National Health Act (Pharmaceutical Benefits - Early Supply) Amendment December 2013 - specification under subsection 84AAA(2) (No. PB 83 of 2013)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

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

 

PB 83 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 three 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 three new pharmaceutical items which have the listed drugs ‘Atorvastatin with ezetimibe’, ‘Ivabradine’ and ‘Olmesartan with amlodipine and hydrochlorothiazide’.

 

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 December 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 December 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 December 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.

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December 2013 – specification under subsection 84AAA(2) is an amendment to the National Health Act 1953, which was enacted to address the issue of early supply of certain pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) that do not attract Safety Net entitlements. This legislative instrument was introduced to specify additional pharmaceutical items that are eligible for early supply without incurring Safety Net costs, thereby ensuring that patients do not face unexpected financial burdens for medications that are supplied before the standard PBS waiting period. This amendment was made under the authority of the Minister for Health, in accordance with subsection 84AAA(2) of the Act, and aligns with the policy objective of providing more timely access to necessary medications while managing costs effectively. The Pharmaceutical Benefits Advisory Committee (PBAC), which comprises experts from various healthcare-related fields, recommended the inclusion of the new pharmaceutical items in the amended instrument. This committee's involvement ensures that decisions about which medications qualify for early supply without Safety Net implications are evidence-based and aligned with public health needs. The amendment, which includes the drugs Atorvastatin with ezetimibe, Ivabradine, and Olmesartan with amlodipine and hydrochlorothiazide, aims to improve patient access to essential medications by reducing wait times for these early supplies. The legislative instrument is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health by facilitating timely access to necessary medications under the PBS.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December 2013 - Specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, 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. This amendment, made under the authority of subsection 84AAA(2) of the National Health Act 1953, inserts three new pharmaceutical items into the instrument. These items include 'Atorvastatin with ezetimibe', 'Ivabradine', and 'Olmesartan with amlodipine and hydrochlorothiazide'. The amendment applies to these specific pharmaceutical items, which must meet the criteria outlined in the Act to be considered early supplies, specifically those supplied within 20 days of a previous supply of the same or equivalent pharmaceutical benefit, excluding supplies resulting from hospital prescriptions. This legislative instrument, which comes into effect on 1 December 2013, is a legislative instrument for the purposes of the Legislative Instruments Act 2003. It ensures that the Pharmaceutical Benefits Advisory Committee's recommendations are implemented, thereby maintaining an evidence-based approach to decisions about subsidised access to medicines on the PBS.

Key Provisions

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December 2013 – specification under subsection 84AAA(2) (F2013L02014) primarily amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by inserting three new pharmaceutical items (sections 1 and 2). These pharmaceutical items are 'Atorvastatin with ezetimibe', 'Ivabradine', and 'Olmesartan with amlodipine and hydrochlorothiazide'. The amendment specifies that early supplies of these pharmaceutical items will not attract Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements, in line with subsection 84AAA(1) of the Act. This means that patients who receive these medications within 20 days of their last supply of the same or a similar pharmaceutical benefit will not be entitled to the PBS Safety Net, provided the other conditions outlined in subsection 84AAA(1) are met. The obligations imposed by this amendment require that the new pharmaceutical items be listed in the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. As stated in subsection 84AAA(2), the Minister is authorised to specify these items through a legislative instrument. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role by recommending these pharmaceutical items to the Minister. PBAC's recommendations are based on consultations with various stakeholders, including consumers, health economists, practising community pharmacists, general practitioners, and specialists. This ensures a balanced and evidence-based approach to the amendments. Breaches of the provisions outlined in this legislation may not explicitly detail specific offences, penalties, or civil/criminal consequences within the provided text. However, the National Health Act 1953, as a whole, includes provisions that could lead to penalties for non-compliance with its requirements. For instance, subsection 119 of the Act states that a person who contravenes certain provisions of the Act can be subject to fines and imprisonment. The exact penalties would depend on the specific contravention and could range from fines to imprisonment terms, as outlined in the Act. It is essential for parties and entities governed by this Act to adhere to its requirements to avoid potential legal repercussions.

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