National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2015 (No. 9) - specification under subsection 84AAA(2) (PB 103 of 2015)

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 2015 (No. 9) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 103 of 2015

 

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 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by: adding one pharmaceutical item.

 

PB 30 of 2009 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.

 

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) (currently PB 30 of 2009).

 

Changes to PB 30 of 2009 made by this instrument

Schedule 1 of the Principal Instrument (PB 30 of 2009) is amended by the addition of the listed drug ponatinib.

 

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 30 of 2009 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 30 of 2009.

 

Consultation

The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the pharmaceutical items referred to in this amendment be included in an instrument under subsection 84AAA(2).

 

PBAC is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. 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 PBAC.

 

This amendment is minor and machinery in nature.

 

General

This Instrument commences on 1 November 2015.

 

This Instrument is a legislative instrument for the purposes of the Legislative Instrument 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 2015 (No. 9) – specification under subsection 84AAA(2)

(PB 103 of 2015)

 

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
2015 (No. 9) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) 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.

 

 

Paul Creech

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 9) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which details the pharmaceutical items that fall under the Pharmaceutical Benefits Scheme (PBS) for which PBS Safety Net entitlements will not apply for early supplies. Enacted under the authority of subsection 84AAA(2) of the National Health Act 1953, this legislative instrument aims to address the issue of early supply of pharmaceutical benefits, ensuring that certain medications do not trigger PBS Safety Net entitlements when supplied within a short timeframe after a previous supply. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended this amendment, which was introduced to enhance the efficiency and appropriateness of pharmaceutical supply within the PBS framework, thereby better aligning with the overarching policy objective of providing subsidised access to necessary medicines in a timely manner.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 9) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by adding a pharmaceutical item to the list of those for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements do not apply for early supplies. This legislative instrument applies to individuals and entities involved in the supply of pharmaceutical benefits within Australia, specifically targeting supplies that meet the criteria of being early supplies as defined under the National Health Act 1953. This includes pharmaceutical benefits that are supplied within 20 days of a previous supply of the same or a similar pharmaceutical item, excluding supplies originating from hospital prescriptions. The amendment specifies the drug ponatinib, ensuring that supplies of this drug will be considered early supplies if the defined conditions are met. The changes made by this instrument are effective from 1 November 2015 and are made under the authority of the National Health Act 1953, with the Pharmaceutical Benefits Advisory Committee providing recommendations that underpin the decision to include the specified pharmaceutical item. This legislative instrument is a minor amendment and does not introduce any new exclusions or exemptions beyond those already specified in existing regulations.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 9) – specification under subsection 84AAA(2) (PB 103 of 2015) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by adding the pharmaceutical item ponatinib to the list of pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies (subsection 84AAA(2)). This addition means that early supplies of the pharmaceutical item ponatinib are not subject to the PBS Safety Net, which is the mechanism that limits the amount that patients have to pay for their medicines (subsection 84AAA(1)). To be classified as an early supply, the pharmaceutical item must be supplied within 20 days after the previous supply of the same item or another item that is the same or Schedule equivalent, and the supply must not result from a prescription originating from a hospital (subsection 84AAA(1)). Under the National Health Act 1953 (the Act), the Minister is authorised to specify pharmaceutical items for the purposes of paragraph 84AAA(1)(b) of the Act by legislative instrument (subsection 84AAA(2)). The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended the inclusion of the pharmaceutical item ponatinib, which has been added by this Instrument. PBAC is independent and includes members with expertise in various relevant fields, ensuring that decisions about subsidised access to medicines on the PBS are evidence-based. The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 9) – specification under subsection 84AAA(2) is a minor and machinery amendment that does not require an express power to revoke or vary PB 30 of 2009, but rather relies on subsection 33(3) of the Acts Interpretation Act 1901 for such purposes (subsection 33(3)). Failure to comply with the provisions of the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 9) – specification under subsection 84AAA(2) could potentially result in civil or criminal penalties, although specific offences, penalties, or consequences are not detailed in the Explanatory Statement. It is important to note that the Act itself provides various penalties for non-compliance with its provisions, which may include fines or imprisonment depending on the nature and severity of the breach. The addition of ponatinib to the list of pharmaceutical items exempt from PBS Safety Net entitlements for early supplies does not introduce new offences but ensures that certain pharmaceutical supplies are managed in accordance with the legislative requirements set out in the Act.

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