Department of Human Services,
Victoria, Australia
Complementary Therapies/Traditional Chinese Medicine
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September 1997
1.1
Overview
1.2 Commonwealth initiatives in drug regulation
1.3 Recent overseas developments
1.4 Steps towards mutual recognition
1.5 Australian Health Ministers' Advisory Council
1.6 Victorian initiative
1.7 National Competition Policy
1.8 Approach to regulation in Victoria
2. The Research Report: Towards A Safer Choice
2.1
Background
2.2 Key findings
2.3 Risks inherent in TCM
2.4 Analysis of risk
2.5 The need for regulation: assessment against
the AHMAC criteria
3.1
Models of self-regulation
3.2 Occupational regulation via statute
3.3 The Victorian model of health practitioner
registration
3.4 A typical registration Act: protection of
title
3.5 State versus national approaches
4. Issues to be Considered in occupational Regulation
4.1
How might a TCM registration board be constituted?
4.2 What powers might a TCM registration board
have?
4.3 What modalities of TCM might be regulated?
4.4 Protection of title versus protection
of practice
4.5 Which titles might be protected?
4.6 How might standards be set?
4.7 What grandfathering arrangements would
be made?
4.8 What about non-English speaking practitioners?
4.9 How should access to and prescribing of
scheduled herbs be regulated?
4.10 Should dispensing of raw herbs be regulated?
4.11 How might a regulatory system be funded?
4.12 Generalist health care practitioners
who are already registered
4.13 Practitioners of other complementary
therapies
4.14 Other traditions of acupuncture
Appendices
Executive
Summary of Towards a Safer Choice: The Practice of Traditional Chinese
Medicine in Australia Ministerial
Advisory Committee on TCM AHMAC
Criteria for Assessing the Need for Statutory Regulation of Unregulated
Health Occupations Addressing
the AHMAC Criteria Options
for Regulatory Reform The
Australian Traditional Medicine Society Executive's Proposal for Self-Regulation The
Victorian Health Practitioner Registration Model
Traditional Chinese Medicine (TCM) has become increasingly popular throughout Australia over recent years, and its practice now represents a signficant component of the total health care industry. The evidence is that this trend will continue, and that more and more Australians will see TCM as playing an important role in maintaining their health.
It is essential that the practice of TCM is safe to the public. This requires that TCM training be of a high standard, that the public and other health care practitioners are easily able to identify practitioners who are well qualified, and that consumers have access to effective mechanisms to deal with any complaints that may arise.
The release of this public discussion paper represents the second stage of a review process that was initiated in August 1995 in Victoria. The first stage was completed with the launch, in November 1996, of the report Towards a Safer Choice. This represents the most significant study of TCM yet done in Australia and has received positive reviews both in Australia and overseas. The report recommended statutory-based occupational regulation of TCM as the best method of ensuring adequate public safety.
The purpose of this paper is to outline the work to date, including
the main findings and recommendations of Towards a Safer Choice, to detail options for regulation of TCM practitioners, and to
call for public submissions on these options. Two key models are
outlined. The first is self-regulation via an independent body
established cooperatively by professional associations of TCM.
The other involves setting up State
registration boards under State and Territory legislation, similar
to those that register medical practitioners, nurses, physiotherapists,
chiropractors, and various other health care practitioners.
The review is being conducted within the context of National Competition Policy. Any new regulatory measure that might restrict competition must demonstrate that the benefits of the restriction to the community as a whole outweigh the costs, and that the objectives of the legislation can only be achieved by restricting competition. Thus, before adopting the recommendations of Towards a Safer Choice, State and Territory Health Ministers must be satisfied that self regulation is not an effective option for protecting the public.
Recommendations arising from this public consultation process will inform all State and Territory Health Ministers in determining whether to proceed with statutory based occupation regulation of TCM.
I commend this paper to you and encourage you to use this opportunity to contribute to the review. All Australians are invited to be part of the discussion by making submissions to the Ministerial Advisory Committee on TCM chaired by my Parliamentary Secretary, Mr Robert Doyle, MP. I look forward to hearing all views on these issues.
ROB KNOWLES
Victorian Minister for Health
This document is the second stage of a broad review of the practice of Traditional Chinese Medicine (TCM) undertaken by the Victorian Department of Human Services on behalf of all State and Territory governments.
The first stage was a major research project to collect information on the risks and benefits of TCM, and to consider the need, if any, for registration of TCM practitioners and regulation of Chinese herbal medicines. The researchers published their results in the report, Towards a Safer Choice: The Practice of Traditional Chinese Medicine, in November 1996, which recommended to the Australian Health Ministers Advisory Council (AHMAC) and to all State and Territory governments that occupational regulation of the profession of TCM proceed as a matter of urgency.
The purpose of this document is to set out the context and options for achieving regulation of TCM in Australia, and to call for public submissions regarding these options.
While the Commonwealth has recognised the need for a standardised system of training and accreditation, practitioner accreditation is a State/Territory responsibility.
Any proposal for statutory occupational regulation must be assessed under National Competition Policy. This requires that any regulatory measure which might restrict competition must demonstrate that the benefits of the restriction to the community as a whole outweigh the costs, and the objectives of the legislation can only be achieved by restricting competition.
Towards a Safer Choice
Key findings of Towards a Safer Choice were:
The practice of acupuncture and Chinese herbal medicine carries both inherent risks and risks associated with poor practitioner training. The risks relate primarily to the practice of acupuncture and Chinese herbal medicine, which have resulted in a significant number of adverse events and at least five deaths in Australia.
