Footnotes

Chapter 2 - Regulatory issues

[1]        Department of Health and Ageing, Review of Health Technology Assessment in Australia, December 2009.

[2]        Department of Health and Ageing, Therapeutic Goods Administration, Reforms in the Medical Devices Regulatory Framework: Discussion Paper, 25 October 2010, p. 4.

[3]        Department of Health and Ageing, Therapeutic Goods Administration, Reforms in the Medical Devices Regulatory Framework: Discussion Paper, 25 October 2010.

[4]        Panel to Review the transparency of the Therapeutic Goods Association, Review to improve the transparency of the Therapeutic Goods Administration, Final Report, June 2011, available at http://www.tga.gov.au/pdf/consult/review-tga-transparency-1101-final-report.pdf, accessed 20 September 2011.

[5]        Tammy Maree Stanford v DePuy International Limited and Johnson & Johnson Medical Pty Limited, Federal Court of Australia Proceedings No. NSD213/2011; Pamela Joan Casey v DePuy International Ltd and Anor, Federal Court of Australia Proceedings No. ACD10/2010.

[6]        Therapeutic Goods Administration, Submission 18, p. 3.

[7]        Therapeutic Goods Administration, Submission 18, p. 3.

[8]        Therapeutic Goods Administration, Submission 18, p. 3.

[9]        Therapeutic Goods Administration, Submission 18, p. 23.

[10]      Therapeutic Goods Administration, Submission 18, p. 4.

[11]      Therapeutic Goods Administration, Submission 18, p. 6.

[12]      Therapeutic Goods Administration, Submission 18, p. 6.

[13]      Therapeutic Goods Administration, Submission 18, p. 6.

[14]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 51.

[15]      Australian Medical Association, Submission 3, p. 1.

[16]      Medibank Private, Submission 1, p. 3.

[17]      Medical Technology Association of Australia, Submission 12, p. 8.

[18]      Department of Health and Ageing, Review of Health Technology Assessment in Australia, December 2009, Recommendation 8b and 8c.

[19]      Therapeutic Goods Administration, Submission 18, p. 4.

[20]      Therapeutic Goods Administration, Submission 18, p. 30.

[21]      Therapeutic Goods Administration, Submission 18, pp 30–31.

[22]      Therapeutic Goods Administration, Submission 18, p. 4.

[23]      Therapeutic Goods Administration, Submission 18, p. 3.

[24]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 55.

[25]      Medtronics Australasia, Supplementary Submission 14, p. 5.

[26]      Therapeutic Goods Administration, Submission 18, p. 3.

[27]      Australian Dental Industry Association, Submission 30, p. 2.

[28]      Australian Dental Industry Association, Submission 30, p. 9.

[29]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 51.

[30]      The TGA defines Manufacturer's Evidence as the conformity assessment evidence that demonstrates that a manufacturer has appropriate manufacturing processes to make the devices. Once the Manufacturer’s Evidence is accepted by the TGA the sponsor can make an application to include their device on the ARTG. Acceptable Manufacturer's Evidence for most medical devices includes equivalent conformity assessment certification issued under the provisions of the European Medical Devices Directives, commonly referred to as CE certificates. See Therapeutic Goods Administration, Submission 18, p. 19.

[31]      Therapeutic Goods Administration, Submission 18, pp 19–20.

[32]      A Level 1 audit assessment includes the original or correctly notarised copy of the manufacturer’s Australian Declaration of Conformity; copy of the latest and current conformity assessment evidence for the medical device; and information about the device, including copies of the label; instructions for use; advertising material such as brochures, web pages and advertisements. Therapeutic Goods Administration, Submission 18, p. 17.

[33]      Therapeutic Goods Administration, Submission 18, pp 17 and 24.

[34]      Australian Medical Association, Submission 3, p. 1.

[35]      Australian Orthopaedic Association, Submission 5, [pp 1–2].

[36]      Australian Orthopaedic Association, Submission 5, [p. 1].

[37]      Australian Orthopaedic Association, Submission 5, [pp 1–2].

[38]      Australian Orthopaedic Association, Submission 5, [p. 5].

[39]      Therapeutic Goods Administration, Submission 18, p. 27.

[40]      Therapeutic Goods Administration, Submission 18, p. 27.

[41]      Therapeutic Goods Administration, Submission 18, p. 27.

[42]      Therapeutic Goods Administration, Submission 18, p. 27.

[43]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 2.

[44]      Australian Orthopaedic Association, Submission 5, [p. 5].

[45]      Radiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. Email correspondence, Kathy Hill, AOA, 23 September 2011.

[46]      Australian Orthopaedic Association, Submission 5, [p. 5].

[47]      Brandwood Biomedical, Submission 7, p. 6.

[48]      Consumers Health Forum of Australia, Submission 2, p. 3.

[49]      Ms Karen Carey, Board Director, Consumers Health Forum of Australia, Committee Hansard, 27 September 2011, p. 32.

[50]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 2.

[51]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 2.

[52]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 2.

[53]      Medtronics Australasia, Submission 14, p. 4.

[54]      Ms Anne Trimmer, Chief Executive Officer, Medical Technology Association of Australia, Committee Hansard, 27 September 2011, p. 7.

