Footnotes

Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013

[1]        Senate Selection of Bills Committee, Report No. 4 of 2013, Appendix 17, 21 March 2013.

[2]        Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013, Explanatory Memorandum, p. 2.

[3]        Explanatory Memorandum, p. 2.

[4]        Explanatory Memorandum, p. 2.

[5]        Explanatory Memorandum, p. 2.

[6]        Explanatory Memorandum, p. 4.

[7]        Explanatory Memorandum, p. 4.

[8]        Explanatory Memorandum, p. 4.

[9]        Explanatory Memorandum, p. 5.

[10]      Explanatory Memorandum, p. 6.

[11]      Department of Health and Ageing website: http://www.health.gov.au/internet/main/publishing.nsf/Content/Consultation%3A+Position+Paper+on+the+Promotion+of+Therapeutic+Goods (accessed 11 April 2013).

[12]      Department of Health and Ageing, Position paper on the promotion of therapeutic goods, 30 June 2010, p. 1.

[13]      Department of Health and Ageing, Position paper on the promotion of therapeutic goods, 30 June 2010, p. 1.

[14]      Department of Health and Ageing, Position paper on the promotion of therapeutic goods, 30 June 2010, pp 1–2.

[15]      Department of Health and Ageing website: http://www.health.gov.au/internet/main/publishing.nsf/Content/Consultation%3A+Position+Paper+on+the+Promotion+of+Therapeutic+Goods (accessed 22 April 2013).

[16]      Working group on promotion of therapeutic products – Report to Parliamentary Secretary Catherine King, p. 5.

[17]      Working group on promotion of therapeutic products – Report to Parliamentary Secretary Catherine King, p. 7.

[18]      Working group on promotion of therapeutic products – Report to Parliamentary Secretary Catherine King, p. 7.

[19]      Department of Health and Ageing, Submission 24, p. 4.

[20]      TGA Reforms: A blueprint for TGA's future, December 2011, p. 11.

[21]      TGA Reforms: A blueprint for TGA's future, December 2011, p. 12.

[22]      Department of Health and Ageing, Submission 24, p. 4.

[23]      Department of Health and Ageing, Submission 24, p. 5.

[24]      Department of Health and Ageing, Submission 24, pp 5–6.

[25]      Medicines Australia website: http://medicinesaustralia.com.au/about-us/ (accessed 26 March 2013).

[26]      Generic Medicines Industry Association website: http://www.gmia.com.au/about-gmia/gmia-members/ (accessed 24 April 2013).

[27]      Generic Medicines Industry Association, Submission 20, p. 4.

[28]      Medicines Australia website: http://medicinesaustralia.com.au/code-of-conduct/ (accessed 26 March 2013).

[29]      Medicines Australia website: http://medicinesaustralia.com.au/code-of-conduct/code-of-conduct-review/ (accessed 26 March 2013).

[30]      Australian Competition and Consumer Commission, Media release NR 229/12, 26 October 2012.

[31]      Authorisation provides statutory protection from court action for conduct that might otherwise raise concerns under the competition provisions of the Competition and Consumer Act 2010. Broadly, the ACCC may grant an authorisation when it is satisfied that the public benefit from the conduct outweighs any public detriment. Australian Competition and Consumer Commission, Media release NR 278/12, 20 December 2012.

[32]      Australian Competition and Consumer Commission, Media release NR 278/12, 20 December 2012.

[33]      Dr Ken Harvey, Submission 4, p. 4.

[34]      Medicines Australia, Code of Conduct Edition 17, p. 65.

[35]      Medicines Australia, Code of Conduct Edition 17, pp 62, 66.

[36]      Medicines Australia, Submission 16, p. 8.

[37]      Transparency Working Group Communiqué of meeting held on 13 March 2013.

[38]      Dr Ken Harvey, Submission 4, p. 1.

[39]      Generic Medicines Industry Association, Submission 20, p. 3.

[40]      Generic Medicines Industry Association, Supplementary Submission 20, p. 3.

[41]      Dr Ken Harvey, Submission 4, p. 1.

[42]      Dr Ken Harvey, Submission 4, p. 1.

[43]      Dr Mary Osborn, Submission 3, p. 3.

[44]      See for example, Dr Ken Harvey, Submission 4, p. 6; Consumers Health Forum of Australia, Submission 14, p. 2; and The University of Sydney, Submission 23, p. 1.

[45]      Dr Ken Harvey, Submission 4, p. 2.

[46]      Australian Medical Association, Submission 7, p. 1.

[47]      See for example, Medicines Australia, Submission 16; Vifor Pharma, Submission 9, pp 1–2; MSD, Submission 10, pp 1–2; and Amgen Australia Pty Ltd, Submission 11, p. 1.

[48]      Pfizer Australia, Submission 8, p. 1.

[49]      Medicines Australia, Submission 16, p. 5.

[50]      Consumers Health Forum of Australia, Submission 14, p. 1.

[51]      Department of Health and Ageing, Submission 24, p. 9.

