BILLS DIGEST NO. 66, 2016–17              22 February 2017

National Health Amendment (Pharmaceutical Benefits) Bill 2016

Sophie Power
Science, Technology, Environment and Resources Section

Alex Grove
Social Policy Section

Date introduced:  24 November 2016

House:  House of Representatives

Portfolio:  Health

Commencement: The day after Royal Assent.

Links: The links to the Bill, its Explanatory Memorandum and second reading speech can be found on the Bill’s home page, or through the Australian Parliament website.

When Bills have been passed and have received Royal Assent, they become Acts, which can be found at the Federal Register of Legislation website.

All hyperlinks in this Bills Digest are correct as at February 2017.

Purpose of the Bill

The purpose of the National Health Amendment (Pharmaceutical Benefits) Bill 2016 (the Bill)[1] is to amend the National Health Act 1953 (the Act) to:

•       allow computer programs to be used for certain administrative decisions and actions

•       reduce administrative requirements for pharmacists needing to operate from alternative premises following disasters or in exceptional circumstances and

•       ensure that PBS entitlements work as intended for concessional beneficiaries and their dependants on the day a person dies.

Background

About the PBS

The Pharmaceutical Benefits Scheme (PBS) provides subsidised access to necessary medicines for Australians. Most of the listed medicines on the PBS are prescribed by doctors, dispensed by pharmacists and used by patients at home. Patients pay a co-payment of $6.30 (for concession card holders) or up to $38.80 (for general patients) towards the cost of each PBS medicine, with the Australian Government paying any remaining cost. Since 1 January 2016, pharmacists have been permitted to offer consumers a discount of up to $1 on each PBS co-payment, as long as the pharmacist absorbs the cost of the discount.[2] There is also a PBS Safety Net scheme which is intended to protect patients needing a large number of medicines in one year from excessive out of pocket costs.[3]

Use of computer programs to make decisions

Responsibility for the PBS lies with the Minister for Health and the Department of Health.[4] The Department of Human Services (DHS), through the Chief Executive Medicare, has a significant role in administering the PBS by processing pharmacy claims, approving authority prescriptions, and approving pharmacies and some doctors and hospitals to supply PBS medicines.[5] The Bill supports ‘the use of computers for fully automated processing of administrative decisions’ relating to the PBS.[6]

Administrative decisions that could be fully automated under the amendments in the Bill include ‘any function for which the decision-making power is held by the Minister for Health, the Secretary of the Department of Health, or the Chief Executive Medicare’.[7]

The use of computer programs to automate Commonwealth decision-making has been around for some time. Programs can be used to provide tools and shortcuts to decision makers to assist in making a decision, but can also involve the computer program making the final decision itself without human involvement.[8] Other Commonwealth legislation has provided legislative authority for the use of computer programs to automate administrative decisions since at least 2001. This includes, for example, social security, migration and family assistance legislation.[9]

The Minister suggested that automated processing has many advantages:

Computer programs handle complex algorithms with ease, are available whenever required, are not subject to bias, and respond instantaneously.

Automated processing reduces errors, increases accountability and generates easily auditable transaction records. Users can be confident that decisions are uniform and fair.[10]

However, automated decision-making is not without risks. For example, an input error may lead to flawed decisions, and a small error in the programming of an automated system can be carried into thousands of decisions, with the potential for significant practical and financial consequences.[11] Automated decision-making systems are currently the focus of significant public and political interest, due to concerns with Centrelink’s automated debt recovery system.[12]

Automated decision-making was considered by the Administrative Review Council (ARC) in 2004. The ARC observed that ‘automated computer systems designed to assist administrative decision makers will become increasingly important tools of government’, particularly in light of ‘their potential for cost savings, efficiencies and greater accuracy in decision making’.[13] The ARC identified a range of ‘best-practice principles’ to ‘ensure that decision making done by or with the assistance of these systems is consistent with administrative law values’.[14] For example, the ARC identified that automated decision-making is generally suitable only for decisions involving non-discretionary elements and should be legislatively sanctioned.[15] At the same time, the report warned that automated systems need to be regularly updated and maintained, and agencies should have ‘robust system-testing processes’ to ensure the initial and continued accuracy and effectiveness of systems used in administrative decision making.[16] The ARC considered:

