EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 110 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 84AF
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).
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.
Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item. The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly. The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or that any other person can be the responsible person for the same brand in an any other pharmaceutical item.
A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act. These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.
The principal instrument made under section 84AF determines the responsible persons for the brands of pharmaceutical items set out in Schedule 1 to the instrument. These persons are bodies corporate and are identified in Schedule 1 by their company name and Australian Business Number (ABN). The names of the responsible persons for many of the pharmaceutical items were notified before the commencement of section 84AF as permitted by subsection 84AF(2).
This legislative instrument amends the determination under section 84AF made by legislative instrument number PB 76 of 2008 which came into effect on 1 August 2008. This instrument amends instrument number PB 76 of 2008 by revoking the determination of a responsible person for the ‘Risperdal’ brand of the ‘Oral solution 1 mg per mL, 30 mL’ form of the listed drug Risperidone. At the same time, the brand determination for this brand will be revoked.
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 because revoking the determinations relevant to the brand and its pharmaceutical item will commence at the same time. That is, there will be no listed brand for which the Responsible person is responsible.
Consultations
This instrument affects a pharmaceutical company with medicines listed on the PBS. In relation to the introduction of the responsible person measure, pharmaceutical companies have been consulted during both the policy development and implementation phases. This has occurred through meetings with both peak body organisations and individual companies. Information on this measure has been disseminated through peak industry bodies and during regular meetings with a Stakeholder Reference Group. Particular information on the Responsible Person provisions has been provided by letter to those companies to whom the provisions will apply. Under section 84AF the Minister may only determine a person to be the responsible person for a brand of a pharmaceutical item if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item. Each of the persons determined in the instrument to be responsible persons has given the required notification to the Minister.
The responsible person that supplies the ‘Risperdal’ brand of the pharmaceutical item that contains the ‘Oral solution 1 mg per mL, 30 mL’ form of the listed drug Risperidone 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. The Pharmaceutical Benefits Advisory Committee (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 concerning suitability of pharmaceutical items for use by particular sub-groups.
Advice from PBAC under section 101(4AB) of the Act was considered by the delegate of the Minister who makes decisions under section 84AH concerning exempt items 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 PB76 of 2008.
Schedule 1: provides for the following amendment:
Item 1: Revokes the determination of a responsible person for the ‘Risperdal’ brand of the ‘Oral solution 1 mg per mL, 30 mL’ form of the listed drug Risperidone by amending the instrument made under section 84AF of the Act.