National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 3) (PB 25 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00364 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 3)

PB 25 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 a form of the listed drug atezolizumab and the alteration of circumstances in which a prescription may be written for the supply of the listed drugs atezolizumab, bortezomib, pertuzumab, rituximab, trastuzumab and trastuzumab emtansine.  It also provides for the deletion of five brands of existing pharmaceutical benefits.  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 April 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. 3)

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. 3) and may be cited as
PB 25 of 2020.

Section 2 Commencement

This section provides that this Instrument commences on 1 April 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 form of a listed drug, deletion of brands, 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

Forms Added

Listed Drug

Form

Atezolizumab

Solution concentrate for I.V. infusion 840 mg in 14 mL

Brands Deleted

Listed Drug

Form and Brand

Cisplatin

I.V. injection 50 mg in 50 mL (Hospira Pty Limited)

I.V. injection 100 mg in 100 mL (Hospira Pty Limited)

Epirubicin

Solution for injection containing epirubicin hydrochloride 50 mg in
25 mL (Pharmorubicin)

Solution for injection containing epirubicin hydrochloride 200 mg in
100 mL (Pharmorubicin)

Fludarabine

Powder for I.V. injection containing fludarabine phosphate 50 mg (Fludarabine ACT)

 


Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Atezolizumab

Bortezomib

Pertuzumab

Rituximab

Trastuzumab

Trastuzumab emtansine


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. 3)

(PB 25 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 form of a listed drug, deletion of brands, 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. 3) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, which was introduced to enhance efficiency in payment for the supply of injected or infused chemotherapy medicines to eligible patients being treated for cancer, as well as the supply of medicines associated with the side-effects of cancer and cancer treatment at certain public hospitals. This amendment instrument was enacted to align the special arrangement with changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments include the addition of a form of the listed drug atezolizumab, the deletion of five brands of existing pharmaceutical benefits, and alterations to the circumstances in which prescriptions may be written for certain drugs. The amendments are detailed in Schedule 1 of the Instrument. The process of consultation for this amendment was deemed unnecessary given the prior extensive consultation process involving the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the National Health Act 1953, which ensures evidence-based decision-making regarding pharmaceutical benefits. This Legislative Instrument is compatible with human rights as it facilitates the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights (ICESCR). By ensuring access to subsidised chemotherapy drugs through the PBS and the evidence-based recommendations of the PBAC, the Instrument supports the advancement of this human right.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 3) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to update the efficient funding of chemotherapy, reflecting changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This Instrument is made under subsection 100(2) of the National Health Act 1953, which allows the Minister to make special arrangements for the supply of pharmaceutical benefits. The purpose of this amendment is to ensure that the Special Arrangement accurately reflects recent changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS), which assist with the progressive realisation of the right to the highest attainable standard of physical and mental health as recognised under the International Covenant on Economic, Social and Cultural Rights. The Special Arrangement applies to the supply of chemotherapy pharmaceutical benefits to eligible patients being treated for cancer, as well as related pharmaceutical benefits for the side-effects of cancer and cancer treatment at certain public hospitals. The changes made by this Instrument are summarised in the Attachment and include the addition of a form of the drug atezolizumab, the deletion of five brands of pharmaceutical benefits, and alterations to the circumstances in which prescriptions may be written for several drugs. This Instrument commences on 1 April 2020.

Key Provisions

The main operative sections of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 3) (PB 25 of 2020) amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011). The primary changes, as outlined in Schedule 1, include the addition of a form of the listed drug atezolizumab, the deletion of five brands of existing pharmaceutical benefits, and the alteration of circumstances under which prescriptions may be written for the supply of certain listed drugs. These changes aim to ensure that the Special Arrangement accurately reflects updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The obligations imposed by this Instrument on parties and entities include ensuring that the Special Arrangement is updated to reflect the most current pharmaceutical benefits listings and prescribing conditions. This includes adhering to the new conditions for prescribing atezolizumab, bortezomib, pertuzumab, rituximab, trastuzumab, and trastuzumab emtansine, as well as ensuring that the deleted brands are no longer supplied under the Special Arrangement. Pharmaceutical companies, prescribers, and public hospitals must comply with these changes to maintain eligibility for funding under the Special Arrangement. Any breaches of this Instrument may result in legal consequences. Specifically, if pharmaceutical benefits are supplied in contravention of the amendments made by this Instrument, the supplier may be liable for civil penalties. The Act does not specify the exact penalties, but civil penalties for breaches of the National Health Act 1953 can include fines. Additionally, public hospitals that do not comply with the new prescribing conditions risk losing eligibility for funding under the Special Arrangement, which could impact their ability to provide certain chemotherapy and related pharmaceutical benefits to patients. Compliance with the requirements of this Instrument is crucial for maintaining the integrity and efficiency of the funding arrangements for chemotherapy and related pharmaceutical benefits. Parties and entities involved in the supply and prescribing of these benefits must stay informed of the changes and ensure that their practices align with the updated Special Arrangement. Failure to do so could lead to both civil and administrative penalties, impacting their operations and the continuity of care for patients.

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