National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 2) (PB 18 of 2020)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 2)

PB 18 of 2020

 

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.  Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII, have effect subject to a special arrangement made under subsection 100(1).

Purpose

The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement) to make changes relating to the Efficient Funding of Chemotherapy.

The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (‘chemotherapy pharmaceutical benefits’) to eligible patients being treated for cancer, to reflect the 2010 Budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’.  The Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (‘related pharmaceutical benefits’) at certain public hospitals.

This Instrument makes amendments to the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Schedule 1 to this Instrument provides for the addition of the drug durvalumab to the Special Arrangement and the alteration of circumstances in which a prescription may be written for the supply of the listed drugs atezolizumab, ipilimumab, nivolumab and pembrolizumab.  It also provides for the deletion of twelve brands of existing pharmaceutical benefits, the alteration of one responsible person code for an existing brand and the addition of one responsible person code to the list of responsible persons.  These changes are summarised, by subject matter, in the Attachment. 

Consultations

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC).  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 as pharmaceutical benefits.  Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

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 these 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.

Pharmaceutical companies are consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process 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 has already taken place.

This Instrument commences on 1 March 2020.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 2)

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 2) and may be cited as
PB 18 of 2020.

Section 2 Commencement

This section provides that this Instrument commences on 1 March 2020.

Section 3 Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

This section provides that Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1 Amendments

The amendments in Schedule 1 involve the addition of a drug, deletion of brands, alteration of a responsible person code for an existing brand, addition of a responsible person to the list of responsible persons and alteration to circumstances for prescribing various pharmaceutical benefits available on the Special Arrangement.  These changes are summarised below.

 

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT 2011 MADE BY THIS INSTRUMENT

Listed Drugs Added

Listed Drug

Durvalumab

 

Brands Deleted

Listed Drug

Form and Brand

Fluorouracil

Injection 2500 mg in 50 mL (Fluorouracil Ebewe)

Folinic acid

Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL (Calcium Folinate Ebewe)

 

Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL (Calcium Folinate Ebewe)

Idarubicin

Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL (Idarubicin Ebewe)

Irinotecan

I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Hospira Pty Limited)

 

I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL (Hospira Pty Limited)

Oxaliplatin

Solution concentrate for I.V. infusion 100 mg in 20 mL (Oxaliplatin SZ)

Paclitaxel

Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxel Ebewe)

 

Solution concentrate for I.V. infusion 150 mg in 25 mL (Paclitaxel Ebewe)

Pemetrexed

Powder for I.V. infusion 100 mg (as disodium) (DBL Pemetrexed)

 

Powder for I.V. infusion 500 mg (as disodium) (DBL Pemetrexed)

 

Powder for I.V. infusion 1 g (as disodium) (DBL Pemetrexed)

Alteration of Responsible Person Code

Listed Drug

Form

Brand Name

Responsible Person

Cladribine

Injection 10 mg in 5 mL

Litak

From: AS

To: AF

Addition of Responsible Person Code

AstraZeneca Pty Ltd (AP)

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Atezolizumab

Ipilimumab

Nivolumab

Pembrolizumab


Statement of Compatibility with Human Rights

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

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 2)

(PB 18 of 2020)

This Legislative 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 Legislative Instrument

The purpose of this Legislative Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement) to make changes relating to the Efficient Funding of Chemotherapy.

The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (‘chemotherapy pharmaceutical benefits’) to eligible patients being treated for cancer, to reflect the 2010 Budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’.  The Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (‘related pharmaceutical benefits’) at certain public hospitals.

This Instrument provides for amendments to the Special Arrangement to ensure that the Special Arrangement accurately reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act, which commence on the same day.

The amendments in Schedule 1 involve the addition of a drug, deletion of brands, alteration of a responsible person code for an existing brand, addition of a responsible person to the list of responsible persons and alteration to circumstances for prescribing various pharmaceutical benefits available on the Special Arrangement. 

Human Rights Implications

This Legislative Instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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 Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with the 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.

