National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 1) (PB 2 of 2021)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00075 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2021 (No. 1)

PB 2 of 2021

 

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) (the Principal Instrument).

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 pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection 84AAA(2); and

(b)           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; 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 this instrument provides for the addition of a form of the listed drug trihexyphenidyl to the list of pharmaceutical items that are in pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.  This change is summarised, by subject matter, in the Attachment.

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 February 2021.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2021 (No. 1)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 1) and may also be cited as PB 2 of 2021.

Section 2 Commencement

This section provides that the Instrument commences on 1 February 2021.

Section 3 Amendment of National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015)

This section provides that Schedule 1 amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015).

Schedule 1 Amendments

The amendment in Schedule 1 involves the addition of a form of a listed drug to the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme safety net entitlements will not apply for early supplies.  This change is summarised below.

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS—EARLY SUPPLY) INSTRUMENT 2015 MADE BY THIS INSTRUMENT

Forms Added

Listed Drug

Form

Trihexyphenidyl

Tablet containing trihexyphenidyl hydrochloride 2 mg (USP)


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 2021 (No. 1)

(PB 2 of 2021)

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 2021 (No. 1) 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.

The amendment in Schedule 1 involves the addition of a form of a listed drug to the list of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme 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.

 

 

 

 

Thea Connolly

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 2021 (No. 1) (PB 2 of 2021) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015) under the authority of subsection 84AAA(2) of the National Health Act 1953. This legislative instrument addresses the need to update the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, thereby ensuring that the regulations align with changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The instrument was enacted by the Minister for Health under the provisions of the National Health Act 1953, with the overarching policy objective of maintaining the integrity and effectiveness of the PBS in providing timely and appropriate access to medicines. This amendment reflects the involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) in providing expert recommendations on the items to be specified in the legislative instrument. By updating the list of pharmaceutical items, the amendment aims to ensure that the PBS continues to function efficiently, providing necessary medications while preventing over-supply and managing costs effectively. The changes introduced by this instrument are of a minor and machinery nature, facilitating the ongoing administration of the PBS in line with contemporary health needs and regulatory standards.

Scope and Application

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 1) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 to specify pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This legislative instrument applies to pharmaceutical items specified under the National Health Act 1953, particularly targeting early supplies of pharmaceutical benefits within 20 days of a previous supply of the same or equivalent pharmaceutical items. The amendment involves the addition of a form of the listed drug trihexyphenidyl to the list of pharmaceutical items affected. The amendment does not specify exclusions or thresholds beyond those defined in the principal instrument and the Act itself, but it relies on the Pharmaceutical Benefits Advisory Committee (PBAC) recommendations for its specifications. The changes reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the legislative instrument remains aligned with broader pharmaceutical benefit listings. This legislative instrument is compatible with human rights, as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring evidence-based decisions on the PBS.

Key Provisions

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2021 (No. 1) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015) by specifying additional pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies (sections 3 and Schedule 1). The key amendment involves the addition of a specific form of the drug trihexyphenidyl to the list of pharmaceutical items affected. This change ensures that certain early supplies of specified pharmaceutical benefits do not attract PBS safety net entitlements, in alignment with the broader objectives of the National Health Act 1953. The Act imposes specific obligations on entities involved in the supply of pharmaceutical benefits. For example, suppliers must ensure that any early supply of the specified pharmaceutical benefits complies with the conditions outlined in subsection 84AAA(1) of the Act (subsection 84AAA(2)). This means that any supply within 20 days of a previous supply of the same or a similar pharmaceutical benefit to the same person must be accounted for under the amended provisions. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) has a statutory role in making recommendations to the Minister regarding which pharmaceutical items should be specified in the instrument (subsection 101(3AA)). There are no explicit offences, penalties, or civil/criminal consequences outlined in the explanatory statement for breaches of the amended provisions. However, non-compliance with the Act's requirements regarding early supplies of pharmaceutical benefits could potentially lead to administrative actions or financial implications as determined by the relevant authorities. The focus of the amendments is to clarify and specify the conditions under which certain pharmaceutical items will not attract PBS safety net entitlements, rather than imposing new penalties for non-compliance.

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