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Schedule 1 of the Therapeutic Goods Regulations explained
This fact sheet addresses misunderstandings about the aims of the Commonwealth Therapeutic Goods Act 1989 ("the Act") and the Therapeutic Goods Regulations 1990 ("the Regulations"), and their effect on the ability of complementary healthcare professionals obtaining access to therapeutic goods and related advertising material.
Purpose of the legislation
The object of the Act is to establish and maintain a national system of controls relating to, among other things, the quality, safety, efficacy and timely availability of therapeutic goods used in or exported from Australia. The legislation also establishes controls relating to the advertising of therapeutic goods which aim to minimise the risk of misuse of such products arising out of, for example, misrepresentation or misunderstanding about the uses of the goods.
The Act does not provide for the registration of healthcare professionals
The Act does not regulate healthcare practice issues, nor does it inhibit related operations. However, it offers the advantage for consumers and healthcare professionals to be able to have confidence in the standard of ready-made proprietary therapeutic goods which they use or prescribe.
Further, there is no requirement in the Act that complementary healthcare professionals be 'registered' and the Act does not recognise the status of any healthcare professionals. The questions of registration or accreditation of healthcare professionals is a State and Territory matter and has no connection with the Commonwealth Act and Regulations.
Advertising requirements of the Therapeutic Goods Act 1989
Irrespective of the target audience, therapeutic goods may only be advertised with claims which are consistent with their indications or intended purpose, as entered in the Australian Register of Therapeutic Goods (ARTG). It constitutes an offence against Chapters 3 and 4 of the Act respectively, to do otherwise.
Further, advertisements directed to the general public (whether published by or on behalf of the sponsor or a healthcare professional) must comply with a range of requirements specified in the Act, including the Therapeutic Goods Advertising Code ("the Code") which precludes reference to serious forms of conditions which require the diagnosis and/or management of a healthcare professional (among other matters). A copy of the Code is available via the following link - Advertising therapeutic products in Australia.
However, these requirements do 'not apply to advice or information given directly to a patient by a healthcare professional, in the course of treatment of that patient'.
Advertising to healthcare professionals
Other than the aforementioned offences, all other advertising offences in the Act do not apply to advertisements directed exclusively at those healthcare professionals noted in s.42AA of the Act (refer to Attachment 1).
These include orthodox practitioners, complementary practitioners such as herbalists, homoeopaths, chiropractors, naturopaths, etc and persons who are members of an Australian branch of one of those bodies listed in Schedule 1 of the Regulations (refer to Attachment 2).
For the purposes of the Act, a person is taken to be a member of a Schedule 1 organisation if, and only if, the person has the qualifications and training that are necessary or appropriate for membership of that organisation. The decision as to who is 'appropriately qualified' is a decision vested in the governing body of the organisation.
Subject to remaining consistent with a product's indications or intended purpose entered in the ARTG, advertisements about therapeutic goods may be distributed to healthcare professionals (who fulfil the above criteria) which contain statements and claims about those goods which are not permitted in advertising to the public - since members of the public may not possess a sufficient knowledge of active ingredients and human health and disease conditions to enable an objective assessment to be made of the promotional information.
Supply of therapeutic goods
There is no restriction on the supply of therapeutic goods (including unscheduled vitamins, herbs, massage oils, and flower remedies) to a retailer or a practitioner providing the relevant statutory requirements relating to entry in the ARTG, labelling and advertising have been satisfied. This is, of course, provided that the therapeutic good is not scheduled as a prescription-only, pharmacist-only or pharmacy medicine (or otherwise not permitted under State and Territory legislation).
Therapeutic goods which are labelled for 'practitioner dispensing only' are not required to state what the product is indicated for. Such goods should only be supplied to an individual after consultation with a healthcare professional. However, regardless of whether the label includes the statement, 'for practitioner dispensing only', all information presented on the label must meet the requirements of the Code unless the appropriate exemption or approval to do otherwise has been granted by the TGA.
These arrangements are commercial decisions made by the sponsors of the goods and the TGA has no objection to this voluntary restriction upon supply.
Do complementary healthcare professionals need to be included in a Schedule 1 organisation?
If the goods healthcare professionals currently use in their practices are labelled with indications or an intended purpose which are acceptable for the public in terms of the Code, supply of such goods to healthcare professionals is not affected by the Act; irrespective of whether that person is included in a Schedule 1 organisation or not.
