Chapter 1 - Introduction

[1]        Journals of the Senate, No. 75, 30 November 2017, p. 2402.

[2]        Senate Community Affairs Legislation Committee, Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 [Provisions], March 2017.

[3]        Journals of the Senate, No. 43, 14 June 2017, pp. 1422–1423.

[4]        TGA Bill Explanatory Memorandum, p. 1; TGCA Bill Explanatory Memorandum, p. 1.

[5]        Lloyd Sansom, Will Delaat and John Horvath, Review of Medicines and Medical Devices Regulation – Stage Two: Report on the Regulatory Frameworks for Complementary Medicines and Advertising of Therapeutic Goods, July 2015, p. 1.

[6]        TGA Bill Explanatory Memorandum, p. 19.

[7]        TGA Bill Explanatory Memorandum, p. 26.

[8]        TGA Bill Explanatory Memorandum, p. 38.

[9]        TGA Bill Explanatory Memorandum, p. 46.

[10]      TGA Bill Explanatory Memorandum, p. 57.

[11]      TGA Bill Explanatory Memorandum, pp. 71, 98.

[12]      TGA Bill Explanatory Memorandum, p. 100.

[13]      TGA Bill Explanatory Memorandum, p. 135.

[14]      TGA Bill Explanatory Memorandum, p. 137.

[15]      TGCA Bill Explanatory Memorandum, p. 1.

[16]      TGCA Bill Explanatory Memorandum, p. 7 (Item 6).

[17]      TGA Bill Explanatory Memorandum, p. 6.

[18]      TGCA Bill Explanatory Memorandum, p. 2.

[19]      Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 12 of 2017, pp. 50–51. Biotronik Australia Pty Ltd also raised concerns about this proposal: Submission 36, p.1.

[20]      Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 13 of 2017, pp. 130–132.  The Department of Health submitted that 'appeals have been limited to the applicant only to prevent competitors delaying provisional registration of a product for commercial reasons as this is not in the interest of public health'. Submission 46, p. 10.

[21]      Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 12 of 2017, pp. 54–55.

[22]      Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 13 of 2017, pp. 125–126.

[23]      Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 13 of 2017, p. 126.

[24]      Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 13 of 2017, p. 127.

[25]      Parliamentary Joint Committee on Human Rights, Human Rights Scrutiny Report, Report 11 of 2017, 17 October 2017, p. 60.

[26]      TGA Bill Explanatory Memorandum, p. 7; TGCA Bill Explanatory Memorandum, p. 4.

[27]      TGA Bill Explanatory Memorandum, p. 17.

Chapter 2 - Key issues

[1]        Dr Jon Wardle in Submission 41, p. 4, argued in relation to the TGCA Bill that: 'Cost-recovery initiatives in the regulation of health products and practices in Australia and other countries has generally resulted in regulators poorly serving the public interest...It is my opinion that it is in the public interest to move the TGA away from being reliant on cost-recovery, to being funded by governments based on the degree required to uphold its public duties'.

[2]        For example, Mr Allan Asher submitted that there had been 'almost no public debate' on the Bill with the community, writing that 'Multiple industry forums have been held but civil society views have not been encouraged'. Submission 31, p. 5.

[3]        PharmaCare Laboratories Pty Ltd, Submission 40, pp. 5, 9. Examples they gave of elements that had not yet been subject to public consultation were Minimum Data Requirements and Evidence Guidelines that would be required under the proposed new assessment pathway in Schedule 3.

[4]        Office of Best Practice Regulation, Department of the Prime Minister and Cabinet, Best Practice Consultation Guidance Note, p. 6, https://www.pmc.gov.au/sites/default/files/publications/best-practice-consultation.pdf (accessed 19 January 2018); PharmaCare Laboratories Pty Ltd, Submission 40, p. 8.

[5]        NICM, Submission 44, p. 1; Medicines Australia, Submission 42, p. 1.

[6]        Medicines Australia, Submission 42, p. 3.

[7]        Department of Health, Submission 46, pp. 4, 5.

[8]        Department of Health, Submission 46, pp. 11, 12, 18, 19, 23, 26, 29.

[9]        GlaxoSmithKline (GSK), Submission 12, p. 1. See also Research Australia, Submission 3, p. 1; Pharmaceutical Society of Australia, Submission 7, p. 2; Rare Voices Australia Ltd, Submission 8, p. 1; Centre for Research in Evidence Based Practice, Submission 13, p. 1; Novartis Pharmaceuticals Australia, Submission 17, p. 1; Consumers Health Forum of Australia, Submission 19, pp. 3, 5; Pfizer Australia, Submission 20, p. 1; Bristol-Myers Squibb Australia Pty Ltd, Submission 27, p. 1; Medicines Australia, Submission 42, p. 1; NICM, Submission 44, p. 1.

