National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 5 of 2010)

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Legislation au F2010L00472 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 5 OF 2010

NATIONAL HEALTH ACT 1953

DETERMINATIONS UNDER SECTIONS 85, 85A and 88

 

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).

Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.

Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).

Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item.  A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item,  or if there is no trade name, the name of the responsible person.  The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.

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(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.

This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A).    

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determinations under sections 85, 85A and 88 made by legislative instrument number PB 114 of 2008 which came into effect on
1 December 2008.  The amendments provide for changes to the names, forms, manners of administration, and brands of listed drugs on the PBS and the conditions for prescribing pharmaceutical benefits.  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 March 2010, was made on 2 February 2010.

 

Consultations

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 March 2010.

Paragraph 2: provides that Schedule 1 amends PB 114 of 2008.

Schedule 1: provides for the following amendments:

 

SCHEDULE 1 ― PART 1

Listed Drugs Added

Nebivolol

Rizatriptan

Triglycerides, long chain with glucose polymer

Ustekinumab

 

Listed Drug Deleted

Influenza Vaccine

 

Forms Added

Candesartan with Hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

Gliclazide

Tablet 60 mg (modified release)

Glucose Indicator—Blood

Test strips, 50 (Accu-Chek Mobile)

Memantine

Tablet containing memantine hydrochloride 20 mg

Olanzapine

Powder for injection 405 mg (as pamoate monohydrate) with diluent

 

Form Deleted

Glucose Indicator—Blood

Test strips, 50 (Glucoboy)

 

Brands Added

Amoxycillin

Capsule 250 mg (as trihydrate) (Amoxycillin-GA)

Calcitriol

Capsule 0.25 microgram (Calcitriol-GA)

Ciprofloxacin

Tablet 500 mg (as hydrochloride) (Ciprofloxacin-GA)

Gabapentin

Capsule 300 mg (Gabapentin-GA)

Lisinopril

Tablet 5 mg (Lisinopril-GA)

Metformin

Tablet containing metformin hydrochloride 500 mg (Metformin-GA)

Oxaliplatin

Powder for I.V. infusion 100 mg (Oxaliplatin Link)

Paracetamol

Tablet 500 mg (Generic Health Pty Ltd)

Pravastatin

Tablet containing pravastatin sodium 80 mg (Pravastatin Sandoz)

 

Brands Deleted

Captopril

Tablet 12.5 mg (Acenorm 12.5 mg)

Tablet 25 mg (Acenorm 25 mg)

Tablet 50 mg (Acenorm 50 mg)

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (GenRx Diclofenac)

Dicloxacillin

Capsule 250 mg (as sodium) (Diclocil)

Quinapril

Tablet 20 mg (as hydrochloride) (Quinapril-DP)

 

Alteration of Manner of Administration

Sodium Chloride

Injection 9 mg per mL, 10 mL

From: Injection

To: Injection/solvent for injectables

 

Alteration of Maximum Number of Repeats

Mesalazine

Suppositories 1 g, 28

From: . .

To: 1

Enemas 1 g in 100 mL, 7

From: . .

To: 1

Enemas 2 g in 60 mL, 7

From: . .

To: 1

Enemas 4 g in 60 mL, 7

From: . .

To: 1

Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g

From: . .

To: 1

 

Alteration of Brands

Alprazolam

Tablet 1 mg

From: Zamhexal 1.0mg

To: Alprazolam Sandoz

Tablet 2 mg

From: Zamhexal 2mg

To: Alprazolam Sandoz

Citalopram

Tablet 20 mg (as hydrobromide)

From: Talohexal  

To: Citalopram Sandoz

Sotalol

Tablet containing sotalol hydrochloride 160 mg

From: Sotahexal  

To: Sotalol Sandoz

 

SCHEDULE 1 ― PART 2

Listed Drug Added

Ustekinumab

 

Form Added

Glucose Indicator—Blood

Test strips, 50 (Accu-Chek Mobile)

 

Form Deleted

Glucose Indicator—Blood

Test strips, 50 (Glucoboy)

 

Brands Added

Paracetamol

Tablet 500 mg (Generic Health Pty Ltd)

Pravastatin

Tablet containing pravastatin sodium 80 mg (Pravastatin Sandoz)

 

Alteration of Purposes

Adalimumab

[addition of the drug ustekinumab to the list of interchangeable biological agents for the treatment of severe chronic plaque psoriasis and amendment of definition of Biological Treatment Cycle)]

Etanercept

[addition of the drug ustekinumab to the list of interchangeable biological agents for the treatment of severe chronic plaque psoriasis and amendment of definition of Biological Treatment Cycle)]

 

