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Regulation of homoeopathic and anthroposophic medicines in Australia

Consultation

1 September 2008

This consultation closed on 1 October 2008.

Introduction

In April 2003, the Expert Committee on Complementary Medicines in the Health System (ECCMHS) recommended that:

"Homoeopathic medicines and related medicines making therapeutic claims be regulated to ensure they meet appropriate standards of safety, quality and efficacy."

Since then widespread consultation has been undertaken, including that carried out as part of the move towards a co-regulatory environment between Australia and New Zealand.

Submissions received from stakeholders, as well as targeted consultation with stakeholder representative groups and expert committees, have helped to develop an appropriate framework for the regulation of homoeopathic and anthroposophic medicines. This regulatory framework takes into account the need to clearly differentiate these medicines from other complementary medicines.

This current consultation invites final comment from stakeholders on the proposed regulatory arrangements for homoeopathic and anthroposophic medicines in Australia.

Consultation paper

How to access a pdf document

Regulation of homoeopathic and anthroposophic medicines in Australia (pdf,496kb)

Contents

  • Introduction
  • How to comment on this consultation paper
  • Proposed regulation of homoeopathic and anthroposophic medicines
  • Appendix 1: Current regulation of homoeopathic medicines
  • Appendix 2: Lists of permitted ingredients

Summary of submissions

26 August 2009

Summary of submissions received in response to September 2008 consultation paper: Regulation of Homoeopathic and Anthroposophic Medicines in Australia

Definitions

Summary of submissions about proposed definitions
No. Summary of Comments No. of related submissions
1 The proposed definition of 'homoeopathic preparation' should not imply that ALL homoeopathic medicines, including those supplied direct to practitioners, must contain only the ingredients in the 'List of Permitted Ingredients for Homoeopathic Medicines' 5
2 The proposed definition of a homoeopathic medicine or preparation does not include the key requirements that embody the philosophical aspects of homoeopathic medicine that distinguish it from other therapies (whereas the current definition does). 7
3 Request a separate definition for Nosodes, Sarcodes and Isopathy, to distinguish them as 'practitioner-only' 1
4 Proposed definition of 'homoeopathic preparation' doesn't include anything about intended use. Suggest changing emphasis from 'permitted ingredients' to 'allowable potencies' 1
5 Organ remedies should not be classed as homoeopathic medicines, so there needs to be a separate definition for them 1
6 Proposed definition of 'mother substance' doesn't include imponderabilia such as Sol, Luna, X-ray 2
7

Do not support proposed definition of 'mother substance'. Suggest alternative wording:

'mother substance means a starting material used in the preparation of a homoeopathic or anthroposophic preparation or medicine, being or derived from a plant or a plant material, an alga, a fungus, a micro-organism, an animal material, a mineral, a mineral compound or a chemical, and may include a composition of such starting material'.

2
8 The definition of 'mother substance' should allow access to a wide variety of substances and ensure that no nosodes and sarcodes are excluded from the ARTG by this definition 1
9 Support the proposed definition of 'Anthroposophic medicine', however recommend changing footnote wording from 'consistent with the anthroposophic teachings of Rudolph Steiner', to 'consistent with the principles of anthroposophy developed by Rudolf Steiner' (or words to that effect) 2
10 Support the proposed definition of 'Homoeopathic medicine', in particular the omission of reference to homoeopathic philosophy or paradigm. The purpose of the definition is to provide a clear reference for regulatory purposes whilst supporting pluralism and freedom of therapies. 2
11

Do not support the proposed definition of 'anthroposophic preparation' and 'homoeopathic preparation'. These definitions should not include a reference to the permitted ingredients lists. Suggested alternative wording:

'Anthroposophic preparation means a preparation prepared: a) from a mother substance, and ...'

'Homoeopathic preparation means a preparation prepared: a) from a mother substance, and ...'

3
12 Believe it is important to make it very clear in the definitions that Homoeopathic Preparations are, in fact, equivalent to starting materials for other listed medicines. 1
13 Support the separation of homoeopathic products from medicines that contain combinations of homoeopathic and non-homoeopathic ingredients. 1

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Standards

Summary of submissions about proposed standards
No. Summary of Comments No. of related submissions
14 Support the proposed list of standards for anthroposophic and homoeopathic medicines 2
15 Swiss Pharmacopoeia "Pharmacopoeia Helvetica" should be added to default list of standards, as it contains important references to anthroposophic medicine. The Swiss Pharmacopoeia is referenced as a standard in the Anthroposophic Pharmaceutical Codex (APC). 2
16 Use of BP and EP as standards should not be limited to Homoeopathic sections only, but broadened to include entire pharmacopoeia. 2
17 Request the inclusion of a list from a reliable homoeopathic software tool such as Radar or MacRepertory, or from a homoeopathic pharmacy which demonstrates GMP such as Brauer (Aus.), Simillimum (NZ) or Helios (UK). 1
18 What circumstances would apply to determining the most appropriate preparation of the mother tincture and the most relevant potencies (of differing monographs)? 1
19 It is noted that only 'western' homoeopathic texts have been proposed as standards. Has consideration been given to the Homoeopathic Pharmacopoeia of India? 1

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What is listable?