Subject to advertisements being consistent with a product's indications or intended purpose, if an advertisement contains statements and claims which are not permitted in advertisements to the public, only those persons who are a healthcare professional as per the provisions of Attachments 1 and/or 2 may receive such advertisements.
Attachment 1: Extract from the Therapeutic Goods Act 1989
Section 42AA This Part not to apply to advertisements directed at health professionals etc.
(1) This Part does not apply to advertisements directed exclusively to:
- (a) medical practitioners, psychologists, dentists, pharmacists, optometrists, chiropractors, physiotherapists, nurses, midwives, dental hygienists, dental prosthetists, dental therapists or osteopaths; or
- (b) persons who are:
- (i) engaged in the business of wholesaling therapeutic goods; or
- (ii) purchasing officers in hospitals; or
- (c) herbalists, homoeopathic practitioners, naturopaths, nutritionists, practitioners of traditional Chinese medicine or podiatrists registered under a law of a State or Territory; or
- (d) a class of persons specified under subsection (1A).
(1A) The Minister may, by legislative instrument, specify a class of persons for the purposes of paragraph (1)(d).
(2) This Part does not apply to advertisements directed exclusively to persons who are members of an Australian branch (however described) of one of the bodies prescribed for the purposes of this subsection.
(3) For the purposes of subsection (2), a person is taken to be a member of an Australian branch of one of those bodies if, and only if, the person has the qualifications and training that are necessary or appropriate for membership of the relevant body.
(4) This Part does not apply to advice or information given directly to a patient by a person referred to in paragraph (1)(a) or (c) or subsection (2) in the course of treatment of that patient.
Attachment 2: Extract from the Therapeutic Goods Regulations 1990
Schedule 1 - Part 2 does not apply to members of an Australian branch of one of these bodies (sub-regulation 4 (2))
|1||Acupuncture Association of Australia|
|2||Acupuncture Ethics and Standards Organisation|
|2A||Association of Natural Health Practitioners Limited|
|3A||Aust China Acupuncture and Chinese Medicine Association Inc.|
|3B||Australasian Federation of Natural Therapists Inc.|
|4||Australian Acupuncture Association Ltd.|
|5||Australasian Association of Ayurveda Incorporated|
|5A||Australian Association of Exercise and Sports Scientists|
|6||Australian Association of Professional Homoeopaths|
|6A||Australian College of Acupuncturists Ltd|
|7||Australian Committee of Natural Therapies Inc. (SA)|
|9||Australian Federation of Homoeopaths|
|9A||Australian Federation of Homoeopaths (Qld.) Inc.|
|9B||Australian Federation of Homoeopaths (WA) Inc.|
|10||Australian Natural Therapists Association Ltd|
|11||Australian Naturopathic Practitioners and Chiropractors Association|
|11A||Australian Society of Homeopaths Inc|
|12||Australian Traditional Chinese Herbalists Association (Qld)|
|13||Australian Traditional Chinese Medicine Association Inc.|
|14||Australian Traditional Medicine Society|
|14A||Australian Unani Medicines Society Inc.|
|15||Chinese Medicine Association Pty Ltd|
|15A||Chinese Medicine Association of Australia Inc.|
|16||Complementary Medicine Association|
|16A||Federation of Chinese Medicine and Acupuncture Societies of Australia|
|17||Homoeopathic Education and Research Association|
|17A||International Association of Trichologists|
|17B||International Christian Association of Natural Therapists Ltd (ICANT)|
|18||National Herbalists Association of Australia|
|18A||Naturopathic Physicians Association of Australia Inc.|
|19||Queensland Naturopathic Association|
|20||Register of Acupuncture and Traditional Chinese Medicine|
|21||Society of Natural Therapists and Researchers [SNTR] Inc.|
|22||Society of Classical Homoeopathy Ltd|
|23||Traditional Medicine of China Society Australia|
|24||Society of Chinese Medicine and Acupuncture (Vic) Inc.|
|25||Naturopathic Practitioners Association Inc.|
|26||The Acupuncture Association of Australia, New Zealand and Asia|
|26A||The Alumni Association of Natural Medicine Practitioners Inc.|
|26AA||The Australian Association of Homotoxicology Incorporated|
|26B||The Australian Podiatry Association (NSW)|
|26BA||The Homeopathic Medicine Association Inc.|
|27||The New South Wales Research Association of Traditional Chinese Medicine|