This section addresses the regulation of TCM in relation to the issues highlighted by the AHMAC criteria.

Criterion 1: It is 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?

Both acupuncture and Chinese herbal medicine have a primary clinical care focus, including preventive health care. Chinese herbalism involves the use of internally administered therapeutic substances and acupuncture employs the use of therapeutic devices including needles for skin penetration.

Some relevant TCM professional associations are listed in Schedule 1 of the Regulations under the Therapeutic Goods Act 1989 (Commonwealth). Complaints against TCM practitioners are within the jurisdiction of the independent complaints units now established in most States and Territories.

Conclusion: It is clearly appropriate for Health Ministers to exercise responsibility for regulating TCM.

Criterion 2: Do the activities of the occupation pose a significant risk of harm to the health and safety of the public?

There is clear evidence that TCM has inherent risks of adverse outcomes, both predictable and unpredictable, which can in extreme cases be life-threatening. Acupuncture is an invasive procedure carrying risks of injury and infection. Chinese herbal medicine involves the topical application or ingestion of herbal medications which can result in toxicity or allergic reactions.

These inherent risks are containable but significant, and have resulted in a number of serious injuries and deaths in Australia. Injuries resulting from TCM are also likely to be under-reported (see Chapter 4). The inherent risks may be exacerbated by:

• use of TCM treatments in combination with western clinical care and/or a failure of TCM practitioners to refer to western clinicians as necessary, for example in cases of diabetes or epilepsy. Thus, recognition of the limits of a TCM practitioner's scope of practice and adequate training in western medicine are vital;
• practitioners who are untrained or poorly trained in TCM. There is evidence that practitioners who have not adhered to adequate standards and appropriate procedures have presented a threat to public health and safety (as reviewed in Chapter Four, the NH&MRC Working Party Report on Acupuncture, and case studies in submissions). These complications have included deaths in Australia; and
• where contaminated, adulterated or substituted herbal preparations are used in patient treatment.

These factors together with the increasing patronage of TCM practitioners for primary care purposes or in combination with western treatments, and the increasing numbers of practitioners with widely variable training offering TCM, are likely to result in an increased propensity for realisation of these risks.

The risks are likely to be reduced by professional monitoring of patient treatment and progress by appropriately trained and qualified practitioners. However, the proliferation of courses and standard setting bodies renders it extremely difficult for consumers seeking to identify competent practitioners.

Medical and other practitioners seeking to make referrals for patients who wish to access a wider range of health care options, are also inhibited by the difficulties of reliably identifying appropriately trained practitioners. This problem has particular ramifications for attempts to promote co-ordinated care options in Australia.

Conclusion: The activities of the practice of Traditional Chinese Medicine clearly pose a significant risk of harm to the health and safety of the public.

Criterion 3: Do existing regulatory or other mechanisms fail to address health and safety issues?

Current regulatory measures do not provide the level of protection the public is entitled to expect given the very real risks of harm identified.

Accreditation of education and training courses by government and self regulation by the profession both have a bearing on the safe practice of TCM in Australia. However, educational standards amongst Australian trained TCM practitioners are extremely variable and there is a plethora of professional associations. The result is that neither the public nor other health care practitioners have a reliable way of assessing who is adequately qualified for safe, competent practice.

Avenues of legal redress through the criminal law or common law actions for negligence and notifications to health complaints agencies are relatively underutilised given the rate of injury noted by practitioners themselves.

Significant gaps have been identified in the regulatory scheme relating to herbal preparations, provided by the <$iTherapeutic Goods Administration> and the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). Similarly concerns exist regarding the adequacy of the Skin Penetration Regulations/Guidelines to deal with the risks of acupuncture. In particular, these mechanisms focus on the environment in which acupuncture is carried out and do not address the competence of the practitioner.

Conclusion: Existing regulatory mechanisms are inadequate in safeguarding and protecting the public as consumers of Traditional Chinese Medicine (acupuncture and Chinese herbal medicine).

Criterion 4: Is regulation possible to implement for the occupation in question?

