National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No. 2) (PB 97 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01602 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.2)

PB 97 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 amends ‘the Responsible Person’ in the Special Arrangement for the listed drug Macrogol 3350 with the brand name LaxaCon.  Actavis Pty Ltd 17 003 854 626 (with the ‘Responsible Person Code’ of GN) has been replaced by Amneal Pharmaceuticals Pty Ltd 11 163 167 851 (with the ‘Responsible Person Code’ of EA) as the Responsible Person.  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 October 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 2)

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 amends ‘the Responsible Person’ in the Special Arrangement for the listed drug Macrogol 3350 with the brand name LaxaCon.  Actavis Pty Ltd 17 003 854 626 (with the ‘Responsible Person Code’ of GN) has been replaced by Amneal Pharmaceuticals Pty Ltd 11 163 167 851 (with the ‘Responsible Person Code’ of EA) as the Responsible Person.  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.

Steve Dunlop

Acting Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No.2) was enacted to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, providing a framework for the supply of pharmaceutical benefits for individuals with paraplegia or quadriplegia. This legislative instrument was introduced by the Australian Government to address the need for updated arrangements in response to changes in the pharmaceutical industry, particularly concerning the listing and supply of certain drugs. The changes are aimed at ensuring that eligible individuals continue to have access to necessary medications under the Paraplegic and Quadriplegic Program. The amendments were made under the authority of the National Health Act 1953, which empowers the Minister to establish and modify special arrangements for the supply of pharmaceutical benefits. The policy objective of this amendment is to ensure the continued provision of essential medications to individuals with paraplegia or quadriplegia, aligning with recommendations from the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No.2) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, implementing changes to the provision of pharmaceutical benefits under the Paraplegic and Quadriplegic Program. This legislative instrument applies to individuals who are eligible for Medicare benefits and who have paraplegia or quadriplegia, as well as to the authorised associations that supply pharmaceutical benefits under the Special Arrangement. The amendments were made to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, specifically regarding the substitution of the Responsible Person for the drug Macrogol 3350 (LaxaCon) from Actavis Pty Ltd to Amneal Pharmaceuticals Pty Ltd. The changes are effective from 1 October 2015 and are consistent with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent body, ensures that decisions about the inclusion of drugs on the Pharmaceutical Benefits Scheme (PBS) are evidence-based and take into account clinical effectiveness, safety, and cost-effectiveness. This legislative instrument aligns with human rights by supporting the progressive realisation of the right to the highest attainable standard of physical and mental health through the PBS.

Key Provisions

The main sections of the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No. 2) (the Instrument) amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (the Special Arrangement) (sections 1 and 2). Specifically, the Instrument changes the entity responsible for supplying the pharmaceutical benefit of the drug Macrogol 3350 (brand name LaxaCon) under the Special Arrangement from Actavis Pty Ltd to Amneal Pharmaceuticals Pty Ltd (sections 3 and 4). This change is reflected in the amendments to Schedule 1 (the list of eligible drugs) and Schedule 2 (the list of responsible persons) of the Special Arrangement (section 4). These amendments were made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and following consultation with relevant pharmaceutical companies (sections 10 and 11). The Instrument imposes obligations on the parties governed by it, primarily the requirement to adhere to the amended Special Arrangement as detailed in Schedules 1 and 2. ‘Authorised associations’ (as defined in the Special Arrangement) must supply pharmaceutical benefits to ‘eligible persons’ (as defined in the Special Arrangement) for the listed drug Macrogol 3350 (LaxaCon). The ‘Responsible Person’ for supplying this drug is now Amneal Pharmaceuticals Pty Ltd, as per the amended Schedule 2. The Instrument also requires compliance with the recommendations of the PBAC and adherence to the consultation processes involved in the amendment of the Special Arrangement. There are no specific offences, penalties, or civil/criminal consequences outlined for breach of the Instrument itself. However, the overarching National Health Act 1953, under which this Instrument is made, provides for various offences and penalties. For instance, providing a pharmaceutical benefit contrary to the provisions of the Act can result in fines, and serious or repeated offences may lead to imprisonment. Additionally, failure to comply with the requirements of the Special Arrangement could result in civil or administrative penalties as prescribed under the Act. The changes effected by the Instrument are aligned with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commenced on 1 October 2015. This ensures that the amendments are part of a cohesive update to the pharmaceutical benefits available under the Special Arrangement, reflecting the latest evidence-based recommendations and industry consultations.

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