ANPA Submission – Options for Regulation of Unregistered Health Practitioners to the Australian Health Ministers’ Advisory Council

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Consultation paper – Options for regulation of unregistered health practitioners (PDF)

Introduction

The Australian Naturopathic Practitioners Association (ANPA) would like to thank the Australian Health Ministers’ Advisory Council (AHMAC) for considering the need to strengthen regulatory protections for consumers using the services of unregistered health practitioners.

ANPA is a democratic association representing Naturopaths across Australia. Founded in 1975 the ANPA values excellence, leadership and integrity in Naturopathic health care. Safety is paramount, and through our members we aim to provide the public with the highest standards of Naturopathic care. To this end we look forward to participating in these important processes focussed on minimising harm to the public.

As a responsible professional organisation ANPA already has in place a Code of Ethics as well as practice guidelines, policies and procedures developed for our member Naturopaths. Presently, there may be as many as 10,000 Naturopaths and Western herbalists in Australia. Naturopaths are primary health care practitioners and offer the Australian public approximately 4.9 million consultations per year (Xue et al. 2007). Naturopaths treat a wide variety of health complaints. As compared to osteopaths who are specialised our scope of practice is much wider therefore creating more potential for risk. ANPA supports the need for the highest level of enforceable regulation for Naturopaths in order to protect consumers from harm through acts of commission or of omission. In spite of there being only a small number of practitioners who engage in serious misconduct, ANPA believes that it is of the highest importance to ‘first do no harm’.

For this reason ANPA believes that options 1, 2 and 3 are inadequate for this purpose and our association does not support options 1, 2 or 3 for Naturopaths.

We do however support strengthening the health complaints mechanisms proposed in Option 3 for all other unregistered health practitioners with a minimum statutory code of conduct to be established and enforced.

The Problem (Section 4)

RISKS for the Public from Unregistered Naturopaths

There are risks associated with the provision of Naturopathy health services by unregistered Naturopaths. The AHMAC consultation paper correctly identifies:

  • There are no nationally uniform or consistent legally enforceable qualifications or probity checks before an unregistered Naturopath commences practice.
  • Negative licensing does not restrict entry to practice.

Not meeting uniform minimal education standards and no barrier for entry into the Naturopathy profession are serious weaknesses of Option 3. Naturopathy practitioners are free to practice until they harm a member of the public under a negative licensing model.

Case 3 highlights a NSW Naturopath implicated in the death of an 18 day old baby where the practitioner advised the parents he had cured the problem. (AHMAC 2011: Appendix 7). Case 3 is an example of the risk of omission, failure to refer as well as misdiagnosis.

ANPA supports a statutory registration model requiring minimum standards of education thus minimising the risk to the public as highlighted in Case 3. The Lin report 2005 states

‘… there remain significant variations among various courses in content and approach. … courses in Naturopathy were found to range from 2 years to 4.5 years. Mean course contact hours also varied. … science content ranged from 300 hours to 1275 hours, and clinical training ranged from 198 hours to 1275 hours; the number of clinical contact hours is especially low compared with institutions in the USA and Canada.’

– Naturopaths prescribe ingestible substances (AHMAC 2011: Appendix 8).

According Lin et al (2005), herbal and nutritional medicines produce both predictable and unpredictable effects. These can include: toxicity related to overdose, interaction with pharmaceutical medications, allergic and anaphylactic reactions as well as idiosyncratic reactions. The Lin et al. (2005) report further stated that official reporting of adverse events is underestimated, and interactions between herbal medicines and pharmaceuticals are increasingly being reported in the literature. A survey showed that 34% of patients who consumed herbal medicine were concurrently taking pharmaceutical medications (Bensoussan et al. 2004).

Naturopathy does satisfy the 6 criteria proposed by AHMAC for occupational regulation.
ANPA highlights criteria 2 and 3 as priorities for improving public safety and minimising harm to consumers. The Lin et al (2005) report also supports the requirement for Criteria 6; that the benefits of promoting public safety outweigh the potential negative impacts of occupational regulation for Naturopaths and Western herbalists.

