EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 64 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER PARAGRAPH 98C(1)(b)
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 (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
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 what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
Paragraph 98C(1)(b) of the Act provides that the Minister may, from time to time, determine the conditions subject to which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
The determination under paragraph 98C(1)(b) of the Act sets out the conditions under which payments will be made in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners.
This legislative instrument amends the determination under section 98C(1)(b) made by legislative instrument number PB 52 of 2007 which came into effect on 1 August 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 Attachment.
This instrument, expressed to commence on 1 July 2008, was made on 3 June 2008.
Consultations
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. 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.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 July 2008.
Paragraph 2: provides that Schedule 1 amends PB 52 of 2007.
Schedule 1: provides for the following amendments:
SCHEDULE 4
Addition of Listed Drugs
Clonazepam Oral liquid 2.5 mg per mL, 10 mL
Memantine Oral drops containing memantine hydrochloride 10 mg per g, 50 g
Addition of Form
Calcipotriol Scalp solution 50 micrograms (as monohydrate) per mL, 30 mL
Alteration of Form
Oestradiol and Oestradiol with Norethisterone
From:
Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate
To:
Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate
From:
Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate
To:
Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate
Overview
The National Health Act 1953, as amended by the legislation F2008L02055, serves as the foundational framework for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable and affordable access to a broad range of medications. This Act, enacted by the Parliament of Australia, addresses the need to regulate the supply of pharmaceutical benefits and to ensure that the PBS remains effective in meeting the health needs of the population. The explanatory statement outlines that the Act provides the Minister with the authority to determine the conditions under which payments will be made for the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. This legislative instrument, which came into effect on 1 July 2008, amends a previous determination made in 2007 to update the list of drugs covered under the PBS, including the addition of new drugs such as Clonazepam and Memantine, and modifications to the form of existing drugs like Oestradiol and Oestradiol with Norethisterone. The policy objective remains to ensure that the PBS continues to provide safe, effective, and cost-efficient pharmaceutical benefits to all Australians.
Scope and Application
The National Health Act 1953, as amended by the instrument F2008L02055, pertains specifically to the Pharmaceutical Benefits Scheme (PBS) under Part VII. This Act applies to all Australians and governs the provision of pharmaceutical benefits, which are medicines listed by the Minister for Health and Ageing. The legislation sets out the criteria for drugs and medicinal preparations to be listed on the PBS, which are typically recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) based on their medical efficacy, safety, and cost-effectiveness. The Act also details the conditions under which payments are made to approved pharmacists and medical practitioners for the supply of these benefits. This instrument, which came into effect on 1 July 2008, amends the previous determination made in 2007 by specifying new additions and alterations to the listed drugs and their forms, such as Clonazepam oral liquid, Memantine oral drops, and changes to Oestradiol and Oestradiol with Norethisterone transdermal patches.
Key Provisions
The main operative sections of this legislative instrument, which amends the National Health Act 1953, are found within the schedule of the instrument. These sections primarily focus on determining the conditions under which payments will be made by the Commonwealth in respect of the supply of pharmaceutical benefits by approved pharmacists and approved medical practitioners. Schedule 1 of the instrument details the specific changes, including the addition of new listed drugs such as Clonazepam oral liquid and Memantine oral drops, as well as the alteration of the form of existing drugs like Oestradiol and Oestradiol with Norethisterone patches. These changes are made in accordance with the legislative framework established in sections 84 to 85 and 84AF of the National Health Act 1953.
The obligations imposed by the Act on the parties it governs are primarily related to the administration and supply of pharmaceutical benefits. Approved pharmacists and approved medical practitioners must adhere to the conditions set out in the amended determination to be eligible for Commonwealth payments. These conditions may include the manner in which drugs are supplied, the form and strength of the drugs, and the brands of pharmaceutical items that qualify for benefits. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) has a critical role in recommending which drugs should be listed on the Pharmaceutical Benefits Scheme (PBS). The Minister for Health and Ageing must consider these recommendations before declaring a drug or medicinal preparation to be a pharmaceutical benefit under the Act.
There are no specific offences, penalties, or civil/criminal consequences detailed in the text of this legislative instrument itself. However, non-compliance with the conditions set out in the amended determination could potentially lead to financial penalties or other administrative consequences. For example, pharmacists or medical practitioners who supply drugs that do not meet the specified conditions may not be eligible for Commonwealth payments, which could impact their ability to provide affordable medications to patients. While the exact penalties for non-compliance are not explicitly stated in this instrument, they would likely be governed by other sections of the National Health Act 1953 or related legislation.