National Health (Indigenous Chronic Disease - PBS Co-payment Measure) Special Arrangement Amendment Instrument 2012 (No. 2) (No. PB 89 of 2012)

Overview

The National Health (Indigenous Chronic Disease – PBS Co-Payment Measure) Special Arrangement Amendment Instrument 2012 (No.2) was enacted to amend the National Health (Indigenous Chronic Disease – PBS Co-Payment Measure) Special Arrangement 2012 in light of legislative changes introduced by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012. This amendment was necessitated by the introduction of provisions allowing for certain medicines to be included on the Pharmaceutical Benefits Scheme (PBS) solely for supply under the prescriber bag provisions of the National Health Act 1953. The instrument was made under the authority provided by subsections 100(1) and (2) of the Act, enabling the Minister to make special arrangements for the supply of pharmaceutical benefits and to vary or revoke such arrangements as necessary. The policy objective of this amendment is to ensure that the Special Arrangement remains consistent with the updated legislative framework concerning the PBS and the prescriber bag provisions, which affect how certain pharmaceutical benefits can be supplied under the Act. This legislative instrument commenced on 1 October 2012 and is subject to the Legislative Instruments Act 2003.

Scope and Application

The National Health (Indigenous Chronic Disease – PBS Co-Payment Measure) Special Arrangement Amendment Instrument 2012 (No. 2) applies to the National Health Act 1953 and specifically modifies the National Health (Indigenous Chronic Disease – PBS Co-Payment Measure) Special Arrangement 2012. This amendment was necessitated by changes introduced by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012, which took effect on 1 October 2012. The Act applies to individuals and entities involved in the supply of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS), particularly affecting medical practitioners, authorised midwives, and authorised nurse practitioners who supply certain medications directly to patients under the prescriber bag provisions. These provisions are detailed in sections 93, 93AA, and 93AB of the Act. The amendment excludes from the scope of the Special Arrangement those pharmaceutical benefits that may only be supplied under the prescriber bag provisions, thereby adjusting the application to align with the recent legislative changes. The instrument extends the jurisdictional reach across the Commonwealth of Australia, and while it does not involve public consultation, it is a legislative instrument governed by the Legislative Instruments Act 2003.

Key Provisions

The primary sections of the National Health (Indigenous Chronic Disease – PBS Co-Payment Measure) Special Arrangement Amendment Instrument 2012 (No.2) include the amendments to the existing special arrangement under the National Health Act 1953 (section 100). This instrument specifically modifies the National Health (Indigenous Chronic Disease – PBS Co-Payment Measure) Special Arrangement 2012 (PB 22 of 2012) to reflect changes in the Act brought about by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012. The key amendment is the exclusion of pharmaceutical benefits that may only be supplied under the prescriber bag provisions (sections 93, 93AA, and 93AB) from the scope of the Special Arrangement. These sections allow certain pharmaceutical benefits to be supplied directly by medical practitioners, authorised midwives, and authorised nurse practitioners to patients. This legislation imposes specific obligations on the parties governed by it. Most notably, it mandates that the Minister for Health may declare that certain drugs can only be supplied under the prescriber bag provisions. This declaration ensures that these drugs are supplied exclusively under the conditions specified by the Act. Similarly, if the Minister determines that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions, this must be adhered to under the Pharmaceutical Benefits Scheme (PBS). The exclusion of certain pharmaceutical benefits from the Special Arrangement aims to streamline the supply process of these specific drugs. Breaching the provisions of this Act could result in various consequences. While the explanatory statement does not detail specific offences or penalties, it is understood that non-compliance with the Act's requirements could lead to administrative or legal action. Typically, breaches of provisions under the National Health Act 1953 could result in penalties such as fines or other civil or criminal consequences, depending on the severity and nature of the breach. The maximum penalties for such breaches are not explicitly stated in this instrument but would be in line with the general provisions of the Act and related regulations.