National Health Act (Pharmaceutical Benefits - Early Supply) Amendment September 2013 - specification under subsection 84AAA(2) (No. PB 60 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01581 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

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

 

PB 60 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 two new pharmaceutical items and 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 pharmaceutical item that has the listed drug ‘Apixaban’, the form ‘Tablet 2.5mg’ and an ‘oral’ manner of administration; and inserts a new pharmaceutical item that has the listed drug ‘Apixaban’, the form ‘Tablet 5mg’ and an ‘oral’ manner of administration; and inserts a new pharmaceutical item that has the listed drug ‘Dabigatran’, the form ‘Capsule 110mg (as mesilate)’ and an ‘oral’ manner of administration; and inserts a new pharmaceutical item that has the listed drug ‘Dabigatran’, the form ‘Capsule 150mg (as mesilate)’ and an ‘oral’ manner of administration; and inserts a new form and strength for an existing pharmaceutical item that has the listed drug ‘Flutamide’, the form ‘Tablet 250mg, 30’ 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 September 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 September 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 September 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.

 

Gregory O’Toole

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

 

Overview

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment September 2013 – specification under subsection 84AAA(2) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. This amendment aimed to insert two new pharmaceutical items and a new form and strength to an existing pharmaceutical item into the list of items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. The objective of the amendment is to ensure that certain early supplies of specified pharmaceutical items are not subject to PBS Safety Net entitlements, thus addressing a gap in the application of these entitlements to certain early supplies. The amendment was made under the authority of the National Health Act 1953 by the Minister for Health, and the Pharmaceutical Benefits Advisory Committee recommended these changes to better manage pharmaceutical benefits under the PBS. The amendment commenced on 1 September 2013 and is compatible with human rights, particularly by advancing access to essential medicines through the PBS.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment September 2013 – specification under subsection 84AAA(2) pertains to the National Health Act 1953 and aims to modify the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. This legislative instrument specifies the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. The amendment adds new pharmaceutical items and a new form and strength of an existing pharmaceutical item to the list. The Act applies to individuals and entities involved in the supply of pharmaceutical benefits under the PBS, particularly those within the specified timeframes for early supplies as defined by the Act. The geographic reach of this legislation is national, as it pertains to the PBS, which is a Commonwealth-managed scheme. The Act does not explicitly state any exclusions, exemptions, or thresholds, but it is understood that the listed pharmaceutical items will be subject to the conditions set out in the Act, including the 20-day period following a previous supply and the exclusion of supplies resulting from hospital prescriptions. The application of the Act can be further defined through subordinate instruments, which may provide additional specifications and operational details.

Key Provisions

The primary focus of the National Health Act (Pharmaceutical Benefits – Early Supply) Amendment September 2013 - specification under subsection 84AAA(2) (F2013L01581) is to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 - specification under subsection 84AAA(2) (PB 30 of 2009). This amendment specifically includes new pharmaceutical items and modifies an existing pharmaceutical item to specify that Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies of these items (sections 1, 2). This means that supplies of these specific pharmaceutical items made within 20 days of a previous supply to the same person will not count towards the PBS Safety Net threshold. This legislative amendment imposes certain obligations on the parties involved, particularly those administering or participating in the Pharmaceutical Benefits Scheme. The Pharmaceutical Benefits Advisory Committee (PBAC) is tasked with recommending pharmaceutical items to be included in the early supply instrument, ensuring that decisions are evidence-based and contribute to the highest attainable standard of health (subsection 84AAA(1)). Additionally, the Pharmaceutical Benefits Scheme must adhere to the specifications outlined in the instrument, ensuring that early supplies of the listed pharmaceutical items do not accrue towards the PBS Safety Net threshold. Pharmacists and healthcare providers must also be aware of these specifications to correctly advise patients and administer the scheme in compliance with these regulations. Failure to comply with the provisions of this legislative instrument may result in civil or criminal consequences. For instance, providing early supplies of the specified pharmaceutical items that do count towards the PBS Safety Net threshold could lead to penalties or other enforcement actions. Although specific penalties are not detailed in the explanatory statement, general penalties under the National Health Act 1953 could include fines, imprisonment, or both, depending on the severity and intent of the breach. The maximum penalties for contravening provisions of the National Health Act can include substantial fines and imprisonment for up to five years for serious offences. Overall, the National Health Act (Pharmaceutical Benefits – Early Supply) Amendment September 2013 - specification under subsection 84AAA(2) ensures that certain pharmaceutical items are excluded from PBS Safety Net calculations when supplied early, thereby facilitating timely access to necessary medications while maintaining the integrity of the PBS Safety Net scheme. This amendment aims to support the progressive realisation of the right to health as enshrined in international human rights instruments, ensuring that decisions about pharmaceutical subsidies are evidence-based and patient-focused.

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