[55]      Ms Anne Trimmer, Chief Executive Officer, Medical Technology Association of Australia, Committee Hansard, 27 September 2011, p. 7.

[56]      Professor Stephen Graves, Director, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 23.

[57]      The Hon Dr Michael Armitage, Chief Executive Officer, Australian Health Insurance Association, Committee Hansard , 27 September 2011, p. 4.

[58]      Mr Robert Lugton, Supplementary Submission 29, [p. 2].

[59]      Mr Richard Bartlett, First Assistant Secretary, Medical Benefits Division, Department of Health and Ageing, Committee Hansard, 27 September 2011, p. 46.

[60]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 3.

[61]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 3.

[62]      Conformité Européenne (CE) marking indicates that a product may be legally sold in all Member States of the European Economic Area. http://www.innovation.gov.au/INDUSTRY/TRADEPOLICIES/MRA/Pages/EuropeanCommunity-AustraliaMutualRecognitionAgreementFAQ.aspx, accessed 26 September 2011.

[63]      Medtronics Australasia, Supplementary Submission 14, p.7.

[64]      Consumers Health Forum of Australia, Submission 2, p. 4.

[65]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms in  the Medical Devices Regulatory Framework: Discussion Paper, 25 October 2010, p.13.

[66]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms to the medical devices regulatory framework: Proposals, 23 September 2011, http://www.tga.gov.au/newsroom/consult-devices-reforms-110923.htm, accessed 29 September 2011.

[67]      Therapeutic Goods Administration, Use of Third Party Conformity Assessment Bodies for Medical Devices Supplied in Australia: Consultation Paper, December 2008, available at  http://www.tga.gov.au/pdf/archive/consult-devices-cab-thirdparty-081222.pdf, accessed 6 October 2011.

[68]      Department of Health and Ageing, Review of Health Technology Assessment in Australia, December 2009.

[69]      Therapeutic Goods Administration, Use of Third Party Conformity Assessment Bodies for Medical Devices Supplied in Australia: Consultation Paper, December 2008, available at  http://www.tga.gov.au/pdf/archive/consult-devices-cab-thirdparty-081222.pdf, accessed 6 October 2011.

[70]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 2.

[71]      Ms Robyn Chu, Director, Health Outcomes, Johnson & Johnson Medical, Committee Hansard, 27 September 2011, p. 42.

[72]      Department of Innovation, Industry, Science and Research, Submission 21, pp 2–3; Max Boccardo Associates, Submission 10, [p. 1]; AusBiotech, Submission 16, pp 2 and 5.

[73]      Max Boccardo Associates, Submission 10, [p. 2].

[74]      Department of Innovation, Industry, Science and Research, Submission 21, p. 2.

[75]      Department of Innovation, Industry, Science and Research, Submission 21, p. 2; see also AusBiotech, Submission 16, pp 5–6.

[76]      Department of Innovation, Industry, Science and Research, Submission 21, p. 2.

[77]      Medical Technology Association of Australia (MTAA), Submission 12, p. 13.

[78]      Boston Scientific Australia New Zealand, Submission 13, p. 8.

[79]      Ms Robyn Chu, Director, Health Outcomes, Johnson & Johnson Medical, Committee Hansard, 27 September 2011, p. 42.

[80]      Brandwood Biomedical, Submission 7, p. 3.

[81]      Brandwood Biomedical, Submission 7, p. 7.

[82]      Johnson & Johnson Medical, Submission 28, p. 10.

[83]      Johnson & Johnson Medical, Submission 28, p. 19.

[84]      Johnson & Johnson Medical, Submission 28, p. 19.

[85]      Department of Health and Ageing, Therapeutic Goods Administration, A Proposal for the Reclassification of Joint Replacement Implants, October 2009, http://www.tga.gov.au/pdf/consult/consult-devices-joint-replacements-091023.pdf, accessed 30 September 2011.

[86]      Department of Health and Ageing, Therapeutic Goods Administration, A Proposal for the Reclassification of Joint Replacement Implants, October 2009, http://www.tga.gov.au/pdf/consult/consult-devices-joint-replacements-091023.pdf, accessed 30 September 2011.

[87]      Department of Health and Ageing, Review of Health Technology Assessment in Australia, December 2009.

[88]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms in the Medical Devices Regulatory Framework: Discussion Paper, 25 October 2010, pp 14–15.

[89]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms to the medical devices regulatory framework: Proposals, 23 September 2011, http://www.tga.gov.au/newsroom/consult-devices-reforms-110923.htm, accessed 29 September 2011, p. 3.

[90]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 55.

[91]      Australian Medical Association, Submission 3, p. 1; St Jude Medical, Submission 8, [p. 11]; Australian Orthopaedic Association, Submission 5, [p. 2]; Johnson & Johnson, Submission 28, p. 12.

[92]      Australian Medical Association, Submission 3, p. 1.

[93]      Australian Orthopaedic Association, Submission 5, [p. 2].

[94]      Johnson & Johnson Medical, Submission 28, pp 5–6.

[95]      Johnson & Johnson Medical, Submission 28, p. 6; see also Medical Technology Association of Australia, Submission 12, p. 4.

[96]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms in the Medical Devices Regulatory Framework: Discussion Paper, 25 October 2010, pp 16–19.

