Regulation of
Practitioners of
Chinese Medicine
in Western
Australia
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Contents
Part 1









1
1A Foreword ....................................................................................................................................................................................2
1B
Background .............................................................................................................................................................................3
1C
Consultation Process .......................................................................................................................................................4
How to have your say ..................................................................................................................................................4
1D Chinese Medicine ................................................................................................................................................................5
What is complementary and alternative medicine? ....................................................................................5
Chinese medicine modalities .................................................................................................................................5
What is acupuncture, Chinese herbal medicine and Chinese herbal dispensing? .....................5
1E Regulation of Chinese Medicine Practitioners in Australia & Internationally ..........................7
Victoria ...............................................................................................................................................................................7
Overview of Chinese Medicine Registration Act (2000) Victoria ..............................................................7
New South Wales .........................................................................................................................................................9
ACT, Northern Territory, Queensland, South Australia & Tasmania .....................................................9
New Zealand ...................................................................................................................................................................9
United Kingdom ............................................................................................................................................................9
United States ..................................................................................................................................................................9
Singapore ...................................................................................................................................................................... 10
China ................................................................................................................................................................................ 10
World Health Organisation ................................................................................................................................... 10
Part 2








11
2A What is Statutory Regulation? ............................................................................................................................... 12
Self-regulation ............................................................................................................................................................. 12
Co-regulation ............................................................................................................................................................... 12
Statutory regulation .................................................................................................................................................. 13
2B Health Practitioner Template Legislation ....................................................................................................... 14
2C
State Administrative Tribunal ................................................................................................................................. 16
2D National Competition Policy .................................................................................................................................... 17
2E Why Regulate? ................................................................................................................................................................... 18
Potential risks to public health and safety ................................................................................................... 19
Complaint resolution mechanisms and disciplinary measures ......................................................... 21
2F
Options for Statutory Regulation ......................................................................................................................... 22
Establishment of a regulatory authority for Chinese medicine in WA ............................................ 22
Joint arrangement with another registration board ................................................................................. 22
2G
Levels of Protection Provided by Regulation ............................................................................................... 24
Protection of title ........................................................................................................................................................ 24
Protection of practice .............................................................................................................................................. 24
2H Who Will Be Registered? ............................................................................................................................................ 26
2I
How Will Registration Occur? ................................................................................................................................. 28
2J What Grandparenting Arrangements Would Be Made? ......................................................................... 31
Annexure 1 Other Relevant Legislation ..................................................................................................................... 33
Annexure 2 Your Views .......................................................................................................................................................... 34
References
................................................................................................................................................................................... 35
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part 1
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omplementary and alternative medicine
has experienced a growing acceptance with the
Australian public over the past twenty years. It has
been estimated that close to 60% of Australians
access some form of complementary or alternative
health services, indicating a widespread
acceptance of complementary and alternative
medicines and therapies.1
In 2000, 52% of the population were estimated
to use at least one non-medically prescribed
complementary medicine while 23% visited at
least one complementary health care practitioner.
Annual retail turnover of complementary medicines
is estimated at $800 million with an additional
20% of Australian output being exported.2 The use
of complementary medicines and therapies is
expected to increase as more people come to view
complementary health as an important contributor
to personal health and well-being.1
With an increasing number of Australian
consumers using a combination of mainstream
healthcare and complementary medicines to
meet health needs, complementary and
alternative medicines and therapies are
becoming a signifi cant component of the
health services industry.2
The growing popularity of complementary and
alternative health services has been attributed to:
• a rising discontentment with conventional,
western medicine;
• a preference for natural (or gentler) alternatives
to pharmaceutical drugs or surgery;
• a desire for greater control over personal
health care; and
•
the low success rate of conventional, western
medicine in treating conditions, such as
chronic pain, for some individuals.
Largely, it appears that consumers who shop
around for healthcare services are targeting the
most effective way to get better.3
A much wider range of health care services are
available in Australia as a result of an increase in
immigration and the associated transmission of
established medicines and therapies from outside
of Australia. Success stories of complementary
and alternative medicine in the media, the
abundance of information available on the Internet
and the high value placed on consumer choice has
also contributed to the growth in complementary
and alternative medicine in Australia.4
Complementary and alternative medicine is widely
available to the public in Western Australia (WA).
Minimum standards should apply to the education,
training and conduct of complementary health
practitioners in order to ensure public safety.
Regulation of practitioners is being considered in
WA as the most appropriate means for establishing
such standards, and providing consumers with
effective complaint handling and dispute
resolution mechanisms.
This discussion paper outlines the movement
in Australia to regulate Chinese medicine
practitioners. Regulating Chinese medicine
practitioners in WA is important given the
potential for serious adverse effects arising from
the practice of the profession. Descriptions
of the three modalities being considered for
regulation are given and the models of regulation
being consideration for WA Chinese medicine
practitioners are explained. Protection of title
is recommended as the form of regulation,
with controls on prescribing and dispensing
rights for restricted herbs. One section reviews
potential registration criteria that practitioners
would be subject to, including options for
an initial grandparenting arrangement to
assist with registering existing practitioners.
Information is also provided on the impact of the
State Administrative Tribunal and the National
Competition Policy on regulating the Chinese
medicine profession.
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Foreword
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BACkground
n August 1995 the Victorian Department of
Human Services (DHS) commenced a review of
traditional Chinese medicine (TCM), on behalf of all
States and Territories. The review was undertaken
in response to a rapid expansion in the practice
of and demand for TCM in Australia and concerns
expressed by consumers, practitioners and
professional groups.5
With joint funding from Victoria, New South Wales
(NSW) and Queensland (Qld), the Southern Cross
University (Qld) and the University of Western
Sydney (NSW) undertook the major national
research project on the practice of TCM. The
research project collected information on the risks
and benefi ts of TCM and the nature of the TCM
workforce. The project also examined the need for
registration of TCM practitioners and regulation
of Chinese herbal medicines.5 In addressing the
criteria set by the Australian Health Ministers
Advisory Council for regulation of professions,
it became apparent that the practice of TCM
involved potential signifi cant risks and therefore
occupational regulation would be appropriate.
The review resulted in a major report in November
1996 entitled Towards a Safer Choice: the practice
of traditional Chinese medicine in Australia.8 The
report recommended the regulation of practitioners
of TCM with the primary purpose of protecting
the public.
In September 1997 the Victorian DHS released
a discussion paper entitled Review of Traditional
Chinese Medicine.6 This paper presented the
options for regulation of the profession of TCM.
In July 1998, the Victorian DHS published
recommendations on a proposal for regulation in
the Traditional Chinese Medicine: Report on Options
for Regulation of Practitioners.5
On completion of their public consultation, the
Victorian Government developed a model for
occupational regulation and passed the Chinese
Medicine Registration Act 2000. The Chinese
Medicine Registration Board (CMRB) of Victoria7
established under the Act, registers Chinese
herbal medicine practitioners, acupuncturists and
Chinese herbal dispensers. The CMRB of Victoria
is also empowered to investigate complaints about
registrants’ professional conduct and fi tness
to practice.
In September 2003 the Therapeutic Goods
Administration (TGA) published a report entitled
Complementary Medicines in the Australian Health
System.2 The report made the following fi nding:
Governments should move more quickly to
nationally consistent, statutory regulation
(where appropriate) of complementary
healthcare professions
(Finding 5.1.1).
The report also made recommendations that:
• all jurisdictions introduce legislation to
regulate practitioners of traditional Chinese
medicine and dispensers of Chinese herbs,
based on existing Victorian legislation, as soon
as possible (Recommendation 27); and
• Health Ministers review the fi ndings of the New
South Wales and Victorian reviews concerning
regulation of complementary healthcare
practitioners and move quickly to implement
statutory regulation where appropriate
(Recommendation 28).
In March 2005 the Commonwealth Government
released the Government Response to the
Recommendations of the Expert Committee on
Complementary Medicines in the Health System.29
The Commonwealth Government noted the
recommendations for regulation of practitioners
and proposed to notify the States and Territories,
through the Australian Health Ministers’
Conference, of their responsibilities in
regulating professions.
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Scope & Aim
This discussion paper forms part of the
consultation process into the regulation of
Chinese medicine practitioners. The purpose of
the consultation process is to seek comment on
a proposed registration framework for Chinese
medicine practitioners in WA. This discussion
paper explains the key issues and options,
and seeks the views of interested groups and
individuals regarding the regulation of Chinese
medicine practitioners in WA.
It is proposed that registration in WA will initially
be limited to three modalities, being acupuncturist,
Chinese herbal medicine practitioner and
Chinese herbal dispenser. These three modalities
were identifi ed as those that should be subject
to registration based on the research and
consultation undertaken by the Victorian
Government, on behalf of all States and Territories.
The Victorian Government based their registration
system on these three modalities in the Chinese
Medicine Registration Act 2000 (Vic).
The consultation period will be approximately
two months and will result in a framework for
developing a draft Chinese Medicine Registration
Bill. An advertisement will also be placed in the
West Australian calling for submissions. Further
consultation will be undertaken on a draft Bill
when it has been prepared.
This discussion paper has been prepared by Legal
and Legislative Services at the Department of
Health, Western Australia.
Further copies of this discussion paper can be
obtained by contacting:
Ms Rose-Marie Garcia
Tel: 08 9222 4038
Fax: 08 9222 4355
Email: Legal.Services@health.wa.gov.au
The discussion paper is also available on
the Department of Health’s Internet site at
http://www.health.wa.gov.au/publications/
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How To Have Your Say
Annexure 2 provides a reference list of the
questions on which your views are sought.
