Footnotes

Chapter 1 - Introduction

[1]        Journals of the Senate, 21 March 2013, p. 3866.

[2]        Department of Health and Ageing, Therapeutic Goods Administration, Who we are & what we do,  http://www.tga.gov.au/about/tga-who-we-are.htm; Department of Health and Ageing, Therapeutic Goods Administration, What the TGA regulates, http://www.tga.gov.au/about/tga-regulates-what.htm

[3]        Therapeutic Goods Act 1989 Section 3(1).

[4]        Department of Health and Ageing, Therapeutic Goods Administration, What the TGA regulates,  http://www.tga.gov.au/about/tga-regulates-what.htm

[5]        Therapeutic Goods Administration website, Australian Register of Therapeutic Goods (ARTG) https://www.ebs.tga.gov.au/; Therapeutic Goods Act 1989

[6]        Department of Health and Ageing, Therapeutic Goods Administration, Medicines and TGA classifications,  http://www.tga.gov.au/industry/regulation-basics-medicines-classifications.htm

[7]        Department of Health and Ageing, Therapeutic Goods Administration, Registered medicines, http://www.tga.gov.au/industry/regulation-basics-medicines-registered.htm

[8]        Department of Health and Ageing, Therapeutic Goods Administration, Medicines and TGA classifications,  http://www.tga.gov.au/industry/regulation-basics-medicines-classifications.htm

[9]        Department of Health and Ageing, Therapeutic Goods Administration, Products regulated as biologicals, http://www.tga.gov.au/industry/biologicals-products-regulated.htm

[10]      Department of Health and Ageing, Therapeutic Goods Administration, What is a medical device?, http://www.tga.gov.au/industry/devices-basics-whatis.htm

[11]      Therapeutic Goods Administration website, About the Australian therapeutic goods legislation http://www.tga.gov.au/industry/legislation-about.htm

[12]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[13]      Department of Health and Ageing, Therapeutic Goods Administration, How the TGA regulates, http://www.tga.gov.au/about/tga-regulates-how.htm

[14]      Department of Health and Ageing, Therapeutic Goods Administration, How the TGA regulates, http://www.tga.gov.au/about/tga-regulates-how.htm

[15]      Department of Health and Ageing, Therapeutic Goods Administration, Searching the Australian Register of Therapeutic Goods (ARTG),  http://www.tga.gov.au/industry/artg-searching.htm

[16]      This list is not exhaustive. Please see Therapeutic Goods Act 1989, Chapter 3, Part 3.2, Division 1 and 2 for a more complete list with respect to Medicines and other therapeutic goods that are not medical devices. Therapeutic Goods Act 1989, Chapter 3, Part 3.2A relates to biological whilst Therapeutic Goods Act 1989, Chapter 4 relates to medical devices.

[17]      Department of Health and Ageing, Therapeutic Goods Administration, Legislation & legislative instruments,  http://www.tga.gov.au/industry/legislation.htm

[18]      Therapeutic Goods Act 1989, Section 28(2).

[19]      This list is not exhaustive and not all reasons for cancellation apply to all classes of therapeutic goods.

[20]      C King, Second Reading Speech: Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, House of Representatives Hansard, 20 March 2013, p. 2739.

[21]      For example: 'power band' bracelets, clothing and household items such as mattresses designed to reduce the effects of dust mites by using bacteria spores. Explanatory Memorandum, p. 1; C King MP, Second Reading Speech: Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, House of Representatives Hansard, 20 March 2013, pp. 2738–2741.

[22]      C King, Second Reading Speech: Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, House of Representatives Hansard, 20 March 2013, p. 2739.

[23]      Explanatory Memorandum, p. 1.

[24]      Explanatory Memorandum, p. 4.

[25]      Explanatory Memorandum, p. 4.

[26]      Explanatory Memorandum, p. 4.

[27]      Explanatory Memorandum, p. 4.

[28]      Explanatory Memorandum, p. 4.

[29]      C King, Second Reading Speech: Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, House of Representatives Hansard, 20 March 2013, p. 2738.

[30]      Human Rights (Parliamentary Scrutiny) Act 2011, s. 7.