[97]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms to the medical devices regulatory framework: Proposals, 23 September 2011, http://www.tga.gov.au/newsroom/consult-devices-reforms-110923.htm, accessed 29 September 2011.

[98]      St Jude Medical Australia, Submission 8, [pp 11–12].

[99]      Brandwood Biomedical, Submission 7, pp 5–6; Medtronic Australasia, Submission 14, pp 7–8.

[100]    Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 55.

[101]    Therapeutic Goods Administration, Submission 18, p. 31.

[102]    Therapeutic Goods Administration, Submission 18, p. 3.

[103]    Panel to Review the transparency of the Therapeutic Goods Association, Review to improve the transparency of the Therapeutic Goods Administration, Final Report, June 2011, available at http://www.tga.gov.au/pdf/consult/review-tga-transparency-1101-final-report.pdf, accessed 20 September 2011.

[104]    Therapeutic Goods Administration, Submission 18, p. 12.

[105]    AusBiotech, Submission 16, p. 8.

[106]    Australian Health Insurance Association, Submission 20, p. 10.

[107]    Medibank Private, Submission 1, p. 6.

[108]    Medibank Private, Submission 1, p. 6.

[109]    Consumers Health Forum of Australia, Submission 2, p. 4.

[110]    Panel to Review the transparency of the Therapeutic Goods Association, Review to improve the transparency of the Therapeutic Goods Administration, Final Report, June 2011, p. 50, available at http://www.tga.gov.au/pdf/consult/review-tga-transparency-1101-final-report.pdf, accessed 20 September 2011.

[111]    Panel to Review the transparency of the Therapeutic Goods Association, Review to improve the transparency of the Therapeutic Goods Administration, Final Report, June 2011, available at http://www.tga.gov.au/pdf/consult/review-tga-transparency-1101-final-report.pdf, accessed 20 September 2011.

[112]    Reporting medical device problems, http://www.tga.gov.au/safety/problem-device.htm, accessed 16 September 2011.

[113]    Cancer Council WA, Submission 19, [p. 3]; Consumers Health Forum of Australia, Submission 2, p. 2.

[114]    Cancer Council WA, Submission 19, [p. 3].

[115]    Consumers Health Forum of Australia, Submission 2, p. 2.

[116]    Consumers Health Forum of Australia, Submission 2, p. 2.

[117]    Australian Private Hospitals Association, Submission 4, [p. 2].

[118]    Australian Medical Association, Submission 3, p. 2.

[119]    Consumers Health Forum of Australia, Submission 2, p. 5.

[120]    Cancer Council WA, Submission 19, [p. 3].

[121]    Consumers Health Forum of Australia, Submission 2, p. 2.

[122]    Consumers Health Forum of Australia, Submission 2, p. 2.

[123]    Consumers Health Forum of Australia, Submission 2, p. 2.

[124]    Medtronic Australasia, Submission 14, p. 9.

[125]    Centre of Research Excellence in Patient Safety, Clinical Registries, http://www.crepatientsafety.org.au/registries, accessed 21 October 2011.

[126]    Australian Commission on Safety and Quality in Health Care, Clinical Quality Registries: Project Overview, http://www.health.gov.au/internet/safety/publishing.nsf/Content/PriorityProgram-08_clinical1, accessed 6 October 2011.

[127]    Therapeutic Goods Administration, Submission 18, pp 13–14.

[128]    Australian Medical Association, Submission 3, p. 2; Consumers Health Forum of Australia, Submission 2, p. 5; Australian Orthopaedic Association, Submission 5, [p. 2], Medical Technology Association of Australia, Submission 12, p. 6.

[129]    Australian Medical Association, Submission 3, p. 2.

[130]    Australian Orthopaedic Association, Submission 5, [p. 4].

[131]    Australian Medical Association, Submission 3, p. 2; Consumers Health Forum of Australia, Submission 2, p. 5; Medical Technology Association of Australia, Submission 12, p. 6; Sportsmed-SA, Submission 15, [pp 1–2], Name Withheld, Submission 27, [p. 2]; The Hon Dr Michael Armitage, Chief Executive Officer, Australian Health Insurance Association, Committee Hansard , 27 September 2011, pp 1, 2.

[132]    Australian Medical Association, Submission 3, p. 2.

[133]    Australian Orthopaedic Association, Submission 5, [p. 2].

[134]    Australian Orthopaedic Association, Submission 5, [p. 2].

[135]    Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 22.

[136]    Professor Stephen Graves, National Joint Replacement Registry, Australian Orthopaedic Association, Committee Hansard, 27 September 2011, p. 23.

[137]    Australian Medical Association, Submission 3, p. 2; Consumers Health Forum of Australia, Submission 2, p. 5; Australian Orthopaedic Association, Submission 5, [p. 2].

[138]    Consumers Health Forum of Australia, Submission 2, p. 5.

[139]    Australian Medical Association, Submission 3, p. 2.

[140]    Medical Technology Association of Australia, Submission 12, p. 6.

[141]    Australian Orthopaedic Association, Submission 5, [p. 3].

[142]    Johnson & Johnson Medical, Submission 28, p. 14.

[143]    Australian Medical Association, Submission 3, p. 2.

[144]    Australian Health Insurance Association, Submission 20, p. 4.

