| 9. The Regulation of Traditional Chinese Medicine - Australia and Overseas This chapter details regulation operating in Australia that impacts on the practice of TCM and summarises occupational regulation of TCM practitioners overseas. `Regulation' refers to instruments of the State (ordinances, proclamations, statutes, subordinate legislation, administrative decrees, guidelines and procedural statements) which bear on the conduct of TCM. Broadly, health regulations are intended to protect public health and safety by means of enforceable controls and sanctions. Regulatory control over a health profession may be exercised by various measures, for example, legislation relating to professional registration, substances and infection control. Areas covered by health regulations may include:
This chapter discusses principally the first three items and, to a lesser extent, the fourth, as regulations governing the places where acupuncture can be conducted are usually related to general hygiene and infection control. Existing regulations in Australian States and Territories are considered first, followed by the regulation of TCM in China. The following countries are reviewed:
A summary of legislation in the jurisdictions reviewed is provided in Table 9.1. Computer database searches and internet searches were used to identify overseas regulations, including:
Internet access through Austlii (Australian Legal Information Institute) included Uncover and ABN (Australian Bibliographic Network). Australian libraries were searched for information on overseas legislation. Other sources included contacts with professional associations both in Australia and overseas, Chinese Medical News in Beijing, and officers of State, Territory, and Commonwealth Departments of Health, including the Therapeutic Goods Administration in Canberra. Table 9.1 summarises the status of occupational regulation in the jurisdictions reviewed in this chapter.
Table 9.1: Status of occupational regulation of TCM practitioners in selected countries
Key:
In Australia:
9.3.1 Skin Penetration 9.3.1.1 Victoria The Health (Infectious Diseases) Regulations 1990 regulate the cleanliness of premises and equipment together with personal hygiene. The Standards of Practice for Acupuncture is published in conjunction with the Regulation providing detail on minimisation of infection and sterilisation procedures. The regulations require that equipment be cleaned and sterilised in accordance with the Standards of Practice. 9.3.1.2 New South Wales From November 1991, acupuncturists have been required to comply with skin penetration provisions of the Public Health Regulation 1991. The guidelines provide details relating to premises, use of equipment, sterilisation procedures, choice and use of needles and use of chemicals such as glutaraldehyde. Compliance with the guidelines is a defence to prosecution under the Regulation. 9.3.1.3 Western Australia The Health (Skin Penetration) Regulations in Western Australia are currently are being reviewed. The Department of Health has advised that the direction likely to be taken is a standard of practice along the lines of the publication Infection Control In Office Practice: Medical, Dental And Allied Health 1994 prepared by the Australian National Council on AIDS in conjunction with the NH&MRC. It is understood that WA will be basing its standard of practice on the 1994 publication as it is a more detailed version of the guidelines prepared by both Victoria and NSW. Topics to be covered include sterilisation, cleaning of facilities, processing of instruments and equipment, staff and patient health and safety, as well as routine precautions. It is unlikely that WA will be requiring local councils to license premises. 9.3.1.4 Queensland The Queensland Department of Health is currently drafting a code of practice for acupuncturists based on the Code of Practice produced by the Australian Acupuncture Association Ltd. The Skin Penetration Regulations 1987 (made under the Health Act) have recently been repealed and the substance of this regulation is now contained within the Health Regulation 1996. This regulation governs cleanliness of premises, equipment, and operators; sterilising and disinfection procedures; and licensing requirements. 9.3.1.5 South Australia In November 1995, the South Australian Health Commission published a Guideline for the Safe and Hygienic Practice of Skin Penetration. The Guideline follows the lead of other Australian States. It covers topics such as cleaning, disinfection and sterilization of equipment, personal hygiene, needle stick injuries and cleaning of wounds, waste disposal, storage and handling of chemicals, and structural matters relating to the premises and fittings. 