Regulation of ‘Complimentary & Unconventional Medicine & Emerging Treatments’

In February the Medical Board Of Australia released a Public Consultation Paper inviting ‘feedback on options for clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments’.

It noted ‘concerns have been raised by stakeholders about this area of practice, suggesting that additional guidance for medical practitioners is needed to support safe practice and ensure safeguards for patients’.

The Board is proposing the following de nition: ‘Complementary and unconventional medicine and emerging treatments include any assessment, diagnostic technique or procedure, diagnosis, practice, medicine, therapy or treatment that is not usually considered to be part of conventional medicine, whether used in addition to, or instead of, conventional medicine. This includes unconventional use of approved medical devices and therapies.’

The Board has identified two options in developing this proposal but prefers Option 2.

  • Option 1 – Retain the status quo of providing general guidance about the Board’s expectations of medical practitioners who provide complementary and unconventional medicine and emerging treatments via the Board’s approved code of conduct.
  • Option 2 – Strengthen current guidance for medical practitioners who provide complementary and unconventional medicine and emerging treatments through practice-speci c guidelines that clearly articulate the Board’s expectations of all medical practitioners and supplement the Board’s Good medical practice: A code of conduct for doctors in Australia.

The discussion paper includes examples of treatments and therapies being o ered, as well as identifying the concerns about the practice to aid stakeholders’ understanding of the issues.

The draft guidelines provide guidance on good medical practice in relation to areas of practice that are within the Board’s de nition of complementary and unconventional medicine and emerging treatments.

However, if approved, the guidelines will be a stand-alone document and will not include the examples currently in the discussion paper. The Board will develop supporting documents (based on the discussion paper) that will be available with the guidelines to provide information on the scope of the guidelines and include examples of complementary and unconventional medicine and emerging treatments. Providing this additional information separately from approved guidelines will enable the Board to update it as needed, as the scope of this area of practice can be subject to rapid changes.

Questions for consideration

The Board is inviting feedback on the issues and options outlined in the discussion paper.

1: Do you agree with the proposed term ‘complementary and unconventional medicine and emerging treatments’? If not, what term should be used and how should it be defined?

2: Do you agree with the proposed de nition of complementary and unconventional medicine and emerging treatments – ‘any assessment, diagnostic technique or procedure, diagnosis, practice, medicine, therapy or treatment that is not usually considered to be part of conventional medicine, whether used in addition to, or instead of, conventional medicine. This includes unconventional use of approved medical devices and therapies.’ If not, how should it be defined?

3: Do you agree with the nature and extent of the issues identified in relation to medical practitioners who provide ‘complementary and unconventional medicine and emerging treatments’?

4: Are there other concerns with the practice of ‘complementary and unconventional medicine and emerging treatments’ by medical practitioners that the Board has not identified?

5: Are safeguards needed for patients who seek ‘complementary and unconventional medicine and emerging treatments’?

6: Is there other evidence and data available that could help inform the Board’s proposals?

7: Is the current regulation (i.e. the Board’s Good medical practice) of medical practitioners who provide complementary and unconventional medicine and emerging treatments (Option 1 above) adequate to address the issues identified and protect patients?

8: Would guidelines for medical practitioners, issued by the Medical Board (Option 2 above) address the issues identi ed in this area of medicine?

9: The Board seeks feedback on the draft guidelines (Option 2) – are there elements of the draft guidelines that should be amended? Is there additional guidance that should be included?

10: Are there other options for addressing the concerns that the Board has not identified?

11: Which option do you think best addresses the issues identi ed in relation to medical practitioners who provide complementary and unconventional medicine and emerging treatments?

  • Option 1
  • Option 2
  • Other – please specify.

‘Beneficial’ versus ‘non-essential’

In commenting on the Public Discussion Paper, Dr Michael Molton, President of the Cosmetic Physicians College of Australasia noted: ‘Historically, the practice
of medicine focused upon the treatment of disease. Then came prevention of disease.

‘Today, the practice of medicine has expanded to encompass treatments which are bene cial to health, in already healthy individuals. ‘Bene cial’ today combines essential and non-essential medical treatments.’

