National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 10) (PB 112 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01492 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2020 (No. 10)

PB 112 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 forms of the listed drugs norethisterone with ethinylestradiol and rivaroxaban to the list of pharmaceutical items that are in pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.  It also provides for the alteration of the maximum quantity or number of units that can be prescribed for the drug mesalazine in the form sachet containing prolonged release granules, 1 g per sachet, and for the addition of a maximum quantity or number of units and maximum number of repeats for the drug venetoclax to the list.  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 December 2020.

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. 10)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 10) and may also be cited as PB 112 of 2020.

Section 2 Commencement

This section provides that the Instrument commences on 1 December 2020.

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 the addition of two forms of two listed drugs, the addition of a maximum quantity or number of units and number of repeats, and the alteration of a maximum quantity or number of units for existing drugs on the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme safety net entitlements will not apply for early supplies.  These changes are summarised below.

 

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

Forms Added

Listed Drug

Form

Norethisterone with ethinylestradiol

Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets USP

Rivaroxaban

Tablet 2.5 mg

Addition of Maximum Quantity or Number of Units and Number of Repeats

Listed Drug

Form

Maximum Quantity or Number of Units

Maximum Number of Repeats

Venetoclax

Tablet 100 mg

120

4

Alteration of Maximum Quantity or Number of Units

Listed Drug

Form

Maximum Quantity or Number of Units

 

Mesalazine

Sachet containing prolonged release granules, 1 g per sachet

From: 120
To: 100

 


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. 10)

(PB 112 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. 10) 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 amendments in Schedule 1 involve the addition of two forms of two listed drugs, the addition of a maximum quantity or number of units and number of repeats, and the alteration of a maximum quantity or number of units for existing drugs on 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.

 

 

 

 

Thea Connolly

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 2020 (No. 10) was enacted to amend the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015). The original instrument 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 2020 amendment introduces minor changes to the list of pharmaceutical items by adding forms of certain drugs, altering maximum quantities or numbers of units, and adding maximum numbers of repeats for some drugs. This adjustment is made to align with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The purpose of these amendments is to ensure consistency and accuracy in the pharmaceutical items that qualify for early supply without incurring PBS safety net entitlements. The instrument was made under subsection 84AAA(2) of the National Health Act 1953 by the Minister for Health, supported by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This legislative instrument was introduced by the Commonwealth Parliament to address the need for updating the list of pharmaceutical items for early supply in accordance with the National Health Act 1953. The amendments were necessary to ensure that the Pharmaceutical Benefits Scheme operates efficiently and in line with current medical standards and practices. The policy objective of these changes is to support the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring that patients have access to necessary medications under the PBS.

Scope and Application

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2020 (No. 10) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015. This Act applies to pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. The amendments specify pharmaceutical items for which the PBS safety net entitlements do not apply when supplied within a specific timeframe after a previous supply to the same person. The changes in the instrument involve the addition of two forms of two listed drugs, the addition of a maximum quantity or number of units and number of repeats, and the alteration of a maximum quantity or number of units for existing drugs on the list of pharmaceutical items that are in pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies. The amendments are effective from 1 December 2020. The Pharmaceutical Benefits Advisory Committee (PBAC) provides advice to the Minister about the drugs and medicinal preparations that should be available to Australians as pharmaceutical benefits, ensuring that decisions about subsidised access to medicines on the PBS are evidence-based. The instrument applies nationally throughout Australia and is a legislative instrument for the purposes of the Legislation Act 2003. The instrument does not contain any exclusions, exemptions, or thresholds. However, the Act may extend or restrict application through subordinate instruments. The instrument is compatible with human rights as 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 PBS is a benefit scheme that assists with the advancement of this human right by providing for subsidised access by patients to medicines.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2020 (No. 10) (PB 112 of 2020) amends the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015 (PB 120 of 2015). This amendment specifically targets the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. The amendments (sections 3 and 4) involve adding new forms of certain drugs, altering the maximum quantity or number of units for some drugs, and adding a maximum number of repeats for other drugs (section 3). These changes are detailed in Schedule 1 and are made to align with the changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The Act imposes obligations on parties involved in the supply of pharmaceutical benefits, particularly focusing on ensuring that certain pharmaceutical items are not subject to PBS safety net entitlements when supplied early. This is achieved through the specification of conditions under which early supplies occur, as defined in subsection 84AAA(1) of the Act. Pharmaceutical Benefits Advisory Committee (PBAC) recommendations, which are pivotal in determining the pharmaceutical items to be included in the list, must be adhered to. Additionally, the Act mandates that the PBS safety net entitlements do not apply to specified early supplies of the listed pharmaceutical items, as outlined in the amended Instrument. Violations of the provisions in this Instrument may result in civil and criminal consequences. For instance, providing early supplies of pharmaceutical items that should not have PBS safety net entitlements applied could lead to penalties. Although the specific penalties are not detailed in the explanatory statement, it is reasonable to infer that penalties would align with those prescribed in the National Health Act 1953 and associated regulations. These penalties could include fines and, in severe cases, criminal charges, depending on the nature and extent of the breach. The Act also provides mechanisms for the revocation or variation of the Instrument, ensuring that the regulations remain current and effective.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Licensing & Registration

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.