National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 7) (PB 74 of 2017)

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 2017 (No. 7)

PB 74 of 2017

 

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 2015 (PB 120 of 2015).

 

PB 120 of 2015 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, and to specify the period following previous supply.

 

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).

 

Changes to PB 120 of 2015 made by this instrument

Schedule 1 to the Principal Instrument is amended by the addition of the listed drug brexpiprazole.  The Schedule is further amended by the addition of auranofin in the form capsule 3 mg.

 

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 120 of 2015 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 120 of 2015.

 

Consultation

The involvement of PBAC constitutes a formal and ongoing process of consultation.  The PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.  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 Committee.  The PBAC has provided advice regarding what should be specified in this Instrument.

 

This amendment is minor and machinery in nature.

 

General

This Instrument commences on 1 October 2017.

 

This Instrument is a legislative instrument for the purposes of the Legislation 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 2017 (No. 7)

(PB 74 of 2017)

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 2017 (No. 7) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 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.

Julianne Quaine
First Assistant Secretary (Acting)

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 7) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2015 to update the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This amendment was introduced to address the need for more precise regulations regarding early pharmaceutical supplies under the National Health Act 1953. Enacted under the authority of the Minister for Health pursuant to subsection 84AAA(2) of the Act, the policy objective is to ensure that the PBS provides efficient and equitable access to necessary medications by clearly defining the circumstances under which certain pharmaceutical benefits will not incur safety net charges. The Pharmaceutical Benefits Advisory Committee (PBAC) was consulted in making these amendments, reflecting the instrument's commitment to evidence-based decision-making in healthcare policy.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 7) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015, which specifies the pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This amendment applies to the supply of pharmaceutical benefits to persons, specifically targeting early supplies of specified pharmaceutical items, as defined under the National Health Act 1953. The Act has a national reach, applying across Australia under the Commonwealth jurisdiction. The amendment adds the listed drug brexpiprazole and auranofin in the form capsule 3 mg to the Schedule of the National Health (Pharmaceutical benefits—early supply) Instrument 2015, thus specifying these items as pharmaceutical benefits that will not have PBS safety net entitlements for early supplies if certain conditions are met. The instrument does not specify any exclusions or exemptions, nor does it set thresholds. The Pharmaceutical Benefits Advisory Committee's recommendations underpin the amendment, ensuring evidence-based decisions about which drugs should be available as pharmaceutical benefits.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 7) (PB 74 of 2017) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 (PB 120 of 2015), specifying the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. Specifically, Schedule 1 to the Principal Instrument is amended by the addition of the listed drug brexpiprazole and auranofin in the form capsule 3 mg (subsection 84AAA(2) of the National Health Act 1953 (the Act)). The changes mean that supplies of these pharmaceutical benefits will be considered early supplies if the requirements of subsection 84AAA(1) of the Act are met, which include a supply within 20 days of a previous supply of the same pharmaceutical benefit or an equivalent one, and certain other conditions (subsection 84AAA(1)(a), (b), and (c) of the Act). The Act imposes obligations on parties and entities by setting the criteria for early supplies and ensuring that certain pharmaceutical benefits do not accrue PBS safety net entitlements if supplied within a specific timeframe. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on what should be specified in the instrument (subsection 101(3AA) of the Act). The PBAC is an independent expert body that includes members from various relevant fields such as consumers, health economists, and practising community pharmacists, ensuring that recommendations are evidence-based and comprehensive. Failure to comply with the provisions of the Act regarding early supplies can result in significant consequences. The Act stipulates that certain supplies of pharmaceutical benefits will not accrue PBS safety net entitlements, and non-compliance may lead to financial penalties or other regulatory actions. The maximum penalties for breaches of the Act are not specified in the provided text but generally can include fines and other sanctions depending on the severity and nature of the breach. The human rights implications of this legislative instrument are considered in line with the International Covenant on Economic, Social and Cultural Rights (ICESCR), particularly Articles 2 and 12, which pertain to the right of everyone to the highest attainable standard of physical and mental health. The PBS facilitates the realisation of this right by providing subsidised access to medicines. The involvement of the PBAC ensures that decisions about access to medicines are evidence-based, thereby advancing the protection of human rights through access to necessary pharmaceutical benefits.

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