“These sceptics have successfully used the media, and abused the advertising complaints system, to force the Department of Health and the TGA into tightening the regulation of complementary medicines into a fully-fledged medical model of regulation, including an evidence regime that could only be met by registered medicines”.
Wendy Morrow, CHC [this and the following article from which the quote comes is copied in the public interest]
From: Special Report: TGA between a rock and a hard place on CMs
The TGA is regularly criticised for failing to control ‘rogue’ complementary medicines makers who break promotional regulations but appear to suffer few consequences, but is it hamstrung by a confused and misdirected regulatory system?
“Supplement regulation by TGA is completely cactus” shouted the headline in online journal The Conversation. It was not the only story and/or commentary stirred up by what is seen as the most recent failure by the medicines regulator to clamp down on weight-loss products.
As a result of events around the cancellation of Swisse Ultiboost Appetite Suppressant and it’s effective reinstatement under another name, the TGA has lately suffered a barrage of criticism, branded a watchdog that is too scared to go out in the rain and subjected to mockery courtesy of the ABC’s comedy-inclined consumer show, The Checkout.
While that program’s coverage of the Swisse controversy has earned its makers a defamation suit, the TGA has chosen not to respond to this latest in a series of attacks on its credibility as a regulator when it comes to the complementary sector.
Pharma in Focus asked the industry associations that represent the CM sector to answer some questions about their view of the TGA’s performance, and the difficulties under which the regulator may be operating when it comes to controlling the promotion of these products
“The architecture of the regulatory system in Australia for complementary medicines is sound. It is consistent with a risk management approach on which low risk products expect a light touch,” says Australian Self-Medication Industry executive director, Deon Schoombie.
But he adds that his organisation does not think the system is perfect and sees opportunities for improvement.
In particular, says Dr Schoombie, the regulator needs to clarify requirements so that no sponsor can claim they don’t know the rules. For example, guidelines for levels of evidence are, in ASMI’s view, not clear.
“This is something we are working with the TGA and consumers to resolve as part of the Blueprint reforms. This work is almost complete but what will happen in an election year is anybody’s guess. There are very few parliamentary sitting days left,” says Dr Schoombie.
The Complementary Healthcare Council’s executive director, Wendy Morrow, sees the architecture as lop-sided with a bias towards treating CMs and a sub-set of prescription drugs.
“Complementary medicines differ from pharmaceutical drugs, and as such, should be regulated differently,” she says. “They have never claimed to be a medical solution to a medical problem; rather, they look at how to assist the overall wellness of consumers to help improve daily lives and help prevent us all from falling sick (or at least reducing the duration) by maintaining a healthy balance.”
The CHC goes so far as to call for a separate regulatory system for CM’s, advocating for Australia to implement an “appropriate Regulatory Framework for Complementary Medicines under an Office of Complementary Medicines Authorisation and Complementary Medicine-relevant legislation.
Such a system would “adopt the principles of minimum effective regulation as opposed to risk elimination or risk aversion, a strategy based on co-regulatory and self-regulatory options that offer the most cost effective regulatory governance and administration,” the group says.
Dr Morrow says the current complex and confused regulatory system has allowed the media to give CM promotion a bad name.
“The TGA state that as part of their goals to enhance the complementary medicine regulatory framework is being seen to ensure that it remains adaptable to community and industry expectations. Potentially as a consequence of this goal, one of the main problems faced by the regulator is trying to negate the criticisms of a handful of complementary medicine sceptics,” she says.
“These sceptics have successfully used the media, and abused the advertising complaints system, to force the Department of Health and the TGA into tightening the regulation of complementary medicines into a fully-fledged medical model of regulation, including an evidence regime that could only be met by registered medicines.”
In particular, she says, “Misleading compliance information released by the TGA in 2011 has been continuously and irresponsibly published in every article that seeks to call for tighter reform of complementary medicines. The compliance information has since been acknowledged as being based on a statistically insignificant sample size of products that were targeted for audit review.”