Written submissions should be made to:
Legal and Legislative Services
Department of Health
PO Box 8172
PERTH BC WA 6849
Alternatively, submissions may be emailed to:
Legal.Services@health.wa.gov.au
The fi nal date for receiving written
submissions is 5pm, 2 September 2005.
Please indicate whether an individual or an
organisation is making the submission. Your
name, address and telephone number should be
included. Anonymous submissions will not be
considered. Individuals or organisations that wish
their comments to be treated confi dentially should
indicate this by marking correspondence private
and confi dential. However, submissions may be
subject to release under the Freedom of Information
Act 1992.
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Chinese
Medicine
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What is complementary
and alternative
medicine?
Complementary and alternative medicine (CAM)
refers to a heterogeneous collection of medical
and health care systems, therapeutic substances
and practices and techniques based on theory and
explanatory mechanisms that are not consistent
with the western clinical model of medicine.8,9
Complementary therapies include a diverse
group of health-related therapies and disciplines
that are not considered to be part of mainstream
medical care in Australia2 such as acupuncture,
naturopathy, meditation, and aromatherapy.10
Chiropractic and osteopathy have been considered
both as complementary therapies and allied
health practices. These professions are regulated
in WA under the Chiropractors Act 1964 and the
Osteopaths Act 1997 respectively.
The Commonwealth Therapeutic Goods Act 1989
defi nes complementary medicines as therapeutic
goods consisting wholly or principally of one
or more active ingredients, each of which has
a clearly established identity and either a
traditional use or any other use prescribed in the
regulations.11 This includes herbal medicines,
homoeopathic medicines, and nutritional and
other supplements.10 The regulatory controls
for medicines are primarily the responsibility
of Australia’s national regulator, the TGA, in
cooperation with State and Territory governments
and the medicines industry.2
The Cochrane Collaboration12 defi ned CAM
as a ‘broad domain of healing resources that
encompasses all health systems, modalities, and
practices and their accompanying theories and
beliefs, other than those intrinsic to the politically
dominant health systems of a particular society or
culture in a given historical period. CAM includes
all such practices and ideas self-defi ned by their
users as preventing or treating illness or promoting
health and well-being.’12
It is interesting to note that in many countries CAM
is considered to be traditional medicine, and forms
the dominant health system or is at least employed
alongside western-type conventional health
practices. For instance, African and western Pacifi c
nations consider that traditional medicine is a
priority for health care in their regions, but in other
regions the role of traditional medicine is treated
as complementary or alternative medicine.13
Chinese medicine
modalities
For the purposes of this discussion paper Chinese
medicine will refer to the three modalities being
considered for regulation: acupuncture, Chinese
herbal medicine and Chinese herbal dispensing.
Importantly, it is the practitioners of these
modalities that are being considered for regulation,
and not the controls relating to the quality and
safety of the medicines or herbs employed within
these modalities. Regulation of practitioners
will include tight controls on the prescribing
and dispensing of restricted herbs. The role of
regulating medicines, including many herbal
products, is undertaken by the TGA.
What is Acupuncture,
Chinese herbal medicine
and Chinese herbal
dispensing?
Descriptions of the modalities being considered
for regulation in Western Australia are given
below and are taken primarily from the Expert
Committee on Complementary Medicines in the
Australian Health System2 report. For the purposes
of this discussion paper the Department of Health
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has attempted to capture the most appropriate
description of acupuncture, Chinese herbal
medicine and Chinese herbal dispensing. It is
acknowledged that there are varying practices
and descriptions available for these modalities,
particularly for acupuncture, which could also
have been included.
Chinese herbal medicine
Traditional Chinese medicine is best known for
the practices of acupuncture and Chinese herbal
medicine, in addition to a wide range of therapies
such as Chinese massage, dietary and lifestyle
advice, orthopaedic manipulations and surgery,
breathing, movement and meditation, and specifi c
techniques including moxibustion, cupping,
scraping and point injection therapy.8 Traditional
Chinese medicine is a complete diagnostic
and treatment system dating back thousands
of years and is based on an understanding of
health and illness that differs substantially from
that in western medicine. Clinical symptoms
are interpreted by reference to theories of bodily
operation that are foreign to the western-trained
scientifi c eye.
Chinese herbalism is the most prevalent of the
ancient herbal traditions. Chinese herbs are
used according to their ascribed qualities such
as cooling (yin) or stimulating (yang). Herbalists
generally use unpurifi ed plant extracts containing
different constituents and often use several
different herbs together.
Chinese herbs can be toxic as they contain active
principles. Herbal extracts contain plant material
with pharmacologically active constituents.
The active principle(s) of an extract, which is in
many cases unknown, may exert its effects at
the molecular level. For example, an extract may
have an enzyme-inhibiting effect. When used in
conjunction with Western medicine, it is important
to be aware of the interactions of Chinese herbs
with Western prescription and non-prescription
pharmaceuticals. It is also important that
practitioners have an understanding of the herbs’
indications and contraindications.
Acupuncture
Acupuncture involves the stimulation of specifi c
points on the skin, usually by the insertion of
needles, for therapeutic or preventative purposes.
The original form of acupuncture was based on
the principles of traditional Chinese medicine
that state that the workings of the human body
are controlled by a vital force or energy called
‘qi’, which circulates between the organs along
channels called meridians.
Traditional acupuncturists use an Oriental
medicine framework for referring to disturbances
believed to cause symptoms, and may use various
adjunctive therapies including moxibustion
and cupping.
Conventional healthcare professionals who
practice acupuncture use acupuncture points
thought to correspond to physiological and
anatomical features.
Japanese and Ayurvedic acupuncture are amongst
other forms of acupuncture practiced in Australia.
Chinese herbal
dispensing
Chinese herbal dispensers fi ll prescriptions from
Chinese herbal medicine practitioners or dispense
medicinal substances for health enhancement
and/or treatment purposes.14 Chinese herbal
dispensing is an established profession in China,
whilst in Australia most Chinese herbal medicine
practitioners carry out their own dispensing.
In Victoria, under section 8(2) of the Chinese
Medicine Registration Act 2000 (Vic), registered
Chinese herbal dispensers are qualifi ed to obtain
and to have in their possession and to use, sell or
supply Schedule 1 poisons within the meaning
of the Drugs Poisons and Controlled Substances
Act 1981 (Vic).
In Victoria, registered Chinese herbal medicine
practitioners may dispense over-the-counter
medicines to their patients without being a
registered Chinese herbal dispenser, as long
as they do not use the title ‘Chinese herbal
dispenser’, or mislead members of the public
into believing that they are a registered Chinese
herbal dispenser. Medicines must be either listed
or registered on the Therapeutic Goods Register
(manufactured medicines) or extemporaneously
dispensed (made up on site to a prescription
for an individual patient). However, to prescribe
or dispense herbs that are restricted under the
Poisons List of the Drugs Poisons and Controlled
Substances Act 1981 (Vic) a Chinese herbal
medicine practitioner must have their registration
endorsed and be legally authorised to prescribe
and dispense these herbs.15
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n Australia, regulation of Chinese medicine
practitioners is a responsibility of States and
Territories.
Victoria
The only State in Australia with registration
legislation for Chinese medicine practitioners
is Victoria. The Chinese Medicine Registration
Act 2000 (Vic) (CMR Act) provides for the
statutory regulation of Chinese herbal medicine
practitioners, acupuncturists and Chinese herbal
dispensers. The Chinese Medicine Registration
Board (CMRB) of Victoria administers this Act.
As at June 2005, the CMRB of Victoria had 779
registered practitioners with 435 registered as
both acupuncturists and Chinese herbal medicine
practitioners, 309 practitioners for acupuncture
only and 35 registered Chinese herbal medicine
practitioners only.16 There were no registered
Chinese herbal dispensers.
Overview of Chinese Medicine Registration
Act 2000 Victoria
The provisions of the CMR Act establish the CMRB
of Victoria and provide for the statutory regulation
of Chinese herbal medicine practitioners,
acupuncturists and Chinese herbal dispensers.
The main purposes of the CMR Act are:
•
to protect the public by providing for the
registration of practitioners of Chinese
medicine and dispensers of Chinese herbs
and investigations into the professional
conduct and fi tness to practise of registered
practitioners of Chinese medicine and
dispensers of Chinese herbs;
•
to regulate the advertising of Chinese medicine
and Chinese herbal dispensing services;
•
to establish the CMRB of Victoria and the
Chinese Medicine Registration Board Fund;
•
to amend the Drugs Poisons and Controlled
Substances Act 1981 (Vic);
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Regulation of
Chinese Medicine
Practitioners
in Australia &
Internationally
7
•
to make amendments to other Acts regulating
health practitioners; and
•
to provide for ot her related matters.
