Footnotes

Chapter 1 - Introduction and overview of the Bill

[1]        Journals of the Senate, 2013-15, No. 96, 16 June 2015, p. 2659.

[2]        House of Representatives Hansard, 27 May 2015, p. 6.

[3]        Parliamentary Library, Bills Digest No. 121, 2014–15, National Health Amendment (Pharmaceutical Benefits) Bill 2015, 16 June 2015, p. 9.

[4]        Department of Health, Pharmaceutical Benefits Scheme Price Disclosure Arrangements: Procedural and Operational Guidelines, Version 5 (July 2014), pp. 7–8.

[5]        House of Representatives Hansard, 27 May 2015, p. 7.

[6]        House of Representatives Hansard, 27 May 2015, p. 7.

[7]        Parliamentary Library, Bills Digest No. 121, 2014–15, National Health Amendment (Pharmaceutical Benefits) Bill 2015, 16 June 2015, p. 10.

[8]        House of Representatives Hansard, 27 May 2015, p. 8.

[9]        House of Representatives Hansard, 27 May 2015, p. 9.

[10]      House of Representatives Hansard, 27 May 2015, p. 9.

[11]      House of Representatives Hansard, 27 May 2015, p. 8.

[12]      House of Representatives Hansard, 27 May 2015, p. 11.

[13]      Department of Health, Submission 10, p. 4.

[14]      Pharmaceutical Benefits Advisory Committee, Recommendation made by the PBAC—April 2015 PBAC Special Meeting, http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2015-04/2015-04-biosimilars.pdf.

[15]      Explanatory Memorandum, p. 7.

[16]      Explanatory Memorandum, pp. 17–18.

[17]      Department of Health, Submission 10, p. 10.

[18]      Department of Health, Submission 10, p. 3.

[19]      House of Representatives Hansard, 27 May 2015, p. 6

[20]      Explanatory Memorandum, p. 3.

[21]      Department of Health, Submission 10, p. 16.

Chapter 2 - Views on the bill

[1]        In addition to witnesses and submissions referenced below, other submissions expressing concern about pharmacy-level substitution of biosimilars included: Mr Stephen Murby, Submission 3; the Australasian College of Dermatologists, Submission 7; Arthritis Australia, Submission 9; name withheld, Submission 12; Dr George Alex, Submission 13; Hospira Inc., Submission 14; and Mrs Katherine Stewart, Submission 17.

[2]        Pharmacy Guild of Australia, Submission 16, p. [2].

[3]        Ms Josephine Root, Policy Manager, Consumers Health Forum of Australia, Proof Committee Hansard, 18 June 2015, p. 3.

[4]        Department of Health, Submission 10, p. 7.

[5]        Pharmacy Guild of Australia, Submission 16, p. 2.

[6]        Department of Health, Submission 10, p. 8.

[7]        Ms Josephine Root, Policy Manager, Consumers Health Forum of Australia, Proof Committee Hansard, 18 June 2015, p. 3.

[8]        Consumers Health Forum of Australia, Submission 8, p. 5.

[9]        Department of Health, Submission 10, p. 8.

[10]      Department of Health, Sixth Community Pharmacy Agreement, May 2015, p. 20.

[11]      Ms Josephine Root, Policy Manager, Consumers Health Forum of Australia,  Proof Committee Hansard, 18 June 2015, p. 3.

[12]      Consumers Health Forum of Australia, Submission 8, p. 4.

[13]      Submission 10, p. 10.

[14]      Mr Tim James, Chief Executive Officer, Proof Committee Hansard, 18 June 2015, p. 2.

[15]      Dr Mona Marabani, President, Australian Rheumatology Association, Proof Committee Hansard, 18 June 2015, p. 2.

[16]      Mr Tim James, Chief Executive Officer, Medicines Australia, Proof Committee Hansard, 18 June 2015, p. 2.

[17]      Proof Committee Hansard, 18 June 2015, p. 2.

[18]      Ms Josephine Root, Policy Manager, Consumers Health Forum of Australia, Proof Committee Hansard, 18 June 2015, p. 3.

[19]      Ms Josephine Root, Policy Manager, Consumers Health Forum of Australia, Proof Committee Hansard, 18 June 2015, p. 7.

[20]      Mrs Belinda Wood, Chief Executive Officer, Generic Medicines Industry Association, Proof Committee Hansard, 18 June 2015, p. 4.

