(Towards a Safer Choice: pp 242-246)
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 NHMRC Working Party Report on Acupuncture, and case studies in submissions). These complications have included deaths in Australia;
where contaminated or adulterated 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 seeking 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 Therapeutic 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 knowledge 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. Appropriate standards of training are 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 area.
Of the 18 professional associations (89%) that responded to the TCM associations survey, 16 were in favour 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 11.1). 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 are likely to be compliant 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 sufficient 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.
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:
Major benefits of registration are that it can:
Conclusion: The benefits of promoting public safety clearly outweigh the potential negative impacts of occupational regulation.
(Towards a Safer Choice: pp 246-248)
The administration of the regulatory scheme for TCM practitioners could be based on one of 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 complainants 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 practitioners. They may choose simply to issue registration certificates through a relevant department on proof that the practitioner has met the qualification standards required by the National Accreditation Board, or to deem practitioners 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 difficulties raised by Option 1.
Disadvantages: It requires two levels of administration, and agreement between the registration boards to establish the accreditation body.