If designed, used and maintained properly, expert systems can offer benefits by reducing inaccuracy and human prejudices and providing the opportunity for making more accurate, consistent, efficient and transparent decisions.[17]

The principles identified in the ARC report are largely reflected in the Australian Government’s ‘Better Practice Guide’ on Automated Assistance in Administrative Decision-Making, published in 2007 to ‘assist Australian Government agencies in the successful deployment of automated systems’.[18]

The Minister has cited two administrative functions as being the first to transition to computer decision-making: online PBS claims processing and online PBS prescribing authorities.[19]

Online PBS claims processing

Online claiming is already in place for the PBS, and allows approved suppliers such as pharmacists to lodge prescription claims with DHS each time a medicine is dispensed. As at 30 June 2016, 99.9 per cent of approved suppliers used online claiming.[20]

According to the Minister, computerised decision-making ‘will enable the claims computer system to match payment assessments against a pharmacy's certification of supply and take the administrative actions that would otherwise be taken by the Chief Executive Medicare’.[21]

Online PBS prescribing authorities

Some medicines on the PBS are known as ‘authority required’ medicines. These medicines cannot be prescribed by a doctor (or other approved prescriber) without the prior approval of DHS. Prescribers can seek approval from DHS by mail, by calling the DHS Telephone Authority Applications Freecall service, or through the Online PBS Authorities system.[22]

DHS received 6.8 million authority requests in 2015–16.[23] According to the Minister’s second reading speech, most requests are currently received by telephone or in writing. Telephone requests are generally made during patient consultations and take an average of 1 minute 27 seconds.[24] DHS commenced a limited trial of a new Online PBS Authorities system on 7 May 2016.[25] The system was tested by around 30 volunteer prescribers and became available to all prescribers in July 2016.[26] Prescribers can use the system to request PBS authority approval online for the majority of PBS items, either through upgraded clinical or prescribing software or DHS’s Health Professional Online Services (HPOS) portal.[27]

It is not clear whether the Online PBS Authorities system that is apparently already operating is currently fully automated or whether there is still an element of human involvement in the final decision. The Explanatory Memorandum does not shed light on this issue, merely stating that ‘computer decision-making will support implementation of streamlined processes such as fully automated online processing of PBS claims and prescribing approvals’.[28]

Pharmacy location rules and pharmacy relocation

Pharmacists need approval under the Act to dispense PBS medicines from a particular pharmacy location.[29] The pharmacist charges the patient the relevant co-payment, and claims the remainder of the PBS-dispensed price for the medicine from the Australian Government. The PBS-dispensed price (also known as the Commonwealth price) is made up of the cost of the medicine to the pharmacist, plus handling, dispensing and other fees.[30]

Pharmacy location rules place restrictions on where pharmacies can be located. The rules are agreed between the Department of Health and the Pharmacy Guild of Australia (which represents the majority of pharmacy owners in Australia).[31] The rules are intended to support the equal distribution of pharmacies across the country. The rules are complex, but the basic principle is that a pharmacy will not be approved to supply PBS medicines if it is within 1.5 kilometres of an existing pharmacy.[32]

Pharmacists dispensing PBS medicines from two or more locations will generally require a separate approval for each location.[33] However, there is currently provision for a pharmacist to supply PBS medicines at a second premises prior to gaining approval for those premises, although they will be only be paid 90 per cent of the usual PBS claim for the medicines supplied at the second premises.[34] The policy intent of this provision is reportedly to assist pharmacies who need to relocate due to damaged premises to supply PBS medicines at an alternative site prior to gaining approval.[35]

The Government announced in the 2016–17 Budget that it would streamline administrative processes for pharmacies forced to relocate due to damaged premises.[36] According to the Department of Health, ‘[a]round 10 pharmacies a year supply PBS medicines at alternative premises before obtaining approval. Of these, only two or three relocate as a result of damaged pharmacy premises, which is in line with the original policy intent’.[37] The Budget measure would ensure that pharmacies relocating due to damaged premises would receive full payment for PBS claims, while also ensuring that pharmacies that had relocated for other reasons did not gain a market advantage by operating from two premises at the same time (with only one approval).[38]

Part 2 of Schedule 1 of the Bill implements this Budget measure.

