An ACCC investigation into breast imaging highlights broader concerns about a lack of regulation of unregistered health practitioners, writes Rebecca Johnson, Policy Advisor, Cancer Council Western Australia.
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Why are health regulators leaving the heavy lifting to the ACCC?
Rebecca Johnson writes:
Early in January, the ACCC launched legal proceedings against two commercial breast imaging operators, alleging that the operators engaged in ‘false and misleading conduct’ by marketing themselves as effective breast cancer detection services.
Both companies use devices based on electrical impedance – the speed at which mild electrical currents pass through tissue – and one uses a thermographic camera to image women’s breasts.
Neither of the devices are supported by evidence showing them to be effective in detecting breast cancer. Yet they, and others like them, are spruiked to consumers, for a considerable fee, in a shower of pink.
Why the concern?
The immediate concern is that women who rely upon test results from these services are unlikely to be aware that the tests have unknown false positive and (more disturbingly) false negative rates.
This means that a woman could be persuaded by an ‘all clear’ after a test from one of the services but in fact have undetected breast cancer. Time can be crucial to good outcomes in breast cancer diagnosis and treatment – that’s why we screen for early detection – and a false ‘all clear’ wastes precious time.
The broad-reaching concern is that the services pointedly and aggressively deter women from participating in the free, evidence-based mammographic screening program on offer through BreastScreen. Mammographic screening is currently subject to intense debate in the public health community.
However, interrogating mammography’s efficacy as a screening method through rigorous scientific processes is an important and necessary part of quality assurance. The imaging methods used by the commercial services targeted by the ACCC have never been subject to rigorous scientific scrutiny; their efficacy in breast cancer detection remains entirely unknown.
The ACCC action is serious business. The companies are up for hefty fines and tough court orders, and at least one director also faces a long disqualification from company directorship. It is encouraging, and significant, to see the consumer law – a legislative instrument that has real teeth -being invoked in an important public health issue.
However, the context and nature of many health consumer issues beg questions about whether (or when) it is in fact appropriate to rely on the consumer watchdog to step in.
Throughout most of Australia, the provision of health-related services by unregistered practitioners is essentially unregulated. Unregistered practitioners include naturopaths, homeopaths, and other practitioners not governed by the Australian Health Practitioner Regulation Agency or recognised professional bodies such as medical colleges.
Alternative breast imaging services are largely carried out by unregistered health practitioners. Currently there is currently no mechanism, such as a code of professional conduct, that holds unregistered health practitioners to standards of safe, ethical and competent conduct on pain of losing their right to practice. Rather, serious or extreme misconduct involving deception, loss, and/or harm must occur before practitioners can be regulated for breach of legal duties under consumer or criminal law.
The consumer law isn’t particularly well cut out to handle complex health consumer issues; court action takes time, evidentiary burdens may be onerous, and health consumers, who may be ill or infirm, often have special vulnerabilities.
Although courts can order redress for damage done, it is more difficult to prevent future misconduct through the court system; injunctions, for example, cannot prevent misconduct of that falls outside their scope.
Finally, capacity is always a consideration; the ACCC and state consumer regulators handle a truly vast spectrum of consumer matters and must weigh the importance of the public interest case in each and every issue.
In February last year, the Australian Ministers’ Health Advisory Committee (AHMAC) opened consultation on the regulation of unregistered health practitioners. The consultation attracted over 180 submissions.
One of the options AHMAC put on the table was to increase regulatory protections for consumers who use the services of unregistered health practitioners via a statutory code of conduct.
A code of conduct, enforced using a ‘negative licensing’ system whereby practitioners found in breach are prevented from practising, is a commendable option. If it was nationally consistent, and it came with strengthened health complaints mechanisms and a consumer education campaign, it could really be a targeted and effective step towards protecting health consumers.
In the breast imaging cases, it is heartening to see the ACCC step into a space where nobody else seems prepared, or able, to act. The Therapeutic Goods Advertising Complaints Resolution Panel came down with determinations against some imaging providers in 2011, but it seems to have no power to enforce its rulings.
The Therapeutic Goods Administration and Department of Health and Ageing did not act on the issue beyond removing the devices from the Australian Register of Therapeutic Goods, despite having statutory power to prosecute the services for continuing to advertise therapeutic goods not on the Register. The blueprint for TGA reforms, released by the Australian Government recently, may change their responses to similar issues down the track.
