National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Highly Specialised Drug Program (No. PB 72 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L02301 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 72 of 2008

NATIONAL HEALTH ACT 1953

AMENDMENT TO SPECIAL ARRANGEMENTS MADE UNDER SUBSECTION 100(1)

HIGHLY SPECIALISED DRUGS PROGRAM

 

Purpose and operation

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).

Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:                

(a) who are living in isolated areas; or

(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits: 

(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or

(ii) are inadequate for that medical treatment.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).

The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies. Under subsection 100AA(1)(c) a special pharmaceutical product, for which special arrangements may be made under section 100, includes a drug or medicinal preparation declared under s85(2) of the Act.  Schedule 6 of the declaration made under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.

The Highly Specialised Drugs Program is a set of Arrangements made under subparagraph 100(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge.

This legislative instrument amends the Arrangements made under subparagraph 100(b)(i) which came into effect on 1 December 2007 (PB 92 of 2007).  This instrument amends PB 92 of 2007 by removing the following form, manner of administration and brand of the listed drug Baclofen from the Arrangements made under subparagraph 100(b)(i):  Intrathecal injection 10 mg in 20 mL, injection, Lioresal Intrathecal. The listed drug Baclofen will no longer be supplied in that form and with that manner of administration under these Arrangements.

A provision-by-provision description of the instrument is contained in the Attachment.

This instrument is expressed to commence at 11.59pm on 31 July 2008 and was made on 19 June 2008.  It commences at 11.59pm on 31 July 2008 so that the product may be supplied under the Arrangement until that time, but still permit an exempt item determination to be made before the expiration of 31 July 2008. The exempt item determination will provide for the remaining brand of the form of the listed drug Baclofen that is administered by intrathecal injection to be excluded from statutory price reductions and price disclosure obligations, including those occurring on 1 August 2008.

Consultations

The pharmaceutical company that supplies the ‘Intrathecal injection 10 mg in 20 mL’ form of the listed drug Baclofen was consulted before the delegate of the Minister decided to make the amendments set out in this instrument.  Another form of the listed drug Baclofen, which has the same manner of administration as the form of Baclofen that is affected by this instrument, will continue to be supplied under the section 100 Arrangements set out in PB 92 of 2007. Immediately following commencement of this instrument the remaining form of the listed drug Baclofen that is administered by intrathecal injection may be determined to be exempt under section 84AH.

The Pharmaceutical Benefits Advisory Committee (PBAC) was also consulted in relation to issues relevant to this determination. PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits and about other matters as required under the Act.  Under subsection 101(4AB) of the Act PBAC provides advice to the Minister if it is satisfied of certain matters concerning suitability of pharmaceutical items for use by particular sub-groups.

Advice from PBAC under section 101(4AB) of the Act was considered by the delegate of the Minister who makes decisions under section 84AH concerning exempt items, and under section 100 concerning Special Arrangements, as part of the process which also included consultations with the pharmaceutical company mentioned above.

 

 


ATTACHMENT

Paragraph 1:  provides that this instrument commences at 11.59pm on 31 July 2008.

Paragraph 2:  provides that Schedule 1 amends PB 92 of 2007.

Item 1 of Schedule 1: Removes the following form, manner of administration and brand of the listed drug Baclofen from Schedule 2 of PB 92 of 2007: Intrathecal injection 10 mg in 20 mL, injection, Lioresal Intrathecal.             

 

 

 

Overview

The National Health Act 1953, as amended by the legislative instrument F2008L02301, addresses the need for special arrangements to ensure the availability of highly specialised drugs to patients who cannot be conveniently or efficiently supplied under the standard provisions of the Pharmaceutical Benefits Scheme (PBS). This legislative instrument specifically amends the Highly Specialised Drugs Program, which provides special arrangements under subsection 100(1)(b)(i) of the Act, to exclude a particular form of the drug Baclofen from the list of drugs covered by these arrangements. Enacted by the Parliament of Australia, this amendment aims to refine the criteria for special arrangements to ensure that resources are allocated efficiently to those most in need. The policy objective behind this amendment is to maintain the integrity and sustainability of the PBS by ensuring that highly specialised drugs are accessible to those who require them, while also managing costs and ensuring that the program remains targeted to its intended purpose.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument PB 72 of 2008, governs the provision of reliable, timely, and affordable access to medicines through the Pharmaceutical Benefits Scheme (PBS). Specifically, it authorises the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to persons living in isolated areas or receiving medical treatment where pharmaceutical benefits under Part VII of the Act are inadequate or cannot be efficiently supplied. This Act applies to the Commonwealth and extends to the provision of listed drugs and medicinal preparations, subject to any special arrangements made under section 100. The Act applies to individuals and entities involved in the provision and administration of these pharmaceutical benefits. Notably, the Act has been amended to exclude the intrathecal injection form of Baclofen from the Highly Specialised Drugs Program, effective from 31 July 2008, thereby adjusting the scope of special arrangements made under section 100(1)(b)(i). This amendment ensures that only certain forms of Baclofen remain eligible for the special arrangements, and it permits the remaining form to be considered for exemption under section 84AH, which excludes it from statutory price reductions and price disclosure obligations. The Minister’s decision to make these amendments was informed by consultations with the pharmaceutical company supplying the drug and advice from the Pharmaceutical Benefits Advisory Committee.

Key Provisions

The main operative sections of this legislation involve amendments to the Highly Specialised Drugs Program under subsection 100(1) of the National Health Act 1953. Specifically, it removes the form, manner of administration, and brand of the listed drug Baclofen from the arrangement (section 1). This amendment affects the intrathecal injection of 10 mg in 20 mL, injection, Lioresal Intrathecal (section 1, item 1). The changes are intended to take effect at 11.59pm on 31 July 2008 (paragraph 1). The Act imposes specific obligations on the Minister for Health and Ageing and other relevant parties to ensure that special arrangements, such as the Highly Specialised Drugs Program, provide an adequate supply of special pharmaceutical products to those in need. The Minister is responsible for making these special arrangements and can vary or revoke them as necessary (subsection 100(1) and (2)). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key advisory role, providing expert recommendations on the suitability of pharmaceutical items for particular sub-groups and advising the Minister on matters concerning these arrangements (subsection 101(4AB)). There are no specific offences, penalties, or consequences mentioned for breaches of the Act in this context. However, the general legal framework within which the Act operates includes potential civil and criminal penalties for non-compliance with health and pharmaceutical regulations. The exact penalties would depend on the nature and severity of the breach, but could include fines or imprisonment as stipulated in other relevant sections of the National Health Act 1953 or related legislation. In summary, this legislation amends the Highly Specialised Drugs Program by removing a specific form of Baclofen from the arrangement, ensuring that the supply of special pharmaceutical products remains adequate for those in need. The Minister and PBAC have specific roles and obligations in managing these arrangements, and while no specific penalties are mentioned, non-compliance could result in legal consequences under broader health regulations.

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