Concessional PBS entitlements on the day of death

A small number of PBS prescriptions (less than one thousand per year) are supplied to concession card holders on the day that they die.[39] Eligibility for a concession card that is linked to a social security payment ceases on the day before a person dies.[40] Since April 2015 (when streamlined processing of claims was introduced) this has resulted in pharmacists being out of pocket by up to $32.50 (the difference between the general co-payment of $38.80 and the concessional co-payment of $6.30) when claiming for a script in this situation.[41] According to the Pharmacy Guild of Australia, this primarily affects community pharmacies who deliver medicines to aged care facilities.[42]

Part 3 of Schedule 1 of the Bill amends the Act to ensure that a person is still treated as a concession card holder for PBS purposes on the day of their death. The amendments are backdated to 1 April 2015 so that pharmacists can receive back payment for affected claims.[43]

Committee consideration

Senate Selection of Bill Committee

On 16 February 2017, the Senate Selection of Bills Committee deferred consideration of the Bill (that is, whether the Bill should be referred to a Senate Committee for inquiry and report) to its next meeting.[44]

Senate Standing Committee for the Scrutiny of Bills

The Senate Standing Committee for the Scrutiny of Bills had no comment on the Bill.[45]

Policy position of non-government parties/independents

At the time of writing, no statements by non-government parties or independents specifically relating to the Bill had been identified.

Position of major interest groups

The Pharmacy Guild of Australia (which represents the majority of pharmacy owners in Australia) has welcomed the emergency relocation and day of death provisions in the Bill. The Guild notes that it has been advocating for these provisions, and that the changes will benefit community pharmacists.[46]

No other stakeholder comment specifically on the Bill has been identified. However, the Australian Medical Association stated in 2015 that it had ‘been lobbying for many years for the [PBS Authority] hotline to be abolished and replaced with an automated online process’.[47]

Financial implications

The Budget measure to streamline administrative processes for pharmacies forced to relocate due to damaged premises is expected to cost $0.9 million over four years from 2016–17.[48] The other changes made by the Bill are expected to have minimal financial impact.[49]

Statement of Compatibility with Human Rights

As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bill is compatible.[50]

Parliamentary Joint Committee on Human Rights

The Parliamentary Joint Committee on Human Rights had no comment on the Bill.[51]

Key issues and provisions

Use of computer programs to make decisions

Part 1 of Schedule 1 of the Bill provides for the use of computers to make administrative decisions under Part VII of the Act, which sets out the legislative basis for the PBS.

Item 1 of the Bill inserts a new section 101B into the Act. Proposed section 101B provides for the Minister,[52] the Secretary of the Department of Health (Secretary),[53] and the Chief Executive Medicare[54] to arrange for the use of computer programs to take administrative actions on their behalf.

An ‘administrative action’ is defined in new subsection 101B(6) to mean making a decision, exercising a power or complying with an obligation (or anything related to these). In other words, computer programs could be used for any function that the Minister, Secretary or Chief Executive Medicare has under Part VII of the Act, or a function under a legislative instrument made for the purposes of Part VII.[55] As noted earlier, the Minister has cited two administrative functions as being the first to transition to computer decision-making: online PBS claims processing and online PBS prescribing authorities.[56]

However, there are numerous other administrative decisions that can be made under Part VII. For example, the Secretary can approve applications for pharmacists, optometrists, medical practitioners and hospitals to supply PBS medicines.[57] The Secretary also issues safety net concession cards and entitlement cards.[58] Proposed section 101B potentially allows for any of these decisions to be automated in the future.