AHMAC Criteria 2

Do the activities of the occupation pose a significant risk or harm to the health and safety of the public?

YES, It is the opinion of the ANPA that some Naturopaths have the potential to cause harm to the public.

The Risk of Harm

A study commissioned by the Federation of Natural and Traditional Therapists (FNTT) and the National Herbalists Association of Australia identified a significant number of adverse reactions occurred from the ingestion of herbal medicine prescribed by Naturopaths and Western herbal medicine practitioners. The number of adverse reactions was similar to that reported for TCM in the report ‘Towards a Safer Choice’ (Bensoussan & Myers, 1996).

Adverse reactions: risk of increasing or decreasing the actions of pharmaceutical medications with the concurrent use of herbal or nutritional medicines. This finding supports the findings in 2005 of Lin et al. suggesting the need for appropriate clinical guidelines when there is concurrent use of pharmaceutical drugs.

In addition, the HCCC report ‘Potential Risks of Unregistered Healthcare Practice’, (Report No 13/53, September 2006,) include two categories of risk:

Risks of Commission:

Removal of appropriate medical treatment,
Incorrect prescribing

Risks of Omission:

Misdiagnosis,
Failure to refer,
Failure to explain precautions,
Failure to identify limits of practice,
Lack of skills/experience in delivery of specific health services,
Financial exploitation,
Sexual exploitation

The public deserves the protection and assurances inherent in a statutory registration model aimed at minimising the potential for both these serious types of risk.

AHMAC Criteria 3

Do existing regulatory or other mechanisms fail to address health and safety issues?

YES, existing mechanisms do not address health and safety issues.

Failure of the Existing System

Presently the self-regulatory model does not address the health and safety concerns of the public. Presently anyone can call themselves a Naturopath and offer consultations to the public. Self-regulation amongst Naturopathic associations presently has no legal authority to shut these operators down.

ANPA asserts that Naturopaths and Western herbalists adequately meet the AHMAC criteria for statutory registration: Criteria 2: Potential for harm and Criteria 3: Failure of the present Self-Regulatory Model. We support the inclusion of Naturopaths into the National Registration and Accreditation Scheme for health professionals.

Statutory registration is the model used by Traditional Chinese Medicine practitioners in Victoria. This legislation is soon to be rolled out in all states and territories across Australia. This model aims to protect the public from harm with the highest level of enforcement when addressing issues of serious medical misconduct. Statutory registration includes ‘protection of title’ and the formation of a public register for the profession.

The Options (Section 6)

Option 1 & 2

As stated above the proposed Options 1 and 2 are insufficient for Naturopaths. Both of these options have failed the public in the past and will do so in the future. Cases 2 (AHMAC 2011; Appendix 7) and 3 identified in the AHMAC’s discussion paper highlight the ineffective mechanisms for public protection inherent in either the ‘no change’ model or a ‘voluntary code of practice’ model present in Australian states, other than NSW and SA today.

‘Negative Licensing’ for Naturopaths

The limitations of ‘Negative Licensing’ for Naturopaths

The NSW scheme of ‘negative licensing’ is inadequate to protect consumers from potential harm from Naturopaths. The significant problem for the public is that the NSW code of conduct can only be used retrospectively; it does not offer the public any form of prospective protection. As primary care practitioners, Naturopaths are able to potentially cause harm by acts of omission, commission, failure to refer or misdiagnosis.

Case 2 highlights how self-regulation failed to protect the public when a NSW based Naturopath was implicated in the death of a patient with end stage renal failure undertaking a live-in detoxification program. A series of legal charges made were made; however the practitioner continued to provide services to the public having changed his name and moved his practice location (AHMAC 2011; Appendix 7).

Statutory registration via the power of a registration board can immediately suspend a practitioners’ right to practice. This means that harm to the public is minimised immediately, not years or months later while a Naturopath is under investigation and still practicing.

In the case of Naturopath Michael Wilson charged with eleven counts of rape and nineteen counts of indecent assault, he continued to abuse patients while under court investigation. His professional association CMA (Complementary Medicine Association) had no legislative power to stop his practice and protect the public. One of his victims approached another association representing Naturopaths ANTA (Australian Natural Therapists Association) who had no ability to act as he was not a member of their organisation.

