National Health (Highly specialised drugs program for private hospitals) Special Arrangements Amendment Instrument 2010 (No. 1) (No. PB 75 of 2010)

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 75 of 2010

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR PRIVATE HOSPITALS) SPECIAL ARRANGEMENTS AMENDMENT INSTRUMENT 2010 (No. 1)

Summary

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends Highly Specialised Drugs Program Arrangements under subparagraph 100(b)(i) made by legislative instrument number
PB 64 of 2010 which came into effect on 1 July 2010.  The amendments provide for changes to highly specialised drugs available at private hospitals to non-admitted patients, day admitted patients or patients on discharge.  The amendments are set out in the items of Schedule 1 to the instrument.

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  subsection 85(2) of the Act.  Schedule 6 of the declaration 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.

These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.

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

This instrument, expressed to commence on 1 August 2010, was made on 27 July 2010.

Consultations

The Pharmaceutical Benefits Advisory Committee (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.  Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared.  When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

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 PBAC.

The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) is a non-statutory body established by the Australian Health Ministers Advisory Council (AHMAC).  The HSDWP makes recommendations to the PBAC on the suitability of certain drugs for listing under the Highly Specialised Drugs Program.  The HSDWP considers the funding and administrative aspects of supply through the hospital system, and a recommendation for listing must be supported by a majority of Working Party members.  The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.

ATTACHMENT

Paragraph 1:  provides that this instrument commences on 1 August 2010.

Paragraph 2:  provides that Schedule 1 amends PB 64 of 2010.

Schedule 1: provides for the following amendments: 

Preamble paragraphs:

Paragraph 3(a) is amended to remove delavirdine from the list of highly specialised drugs for the treatment of HIV or AIDS.

Paragraph 12(a) is amended to include the highly specialised drug tocilizumab.

Paragraph 18(d) is amended to extend the availability of infliximab for the treatment of patients with fistulising Crohn disease.

Paragraph 18(g) is added to reflect the circumstances for the authorisation by the Medicare Australia CEO for the supply of the highly specialised drug tocilizumab.

Paragraph 19(h) is amended to extend the availability of infliximab for the treatment of patients with fistulising Crohn disease.

SCHEDULE 1

Addition of Listed Drug

Deletion of Listed Drug

Alteration of Circumstances

SCHEDULE 2

Addition of Listed Drug

Deletion of Listed Drug

Addition of Forms

SCHEDULE 3

Price Decrease