National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2015 (No. 5) - specification under subsection 84AAA(2) (PB 57 of 2015)

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2015 (No. 5) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 57 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 esomeprazole in the forms capsule (enteric) 20 mg (as magnesium); and capsule (enteric)
40 mg (as magnesium).

 

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 July 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. 5) – specification under subsection 84AAA(2)

(PB 57 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. 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 2015 (No. 5) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which specifies pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This legislative instrument was introduced to address the need to add a specific pharmaceutical item to the list of those for which PBS Safety Net entitlements will not apply in the case of early supplies. Enacted under the authority of the National Health Act 1953, the primary objective of this amendment is to ensure that certain pharmaceutical items are excluded from the PBS Safety Net when supplied early, thereby facilitating better access to essential medications without the constraint of PBS Safety Net thresholds. This instrument was made under subsection 84AAA(2) of the National Health Act 1953 by the Minister for Health, in line with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent body comprising experts from various health-related fields, ensures that decisions regarding the inclusion of pharmaceutical items in the PBS are evidence-based. This amendment, being minor and machinery in nature, aims to enhance the efficiency and accessibility of the PBS by ensuring that specific medications are available to patients without the delays associated with PBS Safety Net thresholds.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 5) – specification under subsection 84AAA(2) amends 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 is made under subsection 84AAA(2) of the National Health Act 1953 and involves adding a specific pharmaceutical item to the list of items for which early supply does not incur PBS Safety Net entitlements. The amendment applies to supplies of pharmaceutical benefits made under the Act, and it is relevant to entities and individuals involved in the supply and administration of pharmaceutical benefits. The amendment extends to all Commonwealth jurisdictions where the National Health Act applies and is limited to the specific pharmaceutical items listed in the amendment, namely esomeprazole in the forms capsule (enteric) 20 mg and capsule (enteric) 40 mg. The amendment does not specify any exclusions or thresholds beyond the mentioned pharmaceutical items and conditions for early supply. The Pharmaceutical Benefits Advisory Committee has recommended these changes, ensuring that decisions about pharmaceutical benefits are evidence-based and aligned with the principles of the PBS.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 5) – specification under subsection 84AAA(2) (PB 57 of 2015) include the amendments to the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009). This amendment involves the addition of specific pharmaceutical items, namely esomeprazole in the forms capsule (enteric) 20 mg (as magnesium) and capsule (enteric) 40 mg (as magnesium) (subsection 84AAA(2)). These changes ensure that certain pharmaceutical benefits will not be subject to Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies (subsection 84AAA(1)). The obligations and requirements imposed by this Act on the parties and entities it governs include ensuring that the amended list of pharmaceutical items (PB 30 of 2009) is adhered to in the supply of pharmaceutical benefits. This means that supplies of the specified pharmaceutical items (esomeprazole in the forms mentioned) within 20 days of a previous supply to the same person will be considered early supplies, and PBS Safety Net entitlements will not apply (subsection 84AAA(1)(b)). The Pharmaceutical Benefits Advisory Committee (PBAC) is also required to make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2) (subsection 101(3AA)). In terms of offences, penalties, or civil/criminal consequences for breach, the Act does not explicitly state any specific penalties for breaches of the provisions concerning early supply of pharmaceutical benefits. However, non-compliance with the Act or the regulations made under it may result in enforcement actions by the relevant authorities, such as the Therapeutic Goods Administration (TGA) or other health regulatory bodies. The severity of penalties would depend on the nature and extent of the breach, and could include fines, corrective actions, or other administrative measures as deemed appropriate by the relevant authorities.

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