National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 5)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00655 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2021 (No. 5)

PB 47 of 2021

 

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 the listed drugs beclometasone with formoterol and glycopyrronium, and galcanezumab, and for the addition and deletion of forms of the listed drug adalimumab to and from 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 June 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 2021 (No. 5)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 5) and may also be cited as PB 47 of 2021.

Section 2 Commencement

This section provides that the Instrument commences on 1 June 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 amendments in Schedule 1 involve the addition of listed drugs, and the addition and deletion of forms of a listed drug to and from 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

 

Listed Drugs Added

Listed Drug

Beclometasone with formoterol and glycopyrronium

Galcanezumab

Forms Added

Listed Drug

Form

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

 

Injection 40 mg in 0.4 mL pre-filled pen

 

Injection 40 mg in 0.4 mL pre-filled syringe

 

Injection 80 mg in 0.8 mL pre-filled pen

 

Injection 80 mg in 0.8 mL pre-filled syringe

 


Forms Deleted

Listed Drug

Form

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled pen, 4

 

Injection 40 mg in 0.8 mL pre‑filled syringe, 6

 

Injection 40 mg in 0.8 mL pre‑filled syringe, 6


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 2021 (No. 5)

(PB 47 of 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.

Overview of the Legislative Instrument

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 5) 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 listed drugs, and the addition and deletion of forms of a listed drug to and from 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.

 

 

 

 

Nikolai Tsyganov

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 2021 (No. 5) was enacted to amend the National Health (Pharmaceutical benefits—early supply) Instrument 2015, which specifies the pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This legislative instrument was introduced to address the need to update the list of pharmaceutical items and forms to which the early supply rules apply, aligning with changes made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments aim to ensure that the Pharmaceutical Benefits Scheme safety net entitlements are applied correctly according to the most recent listings and forms of pharmaceutical items. The instrument was made under the authority of the National Health Act 1953 by the Minister for Health and reflects recommendations made by the Pharmaceutical Benefits Advisory Committee, ensuring the decisions about pharmaceutical benefits are evidence-based. The purpose of this legislative instrument is to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and to ensure consistency in the application of early supply rules across the PBS. By specifying which pharmaceutical items are subject to these rules, the instrument helps to manage and control the supply of medications in a manner that is both efficient and cost-effective, while ensuring access to necessary treatments. This amendment does not alter the fundamental objectives of the PBS but rather refines the operational details to align with current medical and regulatory standards.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2021 (No. 5) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 to specify pharmaceutical items that fall under pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This instrument applies to pharmaceutical items listed under the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and it operates within the Commonwealth jurisdiction. It specifically addresses the early supply of certain pharmaceutical items, which are defined as those supplied within 20 days after the day of a previous supply to the same person of the same or a similar pharmaceutical benefit, excluding supplies originating from a hospital prescription. The changes include the addition of new listed drugs such as beclometasone with formoterol and glycopyrronium, and galcanezumab, as well as the modification of forms for the listed drug adalimumab by adding and removing certain forms. This amendment does not introduce new exclusions or thresholds but modifies the existing list to reflect updates made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The legislative instrument is compatible with human rights, particularly engaging Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by facilitating the progressive realisation of the right to the highest attainable standard of physical and mental health through subsidised access to medicines.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2021 (No. 5) (PB 47 of 2021) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015), updating the list of pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This involves adding certain listed drugs and modifying the forms of some listed drugs included in the list (section 3). Specifically, the amendments add beclometasone with formoterol and glycopyrronium, galcanezumab, and modify the forms of adalimumab by adding and deleting specific forms (Schedule 1). The National Health Act 1953 imposes obligations on the parties involved, requiring that supplies of specified pharmaceutical benefits within 20 days of a previous supply to the same person do not attract PBS safety net entitlements, unless specific conditions are met (subsection 84AAA(1)). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process by making recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits (subsection 101(3AA)). This ensures that decisions about the PBS are evidence-based and aligned with public health needs. Breaches of the provisions outlined in this legislative instrument can lead to significant consequences. While the specific penalties are not detailed in the explanatory statement, non-compliance with the PBS regulations can generally result in civil or criminal penalties. Civil penalties can include fines, while criminal penalties can include imprisonment, reflecting the seriousness of ensuring the proper administration of the PBS and safeguarding public health. The Pharmaceutical Benefits Advisory Committee’s recommendations and the Minister’s decisions based on these recommendations are pivotal in maintaining the integrity of the PBS framework. In summary, the legislative instrument updates the list of pharmaceutical items for which PBS safety net entitlements do not apply for early supplies, ensuring that the PBS remains effective and efficient in providing access to essential medications. This is achieved through the careful oversight and recommendation process involving the PBAC and the Minister, highlighting the importance of evidence-based decision-making in health policy. The potential consequences of non-compliance underscore the critical role of adherence to these regulations in protecting public health and the integrity of the PBS.

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