Subsection 101B(4) provides that when an administrative action is taken by a computer program under section 101B, the action is taken to have been made by the person responsible for that action (the ‘responsible action’). In other words, the action has the same legal effect as if it had been made by that person.[59]

Proposed subsection 101B(5) provides that if the responsible person (that is, the Minister, Secretary or Chief Executive Medicare[60]) is satisfied that the decision made by the operation of the computer program is incorrect, they may substitute their own decision. As the Explanatory Memorandum notes, this means that ‘a substituted decision could be made without the need for a formal appeal’, for example, if the computer program were not functioning properly. The Explanatory Memorandum further states that ‘this will ensure that the responsible person retains final decision-making power for administrative actions for which they are responsible’.[61]

Part VIIA of the Act provides for merits review by the Administrative Appeals Tribunal of certain decisions. This avenue will still be available where those decisions are made by a computer or where a substituted decision has been made. This is reflected in the Note to new subsection 101B(5).

As noted earlier in this Digest, other Commonwealth legislation already contains similar provisions providing for automated decision-making by computer programs. This includes, for example, section 6A of the Social Security (Administration) Act 1999 (Cth);[62] and section 223 of A New Tax System (Family Assistance) (Administration) Act 1999 (Cth).

Temporary pharmacy relocation in disasters or exceptional circumstances

Currently, under section 90 of the Act, when pharmacists are approved to dispense PBS medicines, that approval applies to a particular pharmacy location. Under subsection 90(2), pharmacists dispensing PBS medicines from two or more locations require a separate approval for each location. As such, in circumstances where a pharmacy is affected by disaster or damaged premises and needs to relocate temporarily, the pharmacist needs to submit an application for approval to relocate to the temporary premises and one to return to the original premises.[63] Further, under subsection 99(3A), where a pharmacist supplies PBS medicines at a second premises prior to gaining approval for those premises, they will be only be paid 90 per cent of the usual PBS claim for the medicines supplied at the second premises.[64] As the Minister explained in her second reading speech, preparing an application for approval in a disaster situation ‘can be onerous’:

It may be weeks before the required information can be compiled. This compounds the losses for the pharmacy as the flat 10 per cent reduction on payments for PBS claims continues until the approval is in place. The lost PBS subsidies cannot be recovered later.[65]

Part 2 of Schedule 1 of the Bill therefore proposes to amend the Act to reduce administrative requirements for pharmacies that need to relocate temporarily due to disaster or exceptional circumstances, including damaged premises, and to ensure that PBS claims will be paid at the full rate. As noted earlier in this Digest, this affects around two or three pharmacies each year.

Item 4 inserts a new section 91A into the Act to allow the Secretary, on application by an approved pharmacist, to grant permission to the pharmacist to supply pharmaceutical benefits at alternative premises if satisfied that the pharmacist is unable to supply pharmaceutical benefits at its premises (the ‘affected premises’), or the pharmacy premises are not accessible to the public (or both), as a result of a disaster or other exceptional circumstances. The Explanatory Memorandum gives examples of the disasters and exceptional circumstances that may be relevant under this section, including:

… damage to the approved premises due to fire, flood or motor vehicle collision which makes it impossible or dangerous to operate as a pharmacy. It might also include the premises (which could be otherwise undamaged) being inaccessible to members of the public, due to flood or landside in the vicinity.[66]

Under proposed paragraph 91A(1)(b), the alternative premises must be in ‘substantially the same locality as the affected premises’. The intention of this paragraph is that ‘the alternative premises would provide access to pharmaceutical benefits for essentially the same community as the affected premises’.[67]

Proposed subsection 91A(3) sets out the requirements for the application. For example, the application must be in writing, made ‘as soon as reasonably practicable’ and be accompanied by documentary evidence demonstrating that a particular disaster or other exceptional circumstances have occurred.

