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PB 60 of 2021 Other as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 30 Jun 2021
Tabling HistoryDate
Tabled HR03-Aug-2021
Tabled Senate03-Aug-2021
Date of repeal 19 Oct 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 6)

PB 60 of 2021

 

Purpose

The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.

PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, number of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).

Authority

This Instrument exercises various powers in Part VII of the Act, as set out below:

Pharmaceutical benefits listed on the PBS

Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies.  A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)).  Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug.  A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB).  Subsection 85(6) provides that the Minister may determine a brand of a pharmaceutical item.

The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).  Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.

Prescribing pharmaceutical benefits

Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit.  Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).

Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.

Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion.  Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.  The maximum quantities and repeats may be determined for all purposes or for particular purposes.

Supplying pharmaceutical benefits

Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.

Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.

Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.

Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions.

Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.

Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).

Paragraph 88(1EB) provides that the Minister can list pharmaceutical benefits without determining any authorised prescribers for the benefit allowing the benefit to be supplied only.

Variation and revocation

Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.

Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation.  Advice from the PBAC is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).

Changes to PB 71 of 2012 made by this Instrument

Schedule 1 to this Instrument provides for the addition of forms of the listed drugs cabazitaxel, pancreatic extract, guselkumab, hydromorphone, imipramine, infliximab and tofacitinib, and for the deletion of forms of the listed drugs captopril and carboplatin to and from the Schedule of Pharmaceutical Benefits. It also provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs adalimumab, cabozantinib, guselkumab, ipilimumab, ixekizumab, nivolumab, pazopanib, sapropterin, sunitinib, testosterone, tofacitinib and upadacitinib.

Schedule 1 to this Instrument also provides for the following changes:

·                the addition of 41 brands and deletion of 11 brands of existing pharmaceutical items;

·                the addition of 1 maximum quantity and number of number of repeats for an existing brand of pharmaceutical item;

·                the alteration of responsible person name for 5 existing brands of pharmaceutical items;

·                the addition of 2 responsible person codes for existing brands of pharmaceutical items;

·                the deletion of 1 responsible person code for an existing brand of pharmaceutical item;


 

·                the alteration of responsible person codes for 11 existing brands of pharmaceutical items; and

·                the addition of 12 brands of existing pharmaceutical items to supply only.

These changes are summarised, by subject matter, in the Attachment.

Consultation

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 of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.  The 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.  In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015.  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.

Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings.  This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, guarantee of supply and agreement to final listing details.

It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.

General

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

This Instrument commences on 1 July 2021.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.

 


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 6)

Section 1         Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 6) and may also be cited as PB 60 of 2021.

Section 2         Commencement

This section provides that this Instrument commences on 1 July 2021.

Section 3         Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1       Amendments

The amendments in Schedule 1 involve the addition and deletion of forms of listed drugs, the addition and deletion of brands, the addition of a maximum quantities and number of repeats, the addition, deletion and alteration of responsible person codes for brands of pharmaceutical benefits, the alteration of responsible person names for brands of pharmaceutical benefits, the addition of 12 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme. These changes are summarised below.

SUMMARY OF CHANGES TO THE PHARMACEUTICAL BENEFITS SCHEME
MADE BY THIS INSTRUMENT

Forms Added

Listed Drug

Form

Cabazitaxel

Solution concentrate for I.V. infusion 60 mg in 6 mL

Guselkumab

Injection 100 mg in 1 mL single use pre-filled pen

Hydromorphone

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL

Imipramine

Tablet containing imipramine hydrochloride 10 mg USP

Infliximab

Solution for injection 120 mg in 1 mL pre-filled pen

 

Solution for injection 120 mg in 1 mL pre-filled syringe

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 35,000 BP units of lipase activity

Tofacitinib

Tablet 10 mg

Forms Deleted

Listed Drug

Form

Captopril

Tablet 25 mg

Tablet 50 mg

Carboplatin

Solution for I.V. injection 150 mg in 15 mL

Brands Added

Listed Drug

Form and Brand

Celecoxib

Capsule 100 mg (APX-Celecoxib)

Capsule 200 mg APX-Celecoxib

Everolimus

Tablet 0.25 mg (Everocan)

Tablet 0.5 mg (Everocan)

Tablet 0.75 mg (Everocan)

Tablet 1 mg (Everocan)

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg (Ezetast)

Tablet 10 mg-20 mg (Ezetast)

Tablet 10 mg-40 mg (Ezetast)

Tablet 10 mg-80 mg (Ezetast)

Gliclazide

Tablet 80 mg (APX-Gliclazide)

Lamotrigine

Tablet 25 mg (APX-Lamotrigine)

Tablet 50 mg (APX-Lamotrigine)

Tablet 100 mg (APX-Lamotrigine)

Tablet 200 mg (APX-Lamotrigine)

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg (TRIDOPA)

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg (TRIDOPA)

Tablet 100 mg-25 mg (as monohydrate)-200 mg (TRIDOPA)

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg (TRIDOPA)

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg (TRIDOPA)

