National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 5) (PB 41 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00682 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 2018 (No. 5)

PB 41 of 2018

 

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 makes amendments to Schedules 2 and 4 of 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.

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).  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 June 2018.

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 2018 (No. 5)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 5) and may also be cited as PB 41 of 2018.

Section 2 Commencement

This section provides that this Instrument commences on 1 June 2018.

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 include the deletion of a listed drug, as summarised below.

 

SUMMARY OF CHANGES

Listed Drugs Deleted

Interferon alfa-2b

 


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 2018 (No. 5)

(PB 41 of 2018)

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 Schedules 2 and 4 of 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.

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.

 

 

 

Julianne Quaine

Assistant Secretary

Private Health Insurance and Pharmacy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 5) (PB 41 of 2018) is an amendment to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, which was enacted to enhance the efficiency of funding for chemotherapy medicines and related treatments under the National Health Act 1953. The 2011 Special Arrangement aimed to streamline payment for chemotherapy drugs, reflecting the government’s 2010 Budget measure for the efficient funding of chemotherapy drugs. This amendment, made under the authority of the Minister for Health, ensures that the Special Arrangement accurately reflects recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective of these legislative changes is to maintain the efficiency and relevance of the funding arrangements for chemotherapy and related treatments, ensuring that they align with current therapeutic practices and regulatory updates. The Pharmaceutical Benefits Advisory Committee (PBAC) played a crucial role in the consultation process, ensuring that the recommendations and subsequent legislative changes are evidence-based and meet the needs of patients and healthcare providers.

Scope and Application

The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 5) amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, made under the National Health Act 1953. This Act applies to the supply of pharmaceutical benefits, particularly focusing on the efficient funding of chemotherapy medicines and related pharmaceutical benefits. The legislation primarily targets eligible patients receiving cancer treatment and aims to ensure efficient payment for injected or infused chemotherapy medicines, as well as medicines associated with the side-effects of cancer and cancer treatment at certain public hospitals. The changes made by this Instrument are in response to updates in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and reflect the government's commitment to the progressive realisation of the highest attainable standard of physical and mental health, as recognised in international human rights instruments. This Instrument is subject to consultation processes involving the Pharmaceutical Benefits Advisory Committee, ensuring that decisions about subsidised access to medicines are evidence-based. The changes outlined in this Legislative Instrument are effective from 1 June 2018, aligning with the commencement of the related amendments to the Pharmaceutical Benefits listing.

Key Provisions

The main operative sections of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 5) (PB 41 of 2018) are primarily concerned with the amendment of the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011). Specifically, Section 3 of the Instrument amends Schedules 2 and 4 of the Special Arrangement (Section 100(3) of the National Health Act 1953) to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. This amendment ensures that the Special Arrangement accurately mirrors the updated pharmaceutical benefits listings, which commence on the same day as the Instrument's commencement. The obligations and requirements imposed by the Act on the parties and entities it governs include ensuring that the supply of chemotherapy pharmaceutical benefits and related pharmaceutical benefits is efficiently funded. The Minister has the authority to make special arrangements for the supply of pharmaceutical benefits (Section 100(1) of the Act), and can vary or revoke these arrangements (Section 100(2) of the Act). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process by recommending which drugs and medicinal preparations should be available as pharmaceutical benefits. Pharmaceutical companies are also involved in the consultation process regarding additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS). The ongoing consultation with interested parties ensures that the recommendations made by the PBAC are evidence-based and take into account the clinical effectiveness, safety, and cost-effectiveness of the medicines. The Act imposes several consequences for breaches of its provisions. Under Section 100(2) of the Act, the Minister can vary or revoke special arrangements made under Section 100(1). This power allows for the adjustment of funding arrangements in response to changes in pharmaceutical benefits listings or other relevant factors. The penalties for breaches of the Act are not explicitly stated in the Legislative Instrument, but breaches of the National Health Act 1953 can result in civil or criminal penalties, including fines and imprisonment, depending on the severity of the breach. The maximum penalties for breaches of the Act would be determined by the specific provisions of the Act and any relevant subsidiary legislation. The Instrument also makes amendments to the Special Arrangement, including the deletion of a listed drug, Interferon alfa-2b, from the list of chemotherapy pharmaceutical benefits. This change ensures that the Special Arrangement remains current and accurately reflects the most recent pharmaceutical benefits listings. The amendments are designed to maintain the efficiency of the funding arrangements for chemotherapy and related pharmaceutical benefits, ensuring that eligible patients receive timely and appropriate treatment for cancer and its side effects.

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