[145]    Australian Orthopaedic Association, Submission 5, [p. 2].

[146]    Therapeutic Goods Administration, Submission 18, p. 15.

[147]    Therapeutic Goods Administration, Submission 18, pp 15–16.

[148]    Australian Orthopaedic Association, Submission 5, [p. 4].

[149]    Therapeutic Goods Administration, Acronyms and glossary, http://www.tga.gov.au/about/glossary.htm#s, accessed 4 October 2011.

[150]    Therapeutic Goods Administration, Submission 18, p. 7.

[151]    Therapeutic Goods Administration, Submission 18, p. 7.

[152]    Therapeutic Goods Administration, Submission 18, p. 7.

[153]    Australian Orthopaedic Association, Submission 5, [p. 4].

[154]    Sportsmed-SA, Submission 5, [p. 2].

[155]    Stryker Australia, Submission 11, [p. 1].

[156]    Stryker Australia, Submission 11, [p. 1].

[157]    Johnson & Johnson Medical, Submission 28, p. 19.

[158]    Johnson & Johnson Medical, Submission 28, p. 5.

[159]    St Jude Medical Australia, Submission 8, [p. 13]; see also Johnson & Johnson Medical, Submission 28, Appendix: Reuse of single use medical devices in Australia: safety and performance imperatives and challenges to regulatory compliance, p. 5.

[160]    St Jude Medical Australia, Submission 8, [p. 13]; see also Johnson & Johnson, Submission 28, Appendix: Reuse of single use medical devices in Australia: safety and performance imperatives and challenges to regulatory compliance, p. 5.

[161]    Johnson & Johnson Medical, Submission 28, Appendix: Reuse of single use medical devices in Australia: safety and performance imperatives and challenges to regulatory compliance, p. 5.

[162]    St Jude Medical Australia, Submission 8, [pp 13–14].

[163]    AusBioTech, Submission 16, pp. 7–8.

[164]    St Jude Medical Australia, Submission 8, [p. 15]; see also Johnson & Johnson Medical, Submission 28, p. 33.

[165]    Medtronic Australasia, Submission 14, p. 9.

[166]    Stryker South Pacific, Additional Information provided on 7 October, 2011, pp 2–3.

[167]    Stryker South Pacific, Additional Information provided on 7 October, 2011, p. 4.

[168]    St Jude Medical Australia, Submission 8, [pp. 14–15].

[169]    Johnson & Johnson Medical, Submission 28, p. 33.

[170]    AusBiotech, Submission 16, p. 8.

[171]    Stryker South Pacific, Additional Information provided on 7 October, 2011, p. 10.

[172]    Therapeutic Goods Administration, Submission 18, p. 27.

[173]    Australian Dental Industry Association, Submission 30, p. 3.

[174]    Logic Appeal, Submission 33, p. 1.

[175]    Logic Appeal, Submission 33, p. 1.

[176]    Logic Appeal, Submission 33, p. 1.

[177]    Logic Appeal, Submission 33, p. 1.

[178]    Australian Dental Industry Association, Submission 30, p. 3.

Chapter 3 - High revision rates: the consumer experience

[1]        ABC, Program Transcript, Four Corners, 'Joint Reaction', 16 May 2011.

[2]        ABC, Program Transcript, Four Corners, 'Joint Reaction', 16 May 2011.

[3]        ABC, Program Transcript, Four Corners, 'Joint Reaction', 16 May 2011.

[4]        American Academy of Orthopaedic Surgeons, Hip Arthroscopy, http://orthoinfo.aaos.org/topic.cfm?topic=A00572, accessed 12 September 2011.

[5]        American Academy of Orthopaedic Surgeons, Hip Resurfacing, http://orthoinfo.aaos.org/topic.cfm?topic=A00586, accessed 12 September 2011.

[6]        American Academy of Orthopaedic Surgeons, Hip Implants, http://orthoinfo.aaos.org/topic.cfm?topic=A00355, accessed 12 September 2011.

[7]        Johnson & Johnson Medical, Press Release, 'DePuy Orthopaedics Voluntarily Recalls ASR Hip System', 26 August 2010, http://www.jnj.com/connect/news/all/depuy-orthopaedics-voluntarily-recalls-asr-hip-system, accessed 7 September 2011.

[8]        Therapeutic Goods Administration, Recall of DePuy Orthopaedics hip replacement device, 16 May 2011, http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm, accessed 25 October 2011.

[9]        DePuy ASR Hip Replacement Recall Guide at: http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[10]      DePuy ASR Hip Replacement Recall Guide at: http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[11]      Therapeutic Goods Administration, Recall of DePuy Orthopaedics ASR hip replacement device, 16 May 2011, http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm, accessed 7 September 2011.

[12]      DePuy ASR Hip Replacement Recall Guide at: http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[13]      Barry Meier, 'The Implants Loophole', The New York Times, 16 December 2010.

[14]      Therapeutic Goods Administration, Recall of DePuy Orthopaedics ASR hip replacement device, 16 May 2011, http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm, accessed 7 September 2011.

[15]      DePuy ASR™Hip Recall Guide, http://asrrecall.depuy.com/countries_list, accessed 2 September 2011.

