National Health Act (Pharmaceutical Benefits - Early Supply) Amendment October 2012 - specification under subsection 84AAA(2) (No. PB 86 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01931 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

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

 

PB 86 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 two new pharmaceutical items and remove two existing 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 ‘Pazopanib’, the form ‘Tablet 200 mg (as hydrochloride)’ and an ‘oral’ manner of administration; and inserts a new pharmaceutical item that has the listed drug ‘Pazopanib’, the form ‘Tablet 400 mg (as hydrochloride)’ and an ‘oral’ manner of administration; and removes an existing pharmaceutical item that has the listed drug ‘Nebivolol’, the form ‘Tablet 1.25 mg (as hydrochloride), 28’ and an ‘oral’ manner of administration; and removes an existing pharmaceutical item that has the listed drug ‘Risedronic acid and calcium with colecalciferol’, the form ‘Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms’ 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 2010.

 

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 October 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 October 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 October 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 (Pharmaceutical Benefits – Early Supply) Amendment October 2012 – specification under subsection 84AAA(2) is a legislative instrument made under the National Health Act 1953. This amendment was introduced to update the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, specifically to insert two new pharmaceutical items into the list of those for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies, and to remove two existing pharmaceutical items. The amendment was enacted to ensure that the Pharmaceutical Benefits – Early Supply Instrument remains current and effective in managing the timely supply of pharmaceuticals under the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended these changes, reflecting their importance in maintaining the integrity and effectiveness of the PBS. 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, particularly in advancing the right to the highest attainable standard of physical and mental health.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment October 2012 – specification under subsection 84AAA(2) pertains to the regulation of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) and applies to the conduct of supplying pharmaceuticals to patients within a specified timeframe. This amendment specifically modifies the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which outlines the pharmaceutical items for which PBS Safety Net entitlements do not apply in cases of early supply. The Act applies to entities such as pharmaceutical companies, healthcare providers, and patients receiving pharmaceutical supplies within Australia, impacting the pharmaceutical industry and healthcare providers across the nation. The amendment introduces two new pharmaceutical items involving the drug Pazopanib and removes two existing items involving Nebivolol and Risedronic acid and calcium with colecalciferol. The changes are in effect nationwide, aligning with the overarching provisions of the National Health Act 1953. The Act does not specify any exclusions or exemptions beyond the conditions outlined, and its application is governed by the terms set out in the Act itself. This legislative instrument ensures that the PBS continues to provide timely access to necessary medications while maintaining fiscal responsibility.

Key Provisions

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment October 2012, which amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, introduces changes to the list of pharmaceutical items exempt from Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. Specifically, it adds two new items, Pazopanib in 200 mg and 400 mg tablets, and removes two existing items, Nebivolol 1.25 mg tablets and a combination of Risedronic acid, calcium with colecalciferol (subsection 84AAA(2)). The amendment imposes obligations on the parties involved by specifying which pharmaceutical items qualify for early supply without incurring PBS Safety Net entitlements. Pharmaceutical suppliers and prescribers must ensure compliance with these regulations, particularly by adhering to the time frames and conditions outlined in the Act. The amendment also mandates that the Pharmaceutical Benefits Advisory Committee (PBAC) make recommendations to the Minister, who then specifies the pharmaceutical items under subsection 84AAA(2). This process ensures that the decisions are evidence-based and align with public health needs. Failure to comply with the provisions of this Act can result in civil or criminal penalties. Although specific penalties are not detailed in the explanatory statement, violations of the Act can typically lead to fines or other legal consequences. The severity of penalties would depend on the nature and extent of the breach, as well as any previous violations. Compliance is crucial to avoid these consequences and ensure the smooth operation of the PBS. This legislative instrument is designed to be compatible with human rights, particularly as it aids in the progressive realisation of the right to the highest attainable standard of physical and mental health. By providing subsidised access to essential medicines through the PBS, it supports the overall health and wellbeing of the community. The involvement of the PBAC in the decision-making process ensures that the recommendations are grounded in evidence, thereby advancing public health objectives.

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