National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 3) (PB 86 of 2016)

Overview

The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 3) (F2016L01552) was enacted to amend the National Health (IVF Program) Special Arrangement 2015. This special arrangement was designed to ensure the availability of necessary pharmaceutical benefits for patients undergoing in vitro fertilisation (IVF) treatment, addressing the restriction on the provision of such treatments and the need for a more efficient supply of related pharmaceutical benefits. The instrument was enacted by the Minister for Health under the authority of the National Health Act 1953, reflecting the policy objective of maintaining an adequate supply of pharmaceutical benefits for IVF patients. This legislative instrument adds the pharmaceutical benefit of the listed drug 'Triptorelin', in a specified form, manner of administration, and brand, to the IVF program. The changes were made in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC) and pharmaceutical companies, ensuring that recommendations and final listing details were agreed upon through the relevant consultation processes.

Scope and Application

The National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 3) amends the National Health (IVF Program) Special Arrangement 2015, which was established under the National Health Act 1953 to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. The purpose of this legislative instrument is to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, particularly the addition of the pharmaceutical benefit for the drug 'Triptorelin', in the specified form, manner of administration, and brand. This amendment ensures that the IVF Program continues to meet the needs of patients by providing necessary pharmaceutical benefits under a special arrangement. The Act applies to entities and individuals involved in the supply of pharmaceutical benefits for in vitro fertilisation treatment in Australia, and the changes are applicable nationally. The amendment is subject to the conditions set out in the National Health Act 1953, and any further variations or revocations of the special arrangement would be made in accordance with the Act.

Key Provisions

The main operative sections of the National Health (IVF Program) Special Arrangement Amendment Instrument 2016 (No. 3) involve amendments to the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015) (Special Arrangement). Section 3 of the Instrument, through its Schedule 1, introduces a new pharmaceutical benefit for in vitro fertilisation (IVF) treatment. Specifically, Schedule 1, Item 1, adds the drug 'Triptorelin', in the form 'Injection 100 micrograms (as acetate) in 1 mL pre-filled syringe', with the manner of administration as 'Injection', the brand 'Decapeptyl', and a Section 100 only code of PB(100). This new benefit is designed to ensure an adequate supply of pharmaceutical benefits for patients requiring IVF treatment, thereby enhancing the efficiency and convenience of treatment provision. The Act imposes several obligations and requirements on the parties or entities it governs. Firstly, the Minister for Health is empowered under subsection 100(1) of the National Health Act 1953 to make special arrangements for the supply of pharmaceutical benefits. This includes the ability to vary or revoke such arrangements under subsection 100(2). Additionally, the Minister must consult with the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, when making recommendations on which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC is composed of members from various relevant fields, including consumers, health economists, and medical professionals, ensuring a broad range of perspectives in its recommendations. Furthermore, pharmaceutical companies must be consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS) and for this Special Arrangement, ensuring industry input in the final listing details. Any breach of the provisions within this Act could lead to various offences, penalties, or civil/criminal consequences. Under the National Health Act 1953, specific offences and penalties are not detailed in the Explanatory Statement. However, in general, breaches of the Act may result in civil penalties, which could include fines or other monetary penalties. There may also be criminal consequences, depending on the severity and nature of the breach. For instance, violations that involve fraudulent activities or significant harm to patients could lead to criminal charges, potentially resulting in imprisonment or substantial fines. The exact penalties would be determined based on the specific nature and circumstances of the breach, in accordance with the broader legislative framework of the National Health Act 1953.