[10]      Royal Australasian College of Physicians, Submission 10, p. 1.

[11]      Consumers Health Forum of Australia, Submission 19, p. 5.

[12]      Department of Health, Submission 46, p. 7.

[13]      Department of Health, Submission 46, p. 9.

[14]      TGA Bill Explanatory Memorandum, pp. 2–28.

[15]      Vitaco Health (NZ) Limited, Submission 24, pp. 1–2. See also Complementary Medicines Australia, Submission 34, p. 15.

[16]      Mr Chris Guest, Submission 33, p. 1.

[17]      Associate Professor Ken Harvey, Submission 2, p. 3.

[18]      Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 3.

[19]      Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, pp. 3–4. See also Australian Skeptics, Submission 18, p. 1. See Department of Health, Review of the Australian Government Rebate on Natural Therapies for Private Health Insurance, 2015, p. 9. One submission, however, argued that the report from this review 'did not review any original research studies, excluded subject experts, appointed anti-CM [complementary medicine] activists...did not declare conflicts and did not conduct any targeted cost-benefit analysis'. Your Health Your Choice, Submission 49, p. 7.

[20]      Royal Australasian College of Physicians, Submission 10, p. 1.

[21]      Royal Australasian College of Physicians, Submission 10, p. 2.

[22]      Research Australia, Submission 3, p. 1.

[23]      Lloyd Sansom, Will Delaat and John Horvath, Review of Medicines and Medical Devices Regulation – Stage Two: Report on the Regulatory Frameworks for Complementary Medicines and Advertising of Therapeutic Goods, July 2015, p. xii.

[24]      Vitaco Health (NZ) Limited, Submission 24, p. 1.

[25]      Vitaco Health (NZ) Limited, Submission 24, p. 1; Complementary Medicines Australia, Submission 34, pp. 3, 9.

[26]      Associate Professor Ken Harvey, Submission 2, p. 4; Ms Wendy Logan, Submission 4, p. 2; Australian Skeptics Victoria Branch, Submission 6, p. 3; Royal Australasian College of Physicians, Submission 10, pp. 2–3; Centre for Research in Evidence Based Practice, Submission 13, p. 1; Gold Coast Skeptics, Submission 15, p. 2; Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 4; Australian Skeptics, Submission 18, p. 3; Consumers Health Forum of Australia, Submission 19, pp. 5–6;  Mr Michael Dong, Submission 28, p. 2; Miss Amy Mustac, Submission 30, p. 2; CHOICE, Submission 38, pp. 3–4; Mordi Skeptics, Submission 52, p. 3; Ms Beverley Snell, Submission 53, p. 3.

[27]      Associate Professor Ken Harvey, Submission 2, p. 4; Australian Skeptics Victoria Branch, Submission 6, p. 3; Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 3; Mr Michael Dong, Submission 28, p. 2; CHOICE, Submission 38, pp. 3–4 ; Royal Australasian College of Physicians, Submission 10, pp. 2–3. United States of America Federal Trade Commission, Enforcement policy statement on marketing claims for OTC homeopathic drugs, November 2016, https://www.ftc.gov/system/files/documents/public_statements/996984/p114505_otc_homeopathic_drug_enforcement_policy_statement.pdf (accessed 17 January 2018).

[28]      BioMedica, Submission 21, p. 1; Complementary Medicines Australia, Submission 34, pp. 3, 20–21; Dr Jon Wardle, Submission 41, p. 2; ASMI, Submission 43, pp. 10–11; NICM, Submission 44, p. 2; Your Health Your Choice, Submission 49, pp. 6–7.

[29]      NICM, Submission 44, p. 2.

[30]      Dr Jon Wardle, Submission 41, p. 2.

[31]      Dr Jon Wardle, Submission 41, pp. 3, 4.

[32]      Public Health Association of Australia, Submission 22, pp. 6–7.

[33]      Department of Health, Submission 46, p. 12.

[34]      Department of Health, Submission 46, p. 12.

[35]      Public Health Association of Australia, Submission 22, p. 6.

[36]      ASMI, Submission 43, p. 9.

[37]      National Boards and AHPRA, Submission 47, p. 2.

[38]      Department of Health, Submission 46, p. 13.

[39]      Department of Health, Submission 46, pp. 10–11.

