National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2014 (No. 5) - specification under subsection 84AAA(2) (No. PB 69 of 2014)

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2014 (No. 5) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 69 of 2014

 

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 removing one form of an existing 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 removing the drug Oxprenolol in the form tablet containing oxprenolol hydrochloride 20 mg.

 

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 September 2014.

 

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 2014 (No. 5) – specification under subsection 84AAA(2)

(PB 69 of 2014)

 

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 2014 (No. 5)  – 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.

 

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 5) – specification under subsection 84AAA(2) (PB 69 of 2014) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). Enacted by the Australian Parliament, this amendment responds to the need to update the list of pharmaceutical items specified in the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the amendment to ensure the Pharmaceutical Benefits Scheme (PBS) remains evidence-based and efficient, thereby supporting the progressive realisation of the right to the highest attainable standard of physical and mental health. This minor and machinery amendment removes the drug Oxprenolol in the form of a tablet containing oxprenolol hydrochloride 20 mg from the list of pharmaceutical items for which PBS Safety Net entitlements will not apply for early supplies. This adjustment is aimed at refining the administration of pharmaceutical benefits within the PBS framework.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 5) is an amendment made under the National Health Act 1953, which governs the regulation of pharmaceutical benefits and the Pharmaceutical Benefits Scheme (PBS) in Australia. The instrument modifies the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by removing the pharmaceutical item Oxprenolol in the form of a tablet containing oxprenolol hydrochloride 20 mg from the list of items for which PBS Safety Net entitlements will not apply for early supplies. The amendment applies to all individuals and entities involved in the supply of pharmaceutical benefits, particularly those within the PBS framework, and affects the transactions and conduct related to the early supply of specified pharmaceutical items. The instrument has a national reach, as it operates under the Commonwealth jurisdiction of the National Health Act. There are no specific exclusions or exemptions detailed within the instrument itself, although the scope of its application is defined by the conditions outlined in the Act. The amendment is expected to take effect from 1 September 2014, and its implementation may be further detailed through subordinate instruments as necessary.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 5) – specification under subsection 84AAA(2) (PB 69 of 2014) involve the removal of Oxprenolol in the form tablet containing oxprenolol hydrochloride 20 mg from the list of pharmaceutical items specified in the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). This change is specified in Schedule 1 of the Principal Instrument, which amends PB 30 of 2009 (subsection 84AAA(2)) to exclude Oxprenolol from the list of pharmaceutical benefits for which PBS Safety Net entitlements will not apply for early supplies. This means that if the criteria under subsection 84AAA(1) are met, a supply of this pharmaceutical item will now be considered an early supply of a specified pharmaceutical benefit. The Act imposes several obligations on the parties it governs. Firstly, it 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). The PBAC, which includes representatives from various health-related fields, must ensure that decisions regarding the inclusion of pharmaceutical items are evidence-based. Secondly, the Act mandates that the Minister must specify pharmaceutical items by legislative instrument for the purposes of paragraph 84AAA(1)(b) of the Act, ensuring that the list of pharmaceutical items eligible for early supply under the PBS is updated as necessary. Finally, the Act stipulates 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. In terms of consequences for breach, the Act does not specify any specific offences, penalties, or civil/criminal consequences for non-compliance with the provisions of the instrument. However, any failure to comply with the requirements set out in the Act could potentially lead to administrative actions or other legal consequences. For instance, if a pharmaceutical benefit is supplied without adhering to the conditions outlined in subsection 84AAA(1), it could result in the pharmaceutical item being considered ineligible for the PBS Safety Net entitlements for early supplies. While the Act does not detail specific penalties, any such breaches could have financial implications for suppliers and patients alike, particularly in terms of the availability and cost of pharmaceutical benefits under the PBS.

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