The CHC cites an Australian National Audit Office report on the regulation of CMs as saying, no statistically valid, general conclusion can be drawn about the state of compliance. “In fact, the only true conclusion that could be drawn from this statistic is that it provides evidence as to the efficacy of targeted audits,” says Dr Morrow.
Dr Schoombie says a strong regulatory system is all very well but without enforcement, it becomes a paper tiger. “We can develop the best system on the planet but if not enforced and we don’t have a compliance system in place, it’s no good.”
Despite strong concern about what it regards as a growing tendency towards over-regulation, the CHC agrees. “The CHC believes that increased requirements, in the absence of evidence of any specific consumer safety concern, do not constitute best practice regulation. The CHC does however, support more stringent enforcement action against companies that have made little or no attempt to comply with the regulations, or where a true safety concern is identified,” says Dr Morrow.
She adds that TGA resourcing needs to be improved. “The CHC strongly considers that the TGA require more resources. In particular our first recommendation to government outlined in our Pre-budget Submission 2013/14, was to provide the industry regulator, the Office of Complementary Medicines within the TGA with additional resources to enable more comprehensive, timely and consultative development and implementation of appropriate regulatory reform, including the planned reforms to the advertising framework.”
But while agreeing there may be resourcing issues at play, Dr Schoombie says “industry is sensitive about paying more” without knowing what extra value it would be getting.
“If the TGA could demonstrate added value, that fees translate into outcomes then industry would be willing to discuss. It’s the kind of conversation we should have because there is much room for improvement in compliance.”
However, he adds, ASMI is against the idea that everything should be pre-vetted for quality, safety and efficacy. “This may sound good but it’s completely impractical.”
But as the debates over pushing the promotional boundaries continue to surface, both organisations agree that sanctions on rogue operators need beefing up.
Dr Schoombie says that ASMI recognises that there are ‘cowboys’ and that the possibility of simply re-listing under a different name a product that has been de-listed, means the current system is not effective. “We need incentives to comply through decent penalties and sanctions,” and they need to have a commercial effect, he adds.
“If you know there’s a $10,000 fine or that sort of thing, you may think again before re-listing.”
However, he sees no role for the Australian Competition and Consumer Commission (ACCC) in regulating CM advertising. “My sense is that the ACCC is going after the big boys. The TGA is the right way to do it.”
Dr Morrow is less dismissive of the competition regulator, acknowledging there is an argument for the ACCC taking more of a role. “There is an argument to say that most of the things covered by the TGAC are already covered by the Australian Consumer Law, and that the TGA should be responsible for authorising the product, and writing the code, but the ACCC might be best placed authority to administer the code either with or without advertising pre-approval.
“There is an implicit duplication in having advertising resources in TGA and ACCC, when the job could be more efficiently done if they were in one place. Arguably monitoring and reviewing advertising is not the TGAs forte since most therapeutic goods are not advertised to consumers.”
But, she says, there is an easy answer to the ‘cowboy’ problem, the only problem is that the TGA does not back it.
“An easy answer to stopping rogue companies entering the Australian market and listing their products on the ARTG would be to require all sponsors of products in Australia to nominate an industry code at the time of listing a product on the ARTG. However, the TGA has stated that this is not supported because it departs from the self-regulatory model. It should be noted that prescription medicines, not permitted to advertise directly to consumers, is the only sector that is actually self-regulated.”
Dr Schoombie supports a similar position. “For prescription pharmaceuticals abiding by the Medicines Australia Code of Conduct is a condition of market approval. We would like to see something similar but, while there have been advocates for this, so far there doesn’t seem to be an appetite for it on the government side. From a level-paying-field point of view, this merits discussion,” he says.
In the meantime, both sides await the outcome of proposed amendments to the Therapeutic Goods Act that if passed would mean increased TGA powers to suspend, cancel and remove goods from the ARTG in light of unacceptable presentation of the goods, but with only two weeks of sittings left before the election, there seems little prospect of change before next year at the earliest.