Whatever the outcome of the cases, the action from the consumer watchdog should put a scare into unethical and dishonest practitioners.
In fact, one commercial breast imaging service has already attempted to distance itself from the action with a statement declaring that ‘…the technology [the service uses] is scientifically based and its accuracy has been reported in peer reviewed literature’. It is worth noting that this statement refrains from noting the accuracy rate the technology in fact achieves, which is perhaps a wise question for any potential customer to ask.
The need for proper, targeted, front-end regulation of unregistered health practitioners is plain. Nearly a year on from the consultation, AHMAC’s recommendations are yet to be released.
An enforceable national code of conduct really does have the potential to tackle unscrupulous health service providers and so protect vulnerable health consumers – it would certainly lighten a load on the consumer regulators.
Here’s hoping it’s the result we get.
• This article first appeared in today’s Crikey bulletin.
“Why are health regulators leaving the heavy lifting to the ACCC?” I posed a similar question a year ago, and received a letter from lawyers representing the Department of Health and Ageing demanding a retraction. They said it was “inaccurate and inflammatory” to suggest that the TGA was passing the buck and laying the blame at the feet of dodgy doctors. They may have been right in that other unregistered ‘health practitioners’ have also been spruiking thermal scanners and other quack cancer detection/treatment devices. Having said that, at least one doctor is currently being prosecuted by the ACCC over alleged false claims made for breast imaging.
Why aren’t these lawyers for DoHA and the TGA being used to target those making false and misleading claims about cancer cures?
Michael Woodhead
Editor
6minutes.com.au
I agree on the need for increased need for regulation of new practitioners but would contend that the AHMAC proposals are not proper, front-end nor targeted and therefore do not think that Rebecca will find them as effective as she wishes.
The AHMAC proposal completely lacks proactive elements for the larger professions (for example the training of counsellors) and does little to amend public confusion as to where to report practitioners.
In NSW the statutory Code of Conduct has failed to protect consumers in most cases, as it is only the most egregious cases are actioned, given the resource constraints. It remains to be seen whether the cases she mentioned would be ‘serious’ enough for exploration. If the NSW experience is anything to go by I would not hold out hope. Ditto for ‘mild’ cases of financial exploitation or incompetent misdiagnosis.
Even when the HCCC has taken action then this has not guaranteed protection, as practice rights have been restored and public declarations removed in relation to some practitioners who were acquitted of “legal” wrongdoing, even when grave ethical concerns that would result in de-registration from a professional board remained.
The AHMAC proposal for a statutory Code of Conduct is an excellent catch-all safety net that will offer the public a small increase in protection, but it should never replace real statutory regulation of professions with a large (and increasing) role in Australia. Amongst those professions government reports have consistently recommended regulating are naturopaths and counsellors/psychotherapists.
We were all initially informed in 2009 that as the ‘third stage’ of the introduction of the NRAS AHPRA would review professions that should be included in the national scheme.
However, I fear that the upcoming AHMAC legislation will be used as an excuse to avoid registering new profession under AHPRA, when the changing healthcare landscape in Australia requires a significant expansion of the professions AHPRA regulates. I sincerely hope that AHMAC aren’t trying to pass the buck on this.
The strength of a statutory Code would be its potential comprehensive nature and statutory application with enforceable penalties. A potential weakness is that it is essentially ‘passive’ and has limited capacity for active monitoring and feedback unlike a system of formal registration.
Another weakness is a Code’s limited coverage beyond the activities of practitioners. The regulatory system should capture the responsibility of employers for their directly supervised and employed healthcare practitioners.
The central principle of protecting the public interest remains, and if government is to fulfil its obligations properly, then both operational aspects need to be addressed, albeit there may be different mechanisms involved for an operator to those for an individual.
Government thus carries an underlying obligation to minimise risks in the public interest, not only through the regulation of the individual practitioner, but also through the accreditation, licensing and monitoring of any related entity
that provides direct operational (e.g. clinical) practice support.
There are numerous examples of employers breaching the spirit of a professional practitioner code of conduct and this forms an additional justification for capturing employers and related service providers within the scope of an overall regulatory framework.