Case 3 highlights the failure of the self-regulation model where Naturopathy associations were powerless in protecting the public from serious harm caused by a Naturopath.

A negative licencing model is inadequate and a Statutory Registration Model warranted because:

  • The level of risk is comparable to other regulated professions.
  • There is no legally enforceable regulatory framework governing the prescribing of drugs and poisons by Naturopaths and Western herbal medicine practitioners.
  • There are significant variations in standards for professional education and membership among professional associations, and the professional associations have been unable to agree upon a common arrangement for self-regulation.
  • There are significant variations in standards among education and training institutions and no evidence of movement towards common standards, including the failure of current regulatory frameworks for education to ensure minimum standards.
  • Existing regulatory frameworks provide insufficient protection for consumers against professional misconduct.
  • There is a particular risk related to the interaction of herbal medicines and pharmaceutical drugs and the need for appropriate clinical guidelines

ANPA supports the findings of the Lin et al (2005) report. One of the issues identified in this report was that, although the majority of GP’s surveyed believed that their patients may benefit from seeing a Naturopath for health support they were reluctant to refer because they were unsure of their level of training and competence

Vicarious liability is an issue for health professionals who fear repercussions of referring patients to Naturopaths for health support. Statutory registration would remove barriers for referral so that patients could more easily access benefit from the unique treatments available from Naturopaths and Western herbalists.

‘The Practice and Regulatory Requirements of Naturopathy and Western Herbal Medicine: Summary Report’, (Lin et al. 2005) identifies the statutory registration model including ‘protection of title’ as the preferred option for Naturopaths and Western herbalists.

Protection of Title and Practice

Statutory registration, through legislation via an act of parliament, provides protection of title for a profession. Currently, with no protection of title, the public has no way of discerning unscrupulous, poorly trained or bogus Naturopathy practitioners. Anyone can hang up a shingle and call themselves a Naturopath. This puts the public at risk of an incorrect diagnosis, ill-advised treatment, and fraudulent business practices. With protection of title in place anyone purporting to be a Naturopath will have to be able to prove their specific qualifications in this field of health-care practice, and would not be able to use the title of Naturopath (ND) without the specific Naturopathic training required. This would apply to other health professionals purporting to be Naturopathic in their approach

Jeffrey Dummett, a self-proclaimed Naturopath, was charged with manslaughter over the death of a patient (Potential Risks of Unregistered Health Practice, Report no 13/53, HCCC, Sept. 2006)

National Uniformity (section 6.3.1)

A national scheme is desirable through which consistent arrangements are created to regulate Naturopaths. This uniformity should provide consistent arrangements for investigating breaches of the code or prohibition orders. ANPA supports the National Registration and Accreditation Scheme (NRAS) where a centralised administrative body is already in place for other medical professionals.

Formation of a Public Register

For a number of years ANPA was affiliated with the FNTT (Federation of Natural and Traditional Therapists), an umbrella organisation representing various CAM associations across Australia. They provided mediation support when necessary if there was a complaint against an ANPA member. This distanced our association from the role of ‘prosecuting a case’ enabling ANPA’s role of representing our own member. This offered the opportunity for an unbiased process. In light of the establishment of ARONAH last year and a more consistent push towards registration by the existing CAM associations the FNTT disbanded this year. We believe that ARONAH will play a very important role providing a transparent complaints’ mechanism for our profession until such time as statutory registration occurs.

In the absence of a national register for Naturopaths and western herbalists the Australian Register of Naturopaths and Herbalists (ARONAH) has been engaged in the process of creating an independent register for Naturopaths and herbalists since 2010. Their mandate includes establishing minimum standards of education and the creation of professional, globally-accepted practice standards for Naturopaths and western herbalists.

ARONAH has been created according to the NRAS guidelines for registered health professionals. Independent of any professional association they are also in the process of creating a common centralised complaints mechanism for Naturopaths and herbalists.