Section 68 of the CMR Act sets out the powers,
functions and consultation requirements of the
CMRB of Victoria, and includes:
•
registering persons who comply with the
requirements of the CMR Act so that they may
hold themselves out as registered Chinese
medicine practitioners or registered Chinese
herbal dispensers;
• approving courses of study which provide
qualifi cations for registration as Chinese
medicine practitioners and Chinese
herbal dispensers;
• approving courses of study or training which
provide qualifi cation for endorsement of
registration under section 8;
•
regulating the standards of practice of Chinese
medicine and the dispensing of Chinese herbs
in the public interest;
•
investigating the professional conduct or
fi tness to practise of registered practitioners
and impose sanctions where necessary;
•
issuing and publishing guidelines about the
minimum terms and conditions of professional
indemnity insurance in connection with
the practice of Chinese medicine and the
dispensing of Chinese herbs;
•
recognising post graduate courses in Chinese
medicine and the dispensing of Chinese herbs
in addition to those required for registration;
•
issuing and publishing Codes for the guidance
of registered practitioners about standards
recommended by the Board relating to
the practise of Chinese medicine and the
prescribing, labelling, storage, dispensing
and supply of Chinese herbs including
Schedule 1 poisons within the meaning of
the Drugs, Poisons and Controlled Substances
Act 1981 (Vic);
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•
initiating, promoting or participating in
programs that the Board considers will protect
the public from practitioners whose ability
to practise medicine may be affected by any
matter referred to in section 28;
• advising the Minister on any matters relating
to its functions, providing information when
requested to the Minister, consulting with the
Minister and have regard to the Minister’s
advice in carrying out its functions and
exercising powers; and
• consulting with registered practitioners
before formulating any Codes referred to
in sub-section (1)(h).
The CMR Act comprehensively outlines what
constitutes unprofessional conduct and contains
wide-ranging disciplinary powers for the protection
of the public. The CMR Act makes it a disciplinary
matter for anyone who is not a registered Chinese
medicine practitioner or Chinese herbal dispenser
to use titles which suggest that they are registered
in any of the divisions of the register when they are
not. The CMR Act includes stringent advertising
provisions and enables the Board to prepare
guidelines for minimum acceptable standards
for advertising Chinese medicine services.
A person may apply to the Victorian Civil and
Administrative Tribunal (VCAT) for a review of
decisions made by the CMRB of Victoria where
the decision has been made to refuse that person’s
application for registration, to impose conditions,
limitations or restrictions on the person’s
registration or to suspend their registration.
Appeals against fi ndings/determinations made
by formal hearing panels may also be taken to
the VCAT.
The CMR Act also amended the Drugs, Poisons and
Controlled Substances Act 1981 (Vic) to establish a
new list of Chinese herbs. These provisions control
access by qualifi ed Chinese herbal medicine
practitioners and dispensers to potentially toxic
and dangerous herbs that otherwise are restricted.
Practitioners of other forms of acupuncture such as
Japanese and Ayurvedic acupuncture are enabled
through the CMR Act to register without requiring
an understanding of the full body of Chinese
medicine knowledge.
The Second Reading Speech for the CMR Act
during its passage through the Parliament of
Victoria is available at http://www.cmrb.vic.gov.au/
about/secondreadingspeech.pdf
Other registered health practitioners who
practice Chinese medicine in Victoria
The Health Legislation (Further Amendment)
Act 2003 (Vic) amended the registration Acts
for medical practitioners, nurses, optometrists,
dentists, chiropractors, osteopaths, pharmacists
and physiotherapists. These practitioners, except
pharmacists, who wish to practice acupuncture
alongside their usual professional practices, do
not have to be registered with the CMRB of
Victoria. Instead they may apply for endorsement
or notation of registration from their own
registration boards, effectively exempting the
practitioner from restrictions on using the
protected title of ‘acupuncturist’.
Pharmacists are the only other health profession
able to apply to their registration board for
endorsement of registration effectively exempting
the pharmacist from restrictions on using the
protected title of ‘Chinese herbal dispenser’.
The registration boards for these practitioners
are responsible for assessing the qualifi cations
and training of the practitioners. However, many
registration boards have offi cially requested that
the CMRB of Victoria assess the qualifi cations
of their registered practitioners before an
endorsement or notation of registration is granted
to allow use of the title ‘acupuncturist’ or ‘Chinese
herbal dispenser’. This ensures that the standards
for other health practitioners wishing to practice
acupuncture or Chinese herbal dispensing are
consistent as far as possible with the standards
established by the CMRB of Victoria.
Other registered health practitioners who have
obtained the required endorsement or notation
of their registration from their own registration
board are allowed to use the title ‘acupuncturist’
and advertise that they are qualifi ed to provide
acupuncture services to the public, without
being registered with the CMRB of Victoria. This
endorsement does not, however, legally enable
them to use the title ‘Registered Acupuncturist’.
These titles are reserved for those registered under
the CMR Act in the Division of Acupuncture.
Other unregistered health practitioners who
practice Chinese medicine in Victoria
Unregistered health practitioners in Victoria, such
as massage therapists, homoeopaths, naturopaths
etc are not entitled to advertise that they provide
acupuncture services unless they fi rst register with
the CMRB of Victoria.
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9
Other modalities in Victoria
The 1998 Victorian Traditional Chinese Medicine
Report on Options for Regulation of Practitioners5
recommended that other modalities of
complementary therapies be examined. Research
is being undertaken to identify the risks and
benefi ts of the practice of western herbal medicine
and naturopathy, and assess the need for further
regulation of practitioners and the prescribing
and dispensing of herbal medicines. A report on
the research is due to be released soon. More
information is available at: http://www.dhs.vic.gov.
au/pdpd/workforce/pracreg/naturopathy.htm
New South Wales
In September 2002, the New South Wales (NSW)
Department of Health released a discussion
paper on the regulation of complementary health
practitioners. The discussion paper was entitled
Regulation of Complementary Health Practitioners
– Discussion Paper, September 2002.1
Following the close of the consultation period,
an expert advisory group prepared a report for the
NSW Minister for Health in relation to regulation
of Chinese medicine practitioners. The Minister
is currently considering the options presented
in the report.
ACT, Northern Territory,
Queensland, South
Australia & Tasmania
The Western Australian Department of Health has
been advised that there are no immediate plans to
regulate complementary health practitioners
in these States and Territories.
New Zealand
A Ministerial Advisory Committee on
Complementary and Alternative Health
(Committee) was established in June 2001.
The Committee has released the Complementary
and Alternative Medicine: Current Policies and Policy
Issues in New Zealand and Selected Countries
– A Discussion Document 2003 and the resulting
Summary of Submissions in response to the
discussion document. The Committee provided its
fi nal advice to the New Zealand Minister of Health
in June 2004.
The response of the New Zealand Government17
to the Committee’s report, supported
recommendations for regulation of practitioners
of complementary and alternative health,
according to level of inherent risk and consistent
with the Health Practitioners Competence
Assurance Act 2003 (New Zealand).
A key feature of the New Zealand approach is the
national basis of regulation. This differs from the
Australian State-by-State basis. A single route
to statutory regulation in New Zealand would
be achieved through a ‘single, overarching act
containing a framework for the governance and
functions of registering authorities’.2
United Kingdom
In November 2000 the House of Lords Select
Committee on Science and Technology
recommended in its report on Complementary
and Alternative Medicine that herbal medicine
and acupuncture should be regulated by statute.18
The UK Government endorsed the concept of
statutory regulation.
In March 2004 the UK Department of Health
released a paper entitled Regulation of herbal
medicine and acupuncture – Proposals for statutory
regulation.19 This paper proposes the establishment
of a statutory registration authority for traditional
Chinese medicine and acupuncture, the setting
of standards for entry into the profession and
protection of a range of titles for practitioners.
United States
In 2002 the White House Commission on
Complementary and Alternative Medicine
Policy Final Report20 recommended that public
accountability for complementary and alternative
medicine (CAM) practitioners was required.
The report urged states to consider whether a
regulatory infrastructure for CAM practitioners
was required in order to promote quality of care
and patient safety.1
Each state decides its own independent policy
on the regulation of practitioners within its
jurisdiction. Some states have developed
regulatory or licensing arrangements for some
CAM practitioners. For example, many regulate
acupuncture and require practitioners to be trained
to a specifi ed standard. The National Certifi cation
Commission for Acupuncture and Oriental
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Medicine21 plays a role in setting standards in
individual states. Some states limit the practice
of acupuncture to medical practitioners or to
those under a medical practitioner’s supervision.
Naturopathic medicine is also recognised and
licensed in several states.
Singapore
Health care in Singapore is based on Western
medical science. However, it is common practice
among the various ethnic groups to occasionally
consult traditional medicine practitioners for
general ailments. Chinese medicine is particularly
popular among the Chinese residing in Singapore.
The Traditional Chinese Medicine (TCM) Practitioners
Act was passed on 14 November 2000. The Act
requires TCM Practitioners who practice the
prescribed practice of acupuncture and/or TCM to
be registered and issued with a licence to practice.
A TCM Practitioners Board was established as
the licensing body for the registration of TCM
practitioners, accreditation of TCM schools and
courses for TCM, and regulating the professional
conduct and ethics of registered acupuncturists
and TCM practitioners.22
China
China relied entirely on TCM until Western
medicine was introduced at the end of the 17th
century. Efforts by the Chinese Government kept
TCM from being displaced by western, conventional
medicine in the mid 20th Century.25 Western,
conventional medicine and TCM are now practiced
alongside each other at every level of the health
care system, indicating the integration of both
forms of medicine into primary care and hospital
settings. Dual systems of traditional Chinese and
western medical education exist in China, and
the integrated training of health practitioners is
formalised. The Government of China promotes
equality in policies on traditional and western
conventional medicine.23 The State Administration
of Traditional Chinese Medicine was established in
1986 and regulates TCM practitioners.
World Health
Organisation
In 2002 the World Health Organisation (WHO)
published a WHO Traditional Medicine Strategy
2002 – 2005.13 The strategy acknowledges the
regional diversity in the use and role of traditional,
complementary and alternative medicine. It was
developed to address the issues of policy, safety,
effi cacy, quality, availability, preservation and
further development of traditional, complementary
and alternative medicine.
