National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10) (PB 87 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01395 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2019 (No. 10)

PB 87 of 2019

 

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 2019 (No. 10) (this Instrument).  The purpose of this Instrument, made under subsection 100(2) of 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 amendments made by this Instrument reflect amendments 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.

The amendments made by this Instrument include additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).

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), 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 November 2019.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2019 (No. 10)

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 2019 (No. 10). It can also be cited as PB 87 of 2019.

Section 2 Commencement

This section provides that this Instrument commences on 1 November 2019.

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

The amendments in Schedule 1 provide for additions, deletions and changes to drugs, forms, responsible person codes and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). The amendments also provide for minor changes to the notes in the principle instrument to improve clarity.  These changes are summarised below.

 

SUMMARY OF CHANGES

Part 1, Division 2, Section 7

References to Note 1 and Note 2 substituted with Note.

Part 1, Division 4, Section 14

References to Note 1 and Note 2 substituted with Note.

Part 4, Division 2, Section 30

Reference to Note 1 substituted with Note.

Part 7, Section 51

References to Note 1 and Note 2 substituted with Note.

Brands Deleted

Valganciclovir

Tablet 450 mg (as hydrochloride)
(Valganciclovir AN; Valganciclovir Juno)

Alteration of Circumstances

Azithromycin

 

Ciclosporin

 

Darbepoetin alfa

 

Desferrioxamine

 

Epoetin alfa

 

Epoetin beta

 

Epoetin lambda

 

Everolimus

 

Infliximab

 

Lanthanum

 

Methoxy polyethylene glycol-epoetin beta

 

Mycophenolic acid

 

Natalizumab

 

Sevelamer

 

Sirolimus

 

Sucroferric oxyhydroxide

 

Tacrolimus

 

Teduglutide

 

Ustekinumab

 

Vedolizumab

 

Deletion of Responsible Person

Actelion Pharmaceuticals Australia Pty Ltd (AT)

Alteration of Responsible Person Code

Listed Drug

Form

Brand Name

Responsible Person

Bosentan

Tablet 62.5 mg
(as monohydrate)

Tracleer

From: AT

To: JC

 

Tablet 125 mg
(as monohydrate)

Tracleer

From: AT

To: JC

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium)

Veletri

From: AT

To: JC

 

Powder for I.V. infusion 1.5 mg (as sodium)

Veletri

From: AT

To: JC

Macitentan

Tablet 10 mg

Opsumit

From: AT

To: JC

 

 

 

 

 

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 2019 (No. 10)

(PB 87 of 2019)

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 Instrument

The purpose of this 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 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 Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Ben Sladic

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10) (PB 87 of 2019) was enacted to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) in relation to the Highly Specialised Drugs program. This amendment instrument was made under subsection 100(2) of the National Health Act 1953, which allows the Minister to vary or revoke special arrangements for the supply of pharmaceutical benefits. The purpose of this amendment is to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), ensuring alignment in the treatment of chronic conditions requiring specialised treatment. The policy objective is to ensure that decisions about subsidised access to medicines are evidence-based, which is facilitated by the Pharmaceutical Benefits Advisory Committee's recommendatory role. Consultation for these amendments was primarily through the Pharmaceutical Benefits Advisory Committee, an independent body established under the Act, which includes representatives from various healthcare sectors and professions. The amendments accord with recommendations made by the PBAC, ensuring that the changes made are in line with expert advice. Further consultation was deemed unnecessary due to the extensive consultation already undertaken during the listing process for the Pharmaceutical Benefits Scheme. This amendment instrument commenced on 1 November 2019, and it is compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health by facilitating access to necessary pharmaceutical benefits.

Scope and Application

The National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2019 (No. 10) amends the National Health (Highly specialised drugs program) Special Arrangement 2010, which pertains to the Highly Specialised Drugs program under the National Health Act 1953. This Act applies to the Minister for Health who has the authority to make special arrangements for the supply of pharmaceutical benefits. The amendments, effective from 1 November 2019, include modifications to the drugs, forms, responsible person codes, and prescribing circumstances, including authority requirements. The amendments are made in response to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and follow recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This committee, composed of experts from various health-related fields, ensures that decisions about pharmaceutical benefits are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. The changes are designed to improve access to highly specialised drugs for patients with chronic conditions requiring specialised treatment, and the amendments are subject to the provisions of the National Health Act and any subordinate instruments. The amendments made by this Instrument are limited to the drugs listed and their respective forms, responsible persons, and prescribing conditions, with no broader jurisdictional or geographic limitations beyond the existing scope of the National Health Act. The Instrument itself does not outline any specific exclusions, exemptions, or thresholds, but these would be governed by the overarching provisions of the Act and related instruments. The consultation process involved the PBAC and pharmaceutical companies, reflecting a comprehensive approach to ensuring the amendments align with current medical and economic standards. The amendments are consistent with the human rights principles outlined in the International Covenant on Economic, Social and Cultural Rights, particularly by enhancing access to necessary healthcare services.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2019 (No. 10) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010. The changes include additions, deletions and modifications to the list of drugs, their forms, responsible person codes and the circumstances for prescribing these pharmaceutical benefits (Section 3). These amendments are detailed in Schedule 1 of the Instrument. The obligations under this Instrument primarily revolve around updating the list of drugs available under the Highly Specialised Drugs program, which is a subset of the Pharmaceutical Benefits Scheme (PBS). This entails ensuring that only drugs that meet certain clinical, safety, and cost-effectiveness criteria are included. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent body appointed by the Minister, plays a crucial role in advising on these criteria and recommending changes to the drug list (Sections 100A, 100(2)). The Instrument also requires the Minister to ensure that these changes are implemented effectively within the PBS framework. Failure to comply with the provisions of this Instrument may result in legal consequences. While the Instrument itself does not explicitly state the penalties for non-compliance, breaches of the National Health Act 1953 or related instruments can lead to substantial fines and potential imprisonment. For example, under Section 112 of the National Health Act, an individual can be fined up to 500 penalty units ($83,500 as of 2023) or imprisonment for up to two years, or both, for offences related to the supply of pharmaceutical benefits. Additionally, corporations can face fines up to 50,000 penalty units ($8.35 million as of 2023). These penalties underscore the importance of adhering to the regulations set forth in the Instrument and the overarching Act.

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