National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - Amendment determination under subsection 85(2A) - drugs and medicinal preparations (No. PB 95 of 2010)

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 95 OF 2010

NATIONAL HEALTH ACT 1953

AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)

    AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)

Summary

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 14 of 2010 which came into effect on 1 April 2010.  The amendments declare additions and changes to the list of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances in which the pharmaceutical benefits may be prescribed. The amendments also identify which listed drugs authorised midwives and authorised nurse practitioners are able to prescribe, though this is determined, pursuant to subsections 88(1D) and 88(1E) in a different instrument (PB 96 of 2010, amending PB 68 of 2010).  The amendments are set out in the items 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 in relation to which Part VII applies are declared by the Minister by legislative instrument as such 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 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation. 

Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the PBAC.  Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA).  Subsection 101(4) further provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared.

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

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

This instrument commences on 1 November 2010.

Consultations

Consultation regarding implementation of arrangements for midwives and nurse practitioners as PBS prescribers occurred via advisory groups established to advise on specific issues and technical aspects.  The advisory groups included practitioners from medical and allied health professions, with experience in midwifery, nursing, general practice, obstetrics, and representatives from registration bodies, state and territory health services, regional and remote health services, Indigenous populations, and consumers.  Advice was provided on Medicare eligibility, collaborative arrangements with other health professionals, authorisation as PBS prescribers, and medicines for PBS prescribing.

The involvement of interested parties through the membership of the 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 recommending the listing of 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.

ATTACHMENT

Paragraph 1:  provides that this instrument commences on 1 November 2010.

Paragraph 2:  provides that Schedule 1 amends PB 14 of 2010.

Schedule 1: provides for the following amendments:

Preamble paragraphs

The introductory paragraphs to the principal instrument are amended to reflect the changes in the Act to allow prescribing of certain listed drugs and in specified circumstances by authorised midwives and/or authorised nurse practitioners. 

Definitions – Paragraph 3

Paragraph 3 is amended to insert in alphabetical order the following definitions:

Drugs and medicinal preparations to which Part VII applies

The amendment replaces paragraph 4 and inserts, after paragraph 4, as new paragraphs 4AA, 4AB, 4AC and 4AD, the means of identifying the drugs and medicinal preparations to which Part VII of the Act applies, and the circumstances that apply, for the purposes of the writing of prescriptions by medical practitioners, authorised midwives and authorised nurse practitioners. 

Paragraph 4 is omitted and substituted with a new paragraph 4 to provide that Part VII of the Act applies in relation to each of the drugs and medicinal preparations specified in column 1 of Schedule 1 or 1A, including where [NP] or [NP] [MW] is mentioned in column 1, and the circumstances (if any) specified in column 3 of Schedule 1 or column 2 of Schedule 1A, opposite the name of the drug or medicinal preparation apply when the listed drug is prescribed by a medical practitioner.

Where [MW] is included with the name of a drug or medicinal preparation specified in column 1 of Schedule 1, including where [NP] is also mentioned in column 1, Part VII of the Act applies in relation to each of the drugs and medicinal preparations, and the circumstances (if any) specified in column 3 of Schedule 1 opposite the name of that drug or medicinal preparation apply when the listed drug is prescribed by an authorised midwife, unless [MW] is also mentioned in column 3 of Schedule 1.  The [MW] where included in column 1 does not form part of the name of the listed drug.

Where [MW] is included in column 1 of Schedule 1 and is also mentioned in colum 3 of that Schedule with a form of a listed drug, Part VII of the Act applies for that form, and the circumstances (if any) specified in column 3 apply, when the listed drug is prescribed by an authorised midwife or medical practitioner.  The [MW] where included in column 3 does not constitute part of the form or strength of the listed drug.