WHO has also developed guidelines and standards
relating to the use of herbal medicine and
acupuncture and the training and research into
these practices. A couple of these publications
are Guidelines for the Appropriate Use of Herbal
Medicine 1998 and the Guidelines on Basic Training
and Safety in Acupuncture 1999.24
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part 2
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egulation of practitioners can occur through
statutory regulation, co-regulation or voluntary self-
regulation. These forms of regulation have similar
functions and potential positive outcomes, however
only statutory regulation is upheld by law.25,19
Self-Regulation
Self-regulation typically develops in a profession
where the peak body establishes and maintains
standards and codes of practice, education and
training and formulates a process for complaint
resolution and disciplinary action. For many
professional groups, the typical process has
been for a widely recognised and accepted peak
body to emerge, resulting in the formation of self-
regulation. This form of regulation occurs where
there is no legal requirement for practitioners of a
particular profession to register with a regulatory
body. With minimal barriers to entry in the
profession, self-regulation enables a wide range
of practitioners to practice in the profession.
This provides greater choice to consumers.
There are diffi culties with self-regulation. Self-
regulation relies on voluntary compliance by
members. Its effectiveness depends on the ability of
the professional association to enforce disciplinary
measures. A practitioner’s voluntary membership
of a professional association may be the only
indicator for consumers that a practitioner is
suitably qualifi ed and safe to practice, and subject
to a disciplinary scheme.26 Self-regulation makes
it diffi cult to monitor and maintain standards of
training and practice, resulting in widely varying
standards of practice and levels of qualifi cation.
There is potential for confl ict of interest in the
setting and enforcing of standards as some
professional associations have close links with or
have been established specifi cally to recognise
graduates of particular training institutions.26
Professional associations have generally existed
to protect and promote the interests of members.
This may have the potential to compromise open,
transparent and accountable complaints handling
and disciplinary processes. The voluntary nature
of membership means that the suspension or
cancellation of the membership of a practitioner
may have little or no real effect as a disciplinary
action. Furthermore, self-regulation does not
hinder unqualifi ed practitioners from practising
in the profession.
There are many complementary and alternative
medicine practitioner associations that vary in
size and quality in Australia. Membership of an
association is voluntary. Some associations may
only accept practitioners with particular training
and qualifi cations, and set their own standards
and codes of conduct. The typical process for the
emergence of a peak body has not occurred in
the Chinese medicine profession. There are a large
number of associations in Australia and this has
led to fragmentation of the profession. There is no
single association that is widely recognised and
accepted as the peak body.
Self-regulation is not suitable where there are
potentially serious risks to patients arising from
the practice of a profession.
Co-regulation
Co-regulation is where the government and
professional associations share the regulatory
role. Practitioners would be required to take up
membership with an accredited professional
association. Professional associations would
establish and maintain professional standards,
and administer a disciplinary system to ensure
professional standards. The government would
undertake accreditation and monitoring of the
professional associations in order to promote
public safety.
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What is
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As with self-regulation, co-regulation would
most likely lack the legislative capacity to respond
satisfactorily to complaints and grievances from
the public. Most importantly, there would be no
legal underpinning for a scheme controlling
the prescribing and dispensing of restricted
herbs. Practitioners who are not members of a
co-regulated professional association would not
be legally prevented from practicing or using the
titles of the profession.
Statutory Regulation
Statutory regulation primarily aims to protect
the consumers of particular professional services,
by ensuring that registered practitioners meet
agreed standards of qualifi cations, practice
and competence.19
A statutory regulatory system involves the
establishment of a register of practitioners who
are qualifi ed and competent to practice. The
existence of a register enables the public to identify
registered practitioners who meet the standards
prescribed by the regulatory body.
Regulatory bodies are responsible for the setting,
monitoring and enforcing of minimum practitioner
education standards and ongoing professional
development requirements.27 The system also
provides a mechanism for complaint and dispute
resolution, such as sanctions, suspension or
removal of the practitioner from the register.
Statutory regulation is most often applied to
higher-risk modalities. These include modalities
that use interventions such as spinal manipulation
(eg chiropractic, osteopathy), invasive techniques
(eg acupuncture) or ingested substances (eg
herbal medicine).25
Advantages of statutory regulation for patients,
the public and practitioners are:19
• ensures protection of title: only practitioners
who are registered with the statutory body are
legally entitled to use a particular title;
• ensures that practitioners have an appropriate
level of skill and training;
• establishes a single register of practitioners,
making it easier for the public to fi nd an
appropriately qualifi ed and trained practitioner;
and
• provides a legislative underpinning of the
regulatory body’s disciplinary procedures: a
practitioner who has been removed from the
Register can no longer use the protected title.
2a
What do you consider are/should be important features for statutory
regulation of Chinese medicine practitioners in Western Australia?
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review of Western Australian health
practitioner legislation was conducted in
October 1998. The review sought comments and
submissions on the Osteopaths Act 1997 (the Act),
which was referred to as the template legislation.
This Act was identifi ed as the model legislation
for the regulation of other health professions
in Western Australia. One of the aims of this
review was to provide the health consumers of
Western Australia with effective, modern, readily
understandable and, so far as possible, uniform
health practitioner legislation.28
The template legislation will be used as the model
for all new health practitioner legislation, including
the regulation of Chinese medicine practitioners.
The template will be adjusted as necessary to take
account of particular issues affecting Chinese
medicine practitioners. Competition policy review
of the draft legislation for Chinese medicine
practitioners may involve a more comprehensive
analysis of particular provisions.
Overview of the
template legislation
The template legislation has eight parts. Part 1
contains the defi nitions and interpretation of
terms used in the Act. Part 2 establishes the
registration board, its membership, functions,
and the establishment of committees. Part 3
deals with fi nance and reports.
Part 4 governs the registration of practitioners,
setting out the registration requirements,
and providing for conditional and provisional
registration. The assessment of complaints,
disciplinary proceedings and the role of the State
Administrative Tribunal are set out in Part 5, with
offences provided for in Part 6. Part 7 provides
for the making of codes of practice, rules and
regulations. Miscellaneous items are included
in Part 8.
Overview of the
Osteopaths Act 1997
The Act closely resembles the framework of the
template legislation. The main purpose of the Act
is to regulate the practice of osteopathy and to
provide a system of registration for osteopaths.
The Act provides for a system of regulation that
facilitates the maintenance of appropriate levels
of knowledge and experience and ensure that
osteopaths provide safe standards of care.
Part 1 provides a defi nition of osteopathy. Part 2
establishes the registration board. Members of the
board are appointed by the Minister for Health.
The functions of the board are to administer
the registration scheme established by the Act;
perform disciplinary functions; promote public
education and research relating to the practice
of osteopathy; provide advice on osteopathy
issues to the Minister; and to monitor education
in osteopathy. Part 3 governs the registration of
osteopaths.
Part 4 provides that the board’s funds will consist
of registration fees, grants, gifts and donations,
pecuniary penalties and other money or property
lawfully received by the board in connection with
the performance of its functions. These funds are
available to the board to administer and enforce
the Act, for education purposes and for any other
purpose approved by the Minister.
Part 5 relates to disciplinary and impairment
matters. Disciplinary matters relate to a
person acting carelessly, incompetently and
improperly, breaching the Act, failing to comply
with instructions by the Board, and providing
services that were excessive or not necessary for
the recipient’s well-being. Impairment matters
occur where a person is affected by his or her
dependence on alcohol or drugs to the extent that
it affects their ability to practice as an osteopath.
This part provides for the lodging of complaints
A
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Health
Practitioner
Template
Legislation
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1 5
in respect to disciplinary and impairment matters,
investigations, the role of the board and review
committees, and conciliations. The powers of
the State Administrative Tribunal (see 2C State
Administrative Tribunal) for dealing with a
disciplinary or impairment matter are set out
in Part 5.
Part 6 provides a range of offences under the
Act. Offences include practising as an osteopath
when not registered, using the title ‘osteopath’ or
pretending to be registered as an osteopath when
not registered, failing to comply with a disciplinary
order, providing false information, failing to attend
or take oath, and obstructing an investigator. Part
7 deals with miscellaneous provisions such as
appeals and legal proceedings.
The Act is designed to protect members of the
community through the establishment of a
competent and effective authority to control and
regulate the practice of osteopathy in WA.
All Western Australian state legislation, including
the Osteopaths Act 1997, can be found on the State
Law Publisher’s website www.slp.wa.gov.au, or
contact the State Law Publisher by telephone on
08 9321 7688.
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he State Administrative Tribunal is a
dedicated independent authority, created to
handle the resolution of appeals from a range
of administrative decisions made by the courts,
Government Ministers and public offi cials. It deals
with a number of appeal matters previously dealt
with by various boards and tribunals including:
• disciplinary proceedings affecting a number
of statutory regulated trades and professions,
including lawyers, architects, motor vehicle
dealers, plumbers, electricians, fi nance
brokers, real estate agents and all registered
health professionals; and
• civil complaints ranging from equal opportunity
matters to disputes about strata titles, and
disputes lodged with the Commercial Tribunal.
The State Administrative Tribunal has two
jurisdictions:
1. Original
a) makes original/primary decisions to determine
civil, commercial or personal matters; and
b) decides matters from regulatory bodies
regarding the disciplining of people in various
industries, occupations and professions.