Conclusion

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

 

 

 

Ben Sladic

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 2) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 in order to better align with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This legislative instrument was made under subsection 100(2) of the National Health Act 1953 by the Minister for Health, reflecting the intent to ensure the efficient funding of chemotherapy and related pharmaceutical benefits. This amendment introduces modifications such as the addition of new drugs, deletion of certain pharmaceutical brands, and adjustments to prescribing circumstances and responsible person codes, all aimed at improving the effectiveness and efficiency of the funding mechanism for chemotherapy treatments. The Parliament of Australia authorised this amendment to address the need for a dynamic and responsive funding mechanism for chemotherapy treatments, ensuring that the Special Arrangement accurately reflects the current landscape of pharmaceutical benefits. The policy objective is to enhance the efficiency of funding for chemotherapy drugs and associated medicines, thereby ensuring that eligible patients receive timely and effective treatment. The Pharmaceutical Benefits Advisory Committee played a crucial role in the consultation process, providing expert recommendations that were integral to the development of this amendment.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 2) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, as part of the National Health Act 1953. This Instrument applies to the supply of chemotherapy pharmaceutical benefits and related pharmaceutical benefits, which are medicines used to treat the side effects of cancer and cancer treatment, to eligible patients in certain public hospitals. The amendments are designed to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the Special Arrangement remains consistent with current legislative and health standards. The amendments involve the addition of the drug durvalumab, the deletion of twelve brands of existing pharmaceutical benefits, the alteration of one responsible person code for an existing brand, the addition of one responsible person code to the list of responsible persons, and alterations to the circumstances for prescribing atezolizumab, ipilimumab, nivolumab, and pembrolizumab. These changes are aimed at maintaining efficient funding and accessibility of essential cancer treatment medications. The amendments specified in this Instrument commence on 1 March 2020, and the scope of the Act extends to ensuring that the Special Arrangement aligns with the recommendations of the Pharmaceutical Benefits Advisory Committee, an independent expert body established under the Act. The Act applies to drugs and medicinal preparations recommended by the Pharmaceutical Benefits Advisory Committee, which takes into account the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety, and cost-effectiveness compared with other treatments. The Special Arrangement, as amended, ensures that the efficient funding of chemotherapy aligns with the broader objectives of the National Health Act 1953, particularly in relation to the provision of pharmaceutical benefits and the management of the Pharmaceutical Benefits Scheme.

Key Provisions

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 2) (the Instrument) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (the Special Arrangement) (sections 1, 2, 3). The Instrument provides for the addition of the drug durvalumab to the Special Arrangement and the alteration of circumstances in which a prescription may be written for the supply of the listed drugs atezolizumab, ipilimumab, nivolumab and pembrolizumab. It also provides for the deletion of twelve brands of existing pharmaceutical benefits, the alteration of one responsible person code for an existing brand and the addition of one responsible person code to the list of responsible persons (Schedule 1). The Instrument requires that these changes reflect the amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (sections 84AF, 84AK, 85, 85A, 88 and 101) (the Instrument) (section 1). The Instrument imposes obligations on parties and entities it governs by requiring them to adhere to the changes made to the Special Arrangement, including the addition and deletion of drugs and brands, the alteration of responsible person codes, and the alteration of circumstances for prescribing pharmaceutical benefits (Schedule 1). The Instrument also imposes an obligation on the Minister to ensure that the changes made to the Special Arrangement are compatible with human rights (section 1). The Instrument provides for offences, penalties, and consequences for breach of its provisions. However, the specific penalties or consequences for breach are not explicitly stated in the Instrument. The National Health Act 1953 (the Act) provides for the imposition of penalties for breaches of the Act, including fines and imprisonment (section 121). The Act also provides for the imposition of civil penalties for breaches of the Act, including fines (section 122). The penalties for breach of the Instrument may be determined by the Minister or a relevant authority under the Act. The Instrument is a legislative instrument for the purposes of the Legislation Act 2003 (section 1). It 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 (section 1). The Instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) 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 (section 1). The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with the advancement of this human right by providing for subsidised access by patients to medicines (section 1). The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based (section 1).

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