[16]      DePuy ASR Hip Replacement Recall Guide, http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[17]      DePuy ASR Hip Replacement Recall Guide, http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[18]      DePuy ASR Hip Replacement Recall Guide, http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[19]      DePuy ASR Hip System Recall Guide for Patients, http://asrrecall.depuy.com/aupatient, accessed 7 September 2011.

[20]      Maurice Blackburn Lawyers, DePuy ASR hip implants class action, http://www.mauriceblackburn.com.au/areas-of-practice/class-actions/current-class-actions/depuy-asr-hip-implants-class-action.aspx, accessed 8 September 2011.

[21]      Shine Lawyers, DePuy ASR hip replacement class action, http://www.shine.com.au/pages/depuyhipreplacement.aspx, accessed 13 September 2011.

[22]      Name Withheld, Submission 22, pp 2, 3, 5–6 ; Name Withheld, Submission 23, p. 2 ; Name Withheld, Submission 24, [p. 1] ; Name Withheld, Submission 25, p. 1; Mr Robert Lugton, Submission 29, [pp 1–2]; Name Withheld, Submission 31, [p. 1]; Mr Stuart Cain, Submission 32, [p. 1]; Name Withheld, Submission 34, [p. 1].

[23]      Name Withheld, Submission 22, pp 3, 5, 6, 7; Name Withheld, Submission 23, p. 2; Name Withheld, Submission 25, pp 1–2; Name Withheld, Submission 26, [p. 1]; Name Withheld, Submission 31, [p. 1]; Mr Stuart Cain, Submission 32, [p. 1].

[24]      Name Withheld, Submission 22, pp 6–7; Name Withheld, Submission 25, p. 4.

[25]      Mrs Therese Wood, Submission 9, [p. 1]; Name Withheld, Submission 22, pp 4, 8–15; Name Withheld, Submission 23, pp 1, 2, 4; Name Withheld, Submission 26, [p. 1]; Mr Robert Lugton, Submission 29, [pp 1–2 and 13]; Name Withheld, Submission 31, [p. 1]; Mr Stuart Cain, Submission  32, [p. 2]; Name Withheld, Submission  34, [p. 1].

[26]      Mrs Therese Wood, Submission 9, [p. 1]; Name Withheld, Submission 22, p. 9; Name Withheld, Submission 25, pp 2–3, Mr Robert Lugton, Submission 29, [p. 2].

[27]      Mrs Therese Wood, Submission 9, [p. 1]; Name Withheld, Submission 22, pp 4–8, 11–15; Name withheld, Submission 23, p. 1; Name withheld, Submission 25, p. 1; Name Withheld, Submission 26, [p. 1]; Mr Robert Lugton, Submission 29, [p. 1]; Name Withheld, Submission  31, [p. 1]; Mr Stuart Cain, Submission  32, [p. 1]; Name Withheld, Submission  34, [p. 1].

[28]      Name withheld, Submission 22, [p. 1]; Name Withheld, Submission 23, p. 2; Name Withheld, Submission 25, pp 1–4; Name Withheld, Submission 26, [p. 1]; Mr Robert Lugton, Submission 29, [p. 2]; Name Withheld, Submission 31, [p. 1]; Mr Stuart Cain, Submission 32, [p. 1]; Name Withheld, Submission 34, [p. 1].

[29]      Name Withheld, Submission 22, pp. 5, 8; Name Withheld, Submission 23, pp 1, 2, 4; Name Withheld, Submission 24, [p. 1]; Name Withheld, Submission 25, p. 5; Name Withheld, Submission 26, [p. 1]; Mr Robert Lugton, Submission 29, [p. 2]; Name Withheld, Submission 31, [p. 1]; Mr Stuart Cain, Submission 32, [p. 1]; Name Withheld, Submission 34, [p. 1].

[30]      Name Withheld, Submission 22, p. 5; Mr Robert Lugton, Submission 29, [p. 2]; Name Withheld, Submission 31, [p. 1]; Mr Stuart Cain, Submission 32, [p. 1]; Name Withheld, Submission 34, [p. 1].

[31]      Mr Robert Lugton, Submission 29, [pp 1 and 7].

[32]      Name Withheld, Submission 23, p. 2; Mr Robert Lugton, Submission 29, [pp 1–2].

[33]      Name Withheld, Submission 31, [p. 1].

[34]      Name Withheld, Submission 26, p. 1.

[35]      Name withheld, Submission 22, pp 4 and 13; Name Withheld, Submission 27, [p. 1].

[36]      Name Withheld, Submission 23, p. 2.

[37]      DePuy ASR Hip Replacement Recall Guide, http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[38]      Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

[39]      DePuy ASR Hip Replacement Recall Guide at: http://www.depuy.com/asr-hip-replacement-recall, accessed 7 September 2011.

[40]      Name Withheld, In Camera Committee Hansard, 27 September 2011, p. 1.

[41]      Mr Stuart Cain, Supplementary Submission 32, [pp 1–2].

[42]      Name Withheld, Submission 23, [pp 1–2].

[43]      Mrs Therese Wood, Submission 9, [p. 1]; Mr Robert Lugton, Submission 29, [p. 6]; Name Withheld, Submission 22, p. 11; Name Withheld, Submission 23, p. 2; Name Withheld, Submission 26, [ p. 1].

[44]      Ms Karen Carey, Board Director, Consumers Health Forum of Australia, Committee Hansard, 27 September 2011, p. 32.

