National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 2) – specification under subsection 84AAA(2) (PB 17 of 2015)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2015 (No. 2) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 17 of 2015

 

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 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by: removing one pharmaceutical item.

 

PB 30 of 2009 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.

 

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) (currently PB 30 of 2009).

 

Changes to PB 30 of 2009 made by this instrument

Schedule 1 of the Principal Instrument (PB 30 of 2009) is amended by the addition of the listed drug aripiprazole.

 

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 30 of 2009 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 30 of 2009.

 

Consultation

The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the pharmaceutical items referred to in this amendment be included in an instrument under subsection 84AAA(2).

 

PBAC is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. 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 PBAC.

 

This amendment is minor and machinery in nature.

 

General

This Instrument commences on 1 March 2015.

 

This Instrument is a legislative instrument for the purposes of the Legislative Instrument 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 2015 (No. 2) – specification under subsection 84AAA(2)

(PB 17 of 2015)

 

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
2015 (No. 2) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) 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.

 

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 2) – specification under subsection 84AAA(2) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, 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 a specific gap identified by the Pharmaceutical Benefits Advisory Committee (PBAC) concerning the pharmaceutical item aripiprazole. Enacted under subsection 84AAA(2) of the National Health Act 1953 by the Australian Government, the policy objective of this amendment is to ensure that decisions about pharmaceutical benefits are evidence-based and contribute to the progressive realisation of the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights. This amendment ensures that the PBS continues to provide subsidised access to necessary medicines, aligning with human rights commitments.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 2) specifies a minor amendment to the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which identifies the pharmaceutical items that are subject to Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. This legislative instrument applies to the pharmaceutical industry and the Australian public by specifying the pharmaceutical items for which early supply does not attract PBS Safety Net entitlements. It operates nationally under the authority of the National Health Act 1953 and is effective from 1 March 2015. The Pharmaceutical Benefits Advisory Committee, which comprises experts from various relevant fields, recommended the inclusion of the specified pharmaceutical item. The instrument does not explicitly exclude any particular entities or categories of conduct, but relies on the existing legislative framework to define the scope of its application. The amendment is machinery in nature and does not introduce significant changes to the existing legislative provisions.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 2) – specification under subsection 84AAA(2) (PB 17 of 2015) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009) by removing one pharmaceutical item from the list of items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies (subsection 84AAA(2)). This means that early supplies of the specified pharmaceutical item will now be subject to PBS Safety Net entitlements. A supply is considered early if it is made within 20 days of a previous supply of the same pharmaceutical benefit or another that has the same pharmaceutical item or is Schedule equivalent (subsection 84AAA(1)(a)). The pharmaceutical item in question is specified in an instrument under subsection 84AAA(2) and the supply must not result from a prescription originating from a hospital (subsection 84AAA(1)(b) and (c)). The obligations imposed on parties under this Act include ensuring that any supply of the specified pharmaceutical item that meets the criteria for an early supply (subsection 84AAA(1)) will now be subject to PBS Safety Net entitlements. This means that patients who receive early supplies of this item will be entitled to PBS Safety Net benefits, which can help reduce the cost of medicines for eligible patients. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on what should be specified in the instrument under subsection 84AAA(2) (subsection 101(3AA)). The PBAC is an independent body that includes members from various interests and professions, such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists, as well as other qualified individuals. There are no specific offences, penalties, or civil/criminal consequences mentioned in the text for breaches of this Act. However, the Act generally provides for enforcement mechanisms to ensure compliance with its provisions. For instance, failure to comply with the requirements of the Act or the regulations made under it may result in penalties, including fines or imprisonment, depending on the specific provisions being breached. The maximum penalties for breaches of the National Health Act 1953 and its regulations can vary widely depending on the nature and severity of the offence. It is important for parties governed by this Act to be aware of their obligations and to ensure compliance to avoid potential penalties.

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