National Health Act (Pharmaceutical Benefits - Early Supply) Amendment August 2013 - specification under subsection 84AAA(2)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01456 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH ACT (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT AUGUST 2013 – SPECIFICATION UNDER SUBSECTION 84AAA(2)

 

PB 50 of 2013

 

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 a new form and strength to an existing 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 33(3) of the Acts Interpretation Act 1901 provides the power to vary the instrument.

 

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 form and strength to an existing pharmaceutical item that has the listed drug ‘Rivaroxaban’, the form ‘Tablet 15 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 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 August 2013.

 

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 August 2013 - 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 August 2013 - 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 August 2013 – specification under subsection 84AAA(2) was enacted to modify the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). This amendment, made under subsection 84AAA(2) of the National Health Act 1953, is intended to address the issue of early supply of pharmaceutical benefits by inserting a new form and strength of an existing pharmaceutical item, specifically Rivaroxaban in the form of a 15 mg oral tablet, into the list of items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply. This amendment aims to ensure that the regulation of early pharmaceutical supplies aligns with current medical and administrative needs, reflecting the advice of the Pharmaceutical Benefits Advisory Committee. The amendment was enacted by the Parliament of Australia and aligns with the overarching policy objective of providing evidence-based, cost-effective access to essential medicines through the PBS.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment August 2013 – specification under subsection 84AAA(2) is a legislative instrument that amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. It applies to the Pharmaceutical Benefits Scheme (PBS) and concerns the conditions under which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies of pharmaceutical items. Specifically, this amendment adds a new form and strength of an existing pharmaceutical item to the list of items for which PBS Safety Net entitlements do not apply if the supply is made within 20 days of a previous supply of the same pharmaceutical item. This applies nationally and impacts individuals who receive early pharmaceutical supplies and the entities involved in dispensing these supplies. The amendment is made under the authority of the National Health Act 1953 and is subject to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that decisions about access to medicines are evidence-based. There are no exclusions or exemptions specified in this particular amendment, and it does not extend or restrict application through subordinate instruments beyond the specifications of the amended list.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits – Early Supply) Amendment August 2013 – specification under subsection 84AAA(2) (F2013L01456) are concerned with the amendment of the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). Specifically, section 84AAA(2) allows the Minister to specify, by legislative instrument, pharmaceutical items that are subject to early supply provisions under the National Health Act 1953 (the Act). This amendment inserts a new form and strength of an existing pharmaceutical item, specifically 'Rivaroxaban' in the form of a 'Tablet 15 mg' with an 'oral' manner of administration. The amendment comes into effect on 1 August 2013 and serves to clarify which pharmaceutical items will not incur Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. The obligations and requirements imposed by this Act primarily revolve around the Pharmaceutical Benefits Advisory Committee (PBAC) and the Minister. Section 101(3AA) of the Act requires the PBAC to make recommendations to the Minister regarding what should be specified in the instrument under subsection 84AAA(2). The PBAC comprises members from various fields including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and specialists. The Minister then has the authority under section 84AAA(2) to specify these pharmaceutical items by legislative instrument. The inclusion of 'Rivaroxaban' in the form of a 'Tablet 15 mg' with an 'oral' manner of administration means that any supply of this pharmaceutical item within the specified time frame will be considered an early supply and will not incur PBS Safety Net entitlements. The legislative instrument does not explicitly state any offences, penalties, or civil/criminal consequences for breach. However, by specifying that the pharmaceutical item in question will not incur PBS Safety Net entitlements for early supplies, it implies that any supply of this item that does not adhere to the specified conditions could potentially lead to financial penalties or other repercussions for the parties involved. This includes situations where the supply does not meet the criteria outlined in subsection 84AAA(1), such as not being made within 20 days of a previous supply of the same or equivalent pharmaceutical benefit, or resulting from a prescription originating from a hospital. While the specific penalties for such breaches are not detailed in the document, they would likely be addressed under the general provisions of the National Health Act 1953 or related legislation.

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