[45]      Ms Karen Carey, Board Director, Consumers Health Forum of Australia, Committee Hansard, 27 September 2011, p. 32.

[46]      Name Withheld, In Camera Committee Hansard, 27 September 2011, p. 1.

[47]      Name Withheld, Submission 26, [p. 1].

[48]      Mr Robert Lugton, Submission 29, [p. 6].

[49]      Australian Orthopaedic Association, AOA Submission, Discussion Paper– Reforms in the Medical Devices Regulatory Framework, 17 December 2010, appended to Mr Robert Lugton, Submission 29.

[50]      Mr Robert Lugton, Submission 29, [p. 4].

[51]      Johnson & Johnson Medical, Reforms in the Medical Devices Framework, Submission in Response to the TGA Discussion Paper of 25 October 2010, 7 January 2001, appended to Mr Robert Lugton, Submission 29.

[52]      Mr Robert Lugton, Submission 29, [p. 4].

[53]      Mrs Therese Wood, Submission 9, [p. 1]; Ms Karen Carey, Board Director, Consumers Health Forum of Australia, Committee Hansard, 27 September 2011, p. 33; Name Withheld, Submission 24, [p. 1].

[54]      Ms Karen Carey, Board Director, Consumers Health Forum of Australia, Committee Hansard, 27 September 2011, p. 33.

[55]      Consumers Health Forum of Australia, Submission 2, p. 5; Mrs Therese Wood, Submission 9, [p. 1].

[56]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms in the Medical Devices Regulatory Framework: Discussion Paper 25 October 2010, p. 24.

[57]      Department of Health and Ageing, Therapeutic Goods Administration, Reforms to the medical devices regulatory framework: Proposals, 23 September 2011, http://www.tga.gov.au/newsroom/consult-devices-reforms-110923.htm, accessed 29 September 2011.

[58]      Name Withheld, In Camera Committee Hansard, 27 September 2011, p. 2; Name Withheld, Submission 23, p. 1.

[59]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 20.

[60]      Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Minutes of the Orthopaedic Expert Working Group, 21 May 2008, p. 5.

[61]      Name Withheld, Submission 22, p. 2.

[62]      Mr Richard Bartlett, First Assistant Secretary, Medical Benefits Division, Department of Health and Ageing, Committee Hansard, 27 September 2011, p. 52.

[63]      Ms Cathy Bennett, Chief Executive Officer, Consumers Health Forum of Australia, Committee Hansard, 27 September 2011, p. 33.

[64]      Name Withheld, Submission 24, [p. 1].

[65]      Name Withheld, Submission 24, [p. 1].

[66]      Name Withheld, Submission 22, p. 2.

[67]      Senate Community Affairs Legislation Committee, Answers to questions on notice, Health and Ageing Portfolio, Budget Estimates 2011–2012, 31 May 2011, Question E11–018.

[68]      Senate Community Affairs Legislation Committee, Answers to questions on notice, Health and Ageing Portfolio, Budget Estimates 2011–2012, 31 May 2011, Question E11–019.

[69]      Australian Orthopaedic Association, Answer to question on notice, 17 October 2011.

[70]      Australian Orthopaedic Association, Answer to question on notice, 17 October 2011.

[71]      Australian Orthopaedic Association, Answer to question on notice, 17 October 2011.

[72]      Johnson & Johnson Medical, Answer to question on notice, 14 October 2011.

[73]      Johnson & Johnson Medical, Answer to question on notice, 14 October 2011.

[74]      Tom Moylan, LexisNexis, 'Johnson & Johnson, DePuy Pay $76.9M To Settle Foreign Bribery Claims', http://www.lexisnexis.com/community/corpsec/blogs/fcpa-law-blog/archive/2011/04/12/johnson-amp-johnson-depuy-pay-76-9m-to-settle-foreign-bribery-claims.aspx, accessed 25 October 2011.

[75]      Serious Fraud Office, 'DePuy International Limited ordered to pay 4.829 million pounds in Civil Recovery Order', http://www.sfo.gov.uk/press-room/latest-press-releases/press-releases-2011/depuy-international-limited-ordered-to-pay-4829-million-pounds-in-civil-recovery-order.aspx, accessed 25 October 2011.

[76]      ABC, Program Transcript, Four Corners, 'Joint Reaction', 16 May 2011.

[77]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 18.

[78]      The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 1.

[79]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 18.

[80]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 18.

[81]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 18.

[82]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 20.

[83]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 20.

[84]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 20.

[85]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 20.

[86]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 47.

[87]      Department of Health and Ageing, Answers to questions on notice, 27 September 2011.

[88]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 48.

[89]      Therapeutic Goods Administration, Recall of DePuy Orthopaedics ASR hip replacement device, 16 May 2011, http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm, accessed 7 September 2011.

[90]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 48.

[91]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 49.

[92]      Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Minutes of the Orthopaedic Expert Working Group, 21 May 2008, p. 5.

[93]      Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Minutes of the Orthopaedic Expert Working Group, 21 May 2008, p. 5.

[94]      Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Meeting Record and Outcomes of the Orthopaedic Expert Working Group, 18 June 2008; Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Draft Meeting Record and Outcomes of the Orthopaedic Expert Working Group, 9 December 2009.

