As mentioned in the previous post, The Health Report on ABC’s Radio National has been investigating the regulation of complementary medicines by the Therapeutic Goods Administration (TGA).

Round One

Last Monday (May 16), public health campaigner Dr Ken Harvey argued that the regulations were weak and poorly enforced, and that the misleading promotion of complementary medicines is a problem that is getting worse.

“What we’ve seen is a race to the bottom with claims getting more and more outrageous and even responsible manufacturers starting to produce products and making claims that are less responsible because if they don’t others are and others will make money and they won’t,” he said.

Harvey said two obstacles to reform were industry – which is doing very nicely just as things are, thank you very much – and the TGA itself.

“It’s a risk-based organisation, it can only put its limited resources where it thinks the big problems are and it would regard ripping off consumers as less of a problem than for example some prescription medicines which have really nasty side effects which can kill you,” he said.

“However, not concentrating at all on the problem of complementary medicines has let the problem blow out. I might say there’s one other problem that people have perceived and that is that the TGA is 100% funded now by industry fees and again some people have unkindly suggested that if you’ve got an organisation 100% funded by industry that it may be more reluctant to take measures that would impact on industry profitability and indeed on the TGA’s own finances.”

(For further discussion on the TGA’s funding model, the comment on the bottom of this post is worth reading, suggesting other alternatives to the current situation).

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Round Two

Yesterday,  the TGA’s National Manager, Dr Rohan Hammett, was on the program defending the TGA, and arguing that most of the sector’s regulatory breaches are minor.

He said the TGA was working to ensure complementary medicine companies better understand their obligations under about 150 different regulations.

He dismissed as “absolute nonsense” the claim that the TGA’s work may be affected by its reliance on industry money. Public health concerns are the agency’s driving concern, he said.

“Why should taxpayers have to fund the regulatory cost for a commercial sector that is then going to generate profits from that regulation?” he said. “The TGA’s key stakeholders are clearly the Australian people and that’s who we work for.”

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Round Three

Ken Harvey replies:

The following are some facts as distinct from TGA rhetoric:

1. The argument that 100% cost-recovery by industry saves the taxpayer money is rubbish; industry merely passes on the TGA charges in the price of their products and the consumer pays; in this case more inequitably, as only those who need medicines pay!

2. Dr Rohan Hammett stated that many of the compliance issues found in recent audits were relatively minor, such as the wrong font size in a label. He conveniently didn’t quantify the proportion of minor compared to major issues. However, the TGA’s own report provides more information.

Of 110 “desktop” reviews conducted between 1 July 2009 and 31 March 2010, 41 (37%) products were cancelled by the TGA and an additional 22 were cancelled by the sponsor rather than undergoing a compliance review.

Of the 31 random reviews conducted over this period 22 (71%) had manufacturing non-compliance issues and 14 (45%) had evidence non-compliance issues.

Of the 79 targeted reviews 30 (60%) of 50 investigated had manufacturing non-compliance issues and 9 (64%) of 14 investigated had evidence non-compliance issues.

Similar results were obtained from compliance data from 1 July 2010 to 31 December 2010.

In short, the majority of non-compliance issues found are not “minor”!

3. Dr Hammett stated that the problem is that sponsors do not understand “complex regulations”. This is rubbish! There are numerous excellent seminars on these matters held by the TGACC (which I have attended), see here.

There are also regular seminars by the CHC on sponsor’s obligations (which I have attended), see here.

The problem is not, “poor understanding” or “lack of information” by industry about regulatory requirements; the problem is that the regulators have failed to apply sanctions for Code violations that are timely and outweigh the profits than can accrue from unethical behaviour.

4. Dr Hammett stated that in response to recommendations in 2002, “That Panel (the Complaints Resolution Panel) has been established”.

What he didn’t say was that the 2002 recommendation to give the CRP enforcement powers was NOT implemented.

5. Dr Hammett denied the TGA was under resourced.

So how come there are so few post-listing reviews despite the obvious problems revealed? And how come the CRP has an average time from complaint to determination of 5 months (often much longer). Even then, the CRP has no power to enforce their determinations. As a result, sponsors keep on promoting and keep on laughing all the way to the bank.

6. Dr Hammett said: “We’re not aware that any individual has been subjected to court action as a result of simply complaining through the usual complaint resolution process”.

In fact, both I and my university were threatened with legal action in an attempt to make me withdraw a recent complaint; when I refused the company concerned issued a defamation writ which stopped the CRP from hearing the complaint while allowing the company to continue to promote.

In conclusion, despite protestations to the contrary, Dr Hammett’s performance fails to convince me that the TGA is genuinely concerned about transparency or public health.

• Croakey will seek a response from the TGA to these and other matters raised in this series of posts

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