National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 3) (PB 29 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. 3)

PB 29 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 drugs daclizumab; nintedanib; and tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat.  The Schedule is aso amended by the deletion of acyclovir in the form tablet
800 mg; the listed drug gestrinone; and verapamil in the forms: capsule containing verapamil hydrochloride 160 mg (sustained release), and capsule containing verapamil hydrochloride 240 mg (sustained release).

 

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 PBS Access and Sustainability Package includes measures relating to the Sixth Community Pharmacy Agreement between the Commonwealth of Australia and the Pharmacy Guild of Australia and the Strategic Agreement with the Generic Medicines Industry Association (now known as the Generic and Biosimilar Medicines Association).  The measures were negotiated following consultations during the first half of 2015 by the Minister for Health and the Department of Health with stakeholders from the pharmaceutical sector including industry, consumer, medical, pharmacist and wholesaler groups.  Organisations represented included Medicines Australia, the Generic Medicines Industry Association, the Consumers Health Forum, NPS Medicine Wise, the Australian Medical Association, the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia, the Society of Hospital Pharmacists of Australia, and the National Pharmaceutical Services Association.

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 May 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. 3)

(PB 29 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. 3) 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.

Louise Clarke
First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 3) was enacted to amend the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015 under subsection 84AAA(2) of the National Health Act 1953. This instrument aims to address the problem of early supply of certain pharmaceutical items which were not subject to Pharmaceutical Benefits Scheme (PBS) safety net entitlements, ensuring these items are appropriately specified. The instrument was made by the Minister for Health under the authority granted by the Act and underwent consultation with relevant stakeholders including the Pharmaceutical Benefits Advisory Committee (PBAC), which provides recommendations to the Minister about the pharmaceutical benefits to be included. The objective of this amendment is to maintain the integrity of the PBS by correctly specifying which pharmaceutical items qualify for early supply exemptions. The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 3) was introduced to refine the list of pharmaceutical items that are excluded from PBS safety net entitlements when supplied early. The instrument amends the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015 by adding drugs such as daclizumab, nintedanib, and tenofovir alafenamide with emtricitabine, elvitegravir, and cobicistat, while removing others like acyclovir in the form tablet 800 mg, gestrinone, and certain forms of verapamil. This amendment ensures that the PBS continues to operate efficiently and fairly, reflecting current medical needs and evidence-based recommendations from the PBAC. The changes were made following extensive consultation with industry and health sector stakeholders to ensure they align with the policy objectives of the PBS.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 3) 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 legislative instrument applies to pharmaceutical items specified in the amendment, affecting entities such as pharmaceutical manufacturers, wholesalers, pharmacies, and patients who access the PBS. The geographic scope of the Act is national, as it pertains to the Commonwealth of Australia. The amendment includes the addition of new pharmaceutical items such as daclizumab, nintedanib, and tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat, while removing others like acyclovir in the form tablet 800 mg, gestrinone, and specific forms of verapamil. This amendment is made under the authority of subsection 84AAA(2) of the National Health Act 1953, allowing the Minister to specify pharmaceutical items by legislative instrument. The changes are intended to ensure the PBS operates effectively and sustainably, providing appropriate access to pharmaceuticals while managing costs.

Key Provisions

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 3) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 by specifying the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. The primary provision of the Amendment Instrument is found in Schedule 1, which lists the pharmaceutical items affected by these changes. Specifically, the listed drugs daclizumab, nintedanib, and tenofovir alafenamide with emtricitabine, elvitegravir, and cobicistat are added to the list of pharmaceutical items, while acyclovir in the form tablet 800 mg, gestrinone, and verapamil in certain forms are removed (subsection 84AAA(2), Schedule 1). The Act imposes several obligations on the parties it governs. The Minister is required to specify, by legislative instrument, pharmaceutical items that will not attract PBS safety net entitlements for early supplies (subsection 84AAA(2)). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role by making recommendations to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits (subsection 101(3AA)). Additionally, the Act specifies that a supply of a pharmaceutical benefit is considered an early supply if it is made within 20 days after a previous supply of the same or equivalent pharmaceutical benefit, and it does not result from a prescription originating from a hospital (subsection 84AAA(1)). Breach of the provisions set out in the Amendment Instrument can lead to various consequences. While the text does not explicitly state penalties, non-compliance with the specified conditions for early supply could result in the pharmaceutical benefit not being subsidised under the PBS safety net. This may lead to patients incurring higher costs for these pharmaceuticals. Furthermore, any actions that contravene the requirements of the National Health Act 1953 could potentially result in additional civil or criminal liabilities, although these are not detailed within the Amendment Instrument itself.

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