National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 11) (PB 125 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01681 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2020 (No. 11)

PB 125 of 2020

 

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

(b)           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; 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 this Instrument provides for the addition of a form of the listed drug pindolol to the list of pharmaceutical items that are in pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.  This change is 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 January 2021.

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 2020 (No. 11)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 11) and may also be cited as PB 125 of 2020.

Section 2 Commencement

This section provides that the Instrument commences on 1 January 2021.

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 amendment in Schedule 1 involves the addition of a form of a listed drug to the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme safety net entitlements will not apply for early supplies.  This change is summarised below.

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS—EARLY SUPPLY) INSTRUMENT 2015 MADE BY THIS INSTRUMENT

Forms Added

Listed Drug

Form

Pindolol

Tablet 5 mg (USP)


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 2020 (No. 11)

(PB 125 of 2020)

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 2020 (No. 11) 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.

The amendment in Schedule 1 involves the addition of a form of a listed drug to the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme safety net entitlements will not apply for early supplies.

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.

 

 

 

 

Caroline Turnour

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 11) was enacted to address the need for updating the list of pharmaceutical items in the Pharmaceutical Benefits Scheme (PBS) that are exempt from PBS safety net entitlements for early supplies. This amendment was introduced to ensure consistency with recent changes to the listing of pharmaceutical benefits under the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument was made under subsection 84AAA(2) of the National Health Act 1953, and its policy objective is to refine the criteria for early supply of certain pharmaceuticals, thereby ensuring that the PBS operates effectively and efficiently. The Pharmaceutical Benefits Advisory Committee (PBAC) provided advice on the specifications of this instrument, highlighting the importance of evidence-based decision-making in the management of pharmaceutical benefits. The amendments made by this instrument are intended to maintain the integrity of the PBS, ensuring that it continues to provide affordable access to necessary medications for all Australians.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2020 (No. 11) 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. This amendment adds a form of the listed drug pindolol to the list of pharmaceutical items that are in pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies. The Pharmaceutical Benefits Scheme is a Commonwealth scheme that subsidises the cost of some medicines to make them more affordable and accessible to Australians. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the National Health Act 1953, provides advice to the Minister for Health regarding the listing of pharmaceutical benefits on the PBS. The amendment is applicable to the Commonwealth of Australia and is made under the authority of the National Health Act 1953. The changes made by this Instrument commence on 1 January 2021. 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. It engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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 PBAC ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Key Provisions

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 11) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015). This amendment, effective from 1 January 2021, specifies the addition of a particular form of the drug pindolol to the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This addition is detailed in Schedule 1 of the Instrument. The changes pertain to a specific form of pindolol, namely a 5 mg tablet (USP), which will now be exempt from PBS safety net entitlements if supplied within 20 days of a previous supply of the same pharmaceutical benefit or a similar one. The Instrument imposes specific obligations on the parties it governs, particularly regarding the supply of pharmaceutical items. Suppliers must ensure that the supply of the specified form of pindolol within 20 days of a previous supply does not trigger PBS safety net entitlements. This requirement is outlined in subsection 84AAA(1) of the National Health Act 1953, which defines early supply of pharmaceutical benefits and the conditions under which PBS safety net entitlements do not apply. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on these matters, ensuring that decisions about pharmaceutical benefits are evidence-based and aligned with the highest attainable standard of physical and mental health. Non-compliance with the provisions of this Instrument could potentially lead to legal consequences. While the specific penalties for breaches are not detailed in the Instrument, the general legal framework under the National Health Act 1953 might impose penalties for non-compliance with PBS regulations. These could include fines or other penalties as prescribed under the relevant sections of the Act. Additionally, suppliers failing to adhere to the specified conditions for early supply could face civil or administrative actions for incorrect application of PBS entitlements.

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