2. Review
a) reviews administrative decisions made by
primary decision makers (eg other tribunals,
ministers and public offi cials who can, by
statute, make administrative decisions on a
range of personal and commercial activities);
and
b) reviews decisions made by regulatory bodies
regarding licences to operate in an industry
or profession.
1 6
Health practitioner boards have the power to
receive and investigate complaints and deal
with minor disciplinary matters. More serious
disciplinary matters, such as possible suspension
and cancellation of registration, are referred by the
relevant board to the State Administrative Tribunal.
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National
Competition
Policy
1 7
n 1995 all States and Territories entered into
a group of agreements known as the National
Competition Policy (NCP). NCP requires that
the impact of new and existing legislation on
competition must be assessed. The Competition
Principles Agreement is one element of NCP
and sets out principles to be applied when
implementing reform. Clause 5.1 of this
Agreement states that:
1) legislation should not restrict competition
unless it can be demonstrated that the benefi ts
of the restriction to the community as a whole
outweigh the costs; and
2) the objectives of the legislation can only be
achieved by restricting competition.
Regulatory requirements establish title and
practice protection for health practitioners. These
requirements have been identifi ed as possible
restrictions on competition. However, the intent of
the health practitioner legislation is the protection
of the public. Protection of the public aims to
reduce the potential for risk of harm that may result
from the provision of health practitioner services
by persons who do not possess the knowledge,
skill or competence to provide these services
safely and competently.
The benefi ts of restricting competition through
regulation include:
•
formal establishment and maintenance
of education and training standards and
practices;
• public access to complaints mechanism for
alleged unprofessional conduct by Chinese
medicine practitioners; and
• sanctions and disciplinary measures for
individuals engaging in unprofessional
conduct.
The costs of restricting competition through
regulation include:
• fi nancial costs of administration and
enforcement by the regulatory body;
• only those practitioners that have undergone
a recognised training course will be able to
register as a Chinese medicine practitioner.
Many practitioners that otherwise would be
considered competent in Chinese medicine
may not be able to register, effectively reducing
the number of practitioners that can advertise
their services in the regulated professions. This
cost may be overcome through grandparenting
arrangements which would be as inclusive of
practitioners as possible, while maintaining
safety for the public in the practice of Chinese
medicine; and
• where protection of title is implemented,
unregistered complementary medicine
practitioners will not be able to advertise their
services using the protected titles, or mislead
the public into believing that the practitioner
is registered, unless they fi rst register with
the Chinese medicine registration board.
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he safety of consumers of Chinese medicine
is the primary issue in the discussion about
regulation of practitioners. The widespread use
and increasing popularity of Chinese medicine and
other alternative health services has heightened
concern about the level of risk inherent with some
practices and therapies. A signifi cant risk is the
potential for adverse interactions between Chinese
herbs and western pharmaceuticals.
It has been recognised in Australia that there is
a need for a structure that reduces the risk faced
by consumers of Chinese medicine. Regulation is
considered, both in Australia and internationally,
to be the most effective measure to ensure
practitioners have appropriate education and
training, and facilitate controls on the prescribing
and dispensing of restricted herbs. Furthermore,
the potential risks to the public associated with
the practice of Chinese medicine and the
current absence of complaint and disciplinary
mechanisms would be addressed by statutory
regulation.
The development of regulation legislation for
Chinese medicine practitioners in Western
Australia is supported by recommendations from
national government committees and research
studies recommending statutory regulation.
Expert Committee
on Complementary
Medicines
In 2003 the TGA established the Expert Committee
on Complementary Medicines in the Australian
Health System (Expert Committee). The
Expert Committee produced a report entitled
Complementary Medicine in the Australian
Health System.2
While the focus of the Expert Committee was
on actual medicines, a section of the report was
dedicated to the regulation of practitioners.
The Expert Committee was, in its terms of
reference, asked to examine and provide advice
on the education, training, and regulation
requirements for healthcare practitioners who
are supplying complementary medicines and
providing advice or delivering care to consumers
of complementary medicines.
The fi ndings of the Expert Committee strongly
recommended that all jurisdictions introduce
legislation to regulate practitioners of traditional
Chinese medicine and dispensers of Chinese
herbs, based on existing Victorian legislation,
as soon as possible (Recommendation 27).
The Expert Committee also recommended that
Health Ministers should review the fi ndings
of the New South Wales and Victorian reviews
concerning regulation of complementary
healthcare practitioners and move quickly to
implement statutory regulation where appropriate
(Recommendation 28).
Finding 5.1.1
Governments should move more quickly to
nationally consistent statutory regulation
(where appropriate) of complementary
healthcare professions.2
In March 2005, the Commonwealth Government
released the Government Response to the
Recommendations of the Expert Committee on
Complementary Medicines in the Health System.29
The Government noted Recommendations 27 and
28, identifying that occupational regulation is a
State and Territory responsibility. In response to
the recommendations, the Australian Government
proposed to bring the matter to the attention of
the States and Territories through the Australian
Health Ministers’ Conference.
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Australian Health
Ministers’ Advisory
Council
The Australian Health Ministers’ Advisory Council
(AHMAC) has established a nationally agreed
process for the occupational regulation of health
professions. Included in this process is the
requirement that regulation should only occur with
a majority of jurisdictions agreeing to regulation,
and where the profession meets specifi c criteria.
In 1995 AHMAC adopted six criteria that are to
be applied when assessing the need for statutory
regulation of unregulated health occupations.
These criteria are:
1.
Is it appropriate for Health Ministers
to exercise responsibility for regulating
the occupation in question, or does the
occupation more appropriately fall within
the domain of another Ministry?
2. Do the activities of the occupation pose a
signifi cant risk of harm to the health and
safety of the public?
3. Do existing regulatory or other mechanisms
fail to address health and safety issues?
4.
Is regulation possible to implement for the
occupation in question?
5.
Is regulation practical to implement for the
occupation in question?
The 1996 Victorian report, Towards a Safer Choice:
The Practice of Traditional Chinese Medicine in
Australia addressed the AHMAC criteria with the
following fi ndings:
1.
It is clearly appropriate for Health Ministers
to exercise responsibility for regulating TCM.
2. The activities of the practice of TCM clearly
pose a signifi cant risk of harm to the health
and safety of the public.
3. Existing regulatory mechanisms are
inadequate in safeguarding and protecting
the public as consumers of TCM.
4. There is a defi ned profession for which
regulation is possible to implement.
5. Occupational regulation is practical to
implement for currently unregulated TCM
practitioners.
Following its comprehensive review into
traditional Chinese medicine, Victoria concluded
that statutory regulation of the profession was
necessary for the health and safety of the public.
Towards a Safer Choice recommended the
introduction of statutory occupational regulation
in the form of a restriction of title. The aim was to
introduce a minimal, yet suffi cient, regulation to
ensure adequate public safety and to cause the
least anti-competitive effect in the health care
marketplace.8
Potential Risks to public
health and safety
A number of consumers of complementary
health services believe that the practice of Chinese
medicine poses minimal risk to the public. This
perception may have arisen from the absence or
low level of competency standards, regulation and
surveillance of the industry.1 The availability of
ingredients from health food stores may also
have contributed to this view, as has the belief
that Chinese herbal medicine is safe because
it is ‘natural’.30
There are likely to be some risks associated
with any health care practice. Adverse effects
are possible with any pharmacologically active
ingredients that have the capacity to change
physiological function. While Chinese medicine
may be considered less risky than western
medicine, it is not free from risk. This has been
demonstrated by the occurrence of fatalities
associated with the practice of Chinese medicine.
Chinese medicine appears to pose greater risks
than some regulated health care practices such
as osteopathy and chiropractic.2
Towards a Safer Choice classifi es risks of TCM to
the public as:
•
risks associated with the clinical judgement
of the TCM practitioner;
•
risks related directly to the effects of
acupuncture needling; and
• risks related directly to the consumption of
Chinese herbal medicines.
The following section outlining the risks associated
with TCM has been predominantly taken from
Towards a Safer Choice8, Chapter 4.
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Risks associated with the clinical judgement
of the TCM practitioner
These risks are further grouped into risks of
commission or risks of omission. Risks of
commission relate to direct and inappropriate acts
undertaken by a practitioner during treatment.
They include:
•
recommendations from practitioners that
patients defer or withdraw from appropriate
conventional medical treatment. This may
result in loss of the benefi t of that treatment,
increased morbidity and possibly death;
•
incorrect prescribing. This includes
poor prescribing, failure to observe
contraindications, inappropriate dosage,
inappropriate duration of therapy and failure to
avoid known interactions with pharmaceutical
drugs; and
• negligent practice, such as the use of non-
sterile acupuncture needles. Serious infection
resulting from acupuncture may also affect
the broader public through the spread of
contagious diseases.
Risks of omission occur when practitioners have
inadequate skills or are unaware of the limits of
their practice:
• misdiagnoses, or failure to detect serious
underlying disease or abnormality;
•
failure to refer on, resulting in delay of
diagnosis and appropriate treatment; and
•
failure to explain precautions. This equates to
a failure to obtain informed consent and could
result in direct and serious consequences for a
patient not aware of possible risks.
Other general risks include:
• Mental trauma;
• Unsubstantiated claims of therapeutic benefi t;
• Sexual misconduct; and
• Financial exploitation.
Risks of commission and omission are considered
to be related to educational standards of
practitioners.
Risks related directly to the effects of
acupuncture needling
Predictable adverse reactions to acupuncture
include:
•
Infections: the use of unsterile needles may
cause local infections at the site of needle
entry. Of greater concern are systemic
infections such as endocarditis, septicaemia,
hepatitis B, HIV, osteomyelitis, myositis,
peritonitis and pleuraempyema.
