National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2016 (No. 4) (PB 32 of 2016)

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 2016 (No. 4)

PB 32 of 2016

 

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) by adding two and deleting two pharmaceutical items.

 

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.

 

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 120 of 2015 made by this instrument

Schedule 1 of the Principal Instrument (PB 120 of 2015) is amended by the addition of esomeprazole and clarithromycin and amoxycillin in the form pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate); and the listed drug paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin.  Schedule 1 is further amended by the deletion of auranofin in the form capsule 3 mg and the deletion of tiludronic acid which has been delisted.

 

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 PBS Access and Sustainability Package includes measures relating to the Sixth Community Pharmacy Agreement between the Commonwealth of Australia and the Pharmacy Guild of Australia and the Strategic Agreement with the Generic Medicines Industry Association (now known as the Generic and Biosimilar Medicines Association).  The measures were negotiated following consultations during the first half of 2015 by the Minister for Health and the Department of Health with stakeholders from the pharmaceutical sector including industry, consumer, medical, pharmacist and wholesaler groups.  Organisations represented included Medicines Australia, the Generic Medicines Industry Association, the Consumers Health Forum, NPS MedicineWise, the Australian Medical Association, the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia, the Society of Hospital Pharmacists of Australia, and the National Pharmaceutical Services Association.

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.  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 May 2016.

 

This Instrument is a legislative instrument for the purposes of the Legislation 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 2016 (No. 4)
(PB 32 of 2016)

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 2016 (No. 4) 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.

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.

Penny Shakespeare
First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2016 (No. 4) was enacted to amend the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015 by adding and deleting certain pharmaceutical items. This instrument was introduced to address the need for precise regulation over early supplies of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS), ensuring that the PBS safety net entitlements are correctly applied. The enacting body was the Parliament of Australia, and the policy objective of this legislative instrument is to maintain the integrity and effectiveness of the PBS by ensuring that the safety net entitlements do not apply for early supplies of specified pharmaceutical benefits. This is achieved by specifying which pharmaceutical items are subject to these conditions, thus aligning with the broader goals of the National Health Act 1953 to provide access to affordable and effective medications.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2016 (No. 4) amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015 to update the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This amendment applies to pharmaceutical items specified in the instrument, which are supplied under the National Health Act 1953, and affects entities and individuals involved in the supply and administration of these items. The changes made by this instrument are minor and relate to the addition of specific pharmaceutical items and the deletion of others that have been delisted. The amendment applies across the Commonwealth of Australia and is effective from 1 May 2016. The instrument does not specify exclusions, exemptions, or thresholds beyond those already outlined in the National Health Act 1953 and the associated instruments. The application of the Act is extended and refined through the subordinate instrument, ensuring that the criteria for early supply of specified pharmaceutical benefits are clearly defined and updated as necessary.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2016 (No. 4) primarily amends the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015 by adding two pharmaceutical items and deleting two others. These changes specify which pharmaceutical benefits will not attract Pharmaceutical Benefits Scheme (PBS) safety net entitlements when supplied as early supplies. According to subsection 84AAA(1) of the National Health Act 1953, an early supply occurs when a pharmaceutical benefit is supplied within 20 days of a previous supply to the same person of the same or equivalent pharmaceutical benefit, unless the supply originates from a hospital prescription (subsection 84AAA(1)(c)). The specific pharmaceutical items are outlined in subsection 84AAA(2), which allows the Minister to specify these items through a legislative instrument. The Act imposes several obligations on the parties involved. Firstly, it requires that any supply of the specified pharmaceutical items within 20 days of a previous supply to the same person be recognised as an early supply. Additionally, entities such as hospitals and pharmacies must adhere to the criteria set out in the Act to ensure that the PBS safety net entitlements do not apply to these early supplies. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role by providing recommendations to the Minister about which pharmaceutical items should be specified in the legislative instrument. This ensures that decisions about the inclusion or exclusion of pharmaceutical items are evidence-based and align with the objectives of the PBS. Violations of the provisions outlined in this legislative instrument can lead to various consequences. For instance, supplying a pharmaceutical benefit within the defined period as an early supply without adhering to the Act's stipulations can result in penalties. The specific penalties are not detailed in the explanatory statement but typically include fines and potential criminal charges for severe breaches. The exact penalties can vary and are generally outlined in the relevant sections of the National Health Act 1953 and other associated legislation. Ensuring compliance is therefore critical for all parties involved to avoid these repercussions.

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