National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2018 (No. 4) (PB 32 of 2018)

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 2018 (No.4)

PB 32 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.

 

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

 

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: Balsalazide in the form Capsule containing balsalazide sodium 750 mg with a maximum quantity of 280; and, the listed drug Brivaracetam in five different forms;
  • the deletion of the listed drug Flutamide in the form tablet 250 mg tablet, 30; and
  • the deletion of the listed drug Risedronic acid and calcium with colecalciferol.

 

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 May 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. 4)

(PB 32 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. 4) 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. 4) 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. Enacted under subsection 84AAA(2) of the National Health Act 1953, this amendment ensures that the instrument remains consistent with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments include adding Balsalazide and Brivaracetam in various forms to the list, and removing Flutamide and Risedronic acid and calcium with colecalciferol. The Pharmaceutical Benefits Advisory Committee (PBAC) played a key role in providing advice on the changes, ensuring that the decisions regarding which drugs and medicinal preparations are available as pharmaceutical benefits are evidence-based and contribute to the progressive realisation of the right to the highest attainable standard of physical and mental health. The instrument, which is a legislative instrument for the purposes of the Legislation Act 2003, was introduced to address gaps in the existing list of pharmaceutical items, ensuring that the PBS remains effective and aligned with current medical needs and practices. It reflects ongoing consultation and recommendations from the PBAC and commenced on 1 May 2018. The amendments are minor and machinery in nature, ensuring compatibility with human rights as they assist in advancing the right to health by providing subsidised access to medicines.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2018 (No. 4) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015, specifying the pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This instrument applies to entities and individuals involved in the supply of pharmaceutical benefits, including pharmaceutical manufacturers, suppliers, and pharmacies, as well as patients who may benefit from the specified pharmaceutical items. The instrument's geographic reach is national, aligning with the Australian Commonwealth's legislative jurisdiction under the National Health Act 1953. The amendments reflect updates made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring consistency in the regulation of pharmaceutical benefits. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising on these amendments, ensuring that decisions are evidence-based and in line with the highest attainable standard of physical and mental health. The instrument is compatible with human rights, supporting the right to access health services and medicines as recognised in international human rights instruments.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2018 (No. 4) (PB 32 of 2018) focus on the amendment of the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015 (PB 120 of 2015). Section 1 of the instrument specifies the changes to the list of pharmaceutical items for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This includes the addition of new drugs, such as Balsalazide in the form of a Capsule containing balsalazide sodium 750 mg with a maximum quantity of 280, and Brivaracetam in five different forms. It also involves the deletion of certain drugs, such as Flutamide in the form of a tablet 250 mg tablet, 30, and Risedronic acid and calcium with colecalciferol. These changes reflect the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The obligations and requirements imposed by this Act on the parties or entities it governs include ensuring that pharmaceutical items listed in the amended instrument are correctly identified and managed in accordance with the specified criteria. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on the pharmaceutical items to be specified in the instrument, ensuring that the recommendations are evidence-based and aligned with the progressive realisation of the right to the highest attainable standard of physical and mental health. The PBAC, which comprises members from various relevant fields, ensures that the decisions made are comprehensive and reflect the interests of all stakeholders, including consumers, health economists, and representatives from the pharmaceutical industry. There are no specific offences, penalties, or civil/criminal consequences mentioned in the text for breaches of the provisions in this legislative instrument. However, any failure to comply with the requirements could potentially result in the pharmaceutical items being subject to PBS Safety Net entitlements for early supplies, which could have financial implications for both the suppliers and the beneficiaries of the PBS. The instrument is designed to ensure that the PBS continues to provide efficient and effective access to necessary medications while managing costs effectively.

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