National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10) (PB 95 of 2017)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 10)

 

PB 95 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

This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10) (this Instrument). The purpose of this Instrument is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) program.

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

The amendments in PB 95 of 2017 include: the deletion of a listed drug; the deletion of a form of a listed drug; the deletion of a brand of a listed drug in two forms; and changes to the circumstances for prescribing for a listed drug.

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

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).

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 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. In addition, an industry nominee has been appointed to the PBAC membership. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), the 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.

Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS. This includes consultation through the PBAC process. Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.

Details of this Instrument are set out in the Attachment.

This Instrument commences on 1 December 2017.

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


ATTACHMENT

Provision by provision description of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10)

PART 1 PRELIMINARY

Section 1 Name of Instrument

This section provides the name of this Instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10). It can also be cited as PB 95 of 2017.

 

Section 2 Commencement

This section provides that this Instrument commences on 1 December 2017.

 

Section 3 Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

 

Schedule - Amendments

 

Items 1 to 12 Schedules 1 and 3

Items 1 to 12 provide for: the deletion of a listed drug; the deletion of a form of a listed drug; the deletion of a brand of a listed drug in two forms; and changes to the circumstances for prescribing for a listed drug.

These changes are summarised below.

In addition, several minor changes have been made to reflect the current listings in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

 

SUMMARY OF CHANGES

Listed Drugs Deleted

Foscarnet

 

Forms deleted

Apomorphine

Injection containing apomorphine hydrochloride 10 mg in 1 mL

Brands deleted

Bosentan

Tablet 62.5 mg (as monohydrate) (APO-BOSENTAN)
Tablet 125 mg (as monohydrate) (APO-BOSENTAN)

Alteration of circumstances

Epoetin lambda

 


 

 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10)

(PB 95 of 2017)

This 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 (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the highly specialised drugs program.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.

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 Regulation amendments and this instrument are a positive step towards attaining the highest standard of health for all Australians. 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 (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10) is a legislative instrument designed to amend the National Health (Highly specialised drugs program) Special Arrangement 2010, which governs the supply of highly specialised drugs in Australia. Enacted by the Minister for Health under subsection 100(1) of the National Health Act 1953, this instrument aims to align the Special Arrangement with recent amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The key changes include the removal of certain drugs and forms from the program, the deletion of specific brands, and adjustments to the prescribing conditions for listed drugs. The amendments are in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that the changes reflect evidence-based decisions. This process ensures that the highly specialised drugs program remains effective and up-to-date, supporting the provision of necessary treatments for chronic conditions requiring specialised care.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, which is part of the National Health Act 1953. This amendment instrument applies to the supply of pharmaceutical benefits under the Highly Specialised Drugs (HSD) program, a specific subset of the broader National Health Act. The HSD program provides subsidised access to highly specialised drugs for the treatment of chronic conditions that require specialised treatment. The changes made by this Instrument include the deletion of certain listed drugs, forms of listed drugs, and brands of listed drugs, as well as modifications to the circumstances for prescribing certain listed drugs. These changes are aligned with updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which ensures consistency in the listings of pharmaceutical benefits. The Instrument commenced on 1 December 2017, and its amendments reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on the listing of drugs on the Pharmaceutical Benefits Scheme (PBS). The PBAC’s recommendations consider factors such as clinical effectiveness, safety, and cost-effectiveness, ensuring that decisions about drug subsidies are evidence-based and aligned with public health objectives.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2017 (No. 10) (PB 95 of 2017) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (PB 116 of 2010) to update the Highly Specialised Drugs (HSD) program. The primary changes include the deletion of specific drugs and forms of drugs, and alterations to the prescribing circumstances for certain drugs (Section 3). These amendments reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The amendments also include minor changes to align with the current listings in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The Act imposes obligations on the Minister to make and vary or revoke special arrangements for the supply of pharmaceutical benefits (Section 100(1)-(3)). This includes ensuring that the special arrangements are compatible with human rights as stipulated in the Human Rights (Parliamentary Scrutiny) Act 2011. The Pharmaceutical Benefits Advisory Committee (PBAC), an expert body established under section 100A of the Act, plays a crucial role in recommending which drugs should be included in the pharmaceutical benefits. The recommendations of the PBAC, which include members from various health-related fields, ensure that decisions regarding the listing of medicines on the Pharmaceutical Benefits Scheme (PBS) are evidence-based and consider factors such as clinical effectiveness, safety, and cost-effectiveness. The Instrument also outlines the consequences for non-compliance with the amended special arrangements. While the Instrument itself does not specify detailed penalties, breaches of the National Health Act 1953 could result in civil or criminal penalties depending on the nature and severity of the breach. The Pharmaceutical Benefits Scheme (PBS) is integral to the delivery of these benefits, and any failure to comply with the regulations governing it could lead to legal ramifications. This legislative instrument is designed to be compatible with human rights, specifically engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by facilitating the progressive realisation of the right to the highest attainable standard of physical and mental health. The amendments ensure that the decisions about which drugs are subsidised under the PBS are evidence-based, thereby advancing the protection of human rights in Australia.

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