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Australian Senate Standing Committee for the Scrutiny of Delegated Legislation - Monitor |
National Health (Take Home Naloxone Pilot) Special Arrangement 2019 (PB 97 of 2019)
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FRL No.
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Purpose
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To make special arrangements to establish a pilot to increase the supply of
naloxone to persons who are at risk of an opioid overdose
or who are likely to
be able to assist such persons.
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Authorising legislation
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Portfolio
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Health
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Disallowance
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15 sitting days after tabling (tabled in the Senate
on 4 December 2019). Notice of motion to disallow given on
12 May 2020.[2]
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1.55 The instrument creates a special arrangement to support the establishment of a PBS subsidised pilot program to supply naloxone to people in New South Wales, Western Australia and South Australia who are at risk of an opioid overdose, and to persons who are likely to be able to assist such persons.[3]
1.56 The instrument was made under section 100 of the National Health Act 1953 (National Health Act) by the Deputy Secretary, Health Financing Group, as a delegate of the Minister for Health.
1.57 Subsection 100(1) of the National Health Act empowers the minister to 'make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available' to certain persons specified in paragraphs (a) to (c). Subsection 100(3) provides that Part VII of the Act, and legislative instruments made for the purposes of that Part, have effect subject to a special arrangement made under subsection 100(1).
1.58 On 12 May 2020 the committee placed a protective notice of motion to disallow the instrument to provide additional time for the minister to respond to its scrutiny concerns.
1.59 The committee's scrutiny concerns centre on section 25 of the instrument. Subsection 25(1) provides that:
The Secretary may, in writing, authorise persons having suitable qualifications and experience to perform any of the Secretary's functions, or exercise any of the Secretary's powers, under this instrument on behalf of the Secretary.
1.60 Subsection 25(2) of the instrument clarifies that an authorisation under subsection 25(1) may be in the form of a contract entered into by the Secretary on the Commonwealth's behalf. Subsection 25(3) provides that authorised persons must comply with any directions of the Secretary in performing the Secretary's functions or exercising the Secretary's powers.
1.61 Between February and July 2020 the committee engaged with the minister to seek advice on a range of scrutiny concerns it identified with this section.[4] The committee was primarily concerned with whether section 25 of the instrument was authorised by section 100 of the National Health Act and whether there are appropriate accountability safeguards over the actions of third party administrators.
1.62 The committee thanks the minister and senior departmental officials for their constructive engagement with the committee on these matters.
1.63 Senate standing order 23(3)(a) requires the committee to scrutinise each instrument as to whether it is in accordance with its enabling Act and otherwise complies with all legislative requirements.
1.64 Between February and July 2020 the committee sought the minster's advice as to the source of legal authority for section 25 of the instrument. The committee's requests for advice stemmed from the view that the authorisation of private third parties to perform the functions and exercise the powers of a public office holder is a significant matter that requires express authority in primary legislation. In correspondence with the minister the committee noted that neither the terms of subsection 100(1) of the National Health Act, nor the relevant explanatory materials, indicated that Parliament intended that provision to support the authorisation of private third parties to perform the powers and functions of a departmental secretary in making special arrangements.
1.65 In correspondence with the minister the committee considered the approach taken in other special arrangements made under section 100 of the National Health Act to enabling private third parties to undertake certain actions 'in relation to' the provision of an adequate supply of pharmaceutical benefits to certain persons. In this regard, the committee noted that none of the other special arrangements considered by the committee appear to broadly authorise qualified private third parties to perform all the functions and exercise all of the powers of a public official under that arrangement.
1.66 In correspondence with the committee the minister confirmed that he has received legal advice on section 25 and remains of the view that the section is compliant with section 100 of the National Health Act. The minister reiterated that the relevant authorisation falls within the scope of the minister's power to 'make arrangements for, or in relation to providing that an adequate supply of pharmaceutical benefits will be available to persons'.
1.67 The minister distinguished the examples of other special arrangements made under section 100 of the National Health Act provided by the committee from the current instrument. The minister considers that the committee's examples of special arrangements provide for powers and functions of a different nature to those in the instrument.
1.68 Senate standing order 23(3)(k) requires the committee to consider whether a legislative instrument raises any other technical scrutiny matter. The committee interprets this to include whether the measures in the instrument are subject to appropriate accountability safeguards. This scrutiny principle supplements standing order 23(3)(h) which requires the committee to consider whether an instrument trespasses unduly on personal rights and liberties, and standing order 23(3)(i), which requires the committee to consider whether a legislative instrument unduly excludes, limits, or fails to provide for independent review.
