Regulating complementary, unconventional and emerging treatments in Australia: a missed opportunity

What now for the regulation of complementary, unconventional and emerging treatments following the Medical Board of Australia’s decision not to revise its guidelines?

On 16 February 2021, the Medical Board of Australia announced that it will not be introducing new guidelines regarding medical practitioners’ use of complementary, unconventional and emerging treatments.1 Instead, it will continue to rely on its existing framework as outlined in the Good medical practice: a code of conduct for doctors in Australia (the Code).2 The reasons for doing so, according to its Chairperson, Dr Anne Tonkin, were that the current guidelines were sufficient for managing unconventional practice and that there were significant issues in adequately defining “complementary”, “alternative” and “emerging” practice.3

For some, including medical innovators, researchers and integrative medical practitioners who feared that the proposed guidelines would restrict practice, this may be welcome news.4 But other medical practitioners have responded with dismay that the Board has “backed down” and failed to regulate “non‐evidenced based” practice.5

The consultation

In February 2019, the Medical Board called for submissions to the public consultation on clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments.6 Those making submissions were asked to express their preferences regarding such interventions: either option 1 — to keep the status quo regarding the regulation of complementary, unconventional or emerging treatments — or option 2 — to strengthen the guidance for medical practitioners’ use of these treatments. At the time of its release, the Board expressed a preference for the second option.6

The focus of the consultation was broad. It encompassed complementary and alternative medicines (including the use of homeopathic preparations, naturopathy and nutritional supplements), the use of novel and emerging therapies (eg, stem cells and platelet‐rich plasma), and the use of conventional medicines and diagnostics outside of their usual clinical indication (eg, off‐label prescribing).6

The consultation was driven by the concern that vulnerable patients were being offered inappropriate tests and treatments, were not fully informed about the lack of evidence of safety and efficacy of such treatments, and were being exposed to physical, financial and psychological harm as a result.6 For example, one area of practice identified in the consultation paper was the use of stem cell‐based interventions for a wide range of indications not currently supported by evidence, including Alzheimer and Parkinson disease, and that these interventions may be associated with significant risk of morbidity and mortality.7

The consultation paper also called for medical practitioners to ensure that they manage financial conflicts of interest, given the possibility that they may have a monetary stake in the interventions they are providing.6

Response to the consultation

The Medical Board received over 13 000 submissions to the consultation.8 Several thousand submissions took the form of standardised letters, predominantly from complementary medicine practitioners. Other submissions misinterpreted the purpose of the consultation, expressing concern that certain practices were going to be banned or that medical practitioners who use complementary, alternative or emerging treatments may be de‐registered.8 Another 1200 submissions dealt with issues that were not within scope of the consultation, including access to Medicare, private health care rebates, and the regulation of non‐medical practitioners.8

Of those submissions that addressed the substance of the consultation, there were deeply divided views as to whether or not the Code was sufficient to deal with issues raised by the use of non‐conventional interventions.9,10,11,12,13,14,15 Those opposed to additional guidelines stated that the Code already offers adequate safeguards and protects patients.9,13,14 Additionally, some opponents were concerned revisions to the Code would further segregate integrative medical practitioners from conventional medical practitioners and create a two‐tiered regulatory system.9,14 Those in favour of revisions to the Code argued that they would strengthen public protection, promote positive behaviour change by clinicians and more comprehensively deal with the issues raised by the use of unconventional interventions.10,12,15

Many submissions raised questions about the definition of, and apparent conflation of, complementary medicine, unconventional medicine and emerging treatments put forward by the Medical Board in the consultation draft:

Those concerned with this definition noted that it was potentially confusing and erroneously conflated “complementary” with “unconventional” and “emerging” treatments.9,10,11,12 In this respect, some submissions recommended distinguishing between practices that were supported by at least some evidence and those that were not in order to more clearly distinguish the level of risk associated with the three different areas of practice.10 Both conventional and complementary and alternative medicine organisations also complained that the conflation of different types of practices implied that their own practices were intrinsically problematic.13,14

Complementary and alternative medicine organisations also argued that the proposed guidelines unfairly singled them out for poor practice and greater regulatory control,9,13,14 and that the existing Code was sufficient to protect the community.

