A proposed Therapeutic Goods bill would give unproven medicines a “free kick” and undermine pharmacy professionalism, one critic says

Friends of Science in Medicine and other stakeholders are concerned that the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 would remove pre-approval of advertisements for therapeutic goods in favour of self-regulation.

The Bill would also endorse an industry-submitted list of ‘permissible indications’ for complementary medicines.

Friends of Science in Medicine’s Ian Carr told the AJP that “they’re giving Traditional Chinese Medicine, for example, a free kick – they can say anything about chi and yin and yang and get away with it” due to traditional use.

“Taking the very negative or cynical view of the whole thing, [the bill] is an open invitation to health fraud.”

The Taree pharmacist told the AJP that the current system, which does not require pre-approval of ads on social media, the Internet or subscription television, has seen more than 90% of complaints upheld.

“We’re looking at an industry which can’t be trusted to self-regulate,” he said.

“And I think for pharmacy it quite frankly continues the slide from the professionalism of the pharmacists, into the wants and needs of marketers.

“Even as we speak, every pharmacy chain is throwing catalogues over our front fences with unquestioned pages and pages of supplements advertised, and in terms of that, the new proposed regulatory regime is only going to make it easier to mislead.”

Carl Gibson, CEO of Complementary Medicines Australia, said that “to say that removing the existing pre-approval of adverts will lead to harmful products appearing in newspapers and on the television is a nonsense and disingenuous”.

“The current pre-approval system does not cover all media,” he said. “Pre-approval is not required today for advertising on the internet, social media or subscription television – and yet the sky hasn’t fallen in.

“The pre-approvals is not the last line of defense.  If pre-approvals service is axed advertising will still be subject to the Therapeutic Advertising Code and the ACCC rules on false and misleading claims. 

“Advertisers can only use claims from an approved list agreed by the TGA. And the recent claims by these fringe groups that anyone can advertise anything is just plain wrong. Illegal products are still and remain illegal and cannot be advertised.”

He said he welcomed measures to be introduced including enforceable directions, infringement notices, injunctions, substantiation notices and public warning notices, as well as criminal and civil penalties, “giving the TGA Watchdog much needed teeth”.

Professor Ken Harvey from Monash University, a prominent critic of non-evidence-based medicine, said that “the sky has fallen in continually over the years, and the TGA is belatedly realising that we have to do something about it, but they’re not doing something terribly useful”.

“The pre-approval system is old stuff that hasn’t kept up with new media – and that’s bad, as it should have,” he said.

“We have huge problems with lack of pre-approval with new media. That’s where the majority of complaints are being upheld.

“Ideally you would extend pre-approval to all media – that would be the modern extrapolation from why it started. It was started to get rid of bad ads, realising it wouldn’t get rid of everything, but would get rid of most of it.”

Frustrated at the lack of a public hearing in regard to the bill, stakeholders held their own at Monash University on 24 January. It was sponsored by Choice, Access 2, Monash and RegNet.

The forum saw Choice’s Katinka Day point out that post-marketing surveillance and complaints take a long time to remove bad advertisements and that damage is done in the meantime.

Access 2’s Allan Asher said he was concerned the Bill was silent on both the objectives and the need for regulatory transparency for the new complaint system. Unlike other consumer protection laws, the Bill provides no mechanism for private rights of action or to compensate consumers who suffer injury through misleading or deceptive advertising, nor restitution for economic loss, he said.

The forum ended with a panel discussion involving Jo Root (Consumers’ Health Forum of Australia), John Dwyer AO (Friends of Science in Medicine), Tim Mendham (Australian Skeptics), Tony Zappia MP (Shadow Assistant Minister for Medicare) and the audience.

“There’s lots of good parts in this Bill,” Prof Harvey told the AJP. “We just want to excise a few bits here and there so they can be looked at.”