Proposed subsection 91A(4) provides for the Secretary to ask for further information in relation to the application if required. If that information is not provided, under proposed subsection 91A(5), the Secretary may treat the application as having been withdrawn.[68]

The Secretary is required to give the pharmacist written notice of the Secretary’s decision on the application under proposed subsection 91A(6). If the Secretary refuses permission, the pharmacist may apply to the Administrative Appeals Tribunal for merits review of the decision.[69] An approved pharmacist whose application is refused could still apply to the Secretary for approval to supply pharmaceutical benefits at other premises under the existing section 90 of the Act (as discussed earlier).[70]

Proposed subsection 91A(7) provides that the Act then operates for a temporary period (referred to as the ‘temporary supply period’) in the same way in relation to the pharmacist’s operations at the alternative premises, despite the change of location. For example, the same conditions and requirements will apply to the pharmacist that would apply to an approval granted under section 90 of the Act. As the Explanatory Memorandum states:

It means that all the usual provisions that apply for pharmaceutical benefits supplied by approved pharmacists at approved premises, including patient co-payment changes, the operation of the safety net entitlements, and payment of claims … apply to pharmaceutical benefits supplied at the alternative premises during the temporary supply period.[71]

Proposed subsection 91A(8) defines ‘temporary supply period’ for the purposes of subsubsection 91A(7). In short, the effect of this definition is that permission for a temporary location will generally be granted for up to six months, but this may be extended by the Secretary for an additional period via a similar process (for example, if clean-up or repairs take longer than expected).[72]

Under proposed subsection 91A(9), the Secretary may revoke permission granted under section 91A in certain circumstances. This includes, for example, if the approved pharmacist is unable to supply pharmaceutical benefits at the alternative premises; if the alternative premises are not accessible by members of the public at reasonable times; or if it is in the public interest to do so. An application may be made to the Administrative Appeals Tribunal for review of a Secretary’s decision to revoke permission.[73]

Proposed subsection 91A(10) clarifies the effect of the new provision on state and territory laws, and provides for their concurrent operation. In other words, permits, licences or approvals may still be required for that pharmacy under any relevant state or territory laws.

Proposed subsection 91A(11) allows the Minister to make a legislative instrument determining certain matters that are relevant to section 91A, including:

•       matters to which the Secretary may, must or must not have regard for the purposes of making a decision under section 91A

•       events that are taken to be, or not to be, disasters

•       circumstances that are taken to be, or not to be, exceptional circumstances

•       circumstances in which premises are taken to be, or not to be, in ‘substantially the same locality as other premises’ and

•       the kinds of documentary evidence that may be required to demonstrate that a particular disaster or other exceptional circumstances have occurred.

Item 5 of the Bill then repeals subsection 99(3A) and 99(3B) of the Act. As outlined earlier in this Digest, these subsections provide for situations where a pharmacist supplies PBS medicines at a second premises prior to gaining approval for those premises, and states that they will be only be paid 90 per cent of the usual PBS claim for the medicines supplied at the second premises.

The Minister explained in her second reading speech that, although these provisions were intended to be used in exceptional circumstances, they are ‘sometimes used where a PBS pharmacy is relocating for any reason’:

In these situations, supply of PBS medicines commences at the unapproved premises while the approved pharmacy is still operating. PBS claims are made from the approved pharmacy at the full rate, and from the unapproved premises at the 90 per cent rate, using the same PBS approval number. This continues until an application for PBS approval at the new site is successful, which may take several months. Use of a PBS approval number at two sites simultaneously in this way is contrary to the policy intention of the current law.[74]

This problem apparently involves around seven or eight pharmacies each year, which the Department of Health website suggests ‘undermines the approval process for pharmacies and provides inequitable market share for one pharmacist over others in the area’.[75] The repeal of subsections 99(3A) and (3B) means:

… the only situation in which it will be legal to supply PBS medicines at alternative premises is when the approved pharmacy cannot operate due to disaster or exceptional circumstances, and only for as long as necessary due to the disaster.[76]

It also means that PBS claims will be paid at the full rate during any temporary relocation.

Concessional PBS entitlements on the day of death

Part 3 of Schedule 1 of the Bill amends the Act to ensure that a person is still treated as a concession card holder for PBS purposes on the day of their death.

As noted earlier in this Digest, concession card holders pay a co-payment of $6.30 (compared to up to $38.80 for general patients) towards the cost of each PBS medicine. Under the Act, concession card holders are known as ‘concessional beneficiaries’, entitled to PBS medicines at the concessional rate.