9.3.1.6 Tasmania Tasmania does not have current Skin Penetration Guidelines, however the area is regulated by the Public Health (Skin Penetration) Regulations 1978. These Regulations cover the same areas as the other State/Territory requirements: registration of premises, sterilization of instruments, materials for benches etc, appropriate waste receptacles, cleanliness, and general hygiene. Customers of registered premises are required to notify the operator if suffering from an infectious disease or skin rash, and no skin penetration process is to be carried out on those custom ers. 9.3.1.7 Australian Capital Territory Under the Skin Penetration Procedures Act 1994, the ACT has drafted a Code for Skin Penetration that covers the field from doctor's rooms to beauty salons. The Code was specifically developed in response to the risks associated with the transmission of blood-borne infections. It contains special requirements for the practice of acupuncture, including the licensing of practitioners as well as premises. 9.3.1.8 Northern Territory Territory Health Services (THS) has recently published new Standards for Commercial Skin Penetration, Hairdressing and Beauty and Natural Therapy under the Public Health Act. The Standards provide details relating to premises, use of equipment, sterilisation procedures, choice and use of needles and use of chemical disinfectants other than glutaraldehyde. 9.3.2 Therapeutic Goods Act - Commonwealth 9.3.2.1 Relationship of Commonwealth and State/Territory Laws The Commonwealth Therapeutic Goods Act 1989 is designed to provide a national system of controls over the quality, safety, efficacy and timely availability of imported or locally manufactured therapeutic goods used in Australia and/or exported from Australia. It applies to matters relating to trade or commerce between Australia and other countries, and between States and Territories within Australia. The Therapeutic Goods Administration (TGA), an administrative body within the Commonwealth Department of Human Services and Health is charged with administering the Act. State Therapeutic Goods legislation is concerned with the same areas, where they are carried out by sole traders, partnerships or other unincorporated bodies that are trading within that State only, in accordance with the Constitutional jurisdiction of the States and Territories. States and Territories however, also deal with all issues related to the practice of medicine, including extemporaneously prepared medicines. Practitioners and their practices fall outside Commonwealth jurisdiction and are governed by the States. Pursuant to an Agreement between the States and Territories, all jurisdictions are committed to complementary legislation in respect of therapeutic goods.
These changes will provide the Commonwealth with additional powers to administer the Commonwealth Therapeutic Goods Act in all States and Territories in relation to sole traders, partnerships or other unincorporated bodies trading within that State only. Matters relating to controls over wholesalers, retailers, hawking, and supply through vending machines of therapeutic goods that are scheduled poisons are likely to remain State and Territory responsibilities. 9.3.2.2 Herbal Substances A substance that falls into the category of a therapeutic good as defined by the Commonwealth Therapeutic Goods Act cannot be imported into, exported from, manufactured or supplied for use in humans in Australia unless it is registered or listed under the Act. Exceptions to this rule apply where the therapeutic goods in question are either specifically exempted under the Act, or are brought into the country for the treatment of a specific person. Difficulties have arisen with the application of the Act to herbs and herbal preparations, particularly where the herbs are also used in cooking and other non-therapeutic situations. The TGA has published guidelines to assist with the classification of herbal oils and dried herbs:
Both Guidelines establish which herbal oils, herbs and herbal mixtures will be regarded by the TGA as therapeutic goods and therefore falling within the requirements of the Act. The guidelines state that inclusion does not imply:
Herbs are used in a variety of ways in foods, cosmetics, cleaners and in therapeutic goods. How they are treated depends on the way in which they are presented. Appendices are attached to the Guidelines setting out those herbs that are used principally for therapeutic use (oils) or both therapeutic and non-therapeutic uses (dried herbs). 9.3.2.3 Registration and Listing of Chinese Medicines Depending on how Chinese herbs are to be supplied, the requirements of the Act differ. Supply to the public in consumer-ready packaged form may require registration or listing of the product and manufacture by a manufacturer licensed under the Act. Supply to licensed manufacturers as starting materials or to practitioners as raw materials for extemporaneous dispensing are exempted from these requirements. All classes of therapeutic goods, listed or registered, must comply with the Code of Good Manufacturing Practice (CGMP) which outlines standards of manufacturing for products. Whether a herbal product is listed or registered will depend on the perceived risk to the public and the claims made by the manufacturer.