[40]      Department of Health, Submission 46, p. 12.

[41]      Department of Health, Submission 46, p. 11.

[42]      Department of Health, Submission 46, p. 13. However, some evidence to this inquiry found this proposed requirement 'deeply unsatisfactory' for a number of reasons. See CHOICE, Submission 38, p. 4.

[43]      Department of Health, Submission 46, pp. 12–13.

[44]      ASMI, Submission 43, p. 10.

[45]      National Boards and AHPRA, Submission 47, p. 2.

[46]      Vitaco Health (NZ) Limited, Submission 24, p. 1. See also Consumers Health Forum of Australia, Submission 19,

[47]      Complementary Medicines Australia, Submission 34, p. 7.

[48]      Department of Health, Submission 46, p. 15.

[49]      Department of Health, Submission 46, p. 15.

[50]      Professor Jon Jureidini, Submission 1, p. 1.

[51]      Associate Professor Ken Harvey, Submission 2, p. 2.

[52]      Associate Professor Ken Harvey, Submission 2, p. 3; Ms Wendy Logan, Submission 4, p. 2; NewsMediaWorks, Submission 26, p. 3.

[53]      Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 1.

[54]      Public Health Association of Australia, Submission 22, p. 6; Centre for Research in Evidence Based Practice, Submission 13, p. 1; Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 3.

[55]      Department of Health, Submission 46, pp. 21–22.

[56]      See TGA Bill, Division 6, 42DKB(1) and 42DV (1) and (2). Professor Jon Jureidini, Submission 1, p. 2; Associate Professor Ken Harvey, Submission 2, p. 3; Ms Wendy Logan, Submission 4, p. 2; Centre for Research in Evidence Based Practice, Submission 13, p. 1; Gold Coast Skeptics, Submission 15, pp. 1–2; Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 3; Mordi Skeptics, Submission 52, p. 1.

[57]      Department of Health, Submission 46, p. 21.

[58]      Department of Health, Submission 46, p. 22.

[59]      The Pharmacy Guild of Australia, Submission 45, pp. 3–4. See also Public Health Association of Australia, Submission 22, p. 5; Consumers Health Forum, Submission 19, p. 6.

[60]      See, for example, Mr Allan Asher, Submission 31, pp. 2–3.

[61]      Complementary Medicines Australia, Submission 34, p. 18.

[62]      Medical Technology Association of Australia (MTAA), Submission 25, p. 5. See also Vitaco Health (NZ) Limited, Submission 24, p. 1.

[63]      Complementary Medicines Australia, Submission 34, p. 3. See also National Boards and AHPRA, Submission 47, p. 2.

[64]      Associate Professor Ken Harvey, Submission 2, p. 2; Research Australia, Submission 3, p. 2; Ms Wendy Logan, Submission 4, p. 1; Australian Skeptics Victoria Branch, Submission 6, p. 1; Centre for Research in Evidence Based Practice, Submission 13, p. 1; Gold Coast Skeptics, Submission 15, p. 1; Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 2; Consumers Health Forum, Submission 19, pp. 6–7; Public Health Association of Australia, Submission 22, p. 5; NewsMediaWorks, Submission 26, pp. 2–3; Mr Robin Brown, Submission 29, p. 3; Mr Allan Asher, Submission 31, p. 2; Mr Chris Guest, Submission 33, p. 1; Ms Amy Vaux, Submission 35, p. 3; CHOICE, Submission 38, pp. 5–6; PharmaCare Laboratories Pty Ltd, Submission 40, pp. 5, 7; ASMI, Submission 43, p. 2; The Pharmacy Guild of Australia, Submission 45, p. 2; Mordi Skeptics, Submission 52, p. 3.

[65]      Mr Allan Asher, Submission 31, p. 5.

[66]      Public Health Association of Australia, Submission 22, p. 5.

[67]      CHOICE, Submission 38, p. 5. See also the Pharmacy Guild of Australia, Submission 45, p. 3; ASMI, Submission 43, p. 5.

[68]      The Pharmacy Guild of Australia, Submission 45, p. 3.

[69]      Research Australia, Submission 3, p. 2.

[70]      NewsMediaWorks, About us, http://newsmediaworks.com.au/about-us/ (accessed 18 January 2018).

[71]      NewsMediaWorks, Submission 26, p. 3. See also Free TV Australia, Submission 51, p. 3.

[72]      Pharmaceutical Society of Australia, Submission 7, p. 2. See also Vitaco Health (NZ) Limited, Submission 24, p. 1.

[73]      Accord Australia, Submission 5, p. 2.

