National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2014 (No. 3) - specification under subsection 84AAA(2) (No. PB 39 of 2014)

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2014 (No. 3) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 39 of 2014

 

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) to amend the description of one form of an existing pharmaceutical item and change the maximum quantity relevant to that 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 altering the form description of phenoxybenzamine in the form capsules containing phenoxybenzamine hydrochloride 10 mg, 100.  This form of this pharmaceutical item will now be expressed as capsule containing 10 mg phenoxybenzamine hydrochloride.  As a consequence the maximum quantity relevant to this item is changed from 1 to 100.

 

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 June 2014.

 

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 2014 (No. 3) – specification under subsection 84AAA(2)

(PB 39 of 2014)

 

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 2014 (No. 3)  – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) to specify 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 2014 (No. 3) – specification under subsection 84AAA(2) (PB 39 of 2014) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009) under the authority of subsection 84AAA(2) of the National Health Act 1953. This legislative instrument aims to address the issue of specifying pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies, thereby ensuring that certain pharmaceutical benefits do not accrue Safety Net entitlements when supplied within a short period after a previous supply. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the changes, and the instrument reflects the policy objective of maintaining an evidence-based and efficient pharmaceutical benefits scheme. The instrument was made under the authority of the Commonwealth Parliament and is designed to be machinery in nature, with the purpose of ensuring the PBS operates effectively. It amends the description of a pharmaceutical item, phenoxybenzamine, and changes its maximum quantity from 1 to 100. This alteration aligns the item's description with current declarations and determinations under the Act, facilitating better management of early pharmaceutical supplies and ensuring compliance with the legislative framework governing the PBS.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 3) – specification under subsection 84AAA(2) is a legislative instrument designed to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). This amendment specifically alters the form description of phenoxybenzamine in the form capsules containing phenoxybenzamine hydrochloride 10 mg, 100, re-expressing it as a capsule containing 10 mg phenoxybenzamine hydrochloride. Consequently, the maximum quantity relevant to this pharmaceutical item is adjusted from 1 to 100. This amendment applies to pharmaceutical benefits within the Pharmaceutical Benefits Scheme (PBS), ensuring that early supplies of the specified pharmaceutical item do not trigger PBS Safety Net entitlements. The instrument operates within the Commonwealth jurisdiction and applies to all persons and entities involved in the supply of pharmaceutical benefits under the National Health Act 1953. The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended the changes, ensuring that decisions regarding access to medicines on the PBS are evidence-based and in line with human rights considerations.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 3) – specification under subsection 84AAA(2) (PB 39 of 2014) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). It alters the description of one form of an existing pharmaceutical item and changes the maximum quantity relevant to that item. Specifically, it modifies the description of phenoxybenzamine from capsules containing phenoxybenzamine hydrochloride 10 mg, 100, to capsule containing 10 mg phenoxybenzamine hydrochloride, and changes the maximum quantity from 1 to 100 (Schedule 1). This amendment ensures that certain supplies of these pharmaceutical items are considered early supplies under the National Health Act 1953 (the Act) (subsection 84AAA(1)). The Act imposes obligations on the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2). The Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies of the specified pharmaceutical items. The Act also requires that supplies of pharmaceutical benefits must meet the criteria outlined in subsection 84AAA(1), including the timing of the supply and the circumstances under which it is made. This includes ensuring that the supply does not result from a prescription originating from a hospital. Breach of the provisions of the Act can result in civil or criminal penalties. For instance, supplying a pharmaceutical benefit that is classified as an early supply without adhering to the conditions set forth in the Act can result in financial penalties. The exact penalties for such breaches are not specified in the explanatory statement but would generally be determined by the courts based on the severity and intent of the breach. The Act's provisions are designed to ensure that the PBS operates efficiently and that patients have access to necessary medications while maintaining the integrity of the scheme. This legislative instrument is compatible with human rights, specifically engaging Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). By ensuring that certain pharmaceutical items are available without the application of PBS Safety Net entitlements for early supplies, the Act supports the progressive realisation of the right to the highest attainable standard of physical and mental health. The involvement of the PBAC ensures that decisions about access to medicines on the PBS are evidence-based, further advancing the protection of human rights.

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