[31]      Parliamentary Joint Committee on Human Rights, Sixth report of 2013, May 2013, p. 86.

[32]      Parliamentary Joint Committee on Human Rights, Sixth report of 2013, May 2013, p. 88.

[33]      Parliamentary Joint Committee on Human Rights, Sixth report of 2013, May 2013, p. 88.

[34]      Senate Standing Committee for the Scrutiny of Bills , Alert Digest No.5 of 2013, p. 99.

[35]      Senate Standing Committee for the Scrutiny of Bills , Alert Digest No.5 of 2013, p. 100.

[36]      Senate Standing Committee for the Scrutiny of Bills, Alert Digest No.5 of 2013, p. 101.

[37]      Australian Commission on Safety and Quality in Health Care, Submission 10, p. 1.

[38]      Department of Health, Northern Territory Government, Submission 11, p. 1.

[39]      Australian Dental Industry Association, Submission 4, p. 3.

[40]      Australian Dental Industry Association, Submission 4; Generic Medicines Industry Association, Submission 9; Australian Commission on Safety and Quality in Health Care, Submission 10; Medicines Australia, Submission 6

[41]      Australian Dental Industry Association, Submission 4, p. 4.

[42]      Generic Medicines Industry Association, Submission 9, p. 2.

[43]      Medicines Australia, Submission 6, p. 1.

[44]      Generic Medicines Industry Association, Submission 9, p. 2.

Chapter 2 - Issues

[1]        Explanatory Memorandum, p. 36.

[2]        Therapeutic Goods Act 1989, Section 25(1)(e).

[3]        Therapeutic Goods Act 1989, Section 26(1)(e). See also Explanatory Memorandum, p. 36.

[4]        Therapeutic Goods Act 1989, Section 26A(2)(c).

[5]        Therapeutic Goods Act 1989, Section 3(5).

[6]        Explanatory Memorandum, p. 37.

[7]        As noted above, this does not include medicines, which are listed under 26A.

[8]        Therapeutic Goods Act 1989, Section 30(2).

[9]        Explanatory Memorandum, p. 36.

[10]      These are the existing words that lead into the set of circumstances set out in Therapeutic Goods Act 1989, Section 30(2).

[11]      Proposed section 30(2)(aa).

[12]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 7.

[13]      Explanatory Memorandum, p. 36.

[14]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 7.

[15]      Therapeutic Goods Act 1989, subsection 32GC(1).

[16]      Medicines Australia, Submission 6, p. 2.

[17]      Department of Health and Ageing, Therapeutic Goods Administration,  TGA medicine labelling and packaging review: Consultation, http://www.tga.gov.au/newsroom/consult-labelling-packaging-review-120524-02-about.htm

[18]      Medicines Australia, Submission 6, p. 2.

[19]      Generic Medicines Australia, Submission 9, pp. 2­–3.

[20]      Mr Doug Kentwell, Submission 7, p. 9.

[21]      Department of Health and Aging, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 6. 

[22]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 6, 7.

[23]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 7. Section 10(2)(c) of the Therapeutic Goods Act 1989 currently states that an order can be made to establish standards in relation to labelling and packaging.

[24]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 6, 7. 

[25]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 7. 

[26]      Explanatory Memorandum, p. 1.

[27]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 4; Explanatory Memorandum, p. 1.

[28]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 9, 20. 

[29]      See schedule 3 item 2 of the bill.

[30]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 4; Explanatory Memorandum, p. 1.

[31]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 5.

[32]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 9. 

[33]      Mr Doug Kentwell, Submission 7, p. 5.

[34]      Mr Doug Kentwell, Submission 7, pp. 5, 7.

[35]      Complementary Healthcare Council of Australia, Submission 8, p. 6.

[36]      Complementary Healthcare Council of Australia, Submission 8, p. 6.

[37]      Medicines Australia, Submission 6, p. 2.

[38]      Complementary Healthcare Council of Australia, Submission 8, p. 6.

[39]      Australian Dental Industry Association, Submission 4, p. 5.

[40]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 10. 

[41]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 5; Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 19. 

[42]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 5.

[43]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 19. 

[44]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 10. 

[45]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 10. 

