EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DECLARATION UNDER SUBSECTION 85(2)
NO. PB 2 OF 2005
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.
“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.
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.
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.
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.
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.
The declaration made under subsection 85(2) of the Act on 17 November 2004 with effect from 1 December 2004, as amended on 14 December 2004 and 20 December 2004 with effect from 1 January 2005 and 1 February 2005 respectively, is repealed and substituted with this declaration.
This declaration is remade to give effect, as from 1 April 2005, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as recommended by the Pharmaceutical Benefits Advisory Committee. Subparagraph (a) of the definition of “base-priced drug” in paragraph 3 of the declaration has been amended to take account of the removal of the therapeutic group premiums for nizatidine capsule 150 mg and nizatidine capsule 300 mg. Changes to Schedules 1, 2, 3 and 6 of the declaration are detailed in the attached summary of changes.
Consultations
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.
The declaration gives effect to recommendations made by the PBAC. Prior to the making of this declaration significant consultations have been undertaken by the PBAC by means of its consideration of submissions made by applicants for drugs to be listed on the PBS. 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.
Details of the declaration are set out in the Attachment.
This declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The declaration was made on 22 March 2005 and came into operation on 1 April 2005.
SUMMARY OF CHANGES
SCHEDULE 1
Additions
Aprepitant
Dapsone
Ferrous Sulfate
Fotemustine
Iron Sucrose
Levodopa with Carbidopa and Entacapone
“Lophlex”
Metformin Hydrochloride with Glibenclamide
Modafinil
Pemetrexed Disodium Heptahydrate
Pimecrolimus
Deletions
Diphtheria Antitoxin
Ferrous Sulfate – Dried with Folic Acid
Levamisole Hydrochloride
Tetracycline Hydrochloride
Alteration of Circumstances
Acarbose
Aciclovir [tablet 200 mg]
Adalimumab
Bupropion Hydrochloride
Calcium Folinate [addition of injection equivalent to 100 mg folinic acid in 10 mL]
Candesartan Cilexetil
Cyclosporin
Desmopressin Acetate [deletion of nasal spray (pump pack) 10 micrograms per actuation, 50 actuations, 5 mL]
Entacapone
Eprosartan Mesylate
Etanercept [addition of circumstances pertaining to active ankylosing spondylitis]
Famciclovir
Gemcitabine Hydrochloride
Glucose Indicator—Blood [addition of reagent strips, 51 (Accu-Chek Integra) and addition of reagent strips, 50 (SensoCard)]
Irbesartan
Paracetamol [addition of tablet 665 mg (modified release)]
Risperidone [addition of tablet 0.5 mg, tablet 0.5 mg (orally disintegrating), tablet 1 mg (orally disintegrating), tablet 2 mg (orally disintegrating) and oral solution 1 mg per mL, 30 mL]
Rituximab
Rosiglitazone Maleate
Telmisartan
Valaciclovir Hydrochloride
SCHEDULE 2
Deletions
Tetracycline Hydrochloride
Alteration of circumstances
Paracetamol [addition of tablet 665 mg (modified release)]
SCHEDULE 3
Additions
Levodopa with Carbidopa and Entacapone
Metformin Hydrochloride with Glibenclamide
Deletions
Ferrous Sulfate – Dried with Folic Acid
SCHEDULE 6
Additions
Emtricitabine
Iloprost Trometamol
ATTACHMENT
Paragraph 1 provides that this declaration commences on 1 April 2005.
Paragraph 2 provides that the declaration under subsection 85(2) of the National Health Act 1953 (the Act) made on 17 November 2004, as amended by the declaration under subsection 85(2) of the Act made on 14 December 2004 and by the declaration under subsection 85(2) of the Act made on 20 December 2004, are repealed.
Paragraph 3 defines the following terms for the purposes of the declaration:
- “Act”
- “base-priced drug”;
- “electronic communication”;
- “extemporaneously-prepared pharmaceutical benefit”;
- “Managing Director”;
- “ready-prepared pharmaceutical benefit”; and
- “Regulations”.
Paragraph 4 provides that the drugs and medicinal preparations listed in column 1 of Schedules 1 or 1A are pharmaceutical benefits if prescribed by a medical practitioner in specified circumstances.
Paragraph 4A provides that the drugs and medicinal preparations listed in column 1 of Schedule 2 are pharmaceutical benefits if prescribed by a participating dental practitioner in specified circumstances.
Paragraph 5 provides that a compounded medicinal preparation is a pharmaceutical benefit only where that compound consists of:
- two or more of the pharmaceutical benefits listed in column 1 of Schedule 3; or
- one or more of the pharmaceutical benefits listed in column 1 of Schedule 3 and that the name of that compound is specified in Schedule 4, in which case paragraphs 7 and 8 of this declaration apply.
