National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 2) (PB 13 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00226 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health (Efficient Funding of Chemotherapy)

Special Arrangement Amendment Instrument 2017 (No. 2)

PB 13 of 2017

 

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 Legislative 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 seeks to support the implementation of revised program arrangements for the provision of pharmaceutical benefits relating to chemotherapy infusions, as agreed under the Sixth Community Pharmacy Agreement.

 

This Instrument amends the dates in Sections 46A, 46A (1), 46B and 46B (1) of Part 4, Division 2A of the Special Arrangement to reflect the Departments decision to extend the period for claims based payment arrangements currently in place.

 

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

 

Consultations

 

The Department of Health has consulted with state and territory departments of health and the Department of Human Services.  The extension of the introduction of changed claiming arrangements from 1 April 2017 to 1 February 2018 is in response to requests from the state and territory departments of health. The extension will provide time for full implementation of systems requirements for the changes and prevent supply and access to medicines issues that may occur if the extension were not granted.

 

This Instrument commences on the day after registration.

 

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

 


ATTACHMENT

 

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 2)

Section 1 Name of Instrument

This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 2) and that it may also be cited as PB 13 of 2017.

Section 2 Commencement

This section provides that this Instrument commences on the day after registration.

Section 3 Amendment of 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) (the Special Arrangement).

Schedule 1 Amendments

Item 1 amends the end date of the claims based arrangements period specified in Division 2A, 46A and 46A (1) from 31 March 2017 to 31 January 2018.  This change reflects the decision of the Department of Health to extend the claims based arrangements period. 

Item 2 amends the start date for the revised payment arrangements that allow based on PBS data as specified in Division 2A, 46B and 46B (1) from 1 April 2017 to 1 February 2018.  This change reflects the decision of the Department of Health to delay the commencement of the revised payment arrangements until February 2018.

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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 2013 (No. 4)

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 subsections 100(1) and 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 to the special arrangement 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’. This 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:

  • adds 4 new listed brands for the listed drugs ‘Doxorubicin’, and ‘Gemcitabine’;
  • adds 1 new listed form for the listed drug ‘Aprepitant’;
  • removes 2 listed brands for the listed drug ‘Docetaxel’; and
  • adds new circumstance codes and the associated circumstances for  the listed drug ‘Aprepitant’.

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 advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory

Overview

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 2) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) in order to make changes relating to the efficient funding of chemotherapy drugs. This legislative instrument was introduced to address the need for greater efficiency in the payment for the supply of injected or infused chemotherapy medicines to eligible patients being treated for cancer. The instrument also pertains to the supply of medicines associated with the side-effects of cancer and cancer treatment at certain public hospitals. The policy objective is to support the implementation of revised program arrangements for the provision of pharmaceutical benefits relating to chemotherapy infusions, as agreed under the Sixth Community Pharmacy Agreement. The instrument was enacted by the Parliament of Australia and seeks to align 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, particularly by assisting with the progressive realisation of the right to the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 2) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, primarily extending the period for claims-based payment arrangements and delaying the commencement of revised payment arrangements. The Special Arrangement itself pertains to the efficient funding of chemotherapy pharmaceutical benefits, which include injected or infused chemotherapy medicines for cancer patients, and related pharmaceutical benefits for side-effects of cancer and cancer treatment supplied at certain public hospitals. This legislative instrument applies to entities and individuals involved in the supply of these pharmaceutical benefits, such as hospitals, healthcare providers, and pharmaceutical companies operating within Australia. It does not specify exclusions but operates within the framework of the National Health Act 1953 and is subject to the Minister’s authority to make and vary special arrangements under subsection 100(1) and 100(2) of the Act. The instrument extends the claims-based payment arrangements period from 31 March 2017 to 31 January 2018 and delays the start of revised payment arrangements based on Pharmaceutical Benefits Schedule (PBS) data from 1 April 2017 to 1 February 2018, in response to requests from state and territory health departments to allow for system implementation and to prevent potential supply and access issues. The changes are effective from the day after registration.

Key Provisions

Committee (PBAC) in the evaluation of new pharmaceutical products ensures that the scheme is efficient and meets the needs of the community. This legislative instrument is also compatible with the right to an adequate standard of living, including the right to the highest attainable standard of physical and mental health, as recognised in Article 11 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), and Article 24 of the Convention on the Rights of the Child (CRC). The amendments made by this legislative instrument ensure that the efficient funding of chemotherapy will continue to support access to necessary pharmaceutical benefits for cancer patients. This legislative instrument does not engage any other human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. The main operative sections of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 2) are found in Section 3 and Schedule 1, which amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011. Specifically, Item 1 of Schedule 1 changes the end date of the claims-based arrangements period from 31 March 2017 to 31 January 2018, and Item 2 changes the start date for the revised payment arrangements from 1 April 2017 to 1 February 2018. These changes reflect the Department of Health's decision to extend the claims-based arrangements period and delay the commencement of the revised payment arrangements until February 2018. The obligations and requirements imposed by this Act on the parties or entities it governs include the duty to implement the amended special arrangement, as per the changes made in Schedule 1 of the Instrument. This involves adjusting the claims-based arrangements period and the start date for the revised payment arrangements for chemotherapy pharmaceutical benefits. These changes are intended to ensure that the efficient funding of chemotherapy continues to support access to necessary pharmaceutical benefits for cancer patients. The legislative instrument does not explicitly outline offences, penalties, or civil/criminal consequences for breach. However, non-compliance with the amended special arrangement may result in failure to provide efficient funding of chemotherapy pharmaceutical benefits, which could negatively impact access to necessary treatments for cancer patients. The extent to which non-compliance may lead to legal consequences would depend on the specific circumstances and applicable legislation governing the implementation of the special arrangement.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Commencement Provisions
Regulatory Standards
Reporting & Disclosure Obligations
Catchwords
Chemotherapy Pharmaceutical Benefits

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