Tablet 200 mg-50 mg (as monohydrate)-200 mg (TRIDOPA)

Octreotide

Injection (modified release) 10 mg (as acetate), vial and diluent syringe
(Octreotide Depot)

Injection (modified release) 20 mg (as acetate), vial and diluent syringe
(Octreotide Depot)

Injection (modified release) 30 mg (as acetate), vial and diluent syringe
(Octreotide Depot)

Olmesartan

Tablet containing olmesartan medoxomil 20 mg (APX-Olmesartan)

Tablet containing olmesartan medoxomil 40 mg (APX-Olmesartan)

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg (APX-Olmesartan/HCTZ)

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg (APX-Olmesartan/HCTZ)

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg (APX-Olmesartan/HCTZ)

Pregabalin

Capsule 25 mg (APO-Pregabalin; Blooms The Chemist Pregabalin)

Capsule 75 mg (APO-Pregabalin; Blooms The Chemist Pregabalin)

Capsule 150 mg (APO-Pregabalin; Blooms The Chemist Pregabalin)

Capsule 300 mg (APO-Pregabalin; Blooms The Chemist Pregabalin)

Rosuvastatin

Tablet 5 mg (as calcium) (APX-Rosuvastatin)

Tablet 10 mg (as calcium) (APX-Rosuvastatin)

Tablet 20 mg (as calcium) (APX-Rosuvastatin)

Tablet 40 mg (as calcium) (APX-Rosuvastatin)

Brands Deleted

Listed Drug

Form and Brand

Alendronic acid

Tablet 70 mg (as alendronate sodium) (Alendrobell 70mg)

Candesartan

Tablet containing candesartan cilexetil 16 mg (Candesartan GH)

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg (Candesartan HCT GH 16/12.5)

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg (Candesartan HCT GH 32/12.5)

Irbesartan with hydrochlorothiazide

Tablet 150 mg-12.5 mg (Irbesartan HCT GH 150/12.5)

Tablet 300 mg-12.5 mg (Irbesartan HCT GH 300/12.5)

Tablet 300 mg-25 mg (Irbesartan HCT GH 300/25)

Mirtazapine

Tablet 45 mg (Mirtazapine GH)

Montelukast

Tablet, chewable, 4 mg (as sodium) (Montelukast GH)

Perindopril with indapamide

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate
1.25 mg
(Perindopril/ Indapamide GH 4/1.25)

Simvastatin

Tablet 80 mg (Simvastatin generichealth)


 

Addition of Maximum Quantity and Number of Repeats

Listed Drug

Form

Brand Name

Maximum Quantity

Number of Repeats

Progesterone

Capsule 200 mg

Utrogestan

42

3

Addition of Responsible Person Code

InterPharma Pty Ltd (IT)

Swedish Orphan Biovitrum Pty Ltd (ZO)

Deletion of Responsible Person Code

Eli Lilly Australia Pty Ltd (EL)

Alteration of Responsible Person Name

From:

Accord Healthcare Pty Ltd (OC; OD)

To:

Accord Healthcare Pty. Ltd. (OC; OD)

Orion Laboratories Pty Ltd (ON)

Orion Laboratories Pty. Ltd. (ON)

Otsuka Australia Pharmaceutical Pty Ltd (OS)

Otsuka Australia Pharmaceutical Pty. Ltd (OS)

Vertex Pharmaceuticals (Australia) Pty Ltd (VR)

Vertex Pharmaceuticals (Australia) Pty. Ltd. (VR)

Alteration of Responsible Person Code

Listed Drug

Form

Brand Name

Responsible Person

Anakinra

Injection 100 mg in 0.67 mL single use pre‑filled syringe

Kineret

From: FK

To: ZO

Quetiapine

Tablet 25 mg (as fumarate)

Seroquel

From: AP

To: AL

Tablet (modified release) 50 mg (as fumarate)

Seroquel XR

From: AP

To: AL

Tablet 100 mg (as fumarate)

Seroquel

From: AP

To: AL

Tablet (modified release) 150 mg (as fumarate)

Seroquel XR

From: AP

To: AL

Tablet (modified release) 200 mg (as fumarate)

Seroquel XR

From: AP

To: AL

Tablet 200 mg (as fumarate)

Seroquel

From: AP

To: AL

Tablet (modified release) 300 mg (as fumarate)

Seroquel XR

From: AP

To: AL

Tablet 300 mg (as fumarate)

Seroquel

From: AP

To: AL

Tablet (modified release) 400 mg (as fumarate)

Seroquel XR

From: AP

To: AL

Salbutamol

Pressurised inhalation 100 micrograms
(as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Zempreon CFC-Free with dose counter

From: GC

To: AL


 

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Listed Drug

Adalimumab

Pazopanib

Cabozantinib

Sapropterin

Guselkumab

Sunitinib

Ipilimumab

Testosterone

Ixekizumab

Tofacitinib

Nivolumab

Upadacitinib

Supply Only Status

Note: From 1 November 2020 Supply Only benefits are available on the Schedule for dispensing but not for prescribing, usually for a period of up to 12 months from when it is deleted.

