This article is more than 2 years old

This article is more than 2 years old

Consumers will be left in the dark about unscrupulous advertising of medicines and medical devices if Australia’s drugs regulator implements a new complaints-handling system, public health experts warn.

It comes after an expert review of the regulation of medicines in 2016 recommended the existing Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council be disbanded, and a single agency be formed to manage complaints about the way therapeutic goods are advertised. The review found this would lead to faster and more effective sanctions for regulatory violations.

In response, the government announced that from July the Therapeutic Goods Administration (TGA) would become the single body responsible for handling advertising complaints. Submissions into the TGA’s proposed complaints-handling model closed on Monday.

A submission led by Ass Prof Ken Harvey from Monash University’s school of public health and preventative medicine raises serious concerns about transparency and accountability under the new system, where complaints would be categorised into low, medium, high and critical priority.

But complainants will not be told the priority level their complaint has been assigned to. Regardless of priority, no information will be published by the TGA about which alleged code breaches were upheld, or what penalties were issued.

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“For low-priority cases, no details of who is responsible for the advertisement will be disclosed,” the submission states.

For high- and critical-priority cases, no information will be provided to the complainant or the public until a final outcome is reached, but Harvey said if this involved court action, this disclosure could take years.

“Publishing determinations on all complaints received, including whether compliance was achieved by the regulatory measures undertaken, educates complainants, advertisers and the industry; it is also crucial for monitoring the performance of the regulator,” Harvey told Guardian Australia.

“We are also aware of hundreds of outstanding complaints, sent to the TGA by the Complaints Resolution Panel, which currently lack a public outcome ... there is considerable cynicism about the TGA’s ability to provide an efficient and transparent complaint system.”

However when contacted by Guardian Australia the TGA said there would be more transparency under the new system.

“The new system will be more transparent than the previous one,” a TGA spokeswoman said. “Apart from publication of TGA’s performance against key performance indicators for handling complaints, detailed information on individual complaints will be published for medium-, serious- and critical-level complaints.

“Information on numbers and frequency of low-level complaints and on complaint trends will be published in biannual reports.”

But Harvey said other consumer protection bodies, such as the ACCC, informed the public when from when it began court proceedings and that the TGA should do the same. A letter sent by the ACCC deputy chair, Delia Rickard, to the TGA’s regulatory reforms team raised concerns that low-risk complaints would be hand-balled to the ACCC.

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The letter, sent last year, states: “The ACCC is concerned that the TGA declaring certain regulated products as ‘low risk’ and excluding them from the TGA’s regulatory framework may raise an unrealistic expectation that the ACCC could provide equivalent regulatory oversight through the application of the Australian consumer law”.

“The ACCC recognises the role of specialist regulators and is unable to increase activities in areas vacated (in whole or part) by other regulators. We can not replicate the expertise nor therapeutic based risk assessments that a specialist regulator like the TGA delivers”.

Harvey said it was also concerning that under the new complaints-handling system, the TGA would not routinely evaluate or publicise if regulatory action taken against those making false advertisements resulted in compliance.

“The regulator is piss-weak,” Harvey said. “They lean over backwards to accommodate the profession or the industry and it really isn’t helping consumers. What about consumers misled into non-evidence-based treatment and buggering up their health because of dodgy advertising?”