EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 108 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 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 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.
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 74 of 2008 which came into effect on 1 August 2008. This instrument amends PB 74 of 2008, by revoking the pharmaceutical item Risperidone, in the form ‘Oral solution 1 mg per mL, 30 mL’ and the circumstances for which the form was prescribed. This instrument also amends the circumstances, for which the drug Risperidone in the form ‘Oral solution
1 mg per mL, 100 mL’ can be prescribed. The extension to the availability of the drug Risperidone in the form ‘Oral solution 1 mg per mL, 100 mL’ to provide for the treatment of additional conditions, is as a consequence of revoking the ‘Oral solution 1 mg per mL, 30 mL’ form of Risperidone.
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 both the pharmaceutical item containing the form ‘Oral solution
1 mg per mL, 30 mL’ and the pharmaceutical item in the form ‘Oral solution 1 mg per mL, 100 mL’ was consulted before the delegate of the Minister decided to make the amendments set out in this instrument.
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.
ATTACHMENT
Paragraph 1: provides that this instrument commences at 11.59 pm on 30 November 2008.
Paragraph 2: provides that Schedule 1 amends PB 74 of 2008.
Schedule 1: provides for the following amendments:
Item 1 and 2: Amends the circumstances for which the pharmaceutical item that contains the listed drug Risperidone in the form ‘Oral solution 1 mg, per mL, 100 mL’ may be prescribed.
Item 3: Revokes the circumstances for which the pharmaceutical item that contains the listed drug Risperidone in the form ‘Oral solution 1 mg, per mL, 30 mL’ may be prescribed.