Subsection 84(1) of the Act defines concessional beneficiary to include a person who holds a pensioner concession card, a seniors health card or a health care card under the Social Security Act 1991 (Cth). However, eligibility for a concession card that is linked to a social security payment ceases on the day before a person dies.[77] This means that, if a PBS prescription is supplied to a concession card holder on the day that they die, the general rate applies.

Until streamlined processing of claims was introduced in April 2015, claims for PBS prescriptions supplied to a concessional beneficiary on the day they died were adjusted to account for the difference between the concessional rate and the general rate. However, since April 2015, this adjustment has not occurred and pharmacists have been out of pocket by up to $32.50 (adjusted to 2017 rates) when claiming for a script in this situation.[78] According to the Pharmacy Guild of Australia, this primarily affects community pharmacies who deliver medicines to aged care facilities.[79]

According to the Minister, less than one thousand PBS prescriptions per year are supplied to concession card holders on the day that they die.[80]

Item 10 of the Bill inserts a new subsection 84(3C) into the Act to provide that if a person would have been a concessional beneficiary at a particular time except that the person died on that day then, despite that death, the person is taken still to be a concessional beneficiary at that time. This means that PBS concessional rate continues to apply to that person until midnight on the day of death.

Item 11 of the Bill inserts a new subsection 84(7A) into the Act to make a similar provision relating to the effect of a person’s death on dependents of concessional beneficiaries.[81]

These amendments are designed to ensure that entitlements for concessional beneficiaries and their dependants will apply for pharmaceutical benefits until midnight on the day of a person’s death.

Item 12 of the Bill provides that these amendments apply retrospectively to a person who dies on or after 1 April 2015. This is designed to ensure that pharmacists can receive back payment for affected claims from the introduction of the streamlined claims processing system.[82]

Concluding comments

The Bill will allow the use of computers to automate administrative decisions relating to the PBS, in line with similar provisions in other Commonwealth legislation. The current intention is that online PBS claims processing and PBS prescribing authorities will become fully automated, but a wide range of other decisions relating to the PBS could potentially be automated in the future. The other provisions of the Bill relating to emergency relocation and day of death are minor in nature, have the support of the Pharmacy Guild, and do not appear likely to be controversial.

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[1].              Parliament of Australia, ‘National Health Amendment (Pharmaceutical Benefits) Bill 2016 homepage’, Australian Parliament website.

[2].              Department of Health (DoH), ‘About the PBS’, Pharmaceutical Benefits Scheme (PBS) website, 1 January 2017.

[3].              Department of Human Services (DHS), ‘Pharmaceutical Benefits Scheme (PBS) Safety Net’, DHS website, 1 January 2017.

[4].              DoH, Annual report 2015–16, DoH, Canberra, 17 October 2016, p. 32.

[5].              DHS, Annual report 2015–16, DHS, Canberra, 17 October 2016, p. 61. For example, the role of the Chief Executive Medicare in receiving and processing PBS claims on behalf of the Secretary of the Department of Health is set out in the National Health (Claims and under co-payment data) Rules 2012 (No. PB 19 of 2012).

[6].              S Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, House of Representatives, Debates, 24 November 2016, p. 4311.

[7].              Ibid.

[8].              J Pinder and S Lloyd, ‘Computer says no: automated decision making and administrative law’, LSJ: Law Society of New South Wales Journal, 16, October 2015, p. 70.

[9].              See, for example, section 6A of the Social Security (Administration) Act 1999 (Cth); section 223 of A New Tax System (Family Assistance) (Administration) Act 1999 (Cth); and section 495A of the Migration Act 1958 (Cth). The Veterans’ Affairs Legislation Amendment (Digital Readiness and Other Measures) Bill 2016, which was introduced on the same day as the Bill and is currently before the House of Representatives, also proposes amendments to allow computerised decision-making. See further Administrative Review Council (ARC), Automated assistance in administrative decision making, Report to the Attorney-General, 46, ARC, Canberra, November 2004, p. 19.

[10].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4311.

