National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2014 (No. 2) - specification under subsection 84AAA(2) (No. PB 34 of 2014)

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 2014 (No. 2) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 34 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) is to add one new pharmaceutical item, delete one form and strength of an existing pharmaceutical item and remove a pharmaceutical item which has been de-listed.

 

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 sapropterin in the form tablet (soluble) containing sapropterin hydrochloride 100 mg.  Schedule 1 is further amended by removing the drug pergolide, which has been de-listed; and verapamil in the form tablet containing verapamil hydrochloride 120 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 May 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. 2) – specification under subsection 84AAA(2)

(PB 34 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. 2)  – 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. 2) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which specifies the pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This amendment was introduced to address the need to update the list of pharmaceutical items, including adding new items, removing de-listed items, and deleting certain forms and strengths of existing items. The instrument was made under subsection 84AAA(2) of the National Health Act 1953, with the authority to specify pharmaceutical items for the purposes of the Act coming from subsection 84AAA(1). The policy objective, as recommended by the Pharmaceutical Benefits Advisory Committee, was to ensure that decisions about subsidised access to medicines on the PBS are evidence-based and aligned with human rights obligations. 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 of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The PBS is a benefit scheme that provides for subsidised access by patients to medicines, thereby advancing this human right. The role of the Pharmaceutical Benefits Advisory Committee in making recommendations ensures that the decisions about which pharmaceutical items are included in the instrument are evidence-based and contribute to the protection of human rights. The compatibility of this legislative instrument with human rights was confirmed through the scrutiny process outlined in the Human Rights (Parliamentary Scrutiny) Act 2011.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 2) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) to modify the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements do not apply for early supplies. This legislative instrument applies to pharmaceutical benefits supplied under the National Health Act 1953, specifically those that meet the criteria for early supply, which are defined by the Act as supplies made within 20 days after a previous supply of the same or a similar pharmaceutical benefit, excluding supplies resulting from hospital prescriptions. The amendment adds sapropterin in the form of a soluble tablet containing sapropterin hydrochloride 100 mg to the list, removes pergolide, which has been de-listed, and eliminates verapamil in the form of a tablet containing verapamil hydrochloride 120 mg. This amendment applies nationally within Australia and is enacted under the authority of the National Health Act 1953, which empowers the Minister to specify pharmaceutical items through legislative instruments. The Pharmaceutical Benefits Advisory Committee (PBAC), which includes representatives from various healthcare-related professions and interests, recommended these changes to the list of pharmaceutical items.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 2) – specification under subsection 84AAA(2) (PB 34 of 2014) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). The primary changes include adding sapropterin in the form of a tablet (soluble) containing sapropterin hydrochloride 100 mg, removing the drug pergolide due to its de-listing, and deleting verapamil in the form of a tablet containing verapamil hydrochloride 120 mg (sections 1(1) and 1(2)). These changes pertain to pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies, provided that the conditions outlined in subsection 84AAA(1) of the National Health Act 1953 are satisfied. Under this Act, the Pharmaceutical Benefits Advisory Committee (PBAC) is tasked with recommending pharmaceutical items to the Minister for inclusion in the instrument (subsection 101(3AA)). The PBAC, which is independent of government, comprises members from various relevant fields such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. The PBAC's recommendations ensure that decisions regarding access to medicines on the PBS are evidence-based, thereby advancing the right to the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights. The obligations imposed by this amendment on parties and entities governed by the Act include adhering to the specified conditions for early supply of pharmaceutical benefits and ensuring that these supplies do not result from prescriptions originating from a hospital (subsection 84AAA(1)). Additionally, entities must comply with the criteria for PBS Safety Net entitlements as amended by the changes to PB 30 of 2009. Breach of the provisions outlined in this Act can lead to civil and criminal consequences. For instance, supplying a pharmaceutical benefit that is specified in the instrument within the prohibited timeframe without meeting the conditions set out in subsection 84AAA(1) could result in the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements not applying for that supply. The maximum penalties for such breaches are not explicitly stated in the Act, but they would typically involve fines or other sanctions as prescribed by the relevant legislation. These measures are in place to ensure compliance and maintain the integrity of the PBS.

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