National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 1) (No. PB 11 of 2011)

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Listing of Pharmaceutical Benefits)

Amendment Instrument 2011 (No. 1)

PB 11 of 2011 

Purpose

This legislative instrument provides for amendments to the the Pharmaceutical Benefits Scheme (PBS) listing for ciprofloxacin tablets, 250 mg (as hydrochloride), 500 mg (as hydrochloride) and 750 mg (as hydrochloride) commencing on 20 January 2011.  This amendment to the listing enables the PBS supply of these pharmaceutical benefits for the treatment of skin or soft tissue infections (wound management) where other antimicrobial agents are ineffective or inappropriate.  This additional circumstance to prescribe these pharmaceutical benefits on a temporary basis which applies in all States and Territories, is in support of a Queensland Department of Health initiative for the management of wound infections as a result of exposure to bacteria in the flood waters.

Instrument amends PB 108 of 2010

This Instrument amends PB 108 of 2010 (the PBS listing instrument) which commenced on
1 December 2010.  The PBS listing instrument contains:

• declarations under subsections 85(2), 85(2A) and 101(4AA) of the National Health Act 1953 (the Act); and
• determinations under subsections 84AF(1), 85(3), (5), (6), (7), (8), 85A(2), 88(1A), (1C), (1D) and (1E) of the Act.

The PBS listing instrument determines  the pharmaceutical benefits that are on the PBS (through declarations of drugs and medicinal preparations, and for ready-prepared benefits: determinations of forms, manners of administration and brands).  It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities and numbers of repeats, and whether the pharmaceutical benefit is to be available generally or available only under special arrangements).

The Pharmaceutical Benefits Scheme and the powers exercised in the PBS listing instrument

• Overview

Part VII of the Act is the legislative basis for the PBS under which Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) of the Act provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Other provisions of Part VII provide for the Minister to make declarations and determinations, by legislative instrument, defining those pharmaceutical benefits and matters relating to the prescribing of those benefits.  These are the powers exercised in the PBS listing instrument and they are explained below.

• Minister’s powers – drugs and medicinal preparations, forms, manners of administration and brands

The Minister’s powers to declare drugs and medicinal preparations under subsection 85(2) of the Act, and to determine forms, manners of administration and brands under subsections 85(3), (5) and (6) respectively, are exercised in the PBS listing instrument.

Subsection 85(2) provides for the drugs and medicinal preparations to which Part VII applies.  Part VII applies to the drugs and medicinal preparations declared by the Minister under paragraph 85(2)(a).  Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).  All of the drugs and medicinal preparations in relation to which a declaration is in force under subsection 85(2) are defined as listed drugs.

The Minister may not declare, under paragraph 85(2)(a), a drug or medicinal preparation to be a drug or medicinal preparation in relation to which Part VII applies unless the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Minister that it be so declared (subsection 101(4)).  

The Minister may determine:

• the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3) of the Act);
• the manner of administration of a form of a listed drug (subsection 85(5) of the Act); and
• a brand of a pharmaceutical item (subsection 85(6) of the Act).  The pharmaceutical item is the listed drug in the form with the manner of administration determined (section 84AB). 

For ready-prepared pharmaceutical benefits, these declarations and determinations govern what is a pharmaceutical benefit  under the definition of that term in subsection 84(1) of the Act.  Where a drug has been declared under subsection 85(2), and a form, manner of administration and brand determined under subsections 85(3), (5) and (6) respectively, the pharmaceutical benefit is that brand of the drug in that form with that manner of administration.

• Minister’s powers – prescribing of pharmaceutical benefits

The Minister’s powers to determine authorised prescribers, prescribing circumstances, and maximum quantities and number of repeats that may be prescribed, under section 88, and subsections 85(7) and 85A(2) of the Act, respectively, are exercised in the PBS listing instrument.

Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits.  Subsection 88(1) provides that, subject to Part VII, a medical practitioner is authorised to write a prescription for the supply of a pharmaceutical benefit.  Other subsections of section 88 empower the Minister to determine the pharmaceutical benefits that may be prescribed by the various categories of prescribers mentioned.  The prescribers and the relevant subsections are:

• participating dental practitioners (subsection 88(1A));
• authorised optometrists (subsection 88(1C));
• authorised midwives (subsection 88(1D)); and
• authorised nurse practitioners (subsection 88(1E)).

The Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit (paragraph 85(7)(b)), after determining (under paragraph 85(7)(a)) that the pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A.  Section 88A provides that the writing of a prescription for a relevant pharmaceutical benefit is authorised only in the circumstances determined under subsection 85(7).

The Minister may determine the maximum quantity or number of units of a pharmaceutical benefit or pharmaceutical item that may be directed to be supplied, and the maximum number of occasions on which the supply may be directed to be repeated, in the one prescription (subsection 85A(2)).  The determinations may be made with respect to the writing of prescriptions by persons included in a specified class of persons (ie, particular prescribers), and the maximums may be specified for all purposes or particular purposes.

Changes to the PBS effected by this Instrument

The changes made to the PBS by this Instrument are summarised, by subject matter, in Attachment 2.

Consultation

Consultation and support; the Chair of the PBAC and the PBAC committee members agreed to the amended listing of ciprofloxacin tablets, 250 mg (as hydrochloride), 500 mg (as hydrochloride) and 750 mg (as hydrochloride) on a limited time basis.  Consultation with the Queensland Department of Health and advice and approval from the Chief Medical Officer was also undertaken.

The involvement of interested parties through the membership of PBAC constitutes a formal and ongoing process of consultation. PBAC is an independent expert body established by section 100A of the Act 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  When recommending the listing of a medicine on the PBS, 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 pharmaceutical companies that supply ciprofloxacin tablets, 250 mg (as hydrochloride), 500 mg (as hydrochloride) and 750 mg (as hydrochloride) have been consulted in relation to changes to the listing of these medicines. 

This Instrument

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

The Instrument commences on 20 January 2011.

This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

ATTACHMENT 1

PROVISION BY PROVISION DESCRIPTION OF INSTRUMENT

Section 1   Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 1) and may also be cited as PB 11 of 2011.

Section 2   Commencement

This section provides that the Instrument commences on 20 January 2011.

Section 3   Amendment of PB 108 of 2010

This section provides that Schedule 1 to the Instrument amends PB 108 of 2010.

Schedule 1   Amendments

Schedule 1 sets out the amendments to PB 108 of 2010.  These amendments are summarised in Attachment 2.

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ATTACHMENT 2

SUMMARY OF CHANGES

Alteration of Circumstances