National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 1) (PB 59 of 2017)

Overview

The National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 1), also known as PB 59 of 2017, was introduced to address the specific pharmaceutical needs of patients requiring in vitro fertilisation (IVF) treatment. Enacted by the Australian Government, this amendment to the National Health Act 1953 is designed to ensure an adequate supply of pharmaceutical benefits for IVF patients by making special arrangements for the supply of these benefits. This legislative instrument was made under the authority of subsection 100(2) of the National Health Act 1953, which empowers the Minister to vary or revoke special arrangements. The overarching policy objective is to facilitate the efficient and convenient supply of pharmaceutical benefits for IVF treatments, thereby ensuring patient access to necessary medications. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, adding the drug ‘Chorionic Gonadotrophin’ in a specified form and brand to the list of pharmaceutical benefits available under the IVF program.

Scope and Application

The National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 1) amends 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 amendment specifically addresses the availability of pharmaceutical benefits under the scheme by adding a new benefit, the drug 'Chorionic Gonadotrophin' in a specified form, with a specified manner of administration and brand, effective from 1 August 2017. This legislative instrument applies to pharmaceutical benefits supplied under the National Health Act 1953, particularly within the context of the IVF Program. The amendment is targeted at ensuring that patients have access to necessary medications for IVF treatment, facilitating their supply under special arrangements to circumvent the restrictions on the provision of such treatment. This instrument operates under the Commonwealth jurisdiction, with the changes reflecting modifications to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendment was made in consultation with the Pharmaceutical Benefits Advisory Committee, ensuring recommendations were based on clinical effectiveness, safety, and cost-effectiveness considerations.

Key Provisions

The National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 1) (section 1) amends the National Health (IVF Program) Special Arrangement 2015 (section 3), effective from 1 August 2017 (section 2). The main operative sections of this legislative instrument are found in Schedule 1, which introduces a new pharmaceutical benefit under the IVF Program (item 1). Specifically, the amendment adds a new listed drug, Chorionic Gonadotrophin, in the form of an Injection set containing powder for injection (1,500 units, 3) and solvent (1 mL, 3), administered via injection, and marketed under the brand name 'Pregnyl'. This addition is designed to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. The obligations imposed by this Act on the parties it governs primarily concern the administration and supply of pharmaceutical benefits under the IVF Program. The Minister for Health, under section 100(1) of the National Health Act 1953, has the authority to make special arrangements for the supply of pharmaceutical benefits, with section 100(2) allowing for variations or revocations of these arrangements. The Act ensures that any special arrangement is subject to the overarching provisions of Part VII (section 100(3)). The Pharmaceutical Benefits Advisory Committee (PBAC), established under section 100A of the Act, plays a critical role by recommending drugs and medicinal preparations for inclusion as pharmaceutical benefits, taking into account their clinical effectiveness, safety, and cost-effectiveness. The Act also outlines specific consequences for non-compliance. While the Explanatory Statement does not explicitly detail criminal or civil penalties for breaches, it is reasonable to infer that any failure to comply with the provisions of the Act or the special arrangements could lead to legal repercussions. The Pharmaceutical Benefits Scheme (PBS) is governed by a robust framework that includes various enforcement mechanisms, typically involving penalties for non-compliance with the Act or any special arrangements made under it. The exact nature and severity of these penalties would be determined in the context of the specific breach and applicable legislative provisions. Given the amendments introduced by the National Health (IVF Program) Special Arrangement Amendment Instrument 2017 (No. 1), any entity involved in the supply of pharmaceutical benefits under the IVF Program must ensure compliance with the new listing of Chorionic Gonadotrophin. This includes proper administration, branding, and adherence to the specified form and manner of administration. Non-compliance could potentially lead to revocation of the special arrangement or other legal actions as stipulated under the National Health Act 1953.