The occupation is well defined by both its body of knowledege and methods of practice. Practitioners of Traditional Chinese Medicine are well recognised and regulated in China and some other international jurisdictions.

Traditional Chinese Medicine has been offered as a tertiary education course in Australia for over two decades. Three courses are currently offered in Australian universities which lead to a primary qualification in TCM and others are planned. Appropriate standards of training have been identified with broad professional agreement on core competency and curriculum documents.

Conclusion: There is a defined profession for which regulation is possible to implement.

Criterion 5: Is regulation practical to implement for the occupation in question?

A number of factors outlined in this chapter and elsewhere demonstrate that self-regulation is not a practical alternative to occupational regulation of TCM practitioners. These factors include the increasing proliferation of professional associations representing TCM practitioners, and concern that current standards of education may decline as opportunistic education providers move into the market.

Of the 18 professional associations that responded to the TCM associations survey, 16 (89%) were in favor of occupational regulation. Whilst some associations acknowledged that there are negative aspects to occupational regulation, they also acknowledged the broad public benefit from its introduction.

TCM practitioners responding to the workforce survey identified significant benefits from the introduction of occupational regulation. In response to the question on potential government regulation of TCM practice, the majority believed it would have a positive effect on professional status, standards of practice, standards of education, access to research infrastructure and postgraduate education (see Table 11). Practitioners were more uncertain when it came to the effect of government regulation on practitioner income, possible litigation, patient costs, quality of herbal medicines, access to herbal medicines or definition of occupational boundaries. In balance, however, TCM practitioners believed that occupational regulation would have a positive effect on TCM practice, and they are likely to comply with any statutory requirements of regulation.

There are sufficient numbers in the occupation to fund occupational regulation in the three states reviewed. It is uncertain whether there are sufficent numbers in other Australian States and Territories to fund registration boards in each State, however a number of regulatory options are available that could disperse these costs.

Conclusion: Occupational regulation is practical to implement for currently unregulated TCM practitioners.

Table 11: TCM practitioner beliefs regarding the effect of occupational regulation on selected issues

Criterion 6: Do the benefits to the public clearly outweigh the potential negative impact?

The potential negative impact of occupational regulation is discussed in Chapter 10, under Competition Policy, mutual recognition and occupational regulation. In brief, some of the concerns are that occupational regulation:

• restricts entry to a profession;
• increases the costs of entry in that minimum standards of training and education are set for professional practice and therefore may also narrow the range of persons eligible to practise;
• may stifle innovation and interaction between different groups of health practitioners and/or encourage undesirable `medicalisation' in order to justify TCM practice in western scientific terms; and
• may increase the cost of TCM services to individuals and the community, through passing on of the increased costs associated with educational requirements, indemnity insurance, and the regulatory mechanism.
• Major benefits of registration are that it can:
• help protect the public by promoting the standards established through various national bodies for professionally trained, competent and safe practitioners;
• promote the public's right of access to the health care of their choice, by providing a mechanism for identifying practitioners who should be safe and competent;
• facilitate cross-referral amongst different types of health practitioners and promote the inte gration of patient care;
• provide enforceable sanctions against practitioners whose practice is incompetent or unethical; and
• provide a mechanism for identifying those practitioners who can be safely exempted from the relevant provisions of the TGA.

Conclusion: The benefits of promoting public safety clearly outweigh the potential negative impacts of occupational regulation.

11 Options for Regulatory Reform

The following recommendations are based on the premise that any regulatory model is the minimum necessary to deliver the benefits sought.

A range of options addressing the direct regulation of problems raised by TCM, particularly in relation to Chinese herbal medicine are put forward. Options for a model of statutory occupational regulation for TCM practitioners are also developed based on protection of title only. While protection of practice would prevent unqualified practitioners from offering TCM services to the public and also prevent untrained practitioners from entering the profession, the report suggests that, given the risks of TCM are not more significant than those encountered in the practice of medicine, that the same level of regulation is appropriate.