Listed Drug

Form and Brand

Amisulpride

Tablet 100 mg (Amisulpride Sandoz)

Tablet 200 mg (Amisulpride Sandoz)

Tablet 400 mg (Amisulpride Sandoz)

Amoxicillin

Capsule 250 mg (as trihydrate) (Amoxycillin Sandoz)

Cefalexin

Capsule 250 mg (as monohydrate) (Cefalexin Sandoz)

Cyproterone

Tablet containing cyproterone acetate 50 mg (Androcur)

Entecavir

Tablet 0.5 mg (as monohydrate) (Baraclude)

Tablet 1 mg (as monohydrate) (Baraclude)

Interferon alpha-2a

Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe (Roferon-A)

Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe (Roferon-A)

Moclobemide

Tablet 150 mg (Mohexal)

Raloxifene

Tablet containing raloxifene hydrochloride 60 mg (Evifyne)


 

Documents Incorporated by Reference

Listed Drug

Document incorporated

Document access

Dupilumab

Omalizumab

Mepolizumab

Asthma Control Questionnaire (ACQ-5) and/or Asthma Control Questionnaire interviewer administered version (ACQ-IA).  Asthma Control Questionnaire (ACQ-5) and/or Asthma Control Questionnaire interviewer administered version (ACQ-IA). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The ACQ-5 and the ACQ-IA are widely used tools for measuring how well a patient’s asthma symptoms are being controlled.

Prescribers can contact the suppliers of these asthma medications directly to obtain free copies of the ACQ calculation sheets.  Contact details for the suppliers can be found online at www.pbs.gov.au

Infliximab

Crohn Disease Activity Index (CDAI). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)b of the Legislation Act 2003.

The Crohn’s Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn’s disease.

Crohn Disease Activity Index (CDAI) is available for download for free from the PubMed website:

https://pubmed.ncbi.nlm.nih.gov/12786607/

A CDAI score calculation form is included in the Services Australia application form

Cabozatinib

Pazopanib

Sunitinib

International Metastatic RCC Database Consortium (IMDC) Risk Model for Metastatic Renal Cell Carcinoma.  The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)b of the Legislation Act 2003. The International Metastatic RCC Database Consortium (IMDC) Risk Model for Metastatic Renal Cell Carcinoma is a tool used to predict survival in patients with metastatic renal cell carcinoma who are treated with systemic therapy.

The PBS restriction provides an instructional summary of how to calculate the International Metastatic RCC Database Consortium (IMDC) Risk Model score for Metastatic Renal Cell Carcinoma.

Adalimumab

Infliximab

Tofacitinib

Mayo clinic score and partial Mayo clinic score.  Mayo clinic score and partial Mayo clinic score. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The Mayo clinic score and the partial Mayo clinic score (an abbreviated form of the Mayo clinic score) are medical diagnostic tools used to measure disease activity, in a standardised way, in Ulcerative Colitis through the evaluation of symptoms.

The Mayo clinic score and the partial Mayo clinic score are available to download for free from the Inflammatory Bowel Diseases Journal via the Oxford University Press website: https://academic.oup.com/ibdjournal/article/14/12/1660/4654949?login=true

Adalimumab

Paediatric Ulcerative Colitis Activity Index (PUCAI).  Paediatric Ulcerative Colitis Activity Index (PUCAI). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The PUCAI is a standard medical diagnostic tool used to measure disease activity in children and adolescents with Ulcerative Colitis through the evaluation of symptoms.

The PUCAI is available for download for free from the Inflammatory Bowel Diseases Journal via the Oxford University Press website

https://academic.oup.com/ibdjournal/article/15/8/1218/4643533

Adalimumab

Dupilumab

Guselkumab

Infliximab

Ixekizumab

Omalizumab

Mepolizumab

Tofacitinib

Therapeutic Goods Administration (TGA)-approved Product Information. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine.

TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0

Cabozatinib

Ipilimumab

Nivolumab

Sunitinib

pazopanib

World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The WHO/ECOG performance status is a standard medical diagnostic tool used to measure how cancer impacts a patient’s daily living abilities, by evaluating a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.).

The WHO/ECOG Performance Status is available for download for free from the ECOG-ACRIN Cancer Research Group website: https://ecog-acrin.org/resources/ecog-performance-status


 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 6)

(PB 60 of 2021)

This Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Instrument

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 6) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, schedule equivalence, maximum quantities, number of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).

The amendments in Schedule 1 involve the addition and deletion of forms of listed drugs, the addition and deletion of brands, the addition of a maximum quantities and number of repeats, the addition, deletion and alteration of responsible person codes for brands of pharmaceutical benefits, the alteration of responsible person names for brands of pharmaceutical benefits, the addition of 12 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme.

Human rights implications

This Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.  The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.  The pharmaceutical industry now has a nominee on the PBAC membership.

Conclusion

This Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

 

Nikolai Tsyganov

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health