Products legally on the market in Australia in 1991 (which contained no restricted or scheduled substances), when the Act commenced, were automatically registered or listed on the Register of Therapeutic Goods provided an application was made to the TGA within the presented timeframe. 9.3.2.4 Labelling of Herbs Similar classifications apply for labelling, where starting materials are exempt from the labelling requirements, but products supplied to consumers for therapeutic use must comply with the General Requirements for Labels for Therapeutic Goods (eg. statement of purpose, directions for use, batch number and expiry date). 9.3.2.5 Manufacture of Herbs Manufacturers of therapeutic goods must be licensed under the Act, and a requirement for licensing is demonstrated compliance with the Australian Code of Good Manufacturing Practice (GMP). GMP requirements apply to:
9.3.2.6 Advertising Advertising of all therapeutic goods is subject to the Therapeutic Goods Advertising Code, adopted under the Therapeutic Goods Regulations, and designed to ensure responsible advertising of therapeutic goods that may be purchased by the public without prescription and for which therapeutic claims are made. 9.3.3 State Poisons Legislation Poisons legislation is enacted in every Australian State and Territory either as specific legislation, or as in Queensland, through regulations under the Health Act. The relevance of these Acts to herbal preparations depends solely on whether any of the ingredients of the preparation are listed in the various Poisons Schedules, published in all States and Territories. If they are not listed on a schedule, then the Poisons legislation will not apply. Where a herbal ingredient is included in Schedule 4 to the NSW Poisons Act, for example, it can only be prescribed by a medical practitioner, dentist or veterinary surgeon. Schedule 1, 2 or 3 substances similarly can only be prescribed by a medical practitioner, pharmacist, dentist or veterinary surgeon who is authorised under the Act. Queensland also allows Schedule 2 poisons to be sold at a retail level by certain licensed persons. It is likely that changes will be made to Poisons or other relevant legislation, if only to streamline provisions, provide consistency between the different jurisdictions, and confer functions on the Commonwealth. However, the substantive controls over poisons described below are unlikely to alter. 9.3.3.1 Manufacture All manufacturers and suppliers of therapeutic goods that are also scheduled poisons require licensing, and must maintain records of the quantities of poisons sold. 9.3.3.2 Packaging and Labelling Packaging and labelling requirements are generally standard around Australia, with common requirements, for example, relating to leak-proof containers and packaging capable of being distinguished from food or beverage packaging. Labelling provisions detail size, colour, and content of information. The Australian Health Ministers' Advisory Council (AHMAC) Standard for the Uniform Scheduling of Drugs and Poisons contains labelling and packaging requirements, and is recognised in varying degrees by the States and Territories. Queensland has adopted certain parts of the SUSDP by reference in its Poisons Regulation 1973, for the labelling and packaging of poisons. 9.3.3.3 Storage Storage and access to drugs is the subject of specific provisions, while requirements that certain poisons be locked up exist in Victoria, Queensland and in a limited respect, NSW. 9.4.1 Legislation
9.4.2 Governing Body The principal governing body is the State Administration of Traditional Chinese Medicine (SATCM). The production, sale and distribution of herbal prescriptions in China is managed by the Ministry of Health.1 9.4.3 Titles There are three levels of competency identified in TCM: basic, intermediate/paramedical, tertiary/professional. Only intermediate/paramedical and tertiary/professional levels are permitted to use the title doctor. The title of yi shi (which loosely means `master') is reserved for doctors who have been in continuous practice for twenty years or more. In the three levels of competency, the following training is required.