[46]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 5.

[47]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 5.

[48]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 5. 

[49]      Australian Dental Industry Association, Submission 4, p. 5.

[50]      Australian Dental Industry Association, Submission 4, p. 5.

[51]      Therapeutic Goods Act 1989, subsection 4(1).

[52]      Correspondence from Department of Health and Ageing, received 12 June 2013.

[53]      Acts Interpretation Act 1901, section 15AB(2).

[54]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[55]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[56]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[57]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[58]      See Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, Schedule 3, Item 5.

[59]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[60]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 19. 

[61]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[62]      Medicines Australia, Submission 6, p. 2.

[63]      Australian Dental Industry Association, Submission 4, p. 6.

[64]      Australian Commission on Safety and Quality in Health Care, Submission 10, p. 1.

[65]      Mr Doug Kentwell, Submission 7, p. 6.

[66]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 6.

[67]      Explanatory Memorandum, p. 7.

[68]      Explanatory Memorandum, p. 7.

[69]      Complementary Healthcare Council of Australia, Submission 8, p. 8.

[70]      Mr Doug Kentwell, Submission 7, pp. 4–5.

[71]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 8.

[72]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 8–9.

[73]      Department of Health and Ageing, Therapeutic Goods Administration, Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future, http://www.tga.gov.au/about/tga-reforms-blueprint-implementation-04-attachmenta.htm

[74]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, pp. 7–8.

[75]      It is also an offence to not comply with a request for information from the Secretary under subsection 31(4) of the Act.

[76]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 8.

[77]      Department of Health and Ageing, Therapeutic Goods Administration, Submission 5, p. 8.

[78]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 17.

[79]      Mr Doug Kentwell, Submission 7, p. 13.

[80]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 18.

[81]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 22.

[82]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 22.

[83]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 22, 23.

[84]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 23.

[85]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 23.

[86]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 23.

[87]      Therapeutic Goods Act 1989, Section 23

[88]      Explanatory Memorandum, p. 60.

[89]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 18.

[90]      Therapeutic Goods Act 1989 Section 23(2)(b).

[91]      See Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, Schedule 16, Items 1 and 2.

[92]      Mr Doug Kentwell, Submission 7, p. 14.

[93]      Mr Doug Kentwell, Submission 7, p. 14.

[94]      Mr Doug Kentwell, Submission 7, p. 15.

[95]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 18.

[96]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 18.

[97]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 12.

[98]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 12.

[99]      Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 12.

[100]    Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 14; See Explanatory Memorandum, p.30 regarding Schedule 5, Item 10.

[101]    Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 14.

[102]    See Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, Schedule 5, Item 10.

[103]    Explanatory Memorandum, Statement of Compatibility For a Bill That Raises Human Rights Issues, p. 4.

[104]    See Explanatory Memorandum, p. 30, regarding Schedule 5, Item 10.

[105]    Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 13.

[106]    Explanatory Memorandum, p. 30, regarding Schedule 5, Item 10; Explanatory Memorandum, Statement of  Compatibility For a Bill That Raises Human Rights Issues, pp.4–6.

[107]    Mr Doug Kentwell, Submission 7, p. 1.

[108]    Mr Doug Kentwell, Submission 7, p. 4.

[109]    There are currently only four collective areas where publication in the Gazette only will continue – these involve subsections 18A(10); 32CF(1); 41GW(1); 30F(4); 32CJ(4); 16(2), (3) and (3A) of the Act. Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 4–5;  Explanatory Memorandum, pp. 51–52.

[110]    Australian Dental Industry Association, Submission 4, p. 8; Explanatory Memorandum, p. 52.

[111]    Australian Dental Industry Association, Submission 4, p. 8.

[112]    Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 4–5. 

[113]    Explanatory Memorandum, pp. 51–52.

[114]    Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, Schedule 3, Item 5

[115]    Mr Doug Kentwell, Submission 7, p. 6.

[116]    Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 11, 16. 

[117]    Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), pp. 11, 16. 

[118]    Australian Dental Industry Association, Submission 4, p. 4.

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

[120]    Department of Health and Ageing, Therapeutic Goods Administration, answer to written questions on notice (received 28 May 2013), p. 4.