EXPLANATORY STATEMENT
National Health Act 1953
National Health (Highly specialised drugs program) Special Arrangement Amendment (Authorised Nurse Practitioners) Instrument 2020
PB 26 of 2020
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of certain highly specialised drugs to patients receiving treatment at or from public or private hospitals having access to appropriate specialised facilities.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1) of the Act.
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.
Purpose
Background
Pursuant to subsection 100(2) of the Act, this instrument varies the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement). In particular, the instrument amends the Special Arrangement to allow authorised nurse practitioners to prescribe certain medicines made available through the Highly Specialised Drugs (HSD) program.
The HSD program provides access to specialised Pharmaceutical Benefits Scheme (PBS) medicines to eligible patients, for the treatment of chronic conditions which, because of their clinical use and other special features, have restrictions on where they can be prescribed and supplied. The relevant medicines are referred to throughout the Special Arrangement as “HSD pharmaceutical benefits”. Each HSD pharmaceutical benefit is a brand of a highly specialised drug in a specified form and with a specified manner of administration.
Currently, the medications for the treatment of hepatitis B and HIV are defined in section 4 (definitions) of the Special Arrangement. The medications available for the treatment of hepatitis C are listed in Schedule 3 Part 1 of the Special Arrangement—General Statement for drugs for the treatment of hepatitis C.
Accredited prescribers of medication for the treatment of hepatitis B, hepatitis C and HIV are also defined in section 4 of the Special Arrangement. Currently, section 4 of the Special Arrangement does not include ‘authorised nurse practitioner’ within the definition of accredited prescribers.
Since 2010, eligible nurse practitioners endorsed to prescribe under state or territory legislation have been able to apply for approval as PBS prescribers under the Act. Authorised nurse practitioners are able to prescribe medications for the treatment of hepatitis C where the medicine is available under section 85 of the Act. The same hepatitis C medicines are also available under the HSD program for the same indication, however currently, nurse practitioners are not eligible to prescribe any medicines under the Special Arrangement.
In November 2019 the Pharmaceutical Benefits Advisory Committee (PBAC) endorsed authorised nurse practitioner prescribing for hepatitis B, hepatitis C and HIV medicines under the HSD program. Enabling nurse practitioners to be authorised to prescribe hepatitis B, hepatitis C and HIV medicines under the HSD program is expected to improve access for vulnerable populations including patients in remote and regional areas, those experiencing homelessness, and those in custodial settings. To implement the PBAC recommendation, prescribing eligibility requirements in place for the relevant medicines have been extended to nurse practitioners in the Special Arrangement, including accreditation and/or state or territory approval requirements.
The key variations provided for in this instrument are:
- Including a definition at section 4 of the Special Arrangement for an authorised nurse practitioner. The definition relies on the definition of an authorised nurse practitioner in the Act (Part VII, Division 1, section 84AAJ). Use of this definition will facilitate consistency across related pieces of legislation and to reflect the provisions currently in place for authorised nurse practitioner prescribing for medicines listed under section 85 of the Act. The provisions in the Act (Part VII) form the basis to enable authorised nurse practitioner prescribing in the Special Arrangement. Consistency is particularly important for medicines for the treatment of hepatitis C to avoid confusion and simplify administration processes as they are listed under both section 85 of the Act and the special arrangements for the HSD established by section 100 of the Act. The Act is available on the Federal Register of Legislation at www.legislation.gov.au.
- Including revised definitions of accredited prescriber of medication for the treatment of hepatitis B, hepatitis C, HIV or AIDS, respectively, to allow for authorised nurse practitioners to be accredited prescribers of the HSD medicines used for the treatment of these conditions.
- Including a revised definition at section 4 and introducing section 4A of the Special Arrangement relating to the definition of the term authorised prescriber. The revised definition of authorised prescriber allows for authorised nurse practitioners accredited to prescribe HSD medicines for the treatment of certain conditions to prescribe those HSD pharmaceutical benefits. The table in subsection 4A(3) of the Special Arrangement outlines the authorised prescribers for certain HSD pharmaceutical benefits.
- Flow-on variations to terms related to the previous definition of authorised prescriber that are amended as a consequence of the revised definition.
- Including revised subsections for section 8 of the Special Arrangement which lists who is able to prescribe HSD pharmaceutical benefits. Section 8 of the Special Arrangement outlines the authority under the Act by which a medical practitioner (section 88(1)) and an authorised nurse practitioner (88(1E)) can prescribe pharmaceutical benefits.
- Flow-on variations as a consequence to the change in language from ‘eligible medical practitioner’ to ‘authorised practitioner’ used throughout the Special Arrangement which reflect that authorised nurse practitioners are included in the definition of authorised prescriber.