Barefoot doctors are permitted to progress to the professional doctorate level through additional years of apprenticeship and licensing examinations. TCM nurses and TCM pharmacists and dispensers may also progress to doctorate level through this process.1 9.4.4 Licensing of Traditional Chinese Medical Practices There are detailed regulations governing the establishment of a medical practice in TCM. Licensing or approval is granted at a local county level by the Department of Health and Traditional Chinese Medicine or by the local municipal government. A medical practice must be conducted in a hospital, and there are detailed regulations on what constitutes a `hospital' for this purpose, such as the number of doctors, beds, pharmaceutical supplies and medical instruments. In applying to set up a hospital, all of these details must be provided together with the details of medical and technical staff and their qualifications. Only qualified medical or technical staff may be employed by the medical practice. 9.4.5 Prescribing Medicine Not all doctors may prescribe Chinese or western medication. A doctor must first be nominated by the registrar of the department in which the doctor works, and then be approved by the hospital's management board. A doctor authorised to prescribe medicines must follow specific regulations including following dosages and methods of usage in accordance with the Pharmaco poeia of the People's Republic of China and the relevant regulations of each province. 9.4.6 Pharmacy Regulation Dispensing of TCM medicines is regulated through the occupational regulation of Chinese pharmacists, in a fashion similar to the regulation of pharmacists in Australia for Western pharmaceutical preparations. A pharmacist may not change a doctor's prescription and may only hand over a TCM preparation where the prescription bears a doctor's signature and other identifying information from the hospital. 9.4.7 Infection Control Doctors must operate in sterile environment and use aseptic technique to disinfect acupuncture points. Standard procedures for withdrawing needles must be observed and doctors are responsible for ensuring that all of the equipment that is used is in good condition and proper working order. 9.5.1 Legislation
9.5.2 Summary In 1989 the Hong Kong Government appointed a working party to review and make recommendations on the use and practice of TCM. In its October 1994 report, the working party said that `the spirit of self-regulation' had informed its proposals. All TCM practitioners were to be registered eventually, but in a first stage, a preparatory committee was to draw up a list of those who had been in practice for a specified period and to advise on legislation, which would include the establishment of a statutory body. A separate mechanism was needed to control Traditional Chinese Medicine and a licensing system for proprietary medicines was to be introduced. In due course, "the statutory body should consider restricting the sale of potent herbs only to members of the public who have prescriptions from registered TCM practitioners".2 As with Singapore (see below), references to Chinese medicine regulation appear in the ordinance relating to the registration of medical practitioners. Under Part 5 relating to exemptions and regulations, clause 31 exempts from its provisions any person of Chinese race who practises medicine or surgery according to purely Chinese methods. A Chinese Medicine practitioner cannot mislead a person to believe that the practitioner is qualified to practice medicine or surgery according to modern scientific methods. Various titles are set out in the clause and require the word `herbalist' to be included in such title. There are three principal categories of TCM practitioners in Hong Kong:
9.5.3 Herbal Medicine The Import Export (General) Regulations prohibit the import and export of pharmaceutical products without a license. The Department of Health purchases herbs from the open markets and conducts routine analysis to check for adulteration. All pharmaceuticals are required to be registered under the Pharmacy and Poisons Regulation; however all Chinese herbs listed in the Chinese Herbal Materia Medica are exempt from registration requirements. Nevertheless, the Public Health and Municipal Services Ordinance prohibits possession of any drug deemed toxic. Herbs manufactured on small domestic premises are not subject to licencing or inspection. The lack of formal education or training for TCM dispensers is considered a problem with consequences for the authenticity and safety of herbs prior to delivery to customers.1 9.6 Canada - Province of Alberta 9.6.1 Legislation
9.6.2 Summary Under the Health Disciplines Act, Acupuncture is a designated health profession. As the Act and the Regulations interrelate, the following summary does not include specific reference to either the Act or the Regulation. 9.6.3 Definitions `Acupuncture' is defined to mean "The stimulation of an acupuncture point on or near the surface of the body by the insertion of needles to normalise physiological functions or the flow of Chi for the treatment of discomfort of the body and means the techniques of needle acupuncture, electro-acupuncture, acupressure and moxibustion." 9.6.4 Governing Body The Acupuncture Committee is established by the Minister of Health and comprises between 3 and 9 members, the majority of whom are to be engaged in acupuncture, with remaining members to be knowledgeable in respect of the practice of acupuncture. The main functions of the Committee are to govern registered acupuncturists in the public interest, review applications for registration, hear complaints and advise the Health Disciplines Board on health services to be provided by acupuncturists, standards of conduct, incompetency, qualifications and conditions of eligibility, continuing education, training programs, examinations and regulations. 9.6.5 General Provisions The format of the legislation is very similar to the format of health professional legislation in Australia, and are thus not reported in detail. Areas covered include complaints procedures and investigation powers of the Committee, decisions of the Board, appeals, advertising limitations and general registration requirements. The following provisions are those considered significant in the practice of acupuncture.
