National Health (IVF Program) Special Arrangement Amendment Instrument 2021 (No. 2)

Overview

The National Health (IVF Program) Special Arrangement Amendment Instrument 2021 (No. 2) (PB 123 of 2021) amends the National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015), which was introduced to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment. Enacted by the Australian Parliament under subsection 100(2) of the National Health Act 1953, the purpose of the Instrument is to make changes to the Special Arrangement concerning the IVF Program, specifically to align with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. These changes include the addition of brands to the listed drug follitropin alfa in Schedule 1 of the Special Arrangement, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee. The amendments are designed to maintain a consistent and efficient supply of necessary pharmaceutical benefits for IVF patients, aligning with the overarching policy objective of ensuring access to essential health care through the Pharmaceutical Benefits Scheme.

Scope and Application

The National Health (IVF Program) Special Arrangement Amendment Instrument 2021 (No. 2) amends the National Health (IVF Program) Special Arrangement 2015, made under the National Health Act 1953. This Act applies to the supply of pharmaceutical benefits and allows the Minister to make special arrangements for the same. The Amendment Instrument's purpose is to ensure an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment by amending the Special Arrangement. It reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, adding brands to the listed drug follitropin alfa in Schedule 1 of the Special Arrangement. This instrument commenced on 1 December 2021 and is a legislative instrument for the purposes of the Legislation Act 2003. The changes made by this Instrument are compatible with human rights, particularly the right to social security, as they facilitate access to essential health care through the Pharmaceutical Benefits Scheme. The National Health (IVF Program) Special Arrangement Amendment Instrument 2021 (No. 2) applies nationally, as it is a Commonwealth instrument under the National Health Act 1953. It applies to patients who require in vitro fertilisation treatment, pharmaceutical companies involved in the supply of the amended pharmaceutical benefits, and relevant stakeholders such as the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC, an independent expert body appointed under section 100A of the Act, recommends which drugs should be available as pharmaceutical benefits. This Amendment Instrument involves adding brands to the listed drug follitropin alfa in the Special Arrangement, ensuring continued access to essential medicines for IVF patients. No specific exclusions or thresholds are mentioned in the text, and the application of the Act extends through subordinate instruments such as the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

Key Provisions

The main operative sections of the National Health (IVF Program) Special Arrangement Amendment Instrument 2021 (No. 2) (the Amendment Instrument) pertain to the National Health (IVF Program) Special Arrangement 2015 (the Special Arrangement). Section 3 of the Instrument amends the Special Arrangement by adding brands to the listed drug follitropin alfa in Schedule 1 (subsection 3(1)). This Instrument commences on 1 December 2021 (subsection 2(1)). These amendments reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (subsection 100(3)). The purpose of the Instrument is to amend the Special Arrangement to make changes relating to the IVF Program, ensuring an adequate supply of pharmaceutical benefits for patients requiring in vitro fertilisation treatment (subsection 100(1)). The obligations and requirements imposed by the Act on parties or entities governed by it include ensuring the availability of pharmaceutical benefits for patients requiring IVF treatment, as well as adhering to the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The Pharmaceutical Benefits Advisory Committee, established under section 100A of the Act, makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and specialists. The Minister must consider 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 when recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS). Pharmaceutical companies must also be consulted throughout the process of changes to the listings on the PBS, which includes consultation through the PBAC process. The Act imposes offences, penalties, or civil/criminal consequences for breach, including maximum penalties where stated. Under section 100(2) of the Act, the Minister may vary or revoke a special arrangement made under section 100(1). Furthermore, under section 100(3) of the Act, Part VII of the Act and instruments made for the purposes of Part VII have effect subject to a special arrangement made under section 100(1). The consequences of breach may include revocation of a special arrangement or variation of its terms, which could result in a reduction or denial of pharmaceutical benefits to patients requiring IVF treatment. However, the specific penalties for breach are not outlined in the provided text. The 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. The right to social security is contained in Article 9 of the International Covenant on Economic Social and Cultural Rights (ICESCR). It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation. The 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. The pharmaceutical industry now has a nominee on the PBAC membership. Whether there is any detriment to patients by the deletion of these drugs, and if so, how this is compatible with the right to social security. The UN Committee on Economic Social and Cultural Rights reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society. The amendment in Schedule 1 involves the addition of a brand to the Special Arrangement and is therefore compatible with human rights as it advances the protection of human rights.