• Local trauma: due to the needle, its location
and broken needles. Possible conditions
include pneumothorax, spinal cord injuries,
factitial panniculitis, auricular chondritis,
fatal and non-fatal cardiac tamponade,
pseudoaneurysm, deep vein thrombosis, nerve
damage, burns (from moxibustion) and severe
bruising (from cupping).
• Patient responses such as fainting, nausea
and vomiting.
Unpredictable adverse reactions to acupuncture
include:
• Allergic reactions to the material in the needle
• Depression
•
Insomnia
• Convulsions
• Hypotension
•
Increased pain
• Menstrual disturbance
The Workforce Survey undertaken during research
for Towards a Safer Choice found that the most
common adverse events reported were fainting
during treatment, increased pain and nausea/
vomiting. Serious adverse events included
pneumothorax and convulsions.
A study of adverse event rates for primarily
acupuncture practitioners found that adverse
event rates were higher for practitioners with 0-12
months of CAM education than for those with 37-60
months education.30 This indicates that education
standards are a potential contributing factor for
adverse events.
Risks related directly to the consumption
of Chinese herbal medicines
Chinese herbal medicines are most often used in
combinations that follow traditional prescribing
guidelines where one ingredient is included to
‘counteract’ the toxicity of another. Preparation
methods may alter the toxicity of ingredients.
Intrinsic adverse reactions are directly related
to the active medicine itself. Similar to western
pharmaceutical medicines, Chinese herbal
medicines have predictable and idiosyncratic
(unpredictable) reactions. Predictable reactions
are extensions of the pharmacological effects
of the medicines, are generally dose-dependent
and can be less severe than unpredictable,
idiosyncratic reactions.
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Some ingredients used in Chinese herbal medicine
have direct toxicity and predictable adverse effects,
and are considered suffi ciently toxic to be included
under the Standard for the Uniform Scheduling of
Drugs and Poisons31. Predictable adverse effects
include:
• Aconite poisoning
• Anticholinergic side effects
• Mineralocorticoid effects
• Ginseng abuse syndrome
• Signifi cant allergic reaction
• Overdose
•
Interactions with western pharmaceuticals
Idiosyncratic, unpredictable adverse reactions to
Chinese herbal medicines are reactions that are
not predicted by pharmacology, occur infrequently,
are not related to dose and can cause signifi cant
morbidity or death.
Extrinsic risks of Chinese herbal medicine arise
from the failure of good handling and manufacture
procedures, such as incorrect identifi cation
of materials, contamination, substitution of
ingredients, incorrect preparation, inappropriate
labelling, adulteration with western pharmaceutical
products and lack of standardisation.
The most common adverse events associated
with Chinese herbal medicines, reported during
research for Towards A Safer Choice, were severe
gastrointestinal symptoms, fainting, dizziness
and signifi cant skin reactions. Serious adverse
events included central nervous system effects,
hepatotoxicity, renal toxicity and death.
Furthermore, this research asked practitioners
whether they prescribed any of a range of
specifi ed Chinese herbs either in raw form or
proprietary Chinese medicines, including a
number of scheduled or restricted substances.
Alarmingly, a number of restricted or prohibited
substances were used relatively widely by Chinese
herbalists, indicating either a lack of awareness
by practitioners of the restrictions on these
substances or a lack of willingness to abide
by them.
While complementary and alternative medicine
products are regulated by the TGA, the
practitioners prescribing and dispensing many
of these products are not regulated. Regulation
of Chinese medicine practitioners will reduce
the likelihood of adverse incidents by ensuring
practitioners have a minimum level of education
and training, and by enforcing appropriate practice
standards. Furthermore, effective education of both
practitioners and the public will help minimise
risks and maximise safety.30
With growing public use of Chinese medicine
and the profession not effectively self-regulating,
statutory regulation is seen as the key means to
ensuring adequate mechanisms are in place for
consumers to access Chinese medicine safely.8
Complaints resolution
mechanisms and
disciplinary measures
Currently in WA there are limited complaint
handling and resolution mechanisms available
for people who believe they have a grievance with
a practitioner of Chinese medicine.
Consumers may lodge a complaint with the
Offi ce of Health Review (OHR).32 OHR is a State
Government body that provides a readily accessible
means of having complaints about health and
disability services reviewed, conciliated and dealt
with impartially and in confi dence. OHR will
work towards the resolution of complaints and
will recommend remedies where appropriate.
OHR may also refer complaints to a statutory
registration board.
Statutory regulation would enable disciplining
of practitioners, with suspension or removal of a
practitioner from the register as a possible action
that can be taken by the State Administrative
Tribunal. A registration board will be able to make
an allegation about a complaint or a matter to
the State Administrative Tribunal. See 2C State
Administrative Tribunal regarding the functions of
the Tribunal on dealing with a disciplinary matter.
2 1
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The key reasons for regulating practitioners of Chinese medicine have been given above.
What is your response to the reasons given in this section for regulating Chinese
medicine practitioners? Do you have other comments to make regarding these
reasons? Are there any other reasons for supporting statutory regulation?
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urrently, Chinese medicine practitioners are
not regulated in Western Australia. They are free to
practice and advertise their services in the same
was as any of the unregulated health professions.
Membership of a professional association is
the main indicator that a practitioner is suitably
qualifi ed and subject to professional standards
measures, however membership is voluntary and
not always dependent on qualifi cations.
The Victorian report Towards A Safer Choice based
its recommendations on the premise that any
regulatory model is the minimum necessary to
protect the public.8 These recommendations
included:
• both acupuncturists and traditional Chinese
herbalists be registered under one registration
board, recognising their shared philosophical
base in Chinese medicine;
•
the register records whether the practitioner
is qualifi ed to practice Chinese medicine as
an acupuncturist, a Chinese herbal medicine
practitioner, or both;
•
the model adopted should be suffi ciently
fl exible to allow extension to other related
occupational groups, if appropriate in the
future;
•
the regulatory statute should provide for
the protection of the public by ensuring
practitioners have adequate qualifi cations
for safe and competent practice;
•
the regulatory statute should provide for
accreditation of Chinese medicine education
courses that meet a satisfactory standard; and
•
the regulatory statute should provide effective
disciplinary powers.
There are a number of models of regulation
relevant for regulation of Chinese medicine
practitioners in Western Australia. The cost
and potential size of the register (number
of practitioners) is an important factor for
consideration when assessing suitable models.
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Options for
statutory
regulation
Establishment of a
regulatory authority
for Chinese medicine
in WA
This model would involve establishing a dedicated
regulatory body for the registration of Chinese
medicine practitioners in Western Australian. It
is likely that the regulatory body would be based
on the CMRB of Victoria, which is made up of
three divisions for each of the three registered
modalities, and is administered by one board.
This model is potentially costly with expenses
occurring from establishment of the regulatory
body, including the board, staff, development of
the register, development of guidelines and the
contingency fund and other associated expenses.
The regulatory body is intended to be self-
suffi cient, with all costs of the regulatory body
funded by registration fees. The potentially low
number of practitioners seeking to be registered in
Western Australia would result in registration fees
being set quite high in order to recover costs. This
in turn would raise the cost of Chinese medicine to
the public, as practitioners raise prices to refl ect
their higher operating costs.
Joint arrangement
with another
registration board
A joint arrangement with other States’ registration
boards is a possible model for consideration.
The relatively small number of applicants for
registration in Western Australia means that
this model would enable fees to be kept to a
reasonable level. Additionally, a joint arrangement
would reduce unnecessary duplication of policies,
guidelines and research and would align with aims
for nationally consistent registration arrangements
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for Chinese medicine practitioners. A number of
administrative and legal considerations would need
to be further considered before this model could
be adopted.
For example, there are constitutional barriers
to jointly regulating with another State’s
board because statutory registration of health
occupations is a function of State governments.
However appropriate arrangements could be made
to facilitate a joint arrangement. For example,
each State would have their own board and
regulation body, but the board would be comprised
of the same people across the states. WA would
nominate representatives to the board in the
other State(s), to be appointed by the Minister
for Health in that other State(s), and the other
State(s) would nominate representatives to the
WA board to be appointed by the WA Minister
for Health. Legislation between States would be
comparable to reduce complexity and facilitate
effective carrying out of the powers and functions
of the board.
At present, Victoria is the only other State with
an established registration board for Chinese
medicine practitioners. If a joint arrangement is
the preferred model for regulation of WA Chinese
medicine practitioners, then a joint arrangement
with Victoria would come under consideration.
This would also be subject to Victoria’s approval.
Other States may also be interested in such an
arrangement in the future.
As it is understood that proposing a joint
arrangement may be controversial, further
consultation will be undertaken with key
stakeholders, on receipt of submissions, before
a preferred option for statutory regulation can
be recommended.
2F
Two options for a registration board have been described in this section.
Which option is best suited to registering Chinese medicine practitioners
in Western Australia? Please provide reasons for your answer.
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Protection of Title
Protection of title means that only practitioners
who are registered with the statutory regulatory
body can legally use a particular title.
The aim of protection of title is to protect the
public by ensuring that consumers are able
to identify qualifi ed, competent practitioners.
Protection of title restricts the use of specifi ed
titles to practitioners who have been assessed
as competent to deliver the services associated
with that title.
