EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 6 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)
AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)
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 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 in relation to which Part VII applies are declared by the Minister by legislative instrument as such under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Subsection 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation.
Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee (PBAC). Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA). Subsection 101(4) further provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared.
This legislative instrument in giving effect to recommendations of the PBAC amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 88 of 2007 which came into effect on 1 December 2007. 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 attached Summary of changes.
This instrument, expressed to commence on 1 January 2008, immediately after the commencement of PB 1 of 2008, was made on 14 December 2007.
PB 1 of 2008 expressed to commence on 1 January 2008 and made by the Minister on 19 November 2007 also amends the declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85 (2A) made by legislative instrument number PB 88 of 2007. It is intended that both this instrument and PB 1 of 2008 commence on 1 January 2008, with this instrument commencing immediately after commencement of PB 1 of 2008.
Consultations
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. 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.
In relation to the prescribing of pharmaceutical benefits by optometrists, consultation regarding these arrangements occurred with ophthalmology, medical, optometry and pharmacy groups, including the Royal Australian and New Zealand College of Ophthalmologists, Australian Society of Ophthalmologists, Australian Medical Association, Royal Australian College of General Practitioners, Optometrists Association Australia, Council of Optometry Registration Authorities, Optometry Council of Australia and New Zealand, and the Pharmacy Guild of Australia.
The delegate is satisfied that no further consultation is required concerning this particular instrument because he considers that appropriate consultation has already been undertaken or, in the case of some variations to determinations regarding listed drugs, the delegate considers the variation to be mechanical or minor in nature.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 January 2008 immediately after the commencement of PB 1 of 2008.
Paragraph 2: provides that Schedule 1 amends PB 88 of 2007.
Schedule 1: provides for the following amendments:
SUMMARY OF CHANGES
Addition of paragraph 4B: provides that Part VII applies to a drug or medicinal preparation in Schedule 2A and that the circumstances specified in Schedule 2A apply when it is prescribed by an authorised optometrist. The drugs or medicinal preparations mentioned in Schedule 2A are those for which an authorised optometrist may write a prescription for supply.
Amendment of paragraph 12: the addition of Schedule 2A in this parapgraph provides that, for the purposes of s88A of the Act, the writing of a prescription by an authorised optometrist for the supply of a benefit mentioned in Schedule 2A is authorised only in the circumstances determined under s85(2A) of the Act. Those circumstances are mentioned in Column 2 of Schedule 2A.
Amendment of paragraph 14: subsection 85(2A)(b) of the Act is referred to in place of s88A because the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written are determined under s85(2A)(b).
Amendment of subparagraphs 14(a), 14(b) and 14(c): provides for Schedule 2A to be one of the Schedules to which those paragraphs of the instrument apply.
Amendment of subparagraph 14(d): provides for the authorisation procedures set out in subparagraph 14(d) to apply to the prescription of pharmaceutical benefits set out in Schedule 2A.
Amendment of subparagraph 14(d)(i), 14(d)(i)(A), 14(d)(ii), 14(d)(iii), paragraph 14A, and subparagraphs 15(a)(i) and 15(a)(ii)(A): provides for reference to authorised optometrists in the authorisation procedures set out in those subparagraphs.
Amendment of subparagraph 15A(a): provides for the Medicare Australia CEO to tell the authorised optometrist orally the number allotted to an authorised prescription.
Amendment of subparagraph 15A(b) and paragraph 15B: provides for reference to authorised optometrists in the authorisation procedures set out in those subparagraphs.
SCHEDULE 1
Amendment to Schedule 1
omit from Column 3 heading:
“88A”
and substitute:
“85(2A)(b)”
Listed Drug Deleted
Thioridazine
Alteration of Circumstances
Glucose Indicator—Blood [deletion of discs containing electrode sensors, 10 sensors per disc, 5 and deletion of electrode strips, 50 (Ascensia Elite)]
Influenza Vaccine [addition of injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe]
Lansoprazole [sachet containing granules for oral suspension, 30 mg per sachet]
Oestradiol [deletion of transdermal patches 3.28 mg, 8, transdermal patches 4.33 mg, 8, transdermal patches 6.57 mg, 8 and transdermal patches 8.66 mg, 8]
Varenicline
SCHEDULE 1A
Amendment to Schedule 1A
omit from Column 2 heading:
“88A”
and substitute:
“85(2A)(b)”
SCHEDULE 2
Amendment to Schedule 2
omit from Column 2 heading:
“88A”
and substitute:
“85(2A)(b)”
After Schedule 2, the addition of Schedule 2A –Ready-prepared pharmaceutical benefits when prescribed by an authorised optometrist
SCHEDULE 2A
Aciclovir
Carbomer 974
Carbomer 980
Carmellose
Chloramphenicol
Cromoglycic Acid
Fluorometholone
Flurbiprofen
Hydrocortisone
Hypromellose
Hypromellose with Carbomer 980
Hypromellose with Dextran
Paraffin
Polyethylene Glycol 400 with Propylene Glycol
Polyvinyl Alcohol
Sulfacetamide
SCHEDULE 4
Amendment to Schedule 4
omit from Column 2 heading:
“88A”
and substitute:
“85(2A)(b)”