National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No. 4) (No. PB 94 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L02193 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 2013 (No.4)

PB 94 of 2013

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, APO‑MACROGOL plus ELECTROLYTES, this necessitated an amendment to Schedule 1 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 January 2014.

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 2013 (No.4)

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, APO‑MACROGOL plus ELECTROLYTES, this necessitated an amendment to Schedule 1 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.

Mr Kim Bessell

Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No.4) was enacted to amend the existing special arrangement under the National Health Act 1953, specifically concerning the Paraplegic and Quadriplegic Program. This legislative instrument was introduced to address the need for updates and modifications to the special arrangement, ensuring it aligns with current pharmaceutical benefits and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The purpose of this amendment is to incorporate a new listed brand of the drug Macrogol 3350, APO-MACROGOL plus ELECTROLYTES, into the special arrangement, reflecting changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendment is designed to enhance access to necessary medications for eligible persons, ensuring that they benefit from the most recent advancements in pharmaceutical treatments. This legislative instrument was enacted by the Minister for Health under the authority granted by the National Health Act 1953, aiming to facilitate the progressive realisation of the right to the highest attainable standard of physical and mental health as recognised by the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No. 4) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 to incorporate a new listed brand of the drug Macrogol 3350, APO-MACROGOL plus ELECTROLYTES. This amendment is made under the authority of the National Health Act 1953, which enables the Minister to make special arrangements for the supply of pharmaceutical benefits. The amended arrangement facilitates 'authorised associations' in supplying pharmaceutical benefits to 'eligible persons', who must meet specific criteria including eligibility for Medicare benefits, having paraplegia or quadriplegia, and being members of an authorised association. These changes reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The legislative instrument is compatible with human rights, particularly engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by enhancing access to medicines for paraplegic and quadriplegic individuals, thereby contributing to their right to the highest attainable standard of health.

Key Provisions

The main operative sections of this legislative instrument (F2013L02193) pertain to amendments made under subsections 100(1) and 100(2) of the National Health Act 1953. This instrument seeks to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 to update the supply of pharmaceutical benefits under the program. Specifically, it adds a new listed brand of the drug Macrogol 3350, APO-MACROGOL plus ELECTROLYTES, to Schedule 1 of the Special Arrangement. This amendment is a response to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, reflecting updates to the Pharmaceutical Benefits Scheme (PBS) that commenced on the same day. The obligations and requirements imposed by this Act on the parties or entities it governs include ensuring that ‘authorised associations’ can supply the pharmaceutical benefits to ‘eligible persons’. An ‘eligible person’ is someone who is eligible for Medicare benefits under the Health Insurance Act 1973 and who has paraplegia or quadriplegia, and is a member of an authorised association. The authorised associations must comply with the updated listing details and ensure that the specified drug, APO-MACROGOL plus ELECTROLYTES, is available to eligible persons. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in recommending which drugs should be available as pharmaceutical benefits, ensuring that the decisions are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. The Act does not explicitly outline specific offences, penalties, or civil/criminal consequences for breach in this context. However, any failure by authorised associations to comply with the provisions of the Special Arrangement could potentially lead to administrative actions, including fines or other sanctions as stipulated under the broader legislative framework of the National Health Act 1953. Non-compliance with the PBS requirements or failure to supply the listed pharmaceutical benefits could also result in legal consequences, including civil actions for breach of contract or other remedies available under relevant legislation. The precise penalties would depend on the nature and severity of the breach, as well as the specific provisions of the overarching legislative instruments.

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