SCHEDULE 2 ― PART 1

Listed Drug Added

Methylnaltrexone

 

Brand Deleted

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (GenRx Diclofenac)

 

SCHEDULE 2 ― PART 2

Listed Drug Added

Methylnaltrexone

 

Brand Deleted

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (GenRx Diclofenac)

 

 

SCHEDULE 3 ― PART 1

Brands Added

Amoxycillin

Capsule 250 mg (as trihydrate) (Amoxycillin-GA)

Paracetamol

Tablet 500 mg (Generic Health Pty Ltd)

 

Brands Deleted

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg (GenRx Diclofenac)

Dicloxacillin

Capsule 250 mg (as sodium) (Diclocil)

 


Alteration of Manner of Administration

Sodium Chloride

Injection 9 mg per mL, 10 mL

From: Injection

To: Injection/solvent for injectables

 

SCHEDULE 3 ― PART 2

Brand Added

Paracetamol

Tablet 500 mg (Generic Health Pty Ltd)

 

Overview

The instrument F2010L00472, issued under the National Health Act 1953, addresses the need to update the Pharmaceutical Benefits Scheme (PBS) by amending determinations regarding the forms, brands, and prescription conditions of listed drugs. Enacted by the Australian Parliament, the legislation aims to ensure that the PBS continues to provide affordable access to a range of medicines. This instrument updates the PBS by including new drugs, modifying existing drug forms, and altering prescription conditions based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, ensures that the amendments take into account clinical effectiveness, safety, and cost-effectiveness. The amendments listed in the instrument are set to take effect from 1 March 2010 and include changes such as the addition and deletion of drugs, alterations in drug forms and brands, and adjustments to prescription limits and administration methods.

Scope and Application

The National Health Act 1953, as amended by the legislative instrument F2010L00472, governs the Pharmaceutical Benefits Scheme (PBS) under which the Commonwealth provides access to affordable medicines for all Australians. This instrument applies to the Minister for Health who is authorised to make determinations under sections 85, 85A, and 88 of the Act concerning listed drugs, their forms, manners of administration, and brands, as well as the prescribing conditions for pharmaceutical benefits. These determinations are influenced by recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that evaluates the clinical effectiveness, safety, and cost-effectiveness of medicines. The instrument, which came into effect on 1 March 2010, amends previous determinations to update the list of drugs, their forms, brands, and prescribing conditions, reflecting changes in medical practice and available treatments. It applies nationally across Australia and involves changes such as adding and deleting specific drugs and their forms, altering the manner of administration, and updating brands. This instrument does not specify any exclusions, exemptions, or thresholds, and it operates within the framework established by the Act, with potential further regulation through subordinate instruments.

Key Provisions

The main operative sections of the instrument are those that amend determinations under sections 85, 85A, and 88 of the National Health Act 1953 (the Act). These sections (subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A)) are concerned with the listing, forms, brands, and prescribing conditions of pharmaceutical benefits available under the Pharmaceutical Benefits Scheme (PBS). The instrument amends previous determinations made by legislative instrument number PB 114 of 2008 to incorporate changes recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The amendments include adding and deleting certain drugs and forms from the PBS, altering the manner of administration of some drugs, changing the brands associated with certain drugs, and modifying prescription conditions such as the maximum number of repeats and the authorised prescribers for certain drugs. The obligations and requirements imposed by the Act on parties and entities are primarily concerned with the administration and management of the PBS. The Minister for Health is responsible for determining which drugs and forms are listed on the PBS, the brands associated with these drugs, and the conditions under which these drugs can be prescribed. This involves a process of consultation with the PBAC, an independent expert body that recommends which drugs should be listed on the PBS based on factors such as clinical effectiveness, safety, and cost-effectiveness. The Minister must also ensure that the PBS provides reliable, timely, and affordable access to a wide range of medicines for all Australians. The instrument imposes several penalties and consequences for breaches of the Act. The maximum penalties for offences under the Act can vary depending on the specific provision that has been breached. However, in general, offences under the Act can result in fines of up to $22,000 for individuals and $110,000 for bodies corporate. In addition to criminal penalties, breaches of the Act may also give rise to civil consequences such as the revocation of registration or authorisation to supply pharmaceutical benefits. In summary, the instrument amends determinations under sections 85, 85A, and 88 of the National Health Act 1953 to incorporate changes recommended by the PBAC. The amendments include adding and deleting certain drugs and forms from the PBS, altering the manner of administration of some drugs, changing the brands associated with certain drugs, and modifying prescription conditions such as the maximum number of repeats and the authorised prescribers for certain drugs. The Minister for Health is responsible for determining these matters, and breaches of the Act can result in criminal and civil penalties.

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