National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 4) (PB 38 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00525 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. 4)

PB 38 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 alteration of circumstances in which a prescription may be written for the supply of the listed drugs pertuzumab and trastuzumab emtansine.  It also provides for the addition of one brand to two forms of existing pharmaceutical benefits and for the deletion of one form of the listed drug folinic acid.  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 May 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. 4)

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. 4) and may also be cited as
PB 38 of 2020.

Section 2 Commencement

This section provides that this Instrument commences on 1 May 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 deletion of a form of a listed drug, the addition of a brand to two forms of a listed drug, and the 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 Deleted

Listed Drug

Form

Folinic acid

Injection containing calcium folinate equivalent to
1000 mg folinic acid in 100 mL

Brands Added

Listed Drug

Form and Brand

Trastuzumab

Powder for I.V. infusion 60 mg (Trazimera)

Powder for I.V. infusion 150 mg (Trazimera)

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Pertuzumab

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. 4)

(PB 38 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 deletion of a form of a listed drug, the addition of a brand to two forms of a listed drug, and the 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. 4) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, which was established to enhance the efficiency of payments for the supply of chemotherapy medicines to eligible cancer patients. This legislative instrument, created under the authority of subsection 100(2) of the National Health Act 1953, aims to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective is to ensure that the special arrangement remains consistent with the latest updates to pharmaceutical benefits. The amendments include altering prescription conditions for certain drugs, adding a brand to existing drug forms, and deleting a form of a listed drug. This legislative instrument ensures the efficient and effective funding of chemotherapy, contributing to the overall health and wellbeing of cancer patients in Australia. The instrument was developed with extensive consultation with relevant stakeholders, including the Pharmaceutical Benefits Advisory Committee (PBAC), which makes evidence-based recommendations about the availability of pharmaceutical benefits. Pharmaceutical companies are also consulted during the process of adding or changing listings on the Pharmaceutical Benefits Scheme (PBS). The amendments outlined in the instrument are designed to streamline the funding and supply of chemotherapy drugs, ensuring that the most effective and cost-efficient treatments are accessible to those in need.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 4) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to enhance efficiency in the payment for the supply of chemotherapy and related pharmaceutical benefits, particularly for patients undergoing cancer treatment. This amendment reflects the 2010 Budget measure titled 'Revised arrangements for the efficient funding of chemotherapy drugs'. It applies to entities involved in the supply of chemotherapy medicines to eligible patients and to public hospitals supplying related pharmaceutical benefits. The amendment ensures the Special Arrangement aligns with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commenced on 1 May 2020. The instrument includes specific changes such as the deletion of a form of folinic acid, the addition of a brand to two forms of trastuzumab, and alterations to the circumstances for prescribing certain pharmaceutical benefits. The amendments are designed to improve access to and the efficiency of funding for chemotherapy and related treatments. The changes are made in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that recommends which drugs should be available as pharmaceutical benefits, ensuring that decisions are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness.

Key Provisions

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 4) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to reflect recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment is crucial as it ensures the Special Arrangement accurately reflects these changes, which are effective from the same date. The main changes involve the deletion of a form of the listed drug folinic acid, the addition of a brand to two forms of the listed drug trastuzumab, and alterations to the circumstances under which prescriptions may be written for various pharmaceutical benefits, including pertuzumab and trastuzumab emtansine (sections 3 and Schedule 1). The amended Special Arrangement imposes specific obligations on healthcare providers and entities involved in the supply of chemotherapy pharmaceutical benefits and related pharmaceutical benefits. Healthcare providers must adhere to the new prescription guidelines and ensure that the supply of listed drugs and their forms comply with the amended arrangement. Pharmaceutical companies and suppliers must ensure that the drugs listed under the Special Arrangement are available and correctly branded as per the amendments. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a significant role in advising the Minister on which drugs should be available as pharmaceutical benefits, ensuring that decisions are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. Breaches of the requirements under the amended Special Arrangement may result in legal consequences. While the specific penalties are not detailed in the Explanatory Statement, violations of the National Health Act 1953 and related instruments generally could lead to fines and other administrative penalties. For instance, incorrect supply of pharmaceutical benefits or non-compliance with the Special Arrangement could potentially result in financial penalties for the involved parties, and in severe cases, legal action may be pursued. Additionally, failure to comply with the recommendations of the PBAC or the provisions of the Special Arrangement could lead to the revocation of pharmaceutical benefits listings, affecting the availability and funding of these medications. The legislative instrument is designed to be compatible with human rights, particularly engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). By facilitating access to affordable chemotherapy and related pharmaceutical benefits, the amended Special Arrangement supports the right to the highest attainable standard of physical and mental health. The involvement of the PBAC ensures that the decisions regarding the listing of medicines on the Pharmaceutical Benefits Scheme are made with due consideration of human rights, thereby promoting equitable access to essential health services.

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