[11].              M Perry (Justice of the Federal Court of Australia), iDecide: the legal implications of automated decision-making, speech, University of Cambridge, Cambridge Centre for Public Law Conference 2014: process and substance in public law, September 2014; see also Pinder and Lloyd, ‘Computer says no: automated decision making and administrative law’, op. cit., p. 71.

[12].              See, for example: T McIlroy, ‘Centrelink debt system faces growing chorus of criticism’, The Age, 3 January 2017, p. 9; and C Knaus, ‘Centrelink debt notices based on 'idiotic' faith in big data, IT expert says’, Guardian Australia (online), 30 December 2016. The Commonwealth Ombudsman has launched an own motion investigation into the system and the Senate Community Affairs References Committee is conducting an inquiry.

[13].              ARC, Automated assistance in administrative decision making, op. cit., p. iii.

[14].              Ibid.

[15].              Ibid., p. viii.

[16].              Ibid., p. ix.

[17].              Ibid., p. 36.

[18].              Australian Government, Automated assistance in administrative decision-making: better practice guide, Australian Government, Canberra, February 2007, p. ii.

[19].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4312.

[20].              DHS, Annual report 2015–16, op. cit., p. 63.

[21].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4312. Pharmacists and other authorised persons can already certify that they have supplied a PBS medicine through PBS Online claiming. See DHS, ‘Changes to PBS and RPBS claiming arrangements’, DHS website, 25 January 2016, for details.

[22].              DoH, ‘Prescribing medicines—information for PBS prescribers’, PBS website.

[23].              DHS, Annual report 2015–16, op. cit., p. 64.

[24].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4312.

[25].              DHS, Annual report 2015–16, op. cit., p. 64.

[26].              R Langham, ‘PBS authority problems—what you can do’, Australian Medicine [Australian Medical Association (AMA) publication], 28(5), 20 June 2016, p. 34; AMA, ‘Online PBS authority approvals system goes live’, GP Network News, AMA website, 7 July 2016.

[27].              DHS, ‘PBS authorities’, DHS website, 3 November 2016.

[28].              Explanatory Memorandum, National Health Amendment (Pharmaceutical Benefits) Bill 2016, p. 1.

[29].              National Health Act 1953, section 90.

[30].              DHS, ‘Pricing of Pharmaceutical Benefits Scheme medicine’, DHS website, 6 January 2017. The Commonwealth price is agreed between the Minister and the Pharmacy Guild of Australia under subsection 98BAA(1) of the National Health Act 1953. The current method for determining the Commonwealth price is set out in clause 4 of DoH, Sixth Community Pharmacy Agreement, DoH, Canberra, 24 May 2015.

[31].              DoH, ‘Pharmacy Location Rules (the Rules) and the Australian Community Pharmacy Authority (ACPA)’, DoH website, 28 October 2016.

[32].              L Nissen and J Singleton, ‘Explainer: what is the Community Pharmacy Agreement?’, The Conversation, 7 April 2015. The Pharmacy location rules are set out in the National Health (Australian Community Pharmacy Authority Rules) Determination 2011 made under section 99L of the National Health Act 1953. The Minister for Health has discretionary power to approve pharmacies that don’t comply with the location rules in certain circumstances. See DoH, ‘Pharmacy Location Rules (the Rules) and the Australian Community Pharmacy Authority (ACPA)’, op. cit., for details.

[33].              National Health Act 1953, subsection 90(2).

[34].              National Health Act 1953, subsection 99(3A).

[35].              DoH, Pharmaceutical Benefits Scheme—supply of medicines following damage to pharmacy premises, Canberra, 3 May 2016.

[36].              Australian Government, ‘Part 2: Expense Measures’, Budget measures: budget paper no. 2: 2016–17, p. 116.

[37].              DoH, ‘Pharmaceutical Benefits Scheme—supply of medicines following damage to pharmacy premises’, op. cit.

[38].              Ibid.; and Australian Government, Budget measures: budget paper no. 2: 2016–17, op. cit.

[39].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4315.

[40].              Social Security (Administration) Act 1999, paragraph 123(1)(e).

[41].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4315.

[42].              P Waterman, ‘Guild advocacy produces results’, Forefront [Pharmacy Guild of Australia e-newsletter], 30 November 2016.

