National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 1) (PB 6 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L00068 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 2018 (No. 1)

 

PB 6 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

This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 1) (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 6 of 2018 include additions, deletions and changes to forms, brands, 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), 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 February 2018.

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 2018 (No. 1)

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 2018 (No. 1). It can also be cited as PB 6 of 2018.

 

Section 2 Commencement

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

 

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 11 Schedules 1 and 3

Items 1 to 11 provide for additions, deletions and changes to forms, brands, responsible person codes, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). These changes are summarised below.

 

 

SUMMARY OF CHANGES

Listed Drugs Added

Ocrelizumab

Forms Added

Abacavir with Lamivudine

Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg

Raltegravir

Tablet 600 mg (as potassium)

Alteration of Responsible Person

Listed Drug

Form

Brand Name

Responsible Person

Clozapine

Tablet 25 mg

Clozaril 25

From: NV
To: GO

 

Tablet 100 mg

Clozaril 100

From: NV
To: GO

Alteration of circumstances

Lenalidomide

 

Pomalidomide

 


 

 

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 2018 (No. 1)

(PB 6 of 2018)

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.

Natasha Ploenges

Acting 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 2018 (No. 1) was enacted to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, addressing changes in the provision of highly specialised drugs under the National Health Act 1953. The amendment was initiated by the Minister for Health under the authority granted by the Act, reflecting recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) and changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective is to ensure that the Special Arrangement remains aligned with current medical practices and evidence-based recommendations, thereby maintaining the efficacy and appropriateness of highly specialised drug treatments available under the National Health Act. This legislative instrument is designed to progressively enhance the accessibility and quality of pharmaceutical benefits for patients requiring highly specialised treatments, thereby contributing to the overarching goal of improving the health outcomes for Australians.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 1) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, which pertains to the provision of highly specialised drugs under the National Health Act 1953. This Instrument applies to the Minister for Health, who has the authority to make special arrangements for the supply of pharmaceutical benefits. It specifically targets pharmaceutical benefits that are provided under the Highly Specialised Drugs (HSD) program, ensuring that these medications, which are critical for the treatment of chronic conditions requiring specialised care, are managed in accordance with updated criteria and guidelines. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include modifications to forms, brands, responsible person codes, and prescribing circumstances, including authority requirements. The changes are designed to align with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that advises on the listing of drugs on the Pharmaceutical Benefits Scheme (PBS). The Instrument is applicable nationally, impacting all entities involved in the provision and regulation of highly specialised drugs. This includes pharmaceutical companies, healthcare providers, and patients who rely on these drugs for treatment. The changes made by this Instrument are effective from 1 February 2018.

Key Provisions

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 1) (F2018L00068) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (PB 116 of 2010). This amendment is made under subsection 100(1) of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits. The amendments are effective from 1 February 2018, and reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These changes involve additions, deletions, and modifications to forms, brands, responsible person codes, and prescribing conditions for various pharmaceutical benefits, including authority requirements. The Instrument imposes several obligations on the parties involved, including ensuring that the changes in the Special Arrangement align with the recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is an independent expert body established under section 100A of the Act, which advises the Minister on which drugs should be available as pharmaceutical benefits. The Instrument requires consultation with the PBAC and other interested parties, particularly during the process of listing medications on the Pharmaceutical Benefits Scheme (PBS). Pharmaceutical companies are also required to be consulted throughout the process of changes to the listings on the PBS. Breach of the provisions in this Instrument may lead to several consequences. While the Instrument does not explicitly detail the specific penalties or consequences for non-compliance, the broader National Health Act 1953 provides for various offences and penalties for non-compliance with pharmaceutical regulations. These can include fines, imprisonment, or other civil or criminal penalties, depending on the nature and severity of the breach. The exact penalties are determined by the courts and can vary based on the specific circumstances of each case. In summary, the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2018 (No. 1) amends the Special Arrangement to reflect changes in the pharmaceutical listings on the PBS. It mandates compliance with recommendations from the PBAC and requires consultation with relevant parties. While specific penalties for non-compliance are not detailed in the Instrument itself, they are governed by the broader provisions of the National Health Act 1953.

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