Summary of submissions about what is listable
No. Summary of Comments No. of related submissions
20 Will Schedule 4 - Part 1 (item 5) of the Regulations be removed? 2
21 Will these Listings be limited to 'self-limiting conditions' 1
22 Support the development of a process for nominating new homoeopathic and anthroposophic ingredients and look forward to participation and input into the development of the process. 1
23

Recommend proposed amendment to Schedule 4 - Part 1 of the Regulations be separated into two sections, one for homoeopathic and one for anthroposophic, as follows:

An anthroposophic medicine that:

  1. contains no active ingredient other than a mother substance or a homoeopathic or anthroposophic preparation of a mother substance specified in the [document name TBC]; and
  2. contains no ingredient that is a prohibited import; and
  3. is not required, by a standard, to be sterile.

A homoeopathic medicine that:

  1. contains no active ingredient other than a homoeopathic preparation of a mother substance specified in the [document name TBC]; and
  2. contains no ingredient that is a prohibited import; and
  3. is not required to be sterile; and
  4. may only contain excipients listed in [document name TBC]; and
  5. is only included in a dosage form that is listed in [document name TBC].
2

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Lists of permitted ingredients

Summary of submissions about lists of permitted ingredients
No. Summary of Comments No. of related submissions
24 Wish to establish that the list of substances for homoeopathic medicines is not fixed. Discovery of new substances is ongoing, therefore do not support any restrictions with respect to potential sources for homoeopathic medicines. 1
25

Regarding the process for nominating a new homoeopathic ingredient - assume that manufacturers will have to pay for listing of that substance. If so,

  • How much will they have to pay per Listing?
  • Will evidence be required to attain Listing?
  • How many substances will therefore never be listed?
1
26 Will it be possible to apply for Listing of medicines in groups, to cut down on cost and bureaucratic process? 1
27

Recommend that the List titles be amended to clearly reflect that they only apply to Listed anthroposophic and homoeopathic medicines, eg.

'List of ingredients permitted for use in Listed homoeopathic medicines'.

2
28 Recommend that process used to establish validity of a new anthroposophic ingredient should include reference to the Anthroposophic Pharmaceutical Codex (APC) 2
29 Practitioner-supplied homoeopathic medicines should not be restricted in any way. 3
30 Porcine-derived organotherapy products should be available to practitioners without restrictions, as porcine-derived medicines do not pose the same risks as those derived from cattle, sheep, goats or mule deer 64
31 Homoeopathic medicines derived from starting materials listed in Schedules 8 & 9 of the SUSDP should be available to practitioners without restriction, or in concentrations below 10C (diluted beyond Avogadro's number). 6
32 Request that submissions to the NDPSC, for the re-scheduling of substances, can be made in groups rather than on individual substances. 1
33 Will 'special circumstances' be implemented which permit the 'reference to' scheduled poisons in advertising of homoeopathic medicines? For example, where an active ingredient is otherwise included in Schedule 4, but because of dilution of the substance it is considered a homoeopathic active. Are genuine homoeopathic qualities allowed to be advertised, and the substance mentioned? 1
34 Suggest that the List of Permitted Ingredients should apply to all medicines, including exempt medicines such as those supplied direct to practitioners. 1
35 List of Permitted Ingredients should be re-named 'List of Permitted Concentrations'. Addition of a substance to this list should be a straightforward process after providing evidence of a maximum safe concentration. 1
36 Numerous substance names in the 'List of permitted ingredients for homoeopathic medicines' are not the commonly used homoeopathic names. 5
37 Commonly used homoeopathic ingredients have not been included in the 'List of permitted ingredients for homoeopathic medicines' (eg. imponderables, animal milks). 3
38 Do not agree with/request review of basis for concentration cut-offs for a number of ingredients. 4
39 Propose that, where a concentration cut-off for a substance exists in the SUSDP, the legislation defer to the SUSDP instead of listing the cut-off, to avoid inconsistencies. 2
40 Look forward to participation and input into the development of the list of permitted anthroposophic ingredients. 3
40 Request extension of time to contribute to list of ingredients permitted for use in Listed anthroposophic medicines. 2
42 Request extension of time to review and contribute to the list of ingredients for use in homoeopathic medicines. 1
43 The list of excipients is too restrictive and is unworkable. The application of such a list will stifle innovation and limit evolution of branches of therapy. 1
44 Request additional excipients to be added to permitted excipients list (lists of proposed excipients provided in submissions - available on request) 4
45