Consultation
Following intensive stakeholder discussions, the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) approached the Commonwealth to recommend that nurse practitioners be made eligible to prescribe medicines for the treatment of hepatitis B, hepatitis C, and HIV under section 100 of the Act (the HSD program). ASHM is a peak organisation of health professionals in Australia and New Zealand who work in HIV, viral hepatitis, other blood borne viruses and sexually transmissible infections. ASHM also proposed that nurse practitioners be required to meet the same accreditation criteria as medical practitioners including education and continuing professional development requirements.
Subsequently, in November 2019 the PBAC endorsed authorised nurse practitioner prescribing for medicines for the treatment of hepatitis B, hepatitis C and HIV under the HSD program. The outcomes of the November 2019 PBAC meeting were made publically available in December 2019 via the www.pbs.gov.au website providing information relating to this item for additional interested parties. The amendments made by this instrument accord with the endorsement made by the PBAC.
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.
PBAC is an independent expert body established by section 100A of the Act. PBAC makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.
Further consultation for this instrument was considered unnecessary due to the adequate nature of the consultation that had already taken place in endorsing authorised nurse practitioner prescribing for certain HSD medicines.
Details of this instrument are set out in the Attachment.
This instrument commences on 1 April 2020.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment (Authorised Nurse Practitioners) Instrument 2020
Section 1 Name
This section provides that the name of the instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment (Authorised Nurse Practitioners) Instrument 2020
(the instrument) and may also be cited as PB 26 of 2020.
Section 2 Commencement
This section provides that the instrument commences on 1 April 2020.
Section 3 Authority
This section provides the authority for the instrument is made under subsection 100(2) of the
National Health Act 1953.
Section 4 Schedules
This section provides that the changes are made as specified in the Schedules contained in this instrument.
Schedule 1 – Amendments
Section 1 Section 4 (definition of accredited prescriber of medication for the treatment of hepatitis B)
This section extends the definition of an accredited prescriber of medication for the treatment of hepatitis B to include authorised nurse practitioners in section 4 of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement). These items place authorised nurse practitioners on an equal basis as medical practitioners regarding recognition within individual State or Territory to prescribe the specific medicines under the Highly Specialised Drugs (HSD) program.
Section 2 Section 4 (definition of accredited prescriber of medication for the treatment of hepatitis C)
This section extends the definition of an accredited prescriber of medication for the treatment of hepatitis C to include authorised nurse practitioners in section 4 of the Special Arrangement. These items place authorised nurse practitioners on an equal basis as medical practitioners regarding recognition within individual State or Territory to prescribe the specific medicines under the HSD program.
Section 3 Section 4 (definition of accredited prescriber of medication for the treatment of HIV or AIDS)
This section extends the definition of an accredited prescriber of medication for the treatment of HIV or AIDS to include authorised nurse practitioners in section 4 of the Special Arrangement. These items place authorised nurse practitioners on an equal basis as medical practitioners regarding recognition within individual State or Territory to prescribe the specific medicines under the HSD program.
Section 4 Section 4
This section inserts in section 4 of the Special Arrangement a definition of authorised nurse practitioner. The definition relies on the definition of an authorised nurse practitioner in the Act
(Part VII, Division 1, section 84AAJ) as in force at the date of commencement.
Section 5 Section 4 (definition of authorised prescriber)
This section repeals the current definition of authorised prescriber in section 4 of the Special Arrangement. This section also substitutes a new definition of authorised prescriber to have the meaning given by section 4A of the Special Arrangement.
Section 6 Section 4 (paragraphs (b), (ba) and (c) of the definition of eligible medical practitioner)
This section repeals the paragraphs under the definition of eligible medical practitioner relating to medication for the treatment of hepatitis B, hepatitis C and HIV or AIDS. The content of these paragraphs are included in the revised definition of authorised prescriber, therefore it is no longer necessary to include these paragraphs in the Special Arrangement.
The remaining paragraphs under the definition of eligible medical practitioner remain unchanged.
Section 7 Section 4
This section inserts a definition for medication for the treatment of hepatitis C for consistency of terms as section 4 already contains definitions for medication for the treatment of hepatitis B as well as HIV or AIDS.
Section 8 Section 4 (definition of prescriber code)
This section repeals the definition of prescriber code as the term no longer forms part of the definition of authorised prescriber and is therefore obsolete.
Section 9 At the end of Division 1 of Part 1
This section inserts a new section 4A definition of authorised prescriber that provides the details of who is an authorised prescriber for the purposes of prescribing HSD pharmaceutical benefits.
Paragraphs 1 and 2 of section 4A makes reference to eligible medical practitioners, who have a broader prescribing scope than authorised nurse practitioners under the Special Arrangement.
Paragraph 3 of section 4A specifies who is authorised to prescribe a HSD pharmaceutical benefit listed for the treatment of hepatitis B, hepatitis C and HIV or AIDS which now includes both medical practitioners and authorised nurse practitioners as accredited prescribers of these medications.
Section 10 Section 8 (heading)
This section repeals the current heading of section 8 of the Special Arrangement substituting it with the detailed heading Prescribing of HSD pharmaceutical benefits—authorised prescribers for added clarity.
