EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2)
No. PB 37 OF 2007
Purpose and operation
1. 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.
2. 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.
3. “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Subsection 85(2) of the Act provides that, subject to subsection 85(3) of the Act, the drugs and medicinal preparations to which Part VII of the Act applies are:
(a) drugs and medicinal preparations that are:
(i) declared by the Minister, in writing, to be drugs and medicinal preparations to which Part VII applies; or
(ii) included in a class of drugs and medicinal preparations declared by the Minister, in writing, to be a class of drugs and medicinal preparations to which Part VII applies; and
(b) medicinal preparations composed of:
(i) one or more of the drugs and medicinal preparations referred to in paragraph (a), being a drug or medicinal preparation that is, or drugs or medicinal preparations that are, included in a class of drugs and medicinal preparations declared by the Minister, in writing, to be a class of drugs and medicinal preparations to which this paragraph applies; and
(ii) one or more additives as are declared by the Minister, in writing, to be additives to which this paragraph applies.
5. Subsection 85(2A) of the Act provides that the Minister may, in a declaration under subsection 85(2) of the Act:
(a) declare that a particular pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act; and
(b) specify the circumstances in which the writing of a prescription for the supply of the pharmaceutical benefit is to be authorised under Part VII of the Act.
6. Section 88A of the Act provides that where a pharmaceutical benefit is declared, in a declaration made under subsection 85(2) of the Act, to be a relevant pharmaceutical benefit for the purposes of that section, the writing of a prescription for the supply of the benefit is authorised under Part VII of the Act only in the circumstances specified in the declaration pursuant to subsection 85(2A) of the Act.
7. 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.
8. The declaration made under subsection 85(2) of the Act on 30 March 2007 with effect from 1 May 2007 (No. PB 32 of 2007) is amended by this declaration.
9. This declaration gives effect, as from 1 June 2007, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as detailed in the attached summary of amendments.
Consultations
10. The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, that 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.
11. The declaration gives effect to recommendations made by the PBAC. 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.
12. Details of the declaration are set out in the Attachment.
13. This declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
14. The declaration was made on 26 April 2007 and came into operation on 1 June 2007.
SUMMARY OF AMENDMENTS
SCHEDULE 1
Additions
Olmesartan Medoxomil |
Olmesartan Medoxomil with Hydrochlorothiazide |
Alteration of Circumstances
Glucose Indicator - Blood [addition of electrode strips, 50 (Glucoboy)] |
SCHEDULE 3
Additions
Olmesartan Medoxomil with Hydrochlorothiazide |
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 June 2007.
Paragraph 2 provides that the declaration (No. PB 32 of 2007) under subsection 85(2) of the National Health Act 1953 made on 30 March 2007 with effect from 1 May 2007 is, in this Declaration, referred to as the Principal Declaration.
Paragraph 3 provides for amendments to Schedule 1 to the Principal Declaration.
Paragraph 4 provides for amendments to Schedule 3 to the Principal Declaration.
The Schedules
Schedule 1 to the declaration lists those drugs and medicinal preparations that are pharmaceutical benefits when prescribed by a medical practitioner for the circumstances specified (if any).
Schedule 1A to the declaration lists those drugs and medicinal preparations that are pharmaceutical benefits when prescribed by a medical practitioner for the circumstances specified for patients receiving palliative care.
Schedule 2 to the declaration lists those drugs and medicinal preparations that are pharmaceutical benefits when prescribed by a participating dental practitioner for the circumstances specified (if any).
Schedule 3 to the declaration lists allowable compounds of ready-prepared pharmaceutical benefits.
Schedule 4 to the declaration lists those drugs or medicinal preparations that may be used as ingredients of extemporaneously-prepared pharmaceutical benefits.
Schedule 5 to the declaration lists those drugs and medicinal preparations that may be used as additives in compounds that are pharmaceutical benefits.
Schedule 6 to the declaration lists those additional pharmaceutical benefits that are made available under arrangements provided for by section 100 of the National Health Act 1953.