Paragraph 6 provides that a compound consisting of a ready-prepared pharmaceutical benefit is not a pharmaceutical benefit, unless that ready-prepared pharmaceutical benefit is compounded with sterilised Water for Injections, Sodium Chloride injection or a pharmaceutical benefit specified in column 1 of Schedule 3.
Paragraph 7 provides that a compound consisting of one or more of the drugs or medicinal preparations specified in Schedule 4 is a pharmaceutical benefit.
Paragraph 8 provides that a compound consisting of one or more drugs or medicinal preparations specified in Schedule 4, together with one or more substances listed in Schedule 5, is a pharmaceutical benefit.
Paragraph 9 provides that the substances listed in Schedule 5 may be used as additives in compounds which are pharmaceutical benefits.
Paragraph 10 provides that Part VII of the National Health Act 1953 applies to the drugs and medicinal preparations listed in Schedule 6 of this declaration.
Paragraph 11 provides that the drugs and medicinal preparations listed in Schedule 6 of this declaration are additional pharmaceutical benefits made available under section 100 of the National Health Act 1953.
Paragraph 12 provides that a drug or medicinal preparation specified in column 1 of Schedules 1, 1A, 2 or 4 is only a pharmaceutical benefit when prescribed for the circumstances specified in column 2 of those Schedules.
Paragraph 13 provides that the circumstances that apply to those pharmaceutical benefits listed in column 1 of Schedule 4 also apply to any compounds containing any of those substances.
Paragraph 14 provides that:
(a) where a class of persons is specified in column 2 of Schedules 1, 1A, 2 or 4, the pharmaceutical benefit is to be supplied to a person included in that class of persons;
(b) where a disease or condition is specified in column 2 of Schedules 1, 1A, 2 or 4:
(i) if subparagraph (ii) does not apply, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition; or
(ii) if a class of persons is also specified in those circumstances, 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 Schedules 1, 1A, 2 or 4, the pharmaceutical benefit is to be supplied for that purpose;
(d) where column 2 of Schedules 1, 1A, 2 and 4 specifies that compliance with authority procedures (set out in subparagraph 14(d)) is required, then the medical practitioner must submit the prescription for supply of the pharmaceutical benefit by:
(i) preparing and signing the prescription:
- in a form approved by the Secretary, and completed in ink in the medical practitioner’s handwriting; or
- in a form approved by the Secretary, by means of a computer; or
- in a form prepared by means of a computer and approved in writing for the purpose by the Secretary and in a format approved in writing by the Secretary; or
- by a method approved by the Secretary in writing.
(ii) submitting the prescription by telephone, giving the Managing Director the details of that prescription which has been prepared and signed in accordance with subsubparagaph (i); or
(iii) where the medical practitioner is unable to obtain authorisation from the Managing Director due to failure of telephone systems, submitting the prescription in line with subsubparagraph (ii) and according to the instructions stipulated in an emergency telephone message from the medical practitioner to the Managing Director;
(iv) by submitting the details of the prescription, which has been prepared and signed by the medical practitioner (in accordance with subsubparagraph (i)) to the Managing Director by means of electronic communication (of a kind which has been approved by the Managing Director)
Paragraph 14A provides that, if the prescription has been prepared and signed by the medical practitioner in accordance with subsubparagraph 14(d)(i), that prescription may be submitted by one of that medical practitioner’s employees.
Paragraph 15 provides that, subject to paragraph 15B, where a prescription is submitted under subparagraph 14(d), authorisation may be made:
(a) by the Managing Director signing for the authorisation on the prescription and:
(i) if the Managing Director requires that the medical practitioner must alter the prescription, by returning the prescription to the medical practitioner for alteration before the medical practitioner gives it to the patient; or
(ii) in any other case:
- by returning it to the medical practitioner; or
- by sending it to the person for whom it was prepared; or
(b) orally, at the time the Managing Director is given details of the prescription, if the prescription was submitted in accordance with subsubparagraph 14(d)(ii); or
(c) by the Managing Director sending the authorisation to the medical practitioner by electronic communication, if the prescription was submitted in accordance with subsubparagraph 14(d)(iv).
Paragraph 15A provides that, if the Managing Director authorises a prescription orally, in accordance with subparagraph 15(b) or (c):
(a) the Managing Director must tell the medical practitioner, either orally or by electronic communication, the number of the authority prescription; and
(b) the medical practitioner must mark the number on the prescription and retain a copy of the prescription for 1 year from the date of authorisation.
Paragraph 15B provides that authorisation is deemed to be granted where a medical practitioner has submitted a prescription in accordance with subsubparagraph 14(d)(iii), and where the prescription has been completed in accordance with the instructions stipulated in the emergency telephone message provided by the Managing Director.
Paragraph 16 provides that where the words “for use in accordance with paragraph 16” are used in column 2 of Schedule 1, the pharmaceutical benefit is to be supplied for the treatment of a patient who, after dietary therapy, qualifies to receive the benefit in accordance with the table at paragraph 16
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.