National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 2) (PB 77 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01282 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (IVF PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 2)

 

PB 77 of 2017

 

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 2017 (No. 2) (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 Amendment Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

The amendments in PB 77 of 2017 include the deletion of a form of the drug Chorionic Gonadotrophin, and a change to the format of the table in Schedule 1 so that it is more consistent with the format of the table in Schedule 1 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

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. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), the 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 October 2017.

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


ATTACHMENT

Details of the National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 2)

PART 1 PRELIMINARY

Section 1 Name of Instrument

This section provides the name of this instrument as the National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 2). It can also be cited as PB 77 of 2017.

 

Section 2 Commencement

This section provides that this instrument commences on 1 October 2017.

 

Section 3 Amendment

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

 

Schedule - Amendments

Item 1 amends Schedule 1 of the Special Arrangement by deleting a form of the drug Chorionic Gonadotropin (Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL) and re-formatting the table to:

(a)          remove the ruled lines between each entry in the body of the table; and

(b)          have each individual drug name appear only once in the column headed ‘Listed Drug’, instead of beside each of the different forms.

Re-formatting the table in this way means it is more consistent with the equivalent table in Schedule 1 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

 


 

 

Overview

The National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 2) is an amendment to the National Health (IVF Program) Special Arrangement 2015, which was enacted to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. This amendment was introduced to align the IVF program with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument was enacted by the Minister for Health under the authority provided by the National Health Act 1953, specifically subsection 100(1), which empowers the Minister to make special arrangements for the supply of pharmaceutical benefits. The policy objective of this amendment is to maintain consistency in the scheduling of pharmaceutical benefits across different health programs, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee and ensuring efficient and convenient supply of necessary medications. This legislative instrument commenced on 1 October 2017 and is subject to the provisions of the Legislation Act 2003.

Scope and Application

The National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 2) amends the National Health (IVF Program) Special Arrangement 2015, made under section 100(1) of the National Health Act 1953, to ensure the availability of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. This legislation applies to the supply of pharmaceutical benefits under the special arrangement for IVF, directly affecting patients and pharmaceutical companies involved in the supply of these benefits. It operates at the Commonwealth level, as the National Health Act 1953 is a federal statute. The Amendment Instrument makes technical changes to the format of the table in Schedule 1, including the deletion of a specific form of the drug Chorionic Gonadotrophin and the re-formatting of the table to align with the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes reflect recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body involved in consulting with various stakeholders in the health sector. This instrument commenced on 1 October 2017 and is a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 2) amends the National Health (IVF Program) Special Arrangement 2015, as stated in section 3 of the instrument. This amendment, detailed in Schedule 1, involves the deletion of a specific form of the drug Chorionic Gonadotrophin (an Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL) and a reformatting of the table in Schedule 1 (items 1(a) and 1(b)). This change is intended to bring the IVF Program's schedule more in line with the format of the table in Schedule 1 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The obligations imposed by this Amendment Instrument primarily concern the entities involved in the provision of pharmaceutical benefits under the IVF Program. It requires the entities to adhere to the new schedule outlined in the amended Special Arrangement, ensuring that the deleted drug form is no longer supplied and that the new table format is used. This involves updating records, documentation, and possibly systems to reflect these changes. The entities must ensure that they are compliant with these new requirements, particularly in how they list and supply the drugs under the IVF Program. The Instrument does not explicitly state any specific offences, penalties, or civil/criminal consequences for breaches. However, any non-compliance with the amended Special Arrangement would be subject to the general enforcement mechanisms available under the National Health Act 1953. This could include actions taken by the Minister under section 100(2) of the Act to vary or revoke the special arrangement, which could indirectly result in penalties or other consequences for non-compliance. It is important for entities governed by the IVF Program to ensure adherence to the amended requirements to avoid potential enforcement actions.

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