EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 116 OF 2008

NATIONAL HEALTH ACT 1953

DETERMINATIONS UNDER SUBSECTIONS 85A(1) AND (2) AND 88(1C)

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.

This instrument determines matters under subsections 85A(1) and (2), and 88(1C).  It gives effect, as from 1 December 2008, to provisions so that authorised optometrists may prescribe certain pharmaceutical benefits, sets out the form or forms of pharmaceutical benefit that may be prescribed by an authorised optometrist and makes provisions concerning the maximum quantity of units and repeats and the manner of administration that may be prescribed by authorised optometrists.

A provision-by-provision description of this instrument is contained in Attachment 1.

This instrument (No. PB 116 of 2008) is made under subsections 85A(1) and (2), and 88(1C) of the Act and revokes the instrument previously made under subsections 85A(1) and (2), and 88(1C) of the Act (No. PB 78 of 2008).  The previous instrument was made on 9 July 2008, commenced on 1 August 2008 and was the subject of an amendment which commenced on 1 November 2008. 

Many of the matters determined under this instrument are the same as under the previous instrument, as amended up to 1 November 2008.  The changes made in this instrument to matters determined under subsections 85A(1) and (2), and 88(1C) of the Act since the last amendment to the previous instrument, are set out in Attachment 2 to this Explanatory Statement and is titled Summary of Changes.

This instrument, expressed to commence on 1 December 2008, was made on 5 November 2008.

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.

Consultation regarding the arrangements for optometrists to prescribe pharmaceutical benefits occurred with ophthalmology, medical, optometry and pharmacy groups, including the Royal Australian and New Zealand College of Ophthalmologists, Australian Society of Ophthalmologists, Australian Medical Association, Royal Australian College of General Practitioners, Optometrists Association Australia, Council of Optometry Registration Authorities, Optometry Council of Australia and New Zealand, and the Pharmacy Guild of Australia. 

The list of medicines determined under subsection 88(1C) reflects the recommendations of the PBAC and the outcome of the consultation process.

The delegate is satisfied that no further consultation is required concerning this particular instrument because he considers that appropriate consultation has already been undertaken.

ATTACHMENT 1

Section 1: provides that this instrument commences on 1 December 2008.

Section 2: provides that instrument number PB 78 of 2008 is repealed.

Section 3: defines “Act” for the purposes of the determination.

Section 4: provides that the form of a pharmaceutical benefit an authorised optometrist may prescribe is the form mentioned in the description of the pharmaceutical benefit in the item of Schedule 1.

Section 5: provides that the maximum quantity or number of units of a pharmaceutical benefit an authorised optometrist may prescribe in one prescription is included in the item in Schedule 1 relevant to that pharmaceutical benefit. The maximum quantity is in the form or forms mentioned in the item.

Section 6: provides that the maximum number of repeats an authorised optometrist may prescribe in one prescription for a pharmaceutical benefit is found in the item in Schedule 1 relevant to that pharmaceutical benefit.

Section 7: provides that the manner of administration of a pharmaceutical benefit that an authorised optometrist may direct to be used is outlined in the item in Schedule 1 relevant to that pharmaceutical benefit.

Section 8: provides that an authorised optometrist may write a prescription for the supply of a pharmaceutical benefit that is mentioned in an item of Schedule 1.

Section 9: provides that for sections 5 and 6, if there are any particular purposes for the supply of the pharmaceutical benefit, these are identified in the item in Schedule 1 relevant to that pharmaceutical benefit.

Schedule 1: lists the pharmaceutical benefits which may be prescribed by authorised optometrists, and certain other matters relating to the writing of prescriptions for pharmaceutical benefits when prescribed by an authorised optometrist.

ATTACHMENT 2

SUMMARY OF CHANGES

SCHEDULE 1

Addition of listed drug