National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 11) (No. PB 79 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L02023 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 2013 (No. 11)

PB 79 of 2013

 

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:

  • amends the forms for the listed drug, ‘Ifosfamide’;
  • omits the circumstances codes for  the listed drug ‘Ifosfamide’; and
  • omits the circumstances and purposes for the listed drug ‘Ifosfamide’.

 

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 December 2013.

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 2013 (No. 11)

Section 1  Name of Instrument

This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 11) and that it may also be cited as PB 79 of 2013.

Section 2  Commencement

This section provides that this Instrument commences on 1 December 2013.

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). 

 

Schedule 1

Item 1 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Ifosfamide’ by changing the forms to ‘Powder for I.V. Injection 1 g’ and ‘Powder for I.V. Injection 2 g’ and omitting the circumstances codes ‘C1325’ and ‘C1327’.

Item 2 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Ifosfamide’ by omitting (a) the listed drug ‘Ifosfamide; (b) the circumstances codes ‘C1325’ and ‘C1327’; and (c) the words contained under the circumstances and purposes heading.

 


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 2013 (No. 11) is an amendment to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, introduced to address the efficient funding of chemotherapy and related pharmaceutical benefits under the National Health Act 1953. Enacted by the Australian Government, this instrument aims to align with the 2010 budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’. The policy objective is to ensure that the supply of chemotherapy and related medicines is efficiently funded, reflecting contemporary standards and practices in the provision of healthcare. The instrument was made under the authority of the National Health Act 1953 and commenced on 1 December 2013, providing amendments to the forms, circumstance codes, and purposes for listed drugs such as 'Ifosfamide', ensuring that the special arrangement remains effective and relevant in the provision of necessary medical treatments.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 11) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 to make changes relating to the efficient funding of chemotherapy. The Act applies to pharmaceutical benefits provided under the Special Arrangement, specifically targeting the supply of chemotherapy medicines to eligible patients undergoing cancer treatment and related pharmaceutical benefits at certain public hospitals. This amendment instrument modifies the listed drug 'Ifosfamide' by altering its forms and omitting certain circumstance codes. The amendments reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument is subject to the provisions of the National Health Act 1953 and has a Commonwealth jurisdictional reach, with its commencement date set for 1 December 2013. The instrument does not explicitly mention exclusions or exemptions, but its application is inherently confined to the specific pharmaceutical benefits outlined within the Special Arrangement.

Key Provisions

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 11) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to modify the funding arrangements for the efficient supply of chemotherapy and related pharmaceutical benefits (sections 1 and 3). This amendment primarily affects the listed drug 'Ifosfamide', where it changes the available forms to 'Powder for I.V. Injection 1 g' and 'Powder for I.V. Injection 2 g', and removes the circumstances codes 'C1325' and 'C1327' (Schedule 1, Item 1). Additionally, it removes the entry for 'Ifosfamide', the circumstances codes 'C1325' and 'C1327', and the words under the circumstances and purposes heading in Schedule 4 (Schedule 1, Item 2). The Instrument comes into effect on 1 December 2013 (section 2). The Act imposes several obligations on the parties involved. The Minister is responsible for making special arrangements for the supply of pharmaceutical benefits under section 100(1), which includes the authority to vary or revoke these arrangements (section 100(2)). The Pharmaceutical Benefits Advisory Committee (PBAC), established under section 100A, plays a critical role by recommending which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC’s recommendations are based on the medical conditions for which a medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. The involvement of PBAC ensures that decisions about the funding of chemotherapy and related pharmaceutical benefits are evidence-based and aimed at achieving efficient and equitable access to necessary treatments. Failure to comply with the provisions of this Instrument may result in legal consequences. While the Instrument itself does not explicitly outline specific penalties or consequences for breaches, the overarching National Health Act 1953 provides a framework for enforcement. Under the Act, non-compliance with provisions related to the funding and supply of pharmaceutical benefits could potentially lead to administrative penalties, fines, or legal action. The exact nature and severity of penalties would depend on the specific breach and the context in which it occurs, but they could include civil or criminal liability as outlined in the broader legislative framework of the National Health Act.

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