Section 11 Subsections 8(1), (2) and (3)
This section repeals sections 8(1), (2) and (3) of the Special Arrangement and substitutes new subsections (1) and (2) to provide who is able to prescribe an HSD pharmaceutical benefit.
Subsection 8(1) determines that a medical practitioner is able to prescribe HSD pharmaceutical benefits only if they are an authorised prescriber under the Special Arrangement. The authorisation to prescribe pharmaceutical benefits is provided by subsection 88(1) of the Act.
Subsection 8(2) determines that an authorised nurse practitioner is able to prescribe HSD pharmaceutical benefits only if they are an authorised prescriber under the Special Arrangement. The authorisation to prescribe pharmaceutical benefits is provided by subsection 88(1E) of the Act.
Section 12 Subsection 8(5)
This section determines that subsection 9(1A) of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, made available on the Federal Register of Legislation at www.legislation.gov.au and which provides for the pharmaceutical benefits for which medical practitioners are authorised to write prescriptions does not apply for HSD pharmaceutical benefits other than medications for the treatment of hepatitis C.
Section 13 Subsection 14(1)
This section replaces the term “eligible medical practitioner” with “authorised prescriber for the HSD pharmaceutical benefit” in subsection 14(1) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 14 Subsection 15(1)
This section replaces the term “eligible medical practitioner” with “authorised prescriber for the HSD pharmaceutical benefit” in subsection 15(1) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 15 Subsection 15(6)
This section replaces the term “eligible medical practitioner” with “authorised prescriber for the HSD pharmaceutical benefit” in subsection 15(6) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 16 Section 20
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 20 of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 17 Section 21
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 21 of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 18 Section 21 (note)
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 21 (note) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 19 Subsection 22A(1)
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 22A(1) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 20 Paragraph 22A(1)(a)
This section replaces the term “eligible medical practitioner” with “authorised prescriber” in subsection 22A(1)(a) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 21 Section 23
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 23 of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 22 Subsection 23A(1)
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 23A(1) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 23 Paragraph 23A(1)(a)
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber” in subsection 23A(1)(a) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 24 Subsection 24(1)
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in subsection 24(1) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 25 Subsection 25(1)
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 25(1) of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
Section 26 Section 42
This section reflects the change in language from the use of “eligible medical practitioner” to “authorised prescriber for the HSD pharmaceutical benefit” in section 42 of the Special Arrangement to accommodate that authorised nurse practitioners are included in the definition of authorised prescriber.
The title of section 42 of the Special Arrangement has been amended to be more informative as to the purpose of the section.
A note has been added to section 42 of the Special Arrangement to highlight that the circumstances in which section 42 apply are outlined in section 49 of the National Health (Pharmaceutical Benefits) Regulations 2017.
Section 27 Schedule 1 (table, column headed “Authorised Prescriber”)
This section repeals the column in Schedule 1 headed “authorised prescriber” as the details regarding which HSD program medicines an authorised prescriber is able to prescribe are available in section 4A of the Special Arrangement and are no longer necessary to be included under Schedule 1.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Highly specialised drugs program) Special Arrangement Amendment (Authorised Nurse Practitioners) Instrument 2020
This instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Instrument
Pursuant to subsection 100(2) of the National Health Act 1953 (the Act), this instrument varies the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement). In particular, the instrument amends the Special Arrangement to allow authorised nurse practitioners to prescribe certain medicines made available through the Highly Specialised Drugs (HSD) program.
The HSD program provides access to specialised Pharmaceutical Benefits Scheme (PBS) medicines to eligible patients, for the treatment of chronic conditions which, because of their clinical use and other special features, have restrictions on where they can be prescribed and supplied.
Since 2010, eligible nurse practitioners endorsed to prescribe under state or territory legislation have been able to apply for approval as PBS prescribers under the Act. Authorised nurse practitioners are able to prescribe medications for the treatment of hepatitis C where the medicine is available under section 85 of the Act. The same hepatitis C medicines are also available under the HSD program for the same indication however currently, nurse practitioners are not eligible to prescribe any medicines under the Special Arrangement.
In November 2019 the Pharmaceutical Benefits Advisory Committee (PBAC) endorsed authorised nurse practitioner prescribing for hepatitis B, hepatitis C and HIV medicines under the HSD program. Enabling nurse practitioners to be eligible to prescribe hepatitis B, hepatitis C and HIV or AIDS medicines under the HSD program is expected to improve access for vulnerable populations including patients in remote and regional areas, those experiencing homelessness, and those in custodial settings. To implement the PBAC recommendation, prescribing eligibility requirements in place for the relevant medicines have been extended to include nurse practitioners in the Special Arrangement, including accreditation and/or state or territory approval requirements.
Human rights implications
This instrument engages Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
This instrument assists with the advancement of this right by ensuring continued access to PBS subsidised medicines for the treatment of hepatitis B, hepatitis C and HIV or AIDS.
Conclusion
This instrument is compatible with human rights as it does not raise any human rights issues.