National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Chemotherapy Pharmaceuticals Access Program (No. PB 83 of 2009)

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 83 OF 2009

NATIONAL HEALTH ACT 1953

AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)

CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM

Purpose and operation

The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.

The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.

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

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 and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. 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 Chemotherapy Pharmaceuticals Access Program is a set of Arrangements made under subparagraph 100(b)(i) of the Act for the purpose of the supply of chemotherapy pharmaceuticals at public hospitals to      non-admitted patients, day admitted patients and patients on discharge.

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

As of 1 September 2009, some of the chemotherapy pharmaceuticals that are available for supply under the Program will no longer require an authority from the Medicare Australia CEO. Medical practitioners who prescribe these drugs to their patients (and approved hospital authorities acting on their behalf) will only need to record a four digit code on the patient’s medication chart to indicate that these drugs have been prescribed in accordance with the circumstances set out in this legislative instrument.

This legislative instrument amends Chemotherapy Pharmaceuticals Access Program Arrangements under subparagraph 100(b)(i) made by legislative instrument number PB 55 of 2009 to give effect to the new streamlined authority requirements for some chemotherapy pharmaceuticals. In addition, this instrument gives effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The amendments are set out in the items of Schedule 1 to the instrument.

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

This instrument, expressed to commence on 1 September 2009, was made on 10 August 2009.

Consultations

The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations 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.  When recommending the listing of a medicine 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.

ATTACHMENT

Paragraph 1: provides that this instrument commences on 1 September 2009.

Paragraph 2: provides that Schedule 1 amends PB 55 of 2009.

Schedule 1: provides for the following amendments:

Addition of Paragraphs 14A and 14B:

Paragraph 14A provides that if a chemotherapy pharmaceutical has a four digit code set out in Schedule 1 or Schedule 3, then the patient’s medical practitioner (or the approved hospital authority supplying the chemotherapy pharmaceutical and acting on behalf of the medical practitioner) can record the four digit code applying to that pharmaceutical on the patient’s medication chart but only in the circumstances set out in Schedule 1 or Schedule 3, whichever applies.  If the four digit code is recorded in this way, then the medical practitioner or the approved hospital authority will not be required to obtain a separate authority from the Medicare Australia CEO.

Paragraph 14B provides that paragraph 14A only applies to a medication chart if the chemotherapy pharmaceutical prescribed has a four digit code which applies to that pharmaceutical in the circumstances set out in either Schedule 1 or Schedule 3, whichever applies.

 SCHEDULE 1

Alteration of Circumstances

SCHEDULE 2

Addition of Brand

Deletion of Brands