[43].              Ibid.

[44].              Senate Selection of Bills Committee, Report, 2, 2017, The Senate, 16 February 2017, p. 4. See also Report, 1, 2017, 9 February 2017 and Report, 10, 2016, 1 December 2016.

[45].              Senate Scrutiny of Bills Committee, Alert digest, 10, 2016, The Senate, 30 November 2016, p. 27.

[46].              Waterman, ‘Guild advocacy produces results’, op. cit.

[47].              A Rollins, ‘Online PBS Authority system pushed back to 2016’, Australian Medicine [AMA publication], 27(9A), 6 October 2015, p. 13.

[48].              Australian Government, Budget measures: budget paper no. 2: 2016–17, op. cit., p. 116.

[49].              Explanatory Memorandum, National Health Amendment (Pharmaceutical Benefits) Bill 2016, p. 3.

[50].              The Statement of Compatibility with Human Rights can be found at pages 4–6 of the Explanatory Memorandum to the Bill.

[51].              Parliamentary Joint Committee on Human Rights, Report, 10, 2016, The Senate, 30 November 2016, p. 8.

[52].              Proposed subsection 101B(1).

[53].              Proposed subsection 101B(2).

[54].              Proposed subsection 101B(3).

[55].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4311.

[56].              Ibid., p. 4312.

[57].              National Health Act, sections 84AAB, 90, 92 and 94.

[58].              Ibid., sections 84DA and 84E. PBS safety net cards are issued to a person whose PBS co-payments for the year (possibly together with their family) has reached the applicable PBS safety net threshold. General patients are issued with a safety net concession card and receive further PBS medicines at the concessional price. Concessional patients are issued with a safety net entitlement card and receive further PBS medicines for free. See DoH, ‘5. The Safety Net Scheme’, PBS website, 1 January 2017.

[59].              Explanatory Memorandum, National Health Amendment (Pharmaceutical Benefits) Bill 2016, op. cit., p. 7.

[60].              See the definition of ‘responsible person’ in subsection 101B(6); see also Explanatory Memorandum, National Health Amendment (Pharmaceutical Benefits) Bill 2016, op. cit., p. 8.

[61].              Explanatory Memorandum, National Health Amendment (Pharmaceutical Benefits) Bill 2016, op. cit., p. 8.

[62].              This section was inserted in 2001 by the Family and Community Services and Veterans’ Affairs Legislation Amendment (Debt Recovery) Act 2001 (Cth).

[63].              DoH, Pharmaceutical Benefits Scheme—supply of medicines following damage to pharmacy premises, 3 May 2016, op. cit.

[64].              Ibid.

[65].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4313.

[66].              Explanatory Memorandum, National Health Amendment (Pharmaceutical Benefits) Bill 2016, op. cit., p. 9.

[67].              Ibid., p. 9.

[68].              An application for a review of this decision may be made to the Administrative Appeals Tribunal (AAT): see item 6 (discussed further below).

[69].              See item 6 of the Bill which amends section 105AB of the National Health Act, which sets out the decisions under the Act that are reviewable by the AAT. Item 6 adds decisions to refuse an application under 91A.

[70].              Explanatory Memorandum, National Health Amendment (Pharmaceutical Benefits) Bill 2016, op. cit., p. 11.

[71].              Ibid., p. 11.

[72].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4314.

[73].              See item 6, as discussed earlier.

[74].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., pp. 4313–4314.

[75].              DoH, ‘Pharmaceutical Benefits Scheme—supply of medicines following damage to pharmacy premises’, op. cit.

[76].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4314.

[77].              Social Security (Administration) Act 1999, paragraph 123(1)(e).

[78].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4315.

[79].              Waterman, ‘Guild advocacy produces results’, op. cit.

[80].              Ley, ‘Second reading speech: National Health Amendment (Pharmaceutical Benefits) Bill 2016’, op. cit., p. 4316.

[81].              Subsections 84(4) and (7) of the Act currently define dependent of a concessional beneficiary.

[82].              Waterman, ‘Guild advocacy produces results’, op. cit.