Chapter 1 - Introduction

[1]        Journals of the Senate, No. 9–11 October 2016, pp. 290–291.

[2]        Journals of the Senate, No. 73–28 November 2017, p. 2314.

[3]        Department of Health, 'About us', https://beta.health.gov.au/about-us (accessed 22 March 2018)

[4]        Department of Health, 'Portfolio Outcomes', Outcomes 3 and 5–7, http://www.health.gov.au/internet/main/publishing.nsf/Content/health-portout.htm (accessed 22 March 2018).

[5]        Department of the Prime Minister and Cabinet, 'Regulatory Reform Agenda: Key Achievements (as at December 2015)', https://www.pmc.gov.au/regulation/australias-approach-regulatory-reform/regulatory-reform-agenda-key-achievements-december-2015 (accessed 22 March 2018).

[6]        Department of the Prime Minister and Cabinet, 'Regulatory Reform Agenda: Key Achievements (as at December 2015)', https://www.pmc.gov.au/regulation/australias-approach-regulatory-reform/regulatory-reform-agenda-key-achievements-december-2015 (accessed 22 March 2018).

[7]        Australian Government, Annual Red Tape Reduction Report, 2015, p. 1, https://www.pmc.gov.au/sites/default/files/publications/2015_annual_red_tape_reduction_report.pdf (accessed 22 March 2018).

[8]        Department of Health, Submission 11, p. 1.

[9]        Department of the Prime Minister and Cabinet, 'Regulatory Policy Coordination', https://www.pmc.gov.au/regulation/regulatory-policy-coordination (accessed 22 March 2018).

[10]      Sharon Appleyard, First Assistant Secretary, Office of Health Protection, Department of Health, and Gillian Shaw, Assistant Secretary, Office of Health Protection, Department of Health, Committee Hansard, 9 February 2018, p. 27.

[11]      Department of Health, Submission 11, p. 1.

[12]      Department of Health, 'Expert Review of Medicines and Medical Devices Regulation', http://www.health.gov.au/internet/main/publishing.nsf/Content/Expert-Review-of-Medicines-and-Medical-Devices-Regulation (accessed 22 March 2018).

[13]      Department of Prime Minister and Cabinet, 'Best Practice Regulation', https://www.pmc.gov.au/regulation/best-practice-regulation (accessed 22 March 2018).

[14]      Department of Health, 'Regulation Impact Statements', http://www.health.gov.au/internet/main/publishing.nsf/Content/regulation-impact-statements (accessed 22 March 2018).

Chapter 2 - Key issues

[1]        Department of Health, Submission 1, p. 1.

[2]        For example: Medical Oncology Group of Australia, Submission 5, p. 1; Royal Australian College of General Practitioners, Submission 10, p. 1.

[3]        Australian Dental Industry Association, Submission 7, p. 2.

[4]        Roche Products Pty Ltd, Submission 1, Attachment 1, p. 1.

[5]        Roche Products Pty Ltd, Submission 1, Attachment 1, p. 2. Also see: Medicines Australia, Submission 9, p. 2.

[6]        Day Hospitals Association, Submission 2, p. 6.

[7]        Day Hospitals Association, Submission 2, p. 6.

[8]        Medical Oncology Group of Australia, Submission 5, pp. 1–2; Royal Australian College of General Practitioners, Submission 10, p. 1, which estimated 20 per cent of general practitioners' time was spent in management and administration.

[9]        Royal Australian College of General Practitioners, Submission 10, p. 1.

[10]      Australian Dental Association, Submission 6, pp. 5–6. Also see: p. 1 and Annexure A.

[11]      Australian Institute of Health and Welfare, Health expenditure Australia, 2015–2016, 2017, Tables 3.1 and 3.2, p. 23, https://www.aihw.gov.au/getmedia/3a34cf2c-c715-43a8-be44-0cf53349fd9d/20592.pdf.aspx?inline=true (accessed 22 March 2018).

[12]      Private Healthcare Australia, Submission 8, p. 2. Also see: Evaluate, The Relative Efficiency of the Private Health Insurance Rebate v. Direct Public Health Expenditure, 1 August 2017, https://www.privatehealthcareaustralia.org.au/wp-content/uploads/Evaluate-Report-Relative-Efficiency-of-PHI-Rebate-versus-Direct-Public-Health-Expenditure-1Aug2017.pdf (accessed 22 March 2018), which highlighted the financial benefits of a strong system of private health insurance.

[13]      Pharmaceutical Society of Australia, Submission 4, pp. 4–7. Also see: Medical Oncology Group of Australia, Submission 5, pp. 1–2; Day Hospitals Association, Submission 2, p. 4.

[14]      Department of Health, 'Health Technology Assessment (HTA), http://www.health.gov.au/internet/hta/publishing.nsf/Content/home-1 (accessed 22 March 2018).

