Summary of Recommendations

The report recommends an integrated reform package across the industry. The key aim is to minimise risks to the public that may arise from inadequate education and unsafe practice.

The main recommendation is to introduce appropriate regulation to ensure adequate public safety, while minimising any restriction on competition in the health care marketplace.

The recommendations below are presented in categories related to the target areas of the Traditional Chinese Medicine Review. Whilst they relate to the work of a number of agencies, so far as possible these recommendations should be implemented as a whole in order to have the desired effect of improving public safety in the practice of Traditional Chinese Medicine (TCM).

Statutory Occupational Regulation

This study recommends that:

  • Traditional Chinese Medicine 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.
  • The model of regulation adopted be registration with protection of title rather than licensing for protection of practice.
  • Both acupuncturists and traditional Chinese herbalists be registered under one registration board, recognising their shared philosophical base in TCM.
  • The register record whether the practitioner is qualified to practice TCM as an acupuncturist, a Chinese herbal medicine practitioner, or both.
  • The model adopted should be sufficiently flexible to allow extension to other related occupational groups, if appropriate in the future.
  • The following be considered for adoption as the titles to be protected:
    • Registered Traditional Chinese Medicine practitioner
    • Registered traditional Chinese herbalist
    • Registered acupuncturist
    • Registered traditional Chinese herbalist and acupuncturist
    • Registered Chinese medicine practitioner
    • Registered oriental medicine practitioner.
  • Administration of the regulatory scheme for TCM practitioners be based on one of three options consisting of State and Territory-based registration, or National Accreditiation Board with State and Territory Registration or a National Registration Board.

Regulatory Provisions

Regardless of the model adopted for administration of occupational regulation for Traditional Chinese Medicine 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 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.

Other Registered Practitioners

Individual registration boards and/or professional associations should 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

It is recommended that the Therapeutic Goods Administration, the Australia New Zealand Food Authority and the Australian Quarantine Inspection Service:

  • Work in cooperation 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.

It is also recommended that the Therapeutic Goods Administration 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

It is recommended 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.
  • 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.
  • An appropriate body such as an advisory committee to the Therapeutic Goods Administration Traditional Medicines Evaluation Committee consider developing a numbering system for Chinese herbs and an accompanying manual to decode the numbering system.

Restricted Substances

It is recommended 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.
  • Relevant professional associations involved in consultations on this matter include:
    • practitioners of Chinese herbal medicine;
    • the Nutritional Foods Association;
    • such other peak bodies that are responsible for self regulation of the industry retailing Chinese herbal medicines and nutritional supplements.
  • 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.

Other recommendations to minimise risk

It is recommended that:

  • TCM professional associations in conjunction with relevant government agencies identify and promote a centralised location for reporting and recording of adverse events related to TCM practice. This may be State Drug Information Services, ADRAC, State health care complaints units, or another agency. This central agency must be responsive to the TCM profession, including its cultural mix. The agency's existence should be widely communicated within the TCM profession.
  • TCM professional associations and educational institutions work to engender a consciousness amongst the profession of the need to report adverse events related to TCM practice.
  • National funding bodies such as the National Health and Medical Research Council allocate funding for research into TCM in areas such as the quantification of adverse events in both acupuncture and Chinese herbal medicine, and the interactions between Chinese herbal medicines and western pharmaceutical drugs.
  • Commonwealth and State Health Departments fund the translation into English of the current Chinese language scientific literature pertaining to adverse events of Chinese herbal medicines and interactions between CHM and western pharmaceuticals.
  • Protocols for managing adverse events related to Chinese medicines be reviewed, and developed where necessary, for use in Australian hospitals, and that this review be undertaken by recognised toxicologists.

Education

It is recommended that:

  • A formal review of TCM education be undertaken, based on the finding that the length of education is a modifier of adverse events. This review should aim to set a minimum standard of TCM education for safe practice.
  • TCM educational institutions revisit their course content and ensure adequate training is available to minimise specific adverse events and to promote the ability of practitioners to deal with these adverse events should they occur.
  • Private colleges and universities review the process of appointment to course advisory committees in order to ensure broader representation from the profession. Institutions are encouraged to include representatives from the largest associations representing TCM practitioners.
  • Universities and colleges utilise open and competitive selection procedures (including national advertising and appropriate selection panels) to recruit academic staff in TCM.
  • The Health Insurance Commission re-examine its provision of Medicare rebates for acupuncture performed by medical practitioners who do not have identifiable and adequate qualifications in the area, and establish a minimum acceptable qualification for Medicare rebate.

Professional associations

It is recommended that:

  • The self-regulatory mechanisms of professional associations be strengthened, regardless of whether the establishment of state based occupational regulation proceeds.
  • TCM associations cooperate to standardise continuing education requirements, codes of conduct, disciplinary procedures and other matters related to standards of clinical practice for the TCM profession.
  • Major TCM professional associations closely examine the course requirements for all new courses prior to granting recognition to graduates.
  • Professional associations representing practitioners of registered health occupations (including medicine, nursing, physiotherapy, chiropractic and osteopathy) who utilise TCM, review and upgrade the minimum qualifications required of their members for safe practice, particularly in acupuncture and Chinese herbal medicine.
  • TCM associations establish standard record-keeping procedures for recording adverse incidents, and educate their members on professional and community responsibilities to notify a central body of adverse incidents arising from their treatment.
  • Government ensure that consultation and policy development for the regulation of TCM involve associations representing both Chinese-speaking practitioners and Australian-trained practitioners, most particularly those associations where executive representives have been democratically elected by their membership.

Research

It is recommended that:

  • Australian health authorities promote international mechanisms to facilitate the translation of methodologically sound research on TCM from Chinese into English.
  • National funding bodies such as the National Health and Medical Research Council be encouraged to allocate funding for sound methodological investigations of the clinical efficacy of Chinese herbal medicine and acupuncture, including cost-effectiveness studies.