Request additional dosage forms/edits to dosage forms:

  • Add: Gel - topical
  • Edit: Ointment - remove 'inhalation'
  • Add: Pessary - vaginal
  • Add: Capsule - oral
  • Add: Granule - oral (CHC only)
4

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Exemptions

Summary of submissions about exemptions
No. Summary of Comments No. of related submissions
46 Under 'Exemptions', clause (v) and clause (vi) are contradictory, as (v) implies some SUSDP-listed ingredients may be exempt under certain circumstances, but (vi) states that nothing in the 'Not Exempt' list can be exempt from listing. The 'Not Exempt' list contains the large majority of the substances contained in the SUSDP. 2
47 Sub-section a) under the first paragraph of 'Exemptions' should state that homoeopathic and anthroposophic preparations (not medicines) can be supplied as starting materials for medicines. Also suggest there is ambiguity with use of the word 'medicines' in the second paragraph. 1
48 If none of the SUSDP ingredients can be exempt from Listing in the ARTG, when supplied to practitioners, there will be a significant impact on the homoeopathic and anthroposophic industries. Request consideration for less harmful SUSDP ingredients to be able to be exempt from Listing in the ARTG, at an appropriate cut-off. 3
49 With respect to the 'Not Exempt' list, how does Listing make these substances any less hazardous? 1
50 Doesn't the introduction of GMP for all homoeopathic medicines negate the need for the 'NOT exempt' list, as the quality and safety will now be assured? 2
51 Do not agree with the proposal that medicines made from ingredients in the 'NOT EXEMPT' list cannot be supplied direct to practitioners at any concentration, without prior Listing in the ARTG. These substances should be exempt at an appropriate concentration cut-off. 3
52 Suggest that not all ingredients derived from animal origin should be required to be Listed in the ARTG. Ingredients derived from bees and other insects, and porcine origin, for example, should be able to be exempt, as per the current exemption clauses. 3
53 With regard to medicines made from animal products, does the alcohol used in the tincture not kill prions and some viruses, eg. KJD? 1
54 Do not agree with the proposal that only ingredients at a concentration of 10mg/kg or less be exempt for practitioner supply. Request that consideration be given to ingredients of low-risk (such as Calendula) being exempt at greater concentrations (eg. 3X) 2
55 The 'Not Exempt' list requires review, as some ingredients should be removed from this list. 1
56 Believe the proposed exemptions to be a major weakness in the proposed regulatory scheme for homoeopathic medicines, and a better way to communicate information where appropriate evidence is lacking needs to be developed. 1
57 The current regulatory framework makes reference to situations where a practitioner makes up medicines, in advance, in anticipation of patients who may come onto the premises and ask for the medicine. Explicit statements such as these may be necessary to include in the proposed regulations. 1
58 Support exemptions for extemporaneous compounding 1

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GMP requirements

Summary of submissions about proposed GMP requirements
No. Summary of Comments No. of related submissions
59 Endorse the proposal that all manufacturers of homoeopathic medicines meet the requirements of the cGMP 5
60 Support quality manufacturing processes that consistently deliver safe, quality products. 1
61 How will practitioners evaluate whether an overseas manufacturer complies with Australian GMP standards or equivalent? 1
62 Request further consultation with stakeholders when developing interpretive guidelines for GMP 3
63 Will manufacturers cope with increased costs imposed by GMP requirements? 1
64 The proposed requirement for all homoeopathic medicines to be produced under GMP could prevent homoeopaths from producing their own first aid kits for use by their patients. 1
65 Overseas manufacturers, such as those in India may not have the capacity to meet Australian GMP requirements, and this will limit the possible sources of homoeopathic medicines to local manufacturers, which will be detrimental to competition and therefore to long-term viability of the homoeopathic industry and availability of homoeopathic remedies. 1
66 The same quality requirements for the manufacture of homoeopathic preparations should apply to the manufacture of starting materials for all listed medicines. The verification of these requirements should be the responsibility of the practitioner or licensed medicine manufacturer (whoever distributes the medicine). 1
67 Will the requirement for all homoeopathic medicines to be manufactured under GMP be inclusive or exclusive of the mother tinctures? 1
68 Will the full GMP requirements of ARGCM apply? 1
69 How can it be determined whether a specific homoeopathic medicine contains the mother substance or not? This needs to be considered in the application of GMP. 1

