Swisse is calling for the Government to switch advertising claim regulation of CMs from the TGA to the ACCC and Advertising Standards Bureau
In its pre-Budget submission, the complementary medicines supplier makes four recommendations, including recommendations already made by the Sansom Review.
- The introduction of three-year Intellectual Property protection on scientifically supported claims in the complementary medicines sector.
- A third category be added to the Australian Register of Therapeutic Goods to allow for the marketing of new complementary medicines with higher level scientific claims.
- Allocate responsibility for regulating advertising claims, compliance and complaints of the complementary medicines sector from the Therapeutic Goods Administration (TGA) to the ACCC and Advertising Standards Bureau.
- Support early market access and market penetration into international markets for Australia’s complementary medicines sector through resourcing embassies with personnel who have specialised industry knowledge in, and a mandate for actualizing the results for the complementary medicines sector.
The company describes the upcoming 2017-18 Budget as a “timely opportunity for the Federal Government to support innovation in the industry through continuing the ‘refresh’ of the regulatory framework, the elimination of unnecessary regulation and investment in market access support”.
The Sansom Review recommended that there should be three pathways by which sponsors can seek entry on the ARTG for complementary medicines. This was agreed to by the Government when it responded to the Review’s recommendations, and the TGA is currently accepting input on the matter (until March 28).
“Under the Aust-R category, complementary medicines are eligible to register but will be regulated to a risk level that is appropriate for pharmaceutical medicines and substances deemed toxic to human health,” Swisse says in its submission.
“This presents an unreasonably high financial barrier to entry for complementary medicines.”
“The Aust-L pathway to the ARTG allows for the introduction of complementary medicines at faster speed to market, while protecting consumer health and safety, but limits incentives for investment in further science to support claims.
“A third category under the ARTG, supported by intellectual property protection as described in recommendation one, would allow for investment in science and innovation, and entry to the register at a cost that is proportionate to the consumer health risk posed by complementary medicines.”
Friends of Science in Medicine’s Ken Harvey cautiously welcomed the first two recommendations, but condemned the CM industry’s unwillingness to differentiate such a third ARTG category clearly, as well as the suggested changes to advertising claims regulation.
“The good news is [Swisse] are supporting research innovation, and they’re happy with the new pathway,” Professor Harvey told the AJP. “They say that they like the concept of intellectual protection, and that’s been a key cry from the industry, which I’ve got sympathy for in the sense that if these ingredients are generic, as they often are, they’ve got no intellectual property protection.
“So you can go and do an expensive trial that proves that Vitamin D does this or that, and then everyone else can go and jump on that bandwagon, so there’s no reward for effort.
“On the other hand, what they haven’t said about the new pathway, which they’re supporting, is any reference to the concept that it should have a claimer about the new pathway.
“The Sansom Review recommended a disclaimer that all listed products should have: ‘These products have not been evaluated to see if they work,’ which is what the consumer groups wanted. That didn’t get up, the Government didn’t accept that recommendation.”
He says the CM industry has concerns about the use of a “claimer” instead, which would prominently draw consumers’ attention to the fact that a product falling under the new ARTG category, and potentially thus draw attention to the lack of such claims on other products.
“They wondered about an ‘AUST A’ for ‘assessed’. But nobody understands what AUST L and AUST R mean already! So it’s an interesting debate and a point of controversy that hasn’t been sorted out.”
Changing advertising regulation
Swisse also recommend removing the TGA’s authority over advertising claims.
“There is no longer a need for the TGA to oversee advertising claims when there a mature consumer protection system in place, overseen by the Australian Competition and Consumer Commission and the potential for efficient self-regulatory systems overseen by the Advertising Standards Bureau for advertising claims, compliance and complaints,” Swisse says.
“The ‘novel foods’ category of FSANZ carries a potentially similar consumer risk profile to complimentary medicines and yet is not subject to an additional layer of advertising regulation beyond the regulations of the ACCC and the self-regulatory systems overseen by the Advertising Standards Bureau.
“The TGA risk-management approach that is appropriate for the public health risks associated with pharmaceuticals is not consistent with the public health risks associated with complementary medicines.
“Swisse Wellness remains of the view that the requirement to undergo pre-market advertisement assessment and the existence of a complex, obscure and insufficient complaints resolution process is not best practice. It has had a stifling impact on competition and productivity within the complementary medicines industry.”
Prof Harvey says that addressing a recent ACCC event, its chairman, Rod Sims, explained that it receives 2000 or more complaints each year, across the gamut of consumer affairs from banking to airlines.
“He said they’ve only got resources to investigate about 100 or so, and only the resources to take 20 or 30 to court, so they target the most egregious,” Prof Harvey says.
“So if this is given to the ACCC there will be no complaint process at all, because they haven’t got the resources.
“And the Advertising Standards Bureau is a minefield to navigate and they haven’t got the expertise anyway – at least the current Complaints Resolution Panel has health professionals, industry people who understand what evidence is.
“The Panel is under-resourced, under-funded and has no power, and neither does the TGA, but the answer is to improve that system and make sure there’s powers there.”