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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This declaration under the National Health Act designates which prescription medicines are subsidised by the PBS, effectively creating the formulary Medicare uses to process prescriptions. It shapes patient access, prescribing rules for doctors and dentists, and dispensing by pharmacists.
It imposes clinical eligibility criteria and authority‑approval procedures for costly or restricted drugs, with detailed requirements—examples include biologic treatment cycles, lab thresholds for cholesterol therapies, and rules for compounded medicines—that determine who qualifies and when treatment can continue.
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Direct links to the current provisions in National Health Act 1953 - Declaration under subsection 85(2) (No. PB 30 of 2005).
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
PBS Declaration 85COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85(2)
No. PB 30 of 2005
I, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to subsection 85(2) of the National Health Act 1953, hereby make the following Declaration:
This declaration commences on 1 December 2005.
Declaration No. PB 26 of 2005 under subsection 85(2) of the National Health Act 1953 made on 16 September 2005 with effect from 1 October 2005 is repealed.
In this Declaration:
“Act” means the National Health Act 1953;
“base-priced drug” means —
(a) in relation to cimetidine hydrochloride or ranitidine hydrochloride (tablet, effervescent, equivalent to 150 mg ranitidine or syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine hydrochloride (tablet equivalent to 150 mg ranitidine or tablet equivalent to 300 mg ranitidine); or
(b) in relation to amlodipine besylate or lercanidipine hydrochloride or nifedipine (tablet 20 mg (controlled release)): felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release)); or
(c) in relation to ramipril (capsule 10 mg): captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril erbumine or quinapril hydrochloride or ramipril (tablet 1.25 mg or tablet 2.5 mg or tablet 5 mg) or trandolapril;
“electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;
“extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit;
“Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
“ready-prepared pharmaceutical benefit” means a drug or medicinal preparation in respect of which there is in force a determination under subsection 85(6) of the Act;
“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
4A. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 2 and the circumstances (if any) specified in column 2 of Schedule 2 opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a participating dental practitioner.
A medicinal preparation composed of a compound that includes a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3, other than a compound the name of which is specified in column 2 of that Schedule opposite the name of that pharmaceutical benefit, is not a medicinal preparation to which Part VII of the Act applies, unless the name of that pharmaceutical benefit is also specified in Schedule 4, in which case the provisions of paragraphs 7 and 8 apply.
Part VII of the Act does not apply in relation to a medicinal preparation composed of a compound that includes a ready-prepared pharmaceutical benefit, other than a pharmaceutical benefit the name of which is specified in column 1 of Schedule 3.
Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4.
Part VII of the Act applies in relation to medicinal preparations composed of one or more of the drugs or medicinal preparations the names of which are specified in Schedule 4 with the addition of one or more of the substances the names of which are specified in Schedule 5.
The substances the names of which are specified in Schedule 5 are additives for the purposes of paragraph 85(2)(b) of the Act.
Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in Schedule 6.
The drugs and medicinal preparations the names of which are specified in Schedule 6 are additional pharmaceutical benefits made available under arrangements provided for by section 100 of the Act.
Where circumstances are specified in column 2 of Schedule 1, 1A, 2 or 4 opposite the name of a pharmaceutical benefit specified in column 1 of any of those Schedules, that pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.
Where circumstances are specified in column 2 of Schedule 4 opposite the name of a pharmaceutical benefit specified in column 1 of that Schedule, those circumstances are also specified in relation to any medicinal preparation containing that pharmaceutical benefit.
Subject to paragraph 16, the following circumstances are specified in relation to each relevant pharmaceutical benefit for the purposes of section 88A of the Act:
(a) where a class of persons is specified in column 2 of Schedule 1, 1A, 2 or 4 — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b) where a disease or condition is specified in column 2 of Schedule 1, 1A, 2 or 4 —
(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in column 2 of Schedule 1, 1A, 2 or 4 — that the pharmaceutical benefit is to be supplied for that purpose;
(d) where it is specified in column 2 of Schedule 1 or 1A that compliance with authority procedures set out in subparagraph 14(d) is required — that a medical practitioner has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:
(i) by preparing and signing the prescription:
(A) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or
(B) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or
(C) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
(D) by a method approved in writing by the Secretary; or
(ii) by submitting the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i); or
(iii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO; or
(iv) by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i).
14A. For the purposes of subsubparagraph 14(d)(i), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.
(a) if the prescription was submitted in accordance with subsubparagraph 14(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:
(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
(ii) in any other case:
(A) by returning it to the medical practitioner; or
(B) by sending it to the person in respect of whom it was prepared; or
(b) if the prescription was submitted in accordance with subsubparagraph 14(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or
(c) if the prescription was submitted in accordance with subsubparagraph 14(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner.
15A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 15(b) or (c):
(a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; and
(b) the medical practitioner must:
(i) mark that number on the prescription; and
(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
15B. Notwithstanding paragraph 15, if the prescription was submitted in accordance with subsubparagraph 14(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
| Category of patient | Lipid level |
|---|---|
| (1) patients with existing coronary heart disease | cholesterol greater than 4 mmol per L |
| (2) patients, not in category (1), with 1 or more of the following:diabetes mellitus;familial hypercholesterolaemia;family history of cardiovascular disease (first degree relative less than 60 years of age);hypertension;peripheral vascular disease | cholesterol greater than 6.5 mmol per L; orcholesterol greater than 5.5 mmol per L and high density lipoprotein less than 1 mmol per L |
| (3) patients, not in category (1) or (2), with high density lipoprotein level less than 1 mmol per L | cholesterol greater than 6.5 mmol per L |
| (4) patients, not in category (1), (2) or (3), being men over 34 but less than 76 years of age or post-menopausal women less than 76 years of age | cholesterol greater than 7.5 mmol per L; ortriglyceride greater than 4 mmol per L |
| (5) patients, not in category (1), (2), (3) or (4) | cholesterol greater than 9 mmol per L; ortriglyceride greater than 8 mmol per L |
<table cellspacing="0" cellpadding="0" style="margin-top:0pt; margin-bottom:0pt; border-collapse:collapse"><tbody><tr><td style="width:146pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><a id="bmk85s1"><span>Abciximab</span></a></p></td><td style="width:245.3pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span>In compliance with authority procedures set out in subparagraph 14 (d):</span></p></td></tr><tr><td style="width:146pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span></span></p></td><td style="width:245.3pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable" style="margin-left:11.3pt"><span>Patients undergoing percutaneous coronary balloon angioplasty</span></p></td></tr><tr><td style="width:146pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span></span></p></td><td style="width:245.3pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable" style="margin-left:11.3pt"><span>Patients undergoing percutaneous coronary atherectomy</span></p></td></tr><tr><td style="width:146pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span></span></p></td><td style="width:245.3pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable" style="margin-left:11.3pt"><span>Patients undergoing percutaneous coronary stent placement</span></p></td></tr><tr><td style="width:146pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span>Acamprosate Calcium</span></p></td><td style="width:245.3pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span>In compliance with authority procedures set out in subparagraph 14 (d):</span></p></td></tr><tr><td style="width:146pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span></span></p></td><td style="width:245.3pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable" style="margin-left:11.3pt"><span>For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence</span></p></td></tr><tr><td style="width:146pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span>Acarbose</span></p></td><td style="width:245.3pt; padding-right:1.4pt; padding-left:1.4pt; vertical-align:top"><p class="tTable"><span>—</span></p></td></tr><tr><td style="width:146pt; padding-right:1.4
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