National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2019 (No. 2) (PB 80 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01299 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2019 (No. 2)

PB 80 of 2019

 

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 2019 (No. 2) (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 October 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 2019 (No. 2)

Section 1 Name of Instrument

This section provides the name of this instrument as the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2019 (No. 2). It can also be cited as PB 80 of 2019.

Section 2 Commencement

This section provides that this instrument commences on 1 October 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 – Pharmaceutical benefits for the treatment of children

Somatropin

Injection 10 mg (30 i.u.) vial with diluent (with preservative)

 


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 2019 (No. 2)

(PB 80 of 2019)

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.

 

 

 

Ben Sladic

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

 

Overview

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2019 (No. 2) (PB 80 of 2019) amends the National Health (Growth Hormone Program) Special Arrangement 2015, made under the National Health Act 1953. Enacted by the Australian Parliament, this instrument aims to modify the special arrangements for the supply of pharmaceutical benefits related to growth hormone treatments, ensuring an adequate supply for patients who require such treatment. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, aligning with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). This ongoing consultation process includes stakeholders from various health sectors, ensuring that decisions about the listing of medicines on the Pharmaceutical Benefits Scheme are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. The Instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health through the provision of subsidised access to medicines.

Scope and Application

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2019 (No. 2) amends the National Health (Growth Hormone Program) Special Arrangement 2015, which was established under subsection 100(1) of the National Health Act 1953 to ensure an adequate supply of pharmaceutical benefits for patients requiring growth hormone treatment. This special arrangement aims to provide these benefits more efficiently and conveniently due to restrictions on their provision. The amendments made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and they 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. This amendment instrument applies nationally across Australia and is effective from 1 October 2019. The changes were recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under the Act to advise the Minister on the listing of drugs and medicinal preparations as pharmaceutical benefits. The amendments have been made in consultation with relevant stakeholders, including pharmaceutical companies, and no further consultation was deemed necessary due to the comprehensive nature of prior consultations. This legislative instrument is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The main operative sections of the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2019 (No. 2) (referred to as the "Instrument") are outlined in Section 3, which details the amendments made to the National Health (Growth Hormone Program) Special Arrangement 2015 (referred to as the "Special Arrangement"). The Instrument amends the Special Arrangement to adjust the list of pharmaceutical benefits for growth hormone treatments, including the addition, deletion, and modification of drugs, forms, manners of administration, brands, and section 100 only statuses (Section 3). These amendments reflect the changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring that the Special Arrangement aligns with the latest updates in pharmaceutical benefits listings. The obligations and requirements imposed by the Act on the parties or entities it governs include the involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) in the decision-making process for listing drugs on the Pharmaceutical Benefits Scheme (PBS). As an independent expert body established under the Act, PBAC's recommendations are integral to determining which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC comprises members from various relevant fields, including consumers, health economists, pharmacists, general practitioners, and specialists, ensuring a comprehensive and evidence-based approach to decision-making. The Instrument also requires consultation with pharmaceutical companies and adherence to the recommendations made by PBAC. The Instrument includes provisions for potential offences, penalties, or civil and criminal consequences for breaches. However, the text does not explicitly state the specific penalties or consequences for non-compliance with the amended Special Arrangement. Under the National Health Act 1953, breaches of the Act or its instruments may result in various penalties, including fines and imprisonment, depending on the severity of the breach. The maximum penalties would be determined according to the specific provisions of the Act that are contravened. In summary, the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2019 (No. 2) amends the Special Arrangement to update the pharmaceutical benefits for growth hormone treatments. The Instrument mandates the involvement of PBAC in the decision-making process and requires consultation with pharmaceutical companies. While the specific penalties for non-compliance are not detailed in the text, the Act provides for fines and imprisonment for breaches of its provisions.

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