National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2018 (No. 3) (PB 113 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01815 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 3)

PB 113 of 2018

 

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 (Growth Hormone Program) Special Arrangement Amendment Instrument 2018 (No. 3) (this Instrument).  The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015) (the Special Arrangement), to make changes to the Special Arrangement relating to the Growth Hormone Program.

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 amendments made by this Instrument include additions, deletions and changes to drugs, forms, manners of administration, brands and section 100 only statuses for pharmaceutical benefits listed in Schedule 1 of the Special Arrangement.

A provision by provision description of this Instrument is contained in the Attachment.

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.  In addition, an industry nominee has been appointed to the PBAC membership.  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.  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 January 2019.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 3)

Section 1 Name of Instrument

This section provides the name of this instrument as the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2018 (No. 3). It can also be cited as PB 113 of 2018.

Section 2 Commencement

This section provides that this instrument commences on 1 January 2019.

Section 3 Amendment of National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015)

This section provides that Schedule 1 amends the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015).

Schedule Amendments

The amendments in Schedule 1 provide for additions, deletions and changes to drugs, forms, manners of administration, brands and section 100 only statuses for pharmaceutical benefits listed in Schedule 1 of the Special Arrangement.  These changes are summarised below.

 

SUMMARY OF CHANGES

Forms deleted

Somatropin

Injection 12 mg (36 i.u.) in 1 mL cartridge (with preservative)

Brands added

Somatropin

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) (Scitropin A)

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2018 (No. 3)

(PB 113 of 2018)

This 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 Instrument

The purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015) (the Special Arrangement), to make changes to the Special Arrangement relating to the Growth Hormone Program.

The purpose of the Special Arrangement is to ensure that an adequate supply of pharmaceutical benefits is available for patients who require treatment with growth hormone.  Restrictions on the provision of this treatment mean that these pharmaceutical benefits can more conveniently or efficiently be supplied under a special arrangement.

Human rights implications

This 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 Pharmaceutical Benefits Scheme (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 Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Natasha Ploenges

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

 

Overview

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2018 (No. 3) was enacted to amend the National Health (Growth Hormone Program) Special Arrangement 2015, which governs the supply of pharmaceutical benefits related to growth hormone treatments. This legislative instrument was introduced to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the Special Arrangement remains current with amendments to the Pharmaceutical Benefits Scheme (PBS). The purpose of this amendment is to maintain an adequate supply of necessary pharmaceutical benefits for patients requiring growth hormone treatments, ensuring that these treatments are provided in a convenient and efficient manner. This Instrument was made under the authority of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits. The policy objective behind this amendment is to ensure that the Special Arrangement continues to support the provision of growth hormone treatments effectively, in line with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The amendments include changes to drugs, forms, manners of administration, brands, and section 100 only statuses for pharmaceutical benefits listed in the Special Arrangement, ensuring that the scheme remains relevant and effective in meeting patient needs.

Scope and Application

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2018 (No. 3) amends the National Health (Growth Hormone Program) Special Arrangement 2015, which pertains to the provision of pharmaceutical benefits for patients requiring growth hormone treatment. This legislative instrument, made under subsection 100(2) of the National Health Act 1953, is designed to ensure that an adequate supply of pharmaceutical benefits is available for patients in need of this treatment. The changes made by the Instrument include adjustments to drugs, forms, manners of administration, brands, and section 100 only statuses for pharmaceutical benefits listed in Schedule 1 of the Special Arrangement, reflecting modifications to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These amendments align with recommendations from the Pharmaceutical Benefits Advisory Committee, an independent expert body established under the Act, which advises the Minister on the listing of drugs and medicinal preparations on the Pharmaceutical Benefits Scheme. The Instrument is applicable to the Commonwealth of Australia, and it commenced on 1 January 2019. There are no stated exclusions or exemptions in this Instrument, but it does highlight the compatibility with the human rights and freedoms recognised or declared in the international instruments listed in the Human Rights (Parliamentary Scrutiny) Act 2011, specifically noting its engagement with the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2018 (No. 3) (sections 1-3) amends the National Health (Growth Hormone Program) Special Arrangement 2015 (sections 1-3) by updating the list of pharmaceutical benefits available under the Growth Hormone Program. Specifically, it makes changes to drugs, forms, manners of administration, brands and section 100 only statuses for pharmaceutical benefits listed in Schedule 1 of the Special Arrangement (Schedule). These amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 that come into effect on the same day. The amendments to the Special Arrangement include the deletion of some forms of somatropin injection, the addition of new brands of somatropin solution for injection, and other modifications to drugs, forms, manners of administration, brands and section 100 only statuses (Schedule). These changes aim to ensure that an adequate supply of pharmaceutical benefits is available for patients who require treatment with growth hormone, under restrictions that make a special arrangement necessary. The Act imposes obligations on the Minister to make special arrangements for the supply of pharmaceutical benefits under subsection 100(1) and to consult with the Pharmaceutical Benefits Advisory Committee (PBAC) in making such arrangements (subsections 100(1) and 100A). The Act also provides that the Minister may vary or revoke a special arrangement under subsection 100(2) and that Part VII of the Act, and instruments made for the purposes of Part VII, have effect subject to a special arrangement under subsection 100(3). Breaches of the provisions of the Act or the Special Arrangement may result in civil or criminal consequences, including fines and imprisonment. The maximum penalties for offences under the Act are set out in section 22 of the National Health Act 1953. The Act also provides for the imposition of pecuniary penalties for breaches of the Special Arrangement (subsection 100(4)). However, the specific penalties for breach of the Special Arrangement are not stated in the text.

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