National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 8)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01387 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2017 (No. 8)

PB 87 of 2017

 

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).

 

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.

 

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 of evolocumab in the form injection 420 mg in 3.5 mL single use pre-filled cartridge.

 

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.  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 November 2017.

 

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


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 2017 (No. 8)

(PB 87 of 2017)

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 2017 (No. 8) 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.

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.

Lisa La Rance
Assistant Secretary

Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 8) (PB 87 of 2017) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015) under subsection 84AAA(2) of the National Health Act 1953. This amendment was introduced to address the need to specify pharmaceutical items for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies, thereby ensuring appropriate regulation of early supply of certain pharmaceutical benefits. The amendment was made by the Minister for Health, with the Pharmaceutical Benefits Advisory Committee (PBAC) providing recommendations on the pharmaceutical items to be specified. The purpose of the amendment is to assist in the progressive realisation of the right to the enjoyment of the highest attainable standard of physical and mental health as recognised by Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). This legislative instrument is compatible with human rights as it supports the advancement of the right to access to affordable healthcare through the PBS.

Scope and Application

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 8) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015, specifying the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply in cases of early supply. This applies to supplies made within 20 days of a previous supply of the same pharmaceutical benefit, another benefit with the same pharmaceutical item, or another benefit that is Schedule equivalent, provided the supply is not a result of a prescription originating from a hospital. The amendment adds evolocumab in the form of an injection 420 mg in 3.5 mL single-use pre-filled cartridge to the list of pharmaceutical items for which these conditions apply. This instrument, made under subsection 84AAA(2) of the National Health Act 1953, specifies pharmaceutical items through a legislative instrument, thereby extending or restricting the application of the original instrument. The Pharmaceutical Benefits Advisory Committee (PBAC) provides recommendations to the Minister regarding these specifications, ensuring that decisions are evidence-based. The instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, by advancing 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 2017 (No. 8) (PB 87 of 2017) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015) to specify pharmaceutical items that are subject to certain provisions of the National Health Act 1953 (the Act) regarding early supplies (subsections 84AAA(1) and 84AAA(2)). The amendment involves adding evolocumab in the form injection 420 mg in 3.5 mL single use pre-filled cartridge to the list of pharmaceutical items (Schedule 1 of the Principal Instrument). This addition means that supplies of this specific pharmaceutical item within 20 days of a previous supply to the same person will be considered early supplies, unless certain conditions are met. The Act imposes obligations on parties and entities involved in the supply of pharmaceutical benefits. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, is responsible for making recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The Minister, in turn, specifies pharmaceutical items by legislative instrument under subsection 84AAA(2) of the Act. This ensures that the decisions about which pharmaceutical items are subject to early supply provisions are evidence-based and consider relevant expertise from various fields, including consumer representation, health economics, pharmacy, and medical practice. The Act also mandates that the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements do not apply to early supplies of specified pharmaceutical benefits, as outlined in the amended Instrument. Breach of the provisions in the National Health Act 1953, including those specified in the National Health (Pharmaceutical Benefits—early supply) Amendment Instrument 2017 (No. 8), may result in civil or criminal consequences. Although the specific penalties are not detailed in the explanatory statement, the Act generally provides for a range of penalties for breaches, which may include fines and imprisonment. The exact penalties depend on the nature and severity of the breach, as well as any relevant provisions within the broader legislative framework. It is important for parties involved in the supply of pharmaceutical benefits to adhere to the requirements set out in the Act to avoid potential legal repercussions. The amendment to the National Health (Pharmaceutical benefits—early supply) Instrument 2015, as introduced by the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 8), is a minor and machinery-in-nature change. It is designed to ensure that the provisions of the National Health Act 1953 regarding early supplies of pharmaceutical benefits are up-to-date and accurately reflect the current list of specified pharmaceutical items. The amendment aims to maintain the integrity and effectiveness of the Pharmaceutical Benefits Scheme by clarifying the scope of early supply provisions for certain medicines.

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Health Law
Instrument
Instrument
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Definitions & Interpretation
Reporting & Disclosure Obligations
Regulatory Standards
Consultation Requirements
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Pharmaceutical Benefits

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