AUST L requirements encourage ‘shonky products’


Dr Ken Harvey

Monash University’s Dr Ken Harvey has highlighted issues around the AUST L listing on complementary medicines, which consumers do not understand well, he says, as well as the process for handling complaints about medicines claims and advertising.

Dr Harvey, with the University of South Australia’s Dr Agnes Vitry and the University of Sydney’s Dr Barbara Mintzes, presented at the National Medicines Symposium on “Reinvigorating the regulation of therapeutic goods advertising to consumers”.

He outlined shortcomings in the system for complaining about advertising and claims about various medicines, including over-the-counter and complementary medicines, pointing out that the Complaints Resolution Panel is under-resourced, overloaded and lacks the power to enforce sanctions.

He cited the case of the Nurofen “targeted” pain products, which attracted a Choice “shonky” award in 2009; in 2011 a formal complaint was made to the CRP which was upheld, but Reckitt Benckiser declined to comply; in 2012 another complaint was made to the CRP and in 2014 a TGA “regulation 9 order” was issued. In 2015 the ACCC commenced legal proceedings which led to a determination last December and new pack labels earlier this year.

“You can still find the Nurofen specific range on your local pharmacy shelf,” he told delegates.

As for complementary medicines, “Most are not evaluated to see if they work,” he said. “It’s a trust-based system.

“We’ve got a trust-based system with no penalties for breaching the system so I’m not surprised we’ve got high levels of non-compliance.”

He says that the current system has encouraged manufacturers to “flood the market with shonky products”.

Research has shown that consumers do not understand the difference between AUST L and AUST R labelled products, Dr Harvey says.

Thus, there is little incentive for complementary medicine sponsors to undertake expensive research, compile an extensive dossier and pay the higher fees required for TGA registration.

“And this is a tragedy, because we do need research into complementary medicines.”

He cited the example of the 2015 Nobel Prize in Physiology or Medicine, which went to Beijing researcher Youyou Tu for research into how a herb used in Traditional Chinese Medicine worked in the treatment of malaria.

Dr Mintzes highlighted several recommendations in the Sansom Review which were of great importance, namely enabling the TGA to refuse to list products that “have the potential to undermine Australia’s public health efforts,” maintaining a publicly accessible catalogue of approved ingredients for use in listed medicinal products and establishing an exclusive list of permitted indications; for other health claims, sponsors must provide safety and efficacy evidence.

She said that the health sector needs the Government’s detailed response to all the recommendations of the Sansom Review, but “I have a terrible feeling Government will just cherry-pick”.

Dr Harvey also said that better CMIs are needed in general, but particularly for CMs as these do not tend to have them.

At the end of the session he said that many pharmacists find themselves expected to sell complementary medicines for which there is little evidence, because of the wishes of the owner.

“To be fair, if you’re a fairly junior pharmacist trying to earn a buck then it’s hard to go against the owner of the pharmacy or the chain.”

He reiterated calls for pharmacies to hang signs in their CM areas advising customers that not all the products are tested for efficacy and to speak to the pharmacist about them.

He again slammed the practice of putting naturopaths in pharmacies to advise on complementary medicines.

Pharmacists need to keep up to date with research into the efficacy of complementary medicines in order to best advise on them, he said.

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