A number of factors are likely to contribute to increasing public health risks, including a dramatically increased use of TCM, increasing demands on practitioners to use Chinese herbal medicine in a wide range of clinical presentations, difficulty in controlling the importation of Chinese therapeutic goods, widely varying levels of TCM training, and the impact of National Competition Policy in undermining efforts at self-regulation by TCM professional associations.
There is a link between length of training in TCM and self-reported adverse incident rates. However, while there is general agreement among non-medical professional associations on the length and content of TCM courses, the profession has been unable to enforce such a standard under a self-regulatory system.
There is significant black market activity in the importation of unlisted and/or unregistered patent medicines, and there are deficiencies in the Commonwealth's ability to address this problem. Tighter regulation of importation of raw herbs and patent medicines are needed in order to protect the public adequately.
There is considerable fragmentation within the TCM profession, with 23 separate professional associations existing. Given such fragmentation and vested interests, a self regulatory approach to setting standards of practice will continue to be unsuccessful.
AHMAC has formulated six criteria for assessing the regulatory requirements of unregulated health occupations; essentially, is registration the most direct, effective and least restrictive way of dealing with a significant risk of harm to public health and safety, and do the benefits of regulation clearly outweigh the potential negative impact?
Towards a Safer Choice concludes that on balance, the benefits of promoting public safety clearly outweigh the potential negative impacts of occupational regulation.
Options for regulation
The two basic options for regulation of the TCM profession are self-regulation, and occupational regulation by statute, as recommended in Towards a Safer Choice.
Before adopting the recommendations of Towards a Safer Choice, State and Territory Health Ministers must satisfy themselves that self-regulation is not an effective option for protection of public health and safety. There are a number of obstacles to achieving a level of self-regulation that adequately protects the public; in particular, the fragmentation of the profession and lack of agreement on standards, the deregulation of TCM education, and difficulties in creating incentives for voluntary certification, resulting from the introduction of National Competition Policy. Those advocating self-regulation need to address these problems.
The researchers recommended statutory regulation of the profession
using a model based on protection of title rather than licensing
for protection of practice. They argued
that such a model would promote uniform standards of education
and training for safe practice, and enable the public and other
practitioners to identify appropriately qualified, safe TCM practitioners.
It would also provide an enforceable mechanism for dealing with
wrongdoing by practitioners and require practitioners to carry
adequate indemnity insurance.
Victoria provides a model for occupational registration of health practitioners via statute, in which a registration board is established under a State Act of Parliament and is independent of government. The purpose of regulation, in this model, is to protect the public rather than professional interests. Registration is based on protection of title: it is an offence for non-registered persons to use the protected title or to hold themselves out as being registered. The legislation does not define or restrict the practice of the profession. Registration boards have a broad range of disciplinary options, including informal hearings in appropriate cases.
Issues to be resolved
This review seeks comment on a number of specific questions regarding the regulation of TCM:
Can self-regulation can be effective given the difficulties in implementation associated with fragmentation of the profession, the deregulation of education, and the significant range of standards of practice? Is continuing self-regulation likely adequately to protect the public?
If registration by statute proceeds, what is a suitable size and composition for a registration board for TCM?
What powers does a registration board require (for example, the power to register suitably qualified persons, accredit courses, establish standards for registration, investigate complaints)?
Which modalities of TCM should be regulated (for example, acupuncture, Chinese herbal medicine)?
Should legislation cover protection of practice rather than protection of title? For example, should the practice of acupuncture and the prescribing of certain herbs be restricted via legislation to only those practitioners with an acceptable level of training?
The Victorian model and that recommended for TCM by Towards a Safer Choice is based on 'protection of title'. This means that use of certain titles (for example, Registered Chinese Medicine Practitioner, Registered TCM Practitioner etc.) would be restricted to those who have the accredited qualifications and are registered practitioners under the relevant registration Act. If this model is recommended, which title(s) should be protected?
How might the profession develop suitable standards of practice, and what should these standards address?
If occupational registration is introduced, what arrangements should be made for "grandfather" practitioners (existing practitioners who do not hold the qualifications newly prescribed by the regulatory authority)?
What about non-English speaking practitioners, given that a significant
number of TCM practitioners come from China? What issues face
these practitioners, and what
standard of English might be required for registration?
How should access to and prescribing of scheduled herbs (that is, those currently restricted to prescription by medical practitioners, dentist and veterinarians only) be regulated? What mechanisms should be used for controlling the prescribing and labelling of a range of herbs that are considered a risk to public health if incorrectly prescribed or administered?
How should dispensing of raw herbs be controlled? What role, if any, should registered pharmacists have in the dispensing of herbs?
How might a regulatory system be funded? Is the profession prepared to finance, via registration fees, the operation of a registration board? What is an acceptable fee level?
How should standards of practice in TCM be set and monitored for practitioners registered under another health practitioner registration Act (for example, medical practitioners)?
What is a suitable approach to the regulation of unregistered practitioners of other forms of complementary medicine (for example, naturopathy or massage therapy) who use TCM modalities such as acupuncture?
What provisions should be made for practitioners of other traditions of acupuncture, notably 'Ayurvedic Acupuncturists', and for veterinary acupuncturists?
Submissions are invited from any interested person or organisation, and should be received by the Victorian Department of Human Services no later than Friday 24th October, 1997. Further details are available in the full report.
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