National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 4) (No. PB 31 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L00438 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 2014 (No. 4)

PB 31 of 2014

 

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 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 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 entitled ‘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 makes changes to the pharmaceutical benefits available under the Special Arrangement for the efficient funding of chemotherapy. These changes reflect changes made 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.

This instrument:

  • removes 1 listed brand for the listed drug ‘Docetaxel’;
  • adds 1 listed brand for the listed drug ‘Doxorubicin’;
  • adds the responsible person Mayne Pharma International Pty Ltd (YN)

A provision by provision description of this instrument is contained 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). 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. 

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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (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.

This instrument commences on 1 May 2014.

This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.


ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 4)

Section 1  Name of Instrument

This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 4) and that it may also be cited as PB 31 of 2014.

Section 2  Commencement

This section provides that this Instrument commences on 1 May 2014.

Section 3   Amendments to 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).

 

Item 1 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ by removing a pharmaceutical benefit, which is the listed drug ‘Docetaxel’ in the form ‘Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent’ with manner of administration ‘Injection’ and brand ‘AS-Docetaxel’.

Item 2 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Doxorubicin’ by adding the pharmaceutical benefit, which is the listed drug ‘Doxorubicin’ in the form ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial’ with manner of administration ‘Injection/intravesical’ and brand ‘Doxorubicin MYX’.

Item 3 amends Schedule 3 of the Special Arrangement by adding a new responsible person ‘Mayne Pharma International Pty Ltd (YN).

 

 

 

 

 

 

 

 


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 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.

 

Kim Bessell

 Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor

       Pharmaceutical Benefits Division
   Department of Health and Agein

Overview

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 4) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, with the overarching objective of enhancing the efficiency of funding for chemotherapy treatments under the National Health Act 1953. This amendment responds to the 2010 budget measure designed to revise the arrangements for the efficient funding of chemotherapy drugs, aiming to streamline payments for injected or infused chemotherapy medicines and related pharmaceutical benefits provided at public hospitals. The enactment of this instrument by the Minister for Health under the authority granted by the National Health Act, reflects an ongoing commitment to ensure that the funding mechanisms for critical cancer treatments are both effective and equitable. The policy objective behind this legislative instrument is to maintain and enhance the efficiency of the Pharmaceutical Benefits Scheme (PBS) in funding chemotherapy treatments, ensuring that patients have access to necessary medications while also addressing budgetary constraints. This is achieved through amendments such as the removal and addition of specific pharmaceutical benefits and the inclusion of new responsible entities, thereby aligning the PBS with current medical practices and technological advancements. The changes also incorporate recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body tasked with advising the Minister on the listing of pharmaceutical benefits, thus ensuring that the decisions made are evidence-based and aligned with public health needs.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 4) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, which relates to the efficient funding of chemotherapy drugs provided to eligible patients being treated for cancer, and medicines associated with the side-effects of cancer and cancer treatment at certain public hospitals. This instrument makes changes to the pharmaceutical benefits available under the Special Arrangement, including the addition and removal of specific brands and forms of chemotherapy drugs, and the introduction of new circumstance codes for certain drugs. It is made under subsections 100(1) and 100(2) of the National Health Act 1953, which enables the Minister to make special arrangements for the supply of pharmaceutical benefits and to vary or revoke such arrangements. The instrument commenced on 1 May 2014 and is compatible with human rights, as it assists with the progressive realisation of the right to the highest attainable standard of physical and mental health by providing for subsidised access to medicines through the Pharmaceutical Benefits Scheme. The instrument applies to pharmaceutical benefits provided under the Special Arrangement, which specifically concerns chemotherapy drugs and related pharmaceutical benefits supplied to eligible patients in public hospitals. The changes introduced by this instrument are intended to reflect adjustments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Pharmaceutical Benefits Advisory Committee, an independent expert body that advises the Minister on which drugs and medicinal preparations should be available as pharmaceutical benefits, is involved in the ongoing consultation process regarding the Special Arrangement. This committee ensures that decisions about the inclusion of medicines on the Pharmaceutical Benefits Scheme are evidence-based and consider factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness.

Key Provisions

The primary operative sections of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 4) (the Instrument) are found in Section 3, which details amendments to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement). Section 3(1) removes a pharmaceutical benefit for the drug 'Docetaxel' under certain circumstances, while Section 3(2) adds a pharmaceutical benefit for 'Doxorubicin' under specific conditions. Additionally, Section 3(3) introduces a new responsible person, Mayne Pharma International Pty Ltd (YN), to the Special Arrangement. These amendments are designed to enhance the efficiency of funding for chemotherapy and related pharmaceutical benefits, in line with the 2010 budget measure. The Instrument imposes several obligations on parties and entities it governs. Firstly, it mandates the removal of the specified brand of 'Docetaxel' from the list of pharmaceutical benefits available under the Special Arrangement, as outlined in Section 3(1). Conversely, Section 3(2) requires the addition of 'Doxorubicin' to the list, under specific conditions. Furthermore, the addition of Mayne Pharma International Pty Ltd (YN) as a responsible person under Section 3(3) means that this entity must comply with the requirements set forth in the Special Arrangement. These obligations are critical to ensuring that the funding of chemotherapy drugs remains efficient and aligned with the objectives of the National Health Act 1953. In terms of consequences for non-compliance, the Instrument itself does not explicitly state any specific penalties or consequences for breach. However, given that it is a legislative instrument under the National Health Act 1953, any breach of the requirements set forth in the Special Arrangement could potentially lead to legal action under the Act. Such actions might include fines or other penalties as prescribed by the Act. Additionally, non-compliance could result in the revocation of the special arrangement, impacting the availability and funding of specified chemotherapy drugs and related pharmaceutical benefits for eligible patients. The precise penalties would depend on the nature and severity of the breach, as well as any relevant case law and statutory provisions.

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