National Health (IVF Program) Special Arrangement Amendment Instrument 2018 (No. 1) (PB 69 of 2018)

Administered by Department of Health, Disability and Ageing

Legislation au F2018L01080 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (IVF PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 1)

PB 69 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 (IVF Program) Special Arrangement Amendment Instrument 2018 (No. 1) (the Amendment Instrument).  The purpose of the Amendment Instrument is to amend the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015) (the Special Arrangement), to make changes relating to the IVF Program.

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

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 in PB 69 of 2018 include additions, deletions and changes to drugs, forms, brands and section 100 only statuses 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 the instrument are set out in the Attachment.

This Instrument commences on 1 August 2018.

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


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (IVF PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2018 (No. 1)

Section 1 Name of Instrument

This section provides the name of this instrument as the National Health (IVF Program) Special Arrangement Amendment Instrument 2018 (No. 1).  It can also be cited as PB 69 of 2018.

Section 2 Commencement

This section provides that this instrument commences on 1 August 2018.

Section 3 Amendment of National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015)

This section provides that Schedule 1 amends the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015).

Schedule Amendments

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

 

 

 

SUMMARY OF CHANGES

Listed Drugs Added

Follitropin delta

 


Statement of Compatibility with Human Rights

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

National Health (IVF Program) Special Arrangement Amendment Instrument 2018 (No. 1)

(PB 69 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 (IVF Program) Special Arrangement 2015 (PB 60 of 2015) (the Special Arrangement), to make changes to the Special Arrangement relating to the IVF Program.

The purpose of the Special Arrangement is to ensure that an adequate supply of pharmaceutical benefits is available for patients who require in vitro fertilisation treatment.  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.

 

 

 

Julianne Quaine

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (IVF Program) Special Arrangement Amendment Instrument 2018 (No. 1), also referred to as PB 69 of 2018, amends the National Health (IVF Program) Special Arrangement 2015 to update the IVF Program. Enacted under the authority of the National Health Act 1953, this amendment responds to the need for an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. The policy objective of this instrument is to align the IVF Program with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, ensuring efficient and convenient supply of necessary pharmaceuticals. The amendments reflect recommendations made by the Pharmaceutical Benefits Advisory Committee, ensuring that decisions about the listing of medicines on the Pharmaceutical Benefits Scheme are evidence-based and consider clinical effectiveness, safety, and cost-effectiveness. This legislative instrument is compatible with human rights, particularly engaging Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by advancing the right to the highest attainable standard of physical and mental health through the PBS.

Scope and Application

The National Health (IVF Program) Special Arrangement Amendment Instrument 2018 (No. 1) amends the National Health (IVF Program) Special Arrangement 2015, which is designed to ensure the availability of pharmaceutical benefits necessary for patients undergoing in vitro fertilisation treatment. This instrument applies to the Minister for Health, who is authorised under the National Health Act 1953 to make special arrangements for the supply of pharmaceutical benefits. The amendments introduced by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which pertain to the addition, deletion, and modification of drugs, forms, brands, and section 100 only statuses in Schedule 1 of the Special Arrangement. These changes are intended to keep the IVF Program aligned with updates to the Pharmaceutical Benefits Scheme. The amendments are made in consultation with the Pharmaceutical Benefits Advisory Committee, an independent expert body that recommends which drugs and medicinal preparations should be available as pharmaceutical benefits. This instrument, which commences on 1 August 2018, extends the application of the Act by modifying the Special Arrangement, thereby impacting the availability and scope of pharmaceutical benefits for IVF treatments.

Key Provisions

The National Health (IVF Program) Special Arrangement Amendment Instrument 2018 (No. 1) (referred to as the Amendment Instrument) amends the National Health (IVF Program) Special Arrangement 2015 (the Special Arrangement) to update the list of drugs, forms, brands and section 100 only statuses available under the IVF Program (sections 3 and Schedule). These changes align with the amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which also took effect on 1 August 2018. The purpose of these amendments is to ensure that there is an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment, facilitating their supply under the special arrangement. The Amendment Instrument imposes several obligations on the parties involved. The Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the National Health Act 1953, plays a crucial role in recommending which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC consists of members appointed following nomination by prescribed organisations and associations from various sectors, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists. The remaining members are persons with relevant qualifications and experience appointed by the Minister. The PBAC is tasked with considering the medical conditions for which the medicine has been approved, its clinical effectiveness, safety and cost-effectiveness compared with other treatments when recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS). Failure to comply with the provisions of the Amendment Instrument may result in various consequences. The National Health Act 1953 outlines potential offences and penalties for breaches of its provisions. However, the Amendment Instrument itself does not specify particular offences, penalties, or civil/criminal consequences for non-compliance. The penalties for breaches of the National Health Act 1953 generally depend on the nature and severity of the offence, and can include fines, imprisonment or both. It is important to note that any penalties for non-compliance would be determined in accordance with the broader provisions of the National Health Act 1953, rather than the Amendment Instrument itself.

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