In contrast, many other submissions expressed broad support for the proposed guidelines, while at the same time arguing for further clarification around the definition, demarcation and regulation of complementary, unconventional and emerging interventions.10,11,12,15 The General Practice Advisory Group of the New South Wales Agency for Clinical Innovation noted in its submission that the proposed guidelines offered the opportunity to align medical practice with evidence‐based care and that by doing so they could reduce the risk of harm to patients.10 The Therapeutic Goods Administration, while critical of the lack of granularity in the definition, also agreed with the proposed guidelines, accentuating the need for attention to high risk treatments and medicines.12 The Public Health Association of Australia described the need for comprehensive guidelines for the management of financial conflicts of interest, noting that the proposed guideline on financial conflicts of interest was not pragmatic, given the frequent collaboration between industry and medical practitioners.11 Other submissions supporting the proposed guidelines made recommendations for improving the definitions used, for the management of conflicts of interest and for more clearly articulating what constitutes appropriate training, expertise and experience.15

Future steps

The Board offered two primary reasons for discontinuing its review of the Code: first, that the definitional issue was insurmountable and, second, that there was no need for revision because the existing regulation is adequate. We disagree with both of these points. With respect to definitions, we suggest that this issue could have been dealt with by fairly minor alterations.1 Rather than the use of the terms “complementary”, “unconventional” and “emerging”, which obscure important differences and similarities between different types of practice, the term “non‐conventional medical practice” could have been used.15 Not only is this term less judgemental, it encapsulates the key problems the consultation was trying to address: the use of non‐evidence based (or unproven) diagnostics and interventions (including emerging treatments), and the inappropriate use of complementary and alternative medicines.15

While additional articulation of the key differences between high and low risk practices and their management is necessary, a non‐exceptionalist approach to the management of non‐conventional medical practice is arguably long overdue. This is because this approach has the potential to address the use of non‐conventional interventions in a consistent and equitable manner in different health care contexts. Such an approach may also avoid unnecessary duplication of existing oversight mechanisms (including, for example, professional association guidelines or state‐based policies) and facilitate their integration into existing policies (including the Code).

In relation to the argument that there is no need for reform because the existing regulation is adequate, we believe that the Board has failed to provide an adequate justification for this stance. There are clearly other regulatory mechanisms in place that have offered robust responses to inappropriate unconventional practice (eg, strengthening the Therapeutic Goods Administration’s regulation of stem cell products),16 increasing the requirements for efficacy claims of complementary medicines,17 and legal decisions sanctioning practitioners for inappropriate practice.18 These mechanisms, however, are either difficult to enforce (eg, advertising regulations) or, in the case of individual legal decisions, are not well understood by practitioners or effective at changing behaviour.

We therefore believe that by failing to pursue regulatory reform, the Medical Board has missed an opportunity to develop strategies to protect patients when they are being offered non‐conventional interventions. The primary duty of the Medical Board (as a regulator under the Health Practitioner Regulation National Law) is to protect the public’s health and safety. It does this by licensing health professionals to work within their scope of practice and by controlling practitioners whose behaviour has fallen below an acceptable standard. Those responsibilities are primarily reactive. But the Medical Board can also protect the public proactively by providing medical practitioners with guidance on the best ways to innovate in clinical settings. The proposed policy had the potential to lay a foundation for a culture of excellence in clinical innovation, as it discussed the use of mechanisms such as peer review, disclosure of conflicts, limitations to advertising and special consent provisions. It was also an opportunity to address the use of non‐conventional interventions in medicine in a more consistent and cohesive manner, irrespective of the setting in which they are used. Unfortunately, the decision of the Medical Board means that Australia lacks a clear regulatory stance on the questions of if, when and how doctors should adopt non‐conventional interventions in practice.