In October 1995, the Victorian Department of Human Services (DHS) (formerly known as Health & Community Services) sought tenders for research into the practice of Traditional Chinese Medicine (TCM) in that State. The Department identified a number of reasons for undertaking the project including:

• a perceived significant increase in the demand for, and use of, TCM by Victorians of all ethnic origins including Chinese;
• complaints from consumers dealt with by the Health Protection Section's Therapeutic Goods Unit (DHS), concerning the use of herbal preparations as well as the difficulties experienced by the Commonwealth Therapeutic Goods Administration in controlling this area;
• a series of visits early in 1995 of officials from the TCM Administration in China, who stressed the need for regulation to the Department and offered support in addressing some of the educational and practice issues; and
• the reconvening of the Australian Heath Ministers' Advisory Council (AHMAC) Working Group Advising on Criteria and Process for Assessment of Regulatory Requirements for Unregulated Health Occupations to examine the need for regulation of the practice of TCM.

1.1.2 Purpose

The Department commenced the review in order to assess:

• risks and benefits associated with the practice of TCM;
• the nature of the TCM workforce in Victoria; and
• the need for legislative regulation of TCM practice in Victoria.

Subsequently, the Health Departments of New South Wales and Queensland joined the Review to expand the study to include their States.

The terms of reference and project requirements for the research are found in the Victorian Department of Human Services document titled "Tender Brief No. 335: Research into the Practice of Traditional Chinese Medicine in Victoria" 25th October 1995. The research component of the review is designed to address seven main areas:

• the nature of the TCM workforce;
• the profile of patients who choose to use TCM;l the risks and benefits associated with the practice of TCM;
• the nature and standards of education of TCM in China and Australia;
• the links between TCM practitioners and other western health care providers;
• the regulatory frameworks in Australia, China, and other countries; and
• the adequacy of the existing regulatory framework and the need, if any, for regulation.

The research project represents the most comprehensive investigation of TCM conducted in Australia or internationally. The project is complex in that it includes practitioners with a wide variety of educational backgrounds and a cultural diversity unmatched in other health occupations. The complexities of the field make it a difficult area to research. TCM itself has a large empirical base of knowledge with little tradition of clinical and experimental research.

1.2 AHMAC Working Group

The Australian Health Ministers' Advisory Council (AHMAC) was formed by State and Commonwealth Health Ministers to advise them on health matters. AHMAC has agreed that no State should proceed to register a new health occupation without agreement from a majority of States.

Legislative registration of health occupations is the responsibility of each State government. To assist in the development of a uniform approach to the regulation of health occupations, AHMAC has established:

• criteria for determining whether to proceed with State-based legislative registration of a new health occupation; and
• processes for assessing applications.

An AHMAC Working Group Advising on Criteria and Process for Assessment of Regulatory Requirements for Unregulated Health Occupations has been formed to assess applications from occupational groups.

In February 1996, AHMAC endorsed the Working Group's recommendations that:

• acupuncture and Chinese Herbal Medicine be considered as part of the occupation of Traditional Chinese Medicine for the purposes of assessment against the criteria for regulation;
• any decision on regulation of Traditional Chinese Medicine be deferred until the completion of the research project being conducted by the Victorian Department of Human Services; and
• all the groups that have made submissions [for regulation] be informed of these decisions and be encouraged to make a single submission addressing the criteria.

The Tender Brief for the research review requires an assessment of TCM in relation to certain AHMAC criteria. Information on risks and benefits associated with the practice of TCM and the adequacy of the existing regulatory framework to protect public health will inform AHMAC decisions on whether to recommend to State Health Ministers occupational regulation of TCM practitioners.

The AHMAC criteria which have been comprehensively addressed in this report are:

• Do the activities of the occupation pose a significant risk of harm to the health and safety of the public?
• Do existing regulatory or other mechanisms fail to address health and safety issues?
• Do the benefits to the public of regulation clearly outweigh the potential negative impact of such regulation?

A full listing of the AHMAC criteria is given in Appendix 1.

1.3 The Research Process

1.3.1 The Victorian TCM Review Committee

Prior to the TCM review project being publicly tendered, the Victorian Department of Human Services established a Victorian TCM Review Committee to oversee and advise the TCM research project. The appointed researchers have held extensive meetings with the Victorian TCM Review Committee on five occasions during the project. Further discussions have occurred throughout the period with individual members of the Committee, including staff from the Victorian Department of Human Services. The membership of the Committee and its terms of reference are included as Appendix 2.

1.3.2 Meetings with Professional Associations

At the commencement of the project, executive members of all professional associations representing practitioners who use some aspect of TCM were invited to attend meetings held in Sydney and Melbourne. Representatives included:

• those from dedicated professional associations, that is, whose members only practice TCM; and
• those from associations whose members practice some aspect of TCM as part of other health occupations, for example, medical practitioners who practice acupuncture.

At these meetings advice was sought on aspects of the review (including the piloting of a workforce survey and patient information form). Interviews and discussions were subsequently held with a broad range of executive representatives and their members.

A further three follow-up meetings were held with representatives of medical practitioners involved in practising some aspect of TCM (usually acupuncture). These meetings were held to discuss the main areas of concern regarding occupational boundaries, and the competing views amongst professional associations on the ability of groups to practice TCM competently and safely. The outcome of these meetings was agreement on a set of principles which are reflected in the recommendations of this report.

1.3.3 Meetings with Departmental Staff and Government Agencies

Meetings were held with senior officers of the Victorian Department of Human Services, the NSW and Queensland Departments of Health. The purpose of these meetings was to provide progress reports on the findings of the investigators and to create opportunities for discussion and clarification of any implications of final recommendations.

Selected interviews (face to face and via telephone) were also held with senior staff of the Federal Therapeutic Goods Administration, the Australian Quarantine Inspection Service, and importers of Chinese herbal medicines. Amongst overseas contacts, direct interviews were held with senior executives from:

• the State Administration of TCM (China);
• a principal author of the Hong Kong Report of the Working Party on Chinese Medicine (1994); and

Written communication occurred with the Traditional Remedies Surveillance Branch of the Medical Toxiciology Unit at Guy's and St Thomas Hospital Trust, London and with TCM professional association representatives in the United States and the United Kingdom. All communications have been extremely helpful and confirm that similar issues are faced by many overseas governments.

1.3.4 Publications
The Interim Report

A progress report was provided to government in April 1996 outlining the findings to date. This Interim Report addressed in brief:

• risks and benefits associated with the practice of TCM, particularly with acupuncture and herbal preparations;
• existing regulations covering TCM in Australia and other countries; and
• key stakeholders concerned with the practice of TCM in Australia.

This information was intended to provide a basis for discussion with and comment from the TCM sector. More extensive chapters on these segments of the research review were made available to the Victorian TCM Review Committee and to external advisors for comment prior to the inclusion of these chapters in this final report.

Newsletters

One newsletter has also been published by the Victorian Department of Human Services and widely circulated to keep the profession, the public and relevant agencies informed of the progress of the review. A second newsletter will be published at the time of this final report in order to communicate more widely the findings and recommendations contained herein.

1.3.5 External Advisors

A number of key external advisors have contributed to this report and its findings. Associate Professor Evan Willis, School of Sociology and Anthropology, La Trobe University, and Dr Ted Kaptchuk and Giovanni Macioccia as overseas reviewers have contributed valuable comments to individual chapters of the draft report.

Further details of the review process are included in descriptions of the methodologies used for specific components of the research.