ANPA supports the role of ARONAH in strengthening the profession of Naturopathy. We welcome the unbiased role this body will play in dealing with complaints. It should be noted that the ARONAH Register for Naturopaths and western herbalists is only a first step in enabling these professions to be statutory-registration ready.

With ARONAH established the ANPA looks forward to focusing on the core business of supporting our Naturopath members with continued professional education and continuing to play a central role as the voice for future statutorily registered Naturopaths across Australia.

Statutory Registration

ANPA believes that any model of statutory registration should include protection of title and core Naturopathic practices. Statutory regulation, from which registration arises, is a well-established model for health professions across Australia. The legislative frameworks and operational arrangements used for other health professions can be easily adapted and applied to Naturopathy. This has already been done in the case of Chinese medicine for example. The Register of Naturopaths and Herbalists (ARONAH) board could easily be integrated into the existing national board to improve efficiencies of operation and reduce costs to practitioners.

Statutory Registration will offer the public:

  • a regulatory structure with a register making it easier to identify properly skilled and qualified Naturopaths. With restriction to entry only those Naturopaths that meet the standards set may hold themselves out to be and use the title ‘Naturopath’.
  • a structure for dealing in a timely manner with practitioners who may be predatory or exploitive
  • the ability to identify de-registered practitioners
  • an independent and unbiased complaints mechanism
  • an improved mechanism for reporting adverse drug reactions from CAM practitioners
  • reassurance of quality standards and safety protocols for the use of Naturopathic and Western herbal medicines (WHM)
  • the same protection to consumers of Naturopathy and WHM as is currently available to consumers of conventional medical services.
  • More access to competent Naturopathic support through the register giving reassurance to GPs and other primary health care professionals, enabling them to liase and refer more readily, so avoiding misunderstandings, lack of information and inconsistent management / treatment strategies for their patients

Scope of the Scheme (section 6.3.2)

The statutory code of conduct Option 3 if enacted should apply to all unregistered health practitioners except for Naturopaths and Western Herbalists.

Other Registered Practitioners

Registered health practitioners who provide health services that are directly unrelated to their registration should not be exempt from this scheme (either Option 3 or Statutory Registration). For example registered nurses, doctors, pharmacists should comply with the same requirements as Naturopaths and Western herbalists if they are encroaching into the practice-domains of these professions. Within the bounds of the scheme these practitioners should be required to upgrade their qualifications to the same specific professional standards as Naturopaths and Western herbalists. There is a significant amount of confusion caused to consumers by the blurring of professional boundaries when, for example, a consumer goes, in good faith, to a health care provider who purports to work Naturopathically but may have only undertaken a weekend course in nutrition or herbs. For the public at present there is no obvious way of knowing if they are under the care of a practitioner with appropriate levels of training in Naturopathy or Western herbal medicine. Examples include nurses, GP’s, pharmacists, dentists, chiropractors, or osteopaths.

Conventional medical training for these registered professions does not include the same curriculum, principles of the profession, or specific scope of practice necessary to safely prescribe nutritional or herbal medicines. Through regulation and a national registration scheme the tools of trade for Naturopathy should be protected. Some restricted herbal medicines and nutritional supplements that Naturopaths and herbalists are specifically trained to prescribe can now only be prescribed by GP’s, Dentists and Vets, most of whom have had very limited or, indeed, no training in herbal or nutritional medicine.

The current system of limiting access to certain herbs via the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) causes competent Naturopaths, and western herbalists, to be denied access to important tools of their trade.

Following the implementation of registration for Naturopaths via a national regulation scheme it would become possible to more-easily identify qualified, registered practitioners. Access for these fully qualified practitioners to scheduled herbal preparations would then be possible under state government drugs and poisons legislation.

Delivering Services via the Agency of another Person

The public is also at risk when Naturopaths are employed in businesses, e.g. Health food stores where their personal TGA licence is used by the business to supply practitioner only products when the Naturopath is not on duty. The liability rests with the owner of the TGA certificate if an act of omission or commission occurs. The agency of another person should be immediately prohibited and strictly monitored in an industry where there are unscrupulous operators. Naturopathic tools-of-trade should be protected. Naturopaths need to be made aware of the seriousness of their TGA license being abused. Perhaps additional information should be required on the register if a Naturopath or Western herbalist is employed in an environment where the agency of another person may be a possibility.

