This post is continuing a series of articles related to the Therapeutic Goods Administration (TGA) in general and the regulation of complementary medicines in particular…
Jon Wardle, an NHMRC Research Scholar in the School of Population Health at the University of Queensland, writes below that while regulatory reform of the complementary medicines sector is needed, it should be much broader than simply focusing on the issue of misleading claims. Practitioners and the retail sector also need to be part of any reforms, he says.
He also argues that the TGA is caught in a difficult position as a result of state-federal constitutional responsibility arrangements and other constraints which limit the agency’s regulatory capacity.
Let’s broaden the discussion about complementary medicines and regulatory reform
Jon Wardle writes:
Much discussion is occurring regarding the failure of the TGA to adequately regulate complementary medicines.
However, many commentators are getting carried away, stating that these medicines need to be taken off the shelves or otherwise removed from public access. The issue is about advertising – misleading claims specifically – not access, and this specifically is what needs to be the focus of further attention.
Incredible claims do require incredible evidence. It is entirely reasonable to state that if a company is going to make claims about a product, it needs to demonstrate proof. However, this doesn’t mean that the two-tiered TGA system should be given up entirely.
Even though AUST L may not test for efficacy it does allow for non-registered products to at least be tested for quality and safety. This is a vast improvement over the regulatory environment in most countries. AUST L numbers also allow for ready and specific identification of products when adverse events are reported.
But whilst AUST L products aren’t tested for efficacy, TGA labelling guidelines do require products marketed to the public to state what they are to be used for. For AUST L products this is usually for general symptoms only (i.e. “traditionally used for relief of digestive symptoms”) as more specific claims require specific evidence and often require registration as AUST R.
It also allows for traditional evidence to be used for products continuing approved ingredients like complementary medicines. Full guidelines can be found here.
Practically some broader claims based on traditional use will always be needed, particularly for ‘traditional’ products (such as Chinese medicines), and AUST L allows this.
The only other choice is to leave complementary medicines completely unregulated.
Though the way this is done could be tightened up a little – and certainly policed better – when the claims are made directly to the public.
But products that bear little relation to or are ‘bastardised’ extrapolations of traditional medicines shouldn’t be allowed to claim traditional use and should have to provide their own burden of proof – for example homoeopathic vaccinations or nutraceuticals that are processed in a way that renders them unrecognisable from their ‘traditional’ source.
However, where complementary medicines point to specific or serious conditions, claims should not be made without more detailed evidence of efficacy, as currently exist under regulatory arrangements.
It’s true that some unscrupulous manufacturers take the Mickey out of the current arrangements. This in conjunction with a low audit rate and other problems raised previously by Ken Harvey and Carol Bennett mean that the cowboys do get away with more than they should.
But they aren’t the entire industry either, and the whole system shouldn’t be shut down simply because some abuse it.
Instead, efforts should be refocused on ensuring that the regulations that already exist are appropriately enforced and those that deliberately flout are punished.
In line with Carol Bennett’s sensible suggestion, broader education to the public that AUST L does not imply efficacy should also be encouraged.’
This could be also be stated on labels, and would certainly help to dispel the perception that AUST L implicitly suggest TGA recommendation.
Statements that “traditional use” does not imply “scientifically tested” may also be appropriate.
However, we must avoid confusing advertising with access. A clamp down on products promoting misleading claims is warranted, removal from the shelves of all products without proof of efficacy or AUST R numbers is not.
I wholeheartedly agree that consumers need to be able to identify products that are backed up by evidence, and those that are not. But this doesn’t mean that they should be wholesale denied access to traditional medicines that – although tested for safety – may not be tested for efficacy.
But misleading claims are not just about efficacy
Many complementary medicines are based on natural products, and like many other natural products exhibit enormous variability between products or even between different batches of the same product.
Some companies spend enormous effort ensuring the quality of their raw material product before manufacturing, yet others simply treat the raw material like a commodity – using whatever is cheapest on the international market.
However, under current arrangements poor quality products are allowed to use evidence of ‘high quality’ similar products to back up their claims, without needing to prove that their products undergo the same quality control.
We don’t stand for this in other ‘natural products’ – wine for example – yet for complementary medicines this seems to be okay.
