National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 7) (PB 61 of 2016)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 7)

PB 61 of 2016

 

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) to make changes relating to the efficient funding of chemotherapy.

 

This instrument updates the 1 July 2016 indexed distribution fee amount to $25.92. This fee was previously amended to $26.08 in the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 6) (PB 56 of 2016).

 

A further 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 July 2016, immediately after PB 56 of 2016 commences.

 

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

 

ATTACHMENT

DETAILS OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 7) (PB 61 of 2016)

Section 1  Name of Instrument

This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 7) and that it may also be cited as PB 61 of 2016.

Section 2  Commencement

This section provides that this Instrument commences on 1 July 2016 immediately after the commencement of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 6) (PB 56 of 2016).

Section 3   Amendments to PB 79 of 2011

This section amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1 Amendments

Item 1 repeals the definition of “distribution fee” and substitutes a new definition. The new definition sets the amount as being $25.92 and updates the amount that was inserted by PB 56 of 2016. The new amount of $25.92 applies effective of 1 July 2016 as a result of indexation.


 

 

 

 

 

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 Legislaive Instrument is compatible with human rights because it advances the protection ohuman rights.

 

Overview

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 7) was enacted to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, addressing issues related to the efficient funding of chemotherapy and ensuring that patients have access to necessary pharmaceutical benefits. The Act was enacted by the Minister under the authority provided by the National Health Act 1953, specifically under subsections 100(1) and 100(2), which allow for the making and variation of special arrangements for the supply of pharmaceutical benefits. The policy objective of the Act is to achieve greater efficiency in the payment for the supply of chemotherapy and related medicines, ensuring they are accessible and affordable to eligible patients being treated for cancer. The instrument introduces updates to the distribution fee amount, which was indexed to $25.92, reflecting changes as of 1 July 2016. This amendment follows previous adjustments made by the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 6) (PB 56 of 2016). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process, providing recommendations based on clinical effectiveness, safety, and cost-effectiveness. The ongoing consultation process involving PBAC members, who represent various interests and professions, ensures that decisions are evidence-based and comprehensive. This legislative instrument is compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health by facilitating access to essential medicines through the Pharmaceutical Benefits Scheme (PBS).

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 7) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, made under subsections 100(1) and 100(2) of the National Health Act 1953. This instrument serves to update the efficient funding of chemotherapy by adjusting the distribution fee amount to $25.92, effective from 1 July 2016, following an indexing adjustment. It also includes modifications to the list of drugs and their brands for efficient funding, adding new brands for certain chemotherapy drugs and removing others, while also introducing new circumstance codes for certain pharmaceuticals. The instrument applies to entities and persons involved in the supply and administration of chemotherapy pharmaceutical benefits under the Pharmaceutical Benefits Scheme. It has a national reach, operating under the Commonwealth’s legislative authority. This legislative instrument does not exclude or exempt any specific parties but operates within the broader framework of the National Health Act 1953, with potential further specification through subordinate instruments.

Key Provisions

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 7) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011. Section 3 of the Instrument revises the distribution fee, setting it at $25.92, effective from 1 July 2016 (section 3, item 1). This fee adjustment follows the indexation process and updates the previously set amount of $26.08 in PB 56 of 2016. The Instrument also introduces specific amendments to the list of drugs, including adding four new listed brands for 'Doxorubicin' and 'Gemcitabine', one new listed form for 'Aprepitant', removing two listed brands for 'Docetaxel', and adding new circumstance codes and associated circumstances for 'Aprepitant'. These changes aim to enhance the efficiency of funding and ensure that the supply of chemotherapy medicines and related pharmaceutical benefits are appropriately managed (section 3, items 2-5). The Act imposes several obligations on the parties involved. It requires the Minister to make special arrangements for the supply of pharmaceutical benefits and ensures that these arrangements are updated as necessary to reflect changes such as indexation. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on which drugs should be available as pharmaceutical benefits, ensuring that decisions are evidence-based and consider factors such as clinical effectiveness, safety, and cost-effectiveness. The Act also mandates that the distribution fee be updated to reflect changes in economic conditions, thereby maintaining the efficiency of the funding system. Failure to comply with the provisions of the Act can result in various consequences. While the specific offences and penalties are not detailed in the explanatory statement, breaches of the Act could potentially lead to administrative actions, financial penalties, or other corrective measures. For instance, incorrect administration or non-compliance with the specified distribution fee could result in financial discrepancies or legal challenges. However, the exact penalties are not outlined in this particular explanatory statement and would need to be referred to in the primary legislation or subsequent regulations. The legislative instrument is designed to ensure that the funding of chemotherapy drugs and related pharmaceutical benefits is efficient and effective, thereby supporting the health and well-being of patients undergoing cancer treatment. By amending the distribution fee and updating the list of drugs, the Act aims to provide a stable and sustainable framework for the supply of these essential medicines. The involvement of PBAC ensures that the decisions are based on sound medical and economic evidence, which is crucial for maintaining the integrity and effectiveness of the Pharmaceutical Benefits Scheme.

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