National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No. 3) (PB 116 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01893 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.3)

PB 116 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 deletes the listed brand Bisalax, and the ‘Responsible Person Code’ of AS.  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 December 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 3)

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 Bisalax, and the ‘Responsible Person Code’ of AS.  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 2015 (No. 3) was enacted to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, addressing the need to update pharmaceutical benefits available to individuals with paraplegia or quadriplegia. This amendment was made under the authority of subsections 100(1) and (2) of the National Health Act 1953, empowering the Minister to establish special arrangements for the supply of pharmaceutical benefits. The policy objective of this legislative instrument aligns with ensuring that the Paraplegic and Quadriplegic Program effectively meets the health needs of eligible individuals by updating the pharmaceutical benefits provided through this special arrangement. These changes reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises on which drugs should be listed on the Pharmaceutical Benefits Scheme (PBS), thereby ensuring that decisions are evidence-based and consider factors such as clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No. 3) is a legislative instrument designed to modify the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010, which itself is an arrangement made under the National Health Act 1953. This Act allows the Minister for Health to establish special arrangements for the supply of pharmaceutical benefits, enabling authorised associations to provide certain medications to eligible persons, specifically those with paraplegia or quadriplegia who are members of authorised associations and eligible for Medicare benefits. This amendment removes the brand Bisalax and the corresponding Responsible Person Code from the Special Arrangement, necessitating adjustments to Schedule 1 of the Special Arrangement. These changes align with modifications made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The legislative instrument is grounded in recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body tasked with advising on which drugs should be included in the Pharmaceutical Benefits Scheme, ensuring that decisions are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. This amendment is compatible with human rights as it aids in the progressive realisation of the right to the highest attainable standard of physical and mental health, by facilitating access to necessary medications through the PBS.

Key Provisions

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2015 (No. 3) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010. Specifically, this instrument removes the brand Bisalax from the list of pharmaceutical benefits and updates the 'Responsible Person Code', which necessitated changes to Schedule 1 of the Special Arrangement (sections 1-2). This amendment reflects updates made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commenced on 1 December 2015. Under this amendment, 'authorised associations' can supply pharmaceutical benefits to 'eligible persons' as defined in the Health Insurance Act 1973. An 'eligible person' is someone who is eligible for Medicare benefits, has paraplegia or quadriplegia, and is a member of an 'authorised association'. The changes align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that advises on which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC comprises experts from various health-related fields, including consumers, health economists, and medical practitioners, ensuring a comprehensive evaluation of the drugs listed on the Pharmaceutical Benefits Scheme (PBS). This legislative instrument imposes obligations on authorised associations to supply the specified pharmaceutical benefits to eligible persons. It also mandates that these associations comply with the updated provisions outlined in Schedule 1 of the Special Arrangement. The amendments require authorised associations to ensure that they adhere to the new listing details and that they are aware of the changes made to the brand Bisalax and the 'Responsible Person Code'. Failure to comply with the provisions of this instrument may result in legal consequences. Although the specific offences, penalties, or consequences for breach are not detailed in the explanatory statement, the general legal framework under the National Health Act 1953 includes provisions for penalties and enforcement actions. Typically, breaches of the Act can lead to fines, legal actions, and other regulatory measures to ensure compliance with the stipulated requirements. The exact penalties would depend on the nature and severity of the breach, as outlined in the relevant sections of the National Health Act 1953.

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