A common mechanism for protection of title
is to provide that it would be an offence for an
unregistered person to falsely represent him
or herself by using a protected title or lead the
public to believe they are registered. Protection
of title would prevent unqualifi ed practitioners
from advertising Chinese medicine services to the
public. The public’s use of registered and therefore
suitably qualifi ed practitioners may reduce the
costs to the community from injuries incurred
through inappropriate or unsafe practices.1
A competitive advantage is given to registered
practitioners over other related health practitioners
by preventing unregistered people from using the
title. Unregistered persons and other registered
health care professionals would not be prevented
from using the techniques of the profession, and
competing for business in the marketplace. They
are just prevented from using the restricted titles.
Protection of title is the model adopted by a
number of health professional registration Acts in
WA including the Nurses Act 1992, Occupational
Therapists Registration Act 1980 and Psychologists
Registration Act 1976.
The Victorian CMR Act incorporates protection
of title for registering practitioners.
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Levels of
protection
provided by
regulation
Protection of Practice
Protection of practice places restrictions on
the actual techniques and procedures that may
be performed, and includes protection of title.
In addition to enabling consumers to identify
competent professionals, protection of practice
prohibits the practice of activities that have been
identifi ed as carrying signifi cant risks if performed
by unqualifi ed persons. It is not necessary that all
techniques or procedures used by the profession
would be restricted.
The public is provided with a maximum level
of protection by prohibiting unregistered and
unqualifi ed persons from practising certain
procedures. Consumers would be sure that
potentially harmful practices are only undertaken
by adequately trained practitioners. Untrained
practitioners would be prevented from entering
the profession.
Despite the apparent benefi ts, protection of
practice is the most anti-competitive form of
regulation. It bestows a competitive advantage
for registered practitioners who are deemed to
have the training/education to safely undertake
restricted practices. Any restriction of practice
would need to be considered in the context of the
National Competition Policy.
The enforcement of the restrictions may also be
diffi cult for disciplinary purposes. For example
it may be diffi cult to prove that a person has
practiced a restricted activity. The restriction
of practice has limited effect where registered
practitioners practice beyond their level of
competence.
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2g
Do you support protection of title? Why?
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It would be diffi cult to draft workable defi nitions
for prescribed practices that only registered
practitioners may provide, without affecting the
legitimate scope of other professions. This type of
protection may hinder innovation and improvement
of techniques within the registered group and by
other professional groups with closely related
areas of practice.1
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he modalities being considered for
registration in Western Australia are:
• Chinese herbal medicine practitioner
• Acupuncturist
• Chinese herbal dispenser
This is consistent with regulation of Chinese
medicine practitioners in Victoria. The CMR Act is
based on the position that, at present, only these
three modalities of Chinese medicine have the
potential to be so hazardous to public health and
safety as to require statutory regulation.
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Who will be
registered?
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Other modes of complementary medicine
treatment, such as dietary therapy, physical/
exercise therapy, and massage therapy are not
considered to pose such a risk to the public
that they should be subject to registration
requirements. Other modalities remain regulated
under general law (including consumer protection
and public health legislation) and practitioners
practising in these areas may choose to
self-regulate.1
2H.1
There are three modalities being considered for regulation in Western Australia.
Do you support the regulation of Chinese herbal medicine practitioners,
acupuncturists and Chinese herbal dispensers? Please explain your answer.
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Other registered health
practitioners in WA
Section 1E, page 7, provides information on how
other registered health practitioners in Victoria are
being authorised by their own registration boards
to use protected titles. Chiropractors, dentists,
medical practitioners, nurses, optometrists,
osteopaths and physiotherapists may apply to be
registered as acupuncturists, and pharmacists are
able to register to dispense Chinese herbs.
Any standards to be determined by other
registration boards in relation to qualifi cations
and training required of practitioners for
acupuncture and Chinese herbal dispensing,
would need to be examined. An option would be
to require that the standards of qualifi cations
and training required by other registration boards
are similar to the level required by the Chinese
medicine registration board.
2H.2
Would a system similar to Victoria be suitable for Western
Australian health practitioners?
What measures could be implemented to ensure that other registered
health practitioners have suffi cient level of education and training
to ensure public safety?
Please provide the reasons for your answer.
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How will
registration
occur?
he registration Act will authorise the
regulatory board to grant registration to a
practitioner. This authority will enable the
regulatory board to attach conditions, limitations
and restrictions and to refuse registration on the
grounds set out in the registration Act.
What registration
criteria would be
applied?
It is proposed that registration requirements
for acupuncturists, Chinese herbal medicine
practitioners and Chinese herbal dispensers
would be consistent with the registration
requirements set out in the Western Australian
health practitioner template legislation.
The applicant must:
• be a fi t and proper person;
• have adequate knowledge of the English
language, written and oral;
• possess suffi cient physical and mental
capacity, and skill to practice;
• have the knowledge and practical experience
in the particular profession being registered;
• be qualifi ed; and
• have made adequate arrangements for
professional indemnity insurance.
There is considerable overlap between these
requirements and the key assessment areas for all
applicants for general registration to the CMRB of
Victoria which are:
• adequacy of qualifi cation (minimum
requirements);
•
recency of practice;
• competence;
• good character;
• fi tness to practice;
• having the required professional indemnity
insurance;
• fi rst aid; and
• effective communication arrangements and
English language profi ciency.
Some of these assessment areas are considered
in more detail below.
Qualifi cations
Victoria
A person is qualifi ed under section 5 of the CMR
Act for general registration with the CMRB of
Victoria if they;
a) have successfully completed an approved
course of study; or
b) have a qualifi cation that is substantially
equivalent to an approved course of study: or
c) have passed an examination set by the Board:
or
d) hold a qualifi cation that is recognised in
another State or Territory.
Currently the courses approved by the CMRB of
Victoria are:
RMIT University, Division of Chinese Medicine
• Bachelor of Applied Science (Chinese
Medicine) & Bachelor of Applied Science
(Human Biology) double bachelor
undergraduate program
• Master of Applied Science (Acupuncture)
• Master of Applied Science (Chinese
Herbal Medicine)
• Bachelor of Health Science (Chinese Medicine)
• Bachelor of Applied Science (Human Biology-
Chinese Medicine major) & Bachelor of Applied
Science (Chinese Medicine) double bachelor
undergraduate program
• Bachelor of Applied Science
(Chinese Medicine)
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Australian College of Natural Medicine
• Bachelor of Health Science (Acupuncture)
• Advanced Diploma of Acupuncture
Southern School of Natural Therapies
• Advanced Diploma of Traditional
Chinese Medicine
Other courses are under consideration by the
CMRB of Victoria. More information is available at
the CMRB of Victoria website (http://www.cmrb.vic.
gov.au/registration/approvedcourseintro.html).
The CMRB of Victoria registers Chinese medicine
practitioners for specifi c registration where the
applicant holds qualifi cations in Chinese medicine
which do not qualify that applicant for general
registration. Specifi c registration would enable
an applicant to undertake further study or fi ll a
teaching or research position in Chinese medicine
at a tertiary institution as approved by the Board.
Western Australia
In Western Australia, there is currently no tertiary
level (university) course for Chinese medicine.
Independent organisations throughout the Perth
metropolitan area offer a range of courses in
Chinese medicine.
Practitioners who have completed courses and
training that are not approved, would be required
to demonstrate their knowledge and competence
to practice, in order to register as a Chinese
medicine practitioner in Western Australia. This
could be achieved through the grandparenting
arrangements established by the board (see
section 2J What grandparenting arrangements
would be made? page 29).
Recency of Practice
Recency of practice refers to the experience and
competency of practitioners. Practitioners have
the responsibility of ensuring they maintain their
knowledge and skills. The CMR Act empowers
the CMRB of Victoria to refuse renewal if the
CMRB of Victoria believes the applicant has not
had suffi cient experience in the practice in the
preceding 5 years.
Where the practitioner cannot demonstrate
recency of practice, the CMRB of Victoria requires
the practitioner to complete one clinical practice
unit from within a CMRB-approved course with a
minimum of 200 hours.
The WA health practitioner template legislation
requires applicants to have practiced in the
profession within the 5 years preceding the
application or have acquired suffi cient knowledge
and practical experience in the profession. This
requirement does not apply to recently qualifi ed
applicants registering for their fi rst time.
Professional Indemnity
It is proposed that all practitioners registered for
Chinese medicine will be required to be covered
by a level of professional indemnity insurance
as approved by the Board, prior to commencing
practice as a registered practitioner and
maintained at all times during practice.
Good Character / Fit and Proper Person
People with convictions of crimes relating to
dishonesty or violence, where there is concern that
the offence is such that they are considered unfi t
to practice, should be excluded from registration.
The intent for including the requirement of good
character in the registration criteria is foremost to
support the aim of the legislation in protecting the
public, by ensuring people of disreputable nature
are not able to gain credibility by registering.
Competency in the English Language
It is proposed that practitioners would be required
to be competent in the English language to be
allowed to register. Competency in the English
language would ensure that Chinese medicine
practitioners are able to read and comprehend
conventional western medical prescriptions, are
able to communicate with the growing number of
Australian’s using Chinese medicine, and are able
to contact emergency services in the event of an
adverse reaction to treatment by a patient.
The health practitioner template legislation
contains a requirement for ‘adequate knowledge
of the English language both written and oral’
(Section 22(2)(b)). Knowledge of English is also
a criteria included in other WA registration
legislation such as the Nurses Act 1992 and the
Medical Act 1894.
