National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2018 (No. 2) (PB 15 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00164 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2018 (No.2)

PB 15 of 2018

 

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 deletion of Risedronic acid and calcium in the form Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate).

 

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.  The Committee also includes a pharmaceutical industry nominee.  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 March 2018.

 

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 2018 (No. 2)

(PB 15 of 2018)

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 2018 (No. 2) 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.

Lisa La Rance
Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2018 (No. 2) was enacted to amend the National Health (Pharmaceutical benefits—early supply) Instrument 2015, thereby addressing issues related to the Pharmaceutical Benefits Scheme (PBS) safety net entitlements for early supplies of specified pharmaceutical items. This instrument was developed under subsection 84AAA(2) of the National Health Act 1953 and was enacted by the Australian Parliament. The policy objective of this amendment is to refine the list of pharmaceutical items for which PBS safety net entitlements do not apply for early supplies, thereby enhancing the efficiency and effectiveness of the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) played a crucial role in this amendment process, providing expert recommendations on the pharmaceutical items to be specified. This amendment, considered minor and machinery in nature, ensures that the PBS continues to provide subsidised access to medicines while maintaining the integrity of the safety net entitlements. The instrument is designed to be compatible with human rights by advancing the right to the highest attainable standard of physical and mental health through the provision of accessible and evidence-based pharmaceutical benefits.

Scope and Application

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2018 (No. 2) is a legislative instrument made under the National Health Act 1953. It amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015, which details the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. The legislation applies to persons who receive pharmaceutical benefits and the entities that supply these benefits, including pharmacists and suppliers under the PBS. The Act applies nationally across Australia and involves the modification of regulations concerning the timing of pharmaceutical supplies to ensure they comply with the specified criteria for early supply. The instrument excludes supplies resulting from prescriptions originating from hospitals and specifically modifies the list of pharmaceutical items subject to early supply regulations by deleting Risedronic acid and calcium in the specified form from the list. The instrument's application may be further extended or restricted through subordinate instruments as necessary.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2018 (No. 2) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015, specifically removing Risedronic acid and calcium from the list of pharmaceutical items for which PBS Safety Net entitlements will not apply for early supplies (subsection 84AAA(2)). The definition of early supply remains unchanged: a supply is considered early if it occurs within 20 days of the previous supply of the same or a similar pharmaceutical benefit (subsection 84AAA(1)). This definition includes circumstances where the supply is made under certain repatriation schemes or military compensation provisions, but excludes supplies resulting from hospital prescriptions (subsection 84AAA(1)(c) and (d)). The amendment imposes obligations on suppliers and patients to ensure compliance with the new regulations concerning early supply of specified pharmaceuticals. Suppliers must verify that the supply does not fall within the parameters of an early supply, while patients must be aware that they may be subject to additional costs if they receive an early supply of the specified pharmaceutical items. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising the Minister on the pharmaceutical items to be specified under this instrument, ensuring that decisions about pharmaceutical benefits are evidence-based and aligned with public health needs. Breaches of the provisions outlined in the instrument may result in financial penalties for suppliers who provide early supplies of the specified pharmaceutical items. Although the specific penalties are not detailed in the explanatory statement, it is understood that the National Health Act 1953 provides for penalties for non-compliance, which may include fines. Furthermore, patients who receive early supplies may incur additional costs, as the PBS Safety Net entitlements would not apply. The amendment does not specify criminal penalties for breaches but implies that such breaches could lead to civil consequences, including financial liability for the additional costs of the pharmaceuticals. In summary, the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2018 (No. 2) aims to refine the list of pharmaceutical items exempt from PBS Safety Net entitlements for early supplies. This amendment imposes specific obligations on suppliers and patients to adhere to the new regulations, with potential financial penalties for non-compliance. While the precise penalties are not explicitly stated, the Act provides a framework for enforcing compliance through financial sanctions.

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