National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2014 (No. 1) - specification under subsection 84AAA(2) (No. PB 25 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.1) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 25 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) is to add one new pharmaceutical item, delete one form and strength of an existing pharmaceutical item and insert a circumstance 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 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 glycopyrronium  in the form capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler), manner of administration inhalation by mouth.  The schedule is also amended by removing one form and strength of flutamide in the form tablet 250mg, 30, manner of administration oral. The schedule is further amended by inserting circumstances relating to denosumab.   

 

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 April 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.1) – specification under subsection 84AAA(2)

(PB 25 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.1) –  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.1) – specification under subsection 84AAA(2) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. This legislative instrument, made under subsection 84AAA(2) of the National Health Act 1953, addresses the problem of early pharmaceutical supplies by specifying pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements do not apply. The enacting body is the Minister of Health, who specifies the pharmaceutical items in accordance with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The policy objective is to ensure that the PBS provides equitable access to affordable medicines, advancing the right to the highest attainable standard of physical and mental health. This amendment introduces one new pharmaceutical item, removes one form and strength of an existing item, and adds circumstances to an existing item, all to better manage early supplies of medicines under the PBS. The changes are in response to recommendations from the PBAC, which comprises members with expertise in various relevant fields to ensure evidence-based decision-making. The instrument is compatible with human rights as it supports the progressive realisation of the right to health by ensuring access to affordable medicines.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No.1) – specification under subsection 84AAA(2) pertains to amendments made to the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. This legislation, operating under the National Health Act 1953, specifies pharmaceutical items that are subject to Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. The instrument applies to pharmaceutical benefits provided within Australia and is relevant to entities involved in the supply and administration of pharmaceutical items. The Act is applicable to the Commonwealth and is intended to regulate the supply of pharmaceutical benefits within its jurisdiction. Exclusions from the application of the Act are limited to supplies resulting from a prescription originating from a hospital. The Pharmaceutical Benefits Advisory Committee has provided recommendations that the pharmaceutical items specified in this amendment be included in the instrument. This legislative instrument is compatible with human rights, particularly engaging with Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by supporting access to the highest attainable standard of health through the provision of subsidised medicines.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No.1) – specification under subsection 84AAA(2) (PB 25 of 2014) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009) to add glycopyrronium in the form of a capsule containing powder for oral inhalation, 50 micrograms (as bromide) (for use in Breezhaler), and to remove one form and strength of flutamide, specifically tablet 250mg, 30, manner of administration oral. This legislative instrument also introduces new circumstances relating to denosumab. These changes are intended to refine the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies, as defined under the National Health Act 1953 (the Act). Under this Act, an early supply of a pharmaceutical benefit is defined as a supply made within 20 days after a previous supply of the same or a similar pharmaceutical benefit, provided certain conditions are met (subsection 84AAA(1)). The Minister is authorised to specify which pharmaceutical items qualify for these early supply provisions through a legislative instrument (subsection 84AAA(2)). This amendment to PB 30 of 2009 is based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that decisions are evidence-based and consider various health professional perspectives. The obligations imposed by this Act on parties and entities include ensuring that supplies of specified pharmaceutical items comply with the early supply provisions. This involves adhering to the timeframes and conditions set forth in the Act to avoid triggering PBS Safety Net entitlements for early supplies. Healthcare providers and suppliers must be aware of the changes specified in PB 30 of 2009, particularly the addition and removal of specific pharmaceutical items and the new circumstances for denosumab, to ensure compliance with the legislative requirements. Breaches of the requirements set forth in this Act may lead to civil or criminal consequences, depending on the nature and severity of the violation. The maximum penalties for such breaches are not explicitly stated in the provided text, but they would typically align with the general penalties outlined in the National Health Act 1953. These penalties may include fines or other sanctions, and in severe cases, criminal charges could be pursued against individuals or entities found in violation of the Act’s provisions. The legislative instrument's compatibility with human rights, particularly in advancing the right to the highest attainable standard of physical and mental health, underscores the importance of ensuring that these pharmaceutical supply regulations are effectively implemented.

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