1.1 Overview
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 involved a major research project to collect information on the risks and benefits of TCM and the nature of the TCM work force; and to consider the need, if any, for registration of TCM practitioners and regulation of Chinese herbal medicines. The outcome was that the researchers recommended to the Australian Health Ministers Advisory Council (AHMAC) and to all State 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 a suitable regulatory framework for the practice of TCM in Australia, and to call for public submissions regarding these options.
Traditional Chinese Medicine (TCM) has a history of over 2,000 years in China and in recent times, it has expanded rapidly in most westernised countries. In Australia in 1996-97, the Commonwealth Health Insurance Commission paid over $17.7 million in Medicare rebates for 960,000 acupuncture treatments by registered medical practitioners (1). There has been a similar increase in the practice of other aspects of Traditional Chinese medicine, including herbal medicine, therapeutic massage, manipulation, dietary therapy and exercise therapy.
The Victorian Department of Human Services (formerly Department of Health and Community Services) commenced its review of TCM in August 1995. The impetus for the review arose from:
The University of Western Sydney (Macarthur) and Southern Cross University won the tender to conduct the research project. Departments of Health in New South Wales and Queensland agreed to fund the research jointly with Victoria, resulting in a total research grant of $125,000 ($80,000 from Victoria, $40,000 from New South Wales, and $5,000 from Queensland).
The resulting research report, Towards a Safer Choice: The Practice of Traditional Chinese Medicine in Australia, was launched by the Victorian Minister for Health the Hon. Rob Knowles in November 1996. The researchers found that the risks in the practice of TCM relate primarily to the practice of acupuncture and Chinese herbal medicine, which have resulted in at least five documented deaths in Australia. Towards a Safer Choice identified a number of factors likely to contribute to increasing public health risks, including:
Chapter 2 summarises the findings of the report, and its Executive Summary is reproduced in Appendix 1. Copies of the report are available for sale from:
The Faculty Manager, Faculty of Health
University of Western Sydney, Macarthur
PO Box 55 Campbelltown
NSW 2560
Tel: (046) 203 347
Fax: (046) 254 252
It is also available on the Internet at:
http://www.dhs.vic.gov.au/phd/hce/chinese/report/contents.html
Most practitioners and their representative organisations are in support of occupational registration as a method of protecting the public from untrained practitioners, and the review, through its recommendation, has raised expectations about registration of practitioners and regulation of herbal preparations.
Regulation will take place in the context of a number of international, national, and State initiatives, and these are outlined in the remainder of this chapter.
1.2 Commonwealth initiatives in drug regulation
In mid 1996, the Commonwealth Department of Health and Family Services appointed KPMG to review its Therapeutic Goods Administration (3).
At the same time, an Alternative Medicines Section was established within this Administration, and in October 1996 an Alternative Medicines Summit was held. The Summit noted that "complementary health practitioners who want to be able to prescribe treatments for their patients need to achieve accreditation as a step towards accessing a wider range of medicines" (4).
In response to the KPMG review, the Commonwealth in April 1997 released a statement on drug regulation, in which it recognised the importance to practitioners of the issue of access to scheduled herbs which they have been trained to use, and the fact that such practitioners are currently excluded from such access. At the same time, given that scheduled substances can be dangerous if used by untrained people, the Government asserted the need to restrict use to appropriately qualified practitioners. It recognised the need for a standardised system of training and accreditation, and supported the recommendations to pursue the issue of competencies for professional associations through AHMAC. As practitioner accreditation is a State/Territory responsibility, the Government encouraged State and Territory governments to collaborate on this issue. (5)
Changes proposed in the document included:
1.3 Recent overseas developments
Chapter 9 of Towards a Safer Choice outlined the regulatory approaches in different parts of the world. A number of further developments have occurred since the report was published:
WHO: Following a Consultation on Acupuncture in November 1996, WHO is believed likely to ratify recommendations that the practice of acupuncture be regulated.
Hong Kong: Following on from the Hong Kong Government's Report of the Working Party on Chinese Medicine, a legislation committee has been established to develop a proposal for regulation.
Singapore: The Ministry of Health has established a TCM Unit to oversee and coordinate the development of a regulatory framework for acupuncture and TCM.
Malaysia: The Ministry of Health has recently commenced a review of Traditional Medicines, with a view to recognising and supporting practice and creating a suitable regulatory framework.
1.4 Steps towards mutual recognition
Australian Health Ministers have agreed that mutual recognition is an important first step towards agreed national standards for each health occupation. Mutual recognition helps to ensure that health practitioners registered in one State or Territory are automatically entitled to registration in any other state that registers that occupation. One implication of this is that the minimum standard of education set by one State for registration of practitioners becomes the standard for registration in all other States.
At a special Heads of Governments meeting in May 1992, the Mutual Recognition Agreement was reached between all State and Territory Governments and the Commonwealth. The Commonwealth Mutual Recognition Act 1992 contains the requirements of mutual recognition. Each State has now passed legislation adopting the provisions of that Act. The legislation is designed to promote freedom of movement of goods and services in an integrated Australian market.
As part of the application of Mutual Recognition principles, Australian State and Territory Health Ministers agreed in 1993 that no further action would be taken to regulate any additional health occupations unless the need for doing so had been agreed by the Australian Health Ministers' Conference (via AHMAC).
