National Health Act (Pharmaceutical Benefits – Early Supply) Amendment September 2012 - specification under subsection 84AAA(2) (No. PB 69 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01737 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

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

 

PB 69 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 remove 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 provides for the deletion of three entries; Etidronic Acid, Risedronic acid and calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate), and Verapamil in the form Tablet containing verapamil hydrochloride 160 mg.

 

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 the 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 September 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 September 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 September 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 September 2012 – specification under subsection 84AAA(2) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2), specifically to remove certain pharmaceutical items from the list of items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements do not apply for early supplies. This amendment was introduced by the Parliament of Australia under the authority of the National Health Act 1953. The policy objective is to ensure that decisions regarding the PBS are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which includes members with relevant qualifications and expertise in health-related fields. The amendment is designed to streamline and update the list of pharmaceutical items covered by the PBS Safety Net, thereby maintaining the effectiveness and relevance of the scheme in providing access to necessary medications.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment September 2012 – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) to specify pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. The Act applies to pharmaceutical items specified in the legislative instrument and is administered at the Commonwealth level. The Pharmaceutical Benefits Advisory Committee (PBAC) is responsible for recommending pharmaceutical items to be included in the instrument, ensuring decisions are evidence-based and relevant to public health. The amendment specifies the removal of Etidronic Acid, Risedronic acid and calcium in a specific form, and Verapamil in a specific form from the list of pharmaceutical items exempt from PBS Safety Net entitlements for early supplies. This legislative instrument is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health by ensuring access to subsidised medicines. The instrument commenced on 1 September 2012 and is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Key Provisions

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment September 2012 – specification under subsection 84AAA(2) modifies the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). Specifically, it removes certain pharmaceutical items from the list of those for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. These removed items include Etidronic Acid, Risedronic acid and calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate), and Verapamil in the form Tablet containing verapamil hydrochloride 160 mg (subsection 84AAA(2), PB 69 of 2012). The Act mandates that the Minister can specify, by legislative instrument, pharmaceutical items for the purposes of paragraph 84AAA(1)(b) of the Act. This means the Minister can specify which pharmaceutical items will not have PBS Safety Net entitlements for early supplies. The Pharmaceutical Benefits Advisory Committee (PBAC) is responsible for making recommendations to the Minister about what should be specified in the instrument (subsection 101(3AA)). These recommendations are based on consultations with various stakeholders, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and specialists. Under the Act, any supply of a pharmaceutical benefit that meets the criteria set out in subsection 84AAA(1) is considered an early supply of a specified pharmaceutical benefit (subsection 84AAA(1)(a)-(c)). If the pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection 84AAA(2), and the supply does not result from a prescription originating from a hospital, then the supply will be considered an early supply. 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 the pharmaceutical item. In terms of penalties and consequences, the Act does not explicitly state penalties for breaches related to early supplies of pharmaceutical benefits. However, breaches of other provisions within the National Health Act can result in fines or imprisonment. The exact penalties depend on the specific provision breached and the severity of the breach. For example, section 110 of the Act provides that a person who contravenes certain provisions can be fined up to $11,000 and/or imprisonment for up to 12 months. These penalties apply to any person who contravenes a provision of the Act, including those related to the PBS and early supplies of pharmaceutical benefits.

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Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Regulatory Standards
Pharmaceutical Benefits
Compliance Obligations

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