3.Options for Regulation

3.1 Models of self-regulation

The first question to be addressed in this review is: Should there be legislative regulation of the occupation of Traditional Chinese Medicine, or should less restrictive self-regulatory approaches be adopted?

A number of health occupational groups have set up or are developing structured programs of self-regulation. The Australian Council for Homoeopathy Inc., for example, has established the 'Victorian Register of Certified Homoeopathic Practitioners Inc', an independent incorporated body which is intended to regulate the practice of qualified homoeopaths, and protect the public interest in homoeopathic health care. It also serves as a point of contact for complaints and disputes. Board members are drawn from the homoeopathic profession, the medical professions, the law, leading university academics, and consumer groups. The Victorian Health Services Commissioner, Ms Beth Wilson, acts as a consultant to the Register. The Victorian Minister for Health, the Hon. Rob Knowles, has endorsed the self-regulatory framework as

a mechanism by which the homoeopathic profession endeavours to promote the highest standard of homoeopathic practice, and to provide avenues for dealing with patient complaints. (19)

The Executive of the Australian Traditional Medicine Society Ltd has prepared a proposal for self-regulation of the profession of TCM entitled 'Government Monitored Self Regulation'. The proposal, contained in Appendix 6, includes a structured approach to self-regulation and a suggested process for implementing it.

Before adopting the recommendations of Towards a Safer Choice, State and Territory Health Ministers must satisfy themselves that self-regulation is not an effective option. There are a number of difficulties in achieving a level of self-regulation that adequately protects the public. These difficulties fall into four main areas:

• Fragmentation of the profession and lack of agreement on standards: Within the profession, there are at least 23 associations representing practitioners and varying standards of training. The emergence of a peak body in TCM has been hampered by divergent interests within the profession and historical factors associated with the introduction of acupuncture to the western world. With such fragmentation, it has not been possible to achieve support from all associations for a process to establish a self-regulatory mechanism, or to reach agreement on what standards should be applied for registration. In addition, while educational standards have been agreed to by a majority of the profession, there is no compulsion for providers to comply with these standards.

• Deregulation of education: Government-accredited TCM courses exist at certificate, diploma, advanced diploma and degree levels; however accredition addresses only structure and delivery of courses, not whether course content meets the standard the profession considers acceptable. Many of these courses are not recognised by the leading professional associations as being of an acceptable standard. Under National Competition Policy, in the absence of statutory registration, even a well organised profession is unable to prevent accreditation of a course that is of a standard below that considered desirable by the profession.

• Difficulties in creating incentives for voluntary certification: In the past, eligibility for rebates from private health funds was the main incentive for TCM practitioners to seek membership of associations with higher educational standards. With the introduction of National Competition Policy, private health funds are reluctant to use a practitioner's membership of a given professional association as the criterion for payment of rebates, and are now assessing qualifications on an individual basis. This undermines the ability of associations to impose standards and discipline their members. Under a self regulatory model, The Register of Certified Homoeopathic Practitioners has experienced considerable difficulties in creating incentives for practitioners to seek certification with the Register. Practitioners can continue to practice without the endorsement of the Register and can continue to hold themselves out to the public as qualified even if they do not meet the standards set by the Register.

• Lack of access to scheduled herbs: A number of herbs considered toxic have been scheduled under the Standard for the Uniform Scheduling of Drugs and Poisons (see Section 4.9), so that they can be prescribed legally only by registered medical practitioners. In China, practitioners are trained in prescribing these substances safely and preventing undesirable side-effects, and the herbs are widely prescribed, but similarly trained practitioners in Australia are denied access to these herbs. The Federal Therapeutic Goods Administration recognises the difficulties with the current scheduling arrangements, but states that any change is dependent on State and Territory Governments putting in place arrangements to identify, via accreditation or registration, those practitioners who have training in Chinese herbal medicine that equips them to prescribe these substances safely. A self-regulatory scheme is unlikely to be able to incorporate a mechanism to allow access by trained practitioners to scheduled herbs.

What are your views? This review seeks comments on the proposal of the Executive of the Australian Traditional Medicine Society, and specifically, on whether self-regulation can be effective given the difficulties in implementation associated with fragmentation of the profession, the deregulation of education, and the significant range of standards of practice. Is continuing self-regulation likely adequately to protect the public, given the risks that have been identified?

3.2 Occupational regulation via statute

Towards a Safer Choice made a series of recommendations regarding regulation of the profession of TCM and the prescribing, labelling and dispensing of Chinese herbal medicines. The recommendations were based on the premise that any regulatory model is the minimum necessary to protect the public.

The report recommended statutory regulation of the profession using a model based on protection of title rather than licensing for protection of practice. It argued that such a model 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 Therapeutic Goods Administration;
  
  
• 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. (20)

Statutory-based occupational registration would not exempt practitioners from other requirements such as the need to comply with relevant skin penetration regulations or guidelines. However, it is argued that uniform occupational regulation in Australia.

would enhance compliance with, and facilitate disciplinary action for, notified breaches of the relevant skin penetration regulations and/or guidelines [and] could provide an enforceable mechanism for dealing with wrongdoing by practitioners and require practitioners to be adequately indemnified against damage resulting from such wrongdoing. (21)

What are your views? This review seeks comments on whether there is a need for occupational registration via statute of the profession of TCM. What are the benefits and disadvantages or costs of such regulation?