Dr Molton added: ‘The existence of positive benefit of any medical treatment is reflected in epidemiological studies that withstand vigorous scrutiny. It is these studies that sponsors provide as evidence-based e cacy to the Therapeutic Goods Administration.

‘In the case of complementary medicines, currently there are legislated requirements already in place to qualify listing according to Australian Guidelines for Complementary Medicines (TGA). These guidelines are extensive and rely upon two main aspects:

  • Does the complementary medicine have signi cant risk to bene t ratio to health. If so it must be approved and listed by the TGA.
  • If the complementary medicine does not have signi cant risk, it may be listed by application to the TGA by the sponsor.’

Dr Molton also noted:

‘The creation of a focus on medical practitioners regarding complementary and unconventional medicine does not close the gate for non-registered medical practitioners in Australia; indeed it does not close the gate on all other registered health practitioners (non-doctor health practitioners registered with AHPRA) on the practices that the consultation paper defines.

‘in my opinion, the Medical Board of Australia would provide better protection of the public if it would recommend to the Council Of Australian Government (COAG) that the TGA be directed to identify and prosecute those outside of health practitioners registered with AHPRA (as well as within) where most of the misdemeanours listed in the consultation paper are occurring.’

Education and training

Meanwhile in an initial briefing to all ‘member and friends’, Helen Anton, Director at A5M Medical Education, commented: ‘A5M represents medical practitioners, allied health and aesthetic medicine professionals who are passionate about healthy ageing in the fields of preventative, personalised and aesthetic medicine.

‘The A5M mission is to provide healthcare practitioners with the highest level of education and training in preventative medicine and disease management to promote healthy ageing and provide better outcomes.

‘I would like to assure you that we have commenced work on our submission, providing feedback to the options proposed for clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments. The A5M Advisory panel and I are currently in collaboration with many other organisations and stakeholders to present a stronger and uni ed submission. A5M will also provide our individual submission to the medical board.’

Compounding pharmacists

In an initial briefing to Australian Custom Pharmaceuticals clients, Matt Chalmers, ACP’s Business Development Manager wrote: ‘As you can imagine, many in the Integrative Health industry are viewing this as an attack on their practice of medicine.

‘It would appear that integrative doctors, pathology providers, supplement companies and pharmacists/compounding pharmacists are speci cally ‘under attack’ from such a move.
‘However, it is the position of Australian Custom Pharmaceuticals that, for us, the eventual outcome will change very little.

‘The rules surrounding compounding are clear:

  1. Where there is a medicine registered on the Australian Register of Therapeutic Goods that has the same therapeutic outcome, an item cannot be compounded.
  2. An item can only be compounded under a single patient name and not mass- manufactured.
  3. Compounding of products must be evidence-based.

‘As we comply with all of these rules every day, every time we compound, we feel that ACPHARM has very little concern with any outcome of this consultation paper.
‘Pharmacies who do the same will have nothing to fear from possible changes here, nor do the doctors who utilise their services.’ AMP


Growth in Provision of ‘emerging treatments’

The Discussion Paper notes a range of medical practitioners ‘are practising in the areas of complementary and unconventional medicine and emerging treatments, including medical practitioners with di erent levels of experience and training and varying specialties’.

It is not known how many registered medical practitioners practise in this area.

For example, the MBA notes submissions to the TGA’s 2016 consultation on ‘Regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals’ ‘conservatively estimated there are over 40 private clinics in Australia offering stem cell therapies and this area is growing’.

The Discussion Paper highlights various data on the prevalence and use of complementary medicines, including:

  • The sector in Australia generates revenue of up to $3.5billion annually – this would include over the counter products;
  • A large proportion of consumers (more than two-thirds) report using complementary medicines.

Definitions: ‘Complementary’ & ‘Unconventional’

The MBA is proposing the following de nition: ‘Complementary and unconventional medicine and emerging treatments include any assessment, diagnostic technique or procedure, diagnosis, practice, medicine, therapy or treatment that is not usually considered to be part of conventional medicine, whether used in addition to, or instead of, conventional medicine. This includes unconventional use of approved medical devices and therapies.’

The Public Discussion Paper notes:

• Examples of complementary and alternative medicines commonly considered to fall within that definition include: vitamins, minerals and nutritional supplements (in the absence of a de ciency), herbal medicines, homeopathic preparations and aromatherapy products.