[95]      Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, pp 20, 24; Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Draft Meeting Record and Outcomes of the Orthopaedic Expert Working Group, 9 December 2009.

[96]      Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Draft Meeting Record and Outcomes of the Orthopaedic Expert Working Group, 9 December 2009.

[97]      Professor Stephen Graves, National Joint Replacement Registry, Answers to questions on notice, 25 October 2011, [p. 2].

[98]      Professor Stephen Graves, National Joint Replacement Registry, Answers to questions on notice, 25 October 2011, [p. 3].

[99]      Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 50.

[100]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Minutes of the Orthopaedic Expert Working Group, 9 December 2009, p. 5.

[101]    Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 53.

[102]    The Hon Dr Michael Armitage, Committee Hansard, 27 September 2011, p. 1.

[103]    Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 22.

[104]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011, Draft Meeting Record and Outcomes of the Orthopaedic Expert Working Group, 9 December 2009, p. 2.

[105]    Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 49.

[106]    Johnson & Johnson Medical, Answers to questions on notice, 27 September 2011, p. 1.

[107]    Johnson & Johnson Medical, Answers to questions on notice, 27 September 2011, p. 2.

[108]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

[109]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

[110]    Ms Robyn Chu, Director, Health Outcomes, Johnson & Johnson Medical, Committee Hansard, 27 September 2011, p. 40.

[111]    Therapeutic Goods Administration, Recall of DePuy Orthopaedics ASR hip replacement device, 16 May 2011, http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm, accessed 7 September 2011.

[112]    Senate Community Affairs Legislation Committee, Answers to questions on notice, Health and Ageing Portfolio, Budget Estimates 2011–2012, 31 May 2011, Question E11–017.

[113]    Senate Community Affairs Legislation Committee, Answers to questions on notice, Health and Ageing Portfolio, Budget Estimates 2011–2012, 31 May 2011, Question E11–017.

[114]    Mr Stuart Cain, Submission 32, [p. 1].

[115]    Name Withheld, Submission 23, p. 1.

[116]    Name Withheld, Submission 31, [p. 1].

[117]    Mr Robert Lugton, Submission 29, [p. 1].

[118]    Name Withheld, Submission 34, [p. 2].

[119]    Name Withheld, Submission 34, [p. 2].

[120]    The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 1.

[121]    The Hon Dr Michael Armitage, Australian Health Insurance Association, Committee Hansard, 27 September 2011, p. 1.

[122]    Australian Orthopaedic Association, Submission 5, [p. 4].

[123]    St Jude Medical Australia, Submission 8, [pp 15–16].

[124]    Australian Orthopaedic Association, Submission 5, [p. 4].

[125]    Mr Anthony Bishop, Area Vice President, Australia and New Zealand, Johnson & Johnson Medical, Committee Hansard, 27 September 2011, p. 34.

[126]    Johnson & Johnson Medical, Answers to questions on notice, 14 October 2011.

[127]    Johnson & Johnson Medical, Answers to questions on notice, 14 October 2011.

[128]    Xinzhan Mao, Andrew A Wong and Ross W Crawford, Cobalt toxicity – an emerging clinical problem in patients with metal-on-metal hip prosthesis, Medical Journal of Australia, 2011; 194(12): pp 649–651.

[129]    Stephen E Graves, 'What is happening with hip replacement ?', Medical Journal of Australia, 2011; 194(12): pp 620–621.

[130]    Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 24; Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 56; Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

[131]    Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 24.

[132]    Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 24.

[133]    Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 56.

[134]    Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 57.

[135]    Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p. 24.

[136]    Dr Rohan Hammett, National Manager, Therapeutic Goods Administration, Committee Hansard, 27 September 2011, p. 57.

[137]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

[138]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

[139]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

[140]    Department of Health and Ageing, Answers to questions on notice, 25 October 2011.

Chapter 4 - Subsidised devices

[1]        Department of Health and Ageing, Prostheses List: Guide to listing and setting benefits for prostheses, Part 1 – Understanding the Prostheses Arrangements, July 2010, p. 7.

[2]        Department of Health and Ageing, Prostheses List Advisory Committee, www.health.gov.au/internet/main/publishing.nsf/content/health-privatehealth-PLAC, accessed 12 October 2011.

[3]        Therapeutic Goods Administration, Submission 18, p. 8.

[4]        Therapeutic Goods Administration, Submission 18, Attachment 5, p. 1.

[5]        Therapeutic Goods Administration, Submission 18, p. 8.

[6]        Department of Health and Ageing, Prostheses List: Guide to listing and setting benefits for prostheses, Part 1 – Understanding the Prostheses Arrangements, July 2010, p. 15.

[7]        Therapeutic Goods Administration, Submission 18, p. 8.

[8]        Therapeutic Goods Administration, Submission 18, Attachment 5, p. 2.

[9]        Therapeutic Goods Administration, Submission 18, Attachment 5, pp 3–4.

[10]      Department of Health and Ageing, Review of Health Technology Assessment in Australia, December 2009, p. 18.

[11]      Department of Health and Ageing, Review of Health Technology Assessment in Australia, December 2009, p. 19.

[12]      Therapeutic Goods Administration, Submission 18, pp 11–12; Department of Health and Ageing, Achievements since the release of the Health Technology Assessment Review, www.health.gov.au/internet/hta/publishing.nsf/Content/achievements-1, accessed 12 October 2011.

