National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2014 (No. 9) – specification under subsection 84AAA(2) (No. PB 106 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. 9) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 106 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 six 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 the addition of the listed drugs: empagliflozin; and ezetemibe and rosuvastatin.

 

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 January 2015.

 

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. 9) – specification under subsection 84AAA(2)

(PB 106 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. 9) – 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 (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 9) – specification under subsection 84AAA(2) is an amendment to the National Health Act 1953, enacted to address the issue of early supply of certain pharmaceutical items by modifying the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. This amendment was made under the authority of the Australian Parliament to enhance the Pharmaceutical Benefits Scheme (PBS) by specifying additional pharmaceutical items for which PBS Safety Net entitlements will not apply when supplied early. The policy objective behind this amendment is to ensure that the PBS continues to provide efficient and equitable access to necessary medications while managing costs effectively. This legislative instrument was introduced to address gaps in the existing framework by specifying new pharmaceutical items, empagliflozin, ezetemibe and rosuvastatin, that will be exempt from PBS Safety Net entitlements when supplied early. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body with representatives from various health-related fields, recommended these additions. The amendment is considered minor and of a machinery nature, aiming to maintain the integrity and functionality of the PBS by ensuring it can adapt to new medical needs and supply practices. The changes came into effect on 1 January 2015, aligning with the legislative intent to progressively realise the human right to health as recognised in international human rights instruments.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 9) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by adding six new pharmaceutical items to the list of those for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This instrument applies to pharmaceutical benefits supplied to persons within the Commonwealth of Australia, specifically affecting the entities and individuals involved in the Pharmaceutical Benefits Scheme (PBS) and the Pharmaceutical Benefits Advisory Committee (PBAC). The instrument specifies particular pharmaceutical items that are deemed early supplies if they are supplied within 20 days of a previous supply of the same or similar pharmaceutical items, except when originating from a hospital prescription. The amendment specifies empagliflozin, ezetemibe and rosuvastatin as new pharmaceutical items subject to these conditions. The instrument extends its application through subordinate instruments as necessary and is compatible with human rights, particularly in advancing the right to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 9) – specification under subsection 84AAA(2) (PB 106 of 2014) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by inserting six new pharmaceutical items (Schedule 1). These pharmaceutical items, empagliflozin, ezetemibe, and rosuvastatin, are now included in the list of items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies (subsection 84AAA(2)). This means that when these specific pharmaceutical benefits are supplied within 20 days of a previous supply, the PBS Safety Net will not apply (subsection 84AAA(1)). The Act imposes several obligations on the parties involved. For example, it requires the Minister to specify pharmaceutical items for the purposes of paragraph 84AAA(1)(b) of the Act (subsection 84AAA(2)). The Pharmaceutical Benefits Advisory Committee (PBAC) has a recommendatory role in this process, providing recommendations to the Minister about what should be specified in the instrument (subsection 101(3AA)). The PBAC, which comprises members from various relevant professions, ensures that decisions about subsidised access to medicines are evidence-based and consider the best interests of the public. Failure to comply with the provisions of the Act may result in civil or criminal consequences. For instance, supplying a pharmaceutical benefit that is specified in an instrument under subsection 84AAA(2) within 20 days of a previous supply, without meeting the conditions set out in subsection 84AAA(1), may result in the supply being classified as an early supply of a specified pharmaceutical benefit. This classification can lead to the PBS Safety Net not applying, potentially affecting the financial burden on patients. However, the Act does not specify maximum penalties for such breaches, and the consequences would depend on the specific circumstances and any applicable regulations or guidelines. In summary, the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 9) – specification under subsection 84AAA(2) adds six new pharmaceutical items to the list of items for which PBS Safety Net entitlements will not apply for early supplies. It imposes obligations on the Minister and the PBAC to ensure that decisions about these pharmaceutical items are evidence-based and in the public interest. While the Act does not specify maximum penalties for non-compliance, the consequences can affect the application of the PBS Safety Net and, consequently, the financial burden on patients.

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