National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2021 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00916 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 2021 (No. 1)

PB 66 of 2021

 

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).

Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

 

Purpose

This is the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2021 (No. 1) (this Instrument). The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021 (PB 31 of 2021) (the Special Arrangement) to make changes to the Special Arrangement relating to the Paraplegic and Quadriplegic Program.

The Paraplegic and Quadriplegic Program Special Arrangement provides for ‘authorised associations’ to supply pharmaceutical benefits available under the Special Arrangement to ‘eligible persons’  requiring treatment with bowel management medicines.  A person is an ‘eligible person’ for the purposes of the Special Arrangement if they:

(a)     are an eligible person within the meaning of the Health Insurance Act 1973, and

(b)    have paraplegia or quadriplegia; and

(c)     are a member of an association.

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

The amendment made by this Instrument provides for the deletion of one brand of an existing pharmaceutical item listed in Schedule 1 of the Special Arrangement.

Consultation

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 Pharmaceutical Benefits Advisory Committee (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 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 are consulted throughout the process of changes to the listings on the PBS.  This includes consultation through the PBAC process.

Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.

Details of this Instrument are set out in the Attachment.

This Instrument commences on 1 July 2021.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.

ATTACHMENT

 

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (PARAPLEGIC AND QUADRIPLEGIC PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2021 (No. 1)

Section 1 Name of Instrument

This section provides the name of this instrument as the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2021 (No. 1) and may also be cited as PB 66 of 2021.

Section 2 Commencement

This section provides that this instrument commences on 1 July 2021.

Section 3 Amendment of National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021 (PB 31 of 2021)

This section provides that Schedule 1 amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021 (PB 31 of 2021).

Schedule Amendments

The amendment in Schedule 1 involves the deletion of a brand of a pharmaceutical benefit listed in Schedule 1 of the Special Arrangement.  This change is summarised below.

 

SUMMARY OF CHANGES TO THE PARAPLEGIC AND QUADRIPLEGIC PROGRAM MADE BY THIS INSTRUMENT

Brand Deleted

Listed Drug

Form

Macrogol 3350

Sachets containing powder for oral solution 13.125g with electrolytes, 30
(lax-sachets)


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 2021 (No. 1)

(PB 66 of 2021)

This Special Arrangement 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 Special Arrangement

The purpose of this legislative instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021 (PB 31 of 2021) (the Special Arrangement) to make changes to the Paraplegic and Quadriplegic Program.

The Paraplegic and Quadriplegic Program Special Arrangement provides for ‘authorised associations’ to supply pharmaceutical benefits available under the Special Arrangement to ‘eligible persons’  requiring treatment with bowel management medicines.  A person is an ‘eligible person’ for the purposes of the Special Arrangement if they:

(a)     are an eligible person within the meaning of the Health Insurance Act 1973, and

(b)    have paraplegia or quadriplegia; and

(c)     are a member of an association.

The amendment in Schedule 1 involves the deletion of a brand of a pharmaceutical benefit listed in Schedule 1 of the Special Arrangement.

Human rights implications

This Special Arrangement engages the right to equality and non-discrimination contained Article 2(2) of the International Covenant on Economic, Social and Cultural Rights and the right to health contained in Article 12 of that covenant, 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 Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with the 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 Special Arrangement is compatible with human rights because it promotes the protection of human rights.

 

 

Mariana Crank

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2021 (No. 1) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021 to modify the provision of pharmaceutical benefits for the Paraplegic and Quadriplegic Program. Enacted under subsection 100(2) of the National Health Act 1953, the primary objective of this Instrument is to update the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, effective from the same date. This amendment involves the removal of a specific brand of pharmaceutical product from the list of benefits provided under the Special Arrangement. The Special Arrangement itself enables authorised associations to supply pharmaceutical benefits, specifically bowel management medicines, to eligible persons who meet the criteria of being eligible under the Health Insurance Act 1973, having paraplegia or quadriplegia, and being members of an association. The amendment process involves extensive consultation, particularly through the Pharmaceutical Benefits Advisory Committee, ensuring that changes are evidence-based and take into account clinical effectiveness, safety, and cost-effectiveness. The National Health Act 1953, administered by the Australian Parliament, was enacted to establish a framework for health services and pharmaceutical benefits. This particular amendment addresses a specific gap in the provision of pharmaceutical benefits to persons with paraplegia or quadriplegia by adjusting the Special Arrangement to align with broader changes in the Pharmaceutical Benefits Schedule. The policy objective is to ensure that the provision of essential medicines under the Paraplegic and Quadriplegic Program remains current and effective, supporting the health needs of this vulnerable group. The amendment process ensures that the changes are compatible with human rights, particularly the right to equality and non-discrimination, and the right to health, by providing access to necessary medications in a manner that is evidence-based and cost-effective.

Scope and Application

The National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2021 (No. 1) amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021 to modify the Paraplegic and Quadriplegic Program. This Special Arrangement enables 'authorised associations' to provide pharmaceutical benefits to 'eligible persons' requiring treatment with bowel management medicines. An 'eligible person' under the Special Arrangement must meet the criteria of being an eligible person under the Health Insurance Act 1973, having paraplegia or quadriplegia, and being a member of an association. The amendment removes a brand of an existing pharmaceutical item listed in Schedule 1 of the Special Arrangement. This legislative instrument, governed by subsection 100(2) of the National Health Act 1953, is compatible with human rights, specifically engaging the right to equality and non-discrimination, and the right to health as outlined in the International Covenant on Economic, Social and Cultural Rights. The amendments align with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also underwent changes. Consultation processes involving the Pharmaceutical Benefits Advisory Committee (PBAC) and pharmaceutical companies were integral to the decision-making process. The Instrument commenced on 1 July 2021 and is a legislative instrument under the Legislation Act 2003.

Key Provisions

The main operative sections of the National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2021 (No. 1) (the Instrument) are contained within Section 3, which amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2021 (the Special Arrangement) (subsection 100(2) of the National Health Act 1953). Specifically, the Instrument involves the deletion of a brand of a pharmaceutical benefit listed in Schedule 1 of the Special Arrangement. This amendment is designed to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on 1 July 2021. The Instrument imposes obligations on authorised associations to supply pharmaceutical benefits available under the Special Arrangement to eligible persons requiring treatment with bowel management medicines. To be considered an eligible person, an individual must meet three criteria: they must be an eligible person within the meaning of the Health Insurance Act 1973, they must have paraplegia or quadriplegia, and they must be a member of an association. The Special Arrangement ensures that these individuals have access to the necessary medications to manage their conditions. The Instrument also contains provisions for potential breaches and the associated penalties. While the Instrument itself does not explicitly outline specific offences, penalties, or consequences for breach, it is subject to the broader regulatory framework of the National Health Act 1953. Under this Act, any breaches of the Special Arrangement or related provisions may result in civil or criminal penalties. For example, providing pharmaceutical benefits not authorised under the Special Arrangement could result in fines or other legal repercussions. The exact penalties would depend on the nature and severity of the breach, as governed by the overarching legislation. In summary, the Instrument amends the Special Arrangement to reflect changes in pharmaceutical listings, ensuring that eligible individuals with paraplegia or quadriplegia continue to receive necessary bowel management medications. Authorised associations are required to adhere to the terms of the Special Arrangement, and any breaches may lead to penalties under the National Health Act 1953.

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