Administrative arrangements (section 6.3.3)

The legislative and administrative arrangements for Naturopaths should be according to the requirements of the NRAS already employed for other registered professions. The complaints mechanisms are already in place for breaches of professional conduct. The formation of ARONAH is a preliminary step in the transition to statutory registration with protection of title and tools of trade for Naturopaths.

Content of a National Code of Conduct (section 6.3.4)

This type of regulatory scheme does not set minimum requirements for entry to a profession. Rather, it relies on the making of a complaint to draw the attention of the regulator to poor, unethical or illegal practice, usually after some harm has occurred.

Intervention by government is kept to a minimum, and only occurs when things go wrong resulting in a complaint. It addresses a perceived gap in the regulatory arrangements for those professions and occupations that are unlikely to meet the requirements for statutory registration. The NSW code of conduct referred to in the AHMAC discussion paper is a reasonable minimal standard for most unregistered health practitioners. However, it should not be a substitute for national statutory registration of Naturopaths and Western Herbalists as the potential risk of serious harm is higher due to their use of ingestible treatments.

Prosecutions and Hearings (section 6.3.5)

Under a National Registration Scheme, the hearing and investigations of complaints and the prosecution of practitioners for breach of professional standards would be funded from the registration fees paid by practitioners. Conditions of conduct, health-impairment and performance may be considered for investigation or prosecution. Breaches of professional conduct may be categorized as professional misconduct, unprofessional conduct, and notifiable contact; health-impairment may include a physical or mental impairment, disability, condition or disorder that detrimentally affects, or is likely to detrimentally affect, the person’s capacity to practice their profession; and the performance of a registered practitioner may be reported if it is below the standard reasonably expected of a practitioner of an equivalent level of training or experience.

Issuing Prohibition Orders (section 6.3.6)

Under a National Registration Scheme prohibition orders would be able to be issued in a timely manner in such a way as to protect the public from practitioner activities identified above under investigation by the board. A practitioner’s activity could be restricted, curtailed, or suspended depending upon the level of concern related to their conduct, health or practice, whilst being investigated for the complaints against them.

Conclusion

The Australian Naturopathic Practitioners Association is committed to increasing the safety of health care delivery from Naturopaths to the Australian public. There are inherent risks associated with the provision of certain Naturopathic health services. The number of Naturopathic consultations increases every year and with this comes increased risk.

The inclusion of Naturopaths within a national registration scheme is long overdue. Although option 3 may be suitable for the majority of CAM practitioners it is the considered opinion of the ANPA that the code-of-conduct model and negative-licencing currently in place in NSW is inadequate for Naturopaths and Western Herbalists.

National registration will bring with it national standards of education, codes of practice and legislative regulations that are enforceable and binding. It would provide protection to the public from acts of commission and could assist other primary health care providers to feel more confident about working with Naturopaths, further helping to prevent acts of omission. Through this process the interests of the Australian public will be well served

REFERENCES:

Bensoussan, A., Myers, SP. (1996) Towards a safer choice: the practice of traditional Chinese medicine in Australia, Faculty of Health, University of Western Sydney Macarthur, Campbelltown, NSW.

Bensoussan A., Myers S., Wu S., O’Connor K. (2004); Naturopathic and Western herbal medicine practice in Australia – a workforce survey. Complement Ther. Med.; 12: 17–27.

Lin V., Bensoussan A., Myers S.P., McCabe P., Cohen M., Hill S., Howse G. (2005); The Practice and Regulatory Requirements of Naturopathy and Western Herbal Medicine.
Funded by the Department of Human Services, Victoria

Xue, CC et al (2007); Complementary and alternative medicine use in Australia: a national population-based survey. J Alt. & Comp. Med. 2007 Jul- Aug; 13 (6): 643-50