three times as much on these things [$AUD2.5 billion] as they do on prescription medicines, and frankly they are potentially detrimental to the health of Australians," he added.

The TGA audit of Pan was initiated after 19 victims were hospitalised and nearly 70 experienced "potentially life-threatening" adverse reactions to a medication containing hyoscine hydrobromide. Although Pan was granted its licence to manufacture medicines several years ago, the audit found manipulation of assay data in energy products, vitamin products, and cough and cold medicines.

The TGA's principal medical advisor, Dr John McEwen, said potential symptoms from consumption of the tablets include blurred vision, agitation and loss of balance. McEwen said the TGA was undertaking further investigations and that the situation was of "great concern".

"We want the public to be aware of the potential risk of taking these tablets," he said.

But one industry observer close to the National Health and Medical Research Council, who wished to remain anonymous, said the licensing authorities should be asked to provide confirmation they were not being influenced by the commercial aspirations of drug companies.

"I think they should be pushing much harder -- it's well known that these big companies have a lot of influence in this area. We should be demanding rigorous evidence they are not being soft on these [supplementary medicine manufacturers]," he said.

Mayne Health has issued a voluntary recall of all its products manufactured by Pan. About a third of Mayne's vitamins, herb and minerals supplement range -- including Cenovis, Bio Organics and Golden Glow -- is made by Pan. Estimates indicate the cost of the recall and a write-off of existing stock could cost Mayne up to $AUD20 million.

Blackmores, currently the largest Australian supplementary medicine company, declined to comment on the TGA action, but said in a statement that none of its products were manufactured by or sourced from Pan.

The ASX Healthcare and Biotechnology Index was up slightly at press time, as shareholders dumped Mayne and distributor Australian Pharmaceutical Industries stocks but bought up Sigma and Blackmores.

Sector analyst Kiara Bechta-Metti of UBS Warburg said it was clear that the market was reacting to specific stocks based on their relationships with Pan, and was not punishing the healthcare sector as a whole.

Nikki Capp, a spokeperson for GlaxoSmithKline, said that the Pan revelations would be unlikely to affect the company's future plans for any clinical trials to be held in Australia. "This will have absolutely no effect on our products," she said.

However, representatives of other major pharma were slightly more cautious, describing the situation as "really delicate" and "needing very careful handling to avoid fallout".