It is recognised that a large proportion of
Chinese medicine practitioners have non-English
speaking backgrounds (NESB). A ‘competency
in English’ criteria could hinder the regulation
of these otherwise competent practitioners. To
accommodate such practitioners the following
measures have been identifi ed:5
• Special provision in ‘grandparenting
arrangements’ to enable NESB practitioners
to register based on age and years of safe
practice;
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• Development of guidelines for practitioners
on how to ensure adequate communication
between patient and practitioner where
language barriers exist, particularly to ensure
that patients are able to understand the
instructions relating to their treatment and
administration of Chinese medicine; and
• Development of standards so the practitioner
ensures that the patient has access to a person
with suffi cient competence in the English
language to respond to an
emergency situation.
First Aid
The CMRB of Victoria requires registered
practitioners to hold a current First Aid Certifi cate
Level 2 or have another person present at the clinic
that holds a current First Aid Certifi cate Level 2.
Chinese medicine does have the potential for
complications, and practitioners are responsible
for being aware of potentially dangerous situations
and possible adverse effects arising from the
provision of their services. It is essential that
practitioners be able to administer fi rst aid and
refer patients to appropriate conventional medical
treatment when necessary.
2i
All applications for registration will be assessed against the registration
criteria by the board.
What registration criteria should be adopted? Please explain your answer.
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What
grandparenting
arrangements
would be made?
3 1
randparenting involves the assessment
and registration of existing practitioners where
the qualifi cations of these existing practitioners do
not meet the standards set by a newly established
regulatory body, but who may otherwise be
professionally competent. Grandparenting
arrangements would need to be established to
determine which practitioners are eligible for
registration when regulation is introduced.
Various grandparenting arrangements recognise
that practitioners currently in practice have a
wide range of training, skills and experience. The
arrangements aim to ensure a standard of practice
that will provide the necessary protection for the
public while aiming to be as inclusive as possible.
Factors taken into consideration under
grandparenting schemes could include:6
• Recognition of professional membership:
Membership of a particular professional
association at a specifi c point in time or
for a certain length of time might be used
as the requirement for initial registration.
This should only apply where professional
associations have a long history of adherence
to minimum professional standards, codes of
conduct, evidence of having policed their own
membership, requirements for continuing
education and professional development.
Furthermore, a history of carefully assessing
the qualifi cations for entry to membership
through activities such as examination or
assessment of prior learning is important.
A potential diffi culty is the possibility of a
signifi cant increase in membership of an
association immediately before submission of
the membership record to a regulatory board.
This is of concern particularly where sound
protocols for admission to membership are
not followed.
• Assessment of qualifi cations: The regulatory
board would establish criteria for the evaluation
of qualifi cations. While it would not be
expected that those applying for registration
through the grandparenting arrangements
would be at the same level as registrants who
hold the prescribed qualifi cations, they would
be expected to meet minimum qualifi cations
for safe practice at a basic level. They could be
required to undergo additional education and
training prescribed by the board in order to
obtain a higher level of registration should this
be mandatory for the privilege of being able to
prescribe therapeutic substances on
a ‘restricted’ or ‘poisons’ list.
• Competency-based assessment:
Practitioners could be assessed against
pre-determined competency-based professional
standards and performance indicators.
However, it might be more effective to link the
assessment to a program of education and
training.
• Education and training: To qualify for
registration, registrants might be required to
undertake a program of training, using a range
of methods, and assessment.
• A standard examination: Those seeking
registration whose qualifi cations are not
accepted under other criteria might be required
to sit a formal examination to assess their skills
and knowledge in Chinese medicine.
Practitioners may be registered based on a
combination of their qualifi cations and experience
in Chinese medicine practice. This type of
arrangement would enable practitioners with
overseas qualifi cations and/or long standing
practices to be registered. Applications would
be considered on a case-by-case basis by the
regulatory body.
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The grandparenting arrangement would
be available for a set time period from the
commencement of the register. In Victoria the
transition period was three years, while the New
South Wales discussion paper1 indicated that the
proposed period for grandparenting provisions is
typically one to two years. A person could not use
the protected titles until they were registered,
and risked disciplinary proceedings if they chose
to use the protected titles when they were
not registered.
Registration of practitioners who may be
professionally competent, yet do not comply
with the criteria for registration, could be
granted registration for a limited period while
they gain further qualifi cations to assist them
meet the criteria.
Following a transitional period, the grandparenting
provisions would cease to exist and practitioners
wishing to register after that time would be
required to apply for registration in the same
manner as other applicants.
Victoria’s
Grandparenting Policy
Victoria developed a Grandparenting Policy
following the establishment of the Chinese
Medicine Registration Board (CMRB) of Victoria.33
Following the commencement of the register,
the CMRB of Victoria allowed the registration
of practitioners under the grandparenting
arrangements for a three-year transitional period
from 1 January 2002 to 31 December 2004.
For a person to qualify under the grandparenting
policy, the CMRB of Victoria had to be satisfi ed
that the person:
1. was professionally competent; AND
2. had either:
• obtained a qualifi cation or undergone
training in Chinese herbal medicine,
acupuncture or herbal dispensing that was
considered by the CMRB of Victoria to be
adequate; or
• obtained a qualifi cation or undergone
training that was not, by itself considered
to be adequate, but had also successfully
undergone any further study, training or
supervised practice required by the CMRB
of Victoria; or
• carried on the practice of Chinese
herbal medicine, acupuncture or herbal
dispensing for a total of fi ve years out of the
last ten years prior to the Chinese Medicine
Registration Act (2002) coming into effect;
AND
3.
if required, had successfully completed an
examination set by the CMRB of Victoria.
Professional competence was determined by,
for example, a minimum of ten years professional
practice or fi ve years professional practice
and Australian or international qualifi cations
meeting CMRB of Victoria requirements, or recent
graduation from an accredited course in Australia.
The CMRB of Victoria also took into consideration
other relevant matters such as the grounds for
refusing registration as set out in the Victorian
Chinese Medicine Registration Act 2000. These
mostly referred to the applicant’s character, their
professional competence, physical and mental
capacity to practice and whether they had been
guilty of an offence.
While the Board had the authority to refuse
registration where the applicant was not
suffi ciently competent in English, under
grandparenting arrangements, the Board
was unlikely to refuse registration to existing
practitioners, on the sole basis of their lack of
competence in English.
3 2
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Grandparenting arrangements provide for the registration of existing competent
practitioners that do not have the formal qualifi cations for registration.
What factors or combination of factors for grandparenting arrangements
for Chinese medicine practitioners in Western Australia would be fair and
equitable while ensuring the safety of the public?

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• Trade Practices Act 1974 (Cth), Fair Trading
Act 1987 (WA) 34
Provides for consumer protection laws that
prohibit health practitioners from engaging
in false and misleading conduct.
• Health Services (Conciliation and Review)
Act 1995 (WA)

Establishes the Offi ce of Health Review. The
Offi ce is empowered to investigate complaints
about a provider of a health service.
• Therapeutic Goods Act 1989 (Cth)

Sets out the legal requirements for the import,
export, manufacture and supply of medicines
in Australia, and their quality, safety, effi cacy
and timely availability. This Act also covers
requirements for listing or registering goods
on the Australian Register of Therapeutic
Goods, along with advertising, packaging
and labelling. Furthermore, it provides a
substantially uniform national system of
controls over therapeutic goods, facilitating
trade between States and Territories and
benefi ting both consumers and industry.2
• Health (Skin Penetration Procedure)
Regulations 1998 (WA)

Provides that no person (with the exception
of medical practitioners, dentists, podiatrists
and nurses) may carry out any procedures that
penetrate the skin unless certain requirements
are met. Currently, owners of establishments
where acupuncture and other skin penetration
procedures are carried out must notify the local
government of the name and address of the
establishment.
• Mutual Recognition Act 1992 (Cth),
Mutual Recognition (WA) Act 2001

Under the provisions of the Mutual Recognition
Act 1992 health practitioners registered in one
State or Territory are automatically entitled to
registration in any other State that registers
that occupation. Conditions may exist for
automatic registration, such as lodgement
1

Other
relevant
legislation
of a statutory declaration. The mutual
recognition scheme overrides the provisions
of health practitioner legislation dealing with
reciprocal recognition of health registration
bodies and health practitioners.
• Poisons Act 1964 (WA)

Sets out the controls for the regulation
of drugs, medicines and other controlled
substances in Western Australia. This Act
controls the manufacture, packaging, labelling
and storage of poisons. The prescription
of certain types of drugs for diagnostic or
therapeutic use in humans is limited to
registered medical practitioners, dentists,
veterinarians and pharmaceutical chemists
(dispensing only).
• State Administrative Tribunal Act 2004 (WA)

Creates the authority and the framework for
the resolution of a wide range of disputes
and appeals and will work towards achieving
resolution of questions, complaints or disputes
and make or review decisions within its area
of authority. The Tribunal has the authority to
review licensing decisions for a range of areas
and a wide range of disciplinary functions over
professions, occupations and businesses.
Furthermore, the Tribunal will enable the
separation of the licensing and registration
functions carried out by occupational boards
from the disciplinary function.
• Taxation Legislation

Following the introduction of the national
Goods & Services Tax, services provided by
acupuncturists, naturopaths and herbalists
were GST-free for three years from 1 July 2000.
At 1 July 2003, only practitioners who were
‘recognised professionals’ were entitled to
provide GST-free services. Status of ‘recognised
professional’ was seen as being established
through some kind of national or state
regulatory system either statutory imposed or
self-regulation through national professional
associations.
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