[15]      Department of Health, 'HTA Policy Framework', http://www.health.gov.au/internet/hta/publishing.nsf/Content/policy-1 (accessed 22 March 2018).

[16]      Medicines Australia, Submission 9, p. 4. The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 was passed by the Parliament on 15 February 2018. Also see: Australian Dental Industry Association, Submission 7, p. 4.

[17]      Roche Products Pty Ltd, Submission 1, p. 1. Also see: Attachment 2.

[18]      David Pullar, Head of Government Affairs and Public Policy, Roche Products Pty Ltd, Committee Hansard, 9 February 2018, p. 1. Mr Pullar noted that Roche Products Pty Ltd is working with the Australian Government to introduce more flexibility into the HTA process: pp. 1–2.

[19]      Hon Greg Hunt MP, Minister for Health, 'Major reforms to make private health insurance simpler and more affordable', media release, 13 October 2017, http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2017-hunt106.htm (accessed 22 March 2018).

[20]      Private Healthcare Australia, Submission 8, p. 2. Also see: pp. 7–18.

[21]      Dr Rachel David, Chief Executive Officer, Private Healthcare Australia, Committee Hansard, 9 February 2018, p. 25. Also see: Private Healthcare Australia, Submission 8, pp. 14–16.

[22]      Department of Health, 'The Prostheses List', http://www.health.gov.au/internet/main/publishing.nsf/content/health-privatehealth-prostheseslist.htm, and 'Private health insurance reforms: Prostheses List benefit reductions', http://www.health.gov.au/internet/main/publishing.nsf/content/private-health-insurance-reforms-fact-sheet-prostheses-list-benefit-reductions (both accessed 22 March 2018).       

[23]      Private Healthcare Australia, Submission 8, pp. 16–18.

[24]      Dr Rachel David, Chief Executive Officer, Private Healthcare Australia, Committee Hansard, 9 February 2018, p. 22.  Dr David also commented that price fixing has incentivised a large number of medical devices where there was no clinical benefit: p. 23. Also see: Private Healthcare Australia, Submission 8, pp. 16–18.

[25]      Dr Rachel David, Chief Executive Officer, Private Healthcare Australia, Committee Hansard, 9 February 2018, p. 22.

[26]      See: Department of Health, 'Private Health Insurance‑Prostheses', http://www.health.gov.au/internet/main/publishing.nsf/content/health-privatehealth-PLAC (accessed 22 March 2018), for the agreement between the Australian Government and the Medical Technology Association of Australia.

[27]      Dr Rachel David, Chief Executive Officer, Private Healthcare Australia, Committee Hansard, 9 February 2018, p. 21. Also see: Private Healthcare Australia, Submission 8, pp. 21–23, which cautioned against removing the rebate on extras, which covers, for example, preventative dental care (53 per cent, $2.6 billion each year).

[28]      Medicines Australia, Submission 9, p. 5.

[29]      Also see: Australian Dental Association, Submission 6, pp. 5–6, which referred to regulatory inconsistencies in respect of some teeth-whitening products.

[30]      Australian Dental Industry Association, Submission 7, p. 10.

[31]      Australian Dental Association, Submission 6, p. 4, which argued that annual renewal of registration creates an administrative burden that could be eased if triennial renewal were implemented.

For further information on annual renewal of registration, see: Dental Board of Australia, 'Registration Renewal', http://www.dentalboard.gov.au/Registration/Registration-Renewal.aspx (accessed 22 March 2018).

[32]      Australian Dental Association, Submission 6, p. 2.

[33]      Dr Carmelo Bonanno, Vice President, Australian Dental Association, Committee Hansard, 9 February 2018, p. 13.

[34]      Dr Carmelo Bonanno, Vice President, Australian Dental Association, Committee Hansard, 9 February 2018, p. 14.

[35]      Dr Carmelo Bonanno, Vice President, Australian Dental Association, Committee Hansard, 9 February 2018, p. 13. Also see: Australian Dental Association, Submission 6, p. 3.

[36]      Dr Larry Kelly, First Assistant Secretary, Medicines Regulation, Department of Health, Committee Hansard, 9 February 2018, p. 30.

[37]      Day Hospitals Association, Submission 2, pp. 5–6.

[38]      Pharmaceutical Society of Australia, Submission 4, pp. 14–16.

[39]      Royal Australian College of General Practitioners, Submission 10, pp. 2–3.

[40]      Dr Nathan Pinskier, Chair, RACGP Expert Committee, eHealth and Practice Systems, Royal Australian College of General Practitioners, Committee Hansard, 9 February 2018, p. 10.     

[41]      Dr Nathan Pinskier, Chair, RACGP Expert Committee, eHealth and Practice Systems, Royal Australian College of General Practitioners, Committee Hansard, 9 February 2018, p. 11.

