National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 4) (PB 94 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01661 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 4)

PB 94 of 2016

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

The purpose of this Legislative Instrument, made under subsection 100(2) of the Act, 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.

This Instrument reflects changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.

This Instrument adds a new form of the listed drug ‘Progesterone’ in a specified manner of administration and brand.

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

 

Consultation

The Special Arrangement was made having regard to advice provided by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established by section 100A of the Act, which makes recommendations to the Minister for Health about which drugs and medicinal preparations should be available as pharmaceutical benefits.  Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC.  When making recommendations, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of these interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.

Pharmaceutical companies are consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process and agreement to final listing details.

This Instrument commences on 1 November 2016.

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


ATTACHMENT

 

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (IVF PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 4)

Section 1  Name of Instrument

This section provides that this Instrument is the National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 4), and that it may also be cited as PB 94 of 2016.

Section 2  Commencement

This section provides that this Instrument commences on 1 November 2016.

Section 3   Amendment of PB 60 of 2015

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

Schedule 1 Amendments

Item 1 amends Schedule 1 of the Special Arrangement by adding a new form of the listed drug ‘Progesterone’, being the form ‘Capsule 200 mg’, with the manner of administration of ‘Vaginal’, brand of ‘Utrogestan’ and Section 100 only code of ‘D(100)’.

A Section 100 only code of D(100) provides that the listed drug may only be supplied in accordance with the Special Arrangement and with any other Special Arrangement relating to the listed drug and is not available for general supply on the Pharmaceutical Benefits Scheme.


 

 

 

 

 

Overview

The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 4), or PB 94 of 2016, was enacted to amend the National Health (IVF Program) Special Arrangement 2015, which was established to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. This legislative instrument was introduced to address the limitations in the provision of this treatment, allowing for a more convenient and efficient supply of necessary pharmaceutical benefits. The instrument was enacted by the Minister for Health under the authority granted by the National Health Act 1953. The policy objective underpinning this legislation is to maintain and improve access to essential pharmaceutical benefits for IVF patients, ensuring they receive the necessary treatments recommended by the Pharmaceutical Benefits Advisory Committee, which considers clinical effectiveness, safety, and cost-effectiveness in its recommendations.

Scope and Application

The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 4) amends the National Health (IVF Program) Special Arrangement 2015 to adjust the supply of pharmaceutical benefits for patients requiring in vitro fertilisation (IVF) treatment. The Act applies to entities involved in the supply of pharmaceutical benefits and specifically targets the IVF Program, ensuring an adequate supply of necessary drugs. The amendment extends nationally, as the National Health Act 1953 operates under the Commonwealth jurisdiction. This instrument introduces a new form of the drug Progesterone, specifically a 200 mg vaginal capsule branded as Utrogestan, to the IVF Program. The changes are effective from 1 November 2016 and are made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee, which considers clinical effectiveness, safety, and cost-effectiveness. The Act enables the Minister to make and vary special arrangements, subject to Part VII of the Act, ensuring that the Pharmaceutical Benefits Scheme operates efficiently for the benefit of patients needing IVF treatment.

Key Provisions

The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 4) amends the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015). The key provision of this amendment (section 3) is the addition of a new form of the drug ‘Progesterone’ to the list of pharmaceutical benefits available for patients requiring in vitro fertilisation treatment. This new form is a 'Capsule 200 mg' administered vaginally, under the brand name 'Utrogestan', and it is coded as D(100) under Section 100, indicating it can only be supplied under the special arrangement and not generally through the Pharmaceutical Benefits Scheme (PBS) (section 3, Schedule 1, Item 1). The obligations imposed by this Act on the parties involved are primarily centred around ensuring the availability and supply of specified pharmaceutical benefits for IVF treatment. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drugs and medicinal preparations for inclusion in the PBS, taking into account their clinical effectiveness, safety, and cost-effectiveness (Explanatory Statement). Pharmaceutical companies are also consulted during the process to agree on final listing details, ensuring that the drugs listed are those that meet the required standards and criteria for inclusion in the PBS. Failure to comply with the provisions of the National Health Act 1953, including those related to special arrangements for pharmaceutical benefits, may lead to various legal consequences. While the specific penalties for breach are not detailed in the explanatory statement, the Act generally provides for both civil and criminal penalties for non-compliance with its provisions. The Minister for Health has the authority to vary or revoke special arrangements under subsection 100(2) of the Act, which can be a significant deterrent for non-compliance (subsection 100(2)). The precise nature and severity of penalties would depend on the specific breach and the discretion of the relevant authorities in enforcing the Act.

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