[13]      Medtronic Australasia, Submission 14, p. 8.

[14]      AusBiotech, Submission 16, p. 6.

[15]      Medtronic Australasia, Submission 14, pp 8–9.

[16]      Therapeutic Goods Administration, Submission 18, p. 8.

[17]      Medical Technology Association of Australia, Submission 12, p. 7.

[18]      Johnson & Johnson Medical, Submission 28, p. 20 and p. 24.

[19]      Johnson & Johnson Medical, Submission 28, p. 22.

[20]      Johnson & Johnson Medical, Submission 28, p. 24.

[21]      AusBiotech, Submission 16, p. 7.

[22]      The Hon Dr Michael Armitage, Chief Executive Officer, Australia Health Insurance Association, Committee Hansard, 27 September 2011, p. 1.

[23]      Australia Health Insurance Association, Submission 20, p. 3.

[24]      Medibank Private, Submission 1, p. 3.

[25]      Medibank Private, Submission 1, p. 4.

[26]      Medibank Private, Submission 1, p. 4.

[27]      Australian Health Insurance Association, Submission 20, p. 9.

[28]      Medibank Private, Submission 1, p. 4.

[29]      Australian Orthopaedic Association, Submission 5, p. 2.

[30]      Medibank Private, Submission 1, p. 4.

[31]      Australian Orthopaedic Association, Submission 5, p. 2.

[32]      Australian Private Hospitals Association, Submission 4, p. 4.

[33]      Medibank Private, Submission 1, p. 5; see also Australian Health Insurance Association, Submission 20, p. 4.

[34]      Australian Orthopaedic Association, Submission 5, p. 2.

[35]      Medtronic Australasia, Submission 14, p. 8.

[36]      Australia Health Insurance Association, Submission 20, p. 10.

[37]      Australia Health Insurance Association, Submission 20, p. 4.

[38]      The Hon Dr Michael Armitage, Chief Executive Officer, Australia Health Insurance Association, Committee Hansard, 27 September 2011, p. 1.

[39]      Australian Orthopaedic Association, Submission 5, p. 2.

[40]      Medical Technology Association of Australia, Submission 12, p. 7.

[41]      Australian Private Hospitals Association, Submission 4, p. 3.

[42]      St Jude Medical, Submission 8, p. 3; see also Medical Technology Association of Australia, Submission 12, p. 7.

[43]      Medical Technology Association of Australia, Submission 12, p. 7.

[44]      Boston Scientific Australia New Zealand, Submission 13, p. 8.

[45]      St Jude Medical, Submission 8, p. 6.

[46]      Medical Technology Association of Australia, Submission 12, p. 7.

[47]      Boston Scientific Australia New Zealand, Submission 13, p. 9.

[48]      St Jude Medical, Submission 8, p. 6.

[49]      AusBiotech, Submission 16, p. 7.

[50]      Medtronics Australasia, Submission 14, p. 8.

[51]      Australian Health Insurance Association, Submission 20, p. 4.

Additional Comments by Independent Senator Nick Xenophon

[1]        Professor Stephen Graves, National Joint Replacement Registry, further answers to questions on notice, 21 October 2011, (received 25 October 2011), pp 2-3

[2]        Department of Health and Ageing, answers to questions on notice, 27 September 2011, (received 25 October 2011), Minutes of the Orthopaedic Expert Working Group, 9 December 2009, p 2

[3]        Ibid

[4]        Ibid

[5]        Professor Stephen Graves, National Joint Replacement Registry, further answers to questions on notice, 21 October 2011, (received 25 October 2011), p 2

[6]        Department of Health and Ageing, answers to questions on notice, 27 September 2011, (received 25 October 2011), Minutes of the Orthopaedic Expert Working Group, May 2008 and June 2008

[7]        Professor Stephen Graves, National Joint Replacement Registry, Committee Hansard, 27 September 2011, p 22

[8]        Dr Rohan Hammett, TGA, Committee Hansard, 27 September 2011, p 48

[9]        Ibid

[10]      Department of Health and Ageing, answers to questions on notice, 27 September 2011, (received 25 October 2011), Minutes of the Orthopaedic Expert Working Group, 21 May 2008, p 5

[11]      Ibid

[12]      Professor Stephen Graves, National Joint Replacement Registry, further answers to questions on notice, 21 October 2011, (received 25 October 2011), p 1

[13]      Ms Robyn Chu, Director, Health Outcomes, Johnson & Johnson Medical, Committee Hansard, 27 September 2011, p. 40. 

[14]      Therapeutic Goods Administration, Recall of DePuy Orthopaedics ASR hip replacement device, 16 May 2011, http://www.tga.gov.au/newsroom/btn-dupuy-recall.htm

[15]      The Hon. Dr Michael Armitage, AHIA, Committee Hansard, 27 September 2011, p 4

[16]      Nicholas Campbell, JJM, answers to questions on notice, 27 September, (received 14 October), pp 1-2

[17]      The Hon. Dr Michael Armitage, AHIA, Committee Hansard, 27 September 2011, p 3

[18]      Chris Szeleczky, Stryker Australia, Supplementary Submission 11, p 4