National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2016 (No. 7) (PB 75 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01297 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2016 (No. 7)

PB 75 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).

 

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).

 

Changes to PB 120 of 2015 made by this instrument

Schedule 1 of the Principal Instrument is amended by the addition of exenatide in the form  injection (modified release) 2 mg single dose pre-filled pen.

 

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 Medicine Wise, 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 September 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. 7)
(PB 75 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. 7) 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. 7) was enacted to address the issue of early supplies of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS), ensuring that PBS Safety Net entitlements do not apply to these early supplies. This legislative instrument amends the National Health (Pharmaceutical Benefits—early supply) Instrument 2015, specifying the pharmaceutical items for which early supply does not attract PBS Safety Net entitlements. The instrument was made under the authority of the National Health Act 1953, with the policy objective of maintaining the integrity of the PBS by ensuring appropriate application of Safety Net entitlements. The amendment process involved consultations with various stakeholders from the pharmaceutical sector, including industry, consumer, medical, pharmacist, and wholesaler groups, to ensure that the changes align with the broader objectives of the PBS Access and Sustainability Package. The Pharmaceutical Benefits Advisory Committee (PBAC) played a key role in providing recommendations based on evidence to ensure that decisions about access to medicines are well-founded.

Scope and Application

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2016 (No. 7) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015, which specifies pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This instrument is made under the authority of subsection 84AAA(2) of the National Health Act 1953, allowing the Minister to specify pharmaceutical items by legislative instrument. The amendment adds exenatide in the form injection (modified release) 2 mg single dose pre-filled pen to the list of pharmaceutical items subject to early supply rules, thereby affecting the supply of these pharmaceutical benefits within the PBS. The amendment applies nationally, impacting patients, pharmacists, and pharmaceutical suppliers across Australia, while ensuring that the Pharmaceutical Benefits Advisory Committee continues to play a crucial role in recommending pharmaceutical items for inclusion in such instruments. The application of this instrument is comprehensive, affecting all entities and persons involved in the supply and administration of pharmaceutical benefits under the PBS. It does not apply to supplies originating from hospitals or to repatriation pharmaceutical benefits under certain veterans' and military acts. This amendment is part of the broader measures within the PBS Access and Sustainability Package, reflecting ongoing consultations with various stakeholders, including industry groups, consumer organisations, and professional associations. The instrument is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health by ensuring access to necessary medications, thereby advancing the objectives of the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2016 (No. 7) (PB 75 of 2016) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015) to update the list of pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies (subsection 84AAA(2) and (3) of the National Health Act 1953 (the Act)). Specifically, it adds exenatide in the form injection (modified release) 2 mg single dose pre-filled pen to the list of specified pharmaceutical benefits (Schedule 1 of the Principal Instrument). This amendment means that early supplies of this pharmaceutical item will be subject to the same provisions as outlined in subsection 84AAA(1) of the Act. The Act imposes several obligations and requirements on parties and entities involved in the supply of pharmaceutical benefits. For instance, under subsection 84AAA(1)(a), a supply of a pharmaceutical benefit is considered an early supply if it is made within 20 days after a previous supply to the same person of the same pharmaceutical benefit or another pharmaceutical benefit with the same pharmaceutical item or that is Schedule equivalent. Additionally, the supply must not result from a prescription originating from a hospital. Subsection 84AAA(2) mandates that the Minister may specify, by legislative instrument, the pharmaceutical items for which the PBS safety net entitlements will not apply in the case of early supplies. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role by making recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. Breaches of the provisions outlined in the Act may lead to various consequences. Although specific penalties are not detailed in the explanatory statement, breaches of provisions concerning the PBS can typically result in civil or criminal penalties, depending on the nature and severity of the breach. Such penalties may include fines, imprisonment, or both, as prescribed by relevant legislation. It is essential for parties involved in the supply of pharmaceutical benefits to comply with the Act to avoid these consequences. The legislative instrument also notes that 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. This ensures that any changes or revocations are legally sound and authorised under the appropriate legislative framework. The involvement of the PBAC in the process underscores the importance of expert advice and evidence-based decision-making in matters related to the PBS.

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