The model proposed would:

• promote uniform standards of education and training for safe practice;
• enable the public and other practitioners to identify appropriately qualified, safe TCM practitioners;
• provide protection from false/exaggerated claims;
• promote appropriate referrals to medical or other practitioners;
• promote accountability to the public;
• provide a mechanism for safe exemption of practitioners from the relevant provisions of the TGA;
• focus on competence to use therapeutic tools, in addition to maintaining such tools in an appropriate manner;
• enhance effectiveness of the national framework for therapeutic goods administration.

It would not exempt practitioners from other requirements such as the need to comply with relevant skin penetration regulations or guidelines. However, uniform occupational regulation of acupuncturists in Australia, whether by a professional association or a registration board would enhance compliance with and facilitate disciplinary action for notified breaches of the relevant skin penetration regulations and/or guidelines. It could provide an enforceable mechanism for dealing with wrongdoing by practitioners and require practitioners to be adequately indemnified against damage resulting from such wrongdoing.

The administration of the regulatory scheme for TCM practitioners could be based one of the three options:

Option 1 - A National Registration Board

A national board could be established under the jurisdiction of the Federal Health Minister or AHMAC. It should have the capacity to delegate the investigation of complaints to the State and Territory health complaints bodies as appropriate and to appoint committees at the State/Territory level to hear disciplinary/complaints matters as necessary.

Advantages: This approach would promote national uniformity and to contain the overheads of the regulatory model. A national approach was supported by a number of submissions from TCM professional associations and others. It would be cost-effective given the relatively small number of TCM practitioners in Australia and their maldistribution across the country.

Disadvantages: It would require the states and territories to refer the relevant powers to the Commonwealth and may not receive uniform support. Registration of other health occupations is not currently administered on a national level.

Option 2 - State and Territory based Registration

State and Territory registration boards would be established under the jurisdiction of the relevant State or Territory health minister. Each board would handle complainnts and disciplinary matters as necessary. State or Territories where the TCM constituency is not large enough to warrant a separate board could legislate to recognise statutory regulation in another State or Territory.

Advantages: There may be constitutional and political impediments to the establishment of a national regime. The establishment of State and Territory based boards may present a more practical option.

Disadvantages: The establishment of a board in those jurisdictions where few TCM practitioners operate would be neither practical nor cost effective.

Option 3 - National Accreditation with State and Territory based Registration

A national accreditation body could be established with membership provided by delegates from the State and Territory based registration boards to set out the qualifications which should be accepted by the boards and accredit education programs. Relevant precedents include the Australian Medical Examining Council and similar entities established by agreement between State and Territory registration boards to conduct examinations for overseas trained practitioners and accredit courses.

A variation of this option could see a National Accreditation Board comprised of some delegates from each State and Territory. States with fewer practitioners might then need a less elaborate structure (than a statutory registration board) to register their practitoners. They may choose simply to issue registration certificates through a relevant department on proof that the practitoner has met the qualification standards required by the National Accreditation Board, or to deem practitoners to be registered if they meet the Board's standards.

In either case it may be useful for one State to develop template legislation for use across States and Territories.

Advantages: This combines the features of Options 1 and 2 and avoids the constitutional issues raised by Option 1.

Disadvantages: It requires two levels of administration, and agreement between the registration boards to establish the accreditation body.

References

1. ATMS Submission on the occupational regulation of acupuncture, naturopathy (and other modalities) April 1996.

2 National Health and Medical Research Council, Acupuncture Working Party. Acupuncture. Canberra: NHMRC 1989.

3. St John P. for Victorian Convening Committee of the National Traditional Chinese Medicine Liaison Committee. Draft Submission on the Registration of Traditional Chinese Medicine in Australia.

4. Australian College of Acupuncturists (ACAc) Submission for AHMAC's Criteria on the Regulation of Health Occupations: Acupuncture, 1994.

5. AAcA/AESO Draft Position Paper on the Regulation of TCM in Australia, June 1996.

6. Stone J. Beyond the fringe. Health Matters, Winter 1995;24:18-19.

7. British Medical Association. Complementary medicine: new approaches to good practice. London: BMA 1993.

8. Nurses Board of Victoria. Nexus Newsletter. May 1996;2(1):9.

9. Stone J, Matthews J. The effective regulation of complementary medicine. Complementary Therapies in Medicine. 1995;3:175-178.

