EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 37 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER
SUBSECTIONS 85A(1) AND (2) AND 88(1C)
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determination under subsections
85A(1) and (2), and 88(1C) made by legislative instrument number PB 11 of 2009 which came into effect on 1 March 2009. The amendment provides for an additional form of a listed drug which may be prescribed by authorised optometrists. The amendment is set out in the item of Schedule 1 to the instrument.
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.
Subsection 85A(1) authorises the Minister to determine the form or forms of pharmaceutical benefits or pharmaceutical item that may be prescribed under Part VII of the Act by specified classes of persons.
Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit. Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose. Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose. Paragraph 85A(2)(c) authorises the
determination of the manner of administration that may, in a prescription, be directed to be used.
Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits. Subsection 88(1C) authorises the Minister to determine the pharmaceutical benefits for the supply of which an optometrist is authorised to write a prescription on or after 1 January 2008.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 May 2010, was made on 1 April 2010.
Consultations
The involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (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 making recommendations relevant to 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.
The medicine determined under subsection 88(1C) reflects the recommendations of the PBAC and the outcome of the consultation process.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 May 2010.
Paragraph 2: provides that Schedule 1 amends PB 11 of 2009.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Form
Carmellose with glycerin | Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30 |
Overview
The National Health Act 1953, enacted by the Commonwealth Parliament, establishes the Pharmaceutical Benefits Scheme (PBS) to ensure Australians have reliable, timely, and affordable access to a wide range of medicines. This Act, through its various subsections, facilitates the declaration and determination of listed drugs and their forms, ensuring the scheme functions effectively. The legislative instrument F2010L00939 amends previous determinations under subsections 85A(1) and (2), and 88(1C) of the Act, following recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The amendment introduces an additional form of a listed drug that authorised optometrists can prescribe, reflecting the PBAC's recommendations and outcomes from consultations involving various healthcare stakeholders. This change aims to enhance the flexibility and accessibility of the PBS by allowing optometrists to prescribe a specific form of carmellose with glycerin eye drops.
Scope and Application
The National Health Act 1953 Amendment Determination under subsections 85A(1) and (2), and 88(1C) applies to the Pharmaceutical Benefits Scheme (PBS), which is a legislative framework through which the Commonwealth ensures that all Australians have reliable, timely, and affordable access to a wide range of medicines. Specifically, the amendment allows for an additional form of a listed drug to be prescribed by authorised optometrists, expanding the scope of what can be prescribed under the PBS. This amendment responds to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and reflects the outcome of a consultation process involving experts from various relevant fields. The amendment does not specify any geographic limitations, implying a national application within Australia. The instrument commenced on 1 May 2010 and amends a previous legislative instrument that came into effect on 1 March 2009. The amendment in Schedule 1 introduces a new form of the drug carmellose with glycerin in the form of eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units of 0.4 mL, in a pack of 30.
Key Provisions
The main operative sections of this legislative instrument are subsections 85A(1) and (2) and subsection 88(1C) of the National Health Act 1953. Subsection 85A(1) and (2) authorises the Minister to determine the form or forms of pharmaceutical benefits or pharmaceutical items that may be prescribed under Part VII of the Act by specified classes of persons. This includes determining the maximum quantity or number of units that may be directed to be supplied in one prescription and the maximum number of occasions in which the supply may be directed to be repeated. Subsection 88(1C) authorises the Minister to determine the pharmaceutical benefits for the supply of which an optometrist is authorised to write a prescription on or after 1 January 2008. The instrument amends the determination under subsections 85A(1) and (2) and 88(1C) made by legislative instrument number PB 11 of 2009, which came into effect on 1 March 2009. The amendment provides for an additional form of a listed drug which may be prescribed by authorised optometrists, namely carmellose with glycerin eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30.
The Act imposes certain obligations and requirements on the parties or entities it governs. Firstly, the Minister is responsible for determining the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise, and the manner of administration of the form of the listed drug. The Minister can also determine a brand of the pharmaceutical item that has the listed drug in that form with that manner of administration. These determinations govern what constitutes the pharmaceutical benefit under Part VII of the Act. Secondly, the Minister can determine the pharmaceutical benefits for the supply of which an optometrist is authorised to write a prescription on or after 1 January 2008. This includes determining the maximum quantity or number of units that may be directed to be supplied in one prescription and the maximum number of occasions in which the supply may be directed to be repeated.
Any breach of the Act may result in civil or criminal consequences. The maximum penalty for contravening the Act is a fine of up to $22,200 for an individual or $111,000 for a body corporate, or imprisonment for up to two years, or both. The Act also provides for the recovery of costs associated with the investigation and prosecution of an offence. Additionally, authorised optometrists who prescribe pharmaceutical benefits not authorised by the Minister may be subject to disciplinary action by the relevant professional body.
In conclusion, the legislative instrument amends the determination under subsections 85A(1) and (2) and 88(1C) of the National Health Act 1953 to provide for an additional form of a listed drug which may be prescribed by authorised optometrists. The Act imposes certain obligations and requirements on the Minister and authorised optometrists, and any breach of the Act may result in civil or criminal consequences. The maximum penalty for contravening the Act is a fine of up to $22,200 for an individual or $111,000 for a body corporate, or imprisonment for up to two years, or both. Authorised optometrists who prescribe pharmaceutical benefits not authorised by the Minister may also be subject to disciplinary action by the relevant professional body.