National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2016 (No 2) (PB 35 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L00622 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 2016 (No.2)

PB 35 of 2016

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 deletes the listed brand Glycerol, (with the ‘Responsible Person Code’ of PP).  This necessitated amendments 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 May 2016.

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 2016 (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 deletes the listed brand Glycerol, (with the ‘Responsible Person Code’ of PP).  This necessitated amendments 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.

Julianne Quaine

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2016 (No. 2) was enacted to address specific changes to the provision of pharmaceutical benefits for individuals with paraplegia or quadriplegia under the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010. This legislative instrument was introduced by the Minister for Health under the authority of the National Health Act 1953, aiming to align the Special Arrangement with updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The primary policy objective is to ensure that the Special Arrangement reflects current recommendations and standards, particularly in relation to the availability and accessibility of pharmaceutical benefits for eligible persons, thereby advancing their right to the highest attainable standard of physical and mental health. The amendments made through this instrument were developed in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC) and reflect evidence-based recommendations regarding the cost-effectiveness and clinical appropriateness of the listed pharmaceutical benefits.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2016 (No.2) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 under the authority of the National Health Act 1953. The Act enables the Minister for Health to make special arrangements for the supply of pharmaceutical benefits, particularly to persons with paraplegia or quadriplegia who are eligible to receive Medicare benefits. The amended Instrument removes Glycerol, a previously listed pharmaceutical brand, from the Special Arrangement, reflecting changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendment ensures that the Special Arrangement aligns with the current listings on the Pharmaceutical Benefits Scheme (PBS). The Instrument applies nationally across Australia, overseen by the Pharmaceutical Benefits Advisory Committee (PBAC), which ensures that decisions about the PBS are evidence-based and take into account clinical effectiveness, safety, and cost-effectiveness. This legislative instrument is compatible with human rights, specifically engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by enhancing access to affordable and effective pharmaceutical benefits for eligible persons.

Key Provisions

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2016 (No. 2) (F2016L00622) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010) to update the list of pharmaceutical benefits available under the Paraplegic and Quadriplegic Program. Specifically, it removes the brand Glycerol, identified by the 'Responsible Person Code' of PP, from the schedule of listed brands, necessitating adjustments to Schedule 1 of the Special Arrangement (subsection 100(1) and (2)). This change is in line with modifications to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also took effect on 1 May 2016. The Act mandates that authorised associations provide pharmaceutical benefits to eligible persons, who must be Medicare-eligible, have paraplegia or quadriplegia, and be members of an authorised association (subsection 100(1)). The amendment process involved consultation with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that recommends drugs for inclusion on the Pharmaceutical Benefits Scheme (PBS). The PBAC comprises members nominated by relevant organisations and associations, ensuring a broad representation of interests such as consumers, health economists, pharmacists, and medical practitioners. Pharmaceutical companies were also consulted throughout the process. Entities governed by this Act, such as authorised associations, must ensure that they comply with the updated Special Arrangement by removing Glycerol from their list of supplied pharmaceutical benefits. They must also ensure that their membership and service provisions align with the eligibility criteria set forth in the Act. Failure to comply with these requirements can result in legal repercussions, although specific civil or criminal penalties are not outlined in the text provided. In terms of breaches and penalties, the Act does not explicitly state the penalties for non-compliance with the special arrangement. However, given the authority under subsection 100(2) to vary or revoke special arrangements, it can be inferred that non-compliance might lead to administrative or legal actions, including the potential revocation of the authorisation to supply pharmaceutical benefits. The precise consequences would depend on the severity of the breach and the discretion of the Minister.

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