1.69 The committee sought the minister's advice as to whether amendments could be made to subsection 25(1) and subsection 25(3) to provide safeguards and limitations on the exercise of delegated power by third party administrators. The committee subsequently requested that the minister amend subsection 25(1) of the instrument to expressly state the particular powers and functions which the Secretary may authorise the third party to perform or exercise under the instrument. The committee also requested that the minister amend subsection 25(3) to give the department greater control and oversight of the actions of the third party administrator by providing that the actions of the third party administrator require the express approval of the Secretary or their delegate. Noting that the proposed amendment to subsection 25(3) may add additional administrative steps in the process of making a claim and potentially delay payments, the committee advised it would be satisfied in the alternative if subsection 25(3) is instead amended to provide for internal review by the department of decisions of third party administrators.
1.70 In previous correspondence with the committee the minister outlined the activities that private third party administrators undertake pursuant to their purported authorisation under section 25 of the instrument. These include providing a software solution to:
• enable approved suppliers to make claims for payment of naloxone provided to designated persons;
• collect data used to evaluate the pilot program; and
• provide regular reports on the pilot to the department.
1.71 Whilst reiterating his view that the current arrangement 'is legally sound and reasonable as a matter of policy' the minister indicated his openness to instructing the department to pursue amendments to section 25. These amendments would be 'to clarify the role of third party administrators', or 'to provide additional oversight' of the third party administrators' activities by the department.
1.72 In his most recent correspondence to the committee, the minister agreed to amend the instrument to address the committee's scrutiny concerns about the role of third party administrators, whilst again reiterating his view on the lawfulness of section 25. The minister explained that he will instruct his department to:
• amend subsection 25(1) of the instrument to expressly define the powers and functions which the Secretary may authorise the third party administrator to perform; and
• amend subsection 25(3) of the instrument to provide for internal review of decisions of third party administrators by the department.
1.73 As a matter of principle, the committee remains of the view that the authorisation of private third parties to perform the functions and exercise the powers of a public office holder is a significant matter that requires express authority in primary legislation.
1.74 In this particular instance, noting the purpose and limited duration of the instrument, the committee considers that the amendments to section 25 of the instrument provide the minister and the department with sufficient control and oversight of the actions of the third party administrator to satisfy the committee's scrutiny concerns.
1.75 The committee reiterates its thanks to the minister and senior departmental officers for their constructive engagement with the committee to address its scrutiny concerns.
1.76 In light of these amendments the committee has resolved to conclude its examination of the instrument and to withdraw its notice of motion to disallow the instrument.
[3] Explanatory statement, p.1.
[4] The committee's scrutiny concerns and the minister's responses are outlined in the committee's correspondence with the minister. Copies of the letters are available on the committee's website. See: https://www.aph.gov.au/-/media/Committees/Senate/committee/regord_ctte/index-of-instruments/2020/K-O/F2019L01542.pdf. A summary of the concerns the committee raised previously can also be found in Chapter 1 of Delegated Legislation Monitor 8 of 2020. See: https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Scrutiny_of_Delegated_Legislation/Monitor.
[5] Scrutiny principle: Senate standing order 23(3)(a).
[6] The committee requested the minister's advice in five letters dated 13 February, 3 April, 21 May 2020, 18 June 2020 and 22 July 2020. Copies of the letters are available on the committee's website at https://www.aph.gov.au/-/media/Committees/Senate/committee/regord_ctte/index-of-instruments/2020/K-O/F2019L01542.pdf.
[7] The minister responded to the committee in five letters dated 3 March, 24 April, 5 June, 3 July and 31 July 2020. Copies of the letters are available on the committee's website at https://www.aph.gov.au/-/media/Committees/Senate/committee/regord_ctte/index-of-instruments/2020/K-O/F2019L01542.pdf.
[8] Scrutiny principle: Senate standing order 23(3)(k).
[9] The committee requested the minister's advice in five letters dated 13 February, 3 April, 21 May 2020, 18 June 2020 and 22 July 2020. Copies of the letters are available on the committee's website at https://www.aph.gov.au/-/media/Committees/Senate/committee/regord_ctte/index-of-instruments/2020/K-O/F2019L01542.pdf.
[10] The minister responded to the committee in five letters dated 3 March, 24 April, 5 June, 3 July and 31 July 2020. Copies of the letters are available on the committee's website at https://www.aph.gov.au/-/media/Committees/Senate/committee/regord_ctte/index-of-instruments/2020/K-O/F2019L01542.pdf.
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