Where [NP] is included with the name of a drug or medicinal preparation specified in column 1 of Schedule 1 or 1A, including where [MW] is also mentioned in column 1 of Schedule 1, Part VII of the Act applies in relation to each of the drugs and medicinal preparations, and the circumstances (if any) specified in column 3 of Schedule 1 or column 2 of Schedule 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by an authorised nurse practitioner, unless [NP] is also mentioned in column 3 of Schedule 1.  The [NP] where included in column 1 does not form part of the name of the listed drug.

Where [NP] is included in column 1 of Schedule 1 and is also mentioned in column 3 of that Schedule with the circumstances for a listed drug, a form of a listed drug, or the circumstances for a form of a listed drug, Part VII of the Act applies in relation to the listed drug for those circumstances or for that form, and the circumstances (if any) specified in column 3 for that listed drug, or for that form of the listed drug apply, when prescribed by an authorised nurse practitioner or medical practitioner.  The [NP] where included in column 3 with a circumstance, or form and strength of a listed drug, does not constitute part of the circumstance or form and strength for the listed drug.

Circumstances – Subparagraph 14(d)

Subparagraph 14(d) is omitted and substituted with amended subparagraph 14(d) to require that where it is specified in column 3 of Schedule 1 or column 2 of Schedule 1A (in respect of medical practitioners); or in column 3 of Schedule 1 or column 2 of Schedule 1A where [NP] is included in column 1 with the name of the drug or medicinal preparation, and including where [MW] is also mentioned in column 1, (in respect of authorised nurse practitioners); or in column 2 of Schedule 2A (in respect of authorised optometrists); that compliance with authority procedures set out in subparagraph 14(d) is required, that is, that a medical practitioner, authorised nurse practitioner or authorised optometrist has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit.  This extends the application of authority procedures set out in subparagraph 14(d) to include prescriptions for pharmaceutical benefits written by authorised nurse practitioners for the specified drugs and medicinal preparations.  Subsubparagraphs 14(d)(i) to 14(d)(iii) set out the requirements for authorised nurse practitioners and authorised optometrists, and subsubparagraphs 14(d)(i) to 14(d)(iv) for medical practitioners, in relation to such prescriptions.

Circumstances – subsubparagraphs 14(d)(i), 14(d)(ii) and 14(d)(iii)

Subsubparagraphs 14(d)(i), 14(d)(ii) and 14(d)(iii) are amended to replace mention of “the medical practitioner”, wherever occurring, with “the medical practitioner, authorised nurse practitioner”.

Circumstances – paragraph 14A

Paragraph 14A is amended to replace “the medical practitioner” with “the medical practitioner, authorised nurse practitioner”.

Circumstances – subparagraph 15(a)

Subparagraph 15(a) is amended to replace mention of “the medical practitioner”, wherever occurring, with “the medical practitioner, authorised nurse practitioner”.

Circumstances – paragraph 15A(a)

Subparagraph 15A(a) is omitted and substituted with a new subparagraph 15A(a) that includes authorised nurse practitioners such that the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; or in the case of an authorised nurse practitioner or authorised optometrist, must tell the authorised nurse practitioner or authorised optometrist orally the number that has been allotted to the authorised prescription.

Circumstances - subparagraph 15A(b)

Subparagraph 15A(b) is amended to replace “the medical practitioner”, with “the medical practitioner, authorised nurse practitioner”.

Circumstances - paragraph 15B

Paragraph 15B is amended to replace mention of “the medical practitioner”, wherever occurring, with “the medical practitioner, authorised nurse practitioner”.

Circumstances – paragraph 15C

Paragraph 15C is amended to replace “a medical practitioner” with “a medical practitioner or an authorised nurse practitioner”.

SCHEDULE 1

The drugs listed in Schedule 1 which may be prescribed by authorised midwives are indicated by [MW], and by authorised nurse practitioners by [NP] as applicable.

Addition of Listed Drugs

Deletion of Listed Drug

Alteration of Circumstances

SCHEDULE 1A

The drugs listed in Schedule 1A may be prescribed by authorised nurse practitioners and are indicated by [NP].

SCHEDULE 3

Addition of Allowable Compounds