• Examples of complementary and alternative therapies commonly considered to fall within thatde nition include: homeopathy, naturopathy, energy therapies and Reiki.
The Discussion Paper also notes ‘some de nitions of complementary and/or alternative therapies include the regulated health professions of chiropractic, osteopathy, Chinese medicine and acupuncture.

Other areas of clinical practice ‘where concerns have been raised but which do not fit within the definitions of complementary and/or alternative medicine as de ned above’ include:

• diagnosis of conditions which are not generally accepted, for example:
– Lyme disease (in patients who have not been outside Australia)

• unconventional diagnostic techniques and methods, for example:
– applied kinesiology
– pathology testing in non-accredited laboratories

• conventional medicines and accepted therapies provided outside accepted therapeutic guidelines or protocols and/or without usual clinical indications including o -label use, for example:
– long term antibiotics in the absence of identi ed infection
– hormone therapy and supplements in the absence of a hormone de ciency/identified therapeutic need
– stem cell therapy for conditions without supporting evidence for their use
– chelation therapy for conditions such as cancer or cardiovascular disease

• new and emerging therapies.

In addition to ‘complementary’ and/or ‘alternative’ medicine, the Board has considered a number of other de nition issues so as to ensure that all the relevant areas of practice are captured:

• unconventional medicine

• off-label prescribing

• experimental practice

• unproven therapies

• emerging therapies

• innovative therapies

• entrepreneurial medicine

• progressive practice.

The Board notes it ‘is using the comprehensive description ‘complementary and unconventional medicine and emerging treatments’ in its consultation. The reasons for using these terms are:

• ‘complementary’ to include practice such as herbal medicines and homeopathy – those commonly thought of as ‘complementary and alternative medicine’

• ‘unconventional’ to include conventional treatments provided outside conventional protocols (such as long-term antibiotics for Lyme-like illness)

• ‘emerging’ to include new and experimental treatments such as the expanding use of stem cell therapy.

MBA ‘Issues And Concerns’

The Discussion Paper lists several ‘issues and concerns about this area of practice’.

1: The use of complementary and unconventional medicine and emerging treatments ‘is increasing and includes a wide range of practices from minimally invasive to major complex interventions’. The medicines and therapies ‘may be used as alternatives to conventional medicine or used in conjunction with conventional medicine. They may be used with or without the knowledge of a patient’s other treating practitioners.’

2: The MBA notes ‘patients are being o ered treatments for which the safety and e cacy are not known’. They may be having treatments ‘which may be unnecessary or may result in delayed access to more effective treatment options’. Unnecessary treatments ‘may expose patients to adverse side e ects’. Harm may occur ‘directly from the treatment resulting in an adverse outcome or it may be indirect, associated with delays in accessing other treatment or from the promises of ‘false hope’.’ While there may be bene ts, treatment and therapies ‘may also have no effect, the bene t may be uncertain, or the e ect may potentially be harmful. The harm can be physical, psychological and/or financial.’

3: These treatments are provided by a variety of medical practitioners ‘with varying qualifications and expertise in the therapy and/or the patient’s underlying condition’. There are reports of medical practitioners who are not specialists ‘providing treatments for complex conditions without necessarily having the specialist level knowledge of the disease and its progression’.

The lines between research and commercial advancement ‘can be blurred and conflicts of interest can arise if the provider has a financial interest in the product or service being offered’. Some treatments are being offered ‘on a commercial basis before the usual clinical trials have been completed’. Patients don’t have the usual protections ‘where clinical trials have not been undertaken’. Patients may also be offered treatments, tests or products ‘which are available only through the practitioners offering them, or through other entities with which the practitioners have commercial associations, which may not be disclosed to the patients’.

4: Many of these treatments ‘are funded privately, can be expensive, and may have uncertain results’. Patients may seek complementary and unconventional medicine or emerging treatments because of serious and/or chronic conditions and ‘may be vulnerable to exploitation, including nancial exploitation’. Consumers who see direct-to-consumer marketing of ‘therapies for health and wellness’ ‘may not realise that these are medical interventions with associated risks’.