1.5 Australian Health Ministers' Advisory Council
AHMAC, made up of the heads of all State and Commonwealth health departments, meets regularly to make recommendations to State, Territory and Federal Health Ministers on matters of common concern.
In 1993, AHMAC agreed that before any State proceed with a proposal to register an unregistered health occupation, a majority of States should agree that such registration was required. AHMAC established a working group with representatives from a number of States, to examine and make recommendations concerning the need for occupational registration of any new health practitioner group (6). The working group formulated six criteria for assessing the regulatory requirements of unregulated health occupations (see Appendix 3), which addressed questions similar to those addressed under National Competition Policy:
In 1995, the AHMAC Working Group on Criteria and Processes for Assessment of Regulatory Requirements of Unregulated Health Professions was requested to use the criteria to assess submissions already received from currently unregulated health occupations, requesting regulation. All TCM groups making submissions to AHMAC were encouraged to make a single submission addressing the criteria, and acupuncture and Chinese herbal medicine were considered part of the occupation of TCM for the purposes of evaluation.
In September 1996, the Working Group met to consider the joint submission from the profession, along with the findings of Towards a Safer Choice. At its February 1997 meeting, AHMAC received the final report of the Working Group, and accepted its recommendation:
That States/Territories/Commonwealth should determine the efficacy of their legislation and regulation to respond to the public risks identified in Towards a Safer Choice: The Practice of Traditional Chinese Medicine in Australia, and take remedial action to resolve any problems which are identified. This efficacy assessment should take into account possible improvements to consumer complaints mechanisms to enable consumers of alternative and/or complementary therapies to make complaints about therapies and therapists. (8)
1.6 Victorian initiative
At the launch of the report Towards a Safer Choice, the Victorian Minister for Health announced the formation of a Ministerial Advisory Committee on Traditional Chinese Medicine to assess the findings of the report and make recommendations on a regulatory framework for Victoria. The Committee is chaired by the Minister's Parliamentary Secretary, Mr Robert Doyle MP. Two sub-committees have been set up: the Primary TCM Practitioners Sub-Committee, representing practitioners whose main form of practice is TCM, and the Generalist TCM Practitioners Sub-Committee, representing generalist health care practitioners who use one or more modalities of TCM. Membership and terms of reference of these committees is given in Appendix 2.
AHMAC, at its February 1996 meeting, endorsed the Victorian review process for TCM and agreed to consider recommendations arising from the review in determining policy matters relating to occupational registration of the profession TCM. In February 1997, Victoria sponsored a paper to AHMAC to provide advice on the outcome of the research, and to propose that further work be undertaken on a framework for regulation of TCM practice. The following recommendations were adopted by AHMAC:
That the TCM report be noted and that Victoria take the lead in exploring the feasibility of occupational regulation of Traditional Chinese Medicine, namely:
5. That Victoria report back to AHMAC on the outcome of the review committee's work. (9)
Following this process, AHMAC will make a decision on whether to recommend to State Health Ministers that TCM practitioners be registered and herbal preparations regulated in every State and Territory. This decision will be informed by information on risks and benefits associated with the practice of TCM and the adequacy of the existing regulatory framework to protect public health. Each State and Territory Health Minister may then consider options for formulation of policy on regulation of practitioners and herbal preparations.
1.7 National Competition Policy
The review of TCM is being conducted within the context of National Competition Policy. The National Competition Policy Review (the Hilmer Report) was presented to the Council of Australian Governments in August 1993, and Commonwealth, State and Territory Governments agreed to a combined approach to competition policy, to improve Australia's economic competitiveness within the global market.
Complementary arrangements have been put in place at the State and Territory level to give effect to the National Competition Policy. The Competition Policy Reform (Victoria) Act 1995 came into effect on 21st July 1996, accompanied by complementary Guidelines for the Review of Existing Legislation and Guidelines for the Application of Competition Test to New Legislative Proposals.
Under the guidelines, regulatory proposals such as occupational registration that have the effect of limiting the number of persons engaged in an occupation and preventing any other party from engaging in certain activities of that occupation, are deemed to be restrictions on competition unless proved otherwise. Such restrictions are seen as tending to promote unwarranted rigidities in the workplace and segmentation in the labour market.
Under National Competition Policy, the 'competition test' must be applied to all new regulatory measures, including Acts of Parliament, ordinances, and regulations. Any regulatory measure which might restrict competition must demonstrate that:
When proposed legislation contains competition restrictions, the Minister for Health must obtain a certificate from the Premier to the effect that the restriction has been justified in the public interest (10). Any restrictions on competition contained in proposed health practitioner legislation will therefore come under close scrutiny.
1.8 Approach to regulation in Victoria
In 1987, the Victorian Health Department conducted a review of health practitioner registration. The resulting report, entitled Review of Registration for Health Practitioners, identified the need to standardise the State Government's approach to regulation of health occupations by applying a consistent and "least restrictive" model that focussed on risk of harm and evaluation of alternatives to regulation ( 11,12 ). Since this time, five registration Acts have been passed. The most recent Acts have undergone an assessment under National Competition Policy and provide a model for regulation by statute: Chiropractors Registration Act 1996 and the Osteopaths Registration Act 1996.