National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 4) – specification under subsection 84AAA(2) (No. PB 60 of 2014)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2014 (No. 4) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 60 of 2014

 

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) by inserting two 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

Schedule 1 of the Principal Instrument (PB 30 of 2009) is amended by inserting two new pharmaceutical items which have the listed drugs ‘Aclidinium’ and ‘Betaine’.

 

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 2012 (PB 71 of 2012).

 

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.

 

Variation and revocation

Unless there is an express power to revoke or vary PB 30 of 2009 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 30 of 2009.

 

Consultation

The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the pharmaceutical items referred to in this amendment be included in an instrument under subsection 84AAA(2).

 

PBAC is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. 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 2014.

 

This Instrument is a legislative instrument for the purposes of the Legislative Instrument Act 2003.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 4) – specification under subsection 84AAA(2)

(PB 60 of 2014)

 

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 (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 3)  – 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.

 

 

Paul Creech

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 4) is an amendment to the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which was enacted to address the issue of early supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). This legislative instrument was introduced to amend the earlier instrument by inserting two new pharmaceutical items, namely 'Aclidinium' and 'Betaine', which will not attract PBS Safety Net entitlements for early supplies. Enacted under the authority of the National Health Act 1953, this amendment responds to recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). The policy objective of this legislative instrument is to progressively realise the right of everyone to the enjoyment of the highest attainable standard of physical and mental health by facilitating access to essential medicines through the PBS, while ensuring that decisions about the inclusion of pharmaceutical items on the scheme are evidence-based. This amendment is a minor and machinery in nature, ensuring that the legislative instrument aligns with the human rights and freedoms recognised or declared in the international instruments listed in the Human Rights (Parliamentary Scrutiny) Act 2011. By including 'Aclidinium' and 'Betaine' in the list of pharmaceutical items for which PBS Safety Net entitlements will not apply for early supplies, the government aims to support the progressive realisation of the right to health, thereby advancing the protection of human rights. This legislative instrument is compatible with human rights because it supports the provision of subsidised access to essential medicines, ultimately contributing to better health outcomes for the community.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 4) – specification under subsection 84AAA(2) (PB 60 of 2014) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by inserting two new pharmaceutical items, specifically ‘Aclidinium’ and ‘Betaine’, which are now excluded from Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. This amendment applies to individuals who receive early supplies of these specified pharmaceutical benefits under the Pharmaceutical Benefits Scheme, which is a Commonwealth initiative aimed at ensuring affordable access to essential medicines. The legislation operates within the geographical jurisdiction of Australia, affecting entities such as pharmaceutical companies, healthcare providers, and patients within the Australian healthcare system. The changes to PB 30 of 2009 were recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), which comprises members from various relevant fields such as consumers, health economists, and medical specialists, ensuring that the recommendations are evidence-based and comprehensive. The legislative instrument is effective from 1 August 2014 and is compatible with human rights, advancing the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 4) – specification under subsection 84AAA(2) (PB 60 of 2014) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by inserting two new pharmaceutical items into the list of those for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This means that supplies of the specified drugs 'Aclidinium' and 'Betaine' within 20 days of a previous supply to the same person will not count towards the Safety Net threshold. The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended these changes, ensuring that the decisions are evidence-based and contribute to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Act imposes several obligations on the parties involved. Firstly, it requires the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations to the Minister regarding the pharmaceutical items that should be specified in the instrument. These recommendations must be based on evidence and consider the impact on health outcomes. Secondly, the Minister must specify the pharmaceutical items by legislative instrument, ensuring that the provisions are clearly defined and implemented. The Act also mandates that the pharmaceutical items listed in the instrument must meet the criteria outlined in subsection 84AAA(1) and must not result from prescriptions originating from a hospital. Furthermore, the Act specifies that the instrument may be varied or revoked by the Minister unless there is an express power to do so cited in the instrument itself. There are no specific offences or penalties mentioned in the Act for breaches of the provisions related to early supply of pharmaceutical benefits. However, the Act does provide a framework for the regulation and oversight of pharmaceutical benefits under the PBS. The primary consequence of non-compliance would be the application of PBS Safety Net entitlements for early supplies, which could potentially increase the financial burden on patients. The Act relies on the overarching legislative framework and administrative processes to ensure compliance and address any breaches, ensuring that the provisions are effectively implemented and enforced. The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 4) – specification under subsection 84AAA(2) (PB 60 of 2014) 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. 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 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 the 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, furthering the protection of human rights.

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