[21]      Mrs Belinda Wood, Chief Executive Officer, Generic Medicines Industry Association, Proof Committee Hansard, 18 June 2015, p. 8.

[22]      Mr Tim James, Chief Executive Officer, Medicines Australia, Proof Committee Hansard, 18 June 2015, p. 8; Dr Mona Marabani, President, Australian Rheumatology Association, Proof Committee Hansard, 18 June 2015, p. 2.

[23]      Australian Rheumatology Association, Submission 5, p. 1.

[24]      Alliance for Safe Biologic Medicines, Submission 2, pp. 1–2.

[25]      Pharmaceutical Benefits Advisory Committee, statement, 'Safety of biosimilar medicines', 18 June 2015, p. 1.

[26]      Mrs Belinda Wood, Chief Executive Officer, Generic Medicines Industry Association, Proof Committee Hansard, 18 June 2015, p. 4.

[27]      CreakyJoints Australia, Submission 6, p. 3.

[28]      Dr Krishan Thiru, Member Company Representative, Medicines Australia, Proof Committee Hansard, 18 June 2015, p. 7.

[29]      Submission 22, p. 3.

[30]      Submission 22, p. 6.

[31]      Submission 22, p. 8.

[32]      Submission 21, p. 1.

[33]      Submission 21, p. 4.

[34]      Dr Mona Marabani, President, Australian Rheumatology Association, Proof Committee Hansard, 18 June 2015, p. 2. Also see Australian Rheumatology Association, Submission 5,
p. 1.

[35]      Proof Committee Hansard, 18 June 2015, p. 9.

[36]      Proof Committee Hansard, 18 June 2015, p. 9.

[37]      Submission 21, p. 1.

[38]      Submission 21, p. 2.

[39]      Submission 15, p. 1.

[40]      Pharmaceutical Benefits Advisory Committee, Recommendation made by the PBAC – April 2015 PBAC Special Meeting, http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2015-04/2015-04-biosimilars.pdf.

[41]      Dr Krishan Thiru, Member Company Representative, Medicines Australia, Proof Committee Hansard, 18 June 2015, p. 10.

[42]      Alliance for Safe Biologic Medicines, Submission 2, p. 1.

[43]      Biotechnology Industry Organization, Submission 15, p. 2.

[44]      Dr Paul Kubler, Member, Australian Rheumatology Association, Proof Committee Hansard, 18 June 2015, pp. 8–9.

[45]      Mr Tim James, Chief Executive Officer, Medicines Australia, Proof Committee Hansard, 18 June 2015, p. 3.

[46]      Gastroenterological Society of Australia, Submission 1, p. 2.

[47]      International Cancer Advocacy Network (ICAN), Submission 4, p. 2.

[48]      Gastroenterological Society of Australia, Submission 1, pp. 2–3.

[49]      Pharmaceutical Benefits Advisory Committee, statement, 'Safety of biosimilar medicines', 18 June 2015, p. 1.

[50]      Pharmaceutical Benefits Advisory Committee, statement, 'Safety of biosimilar medicines', 18 June 2015, p. 1.

[51]      Mrs Belinda Wood, Chief Executive Officer, Generic Medicines Industry Association, Proof Committee Hansard, 18 June 2015, p. 10.

[52]      Mr David Quilty, Executive Director, Pharmacy Guild of Australia , Proof Committee Hansard, 18 June 2015, p. 10.

[53]      Proof Committee Hansard, 18 June 2015, p. 12.

[54]      Mr Andrew Stuart, Deputy Secretary, Department of Health, Proof Committee Hansard, 18 June 2015, p. 12.

[55]      Proof Committee Hansard, 18 June 2015, p. 14.

[56]      Proof Committee Hansard, 18 June 2015, p. 5.

[57]      Proof Committee Hansard, 18 June 2015, p. 5.

[58]      Proof Committee Hansard, 18 June 2015, p. 6.

[59]      Submission 22, p. 1.

[60]      Mrs Felicity McNeill, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, Proof Committee Hansard, 18 June 2015, p. 16.

[61]      Mrs Felicity McNeill, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, Proof Committee Hansard, 18 June 2015, p. 16.

[62]      Pharmaceutical Benefits Advisory Committee, statement, 'Safety of biosimilar medicines', 18 June 2015, p. 2.

[63]      Mrs Felicity McNeill, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, Proof Committee Hansard, 18 June 2015, p. 18.

[64]      Submission 22, p. 1.