10. Adams D. Herbal tea made woman's face `stop light', court told. The Age. 12 December 1995:145.

12. Correspondence from Steve Holroyd, SCC Health Manager to Australian College of Acupuncturists, January 16, 1996.

Professional Association Submissions

Acupuncture Association of Victoria. Correspondance to Department of Human Services and TCM Researchers. September 1996.

AESO Proposal to Victorian Minister for Health: The Registration of Acupuncture in Victoria Dec 1991.

AAcA/AESO Draft Position Paper on the Regulation of TCM in Australia, June 1996.

Australian College of Acupuncturists (ACAc) Submission for AHMAC's Criteria on the Regulation of Health Occupations: Acupuncture, 1994.

ANTA Submission for Regulation of Natural Therapists: Single Title Registration Versus Multi-title Registration, March 1992.

ANTA Submission: Registration of Qualified Naturopaths - To Be or Not To Be, March 1992.

ANTA Submission to H&CS Public Health Branch on Research into the Practice of TCM in Victoria, November 1995.

ATMS View on TCM Registration 22 February, 1996.

ATMS Submission on the occupational regulation of acupuncture, naturopathy (and other modalities) April 1996.

Australian Acupuncture Association Ltd (AAcA Ltd) AHMAC Submission 10 May 1995.

Correspondence from Steve Holroyd, SCC Health Manager to Australian College of Acupuncturists, January 16, 1996.

Federation of Chinese Medicine and Acupuncture Societies of Australia Inc. The Regulation of the Chinese Medicine Profession in Australia. Submission to Victorian Department of Human Services. 1996.

May B. for the Register of Acupuncture and Traditional Chinese Medicine Inc. Draft Position Paper. July 1996.

St John P, Submission to AHMAC on the Registration of Traditional Chinese Medicine, September 1995.

Regulation of Chinese Medicine Profession in Australia: A Submission from the FCMA and ACACM and SCMA prepared by Prof. T. Chiang Lin, Sept 1995.

St John P. for Victorian Convening Committee of the National Traditional Chinese Medicine Liaison Committee. Draft Submission on the Registration of Traditional Chinese Medicine in Australia.

Chapter 11 The Need for Regulation

Summary of Findings

• It is appropriate for Health Ministers to exercise responsibility for regulating Traditional Chinese Medicine.
• Some activities within the practice of Traditional Chinese Medicine pose a significant risk of harm.
• Existing regulatory mechanisms are inadequate in safeguarding and protecting the public as consumers of TCM (both acupuncture and Chinese herbal medicine).
• TCM is a defined profession for which regulation would be possible to implement.
• Occupational regulation is practical to implement for currently unregulated TCM practitioners.
• The benefits of promoting public safety through occupational regulation of TCM outweigh the potential negative impacts of such regulation.

Chapter 11The Need for Regulation

Recommendations

Statutory Occupational Regulation

• That TCM practitioners be subject to statutory occupational regulation and that the focus of this regulation be the protection of the public by ensuring practitioners have adequate qualifications for safe and competent practice.
• That the model of regulation adopted be registration with protection of title rather than licensing for protection of practice.
• That both acupuncturists and traditional Chinese herbalists be registered under one registration board, recognising their shared philosophical base in TCM.
• That the register record whether the practitioner is qualified to practice TCM as an acupuncturist, a Chinese herbal medicine practitioner, or both.
• That the model adopted should be sufficiently flexible to allow extension to other related occupational groups if appropriate in the future.
• That the following be considered for adoption as the titles to be protected:

• • Registered TCM practitioner
  • Registered traditional Chinese herbalist
  • Registered acupuncturist
  • Registered traditional Chinese herbalist and acupuncturist
  • Registered Chinese medicine practitioner
  • Registered oriental medicine practitioner.
• That administration of the regulatory scheme for TCM practitioners be based on one of three options consisting of State and Territory-based registration, or National Accreditation Board with State and Territory Registration or a National Registration Board.

