National Health Act (Pharmaceutical Benefits - Early Supply) Amendment December 2012 - specification under subsection 84AAA(2) (No. PB 104 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L02292 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH ACT (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT DECEMBER 2012 – SPECIFICATION UNDER SUBSECTION 84AAA(2)

 

PB 104 of 2012

 

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 insert four new pharmaceutical items.

 

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

 

This instrument inserts a new pharmaceutical item that has the listed drug ‘Atenolol’, the form ‘Oral solution 50 mg in 10 mL, 300 mL’, and an ‘oral’ manner of administration; and inserts a new pharmaceutical item that has the listed drug ‘Pazopanib’, the form ‘Tablet 200 mg (as hydrochloride)’, an ‘oral’ manner of administration, and ‘30’ maximum quantity or number of units; and inserts a new pharmaceutical item that has the listed drug ‘Pazopanib’, the form ‘Tablet 400 mg (as hydrochloride)’, an ‘oral’ manner of administration, and ‘30’ maximum quantity or number of units; and inserts a new pharmaceutical item that has the listed drug ‘Rivaroxaban’, the form ‘Tablet 20 mg’, and an ‘oral’ manner of administration.

 

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.

 

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.

 

Consultation

 

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

 

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 PBAC.

 

This amendment is minor and machinery in nature.

 

General

 

This Instrument commences on 1 December 2012.

 

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


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December 2012 - specification under subsection 84AAA(2)

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 Act (Pharmaceutical Benefits – Early Supply) Amendment December 2012 - 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.

 

Adriana Platona

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

 

Overview

The National Health Act 1953, as amended by the National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December 2012, aims to address the issue of early supply of certain pharmaceutical items by amending the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. The purpose of this legislative instrument, made under subsection 84AAA(2) of the Act, is to insert four new pharmaceutical items into the Instrument, thereby specifying pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. Enacted by the Parliament of Australia, the policy objective of this amendment is to ensure that certain pharmaceutical items are accessible without the PBS Safety Net applying to early supplies, thereby facilitating timely access to these medications. This legislative change was recommended by the Pharmaceutical Benefits Advisory Committee, which plays a crucial role in providing evidence-based recommendations to the Minister regarding the pharmaceutical items to be included in the Instrument.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December 2012 – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 to include four new pharmaceutical items that are exempt from Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. This amendment applies to persons who receive supplies of the specified pharmaceutical items within 20 days of a previous supply, as defined by the Act. The amendment specifies particular pharmaceutical items by their listed drug, form, manner of administration, and maximum quantity, which are declared and determined under the Act. The amendment is a legislative instrument under the Legislative Instruments Act 2003, and it is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring access to medicines through the PBS. The Pharmaceutical Benefits Advisory Committee's role in recommending pharmaceutical items for inclusion ensures that decisions are evidence-based and contribute to the protection of human rights.

Key Provisions

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December 2012 – specification under subsection 84AAA(2) (PB 104 of 2012) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009) by inserting four new pharmaceutical items that are exempt from Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. These new pharmaceutical items include Atenolol in the form of an oral solution, and Pazopanib and Rivaroxaban in tablet form, each with specified forms and administration details (subsection 84AAA(2)). This legislative change ensures that certain supplies of these medications are recognised as early supplies of specified pharmaceutical benefits under the Act, provided the criteria in subsection 84AAA(1) are met. The Act imposes specific obligations on parties involved in the supply of pharmaceutical benefits. Pharmaceutical suppliers must ensure that the supplies of the newly specified pharmaceutical items meet the conditions outlined in subsection 84AAA(1), which includes the timing of the supply and the nature of the previous supply. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) is responsible for making recommendations to the Minister regarding what should be specified in the instrument under subsection 84AAA(2), ensuring that decisions about the inclusion of pharmaceutical items are evidence-based and aligned with public health needs (subsection 101(3AA)). The Minister has the authority to specify pharmaceutical items through legislative instruments, which must be consistent with the criteria set out in the Act. Breach of the requirements set out in the National Health Act can lead to civil or criminal consequences. For instance, supplying a pharmaceutical benefit that does not comply with the provisions regarding early supplies could result in financial penalties. The Act does not specify maximum penalties for these breaches, but generally, penalties for non-compliance with health regulations can be significant and may include fines or other sanctions. Additionally, the Act ensures that the human rights and freedoms recognised in international instruments, such as the International Covenant on Economic, Social and Cultural Rights (ICESCR), are respected and advanced through its provisions, emphasising the importance of accessible and affordable healthcare.

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