National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2020 (No. 1) (PB 6 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00071 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 1)

PB 6 of 2020

 

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 2020 (No. 1) (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 February 2020.

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 2020 (No. 1)

Section 1 Name of Instrument

This section provides the name of this instrument as the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2020 (No. 1). It can also be cited as PB 6 of 2020

Section 2 Commencement

This section provides that this instrument commences on 1 February 2020.

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 added – Pharmaceutical benefits for treatment of adults

Listed Drug

Form

Somatropin

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre‑filled pen

 


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 2020 (No. 1)

(PB 6 of 2020)

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 2020 (No. 1) amends the National Health (Growth Hormone Program) Special Arrangement 2015, which was established under the National Health Act 1953 to ensure an adequate supply of pharmaceutical benefits for patients requiring growth hormone treatment. This amendment responds to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, reflecting modifications to drugs, forms, manners of administration, brands, and section 100 only statuses for pharmaceutical benefits listed in Schedule 1 of the Special Arrangement. The amendments were made following recommendations by the Pharmaceutical Benefits Advisory Committee (PBAC) and consultation with pharmaceutical companies. The Instrument commenced on 1 February 2020 and aligns with the human rights principles outlined in the International Covenant on Economic, Social and Cultural Rights, particularly in advancing the right to the highest attainable standard of physical and mental health through the provision of subsidised access to medicines via the Pharmaceutical Benefits Scheme (PBS). The enactment of this amendment by the Minister under subsection 100(2) of the National Health Act 1953 aims to update the Special Arrangement to reflect current clinical and regulatory standards, ensuring that patients have access to necessary growth hormone treatments. This legislative action underscores the commitment to providing evidence-based, accessible healthcare solutions and is compatible with human rights as it supports the progressive realisation of health rights through the PBS.

Scope and Application

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2020 (No. 1) amends the National Health (Growth Hormone Program) Special Arrangement 2015 under subsection 100(2) of the National Health Act 1953. The purpose of this amendment is to update the Special Arrangement relating to the Growth Hormone Program, ensuring an adequate supply of pharmaceutical benefits for patients requiring growth hormone treatment. This special arrangement is necessary due to restrictions on the provision of such treatments, which can be more efficiently managed under a dedicated arrangement. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, involving additions, deletions, and modifications to drugs, forms, manners of administration, brands, and section 100 only statuses for pharmaceutical benefits listed in Schedule 1 of the Special Arrangement. These amendments were recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises on which drugs should be available as pharmaceutical benefits, considering clinical effectiveness, safety, and cost-effectiveness. This Instrument applies to pharmaceutical benefits provided under the Growth Hormone Program, affecting entities involved in the supply and administration of these benefits, including pharmaceutical companies, healthcare providers, and patients. The amendments have a national reach, as they relate to the National Health Act, which operates throughout Australia. There are no specific exclusions or thresholds stated in the text, but the application of the amendments is contingent on the provisions outlined in the National Health Act and the Special Arrangement. The Instrument is compatible with human rights, particularly advancing the right to the highest attainable standard of physical and mental health, as outlined in the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2020 (No. 1) (the Instrument) amends the National Health (Growth Hormone Program) Special Arrangement 2015 (the Special Arrangement) (sections 1, 2 and 3). This Instrument aims to update the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Listing Instrument). The amendments in the 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 (section 3). The Instrument came into effect on 1 February 2020 (section 2). The amendments made by the Instrument align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and follow a formal process of consultation involving stakeholders, including the PBAC. The Instrument imposes obligations on the parties governed by it, primarily ensuring that the Special Arrangement accurately reflects the changes made to the Listing Instrument. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in this process, as it is responsible for making recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC's involvement ensures that decisions about the listing of medicines on the Pharmaceutical Benefits Scheme (PBS) are based on evidence, taking 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. Additionally, pharmaceutical companies are consulted throughout the process of changes to the listings on the PBS, including through the PBAC process. There are no specific offences, penalties, or consequences outlined in the Instrument itself. However, any breaches of the requirements under the National Health Act 1953 (the Act) or the Special Arrangement may result in civil or criminal consequences, depending on the nature of the breach. The Act provides for a range of penalties, including fines and imprisonment, for offences related to the supply of pharmaceutical benefits. The Pharmaceutical Society of Australia Act 2009 and the Crimes Act 1900 may also apply in certain circumstances, resulting in fines or imprisonment. The maximum penalties for offences under these Acts depend on the specific offence and jurisdiction.

Legal classification tags

Area of Law
Health Law
Instrument
Statutory Instrument
Concepts
Reporting & Disclosure Obligations
Licensing & Registration
Consultation Requirements
Catchwords
Pharmaceutical Benefits

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