Regulatory Provisions

That regardless of the model adopted for administration of occupational regulation for TCM practitioners, the regulatory statute should provide for:

• protection of the public by ensuring practitioners have adequate qualifications for safe and competent practice;
• accreditation of TCM education courses that meet a satisfactory standard;
• board membership to include:

• • some diversity of health practitioners
  • at least one overseas trained practitioner
  • persons able to represent the interests of consumers
  • an appropriately experienced lawyer;

• effective disciplinary procedures, including a range of possible sanctions to enable appropriate responses to consumer complaints.

The range of options proposed in the Victorian Review of Regulation for Health Practitioners provides a useful model;

• effective disciplinary powers to address areas such as:
• • practice beyond the scope of training/competence
  • failure to refer for treatment to a medical practitioner as appropriate
  • advice to a patient to discontinue any treatment prescribed by a registered medical practitioner
  • failure to hold professional indemnity insurance
  • failure to provide consumers with written prescriptions adequately identifying the herbs prescribed
  • prescription of medicines containing, or labelled as containing, endangered species.
• remedial measures that may be imposed as sanctions including a power to require a practitioner to practice only under supervision and/or to undertake further education.

Other Registered Practitioners

• That individual registration boards and/or professional associations develop and issue guidelines for medical and other registered practitioners wishing to practice TCM modalities, stressing:
• • the need for adequate training before offering such services and
  • the need to practise only within the limits of their competence in these therapies.

• • Therapeutic Goods Administration
• That the Therapeutic Goods Administration, the Australia New Zealand Food Authority and the Australian Quarantine Inspection Service:
• • work in liaison with State authorities to resolve the issue of responsibility for raw Chinese herbal preparations used for therapeutic purposes;
  • examine whether protection against contaminants is most appropriately achieved through education of importers and manufacturers and/or mandatory requirement for certificates of analysis and/or random surveillance.
• That the TGA identify, and adopt as standards, suitable monographs and references, such as the Pharmacopoeia of the People's Republic of China, which have set standards for Chinese medicinal substances, including the ingredients of prepared Chinese medicines.

Labelling

• That regulations for the labelling of compounded raw herbal medicines be developed in each State and Territory. For Victoria this could be done under the head of power in the Therapeutic Goods (Victoria) Act 1994.
• That these regulations include requirements for labels to provide a reference number identifying the dispenser and prescriber. This could be complemented by a provision in any Act for registration of TCM practitioners, that failure by practitioners to provide a reference number together with a detailed prescription identifying the ingredients in any herbal preparation dispensed, would be a matter for disciplinary action by the registration board.
• This would provide a direct mechanism for ensuring ready advice as to the content of herbal preparations for consumers and/or other health care practitioners in the event of an adverse reaction. Such regulations would need to meet the requirements of a regulatory impact statement in Victoria, and similar mechanisms would need to be identified in other States.
• That an appropriate body such as an advisory committee to the TGA Traditional Medicines Evaluation Committee consider developing a numbering system for Chinese herbs and an accompanying manual to decode the numbering system.
• This would also provide a mechanism for ascertaining the contents of herbal preparations. Hospitals and poisons information services could use the manual to establish the ingredients in herbal preparations ingested by persons showing symptoms of toxic reaction. The mechanism, however, may be cumbersome and may not deal with the problem of the dispenser having changed a prescription by substitution of different herbs.

Restricted Substances

• That a joint committee, which may consist of the TGA Traditional Medicines Evaluation Committee and the AHMAC Drugs and Poisons Scheduling Committee, assess
• • which substances currently on the Schedule of Drugs and Poisons should be made more available to TCM practitioners; and
  • which herbal preparations currently available without prescription should be subject to stricter controls.
• That relevant professional associations included in consultations on this matter include
• • practitioners of Chinese herbal medicine
  • the Nutritional Foods Association
  • such other peak bodies as are responsible for self regulation of the industry retailing Chinese herbal medicines and nutritional supplements.
• That dispensers in premises registered under the State Drugs and Poisons Acts be required to keep a log of restricted preparations dispensed on prescription from TCM practitioners, including details of the prescribing practitioner.