3.3 The Victorian model of health practitioner registration

The basis of the models recommended in Towards a Safer Choice is State and Territory based occupational registration via statute. In Victoria, statutory based registration boards are established under a State Act of Parliament and are independent of government. They are incorporated so as to avoid any personal liability for their members. Membership consists of a majority from the profession involved. Boards are required to consult the Minister for Health and take notice of his/her views, but the Minister cannot direct them. Boards are self-funding, and are responsible for setting their own fees and meeting all their expenses such as renting premises, hiring staff, and paying legal counsel.

The key features of the Victorian legislative model of health practitioner registration are as follows:

• The purpose of regulation is to protect the public rather than to protect and promote professional interests.
  
  
• The main privilege of registration is the right to use the relevant title; it does not define the practice of the profession.
  
  
• It is an offence for non-registered persons to use the relevant title or to hold themselves out as being registered.
  
  
• Registration boards must be incorporated as legal entities.
  
  
• Board members are appointed on recommendation from the Minister for Health.
  
  
• All boards must include legal and community representation.
  
  
• Boards have a broad range of disciplinary options, including informal hearings in appropriate cases.
  
  
• A standard definition of 'unprofessional conduct' is adopted.
  
  
• Legislation includes standard powers of boards to deal with false and misleading advertising.
  
  
• Boards have the power, if necessary, to suspend the registration of a practitioner immediately in order to protect the public.
  
  
• Hearings are open, but with provision for closed hearings if necessary.
  
  
• Complainants have the right to be present at a hearing.
  
  
• Appeals from a decision are directed to the Administrative Appeals Tribunal.

Specific issues arising from application of the model to the profession of TCM are raised in Chapter 4 of this document. Appendix 7 sets out in detail the Victorian model of health practitioner registration that was adopted with the passage of the Victorian Medical Practice Act 1994, the Nurses Act 1993, and more recently, the Chiropractors Registration Act 1996 and the Osteopaths Registration Act 1996.

3.4 A typical registration Act: protection of title

The Victorian Medical Practice Act 1994 is a typical registration act. Section 1(a) states that the Act's main purposes include:

to protect the public by providing for the registration of medical practitioners, investigations into the professional conduct and fitness to practise of registered medical practitioners.

Section 62 prohibits a non-registered person from representing themselves as a registered practitioner of medicine. The Act does not prohibit an unregistered person practising medicine per se: provisions in other legislation achieve this through restricting to legally qualified medical practitioners the right, for instance, to prescribe various medications, issue various medical certificates, recommend involuntary admission to psychiatric facilities, and receive reimbursement for Medicare services under the Commonwealth Health Insurance Act 1973 (22). Towards a Safer Choice summarises the situation:

The registration of medical practitioners is based only on their achievement of qualifications considered to indicate competence to practise. The registration board's role in ensuring that practitioners maintain standards is enforced only in the breach through the disciplinary process. Ensuring that practitioners maintain annually certified levels of competence is left up other mechanisms such as the activities of the professional colleges. Maintaining theoretical and practical standards is thus the task of continuing medical education, peer review and quality assurance activities. However, this approach is complemented by expanded disciplinary capacities. For example, the board has the capacity to make orders requiring participation in such activities as an outcome of a disciplinary hearing. (23)

3.5 State versus national approaches

Towards a Safer Choice proposed that administration of the regulatory scheme for TCM practitioners could be based on one of three options:

• a national registration board under Federal jurisdiction with power to delegate investigation of complaints to State and Territory health complaints bodies and to appoint committees at the State/Territory level to hear disciplinary or complaints matters;

• State and Territory based registration boards under the jurisdiction of the relevant State or Territory Health Minister. States 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;

• a national accreditation body made up of delegates from State and Territory based registration boards, to accredit education programs and set out the qualifications that should be accepted by the boards for registration. States with fewer practitioners might 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 body, or to deem practitioners to be registered if they meet standards prescribed by that body.

While there is widespread support for a national approach to setting standards of practice in TCM, statutory registration of health occupations is a State power, under the Australian constitution, and there is no precedent for occupational regulation at a federal level. There are, therefore, constitutional and political barriers to achieving a federal system of occupational registration for TCM. It is unlikely in the immediate future that States and Commonwealth will reach agreement on a ceding of powers required to enable the establishment of a national scheme.

Models of health practitioner registration exist which incorporate a national approach to setting standards and accreditation of training courses:

• In medicine and optometry, for instance, State-based registration boards operate alongside national bodies whose role is to accredit training courses and conduct, or commission the conduct of, examinations for applicants. In optometry, establishment of national accreditation body has arisen out of a strong State-based regulatory system, with support from States. The newly constituted Optometry Council is funded by pro rata contributions from State registration boards, based on the number of registered practitioners in each State.

• In nursing, the Australian Nursing Council accredits overseas courses and assesses overseas trained nurses, but State boards continue to have responsibility for accrediting nursing courses within their States.

There are a number of options for achieving a national approach to standard setting:

• One State could develop template occupational registration legislation for use across other States and Territories. The responsibility for setting the educational standards required for registration would fall to the first State to introduce the legislation and set up a registration board.

• A single State registration board could be established initially, with powers to register applicants from other States and to appoint interstate members to inquiry panels for complaints and disciplinary proceedings. Other States may set up their own registration boards at a later date.

• Where the number of practitioners in a State is too small to support a registration board, that State could recognise 'by reference' a registration Act in another State, and practitioners would be required to seek registration with the interstate board.

• State registration boards could be established, with agreement sought to set up at a later date a national body to accredit courses and set standards (as has occurred in medicine, nursing and optometry).

 

What are your views? The review invites comments on approaches to regulation and which of the models and options outlined above, if any, are preferred.