National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No.1) (PB 62 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01068 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No.1)

PB 62 of 2015

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).

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and (2) of the Act (this Instrument), is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010) (the Special Arrangement) to make changes to the Special Arrangement relating to the Paraplegic and Quadriplegic Program.

‘Authorised associations’ may supply pharmaceutical benefits under the Special Arrangement to ‘eligible persons’. A person is an ‘eligible person’ for the purposes of the Special Arrangement if:
 

(a)        they are an ‘eligible person’ within the meaning of the Health Insurance Act 1973, that is, eligible to receive Medicare benefits, and

(b)       have paraplegia or quadriplegia, and

(c)        are a member of an ‘authorised association’.

 

This Instrument adds a new listed brand of the listed drug Macrogol 3350, Chemists’ Own Macrogol with Electrolytes.  It also amends ‘the Responsible Person’ list to include: Fawns and McAllan Proprietary Ltd – 16 004 296 066 (with the ‘Responsible Person Code’ of FM).  This necessitated amendments to Schedule 1 and Schedule 2 of the Special Arrangement.

These changes reflect changes made 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.

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. 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 and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.

This instrument commences on 1 July 2015.

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


Statement of Compatibility with Human Rights

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

 

National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No 1)

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 (2) of the Act, is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010) (the Special Arrangement) to make changes to the special arrangement relating to the Paraplegic and Quadriplegic Program.

This Instrument adds a new listed brand of the listed drug Macrogol 3350, Chemists’ Own – Macrogol with Electrolytes.  It also amends ‘the Responsible Person’ list to include: Fawns and McAllan Pty Ltd – 16 004 296 066 (with the ‘Responsible Person Code’ of FM).  This necessitated amendments to Schedule 1 and Schedule 2 of the Special Arrangement.

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 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 Legislative Instrument is compatible with human rights because it advances the protection of human rights.

Julianne Quaine

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health Act 1953 was enacted to establish a framework for the provision of health services in Australia. The Act, administered by the Commonwealth Parliament, was introduced to address the need for a structured approach to the delivery of health services, ensuring that the Australian public has access to essential health benefits. One significant amendment to the Act is the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No 1), which was created to refine the provisions of the Special Arrangement relating to the Paraplegic and Quadriplegic Program. This amendment was designed to enhance the accessibility of pharmaceutical benefits for eligible individuals, particularly those with paraplegia or quadriplegia, by updating the list of authorised drugs and entities responsible for their supply. The policy objective underpinning this amendment is to ensure that the Pharmaceutical Benefits Scheme (PBS) continues to provide evidence-based, cost-effective access to necessary medications, thereby supporting the right to the highest attainable standard of physical and mental health as outlined in international human rights instruments.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No 1) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, enhancing the Pharmaceutical Benefits Scheme to include a new brand of the drug Macrogol 3350, Chemists' Own – Macrogol with Electrolytes, and the addition of Fawns and McAllan Proprietary Ltd as a responsible person with the code FM. This amendment applies to eligible persons who meet the criteria under the Health Insurance Act 1973, have paraplegia or quadriplegia, and are members of an authorised association. The changes reflect updates made under the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and align with recommendations from the Pharmaceutical Benefits Advisory Committee. The legislative instrument operates nationally, as it is made under the authority of the National Health Act 1953, which is a Commonwealth Act. There are no specific exclusions mentioned in the instrument itself, though the application of the special arrangement is inherently limited to the specified conditions and eligible persons.

Key Provisions

The main operative sections of this legislative instrument (National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No. 1)) include the amendments to the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, particularly the addition of a new listed brand of the drug Macrogol 3350, Chemists’ Own – Macrogol with Electrolytes, and the inclusion of Fawns and McAllan Proprietary Ltd on the Responsible Person list (section 2). These changes are detailed in Schedule 1 and Schedule 2 of the Special Arrangement and reflect updates made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (section 3). The purpose of these amendments is to align the Special Arrangement with the changes in the Pharmaceutical Benefits Scheme (PBS) and ensure continued access to necessary medications for eligible persons with paraplegia or quadriplegia. The Act imposes specific obligations on the parties involved. Eligible persons, who must be members of an authorised association and meet the criteria set out in the Health Insurance Act 1973, are entitled to access the listed pharmaceutical benefits under the Special Arrangement (section 3). Authorised associations, such as Fawns and McAllan Proprietary Ltd, are required to supply the listed pharmaceutical benefits to eligible persons and adhere to the terms set forth in the Special Arrangement (section 2). The Minister for Health, through the Pharmaceutical Benefits Advisory Committee (PBAC), is responsible for making recommendations regarding the listing of pharmaceutical benefits and ensuring that decisions are evidence-based and aligned with the principles of the PBS (section 4). There are no explicit offences, penalties, or civil/criminal consequences outlined in this legislative instrument for breaches of the Special Arrangement. However, the amendments to the Special Arrangement are made to ensure compliance with the National Health Act 1953 and the Pharmaceutical Benefits Scheme. The Minister retains the authority to vary or revoke special arrangements under subsection 100(2) of the Act, providing a mechanism to address any non-compliance or issues that may arise (section 5). The ongoing consultation process with relevant stakeholders, including pharmaceutical companies and PBAC, ensures that the Special Arrangement remains effective and responsive to the needs of eligible persons.

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