9.7.1 Federal Legislation and US Code Title 42 The Public Health and Welfare, Chapter 6A The Public Health Service, National Research Institutes, National Institutes of Health (1995 Amendments). These amendments established the Office of Alternative Medicine within the Office of the Director of National Institutes of Health. The purpose of the Office is stated as being to facilitate the evaluation of alternative medical treatment modalities, including acupuncture and Oriental medicine, homeopathic medicine and physical manipulation therapies. An advisory council was established together with an information clearing house to exchange information with the public about alternative medicine, provide support for research training (not fellowship support or residency training) and prepare biennial reports on its activities. The Social Security Act has recently been amended to provide coverage of qualified acupunturist services under part B of the Medicaid program to an amount not exceeding 65% of the scheduled fee for that service if it were performed by a physician. The US Code has also been amended to provide coverage of such services under the Federal Employees Health Benefits Program. Nurse midwife acupuncturists are also included. The amendments are to take effect January 1, 1997. 9.7.1 State Legislation Twenty-seven US states have enacted specific legislation for the practice of acupuncture. Many of these acts deal also with the broader concept of `Oriental Medicine'. A further four states permit the practice of acupuncture under the supervision of a medical doctor. Four states, California, Nevada, New Mexico and New York represent different styles of regulations and are discussed below. 9.8.1 Legislation 9.8.2 Definitions `Acupuncture' is defined in the Act to mean: "the insertion of needles into the human body by piercing the skin of the body to control and regulate the flow and balance of energy in the body and the cure, relieve or palliate: (a) any ailment or disease of the mind or body; or (b) any wound, bodily injury or deformity". `Herbal Medicine' and `Practice of Herbal Medicine' means suggesting, recommending, prescribing or directing the use of herbs for the cure, relief or palliation of any ailment or disease of the mind or body, or for the cure or relief of any wound, bodily injury or deformity. `Oriental Medicine' means that system of the healing art which places the chief emphasis on the flow and balance of energy in the body mechanism as being the most important single factor in maintaining the well being of the organism in health and disease. The term includes the practice of acupuncture and herbal medicine and other services approved by the Board. `Herbs' means plants or parts of plants valued for medicinal qualities. 9.8.3 Governing Body The Board comprises three members licensed under the Act, and two members of the general public. 9.8.4 Titles `Licensed Assistant in Acupuncture' means a person who assists in the practice of acupuncture under the direct supervision of a person licensed under the Act to practise oriental medicine or acupuncture. `Doctor of Acupuncture' and `Doctor of Oriental Medicine' refers to persons licensed under the respective provisions of the Act. A person licensed to practice oriental medicine under the Act may refer to themselves as a physician of oriental medicine. 9.8.5 Practice of Traditional Chinese Medicine by Other Health Care Providers Doctors may practice acupuncture if they have received `adequate training', however chiropractors may neither practice nor supervise acupuncture. 9.8.6 Eligibility Requirements Licenses to practise oriental medicine or acupuncture are separate licenses, the requirements for which are four years study in oriental medicine or three years in acupuncture, at an approved college or school (or equivalent qualifications), practise in oriental medicine (including acupuncture and herbal medicine) for six years, and passing an examination of the Board. A school or college of oriental medicine may only be established if approved by the Board and if its curriculum is also approved annually by the Board. The Board may prescribe courses of study for the degrees of doctor of acupuncture and doctor of oriental medicine. 9.8.7 Supervision/Referral Requirements A Licensed Assistant in Acupuncture may assist in the practice of acupuncture under the direct supervision of a person licensed under the Act to practise oriental medicine or acupuncture. 9.8.8 Continuing Education Ten hours per year for active licensees3. 9.8.9 Professional Misconduct The Board is empowered to employ attorneys and investigators, to conduct examinations, maintain offices in as many localities as deemed necessary, adopt regulations including a code of ethics, and compel the attendance of witnesses and the production of evidence by subpoena. 9.8.10 Other For the purpose of Public Health and Safety - County Hospitals and Hospital District Definitions (Title 40 Chapter 450, 1975), oriental medicine or acupuncture is included in the definition of `allied health profession' (in 1991 the term `oriental medicine or acupuncture' was replaced with `Traditional Oriental Medicine').
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