[74]      Associate Professor Ken Harvey, Submission 2, p. 2; Centre for Research in Evidence Based Practice, Submission 13, p. 1; Gold Coast Skeptics, Submission 15, p. 1; Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 2; Consumers Health Forum, Submission 19, p. 6; Public Health Association of Australia, Submission 22, p. 5; CHOICE, Submission 38, p. 1.

[75]      ASMI, Submission 43, p. 2; NewsMediaWorks, Submission 26, p. 3.

[76]      Department of Health, Submission 46, p. 6.

[77]      Department of Health, Submission 46, p. 20.

[78]      Department of Health, Submission 46, p. 24.

[79]      Department of Health, Submission 46, p. 20.

[80]      Department of Health, Submission 46, pp. 18–19.

[81]      Department of Health, Submission 46, p. 20.

[82]      ASMI, Submission 43, p. 4. See also Lloyd Sansom, Will Delaat and John Horvath, Review of Medicines and Medical Devices Regulation – Stage Two: Report on the Regulatory Frameworks for Complementary Medicines and Advertising of Therapeutic Goods, July 2015, p. xv.

[83]      ASMI, Submission 43, p. 5.

[84]      ASMI, Submission 43, pp. 7–8.

[85]      ASMI, Submission 43, p. 6.

[86]      PharmaCare Laboratories Pty Ltd, Submission 40, p. 7.

[87]      PharmaCare Laboratories Pty Ltd, Submission 40, p. 11.

[88]      The Pharmacy Guild of Australia, Submission 45, p. 2.

[89]      Free TV Australia, Submission 51, p. 2.

[90]      Free TV Australia, Submission 51, p. 2.

[91]      Research Australia, Submission 3, p. 3; National Boards and AHPRA, Submission 47, p. 2.

[92]      Australian Dental Industry Association, Submission 9, p. 5.

[93]      Complementary Medicines Australia, Submission 34, p. 18.

[94]      Department of Health, Submission 46, p. 24.

[95]      Department of Health, Submission 46, pp. 21–22.

[96]      Associate Professor Ken Harvey, Submission 2, p. 5; Centre for Research in Evidence Based Practice, Submission 13, p. 2; Gold Coast Skeptics, Submission 15, p. 2; Assistant Professor Bruce Baer Arnold and Associate Professor Wendy Bonython, Submission 16, p. 4; Public Health Association of Australia, Submission 22, pp. 4–5; Ms Amy Vaux, Submission 35, p. 1; The Royal Australian College of General Practitioners, Submission 39, p. 3. The Department of Health in its submission responded to this concern, writing that: 'it is beyond the scope of advertising provisions of the Therapeutic Goods Act (even if they were extensively amended) and potentially beyond the Commonwealth’s constitutional powers for the TGA to be able to manage complaints related to foods that make health claims' (Submission 46, p. 24).

[97]      Mr Allan Asher, Submission 31, p. 3. However, the Department of Health stated its commitment to introducing educational programs for consumers once the final legislation introducing changes to the system is passed. Department of Health, Submission 46, p. 12.

[98]      Mr Robin Brown, Submission 29, pp. 1–2; ACCESS 2: Foundation for Effective Markets and Governance, Submission 32, p. 8.

Australian Greens' Dissenting Report

[1]        See, for example, Choice, Submission 38; Consumers Health Forum, Submission 19; Access 2: Foundation for Effective Markets and Governance, Submission 32; and additional information provided to the Committee by the Friends of Science in Medicine.

[2]        Consumers Health Forum of Australia, Submission 19, pp. 5–6.

[3]        Royal Australian College of General Practitioners, Submission 39, pp. 2–3.

[4]        Recommendation 44, Lloyd Sansom, Will Delaat and John Horvath, Review of Medicines and Medical Devices Regulation – Stage Two: Report on the Regulatory Frameworks for Complementary Medicines and Advertising of Therapeutic Goods, July 2015, p. 38.

[5]        ASMI, Submission 43, p. 5.

[6]        See, for example, Associate Professor Ken Harvey, Submission 2; Centre for Research in Evidence Based Practice, Submission 13; Consumers Health Forum of Australia, Submission 19, Public Health Association of Australia, Submission 22; Mr Allan Asher, Submission 31; CHOICE, Submission 38.

[7]        The TGA has committed to an 'external review of the complaints model after three years'. See Department of Health, Submission 46, p. 19; Therapeutic Goods Administration, TGA business plan 2017–18, https://www.tga.gov.au/book-page/regulatory-reform-0 (accessed 1 February 2018).