This only disadvantages companies that do spend resources ensuring a quality product, and rewards those who cut corners. This is also an issue the TGA needs to look at incorporating into claim evaluation if it is to properly protect consumers.
Enforcement is the issue, not the laws
Regulators need teeth in order to be effective. Realistically the TGA should be acknowledged for doing a reasonable job considering the legislative impediments that don’t allow it the power it really needs.
But Ken Harvey makes a valid point that claims by some in the sector are getting more absurd over time and a ‘race to the bottom’ is ensuing – as even formerly responsible companies are being forced ‘down to the level’ of cowboys to compete.
The TGA needs to have more enforcement power – and it needs to use it.
Publicly disciplining those that have deliberately done the wrong thing under current arrangements would send a very clear message to industry that misleading claims will be taken seriously.
Increasing the rate of audits can also help, the reason so many can fall through the cracks is because many know that very few of them will actually be audited.
But Rohan Hammett is in fact quite correct when he says that most breaches are minor and his calls for increased transparency and independence are welcome.
However, we would trust the TGA much more if access to details of breaches was public and accessible. Making these public would also make a sponsor think twice before trying their luck. Consolidating above-the-line and below-the-line complaints processes so that all product promotion is dealt with by an independent and transparent body would also help.
Some guidelines could also be strengthened. Some conditions – that whilst not necessarily ‘serious’ can be emotive in nature and easily be exploited – could to be added to the list of conditions that require product registration for claims to be made in the first place. Including issues relating to sexual dysfunction or weight would help with some of the more extreme breaches.
But it’s not just the manufacturing sector and the TGA
The manufacturing, practitioner and retail sectors in complementary medicines are interwoven and any viable and sustainable solution to misleading claims and predatory behaviour towards consumers needs to acknowledge this complex interaction.
Moreover, the jurisdictional quagmire that makes reform in this area impossible needs to be properly addressed.
The fact that Nicola Roxon can’t deal with ‘complementary medicine’ issues and Catherine King can’t deal with complementary medicine ‘practitioner’ issues makes for a convenient political no-man’s-land to divert responsibility, but it doesn’t allow for a comprehensive solution to issues to occur.
Add in the confusion of state-Commonwealth responsibilities on complementary medicine industry matters and retaining the status quo becomes incredibly attractive.
Practitioners and retail need to be included in a comprehensive solution
Some of the more outlandish claims on products come from CM practitioners, not product companies. The new regulatory arrangements proposed for unregistered practitioners – based on the NSW Code – is unlikely to nip this in the bud.
NSW Health Commissioner Kieran Pehm frankly admitted at the Sydney AHPRA consultation session that such a scheme does not worry about ‘minor’ breaches such as misleading claims, instead only acting when serious harm is caused to the patient.
Regulatory attention for misleading claims also needs to be drawn to the CM retail sector, which beyond potential financial conflicts may exacerbate misleading manufacturer claims with more than a few of their own.
In fact, issues with pharmacies and health food stores prescribing or substituting products is one of the major reasons complementary medicines practitioners don’t feel comfortable referring product sales outside their practice, even though it is often the practitioners that are seen as displaying the most conflict of interest.
A broad, comprehensive approach needed
A co-ordinated and systematic approach is needed to deal with the complex issues around the complementary medicines sector, rather than the current ad-hoc and ‘on-the-fly’ approaches.
After Pan, the federal government initiated a co-ordinated inquiry that delved into the many issues associated with complementary medicines regulation. This led to recommendations for further regulation to deal with problems in the sector, most of them taken up by the government. A lot has changed since then, and resolving many issues has allowed new ones to come to the fore.
Nearly a decade on from this inquiry, perhaps it is time for the government to initiate a new inquiry into these issues and fully bring the development of regulatory arrangements for complementary medicines – which may now account for up to half the healthcare sector – into the broader healthcare reform agenda.
For now though, many of the regulatory processes are in place to deal with the worst of these issues. It’s just that they’re not being actively used.
• Jon Wardle is Director of the Research Capacity Stream, NORPHCAM (Network of Researchers in the Public Health of Complementary and Alternative Medicine).
• Croakey will seek TGA responses to this and other recent posts: