EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 109 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT TO THE INSTRUMENT THAT MAKES DETERMINATIONS UNDER SECTIONS 85, 85A and 88
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 the 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 to which Part VII applies are declared by the Minister by legislative instrument to be so 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).
Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.
Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).
Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item. A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item, or if there is no trade name, the name of the responsible person. The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.
This legislative instrument amends the principal instrument that makes determinations under sections 85, 85A and 88 (PB 75 of 2008 which came into effect on 1 August 2008). This instrument amends
PB 75 of 2008, by revoking the pharmaceutical item Risperidone, in the form ‘Oral solution 1 mg per mL, 30 mL’ orally administered. The listed drug Risperidone will no longer be supplied in that form and with that manner of administration. This instrument also amends the maximum number of repeats which may be prescribed depending on the purposes for which the drug Risperidone in the form ‘Oral solution 1 mg per mL, 100 mL’ is being prescribed.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument is expressed to commence at 11.59 pm on 30 November 2008 and was made on
3 November 2008. It commences at 11.59 pm on 30 November 2008 so that the pharmaceutical item containing the drug Risperidone, in the form ‘Oral solution 1 mg per mL, 30 mL’ to be taken orally may remain available on the PBS until that time, but still permit an exempt item determination (made under section 84AH in relation to another oral solution form Risperidone) to be made before the expiration of 30 November 2008. The exempt item determination will provide for the ‘Oral solution
1 mg per mL, 100 mL’ form of the listed drug Risperidone to be excluded from statutory price reductions and price disclosure obligations, including those occurring on 1 December 2008.
Consultations
The responsible person that supplies the pharmaceutical item containing the form ‘Oral solution 1 mg per mL, 30 mL’, was consulted before the delegate of the Minister decided to make the amendments set out in this instrument.
The Pharmaceutical Benefits Advisory Committee (PBAC) was also consulted in relation to issues relevant to this determination. PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits and about other matters as required under the Act. Under subsection 101(4AB) of the Act PBAC provides advice to the Minister if it is satisfied of certain matters relevant to suitability of pharmaceutical items for use by particular sub-groups.
Advice from PBAC under section 101(4AB) of the Act was considered by the person making decisions under s84AH concerning exempt item determinations as part of the process which also included consultations with the responsible person mentioned above.
ATTACHMENT
Paragraph 1: provides that this instrument commences at 11.59 pm on 30 November 2008.
Paragraph 2: provides that Schedule 1 amends PB 75 of 2008.
Schedule 1: provides for the following amendments:
Item 1: Revokes the form, manner of administration, brand, maximum quantity and maximum number of repeats determinations of the pharmaceutical item that contains the listed drug Risperidone in the form ‘Oral solution 1 mg, per mL,
30 mL’ by making deletions from Schedule 1, Part 1.
Item 2: Amends the maximum number of occasions for which the supply of the pharmaceutical benefit Risperidone in the form ‘Oral solution 1 mg per mL,
100 mL’ can be repeated in one prescription by amending the maximum number of repeats from ‘5’ to ‘2’ in Schedule 1, Part 1.
Item 3: Allows for the listed drug Risperidone in the form ‘Oral solution 1 mg, per mL, 100 mL’ to be added to Schedule 1, Part 2, providing the maximum quantity and the maximum number of repeats of the pharmaceutical benefit, which can be prescribed for a particular purpose.