[42]      Dr Nathan Pinskier, Chair, RACGP Expert Committee, eHealth and Practice Systems, Royal Australian College of General Practitioners, Committee Hansard, 9 February 2018, p. 12.

[43]      Dr Carmelo Bonanno, Vice President, Australian Dental Association, Committee Hansard, 9 February 2018, p. 12. Also see: Dr Nathan Pinskier, Chair, RACGP Expert Committee, eHealth and Practice Systems, Royal Australian College of General Practitioners, Committee Hansard, 9 February 2018, pp. 12–13, who commented on variation in electronic capabilities in the healthcare sector, and p. 13, where state/territory requirements for 'wet' (non-electronic) signatures were noted.

[44]      Medical Oncology Group of Australia, Submission 5, p. 3. Also see: Day Hospitals Association, Submission 2, pp. 4–5, which commented on the compliance burden of having to provide data more than once.

[45]      Dr Nathan Pinskier, Chair, RACGP Expert Committee, eHealth and Practice Systems, Royal Australian College of General Practitioners, Committee Hansard, 9 February 2018, p. 17.

[46]      Mark Cormack, Deputy Secretary, Health Financing Group, Department of Health, Committee Hansard, 9 February 2018, p. 27. Mr Cormack cited the Electronic Recording and Reporting of Controlled Drugs system initiative as an example of current Council of Australian Governments' discussions: p. 28.

[47]      Mark Cormack, Deputy Secretary, Health Financing Group, Department of Health, Committee Hansard, 9 February 2018, p. 29.

[48]      Rachel Sierant, Director, Electronic Medication Management Section, Department of Health, Committee Hansard, 9 February 2018, p. 29. Ms Sierant added that an electronic prescribing working group has been established through the Australian Health Ministers' Advisory Council and is activing working on this digital reform.

[49]      Roche Products Pty Ltd, Submission 1, p. 1; Medical Technology Association of Australia, Submission 3, p. 3; Medicines Australia, Submission 9, pp. 1–2.

[50]      Helen Aunedi, Country Head, Country Clinical Operations, Roche Products Pty Ltd, Committee Hansard, 9 February 2018, p. 3. Also see: p. 5.

[51]      For example: David Pullar, Head of Government Affairs and Public Policy, Roche Products Pty Ltd, Committee Hansard, 9 February 2018, p. 1; Medical Technology Association of Australia, Submission 3, p. 3; Medicines Australia, Submission 9, p. 2

[52]      Medicines Australia, Submission 9, p. 2.

[53]      David Pullar, Head of Government Affairs and Public Policy, Roche Products Pty Ltd, Committee Hansard, 9 February 2018, p. 3. Also see: p. 6.

[54]      Elizabeth De Somer, Director, Policy and Research, Medicines Australia, Committee Hansard, 9 February 2018, p. 20.

[55]      Senate Select Committee into Funding for Research into Cancers with Low Survival Rates, Report, 28 November 2017, Recommendation 7, p. 89, https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Funding_for_Research_into_Cancers/FundingResearchCancers/Report (accessed 22 March 2018).

[56]      Australian Dental Industry Association, Submission 7, p. 13.

[57]      Australian Dental Association, Submission 6, p. 3.

[58]      Dr Carmelo Bonanno, Vice President, Australian Dental Association, Committee Hansard, 9 February 2018, pp. 14–15.

[59]      Troy Williams, Chief Executive Officer, Australian Dental Industry Association, Committee Hansard, 9 February 2018, p. 9. Also see: Australian Dental Industry Association, Submission 7, p. 13.

[60]      Parliament of Australia, 'Availability and accessibility of diagnostic imaging equipment around Australia', https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Diagnosticimaging (accessed 22 March 2018).

[61]      Department of Health, 'Australian Government Response to the Review of Medicines and Medical Devices Regulation', http://www.health.gov.au/internet/main/publishing.nsf/Content/MMD-govresp (accessed 22 March 2018).

[62]      Department of Health, Submission 11, p. 2.

[63]      For example, see: Medicines Technology Association of Australia, Submission 3, pp. 1–2; Medical Oncology Group of Australia, Submission 5, p. 2; Australian Dental Industry Association, Submission 7, p. 3; Medicines Australia, Submission 9, p. 1.

[64]      Australian Dental Industry Association, Submission 7, p. 7. Also see: Williams, p. 2, where ADIA questioned whether the regulatory cost to Australian businesses had been properly assessed by the TGA.  The submission suggested that the Therapeutic Goods Administration is starting to exhibit a non-risk based approach to regulation: p. 8.

[65]      David Pullar, Head of Government Affairs and Public Policy, Roche Products Pty Ltd, Committee Hansard, 9 February 2018, p. 3.