[52]      Dr Ken Harvey, Submission 4, p. 5.

[53]      Medicines Australia, Submission 16, p. 9.

[54]      Australian Medical Association, Submission 7, p. 3.

[55]      Mr Peter Woodley, Assistant Secretary, Blood, Organ and Regulatory Policy Branch, Department of Health and Ageing, Proof Committee Hansard, 29 April 2013, p. 35.

[56]      Dr Steven Hambleton, Federal President, Australian Medical Association, Proof Committee Hansard, 29 April 2013, p. 11.

[57]      Department of Health and Ageing, Submission 24, p. 7.

[58]      Dr Ken Harvey, Submission 4, p. 1; Consumers Health Forum of Australia, Submission 14, p. 4; Ms Lisa Maguire, Associate Director, GlaxoSmithKline, Proof Committee Hansard, 29 April 2013, p. 15.

[59]      See for example, Dr Ken Harvey, Submission 4, p. 1; Allegan Australia Pty Ltd, Submission 12, p. 1.

[60]      Pfizer Australia, Submission 8, p. 3.

[61]      Australian Medical Association, Submission 7, p. 3.

[62]      Dr Steven Hambleton, Federal President, Australian Medical Association, Proof Committee Hansard, 29 April 2013, p. 10.

[63]      The University of Sydney, Submission 23, p. 3.

[64]      The University of Sydney, Submission 23, p. 3.

[65]      Dr Ken Harvey, Submission 4, p. 2.

[66]      Pfizer Australia, Submission 8, p. 3.

[67]      Ms Deborah Monk, Director Innovation and Industry Policy, Medicines Australia, Proof Committee Hansard, 29 April 2013, p. 29.

[68]      Pfizer Australia, Submission 8, p. 3.

[69]      Department of Health and Ageing, Submission 24, p. 8.

[70]      Ms Lisa Maguire, Associate Director, GlaxoSmithKline, Proof Committee Hansard, 29 April 2013, p. 14.

[71]      See for example, Medicines Australia, Submission 16, p. 11; MSD, Submission 10, p. 1; Amgen Australia, Submission 11, pp 1–2; Lundbeck Australia, Submission 13, p. 1.

[72]      Australian Medical Association, Submission 7, p. 1.

[73]      See for example, Mr Geoff McDonald, General Manager, GlaxoSmithKine, Proof Committee Hansard, 29 April 2013, p. 24.

[74]      See for example, Vifor Pharma, Submission 9, p. 2; Amgen Australia Pty Ltd, Submission 11, p. 2.

[75]      Ms Lisa Maguire, Associate Director, GlaxoSmithKline, Proof Committee Hansard, 29 April 2013, p. 14.

[76]      Mr Geoff McDonald, General Manager, GlaxoSmithKine Proof Committee Hansard, 29 April 2013, p. 28.

[77]      The University of Sydney, Submission 23, p. 2.

[78]      For example, see Medical Technology Association of Australia and IVD Australia, Submission 6, p. 6.

[79]      Pfizer Australia, Submission 8, p. 4.

[80]      Janssen-Cilag Pty Ltd, Submission 15, pp 4–5.

[81]      SANOFI, Submission 5, p. 1.

[82]      Medicines Australia, Submission 16, p. 8.

[83]      Medical Technology Association of Australia and IVD Australia, Submission 6, p. 1.

[84]      Dr Steven Hambleton, Federal President, Australian Medical Association, Proof Committee Hansard, 29 April 2013, p. 11.

[85]      The University of Sydney, Submission 23, p. 2.

[86]      Dr Ken Harvey, Proof Committee Hansard, 29 April 2013, p. 4.

[87]      See for example, Medicines Australia, Submission 16, p. 3; Medical Technology Association of Australia and IVD Australia, Submission 6, p. 1; Dr Ken Harvey, Submission 4, p. 6.

[88]      TGA Reforms: A blueprint for TGA's future, 2011, p. 25.

[89]      Dr Barnes, Medicines Australia, Proof Committee Hansard, 29 April 2013, pp 23–24.

[90]      Dr Ken Harvey, Proof Committee Hansard, 29 April 2013, p. 2.

Australian Greens Dissenting Comments

[1]        Department of Health and Ageing, Submission 24, p. 7.

[2]        Dr Ken Harvey, Submission 4, p. 3.

[3]        Dr Ken Harvey, Submission 4, p. 4.

[4]        See for example, Medicines Australia, Submission 16, p.3; MTAA and IVDA, Submission 6, p. 1; Dr Ken Harvey, Submission 4, p. 6.

[5]        TGA Reforms: A blueprint for TGA's future, 2011, p. 25.

[6]        GlaxoSmithKline, Submission 17, p. 4.

[7]        Dr Ken Harvey, Submission 4, p. 1.

[8]        The University of Sydney, Submission 23, p. 3.

[9]        The University of Sydney, Submission 23, p. 3.

[10]      Pfizer Australia, Submission 8, p. 3.