National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 3) – specification under subsection 84AAA(2) (PB 36 of 2015)

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 2015 (No. 3) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 36 of 2015

 

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 one pharmaceutical item and removing one 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 mesalazine in the form sachet containing prolonged release granules, 4 g per sachet; and removing salcatonin in the form injection 50 I.U. in 1 mL ampoule.

 

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 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 2015 (No. 3) – specification under subsection 84AAA(2)

(PB 36 of 2015)

 

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
2015 (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.

 

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 3) is an amendment to the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, made under subsection 84AAA(2) of the National Health Act 1953. This legislative instrument aims to adjust the list of pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. Enacted by the Parliament of Australia, the amendment responds to the need for a more precise regulation of early supply provisions in the PBS to ensure efficient and equitable access to essential medications. The overarching policy objective is to refine the list of pharmaceutical items exempt from PBS Safety Net entitlements when supplied early, thereby enhancing the efficiency and effectiveness of the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body comprising experts from various health-related fields, recommended the changes incorporated in this amendment. The PBAC's role in advising on the inclusion of specific pharmaceutical items ensures that the decisions regarding PBS subsidies are evidence-based and aligned with public health objectives. This amendment, which introduces one new pharmaceutical item and removes another, aims to address any gaps in the current regulatory framework, ultimately contributing to the progressive realisation of the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights (ICESCR).

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 3) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009) to adjust the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This instrument applies to the Pharmaceutical Benefits Scheme administered by the Commonwealth under the National Health Act 1953, impacting pharmaceutical items listed for early supply. It specifies the pharmaceutical items, including the addition of mesalazine in the form of sachets containing prolonged release granules, 4 g per sachet, and the removal of salcatonin in the form of injection 50 I.U. in 1 mL ampoule. The changes are applicable nationally across Australia, affecting all entities and individuals who supply or receive pharmaceuticals under the PBS. The amendments come into effect on 1 April 2015, and while there is no express power cited for revocation or variation of PB 30 of 2009, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon for any necessary revocation or variation. The instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003, and it has been prepared in accordance with the Human Rights (Parliamentary Scrutiny) Act 2011, confirming its compatibility with human rights.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 3) – specification under subsection 84AAA(2) (PB 36 of 2015) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). The primary change introduced by this amendment is the addition of mesalazine in the form of a sachet containing prolonged release granules, 4 g per sachet, and the removal of salcatonin in the form of an injection 50 I.U. in 1 mL ampoule. This amendment specifically targets the pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies (subsection 84AAA(2)) (subsection 84AAA(1)). Under the Act, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role by making recommendations to the Minister about what should be specified in the instrument (subsection 101(3AA)). For this amendment, PBAC recommended the inclusion of the specified pharmaceutical items. The Act also requires that these pharmaceutical items be listed in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), detailing the ‘listed drug’, ‘form’, ‘manner of administration’, ‘maximum quantity or number of units’, and ‘maximum number of repeats’ for a pharmaceutical item. The Act imposes obligations on parties and entities it governs, ensuring that early supplies of specified pharmaceutical items do not incur PBS Safety Net entitlements. Early supplies are defined as those made within 20 days after the day of a previous supply to the person of the same pharmaceutical benefit, another pharmaceutical benefit that has the same pharmaceutical item, or another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit, provided the supply does not result from a prescription originating from a hospital (subsection 84AAA(1)). The instrument specifies these pharmaceutical items under subsection 84AAA(2) and may refer 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 (subsection 84AAA(3)). There are no specific offences, penalties, or civil/criminal consequences mentioned for breach of this legislative instrument. However, non-compliance with the Act’s provisions regarding pharmaceutical benefits and the PBS could potentially lead to administrative actions or other legal consequences as determined by the relevant authorities. The Act’s overarching aim is to ensure that the PBS operates effectively to provide access to necessary medications while managing costs and entitlements appropriately.

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