National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 7) (PB 60 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01009 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2019 (No. 7)

PB 60 of 2019

 

Purpose

The purpose of this legislative instrument, made under subsection 84AAA(2) of the National Health Act 1953 (the Act) is to amend the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015) (the Principal Instrument).

PB 120 of 2015 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, and to specify the period following previous supply.

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Authority

Subsection 84AAA(1) of the Act provides that a supply of a pharmaceutical benefit (whether or not the supply is of a kind described in paragraph 84C(4A)(a) of the Act) to a person is an early supply of a specified pharmaceutical benefit if:

(a)           The supply is made within 20 days after the day of a previous supply to the person of:

(i)                  the same pharmaceutical benefit; or

(ii)               another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or

(iii)             another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit;

whether or not the previous supply is a supply of a kind described in paragraph 84C(4A)(a) of the Act; and

(b)           The pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection 84AAA(2); and

(c)           The supply does not result from a prescription originating from a hospital.

Subsection 84AAA(2) of the Act provides that the Minister may specify, by legislative instrument, pharmaceutical items for the purposes of paragraph 84AAA(1)(b) of the Act.

Subsection 84AAA(3) provides that the instrument may specify a pharmaceutical item by reference to the circumstances in which a pharmaceutical benefit that has the pharmaceutical item is supplied or any other circumstances in relation to a pharmaceutical benefit that has the pharmaceutical item.

Paragraph 84C(4A) of the Act refers to repatriation pharmaceutical benefits supplied under the schemes established under section 91 of the Veterans’ Entitlements Act 1986 or section 18 of the Australian Participants in British Nuclear Tests (Treatment) Act 2006 or supplied in accordance with a determination made under paragraph 256(1)(c) of the Military Rehabilitation and Compensation Act 2004.

Subsection 101(3AA) of the Act requires the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2).

Changes to PB 120 of 2015 made by this instrument

Schedule 1 to the Principal Instrument is amended by the addition, deletion and alteration of listed pharmaceutical items and associated periods and circumstances.  These changes are summarised, by subject matter, in the Attachment.

The ‘listed drug’, ‘form’, ‘manner of administration’, ‘maximum quantity or number of units’ and ‘maximum number of repeats’ for a pharmaceutical item are the same as declared and determined under the Act for pharmaceutical benefits that have a pharmaceutical item.  These declarations and determinations are made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Therefore, a supply of a pharmaceutical benefit that has this pharmaceutical item will be an early supply of a specified pharmaceutical benefit providing the requirements of subsection 84AAA(1) are met.

Variation and revocation

Unless there is an express power to revoke or vary PB 120 of 2015 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 120 of 2015.

Consultation

The involvement of PBAC constitutes a formal and ongoing process of consultation.  The PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.  PBAC members are selected 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.  The Committee also includes a pharmaceutical industry nominee.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the Committee.  The PBAC has provided advice regarding what should be specified in this Instrument.

This amendment is minor and machinery in nature.

General

This Instrument commences on 1 August 2019.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2019 (No. 7)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 7) and may also be cited as PB 60 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 August 2019.

Section 3 Amendment of National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015)

This section provides that Schedule 1 amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015).

Schedule 1 Amendments

The amendments in Schedule 1 involve additions, deletions and changes to pharmaceutical items listed in Schedule 1 of the Principle Instrument and the associated periods (days) and circumstances.  These changes are summarised below.

SUMMARY OF CHANGES

Listed Drugs Added

Fluticasone furoate

Powder for oral inhalation in breath actuated device containing fluticasone furoate
100 micrograms per dose, 30 doses

Powder for oral inhalation in breath actuated device containing fluticasone furoate
200 micrograms per dose, 30 doses

Tocilizumab

Injection 162 mg in 0.9 mL single use pre-filled pen

Injection 162 mg in 0.9 mL single use pre-filled syringe

Forms Added

Testosterone

Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses

Forms Deleted

Calcium

Tablet, chewable, 500 mg (as carbonate)


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 7)

(PB 60 of 2019)

This Legislative 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 Legislative Instrument

The National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 7) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 which specifies the pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.

Schedule 1 to the Principal Instrument is amended by the addition, deletion and alteration of listed pharmaceutical items and associated periods and circumstances.

Human rights implications

This Legislative Instrument engages Articles 2 and 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.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.  The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

This Legislative Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Thea Daniel

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 7) was enacted to amend the National Health (Pharmaceutical Benefits—early supply) Instrument 2015, which specifies the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This legislative instrument, made under subsection 84AAA(2) of the National Health Act 1953, was introduced to address the need for updating the list of pharmaceutical items in alignment with changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments made by this instrument reflect the recommendations of the Pharmaceutical Benefits Advisory Committee, which advises the Minister on matters related to the PBS. The purpose of these amendments is to ensure that the list of pharmaceutical items subject to early supply provisions remains current and reflective of changes in the pharmaceutical benefits listed under the Act. The National Health Act 1953 provides the legal framework for the PBS, and the amendments made by this instrument are intended to maintain the integrity and effectiveness of the scheme by ensuring that the early supply provisions are aligned with the most recent updates to the list of pharmaceutical benefits. This legislative instrument, which commenced on 1 August 2019, is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 7) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015) which specifies the pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This legislative instrument applies to pharmaceutical items listed in Schedule 1 of the Principal Instrument and their associated periods and circumstances. The amendments involve additions, deletions, and alterations to the listed pharmaceutical items. The instrument is applicable across Australia, as it is made under the authority of the National Health Act 1953, a Commonwealth Act. There are no stated exclusions, exemptions, or thresholds in the instrument, but it does extend or restrict application through subordinate instruments. The Pharmaceutical Benefits Advisory Committee (PBAC) has provided advice regarding what should be specified in this Instrument. This amendment is minor and machinery in nature, and it engages Articles 2 and 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. The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme that assists with the advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based. The 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. This Legislative Instrument advances the protection of human rights as it assists 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. The instrument is compatible with human rights because it advances the protection of human rights.

Key Provisions

The National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 7) (PB 60 of 2019) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015), which specifies the pharmaceutical items for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies (subsection 84AAA(1)(b) and (c) of the National Health Act 1953). The amendments involve the addition, deletion, and alteration of listed pharmaceutical items and associated periods and circumstances (section 3). For example, the listed drugs added include Fluticasone furoate powder for oral inhalation and Tocilizumab injection, while the forms added include Testosterone transdermal gel (section 1 of Schedule 1). The Act imposes several obligations on parties and entities it governs. Firstly, it requires the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2) (subsection 101(3AA) of the Act). Secondly, the Minister must make the legislative instrument specifying pharmaceutical items for early supply under subsection 84AAA(2) of the Act (subsection 84AAA(2)). The instrument specifies the circumstances under which a pharmaceutical benefit that has a pharmaceutical item is supplied and any other circumstances in relation to a pharmaceutical benefit that has the pharmaceutical item (subsection 84AAA(3) of the Act). There are no specific offences or penalties stated in the legislative instrument itself. However, any breaches of the Pharmaceutical Benefits Scheme (PBS) safety net entitlements would typically be subject to the penalties and consequences outlined in the National Health Act 1953. These could include financial penalties, imprisonment, or both, depending on the nature and severity of the breach. For example, subsection 120A(1) of the Act provides that a person who contravenes certain provisions of the Act is liable to a penalty not exceeding $105,000 or, in the case of a corporation, a penalty not exceeding $525,000. Subsection 120A(2) also provides that a court may order that the contravention be published in a newspaper or in such other manner as the court thinks fit.

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