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Evidentiary requirements

Summary of submissions about proposed evidentiary requirements
No. Summary of Comments No. of related submissions
70 Note that evidentiary requirements for homoeopathic ingredients in Listed medicines are currently under review, and look forward to participation and input into the review. 1
71 Evidentiary requirements for homoeopathic medicines should be equivalent to those for conventional medicines. 3
72 Homoeopathic medicines that rely upon homoeopathic tradition to support a claim for efficacy must make this clear by a statement, "Traditionally used in homoeopathic practice for the relief of xyz" 2
73 Any claim made that is not related to traditional use (including claims for mixtures of homoeopathic and other ingredients) must be substantiated by providing evidence of efficacy from well conducted clinical trials. 2
74 Propose a list of Anthroposophic texts to be evaluated as potential 'approved' reference sources for anthroposophic medicine, similar to 'approved Materia Medica' for homoeopathic medicines. (List available on request) 2
75 Suggest that in certain circumstances only one source of evidence would be necessary in order to provide support for claims for anthroposophic and homoeopathic medicines, for example where the evidence source has been derived from an approved TGA reference. 2
76 Propose that there should be no requirement to word homoeopathic claims with reference to the traditional use. There is already a provision in the Labelling Order that such products include 'homoeopathic medicine' on the label. The additional requirement of the words 'traditional use' would restrict the development of new medicines that do not meet the definition of 'traditional use' 2
77 Should homoeopathic proving studies carried out in Australia be managed as Clinical trials? 1
78 Will availability through any country's government public dispensaries for the indication claimed continue to be suitable criteria? 1
79 All information on the ARTG and the evidence supporting therapeutic claims for every homoeopathic medicine should be publicly available on the TGA website. 1

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Labelling

Summary of submissions about labelling
No. Summary of Comments No. of related submissions
80 Labelling and advertising of homoeopathic and anthroposophic medicines should be based on the appropriate level of evidence and efficacy 1
81 Homoeopathic medicines must include on their labels (and promotional information) the statement, "This medicine has NOT been evaluated by Australian health authorities for efficacy". 2
82 It should be compulsory for all homoeopathic medicines to include a statement of the content of the mother substance in an appropriate metric (eg. micrograms/kilogram) or ratio measurements (eg. 1:1,000,000). 2
83 The proposed section 5c of the Draft TGO 79, designates 'nM' where dilution is 1000 centesimal dilutions. This definition is not consistent with U.S or European use. It is generally accepted that the upper case 'M' designates 1000 centesimal. For example, 1M means 1000C. 1
84 Recommend that the requirement for a statement such as 'contains homoeopathic preparation' to be included on the front label of homoeopathic medicines be amended to allow placement elsewhere on the product. As homoeopathic medicines will be regulated, suggest that the concerns which initially led to this requirement are no longer relevant. 2
85 The TGA has not specified sufficient detail regarding labelling guidelines for products containing combinations of homoeopathic and non-homoeopathic ingredients. 1

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Implementation

Summary of submissions about implementation
No. Summary of Comments No. of related submissions
86 Timeline for transition period has not been defined
(CHC recommend 3 years, with provision to apply for extension where justified)
3

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General comments

Summary of submissions about general comments
No. Summary of Comments No. of related submissions
87 Concerned about the regulator's motives and incentives for overregulation of CAM in view of the Pan incident 1
88 Current proposal for regulation is not commensurate with the established low risk of the medicines 1
89 In accordance with the governments response in May 2006 it was recommended 'As part of the development of more detailed proposals for the regulation of homoeopathic medicines, a further RIS will be prepared by the responsible agency that will examine the impacts of all options including the status quo.' This has not been done, when will this be done? 1
90 Request further consultation with industry to discuss potential solutions for making available subcutaneous and intracutaneous injectable homoeopathic and anthroposophic medicines, other than via the registration process 5
91 All previous listings (and all new entries) of homoeopathic medicines in the ARTG must be checked to ensure compliance with evidentiary requirements. 1
92 Information in the ARTG, including details of the ingredients, amounts, dilutions and the product indications, claims and the supporting evidence, must be made publicly available on the ARTG web site. 1
93 All determinations of the Complaints Resolution Panel (CRP) which find a breach of the Therapeutic Goods Advertising Code in claims made for homoeopathic and anthroposophic medicines must be followed up by the TGA to check compliance. Non-compliance must be severely dealt with by effective sanctions such as substantial fines and corrective advertising orders, and the outcome (and time taken) must be made publicly available on the CRP and/or TGA web site. 1
94 Accepting homoeopathic products into the listing system suggests that they work and this may delay people with health conditions using proven treatments. 1
95 The August 2008 Consultation Document does not address the subject of efficacy. 2
96 Strongly support the regulation and use of all medicines to be evidence based. While Australian consumers are reasonably well informed about health issues and therapeutic products, many people still do not fully understand the mechanism and criteria around the registration and listing or products on the ARTG 1
97 There is a lack of available evidence for homoeopathic and anthroposophic medicines 1

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